As filed with the Securities and Exchange Commission on September 12, 2023

No. 333-273101

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

––––––––––––––––––––––––––––––––––––––

to

FORM S-4
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933

––––––––––––––––––––––––––––––––––––––

 i COHBAR, INC.
(Exact name of registrant as specified in its charter)

––––––––––––––––––––––––––––––––––––––

1455 Adams Drive, Suite 1308
Menlo Park, CA 94025
(650) 446-7888
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

––––––––––––––––––––––––––––––––––––––

Jeffrey F. Biunno
Chief Financial Officer
CohBar, Inc.
1455 Adams Drive, Suite 1308
Menlo Park, CA 94025
(650) 446-7888
(Name, address, including zip code, and telephone number, including area code, of agent for service)

––––––––––––––––––––––––––––––––––––––

Copies of all communications, including communications sent to agent for service, should be sent to:

––––––––––––––––––––––––––––––––––––––

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after the effective date of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer) ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) ☐

The information in this proxy statement/prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus is not an offer to sell and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED SEPTEMBER 12, 2023

PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT

––––––––––––––––––––––––––––––––––––––

To the Stockholders of CohBar, Inc. and Morphogenesis, Inc.,

CohBar, Inc., a Delaware corporation (“CohBar”), and Morphogenesis, Inc., a Delaware corporation (“Morphogenesis”), entered into an Agreement and Plan of Merger, as amended from time to time (the “Merger Agreement”) on May 22, 2023, pursuant to which, among other matters, Chimera MergeCo, Inc., a Delaware corporation and wholly owned subsidiary of CohBar, will merge with and into Morphogenesis, with Morphogenesis surviving as a wholly owned subsidiary of CohBar and CohBar being the surviving corporation of the Merger (the “Merger”). The surviving corporation following the Merger is referred to herein as the “combined company.”

Subject to the terms and conditions of the Merger Agreement, at the closing of the Merger, (a) each then-outstanding share of common stock, par value $0.001 per share, of Morphogenesis (the “Morphogenesis Common Stock”) (other than shares held in treasury and Dissenting Shares (as defined in the Merger Agreement)) will be converted into and become exchangeable for a number of shares of common stock, par value $0.001 per share, of CohBar (the “CohBar Common Stock”) calculated in accordance with the Merger Agreement (the “Exchange Ratio”), (b) each then-outstanding option to purchase Morphogenesis Common Stock will be assumed and converted by CohBar into an option to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement, and (c) each then-outstanding warrant to purchase shares of Morphogenesis Common Stock will be converted into and exchangeable for a warrant of like tenor entitling the holder to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement.

The Exchange Ratio will be equal to the quotient obtained by dividing (a) the Company Merger Shares by (b) the Company Outstanding Shares, as those terms are defined and further described in the Merger Agreement, which has the effect and purpose of determining the number of shares to be issued to pre-Merger Morphogenesis stockholders (or issuable to pre-Merger Morphogenesis option and warrant holders in respect of such options and warrants) based on the relative valuations and fully-diluted shares of each of CohBar and Morphogenesis as of immediately prior to the closing of the Merger. For purposes of calculating the Exchange Ratio, (i) shares of CohBar Common Stock underlying CohBar stock options and warrants outstanding as of immediately prior to the closing of the Merger with an exercise price per share of less than $2.00 (subject to adjustment pursuant to the Merger Agreement) will be deemed to be outstanding and (ii) all shares of Morphogenesis Common Stock underlying outstanding Morphogenesis preferred stock, stock options, and warrants will be deemed to be outstanding.

Concurrently with the execution and delivery of the Merger Agreement, CohBar entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with K & V Investment Two, LLC, a Florida limited liability company (the “Investor”). Pursuant to the Stock Purchase Agreement, CohBar will issue, subject to adjustments contained in the Stock Purchase Agreement, 7,500,000 shares of CohBar Common Stock for an aggregate purchase price of $15 million (the “Initial Financing”) immediately prior to the effective time of the Merger (the “Initial Closing”). The consummation of the Initial Financing is conditioned on the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement. In addition, pursuant to the Stock Purchase Agreement, CohBar has agreed to sell, at the election of the Investor within six months after the Initial Closing and subject to the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement, an aggregate of 7,500,000 additional shares of CohBar Common Stock, subject to adjustments contained in the Stock Purchase Agreement, for an aggregate purchase price of up to $15 million at the same price per share as sold in connection with the Initial Closing (the “Second Closing”).

In addition, as contemplated by the Merger Agreement, CohBar will make a dividend to the holders of CohBar Common Stock as of the close of business on the business day immediately prior to the date of the closing of the Merger or such other date pursuant to the terms of the Merger Agreement (the “Record Date”) equal to approximately 3.3 shares

of CohBar Common Stock per each share of CohBar Common Stock issued and outstanding as of the Record Date (the “Stock Dividend”). The payment date for the Stock Dividend is anticipated to be immediately prior to the effective time of the Merger (or such other date as necessary on or before the Reverse Stock Split (as defined below)). The purpose of the Stock Dividend is to increase the amount of the total number of shares of CohBar Common Stock held by pre-Merger CohBar equityholders to give effect to the Exchange Ratio so that, immediately after the Merger, on a pro forma basis, including the Stock Dividend and after taking into account the Initial Financing, pre-Merger CohBar equityholders would own approximately 15% of the combined company.

Prior to the closing of the Merger, CohBar, at the discretion of the CohBar Board, will conduct a reverse stock split of the CohBar Common Stock, at a ratio of not less than 1-for-1.5 and not more than 1-for-10 and thereafter, each share of CohBar Common Stock and option to purchase CohBar Common Stock that is issued and outstanding at the effective time of the Merger will remain issued and outstanding and such shares will be unaffected by the Merger. It is expected that the reverse stock split will be effected immediately prior to the closing of the Merger.

Immediately after the closing of the Merger, on a pro forma basis, including the Stock Dividend and after taking into account the Initial Financing, pre-Merger Morphogenesis equityholders would own approximately 77% of the combined company, pre-Merger CohBar equityholders would own approximately 15% of the combined company, and the Investor would own approximately 9% of the combined company (excluding in each such case the effect of out-of-the-money options and warrants of CohBar that will remain outstanding after the Merger).

Immediately after the closing of the Merger, the board of directors of the combined company is expected to consist of six members, four of whom will be designated by Morphogenesis and two of whom will be designated by CohBar, and the officers of Morphogenesis as of immediately prior to the effective time are expected to become the officers of the combined company.

Shares of CohBar Common Stock are currently listed on The Nasdaq Capital Market (“Nasdaq”) under the symbol “CWBR.” CohBar has filed an initial listing application for the common stock of the combined company with Nasdaq. It is a condition of the closing of the Merger that the initial listing application with Nasdaq shall have been approved. If such condition is not satisfied, the Merger may not be consummated. Each of CohBar and Morphogenesis may waive this condition as set forth in the Merger Agreement. Nasdaq’s determination is not expected to be known at the time that CohBar stockholders are asked to vote on the proposals at the CohBar Special Meeting. After completion of the Merger, CohBar will be renamed “TuHURA Biosciences, Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “HURA.” On September 11, 2023, the last trading day before the date of this proxy statement/prospectus, the closing sale price of CohBar Common Stock was $2.96 per share.

CohBar stockholders are cordially invited to attend the special meeting in lieu of annual meeting of CohBar stockholders. CohBar is holding its special meeting in lieu of annual meeting of stockholders (the “CohBar Special Meeting”) on October 4, 2023, at 8:00 a.m. Eastern Time, unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the Merger and related matters. The CohBar Special Meeting in lieu of annual meeting will be held entirely online. CohBar stockholders will be able to attend and participate in the CohBar Special Meeting online by visiting www.virtualshareholdermeeting.com/CWBR2023, where they will be able to listen to the meeting live, submit questions and vote. At the CohBar Special Meeting, CohBar will ask its stockholders:

1.      To approve (i) the issuance of shares of CohBar Common Stock, which will represent more than 20% of the shares of CohBar Common Stock outstanding immediately prior to the Merger, to stockholders of Morphogenesis, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A to this proxy statement/prospectus, and (ii) the change of control of CohBar resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively (the “Nasdaq Stock Issuance Proposal” or “Proposal No. 1”);

2.      To approve an amendment to the third amended and restated certificate of incorporation of CohBar (the “CohBar Charter”) at the option of the CohBar board of directors (the “CohBar Board”) to increase the number of authorized shares of CohBar Common Stock to 200,000,000 and increase the number of authorized shares of CohBar preferred stock (“CohBar Preferred Stock”) to 20,000,000 (the “Authorized Share Increase”) (the “Authorized Share Increase Proposal” or “Proposal No. 2”);

3.      To adopt and approve an amendment to the CohBar Charter to effect a reverse stock split of CohBar Common Stock (the “Reverse Stock Split”), by a ratio of not less than 1-for-1.5 and not more than 1-for-10, such ratio and the implementation and timing of the Reverse Stock Split to be determined in the discretion of the CohBar Board (the “Reverse Stock Split Proposal” or “Proposal No. 3”);

4.      To approve, on an advisory (non-binding) basis, certain compensation payments that will or may be made by CohBar to its named executive officers in connection with the Merger (the “Golden Parachute’s Compensation Proposal” or “Proposal No. 4”);

5.      To elect a board of directors named in this proxy statement/prospectus, up to the number of directorships subject to election (being seven or two), to serve until the next annual meeting of stockholders or until their successors are duly elected and qualified (the “Director Election Proposal” or “Proposal No. 5”);

6.      To ratify the appointment of Marcum LLP as CohBar’s independent registered public accounting firm for the year ending December 31, 2023 (the “Auditor Ratification Proposal” or “Proposal No. 6”);

7.      To approve the TuHURA Biosciences, Inc. 2023 Equity Incentive Plan, in the form attached as Annex H to this proxy statement/prospectus (the “2023 Equity Incentive Plan Proposal” or “Proposal No. 7”);

8.      To approve an adjournment of the CohBar Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals 1, 2, 3, 4 and 7 (the “Adjournment Proposal” or “Proposal No. 8”); and

9.      To transact such other business as may properly come before the stockholders at the CohBar Special Meeting or any adjournment or postponement thereof.

Concurrently with the execution of the Merger Agreement, (i) certain stockholders of Morphogenesis (solely in their respective capacities as Morphogenesis stockholders) have entered into support agreements with CohBar and Morphogenesis to vote all of their shares of Morphogenesis Common Stock in favor of the adoption and approval of the Merger Agreement and the transactions contemplated thereby and against any alternative acquisition proposals and (ii) certain officers and directors of CohBar have entered into support agreements with CohBar and Morphogenesis to vote all of their shares of CohBar Common Stock in favor of the adoption and approval of the Merger Agreement, the Merger and related transactions contemplated by the Merger Agreement and against any alternative acquisition proposals.

After careful consideration, each of the CohBar and Morphogenesis boards of directors have approved the Merger Agreement and have determined that it is advisable to consummate the Merger. The CohBar Board has approved the proposals described in the accompanying proxy statement/prospectus and recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.

More information about CohBar, Morphogenesis, the Merger Agreement, the Merger and transactions contemplated thereby and the foregoing proposals is contained in the accompanying proxy statement/prospectus. CohBar urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 26 OF THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS.

CohBar and Morphogenesis are excited about the opportunities the Merger brings to CohBar’s and Morphogenesis’ stockholders and thank you for your consideration and continued support.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the accompanying proxy statement/prospectus. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus is dated September 12, 2023, and is first being mailed to CohBar’s stockholders on or about September 12, 2023.

COHBAR, INC.
1455 Adams Drive, Suite 1308
Menlo Park, CA 94025

NOTICE OF SPECIAL MEETING IN LIEU OF ANNUAL MEETING OF STOCKHOLDERS

To the stockholders of CohBar, Inc.:

NOTICE IS HEREBY GIVEN that a virtual special meeting in lieu of annual meeting of stockholders (the “CohBar Special Meeting”) will be held on October 4, 2023 at 8:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The CohBar Special Meeting will be held entirely online. You will be able to attend and participate in the CohBar Special Meeting online by visiting www.virtualshareholdermeeting.com/CWBR2023, where you will be able to listen to the meeting live, submit questions and vote.

The CohBar Special Meeting will be held for the following purposes:

1.      To approve (i) the issuance of shares of CohBar Common Stock, which will represent more than 20% of the shares of CohBar Common Stock outstanding immediately prior to the Merger, to stockholders of Morphogenesis, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A to the accompanying proxy statement/prospectus, and (ii) the change of control of CohBar resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively (the “Nasdaq Stock Issuance Proposal” or “Proposal No. 1”);

2.      To approve an amendment to the CohBar Charter at the option of the CohBar Board to effect the Authorized Share Increase (the “Authorized Share Increase Proposal” or “Proposal No. 2”);

3.      To adopt and approve an amendment to the CohBar Charter to effect a reverse stock split of CohBar Common Stock (the “Reverse Stock Split”), by a ratio of not less than 1-for-1.5 and not more than 1-for-10, such ratio and the implementation and timing of the Reverse Stock Split to be determined in the discretion of the CohBar Board (the “Reverse Stock Split Proposal” or “Proposal No. 3”);

4.      To approve, on an advisory (non-binding) basis, certain compensation payments that will or may be made by CohBar to its named executive officers in connection with the Merger (the “Golden Parachute’s Compensation Proposal” or “Proposal No. 4”);

5.      To elect a board of directors named in this proxy statement/prospectus, up to the number of directorships subject to election (being seven or two), to serve until the next annual meeting of stockholders or until their successors are duly elected and qualified (the “Director Election Proposal” or “Proposal No. 5”);

6.      To ratify the appointment of Marcum LLP as CohBar’s independent registered public accounting firm for the year ending December 31, 2023 (the “Auditor Ratification Proposal” or “Proposal No. 6”);

7.      To approve the TuHURA Biosciences, Inc. 2023 Equity Incentive Plan, in the form attached as Annex H to this proxy statement/prospectus (the “2023 Equity Incentive Plan Proposal” or “Proposal No. 7”);

8.      To approve an adjournment of the CohBar Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals 1, 2, 3, 4 and 7 (the “Adjournment Proposal” or “Proposal No. 8”); and

9.      To transact such other business as may properly come before the stockholders at the CohBar Special Meeting or any adjournment or postponement thereof.

These proposals are collectively referred to as the “Proposals.”

The CohBar Board has fixed August 31, 2023 as the record date for the determination of stockholders entitled to notice of, and to vote at, the CohBar Special Meeting and any adjournment or postponement thereof. Only holders of record of shares of common stock of CohBar at the close of business on the record date are entitled to notice of, and to vote at, the CohBar Special Meeting. At the close of business on the record date, CohBar had 2,906,926 shares of common stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of the holders of a majority of all of the shares of CohBar Common Stock present or represented by proxy at the CohBar Special Meeting and voting on such matter is required for approval of Proposal Nos. 1, 2, 3, 4, 6, 7 and 8. With respect to Proposal No. 5, directors are elected by a plurality of the votes cast by the stockholders entitled to vote on the election at the CohBar Special Meeting, and the nominees for director receiving the highest number of affirmative votes, up to the number of directorships subject to election, will be elected. Approval of each of Proposal No. 1, Proposal No. 2 and Proposal No. 3 is a condition to the completion of the Merger. Therefore, the Merger cannot be consummated without the approval of Proposal Nos. 1, 2 and 3.

Even if you plan to virtually attend the CohBar Special Meeting, CohBar requests that you sign and return the enclosed proxy or vote by mail or online to ensure that your shares will be represented at the CohBar Special Meeting if you are unable to virtually attend. You may change or revoke your proxy at any time before it is voted at the CohBar Special Meeting.

COHBAR’S BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS FAIR TO, IN THE BEST INTERESTS OF, AND ADVISABLE TO COHBAR AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. COHBAR’S BOARD OF DIRECTORS RECOMMENDS THAT COHBAR STOCKHOLDERS VOTE “FOR” EACH NOMINEE AND “FOR” EACH SUCH PROPOSAL.

Important Notice Regarding the Availability of Proxy Materials for the Stockholders’ Meeting
to Be Held on October 4, 2023 at 8:00 a.m. Eastern Time via the internet

The proxy statement/prospectus and annual report to stockholders are available at
www.virtualshareholdermeeting.com/CWBR2023

By Order of CohBar’s Board of Directors,

Dr. Joseph J. Sarret
President, Chief Executive Officer
September 12, 2023

TABLE OF CONTENTS

QUESTIONS AND ANSWERS ABOUT THE MERGER

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed Reverse Stock Split described in Proposal No. 3 of this proxy statement/prospectus.

The following section provides answers to frequently asked questions about the Merger. This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.

Q:     What is the Merger?

A:     On May 22, 2023, CohBar, Inc., a Delaware corporation (“CohBar”), Chimera MergeCo, Inc., a Delaware corporation and wholly owned subsidiary of CohBar (“Merger Sub”), and Morphogenesis, Inc., a Delaware corporation (“Morphogenesis”), entered into an Agreement and Plan of Merger, as amended from time to time (the “Merger Agreement”), a copy of which is attached as Annex A. Pursuant to the Merger Agreement, Merger Sub will merge with and into Morphogenesis, with Morphogenesis continuing as a wholly owned subsidiary of CohBar and CohBar being the surviving corporation of the Merger (the “Merger”). The Merger Agreement contains the terms and conditions of the proposed Merger. After the completion of the Merger, CohBar will change its corporate name to “TuHURA Biosciences, Inc.” CohBar following the Merger is referred to herein as the “combined company.”

At the closing of the Merger, (a) each then-outstanding share of common stock, par value $0.001 per share, of Morphogenesis (the “Morphogenesis Common Stock”) (other than shares held in treasury and Dissenting Shares (as defined in the Merger Agreement)) will be converted into and become exchangeable for a number of shares of common stock, par value $0.001 per share, of CohBar (the “CohBar Common Stock”) calculated in accordance with the Merger Agreement (the “Exchange Ratio”), (b) each then-outstanding option to purchase Morphogenesis Common Stock will be assumed and converted by CohBar into an option to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement, and (c) each then-outstanding warrant to purchase shares of Morphogenesis Common Stock will be converted into and exchangeable for a warrant of like tenor entitling the holder to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement.

The Exchange Ratio will be equal to the quotient obtained by dividing (a) the Company Merger Shares by (b) the Company Outstanding Shares, as those terms are defined and further described in the Merger Agreement, which has the effect and purpose of determining the number of shares to be issued to pre-Merger Morphogenesis stockholders (or issuable to pre-Merger Morphogenesis option and warrant holders in respect of such options and warrants) based on the relative valuations and fully-diluted shares of each of CohBar and Morphogenesis as of immediately prior to the closing of the Merger. For purposes of calculating the Exchange Ratio (as defined in the Merger Agreement), (i) shares of CohBar Common Stock underlying CohBar stock options and warrants outstanding as of immediately prior to the closing of the Merger with an exercise price per share of less than $2.00 (subject to adjustment pursuant to the Merger Agreement) will be deemed to be outstanding and (ii) all shares of Morphogenesis Common Stock underlying outstanding Morphogenesis preferred stock, stock options, and warrants will be deemed to be outstanding.

Immediately after the closing of the Merger, on a pro forma basis, including the Stock Dividend and after taking into account the Initial Financing (as discussed below), pre-Merger Morphogenesis equityholders would own approximately 77% of the combined company, pre-Merger CohBar equityholders would own approximately 15% of the combined company, and the Investor would own approximately 9% of the combined company (excluding in each such case the effect of out-of-the-money options and warrants of CohBar that will remain outstanding after the Merger).

Q:     Why are the two companies proposing to merge?

A:     CohBar and Morphogenesis believe that combining the two companies will result in a company with a promising pipeline, a strong leadership team and substantial capital resources, positioning it to become a great oncology-focused company. If the Merger is completed, the combined company will focus on developing Morphogenesis’ product candidates, which are described on page 220 under the section titled “Morphogenesis’ Business,” and it is anticipated that the combined company will not continue to develop CohBar’s product candidates. If the Merger is not completed, CohBar will reconsider its strategic alternatives. For a more

complete description of the reasons for the Merger, please see the sections titled “The Merger — CohBar’s Reasons for the Merger; Recommendation of the CohBar Board” and “The Merger — Morphogenesis’ Reasons for the Merger” beginning on pages 117 and 123, respectively, of this proxy statement/prospectus.

Q:     Why am I receiving this proxy statement/prospectus?

A:     You are receiving this proxy statement/prospectus because you have been identified as a stockholder of CohBar as of the record date, and you are entitled to vote to approve the matters set forth herein. This document serves as:

•        a proxy statement of CohBar used to solicit proxies for a virtual special meeting in lieu of annual meeting of stockholders (the “CohBar Special Meeting”) to vote on the matters set forth herein; and

•        a prospectus of CohBar used to offer shares of CohBar Common Stock in exchange for shares of Morphogenesis Common Stock (other than shares held in treasury and Dissenting Shares) in the Merger.

Q:     What is the Stock Dividend?

A:     As contemplated by the Merger Agreement, CohBar will make a dividend to the holders of CohBar Common Stock as of the close of business on the business day immediately prior to the date of the closing of the Merger or such other date pursuant to the terms of the Merger Agreement (the “Record Date”) equal to approximately 3.3 shares of CohBar Common Stock per each share of CohBar Common Stock issued and outstanding as of the Record Date (the “Stock Dividend”).

The payment date for the Stock Dividend is anticipated to be immediately prior to the effective time of the Merger (the “Effective Time”) (or such other date as necessary on or before the Reverse Stock Split).

The purpose of the Stock Dividend is to increase the amount of the total number of shares of CohBar Common Stock held by pre-Merger CohBar equityholders to give effect to the Exchange Ratio so that, immediately after the Merger, on a pro forma basis, including the Stock Dividend and after taking into account the Initial Financing, pre-Merger CohBar equityholders would own approximately 15% of the combined company.

Q:     What is the Initial Financing and the Second Financing?

A:     On May 22, 2023 and concurrently with the execution and delivery of the Merger Agreement, CohBar entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with K & V Investment Two, LLC, a Florida limited liability company (the “Investor”). Pursuant to the Stock Purchase Agreement, CohBar will issue, subject to adjustments contained in the Stock Purchase Agreement, 7,500,000 shares of CohBar Common Stock for an aggregate purchase price of $15 million (the “Initial Financing”) immediately prior to the Effective Time (the “Initial Closing”). The consummation of the Initial Financing is conditioned on the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement. In addition, pursuant to the Stock Purchase Agreement, CohBar has agreed to sell, at the election of the Investor within six months after the Initial Closing and subject to the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement, an aggregate of 7,500,000 additional shares of CohBar Common Stock, subject to adjustments contained in the Stock Purchase Agreement, for an aggregate purchase price of up to $15 million at the same price per share as sold in connection with the Initial Closing (the “Second Financing”). Immediately after the closing of the Merger, on a pro forma basis, including the Stock Dividend and after taking into account both the Initial Financing, the Investor would own approximately 9% of the combined company (excluding the effect of out-of-the-money options and warrants of CohBar that will remain outstanding after the Merger).

Q:     What proposals will be voted on at the CohBar Special Meeting in connection with the Merger?

A:     Pursuant to the terms of the Merger Agreement, the following proposals must be approved by the requisite stockholder vote at the CohBar Special Meeting in order for the Merger to close:

•        Proposal No.  1 — The Nasdaq Stock Issuance Proposal to approve (i) the issuance of shares of CohBar Common Stock, which will represent more than 20% of the shares of CohBar Common Stock outstanding immediately prior to the Merger, to stockholders of Morphogenesis, pursuant to the terms

of the Merger Agreement, a copy of which is attached as Annex A to this proxy statement/prospectus, and (ii) the change of control of CohBar resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively (the “Nasdaq Stock Issuance Proposal” or “Proposal No. 1”);

•        Proposal No.  2 — The Authorized Share Increase Proposal to approve an amendment to the third amended and restated certificate of incorporation of CohBar (the “CohBar Charter”) at the option of the CohBar board of directors (the “CohBar Board”) to increase the number of authorized shares of CohBar Common Stock to 200,000,000 and to increase the number of authorized shares of CohBar Preferred Stock to 20,000,000 (the “Authorized Share Increase”) (the “Authorized Share Increase Proposal” or “Proposal No. 2”); and

•        Proposal No. 3 — The Reverse Stock Split Proposal to approve an amendment to the CohBar Charter to effect the Reverse Stock Split, by a ratio of not less than 1-for-1.5 and not more than 1-for-10, such ratio and the implementation and timing of the Reverse Stock Split to be determined in the discretion of the CohBar Board (the “Reverse Stock Split Proposal” or “Proposal No. 3”).

The approval of each of Proposal Nos. 1, 2 and 3 is a condition to completion of the Merger. The issuance of CohBar Common Stock in connection with the Merger and the change of control of CohBar resulting from the Merger will not take place unless Proposal No. 1 is approved by CohBar stockholders and the Merger is consummated. The amendment to the CohBar Charter to effect the Authorized Share Increase will not take place unless Proposal No. 2 is approved by the requisite CohBar stockholders. The amendment to the CohBar Charter to effect a Reverse Stock Split of CohBar’s issued and outstanding common stock will not take place unless Proposal No. 3 is approved by the requisite CohBar stockholders. The CohBar Board may determine to effect the Reverse Stock Split, if it is approved by the stockholders, even if the other proposals to be acted upon at the meeting are not approved, including Proposal No. 1 and Proposal No. 2.

In addition to the requirement of obtaining CohBar stockholder approval of Proposal Nos. 1, 2 and 3, the closing of the Merger is subject to the satisfaction or waiver of each of the other closing conditions set forth in the Merger Agreement. For a more complete description of the closing conditions under the Merger Agreement, please see the section titled “The Merger Agreement — Conditions to the Completion of the Merger” beginning on page 161 of this proxy statement/prospectus.

The presence, by accessing online or being represented by proxy, at the CohBar Special Meeting of the holders of not less than one-third of the total voting power of shares of CohBar Common Stock issued and outstanding and entitled to vote at the CohBar Special Meeting is necessary to constitute a quorum at the meeting for the Proposals.

Q:     What proposals are to be voted on at the CohBar Special Meeting, other than the Nasdaq Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal?

A:     At the CohBar Special Meeting, the holders of CohBar Common Stock will also be asked to consider the following proposals:

•        Proposal No.  4 — The Golden Parachute’s Compensation Proposal to approve, on an advisory (non-binding) basis, certain compensation payments that will or may be made by CohBar to its named executive officers in connection with the Merger (the “Golden Parachute’s Compensation Proposal” or “Proposal No. 4”);

•        Proposal No.  5 — The Director Election Proposal to elect a board of directors named in this proxy statement/prospectus, up to the number of directorships subject to election (being seven or two), to serve until the next annual meeting of stockholders or until their successors are duly elected and qualified (the “Director Election Proposal” or “Proposal No. 5”);

•        Proposal No.  6 — The Auditor Ratification Proposal to ratify the appointment of Marcum LLP as CohBar’s independent registered public accounting firm for the year ending December 31, 2023 (the “Auditor Ratification Proposal” or “Proposal No. 6”);

•        Proposal No.  7 — The 2023 Equity Incentive Plan Proposal to approve the TuHURA Biosciences, Inc. 2023 Equity Incentive Plan, in the form attached as Annex H to this proxy statement/prospectus (the “2023 Equity Incentive Plan Proposal” or “Proposal No. 7”); and

•        Proposal No.  8 — The Adjournment Proposal to approve an adjournment of the CohBar Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals 1, 2, 3, 4 and 7 (the “Adjournment Proposal” or “Proposal No. 8”).

The approval of each of Proposal Nos. 4, 5, 6, 7 and 8 is not a condition to the Merger. CohBar does not expect that any matter other than the Proposals will be brought before the CohBar Special Meeting.

The presence, by accessing online or being represented by proxy, at the CohBar Special Meeting of the holders of not less than one-third of the total voting power of shares of CohBar Common Stock issued and outstanding and entitled to vote at the CohBar Special Meeting is necessary to constitute a quorum at the meeting for the Proposals.

Q:     What stockholder votes are required to approve the Proposals at the CohBar Special Meeting?

A:     The affirmative vote of the holders of a majority of all of the shares of CohBar Common Stock present or represented by proxy at the CohBar Special Meeting and voting on such matter is required for approval of Proposal Nos. 1, 2, 3, 4, 6, 7 and 8. With respect to Proposal No. 5, directors are elected by a plurality of the votes cast by the stockholders entitled to vote on the election at the CohBar Special Meeting, and the nominees for director receiving the highest number of affirmative votes, up to the number of directorships subject to election, will be elected.

Votes will be counted by the inspector of election appointed for the meeting, who will separately count “FOR,” “AGAINST” and “WITHHOLD” votes, abstentions and broker non-votes, as applicable to each proposal. Abstentions and broker non-votes, if any, will also be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the CohBar Special Meeting. Votes withheld, abstentions and broker non-votes, if any, will not be counted as “votes cast” and will therefore have no effect on Proposal Nos. 1, 2, 3, 4, 5, 6, 7 and 8.

Q:     What are the contingent value rights (“CVRs”) being issued to CohBar stockholders and warrant holders in connection with the Merger?

A:     At or prior to the Effective Time, CohBar will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a rights agent (“Rights Agent”), pursuant to which CohBar’s pre-Merger common stockholders and certain warrant holders of record as of the Record Date will receive one CVR for each outstanding share of CohBar Common Stock held by such stockholder (or, in the case of the warrants, each share of CohBar Common Stock for which such warrant is exercisable). A copy of the form of CVR Agreement is included as Annex F to this proxy statement/prospectus.

Pursuant to the CVR Agreement, each CVR will entitle the holder thereof to receive certain cash payments from the net proceeds, if any, related to the disposition of CohBar’s legacy assets pursuant to any disposition agreement entered into within three years of the closing of the Merger. CohBar’s legacy assets include the tangible and intangible assets primarily used in or primarily related to the development and optimization of novel therapeutics that are analogs of mitochondrial derived peptides, including without limitation CohBar’s CB4211 candidate and CB5138 Analogs.

The contingent payments under the CVR Agreement, if they become payable, will become payable to the Rights Agent for subsequent distribution to the holders of the CVRs. In the event that no such proceeds are received, holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any holders of CVRs will receive any payments with respect thereto.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the SEC. The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in CohBar or the combined company or any of its affiliates. No interest will accrue on any amounts payable in respect of the CVRs.

The payment date for the CVRs will be three business days after the Effective Time, provided, that CohBar will make additional CVR distributions to certain CohBar warrant holders from time to time to the extent such warrant holders become entitled to the CVR in accordance with the terms of such warrants.

For a more detailed description of the CVRs and the CVR Agreement, see “Agreements Related to the Merger — Contingent Value Rights Agreement” elsewhere in this proxy statement/prospectus.

Q:     What will Morphogenesis equityholders receive in the Merger?

A:     At the closing of the Merger, (a) each then-outstanding share of Morphogenesis Common Stock (other than shares held in treasury and Dissenting Shares) will be converted into and become exchangeable for a number of shares of CohBar Common Stock calculated in accordance with the Exchange Ratio, (b) each then-outstanding option to purchase Morphogenesis Common Stock will be assumed and converted by CohBar into an option to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement, and (c) each then-outstanding warrant to purchase shares of Morphogenesis Common Stock will be converted into and exchangeable for a warrant of like tenor entitling the holder to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement.

The Exchange Ratio will be equal to the quotient obtained by dividing (a) the Company Merger Shares by (b) the Company Outstanding Shares, as those terms are defined and further described in the Merger Agreement, which has the effect and purpose of determining the number of shares to be issued to pre-Merger Morphogenesis stockholders (or issuable to pre-Merger Morphogenesis option and warrant holders in respect of such options and warrants) based on the relative valuations and fully-diluted shares of each of CohBar and Morphogenesis as of immediately prior to the closing of the Merger. For purposes of calculating the Exchange Ratio, (i) shares of CohBar Common Stock underlying CohBar stock options and warrants outstanding as of immediately prior to the closing of the Merger with an exercise price per share of less than $2.00 (subject to adjustment pursuant to the Merger Agreement) will be deemed to be outstanding and (ii) all shares of Morphogenesis Common Stock underlying outstanding Morphogenesis preferred stock, stock options, and warrants will be deemed to be outstanding.

For a more complete description of the treatment of Morphogenesis Common Stock and Morphogenesis’ options and warrants in the Merger, please see the sections titled “The Merger Agreement — Merger Consideration” and “The Merger Agreement — Exchange Ratio” beginning on pages 148 and 149, respectively, of this proxy statement/prospectus.

Q:     Will the common stock of the combined company trade on an exchange?

A:     Shares of CohBar Common Stock are currently listed on Nasdaq under the symbol “CWBR.” CohBar has filed an initial listing application for the common stock of the combined company with Nasdaq. It is a condition of the closing of the Merger that the initial listing application with Nasdaq shall have been approved. If such condition is not satisfied, the Merger may not be consummated. Each of CohBar and Morphogenesis may waive this condition as set forth in the Merger Agreement. Nasdaq’s determination is not expected to be known at the time that you are asked to vote on the Proposals at the CohBar Special Meeting. After completion of the Merger, CohBar will be renamed “TuHURA Biosciences, Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “HURA.” On September 11, 2023, the last trading day before the date of this proxy statement/prospectus, the closing sale price of CohBar Common Stock was $2.96 per share.

Q:     Who will be the directors of the combined company following the Merger?

A:     Immediately following the Merger, the combined company’s board of directors is expected to be composed of six members, consisting of James Manuso, Alan List, George Ng, James Bianco, Misha Petkevich and Joanne Yun, four of whom will be designated by Morphogenesis and two of whom will be designated by CohBar.

Q:     Who will be the executive officers of the combined company immediately following the Merger?

A:     Immediately following the Merger, the executive management team of the combined company is expected to consist of members of the Morphogenesis executive management team prior to the Merger, including:

Q:     As a CohBar stockholder, how does the CohBar Board recommend that I vote?

A:     After careful consideration, the CohBar Board recommends that CohBar stockholders vote “FOR” all of the Proposals.

Albion J. Fitzgerald, one of the seven members of the CohBar Board, did not vote in favor of the Merger and the transactions contemplated by the Merger Agreement. The other six directors, after weighing various factors, voted in favor of the board approvals and recommendations regarding the Merger and the Proposals because they believed that, taking all relevant factors into account, the Merger Agreement and the Merger were in the best interests of CohBar and its stockholders. For more information, please see the section titled “CohBar’s Reasons for the Merger; Recommendation of the CohBar Board — Concerns of Dissenting Director” beginning on page 122 of this proxy statement/prospectus.

Q:     What risks should I consider in deciding whether to vote in favor of the Merger?

A:     You should carefully review the section titled “Risk Factors” beginning on page 26 of this proxy statement/prospectus and the documents incorporated by reference herein, which set forth certain risks and uncertainties related to the Merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of CohBar and Morphogenesis, as independent companies, are subject.

Q:     When do you expect the Merger to be consummated?

A:     The Merger is anticipated to close in the third quarter of 2023, but the exact timing cannot be predicted. For more information, please see the section titled “The Merger Agreement — Conditions to the Completion of the Merger” beginning on page 161 of this proxy statement/prospectus.

Q:     What do I need to do now?

A:     CohBar urges you to read this proxy statement/prospectus carefully, including the annexes and the documents incorporated by reference, and to consider how the Merger affects you.

If you are a CohBar stockholder of record, you may provide your proxy instructions in one of four (4) different ways:

•        You can vote using the proxy card, simply complete, sign and date the accompanying proxy card and return it promptly in the envelope provided. If you return your signed proxy card before the CohBar Special Meeting, CohBar will vote your shares in accordance with the proxy card.

•        You can vote by proxy over the internet, follow the instructions provided on the Notice of Internet Availability.

•        You can vote by telephone by calling the toll-free number found on the Notice of Internet Availability.

•        You may attend the CohBar Special Meeting online and vote by following the instructions at www.virtualshareholdermeeting.com/CWBR2023.

Your signed proxy card, telephonic proxy instructions, or internet proxy instructions must be received by October 3, 2023 at 11:59 p.m. Eastern Time to be counted.

If you hold your shares in “street name” (as described below), you may provide your proxy instructions via telephone or the internet by following the instructions on your vote instruction form provided by your broker. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the CohBar Special Meeting.

Q:     What happens if I do not return a proxy card or otherwise vote or provide proxy instructions, as applicable?

A:     If you are a CohBar stockholder, the failure to return your proxy card or otherwise vote or provide proxy instructions will reduce the aggregate number of votes required to approve Proposal Nos. 1, 2, 3, 4, 5, 6 and 7.

Q:     May I attend the CohBar Special Meeting and vote in person?

A:     Stockholders of record as of August 31, 2023 will be able to attend and participate in the CohBar Special Meeting online by accessing www.virtualshareholdermeeting.com/CWBR2023. To join the CohBar Special Meeting, you will need to have your 16 digit control number which is included on your Notice of Internet Availability of Proxy Materials and your proxy card. If your shares are held in “street name,” you should contact your bank, broker or other nominee if you did not receive a 16 digit control number.

Q:     Who counts the votes?

A:     Broadridge Financial Solutions, Inc. (“Broadridge”) has been engaged as CohBar’s inspector of election. If you are a stockholder of record, your executed proxy card is returned directly to Broadridge for tabulation. If you hold your shares through a broker, your broker returns one proxy card to Broadridge on behalf of all its clients.

Q:     If my CohBar shares are held in “street name” by my broker, will my broker vote my shares for me?

A:     If you hold shares beneficially in street name and do not provide your broker or other agent with voting instructions, your shares may constitute “broker non-votes.” A “broker non-vote” occurs when shares held by a broker are not voted with respect to a particular proposal because the broker does not have or did not exercise discretionary authority to vote on the matter and has not received voting instructions from its clients. These matters are referred to as “non-routine” matters. On non-routine items for which you do not give your broker instructions, shares of CohBar Common Stock will be treated as broker non-votes. Whether a proposal is considered routine or non-routine is subject to stock exchange rules and final determination by the stock exchange. To make sure that your vote is counted, you should instruct your broker to vote your shares, following the procedures provided by your broker.

Q:     What are broker non-votes and do they count for determining a quorum?

A:     Generally, a “broker non-vote” occurs when shares held by a broker are not voted with respect to a particular proposal because the broker does not have or did not exercise discretionary authority to vote on the matter and has not received voting instructions from its clients.

Broker non-votes, if any, will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the CohBar Special Meeting. Broker non-votes, if any, will not be counted as “votes cast” and will therefore have no effect on Proposal Nos. 1, 2, 3, 4, 5, 6, 7 and 8.

Q:     May I change my vote after I have submitted a proxy or provided proxy instructions?

A:     CohBar stockholders of record, unless such stockholder’s vote is subject to a support agreement, may change their vote at any time before their proxy is voted at the CohBar Special Meeting in one of four ways:

•        You may submit another properly completed proxy with a later date by mail or via the internet.

•        You can provide your proxy instructions via telephone at a later date.

•        You may send a notice that you are revoking your proxy over the internet, following the instructions provided on the Notice of Internet Availability.

•        You may attend the CohBar Special Meeting online and vote by following the instructions at www.virtualshareholdermeeting.com/CWBR2023. Simply attending the CohBar Special Meeting will not, by itself, revoke your proxy.

Your signed proxy card, telephonic proxy instructions, internet proxy instructions, or written notice must be received by October 3, 2023, 11:59 p.m. Eastern Time to be counted.

If a CohBar stockholder who owns CohBar shares in “street name” has instructed a broker to vote its shares of CohBar Common Stock, the stockholder must follow directions received from its broker to change those instructions.

Q:     Who is paying for this proxy solicitation?

A:     CohBar and Morphogenesis will share equally the cost of printing and filing of this proxy statement/prospectus and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of CohBar Common Stock for the forwarding of solicitation materials to the beneficial owners of CohBar Common Stock. CohBar will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. CohBar has retained Morrow Sodali LLC, 333 Ludlow Street, 5th Floor, South Tower, Stamford, CT 06902 (“Morrow”), to assist it in soliciting proxies using the means referred to above. CohBar will pay the fees of Morrow, which CohBar expects to be approximately $40,000 plus reimbursement of out-of-pocket expenses. Solicitations also may be made by personal interview, mail, telephone, and electronic communications by directors, officers, and other employees without additional compensation.

Q:     What are the material U.S. federal income tax consequences of the Merger to holders of CohBar capital stock?

A:     CohBar stockholders will not sell, exchange or dispose of any shares of CohBar Common Stock as a result of the Merger. Thus, there will be no material U.S. federal income tax consequences to CohBar stockholders as a result of the Merger. Accordingly, CohBar stockholders will not recognize any gain or loss for U.S. federal income tax purposes as a result of the Merger.

Q:     What are the material U.S. federal income tax consequences of the Merger to United States holders of Morphogenesis capital stock?

A:     The Merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) for U.S. federal income tax purposes. However, it is not a condition to the parties’ obligations to complete the Merger that the Merger so qualifies. Nevertheless, assuming that the Merger so qualifies, U.S. holders (as defined in the section entitled “The Merger — Material U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of Morphogenesis Common Stock” beginning on page 140) of shares of Morphogenesis Common Stock will generally not recognize any gain or loss for U.S. federal income tax purposes on the exchange of their shares of Morphogenesis Common Stock for shares of CohBar Common Stock in the Merger. Morphogenesis and CohBar have not sought and will not seek any ruling from the Internal Revenue Service (the “IRS”) regarding any matters relating to the transactions and, as a result, there can be no assurance that the IRS would not assert, or that a court would not sustain, a position contrary to any of the conclusions set forth herein.

Q:     What are the material U.S. federal income tax consequences of the issuance of the CVRs, including any distributions of CohBar Common Stock under the CVRs?

A:     Because no authority directly addresses the U.S. federal income tax treatment of the CVRs, the amount of income or gain, and the timing and character of the income or gain, a holder of CohBar stock may recognize with respect to the CVRs is uncertain. Please review the information in the section titled “Agreements Related to the Merger — Contingent Value Rights Agreement — Material U.S. Federal Income Tax Consequences of the CVRs to Holders of CohBar Common Stock” for a discussion of the material U.S. federal income tax consequences of the CVRs to holders of CohBar Common Stock.

Q:     What are the material U.S. federal income tax consequences of the Reverse Stock Split to holders of CohBar Common Stock?

A:     A holder of CohBar Common Stock should not recognize gain or loss upon the Reverse Stock Split, except to the extent such holder receives cash in lieu of a fractional share of CohBar Common Stock, and subject to the discussion in the section titled “Proposal No. 3 — The Reverse Stock Split Proposal.” Please review the information in the section titled “Proposal No. 3 — The Reverse Stock Split Proposal — Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” for a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to holders of CohBar Common Stock.

RISK FACTORS

Risks Related to the Merger

The merger consideration at the closing of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed because of the fixed Exchange Ratio.

Subject to the terms and conditions of the Merger Agreement, at the closing of the Merger, each then-outstanding share of Morphogenesis Common Stock will be converted into shares of CohBar Common Stock. Applying the Exchange Ratio, on pro forma basis, including the Stock Dividend and, after taking into account the Initial Financing, pre-Merger Morphogenesis equityholders are expected to own approximately 77% of the combined company, pre-Merger CohBar equityholders are expected to own approximately 15% of the combined company, and the Investor is expected to own approximately 9% of the combined company (excluding in each such case the effect of out-of-the-money options and warrants of CohBar that will remain outstanding after the Merger), subject to certain assumptions, including, but not limited to, (i) a valuation for CohBar equal to $25.0 million, (ii) a valuation for Morphogenesis equal to $130.6 million and (iii) gross proceeds of $15.0 million from the Initial Financing, in each case as further described in the Merger Agreement. Accordingly, the Exchange Ratio is fixed (subject to certain adjustments in relation to the capitalization of CohBar and Morphogenesis as set forth in the Merger Agreement) and will not change or otherwise be adjusted based on the market price of CohBar Common Stock.

Any changes in the market price of CohBar Common Stock before the completion of the Merger will not affect the number of shares Morphogenesis stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger, the market price of CohBar Common Stock increases from the market price on the date of the Merger Agreement, then Morphogenesis stockholders could receive merger consideration with substantially more value for their shares of Morphogenesis capital stock than the parties had negotiated when they established the Exchange Ratio. Similarly, if before the completion of the Merger the market price of CohBar Common Stock declines from the market price on the date of the Merger Agreement, then Morphogenesis stockholders could receive merger consideration with substantially lower value. The Merger Agreement does not include a price-based termination right.

Failure to complete the Merger may result in either CohBar or Morphogenesis paying a termination fee to the other party and could harm the price of CohBar Common Stock and future business and operations of each company.

If the Merger is not completed, CohBar and Morphogenesis are subject to the following risks:

•        if the Merger Agreement is terminated under specified circumstances, CohBar could be required to pay Morphogenesis a termination fee of $1.0 million, or Morphogenesis could be required to pay CohBar a termination fee of $3.0 million, plus, in each case, up to $1.5 million in expense reimbursements, respectively;

•        the price of CohBar Common Stock may decline and could fluctuate significantly; and

•        costs related to the Merger, such as financial advisor, legal and accounting fees, a majority of which must be paid even if the Merger is not completed.

If the Merger Agreement is terminated and the CohBar Board or the Morphogenesis Board determines to seek another business combination, there can be no assurance that either CohBar or Morphogenesis will be able to find another third party to transact a business combination with, or that if either CohBar or Morphogenesis is successful in finding such a third party, that such a business combination would yield comparable or greater benefits.

The issuance of CohBar Common Stock to Morphogenesis stockholders pursuant to the Merger Agreement and the resulting change in control from the Merger must be approved by CohBar stockholders, and the Merger Agreement and transactions contemplated thereby must be approved by the Morphogenesis stockholders. Failure to obtain these approvals would prevent the closing of the Merger.

Before the Merger can be completed, the CohBar stockholders must approve, among other things, the issuance of CohBar Common Stock to Morphogenesis stockholders pursuant to the Merger Agreement and the resulting change in control from the Merger, and Morphogenesis stockholders must adopt the Merger Agreement and approve the Merger and the related transactions. Failure to obtain the required stockholder approvals, including due to the inability to obtain a quorum to hold the CohBar Special Meeting, may result in a material delay in, or the abandonment of, the Merger. Any delay in completing the Merger may materially adversely affect the timing and benefits that are expected to be achieved from the Merger or the ability of CohBar or Morphogenesis to complete the Merger in accordance with the Merger Agreement.

If the conditions to the Merger, including the condition for CohBar to have at least $4.0 million cash and cash equivalents at the Effective Time, are not satisfied or waived, the Merger may not occur, the closing of the Merger could be delayed or pre-Merger CohBar stockholders could be diluted.

Even if the Merger is approved by the stockholders of Morphogenesis and Proposal Nos. 1, 2 and 3, as described in this proxy statement/prospectus are approved by the CohBar stockholders, specified conditions must be satisfied or, to the extent permitted by applicable law, waived to complete the Merger. One such condition is that CohBar shall have at least $4 million cash and cash equivalents after taking into account any of its transaction expenses as of the Effective Time. If this condition is not satisfied, the parties may renegotiate the terms of the Merger Agreement and/or the Merger may not occur or, even if this condition is waived by Morphogenesis, not satisfying this condition may adversely impact negotiations between CohBar and Morphogenesis to complete the Merger and/or a lower valuation being attributed to CohBar under the Merger Agreement, which could cause dilution to pre-Merger CohBar stockholders. These conditions are set forth in the Merger Agreement and each material condition to the completion of the Merger is described in the section titled “The Merger Agreement — Conditions to the Completion of the Merger” beginning on page 161 of this proxy statement/prospectus. CohBar and Morphogenesis cannot assure you that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the closing may be delayed. Any delay in completing the Merger may materially adversely affect the timing and benefits that are expected to be achieved from the Merger.

The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.

In general, neither CohBar nor Morphogenesis is obligated to complete the Merger if there is a material adverse effect affecting the other party between May 22, 2023, the date of the Merger Agreement, and the closing of the Merger. However, certain types of causes are excluded from the concept of a “material adverse effect.” Such exclusions include, but are not limited to, changes or conditions generally affecting the industries in which Morphogenesis operates, the economy, financial markets or regulatory or political conditions or developments, changes resulting from the announcement of the Merger, natural disasters, pandemics (including the coronavirus (“COVID-19”) pandemic), other force majeure events, acts of terrorism, war and certain governmental responses in relation thereto, changes in law or the generally accepted accounting principles in the U.S. (“GAAP”) and certain actions taken or not taken by Morphogenesis. Therefore, if any of these events were to occur or adversely affect CohBar or Morphogenesis, the other party would still be obliged to consummate the closing of the Merger notwithstanding such material adverse effect. If any such adverse effects occur and CohBar and Morphogenesis consummate the closing of the Merger, the stock price of the combined company may suffer. This in turn may reduce the value of the Merger to the stockholders of CohBar, Morphogenesis or both. For a more complete discussion of what constitutes a material adverse effect on CohBar or Morphogenesis, see the section titled “The Merger Agreement — Representations and Warranties” beginning on page 152 of this proxy statement/prospectus.

If CohBar and Morphogenesis complete the Merger, CohBar has agreed to issue and sell additional CohBar Common Stock in the Initial Financing and Second Financing, which will result in dilution of pre-Merger stockholders of CohBar and Morphogenesis if completed, and, even if the Initial Financing and Second Financing are each completed, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause further dilution to the combined company’s stockholders or restrict the combined company’s operations.

On May 22, 2023, CohBar entered into the Stock Purchase Agreement with the Investor pursuant to which CohBar agreed to participate in the Initial Financing at the Initial Closing. The consummation of the Initial Financing is conditioned on the satisfaction or waiver of the conditions of the Merger and the other conditions set forth in the Stock Purchase Agreement. In addition, pursuant to the Stock Purchase Agreement, CohBar has also agreed to participate in the Second Financing at the Second Closing. Any shares of CohBar Common Stock issued in the Initial Financing at the Initial Closing will result in dilution to the pre-Merger Morphogenesis equityholders and pre-Merger CohBar equityholders ownership interests of the combined company. Any shares of CohBar Common Stock issued in the Second Financing at the Second Closing will result in dilution to the then-existing securityholders’ ownership interests of the combined company. The Initial Financing and Second Financing are more fully described under the section titled “Agreements Related to the Merger — Stock Purchase Agreement” beginning on page 168 of this proxy statement/prospectus.

Even if the Initial Financing and Second Financing are completed, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements. Additional financing may not be available to the combined company when it is needed or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such financing will cause additional dilution to all then-existing securityholders of the combined company. It is also possible that the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company. For additional information relating to the risks and uncertainties regarding the combined company’s need to raise additional capital, see “Risks Related to the Combined Company — The combined company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.”

Some CohBar and Morphogenesis directors and executive officers have interests in the Merger that are different from yours and that may influence them to support, approve or vote against the Merger without regard to your interests.

Directors and executive officers of CohBar and Morphogenesis may have interests in the Merger that are different from, or in addition to, the interests of other CohBar stockholders generally. These interests with respect to CohBar’s directors and executive officers may include, among others, acceleration of stock option, warrant or equity grant vesting, retention bonus payments, extension of exercisability periods of previously issued stock option grants, severance payments if employment is terminated in a qualifying termination in connection with the Merger and rights to continued indemnification, expense advancement and insurance coverage. Two members of the CohBar Board are expected to continue as directors of the combined company after the Effective Time, and, following the closing of the Merger, are expected to be eligible to be compensated as non-employee directors of the combined company. These interests with respect to Morphogenesis’ directors and executive officers may include, among others, certain of Morphogenesis’ directors and executive officers have options, subject to vesting, to purchase shares of Morphogenesis Common Stock which, after the Effective Time, will be converted into and become options to purchase shares of the common stock of the combined company; Morphogenesis’ executive officers are expected to continue as executive officers of the combined company after the Effective Time; and all of Morphogenesis’ directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.

In addition, certain current members of the Morphogenesis Board will continue as directors of the combined company after the Effective Time, and, following the closing of the Merger, will be eligible to be compensated as non-employee directors of the combined company pursuant to the combined company’s non-employee director compensation policy.

The CohBar Board and Morphogenesis Board were aware of and considered such interests, among other matters, in reaching their decisions to approve and adopt or vote against the adoption of the Merger Agreement, approve or vote against the Merger and recommend the approval or disapproval of the Merger Agreement to CohBar and Morphogenesis stockholders. These interests, among other factors, may have influenced the directors and executive officers of CohBar and Morphogenesis to support, approve or vote against the Merger.

For more information regarding the interests of CohBar and Morphogenesis directors and executive officers in the Merger, please see the sections titled “The Merger — Interests of CohBar’s Directors and Executive Officers in the Merger” beginning on page 134 and “The Merger — Interests of Morphogenesis’ Directors and Executive Officers in the Merger” beginning on page 137 of this proxy statement/prospectus.

CohBar stockholders and Morphogenesis stockholders may not realize a benefit from the Merger commensurate with the ownership interest dilution they will experience in connection with the Merger, including due to any shares of CohBar Common Stock issued in the Initial Financing.

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, CohBar stockholders and Morphogenesis stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

If the Merger is not completed, CohBar’s stock price may decline significantly.

The market price of CohBar Common Stock is subject to significant fluctuations. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of CohBar Common Stock will likely be volatile based on whether stockholders and other investors believe that CohBar can complete the Merger or otherwise raise additional capital to support CohBar’s operations if the Merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of CohBar Common Stock has been and may be exacerbated by lower trading volume. Additional factors that may cause the market price of CohBar Common Stock to fluctuate include:

•        the entry into, or termination of, key agreements, including commercial partner agreements;

•        announcements by commercial partners or competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

•        the loss of key employees;

•        future sales of its common stock;

•        general and industry-specific economic conditions that may affect its research and development expenditures;

•        the failure to meet industry analyst expectations; and

•        period-to-period fluctuations in financial results.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of CohBar Common Stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

The market price of the combined company’s common stock following the Merger may decline as a result of the Merger.

The market price of the combined company’s common stock may decline as a result of the Merger for a number of reasons, including if

•        investors react negatively to the prospects of the combined company’s product candidates, business and financial condition following the Merger;

•        the effect of the Merger on the combined company’s business and prospects is not consistent with the expectations of financial or industry analysts; or

•        the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts.

For additional information relating to the risks and uncertainties regarding the market price of the combined company’s common stock following the Merger, see “Risks Related to the Combined Company — The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.”

CohBar and Morphogenesis stockholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.

After the completion of the Merger, the current stockholders of CohBar and Morphogenesis will generally own a smaller percentage of the combined company than their ownership of their respective companies prior to the Merger. Immediately after the Merger, including the Stock Dividend and, after taking into account the Initial Financing, pre-Merger Morphogenesis stockholders are expected to own approximately 77% of the combined company, pre-Merger CohBar stockholders are expected to own approximately 15% of the combined company, and the Investor is expected to own approximately 9% of the combined company (excluding in each such case the effect of out-of-the-money options and warrants of CohBar that will remain outstanding after the Merger), subject to certain assumptions, including, but not limited to, (i) a valuation for CohBar equal to $25.0 million, (ii) a valuation for Morphogenesis equal to $130.6 million and (iii) gross proceeds of $15.0 million from the Initial Financing, in each case as further described in the Merger Agreement. The Chief Executive Officer and Chief Financial Officer of Morphogenesis will serve as the Chief Executive Officer and Chief Financial Officer of the combined company, respectively, following the completion of the Merger.

During the pendency of the Merger, CohBar and Morphogenesis may not be able to enter into a business combination with another party on more favorable terms because of restrictions in the Merger Agreement, which could adversely affect their respective business prospects.

Covenants in the Merger Agreement impede the ability of CohBar and Morphogenesis to make acquisitions during the pendency of the Merger, subject to specified exceptions. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating or knowingly encouraging, inducing or facilitating the communication, making, submission or announcement of any acquisition proposal or acquisition inquiry or taking any action that could reasonably be expected to lead to any acquisition proposal or acquisition inquiry regarding transactions involving a third party, including a merger, consolidation or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “The Merger Agreement — Non-Solicitation” beginning on page 157 of this proxy statement/prospectus.

Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.

The terms of the Merger Agreement prohibit each of CohBar and Morphogenesis from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances as described in further detail in the section titled “The Merger Agreement — Non-Solicitation” beginning on page 157 of this proxy statement/prospectus. In addition, if CohBar terminates the Merger Agreement under specified circumstances, CohBar could be required to pay Morphogenesis a termination fee of $1.0 million, or Morphogenesis could be required to pay CohBar a termination fee of $3.0 million, plus, in each case, up to $1.5 million in expense reimbursements. The termination fee provisions may discourage third parties from submitting competing proposals to CohBar, Morphogenesis or their respective stockholders, and may cause the CohBar Board or the Morphogenesis Board to be less inclined to recommend a competing proposal.

Because the lack of a public market for Morphogenesis’ capital stock makes it difficult to evaluate the fair market value of Morphogenesis’ capital stock, the value of the CohBar Common Stock to be issued to Morphogenesis stockholders may be more or less than the fair market value of Morphogenesis’ capital stock.

The outstanding capital stock of Morphogenesis is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Morphogenesis’ capital stock. Because the percentage of CohBar equity to be issued to Morphogenesis stockholders was determined based on negotiations between the parties, it is possible that the value of the CohBar Common Stock to be issued to Morphogenesis stockholders will be more or less than the fair market value of Morphogenesis’ capital stock.

If the Merger does not qualify as a reorganization under the Code, U.S. holders of Morphogenesis Common Stock may be taxed on the full amount of the consideration received in the Merger.

As discussed more fully under the section titled “The Merger — Material U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of Morphogenesis Common Stock,” the Merger is intended to qualify for U.S. federal income tax purposes as a “reorganization” within the meaning of Section 368(a) of the Code. Assuming the Merger so qualifies, no gain will be recognized by U.S. holders of Morphogenesis Common Stock who receive only CohBar Common Stock in the Merger. It is not, however, a condition to Morphogenesis’ obligation or CohBar’s obligation to complete the transactions that the Merger so qualifies. None of the parties to the Merger Agreement have sought or intend to seek any ruling from the IRS regarding the qualification of the Merger as a reorganization within the meaning of Section 368(a) of the Code. If the Merger does not qualify for the U.S. federal income tax treatment described herein, U.S. holders of Morphogenesis Common Stock may be taxed on any gain realized up to the full fair market value of any CohBar Common Stock received in the Merger.

Litigation has arisen, and more could arise, in connection with the Merger, against CohBar, the CohBar Board, Morphogenesis or the Morphogenesis Board, which could be costly, prevent consummation of the Merger, divert management’s attention and otherwise materially harm CohBar’s, Morphogenesis’s or the combined company’s business.

In the past, securities litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. CohBar, the CohBar Board, Morphogenesis, the Morphogenesis Board or the combined company may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect the business and cash resources or either party and the ability of either party to consummate the Merger or a potential strategic alternative (in the case the Merger is not approved or does not occur) or the ultimate value the CohBar or Morphogenesis stockholders receive in any such transaction.

In July, 2023, two lawsuits were filed against CohBar and the CohBar Board in connection with the Merger, each generally alleging that the proxy statement/prospectus misrepresents and/or omits certain purportedly material information relating to the Merger (the “Merger Actions”). Each of the Merger Actions asserts violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder against CohBar and the CohBar Board and violations of Section 20(a) of the Exchange Act against the CohBar Board. CohBar believes the Merger Actions to be without merit.

It is possible that additional putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against CohBar, the CohBar Board, Morphogenesis or the Morphogenesis Board in connection with the transactions contemplated by the Merger Agreement. The outcome of litigation is inherently uncertain, and CohBar and Morphogenesis may not be successful in defending against existing or future claims. Regardless of the outcome of any litigation, including the Merger Actions, such litigation may be time-consuming and expensive, could delay or prevent the Merger, and may distract management of CohBar or Morphogenesis from running the day-to-day operations of their respective businesses. The litigation costs and diversion of Cohbar’s or Morphogenesis’ management’s attention and resources to address the claims and counterclaims in any litigation related to the Merger may materially adversely affect the business, results of operations, prospects, and financial condition of CohBar, Morphogenesis or the combined company.

If the Merger is not consummated for any reason, litigation could be filed in connection with the failure to consummate the Merger. Any litigation related to the Merger may result in negative publicity or an unfavorable impression of CohBar, Morphogenesis or the combined company, which could adversely affect the price of CohBar Common Stock, Morphogenesis Common Stock or the combined company’s common stock, impair the ability of CohBar, Morphogenesis or the combined company to recruit or retain employees, damage relationships with customers, suppliers, and other business partners, or otherwise materially harm CohBar’s, Morphogenesis’s or the combined company’s operations and financial performance.

The opinion delivered by Ladenburg to the CohBar Board on May 22, 2023 does not reflect changes in circumstances that may have occurred since the date of the opinion.

The CohBar Board has not obtained an updated opinion either as of the date of this proxy statement/prospectus or as of any other date subsequent to the date of the opinion from Ladenburg, CohBar’s financial advisor. Changes in circumstances since the date of that opinion, including in the operations and prospects of CohBar or Morphogenesis, stock prices, general market and economic conditions and other factors, some or all of which may be beyond the control of CohBar and Morphogenesis are not reflected in its opinion. The opinion does not speak as of any date other than the date of the opinion.

CohBar’s stockholders may potentially not receive any payment on the CVRs and the CVRs may otherwise expire valueless.

The Merger Agreement contemplates that, at or prior to the Effective Time, CohBar will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a rights agent pursuant to which each of CohBar’s stockholders of record immediately prior to the Merger and certain warrant holders of record as of the close of business on the business day immediately prior to the date of the closing of the Merger or such other date pursuant to the terms of the Merger Agreement will receive one CVR for each outstanding share of CohBar Common Stock held by such stockholder or, in the case of the warrants, each share of CohBar Common Stock for which such warrant is exercisable on such date, in each case, subject to and in accordance with the terms and conditions of the CVR Agreement. Each CVR will entitle the holder thereof to receive certain cash payments from the net proceeds, if any, related to the disposition of CohBar’s legacy assets pursuant to any disposition agreement entered into within three years of the closing of the Merger. The right of CohBar’s stockholders to derive any value from the CVRs will be contingent solely upon the disposition of such assets within the time periods specified in the CVR Agreement. CohBar’s legacy assets include the tangible and intangible assets primarily used in or primarily related to the development and optimization of novel therapeutics that are analogs of mitochondrial derived peptides, including without limitation the CohBar’s CB4211 candidate and CB5138 Analogs.

CohBar, or the combined company, may not be able to dispose of, or achieve successful results from the disposition of, such assets as described above. If CohBar, or the combined company, is not able to dispose of, or achieve successful results from the disposition of, such assets for any reason within the time periods specified in the CVR Agreement, including due to any permitted deductions set forth in the CVR Agreement being greater than any gross proceeds, no payments will be made under the CVRs, and the CVRs will expire valueless.

The tax treatment of the CVRs is uncertain.

CohBar intends to treat the issuance of the CVRs to the persons who prior to completion of the Merger were CohBar stockholders as a distribution of property with respect to CohBar Common Stock. However, the U.S. federal income tax treatment of the CVRs is uncertain. There is no legal authority directly addressing the U.S. federal income tax treatment of contingent value rights with characteristics similar to the CVRs. Therefore, it is possible that

the issuance of the CVRs may be treated as a distribution of equity with respect to CohBar Common Stock, as an “open transaction,” or as a “debt instrument” for U.S. federal income tax purposes, and such questions are inherently factual in nature. For more information regarding the U.S. federal income tax consequences of the CVRs, see the section titled “Agreements Related to the Merger — Contingent Value Rights Agreement — Material U.S. Federal Income Tax Consequences of the CVRs to Holders of CohBar Common Stock.”

Risks Related to the Proposed Reverse Stock Split

The proposed reverse stock split may not increase the combined company’s stock price over the long-term.

The principal purposes of the reverse stock split are to (i) increase the per-share market price of CohBar Common Stock above the minimum bid price requirement under Nasdaq listing rules so that the listing of CohBar and the shares of CohBar Common Stock being issued in the Merger on Nasdaq will be approved and (ii) increase the number of authorized and unissued shares available for future issuance. It cannot be assured, however, that the reverse stock split will accomplish any increase in the per-share market price of CohBar Common Stock for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of CohBar Common Stock, it cannot be assured that the reverse stock split will increase the market price of its common stock by a multiple of the reverse stock split ratio determined in the discretion of the CohBar Board in consultation and cooperation with Morphogenesis, or result in any permanent or sustained increase in the market price of CohBar Common Stock, which is dependent upon many factors, including CohBar’s business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of CohBar might meet the listing requirements for Nasdaq initially after the reverse stock split, it cannot be assured that it will continue to do so.

The proposed reverse stock split may decrease the liquidity of CohBar Common Stock or the combined company’s common stock.

Although the CohBar Board believes that the anticipated increase in the market price of the combined company’s common stock resulting from the proposed reverse stock split could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the reverse stock split. The reduction in the number of outstanding shares may lead to reduced trading in and a smaller number of market makers for the combined company’s common stock. In addition, the reverse stock split may not result in an increase in the combined company’s stock price necessary to satisfy Nasdaq’s initial listing requirements for the combined company.

If the Merger does not occur and the CohBar Board were to effect the reverse stock split, the reduction in the number of outstanding shares of CohBar Common Stock after the reverse stock split could reduce the liquidity of CohBar Common Stock. The reduction in the number of outstanding shares may lead to reduced trading in and a smaller number of market makers for CohBar Common Stock. Additionally, there is no guarantee that the reverse stock split would increase the price of CohBar Common Stock to the price necessary to comply with the Nasdaq minimum bid price listing requirements.

The proposed reverse stock split may lead to a decrease in the overall market capitalization of the combined company or CohBar.

Should the market price of the combined company’s common stock or CohBar Common Stock (in the case the Merger does not occur and the CohBar Board were to effect the reverse stock split) decline after the reverse stock split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the reverse stock split. A reverse stock split is often viewed negatively by the market and, consequently, can lead to a decrease in the overall market capitalization the combined company or CohBar, as applicable. If the per-share market price does not increase in proportion to the reverse stock split ratio, then the value of the combined company or CohBar, as applicable, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of the combined company’s common stock or CohBar Common Stock, as applicable, will remain the same after the reverse stock split is effected, or that the reverse stock split will not have an adverse effect on the price of the combined company’s common stock or CohBar Common Stock, as applicable, due to the reduced number of shares outstanding after the reverse stock split.

Risks Related to CohBar

Unless the context otherwise requires, references to “we,” “us,” “our” or “Company” in this subsection “— Risks Related to CohBar” generally refer to CohBar.

Risks Related to Strategic Alternative Process and Potential Strategic Transaction

If the Merger is not approved or does not occur, we may decide to dissolve and liquidate our Company, and the amount of cash that may be available for distribution to our stockholders is uncertain.

If the Merger is not approved or does not occur, we may decide to pursue a dissolution and liquidation of our Company, and the amount of cash that may be available for distribution to our stockholders is uncertain. This amount will depend on the resolution of our financial commitments and contingent liabilities and the timing of the decision to liquidate. Our financial commitments and contingent liabilities include: (i) personnel costs, including severance; (ii) contractual obligations to vendors and clinical study sites; and (iii) non-cancelable lease obligations. In addition, if the Merger Agreement is terminated under specified circumstances, we could be required to pay Morphogenesis a termination fee of $1.0 million, plus up to $1.5 million in expense reimbursements. Even if a termination fee or expense reimbursements are not payable in connection with a termination of the Merger Agreement, we will have incurred significant fees and expenses, which must be paid whether or not the Merger is completed.

If the Merger is not approved or does not occur, we may not be successful in identifying and implementing any strategic alternatives and any future strategic transactions could have negative consequences.

If the Merger is not approved or does not occur, we may seek strategic alternatives, including a merger, business combination, investment into CohBar, asset sale or other strategic transaction. The process of continuing to evaluate these strategic alternatives is costly, time-consuming and complex, and we have incurred, and may in the future incur, significant costs related to this continued evaluation, such as legal and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this process. A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed, decreasing the remaining cash available for use in our business. This reduction in our available cash may make us less attractive to potential partners.

Potential counterparties in a strategic transaction involving our Company may place minimal or no value on our assets. Further, the development and any potential commercialization of our product candidates will require substantial additional cash to fund the costs associated with conducting the necessary preclinical and clinical testing and obtaining regulatory approval. Consequently, any potential counterparty in a strategic transaction involving our Company may choose not to spend additional resources and continue to utilize CohBar’s peptide library and technology platform and may attribute little or no value, in such a transaction, to those product assets.

There can be no assurance that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated, lead to increased stockholder value, or achieve the anticipated results. If we are unable to consummate the Merger or a strategic transaction, the CohBar Board may decide to pursue a dissolution and liquidation.

Even if we are successful in completing the Merger or a strategic alternative, we may be exposed to other operational and financial risks.

Although there can be no assurance that the Merger or a strategic alternative (in the case the Merger is not approved or does not occur) will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation and consummation of any such transaction requires significant time on the part of our management, which results in disruption to our business.

The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose us to other operational and financial risks, including:

•        increased near-term and long-term expenditures;

•        exposure to unknown liabilities;

•        higher than expected acquisition or integration costs;

•        incurrence of substantial debt or dilutive issuances of equity securities to fund future operations;

•        write-downs of assets or goodwill or incurrence of non-recurring, impairment or other charges;

•        increased amortization expenses;

•        difficulty and cost in combining the operations and personnel of any acquired business with our operations and personnel;

•        impairment of relationships with key suppliers or customers of any acquired business due to changes in management and ownership;

•        inability to retain key employees of our Company or any acquired business; and

•        possibility of future litigation.

Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects.

Our ability to consummate the Merger or a strategic alternative depends on our ability to retain our employees required to consummate such transaction.

Our ability to consummate the Merger or a strategic alternative (in the case the Merger is not approved or does not occur) depends upon our ability to retain our employees required to consummate such a transaction, in particular our Chief Executive Officer and Chief Financial Officer, the loss of whose services may adversely impact the ability to consummate such transaction. If we are unable to successfully retain these employees, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business operations.

Risks Related to Our Financial Position and Need for Additional Capital

We have had a history of losses and no revenue.

We have generated substantial accumulated losses since our inception. We have not generated any revenues from our operations to date and do not expect to generate any revenue in the near future. As a result, our management expects the business to continue to experience negative cash flow for the foreseeable future. We can offer no assurance that we will ever operate profitably or that we will generate positive cash flow in the future.

Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing, the Merger, the Initial Financing, the Second Financing or one or more strategic alternatives (as discussed above). We will need to raise additional funds, and such funds may not be available on commercially acceptable terms, if at all. If we are unable to raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements. This may seriously harm our business, financial condition and results of operations. In the event we are not able to continue operations, investors will likely suffer a complete loss of their investments in our securities.

We are an early-stage biotechnology company and may never be able to successfully develop marketable products or generate any revenue and there is no assurance that our future operations will result in profits.

We are an early-stage company. Our operations to date have been limited to organizing and staffing our Company, business planning, raising capital, identifying MDPs for further research, developing our intellectual property portfolio, performing research on identified MDPs and our novel analogs and progressing our most advanced drug candidate into and through clinical studies. We have not generated any revenues to date. In December 2022, we announced that we had suspended further IND-enabling activities for our CB5138-3 product candidate due to challenges in identifying a suitable formulation for clinical development. Similarly, we have not been able to identify a formulation for CB4211 that would be suitable to move it forward to the next stage of clinical development. We have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, evaluating and implementing the Merger or a strategic alternative

(as discussed above), failure of potential drug candidates either in research, preclinical testing or in clinical trials, and failure to establish business relationships and competitive advantages against other companies. If we fail to consummate the Merger or otherwise become profitable, we may be forced to further suspend or cease operations.

If we fail to demonstrate efficacy or safety in any future research and clinical trials, our future business prospects, financial condition and operating results will be materially adversely affected.

The success of any future research and development efforts will greatly depend on our ability to demonstrate efficacy of our novel peptide analogs in non-clinical studies, as well as in clinical trials. Non-clinical studies involve testing potential drug candidates in appropriate non-human disease models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in humans. If certain non-clinical data reveals potential safety issues or the results are inconsistent with an expectation of the potential drug’s efficacy in humans, the program may be discontinued or the regulatory agencies may require additional testing before allowing human clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our potential drugs if, in the judgment of our management and advisors, the non-clinical test results do not support further development. For example, in December 2022, we announced that we had suspended further IND-enabling activities for our CB5138-3 product candidate due to challenges in identifying a suitable formulation for clinical development.

Moreover, success in future research, preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and non-clinical testing. Any future clinical trial process may fail to demonstrate that our potential drug candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a drug candidate and may delay development of other potential drug candidates. Any delay in, or termination of, future non-clinical testing or clinical trials will delay the filing of any future investigational new drug application and new drug application with the FDA or the equivalent applications with pharmaceutical regulatory authorities outside the United States and, ultimately, our ability to commercialize any potential drugs and generate product revenues. In addition, our Phase 1a/1b trial of CB4211, our most advanced drug candidate, involved, and we expect that any future early clinical trials that we may conduct will involve, small patient populations. Because of these small sample sizes, the results of these early clinical trials, including the topline data from our CB4211 Phase 1a/1b trial, may not be indicative of future results.

Risks Related to Discovery, Development and Commercialization

If any future clinical trials are delayed, suspended or terminated, we may be unable to develop future product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of any approved products.

We cannot predict whether we will encounter problems with our future clinical trials that will cause regulatory agencies, institutional review boards or us to suspend or delay a trial. We have experienced delays in both our CB4211 and CB5138-3 programs. Our Phase 1a/1b clinical trial for CB4211 was suspended in November 2018 in order to address injection site reactions, and was delayed again in March 2020 due to impacts of the COVID-19 pandemic. Our planned IND filing for our CB5138-3 product candidate was delayed from the second half of 2022 to the second half of 2023 due to the observation of injection site reactions in our preclinical toxicology studies. Ultimately, our efforts to mitigate these injection site reactions by improving the formulation for this product candidate were unsuccessful and in December 2022, we announced that we had suspended further IND-enabling activities for this peptide.

Clinical trials and clinical data collection protocols can be delayed for a variety of reasons, including:

•        unanticipated consequences of the formulation of the product candidate requiring us to pause the trial to investigate alternative formulations;

•        the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials;

•        discussions with the FDA regarding the scope or design of our clinical trials and clinical data collection protocols;

•        delays or the inability to obtain required approvals from institutional review boards or other responsible entities at clinical sites selected for participation in our existing or future clinical trials;

•        adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;

•        the amendment of clinical trial or data collection protocols to reflect changes in regulatory requirements and guidance or other reasons, as well as subsequent re-examination of amendments of clinical trial or data collection protocols by institutional review boards or other responsible bodies; and

•        the need to repeat or conduct additional clinical trials as a result of inconclusive or negative results, failure to replicate positive early clinical data in subsequent clinical trials, failure to deliver an efficacious dose of a product candidate, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol, an unacceptable study design or other problems.

In addition, a future clinical trial or development program may be suspended or terminated by us, institutional review boards, the FDA or other responsible bodies due to a number of factors, including:

•        failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

•        inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

•        inability to resume a suspended trial in a timely manner, which we cannot predict with certainty, if at all;

•        unforeseen safety issues or any determination that a trial presents unacceptable health risks;

•        inability to deliver an efficacious dose of a product candidate; and

•        lack of adequate funding to continue the clinical trial.

If the results of our future clinical trials are not available when we expect or if we encounter any delay in the analysis of data from our future clinical trials, we may be unable to conduct additional clinical trials on the schedule we anticipate. Many of the factors that cause, or lead to, a delay in the commencement or completion of future clinical trials may also ultimately lead to the denial of regulatory approval of a future product candidate. Any delays in completing a clinical trial could increase our development costs, delay or prevent the availability of topline data expected to be available from the trial, delay product development and regulatory submission process or make it difficult to raise additional capital.

If we do not achieve any future projected development goals in the time frames we announce and expect, the commercialization of any such future products may be delayed and, as a result, our stock price may decline.

From time to time, we have estimated the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we have publicly announced and may in the future publicly announce the expected timing of some of these milestones. All of these milestones have been and will be based on numerous assumptions, including timely performance by our CROs and other vendors, positive clinical and preclinical results, our ability to develop commercially viable formulations for our product candidates, and sufficient funding from partnering and general fundraising. The actual timing of these milestones have varied dramatically compared to our estimates, in some cases for reasons beyond our control. For example, we initially projected that we would have topline results from our 1a/1b clinical trial for CB4211 trial in early 2019. The trial was substantially delayed, and we did not release topline results for this study until August of 2021. For our CB5138-3 product candidate, we initially projected that we would file an IND for this program in the second half of 2022. We later revised this estimate to the second half of 2023 and, in December 2022, we announced the suspension of IND-enabling activities for this program due to challenges in identifying a suitable formulation for clinical development. The delays in each of these programs resulted in declines in our stock price. If we fail to meet future milestones as publicly announced, or at all, our revenue may be lower than expected, the commercialization of our products may be delayed or never achieved and, as a result, our stock price may decline.

Our future success depends on our Chief Executive Officer and Chief Financial Officer.

We are highly dependent on our Chief Executive Officer and Chief Financial Officer who are employed “at will,” meaning they may terminate the employment relationship at any time. We do not maintain “key person” insurance for any of the key members of our team. We have in the past and may in the future continue to experience changes in our executive management team resulting from the departure of executives or subsequent hiring of new executives. The loss of the services of our Chief Executive Officer or Chief Financial Officer could impede our ability to consummate the Merger or any other strategic alternatives, as discussed above.

We may seek to establish development and commercialization collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our potential future drug development programs and the potential commercialization of our future drug candidates will require substantial additional cash to fund expenses. We may decide to collaborate with biopharmaceutical companies in connection with the development or commercialization of our potential future drug candidates.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive collaboration agreement will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the expected efficacy, safety and tolerability of the subject product candidate, the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential reimbursement rates for such product candidates, the potential of competing products, the strength of our data supporting the mechanism of action of the subject product candidate, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar disease indications on which to collaborate, and whether such alternative collaboration project could be more attractive than one with us for our product candidate.

There are a limited number of large biopharmaceutical companies with whom we could potentially collaborate, and collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on a timely basis, on acceptable terms or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund future development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop future product candidates or bring them to market and generate product revenue.

We may not be successful in any future efforts to identify or discover potential drug development candidates.

A key element of our strategy has been to identify and test MDPs and novel analogs that play a role in cellular processes underlying our targeted disease indications. Any drug discovery efforts may not be successful in identifying novel peptide analogs that are useful in treating disease. Our research programs may initially show promise in identifying potential drug development candidates, yet fail to yield candidates for preclinical and clinical development. For example, in December 2022, we announced that we had suspended further IND-enabling activities for our CB5138-3 product candidate due to challenges in identifying a suitable formulation for clinical development. Similarly, we have not been able to identify a formulation for CB4211 that would be suitable to move it forward to the next stage of clinical development. There are a number of reasons why any future research efforts may not yield appropriate development candidates, including:

•        the research methodology used may not be successful in identifying appropriate potential drug development candidates;

•        we may not be able to identify the mechanism of action for potential drug candidates, which may make it more difficult to develop and commercialize such drug candidates due to the potential desire of the FDA and other regulatory bodies, potential partners, physicians and patients to understand such mechanism of action; or

•        potential drug development candidates may, on further study, be shown not to be effective in humans, or to have unacceptable toxicities, harmful side effects, properties that make them difficult or impossible to formulate in a commercial fashion, or other characteristics that indicate that they are unlikely to be medicines that will receive marketing approval and achieve market acceptance.

We have not been successful to date in our efforts to develop commercially viable formulations for our product candidates.

Our product candidates are comprised of novel peptide analogs. We expect that our product candidates will need to be delivered via subcutaneous injection and may cause local injection site reactions (“ISRs”), which is a common finding in peptide therapeutic product candidates. While not necessarily adverse to patients’ health, ISRs could substantially limit the commercial appeal of our product candidates, and we may decide or be required to perform additional preclinical studies or to halt or delay further clinical development of our product candidates. To date, we have not been able to identify suitable formulations for our CB4211 or CB5138-3 product candidates. It is possible that other product candidates that we may identify will also result in ISRs. Our approach to address these ISRs is to develop novel formulations that decrease or eliminate these reactions. If we are unable to successfully develop such formulations, we may decide to abandon those drug candidates as we have done with CB5138-3. Any efforts to identify alternate drug candidates that do not cause ISRs would take additional time and expense and may not be successful.

Our future research and development plans will require substantial additional funding which could impact our operational and financial condition. Without the required additional funds, we will likely cease operations.

It will take several years before we are able to develop potentially marketable products, if at all. Our future research and development plans will require substantial additional capital to:

•        conduct research, preclinical testing and human studies;

•        manufacture any future drug development candidate or product at pilot and commercial scale;

•        develop and manufacture devices compatible with our drug products that are suitable for use by patients to inject our drug products on a chronic basis; and

•        establish and develop quality control, regulatory, and administrative capabilities to support these programs.

Our future operating and capital needs will depend on many factors, including:

•        the pace of scientific progress in our future research programs and the magnitude of these programs;

•        the scope and results of preclinical testing and human studies;

•        the time and costs involved in obtaining regulatory approvals;

•        the time and costs involved in preparing, filing, prosecuting, securing, maintaining and enforcing intellectual property rights;

•        the complexity of any delivery device that we develop for use in combination with our drug products;

•        competing technological and market developments;

•        our ability to establish additional collaborations;

•        changes in any future collaborations;

•        the cost of manufacturing any drug products and any related delivery device; and

•        the cost and effectiveness of efforts to commercialize and market any products.

We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include the initiation and success of any future research and development initiatives, regulatory approvals, the timing of events outside our direct control such as negotiations with potential strategic partners, and other factors. Any of these uncertain events can significantly change our cash requirements as they determine such one-time events as the receipt or payment of major milestones and other payments.

Additional funds will be required to support our operations, and if we are unable to obtain them on favorable terms or at all, we may be required to cease or reduce future research and development of our drug product programs, sell or abandon some or all of our intellectual property, merge with another entity or cease operations.

Even if we are able to develop future potential drug candidates, we may not be able to obtain regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results and financial condition, and we will have to delay or terminate some or all of our research and development plans, which may force us to cease operations.

All of our future potential drug candidates will require extensive additional research and development, including preclinical testing and clinical trials, as well as regulatory approvals, before we can market them. We cannot predict if or when any future potential drug candidate will be approved for marketing. There are many reasons that we may fail in our efforts to develop our future potential drug candidates. These include:

•        the possibility that preclinical testing or clinical trials may show that our potential drugs are ineffective and/or cause undesirable or harmful side effects or toxicities;

•        we may not be able to develop commercially viable formulations for our potential drug candidates;

•        our potential drugs may prove to be too expensive to manufacture or administer to patients;

•        our potential drugs may have routes of administration that are less convenient or acceptable to patients;

•        we may not understand the mechanism of action of our potential drugs, which could negatively impact our ability to recruit patients to participate in the clinical trials necessary for regulatory approval of our potential drugs;

•        our potential drugs may fail to receive necessary regulatory approvals from the FDA or foreign regulatory authorities in a timely manner, or at all;

•        even if our potential drugs are approved, we may not be able to produce them in commercial quantities or at reasonable costs;

•        even if our potential drugs are approved, they may not achieve commercial acceptance;

•        even if our potential drugs are approved and commercially launched, the costs of any delivery device used in combination with our drug products may result in an overall manufacturing cost that is not competitive with competing products that do not require a delivery device;

•        even if our potential drugs are approved and commercially launched, they may not receive desirable payor reimbursement and formulary access;

•        regulatory or governmental authorities may apply restrictions to any of our potential drugs, which could adversely affect their commercial success; and

•        the proprietary rights of other parties may prevent us or our potential collaborative partners from marketing our potential drugs.

If we fail to develop future potential drug candidates, our financial results and financial condition will be adversely affected, we will have to delay or terminate some or all of our research and development plans and may be forced to cease operations.

Risks Related to Our Reliance on Third Parties

If we do not maintain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be limited, which would have a material adverse effect on our business.

We will need to maintain our existing relationships with leading scientists and/or establish new relationships with scientific collaborators. We believe that such relationships are pivotal to establishing products using our technologies as a standard of care for various disease indications. There is no assurance that our founders, scientific advisors or research partners will continue to work with us or that we will be able to attract additional research partners. If we are not able to establish scientific relationships to assist in future research and development, we may not be able to successfully develop potential drug candidates in the future. If this happens, our business will be adversely affected.

We expect to rely on third parties to conduct any future clinical trials and some aspects of any future research and preclinical testing. These third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or preclinical testing.

We expect to rely on third parties to conduct some aspects of our future research and expect to rely on third parties to conduct additional aspects of our future research and preclinical testing, as well as any future clinical trials. Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it would delay our future product research and development activities.

Our reliance on these third parties for future research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our future drug candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our medicines. For example, we experienced delays in receiving the data from our third-party CRO conducting our CB4211 Phase 1b study, which delayed our analysis and release of topline data.

We expect to rely on other third parties to store and distribute drug supplies for our future clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our future drug candidates or commercialization of any future products, producing additional losses and depriving us of potential product revenue.

Risks Related to Product Development and Regulatory Approval

Even if we are successful in developing future drug candidates, we may not be able to market or generate sales of such future products to the extent anticipated. Our business may fail, and investors could lose all of their investment in our Company.

Assuming that we are successful in developing any future potential drug candidates and receiving regulatory clearances to market our potential products, our ability to successfully penetrate the market and generate sales of such future products may be limited by a number of factors, including the following:

•        if our competitors receive regulatory approvals for and begin marketing similar products in the United States, the European Union (“EU”), Japan and other territories before we do, greater awareness of their products as compared to ours will cause our competitive position to suffer;

•        information from our competitors or the academic community indicating that current products or new products are more effective, have better safety or tolerability profiles or offer compelling other benefits than our future products could impede our market penetration or decrease our future market share; and

•        the pricing and reimbursement environment for our future products, as well as pricing and reimbursement decisions by our competitors and by payers, may have an effect on our revenues.

If any of these occur, our business could be adversely affected.

Interim and preliminary or topline data from our future clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim topline or preliminary data from our future clinical trials. Interim data from future clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary or topline data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between interim or preliminary or topline data and final data could significantly harm our reputation and business prospects.

Any future product candidate we are able to develop and commercialize would compete in the marketplace with existing therapies and new therapies that may become available in the future. These competitive therapies may be more effective, safer, better tolerated, less costly, more easily administered or offer other advantages over any product we seek to market.

There are numerous therapies currently marketed to treat IPF, diabetes, cancer, and other diseases for which our future potential product candidates may be indicated. These therapies are varied in their design, therapeutic application and mechanism of action and may provide significant competition for any of our future product candidates for which we obtain market approval. New products may also become available that provide efficacy, safety, tolerability, convenience and other benefits that are not provided by currently marketed therapies. As a result, they may provide significant competition for any of our future product candidates for which we obtain market approval. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, better tolerated, more effective, have fewer or less severe side effects, are more conveniently administered (i.e., are administered via methods other than subcutaneous injection) or stored or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers’ or other third-party payers’ reimbursement polices seeking to encourage the use of existing products that are generic or are otherwise less expensive to provide.

The use of any of our future product candidates in clinical trials, and the results of those trials, may expose us to liability claims, which may cost us significant amounts of money to defend against or pay out, causing our business to suffer.

The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of our potential products. If any of our future drug candidates are used in clinical trials, or if any of our future drug candidates become marketed products, they could potentially harm people or allegedly harm people, possibly subjecting us to costly and damaging product liability claims. Some of the patients who participate in clinical trials are already ill when they enter a trial or may intentionally or unintentionally fail to meet the exclusion criteria. The waivers we obtain may not be enforceable and may not protect us from liability or the costs of product liability litigation. Although we obtained product liability insurance, which we believe is adequate, we are subject to the risk that our insurance will not be sufficient to cover claims. We anticipate that we will need to increase our insurance coverage if we successfully commercialize any product candidate. The insurance costs along with the defense or payment of liabilities above the amount of coverage could cost us significant amounts of money and management distraction from other elements of the business, decrease demand for any product

candidates that we may develop, injure our reputation and attract significant negative media attention, and lead to the withdrawal of clinical trial participants, causing our business to suffer. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult and costly, particularly in light of increased focus on privacy issues in countries around the world, including the United States and the EU.

We are subject to various domestic and international privacy and security regulations. The confidentiality, collection, use and disclosure of personal data, including clinical trial patient-specific information, are subject to governmental regulation generally in the country that the personal data were collected or used. In the United States, we are subject, or expect to be subject, to various state and federal privacy and data security regulations, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009. HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions, as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In the EU, personal data includes any information that relates to an identified or identifiable natural person with health information carrying additional obligations, including obtaining the explicit consent from the individual for collection, use or disclosure of the information. In addition, the protection of and cross-border transfers of such data out of the EU has become more stringent with the EU’s General Data Protection Regulation which came into effect in May 2018. Furthermore, the legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues. The United States and the EU and its member states continue to issue new privacy and data protection rules and regulations that relate to personal data and health information. Compliance with these laws may be time consuming, difficult and costly. If we fail to comply with applicable laws, regulations or duties relating to the use, privacy or security of personal data, we could be subject to the imposition of significant civil and criminal penalties, be forced to alter our business practices and suffer reputational harm.

We may not be able to obtain agreement with regulatory authorities regarding an acceptable development plan for our future product candidates, the outcome of our future clinical trials may not be favorable or, even if favorable, regulatory authorities may not find the results of our future clinical trials to be sufficient for marketing approval.

In the United States, the FDA generally requires two adequate and well-controlled pivotal clinical trials to approve a new drug application (“NDA”). Furthermore, for full approval of an NDA, the FDA requires a demonstration of efficacy based on a clinical benefit endpoint. The FDA may grant accelerated approval based on a surrogate endpoint reasonably likely to predict clinical benefit. Even if any future pivotal clinical trials for a specific indication were to achieve their primary endpoints and may be reasonably believed by us to be likely to predict clinical benefit, the FDA may not accept the results of such trials or approve our future product candidates on an accelerated basis, or at all. It is also possible that the FDA may refuse to accept for filing and review any regulatory application we submit for regulatory approval in the United States. Even if our regulatory application is accepted for review, there may be delays in the FDA’s review process, and the FDA may determine that such regulatory application does not contain adequate clinical or other data or support the approval of our future product candidate. In such a case, the FDA may issue a complete response letter that may require that we conduct and/or complete additional clinical trials and preclinical studies or provide additional information or data before it will reconsider an application for approval. Any such requirements may be substantial, expensive and time-consuming, and there is no guarantee that we will continue to pursue such application or that the FDA will ultimately decide that any such application supports the approval of our future product candidate. Furthermore, the FDA may also refer any regulatory application to an advisory committee for review and recommendation as to whether, and under what conditions, the application should be approved. While the FDA is not bound by the recommendation of an advisory committee, it considers such recommendations carefully when making decisions. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product to market could decrease our ability to generate sufficient revenue to maintain our business.

The regulatory approval process is lengthy, expensive and uncertain, and we may be unable to obtain regulatory approval for our future product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of our future product candidates and adversely impact our ability to generate revenue, our business and our results of operations.

The development, research, testing, manufacturing, labeling, approval, selling, import, export, marketing, promotion and distribution of drug products are subject to extensive and evolving regulation by federal, state and local governmental authorities in the United States, principally the FDA, and by foreign regulatory authorities, which regulations differ from country to country. Neither we nor any future collaborator is permitted to market any of our product candidates in the United States until we receive regulatory approval of an NDA from the FDA.

Obtaining regulatory approval of an NDA can be a lengthy, expensive and uncertain process. Prior to obtaining approval to commercialize our future product candidate in the United States or abroad, we or our collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or other foreign regulatory authorities, that such product candidates are safe and effective for their intended uses. The number of nonclinical studies and clinical trials that will be required for regulatory approval varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate.

Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for our future product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. Administering product candidates to humans may produce undesirable side effects, which could interrupt, delay or halt clinical trials and result in the FDA or other regulatory authorities denying approval of a product candidate for any or all indications. The FDA may also require us to conduct additional studies or trials for our product candidates either prior to or post-approval, such as additional clinical pharmacology studies or safety or efficacy studies or trials, or it may object to elements of our clinical development program such as the primary endpoints or the number of subjects in our clinical trials.

The FDA or any foreign regulatory bodies can delay, limit or deny approval of our product candidates or require us to conduct additional nonclinical or clinical testing or abandon a program for many reasons, including:

•        the FDA or the applicable foreign regulatory authority’s disagreement with the design or implementation of our clinical trials;

•        negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•        serious and unexpected drug-related side effects experienced by participants in our clinical trials;

•        our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory authority that our product candidates are safe and effective for the proposed indication;

•        the FDA’s or the applicable foreign regulatory authority’s disagreement with the interpretation of data from nonclinical studies or clinical trials;

•        our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks;

•        the FDA’s or the applicable foreign regulatory authority’s requirement for additional nonclinical studies or clinical trials;

•        the FDA’s or the applicable foreign regulatory authority’s disagreement regarding the formulation, labeling and/or the specifications of our product candidates;

•        the FDA’s or the applicable foreign regulatory authority’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract;

•        the potential for approval policies or regulations of the FDA or the applicable foreign regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval; or

•        the FDA or the applicable foreign regulatory authority’s disagreement with the sufficiency of the clinical, non-clinical and/or quality data in the NDA or comparable marketing authorization application.

Of the large number of drugs in development, only a small percentage successfully complete the FDA or other regulatory approval processes and are commercialized. The lengthy development and approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our future product candidates, which would significantly harm our business, financial condition, results of operations and prospects.

Any future product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our future product candidates, when and if any of them are approved.

Our future product candidates and the activities associated with their development and potential commercialization, including their testing, manufacturing, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other U.S. and international regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, requirements relating to manufacturing, including current good manufacturing practices (“cGMP”), quality control, quality assurance and corresponding maintenance of records and documents, including periodic inspections by the FDA and other regulatory authorities and requirements regarding the distribution of samples to providers and recordkeeping.

The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of any approved product. The FDA closely regulates the post-approval marketing and promotion of drugs and biologics to ensure drugs and biologics are marketed only for the approved disease indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding use of their products. If we promote our future product candidates in a manner inconsistent with FDA-approved labeling or otherwise not in compliance with FDA regulations, we may be subject to enforcement action. Violations of the Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws and similar laws in international jurisdictions.

In addition, later discovery of previously unknown adverse events or other problems with our future product candidates, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

•        restrictions on such product candidates, manufacturers or manufacturing processes;

•        restrictions on the labeling or marketing of a product;

•        restrictions on product distribution or use;

•        requirements to conduct post-marketing studies or clinical trials;

•        warning or untitled letters;

•        withdrawal of any approved product from the market;

•        refusal to approve pending applications or supplements to approved applications that we submit;

•        recall of product candidates;

•        restrictions on product distribution or use;

•        fines, restitution or disgorgement of profits or revenues;

•        suspension or withdrawal of marketing approvals;

•        refusal to permit the import or export of our product candidates;

•        product seizure; and

•        injunctions or the imposition of civil or criminal penalties.

Non-compliance with European requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the EU’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

The patent positions of biopharmaceutical products are complex and uncertain, and we may not be able to protect our patented or other intellectual property. If we cannot protect this property, we may be prevented from using it, or our competitors may use it, and our business could suffer significant harm. Also, the time and money we spend on acquiring and enforcing patents and other intellectual property will reduce the time and money we have available for our business.

We own or exclusively license patents and patent applications related to our MDPs and potential drug candidates comprised of novel analogs. However, neither patents nor patent applications ensure the protection of our intellectual property for a number of reasons, including the following:

•        The United States Supreme Court rendered a decision in Molecular Pathology vs. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) (“Myriad”), in which the court held that naturally occurring DNA segments are products of nature and not patentable as compositions of matter. On March 4, 2014, the United States Patent and Trademark Office (“USPTO”) issued guidelines for examination of such claims that, among other things, extended the Myriad decision to any natural product. Since MDPs are natural products isolated from cells, the USPTO guidelines may affect allowability of some of our patent claims (pertaining to natural MDP sequences) that are filed in the USPTO but are not yet issued. Further, while the USPTO guidelines are not binding on the courts, it is likely that as the law of subject matter eligibility continues to develop, Myriad will be extended to natural products other than DNA. Thus, our issued U.S. patent claims directed to MDPs as compositions of matter may be vulnerable to challenge by competitors who seek to have our claims rendered invalid. While Myriad and the USPTO guidelines described above will affect our patents only in the United States, there is no certainty that similar laws or regulations will not be adopted in other jurisdictions.

•        Competitors may interfere with our patenting process in a variety of ways. Competitors may claim that they invented the claimed invention prior to us. Competitors may also claim that we are infringing their patents and restrict our freedom to operate. Competitors may also contest our patents and patent applications, if issued, by showing in various patent offices that, among other reasons, the patented subject matter was not original, was not novel or was obvious. In litigation, a competitor could claim that our patents and patent applications are not valid or enforceable for a number of reasons. If a court agrees, we would lose some or all of our patent protection.

•        As a company, we have no meaningful experience with competitors interfering with our patents or patent applications. In order to enforce our intellectual property, we may need to file a lawsuit against a competitor. Enforcing our intellectual property in a lawsuit can take significant time and money. We may not have the resources to enforce our intellectual property if a third party infringes an issued patent claim. Infringement lawsuits may require significant time and money resources. If we do not have such resources, for patents that we have licensed from a third party, the licensor is not obligated to help us enforce our patent rights. If the licensor does take action by filing a lawsuit claiming infringement, we will not be able to participate in the suit and therefore will not have control over the proceedings or the outcome of the suit.

•        Because of the time, money and effort involved in obtaining and enforcing patents, our management may spend less time and resources on other aspects of our business than they otherwise would, which could increase our operating expenses and delay any future product programs.

•        There can be no assurance that any of our patent applications, including any licensed patent applications, will result in the issuance of patents, and we cannot predict the breadth of claims that may be allowed in our currently pending patent applications or in patent applications we may file or license from others in the future.

•        Issuance of a patent may not provide much practical protection. If we receive a patent of narrow scope, then it may be easy for competitors to design products that do not infringe our patent(s).

•        If a court decides that the method of manufacture or use of any of our drug candidates infringes on a third-party patent, we may have to pay substantial damages for infringement.

•        A court may prohibit us from making, selling or licensing a potential drug candidate unless the patent holder grants a license. A patent holder is not required to grant a license. If a license is available, we may have to pay substantial royalties or grant cross licenses to our patents, and the license terms may be unacceptable.

•        Redesigning our potential drug candidates so that they do not infringe on other patents may not be possible or could require substantial funds and time.

It is also unclear whether our trade secrets are adequately protected. While we use reasonable efforts to protect our trade secrets, our employees or consultants may unintentionally or willfully disclose our information to competitors. Enforcing a claim that someone illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Our competitors may independently develop equivalent knowledge, methods and know-how. We may also support and collaborate in research conducted by government organizations, hospitals, universities or other educational institutions. These research partners may be unable or unwilling to grant us exclusive rights to technology or products derived from these collaborations prior to entering into the relationship.

If we do not obtain required intellectual property rights, we could encounter delays in any future drug development efforts while we attempt to design around other patents or even be prohibited from developing, manufacturing or selling potential drug candidates requiring these rights or licenses. There is also a risk that disputes may arise as to the rights to technology or potential drug candidates developed in collaboration with other parties.

General Risk Factors

If we fail to establish and maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures and that we furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis. Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting. However, for as long as we are not an accelerated filer or large accelerated filer, we intend to take advantage of the exemption permitting us not to comply with the independent registered public accounting firm attestation requirement.

Our compliance with Section 404 will require us to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue taking steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a

risk that we will not be able to conclude that our internal control over financial reporting is effective as required by Section 404. For example, we concluded as of the end of the second quarter of 2023 that our disclosure controls and procedures were not effective due to a material weakness. The material weakness relates to a lack of segregation of duties as we currently have only one employee assigned to positions that involve processing financial information. As a result, not all of our journal entries and account reconciliations have been reviewed by someone other than the preparer, heightening the risk of error or fraud. There can be no assurance of when, if ever, we will be able to remediate the identified material weaknesses. The presence of this or other material weaknesses could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. In addition, if we are not able to continue to meet these requirements, we may not be able to remain listed on Nasdaq. If material weaknesses or deficiencies in our internal controls exist and go undetected or unremedied, our financial statements could contain material misstatements that, when discovered in the future, could cause us to fail to meet our future reporting obligations and cause the price of our common stock to decline.

Significant disruptions of information technology systems or security breaches could adversely affect our business.

We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information (including, among other things, trade secrets or other intellectual property, proprietary business information and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations to third parties, and as a result we have managed, and may in the future continue to manage, a number of third-party vendors who may or could have access to our confidential information. Attacks on information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being conducted by increasingly sophisticated and organized groups and individuals with a wide range of motives and expertise. The size and complexity of our information technology systems, and those of third-party vendors with whom we contract, and the large amounts of confidential information potentially stored on those systems, make such systems vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious third parties. Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information.

Significant disruptions of our information technology systems, or those of our third-party vendors, or security breaches could adversely affect our business operations and/or result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information, including, among other things, trade secrets or other intellectual property, proprietary business information and personal information, and could result in financial, legal, business and reputational harm to us.

Any failure or perceived failure by us or any third-party collaborators, service providers, contractors or consultants to comply with our privacy, confidentiality, data security or similar obligations to third parties, or any data security incidents or other security breaches that result in the unauthorized access, release or transfer of sensitive information, including personally identifiable information, may result in governmental investigations, enforcement actions, regulatory fines, litigation or public statements against us, could cause third parties to lose trust in us or could result in claims by third parties asserting that we have breached our privacy, confidentiality, data security or similar obligations, any of which could have a material adverse effect on our reputation, business, financial condition or results of operations. Moreover, data security incidents and other security breaches can be difficult to detect, and any delay in identifying them may lead to increased harm. While we have implemented data security measures intended to protect our information technology systems and infrastructure, there can be no assurance that such measures will successfully prevent service interruptions or data security incidents.

Public health crises such as pandemics or similar outbreaks could adversely impact our business.

Public health crises such as pandemics or similar outbreaks could adversely impact our business.

The trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic and the resulting impact on the macroeconomic environment, including rising interest rates, inflation and recessionary fears. Future public health crises, including pandemics or similar outbreaks such as COVID-19, may adversely impact our business, strategy and financial condition. The extent to which any public health crises impacts our business, strategy or financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the emergence of novel variants, the impact of vaccinations and vaccination rates, travel restrictions and actions to contain new outbreaks or resurgences or treat its impact, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat resurgences or novel variants.

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.

The trading market for our common stock can be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. If any of the analysts who may cover us change their recommendation regarding our stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would likely decline. If any analysts who may cover us were to cease coverage of our Company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

The volatility in the price of our common stock could result in substantial losses to our stockholders.

The market price of our common stock has been and is likely to continue to be volatile. The stock market in general, and the market for biotechnology companies in particular has experienced extreme volatility that can be unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:

•        developments concerning the Merger or Morphogenesis;

•        results of preclinical studies or clinical trials of our future product candidates or those of our competitors;

•        unanticipated or serious safety concerns related to the use of any of our future product candidates;

•        challenges in developing commercially viable formulations for our future product candidates;

•        adverse regulatory decisions, including failure to receive regulatory approval for any of our future product candidates;

•        the success of competitive drugs or technologies;

•        regulatory or legal developments in the United States and other countries applicable to our future product candidates;

•        the size and growth of our prospective patient populations;

•        developments concerning our future collaborators, our external manufacturers or in-house manufacturing capabilities;

•        inability to obtain adequate product supply for any future product candidate for preclinical studies, clinical trials or future commercial sale or inability to do so at acceptable prices;

•        developments or disputes concerning patent applications, issued patents or other proprietary rights;

•        the recruitment or departure of key personnel;

•        the level of expenses related to any of our future product candidates or clinical development programs;

•        the results of our efforts to discover, develop, acquire or in-license additional product candidates or drugs;

•        actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts or publications of research reports about us or our industry;

•        variations in our financial results or those of companies that are perceived to be similar to us;

•        changes in the structure of healthcare payment systems;

•        market conditions in the biotechnology sector;

•        our cash position or the announcement or expectation of additional financing efforts;

•        the impact of rising inflation, including wage inflation;

•        general macroeconomic, industry, geopolitical and market conditions; and

•        other factors, including those described in this “Risk Factors” section, many of which are beyond our control.

If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our common stock could be delisted.

Our common stock is currently listed on Nasdaq. To maintain this listing, we must satisfy continued listing requirements and standards. There can be no assurances that we will be able to comply with the applicable listing requirements and standards. For example, in November 2021, we received a notice from the Nasdaq Listing Qualifications Department notifying us that for 30 consecutive trading days, the bid price of our common stock had closed below the minimum $1.00 per share requirement. In accordance with Nasdaq’s listing rules, we were afforded a grace period of 180 calendar days, or until May 9, 2022, to regain compliance with the bid price requirement. In order to regain compliance, the bid price of our common stock had to close at a price of at least $1.00 per share for a minimum of 10 consecutive trading days.

On May 10, 2022, Nasdaq notified us that we had not regained compliance by May 9, 2022, but that Nasdaq had granted us an additional 180 day period to regain compliance because we met the continued listing requirement for market value of publicly held shares and all other applicable Nasdaq listing requirements (other than the minimum closing bid price requirement) and we provided written notice to Nasdaq of our intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. On September 23, 2022, we executed a reverse stock split of our common stock at a ratio of 1-for-30. In response to their non-compliance notification on May 10, 2022, and as a result of the reverse stock split, we received notification from The Nasdaq Stock Market Listing Qualifications Staff on October 7, 2022, that we were in compliance with its minimum bid price requirement and the matter was closed.

If our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, including as a result of our failure to meet the bid price requirement, trading of our shares of common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities. In such event, it would likely become more difficult to dispose of, or obtain accurate price quotations for, shares of our common stock.

Our business could be negatively affected as a result of significant stockholders or potential stockholders attempting to effect changes or acquire control over CohBar, which could cause us to incur significant expense, hinder execution of our business strategy, including consummation of the Merger, and impact the trading value of our securities.

Our stockholders may from time-to-time attempt to effect changes, engage in proxy solicitations or advance stockholder proposals. Responding to proxy contests and other actions by activist shareholders can be costly and time-consuming, disrupting our operations and diverting the attention of the CohBar Board and senior management from the pursuit of business strategies, including the consummation of the Merger. Any of these impacts could

materially and adversely affect our business and operating results. Further, the market price of our common stock, which has been trading below book value, could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties described above.

The requirements of being a public company may strain our resources, divert management’s attention and require us to disclose information that is helpful to competitors, make us more attractive to potential litigants and make it more difficult to attract and retain qualified personnel.

As a public company, we are subject to the reporting requirements of the Securities Act of 1933, as amended, the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and applicable Canadian securities rules and regulations. Despite reforms made possible by the JOBS Act, compliance with these rules and regulations creates significant legal and financial compliance costs and makes some activities difficult, time-consuming or costly. The Exchange Act and applicable Canadian provincial securities legislation require, among other things, that we file annual, quarterly and current reports with respect to our business and operating results.

Additionally, the Sarbanes-Oxley Act and the related rules and regulations of the SEC and Nasdaq require us to implement particular corporate governance practices and adhere to a variety of reporting requirements and complex accounting rules. Among other things, we are subject to rules regarding the independence of the members of the CohBar Board and committees of the board and their experience in finance and accounting matters, rules regarding the diversity of the CohBar Board and certain of our executive officers are required to provide certifications in connection with our quarterly and annual reports filed with the SEC. The perceived personal risk associated with these rules may deter qualified individuals from accepting these positions. Accordingly, we may be unable to attract and retain qualified officers and directors. If we are unable to attract and retain qualified officers and directors, our business and our ability to maintain the listing of our shares of common stock on Nasdaq or another stock exchange could be adversely affected.

Changes in U.S. federal income and other tax laws could adversely affect us.

New U.S. legislation or regulations that could affect our tax burden could be enacted by the U.S. government. We cannot predict the timing or extent of such tax-related developments that could have a negative impact on our financial results. Additionally, we use our best judgment in attempting to quantify and reserve for these tax obligations. However, a challenge by a taxing authority, our ability to utilize tax benefits such as carryforwards or tax credits, or a deviation from other tax-related assumptions could have a material adverse effect on our business, results of operations, or financial condition.

Unfavorable global macroeconomic conditions and geopolitical uncertainty could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy, such as the inflationary environment, financial institution instability and recessionary fears, in the global financial markets and due to geopolitical uncertainty, such as the ongoing conflict in Ukraine and rising tensions between China and Taiwan. For example, the global financial crisis caused extreme volatility and disruptions in the capital and credit markets, and the recent and ongoing armed conflict in Ukraine had similar impacts on the global financial markets. A severe or prolonged economic downturn, such as a global financial crisis, could result in a variety of risks to our business, including, weakened demand for our product candidates and our weakened ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our future suppliers, possibly resulting in supply disruptions. Any of the foregoing could harm our business, and we cannot anticipate all of the ways in which the current macroeconomic climate, geopolitical uncertainty and financial market conditions could adversely impact our business.

We maintain our cash at financial institutions. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.

Our cash is held at banking institutions in non-interest-bearing and interest-bearing accounts. If such banking institutions were to fail, similar to Silicon Valley Bank in March 2023, we could lose access to our accounts or our assets held in our accounts or our access to our accounts or assets may be materially delayed. Any material loss that

we may experience in the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability to pay our operational expenses or make other payments, which could adversely affect our business.

We or the future third parties upon whom we may depend may be adversely affected by natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters could severely disrupt our operations and have a material adverse effect on our business, results of operations, financial condition and prospects. For example, our corporate headquarters are located in the San Francisco Bay Area, which has experienced both severe earthquakes and the effects of wildfires. We do not carry earthquake insurance. In addition, the long-term effects of climate change on general economic conditions and the biopharmaceutical industry in particular are unclear, and may heighten or intensify existing risk of natural disasters. If an earthquake, wildfire, other natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business.

Our employees, directors, and potential future principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, directors, and potential future principal investigators, consultants and commercial partners. Misconduct by these parties could include intentional failures to comply with the regulations of FDA and non-U.S. regulators, provide accurate information to the FDA and non-U.S. regulators, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of ethics, but it is not always possible to identify and deter employee or director misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Risks Related to Morphogenesis

Risks Related to Morphogenesis’ Business and Industry

Morphogenesis is a clinical-stage company and has a limited operating history, which may make it difficult to evaluate Morphogenesis’ current business and predict its future performance.

Morphogenesis is a clinical-stage pharmaceutical company that was formed in 1995. Morphogenesis has no products approved for commercial sale and has not generated any revenue. Morphogenesis employs a multi-indication immunomodulator platform (ImmuneFx) that utilizes both cell and gene therapies, together, to stimulate the immune system to recognize and combat tumor cells. Although there have been significant advances in cell and gene-based immunotherapies, Morphogenesis’ immunomodulatory platforms are new and largely unproven. Morphogenesis’ operations to date have been limited to organizing and staffing the company, business planning, raising capital, developing its technology, identifying potential product candidates, undertaking preclinical studies, and conducting clinical trials. If one of Morphogenesis’ product candidates received regulatory approval, Morphogenesis would need to transition from a company with a research and

development focus to a company capable of supporting commercial activities. Morphogenesis may not be successful in such a transition. In addition, Morphogenesis’ limited operating history, particularly in light of the rapidly evolving cancer immunotherapy field, may make it difficult to evaluate its current business and predict its future performance. Morphogenesis will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields. If it does not address these risks successfully, Morphogenesis’ business will suffer.

Morphogenesis has incurred significant losses since inception and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future.

Morphogenesis is not profitable and has incurred significant losses in each period since Morphogenesis’ inception, including net losses of $7.0 million for the year ended December 31, 2021, $9.4 million for the year ended December 31, 2022, and $22.1 million for the six months ended June 30, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, Inc., of which $15 million was paid in the form of Morphogenesis Common Stock). To date, Morphogenesis has financed its operations primarily through private placements of its preferred stock and convertible notes. Morphogenesis has not commercialized any products and has never generated any revenue from product sales. Morphogenesis expects these losses to increase as it continues to incur significant research and development and other expenses related to Morphogenesis’ ongoing operations, seeks regulatory approvals for Morphogenesis’ product candidates, scales-up manufacturing capabilities and hires additional personnel to support the development of its product candidates and to enhance its operational, financial and information management systems.

A critical aspect of Morphogenesis’ strategy is to invest significantly in its technology platform to improve the efficacy and safety of its product candidates. To become and remain profitable, Morphogenesis must develop and eventually commercialize products with significant market potential, which it may never achieve. Even if Morphogenesis succeeds in commercializing one or more of these product candidates, Morphogenesis will continue to incur losses for the foreseeable future relating to its substantial research and development expenditures to develop Morphogenesis’ technologies. Morphogenesis may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The size of Morphogenesis’ future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue. Morphogenesis’ prior losses and expected future losses have had and will continue to have an adverse effect on its stockholders’ equity and working capital. Further, the net losses Morphogenesis incurs may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of its results of operations may not be a good indication of Morphogenesis’ future performance. If Morphogenesis does not achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Morphogenesis’ failure to become and remain profitable would decrease the value of the company and could impair its ability to raise capital, maintain its discovery and preclinical and clinical development efforts, expand its business or continue its operations and may require Morphogenesis to raise additional capital that may dilute your ownership interest. A decline in the value of Morphogenesis could also cause you to lose all or part of your investment.

Morphogenesis has never generated any revenue from product sales for its human drug candidates and its ability to generate revenue from product sales and become profitable depends significantly on its success in numerous endeavors.

Morphogenesis has no products approved for commercial sale, has not generated any revenue from product sales, and does not anticipate generating any revenue from product sales until sometime after Morphogenesis has received regulatory approval for the commercial sale of a product candidate. Morphogenesis’ ability to generate revenue and achieve profitability depends significantly on its success in many endeavors, including:

•        completing research regarding, and nonclinical and clinical development of, Morphogenesis’ product candidates;

•        obtaining regulatory approvals and marketing authorizations for product candidates for which Morphogenesis completes clinical trials;

•        developing a sustainable and scalable manufacturing process for Morphogenesis’ product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing Morphogenesis’ own manufacturing capabilities and infrastructure;

•        launching and commercializing product candidates for which Morphogenesis obtains regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;

•        obtaining market acceptance of Morphogenesis’ product candidates as viable treatment options;

•        addressing any competing technological and market developments;

•        identifying, assessing, acquiring and/or developing new product candidates;

•        negotiating favorable terms in any collaboration, licensing, or other arrangements into which Morphogenesis may enter;

•        maintaining, protecting, and expanding Morphogenesis’ portfolio of intellectual property rights, including patents, trade secrets, and know-how; and

•        attracting, hiring, and retaining qualified personnel.

Because of the numerous risks and uncertainties associated with biopharmaceutical product development, Morphogenesis is unable to accurately predict the timing or amount of increased expenses or when, or if, Morphogenesis will be able to achieve profitability. If Morphogenesis is required by the U.S. Food and Drug Administration (the “FDA”), or other regulatory agencies, domestic or foreign, or other comparable foreign authorities, to perform preclinical studies or clinical trials in addition to those Morphogenesis currently anticipates, or if there are any delays in completing its clinical trials or the development of any of its product candidates, Morphogenesis’ expenses could increase and revenue could be further delayed.

Even if one or more of the product candidates that Morphogenesis develops is approved for commercial sale, Morphogenesis anticipates incurring significant costs associated with commercializing any approved product candidate. Morphogenesis’ expenses could increase beyond expectations if Morphogenesis is required by the FDA or other regulatory agencies, domestic or foreign, to change its manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that Morphogenesis currently anticipates. If Morphogenesis is successful in obtaining regulatory approvals to market of one or more of its product candidates, its revenue will be dependent, in part, upon the size of the markets in the territories for which Morphogenesis gains regulatory approval, the accepted price for the product, the ability to get reimbursement at any price, and whether Morphogenesis owns the commercial rights for that territory. If the number of Morphogenesis’ addressable disease patients is not as significant as it estimates, the indication approved by regulatory authorities is narrower than it expects, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, Morphogenesis may not generate significant revenue from sales of such products, even if approved. If Morphogenesis is not able to generate revenue from the sale of any approved products, Morphogenesis may never become profitable.

Even if the Merger and the Initial Financing and Second Financing are successful, Morphogenesis will require substantial additional capital to finance its operations in the future. If Morphogenesis fails to obtain additional financing on acceptable terms or at all, it may be unable to complete the development and commercialization of its product candidates.

Morphogenesis’ operations have required substantial amounts of cash since inception. Morphogenesis expects to continue to spend substantial amounts to continue the clinical development of its product candidates, particularly as Morphogenesis advances the development of its lead product candidate IFx-Hu2.0 as a potential treatment for patients with melanoma, bladder and cervical cancers. If Morphogenesis obtains orphan drug designation and marketing approval for IFx or any of Morphogenesis’ product candidates, Morphogenesis expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.

As of June 30, 2023, Morphogenesis had approximately $6.2 million in cash and cash equivalents. Following the Merger and the Initial Financing and Second Financing, Morphogenesis will also incur additional costs associated with operating as a public company. Accordingly, Morphogenesis will require substantial additional funding to continue its operations. Based on its current operating plan, and assuming the Merger and Initial Financing and Second Financing are successfully completed, Morphogenesis believes that its existing cash, cash equivalents and short-term investments should be sufficient to fund its operations through the third quarter of 2025. This estimate is based on assumptions that may prove to be materially

wrong, and Morphogenesis could use its available capital resources sooner than it currently expects because of circumstances beyond its control. Morphogenesis may require additional capital for the further development and commercialization of Morphogenesis’ product candidates and may need to raise additional funds sooner if Morphogenesis chooses to pursue additional indications or geographies for its product candidates or otherwise expand more rapidly than it presently anticipates. Any additional fundraising efforts may divert Morphogenesis’ management from their day-to-day activities, which may adversely affect Morphogenesis’ ability to develop and commercialize its product candidates.

Morphogenesis cannot be certain that additional funding will be available on acceptable terms, or at all. Morphogenesis’ ability to raise additional funding will depend on financial, economic and market conditions and other factors, over which Morphogenesis may have no or limited control. In addition, Morphogenesis’ ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances resulting from the COVID-19 pandemic and the ongoing military conflict between Russian and Ukraine. Morphogenesis has no committed source of additional capital and if it is unable to raise additional capital in sufficient amounts or on terms acceptable to the company, Morphogenesis may have to significantly delay, scale back or discontinue the development or commercialization of its product candidates or other research and development initiatives. Morphogenesis’ license and collaboration agreements may also be terminated if it is unable to meet the payment obligations under the agreements. Morphogenesis could be required to seek collaborators for its product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms Morphogenesis’ rights to its product candidates in markets where it otherwise would seek to pursue development or commercialization itself.

Any of the above events could significantly harm Morphogenesis’ business, prospects, financial condition, and results of operations and cause the price of Morphogenesis’ Common Stock to decline.

The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition. Morphogenesis may be unable to compete with more substantial enterprises.

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As a result, Morphogenesis’ actual or proposed immunotherapies could become obsolete before Morphogenesis recoups any portion of Morphogenesis’ related research and development and commercialization expenses. Competition in the biopharmaceutical industry is based significantly on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain governmental approval for testing, manufacturing, and marketing. Morphogenesis competes with specialized biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area, including cancer. Many major pharmaceutical companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with Morphogenesis in recruiting and retaining highly qualified scientific personnel and consultants. Morphogenesis’ ability to compete successfully with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to the company.

Morphogenesis is aware of certain investigational new drugs under development or approved products by competitors that are used for the prevention, diagnosis, or treatment of certain diseases Morphogenesis has targeted for drug development. Various companies are developing biopharmaceutical products that have the potential to directly compete with Morphogenesis’ immunotherapies even though their approach may be different. The competition comes from both biotechnology firms and from major pharmaceutical companies. Many of these companies have substantially greater financial, marketing, and human resources than Morphogenesis. Morphogenesis also experiences competition in the development of its immunotherapies from universities, other research institutions and others in acquiring technology from such universities and institutions.

In addition, certain of Morphogenesis’ immunotherapies may be subject to competition from investigational new drugs and/or products developed using other technologies, some of which have completed numerous clinical trials.

The successful development of immunotherapies is highly uncertain.

Successful development of biopharmaceuticals is highly uncertain and depends on numerous factors, many of which are beyond Morphogenesis’ control. Immunotherapies that appear promising in the early phases of development may fail to reach the market for several reasons including:

•        clinical study results that may show the immunotherapy to be less effective than expected (e.g., the study failed to meet its primary endpoint) or to have unacceptable side effects;

•        failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis, or preparation of Biologics License Application (“BLA”), discussions with the FDA, an FDA request for additional preclinical or clinical data, or unexpected safety or manufacturing issues;

•        manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical; and

•        the proprietary rights of others and their competing products and technologies that may prevent the immunotherapy from being commercialized.

Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit, or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to the next and may be difficult to predict. The evidence of clinical response rates received to date for IFx-2.0, Morphogenesis’ principal product candidate, as well as the other clinical activity and results described in this proxy statement/prospectus, does not mean that IFx-2.0 or any other product candidate has demonstrated, or that such clinical response data will predict, sufficient clinical efficacy and prove the required level of safety in order to receive FDA approval or any other required regulatory approval.

In addition, although Morphogenesis is in discussions with the FDA regarding the initiation of a single registration-directed trial utilizing the FDA’s accelerated approval pathway for IFx-2.0 that would be conducted under a Special Protocol Assessment Agreement, there is no guarantee that Morphogenesis will ultimately receive a Special Protocol Assessment Agreement with the FDA for such a trial. Even if a Special Protocol Assessment Agreement for such a trial is granted, such agreement does not increase the likelihood of marketing approval for the product and may not lead to a faster or less costly development, review, or approval process.

Even if Morphogenesis is successful in getting market approval, commercial success of any of its product candidates will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care. Third-party payors could require Morphogenesis to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert Morphogenesis’ resources. If government and other health care payors were not to provide adequate coverage and reimbursement levels for any of Morphogenesis’ products once approved, market acceptance and commercial success would be reduced.

Morphogenesis’ technology platform, including its proprietary, multi-indication immunomodulatory platform (ImmuneFx IFx), technology is a new approach to treat cancer and other immune-related diseases that presents significant challenges.

Morphogenesis has concentrated its research and development efforts on advancing a new generation of immunotherapies based on the IFx platform, and its future success is highly dependent on the successful development of its product candidates, which target cancer and other immune-related diseases. Morphogenesis cannot be sure that its IFx platform will yield satisfactory products that are safe and effective, scalable, or profitable.

Although Morphogenesis is a cell therapy company its technology could become subject to many of the challenges and risks that gene therapies face, including:

•        regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future;

•        the FDA could recommend follow-up observation period of up to 15 years for all patients who receive Morphogenesis’ treatment. Morphogenesis may need to adopt such an observation period for its product candidates; and

•        clinical trials using genetically modified cells conducted at institutions that receive funding for recombinant DNA research from the U.S. National Institutes of Health (the “NIH”) are subject to review by the NIH Office of Biotechnology Activities’ Recombinant DNA Advisory Committee (the “RAC”). Although the FDA decides whether individual protocols may proceed, the RAC review process can impede the initiation of a clinical trial, even if the FDA has reviewed the study and approved its initiation.

Moreover, public perception of therapy safety issues, including adoption of new therapeutics or novel approaches to treatment, may adversely influence the willingness of subjects to participate in clinical trials, or if approved, of physicians to subscribe to the novel treatment mechanics. Physicians, hospitals and third-party payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training. Physicians may not be willing to undergo training to adopt this novel and personalized therapy, may decide the therapy is too complex to adopt without appropriate training and may choose not to administer the therapy. Based on these and other factors, hospitals and payors may decide that the benefits of this new therapy do not or will not outweigh its costs.

Morphogenesis’ near-term ability to generate product revenue is dependent on the success of one or more of its product candidates, each of which are at an early stage of development and will require significant additional clinical testing before it can seek regulatory approval and begin commercial sales.

Morphogenesis’ near-term ability to generate product revenue is highly dependent on its ability to obtain regulatory approval of and successfully commercialize one or more of its product candidates. IFx-Hu2.0 and IFx-Hu3.0 are in the early stages of development and will require additional clinical and nonclinical development, regulatory review, and approval in each jurisdiction in which Morphogenesis intends to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before it can generate any revenue from product sales. Before obtaining marketing approval from regulatory authorities for the sale of Morphogenesis’ product candidates, Morphogenesis must conduct extensive clinical trials to demonstrate the safety, purity, and potency of the product candidates in humans. Morphogenesis cannot be certain that any of its product candidates will be successful in clinical trials and they may not receive regulatory approval even if they are successful in clinical trials.

Before Morphogenesis can generate any revenues from sales of its lead product candidates, it must complete the following activities for each of them, any one of which it may not be able to successfully complete:

•        conduct additional preclinical and clinical development with successful outcomes;

•        manage preclinical, manufacturing, and clinical activities;

•        obtain regulatory approval from the FDA and other comparable foreign regulatory authorities;

•        establish manufacturing relationships for the clinical and post-approval supply of the applicable drug candidate in compliance with all regulatory requirements;

•        build a commercial sales and marketing team, either internally or by contract with third parties;

•        establish and maintain patent and trade secret protection or regulatory exclusivity for Morphogenesis’ product candidates;

•        develop and implement marketing strategies for successful commercial launch of Morphogenesis’ product candidates, if, and when, approved;

•        secure and maintain acceptance of Morphogenesis’ products, if, and when approved, by patients, from the relevant medical communities and from third-party payors;

•        compete effectively with other therapies;

•        establish and maintain adequate health care coverage and reimbursement from third-party payors;

•        ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any required post-marketing clinical trials or the elements of any post-marketing Risk Evaluation and Mitigation Strategy (“REMS”), that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the product outweigh its risks;

•        maintain continued acceptable safety profile of the product candidates following approval; and

•        invest significant additional cash in each of the above activities.

If Morphogenesis is unable to address one or more of these factors in a timely manner or at all, it could experience significant delays in the successful commercialization of, or an inability to successfully commercialize, Morphogenesis’ product candidates, which would materially harm its business. If Morphogenesis does not receive regulatory approvals for one or more of its product candidates, Morphogenesis may not be able to continue its operations. Even if Morphogenesis successfully obtains regulatory approvals to manufacture and market its product candidates, its revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and has commercial rights. If the markets for patient subsets that Morphogenesis is targeting are not as significant as it estimates, Morphogenesis may not generate significant revenues from sales of such products, if approved.

Morphogenesis may encounter substantial delays in its clinical trials or may not be able to conduct its trials on the timelines it expects.

Clinical testing is expensive, time consuming, and subject to uncertainty. Morphogenesis cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing, and Morphogenesis’ future clinical trials may not be successful. Events that may prevent successful or timely completion of clinical development include:

•        inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;

•        delays in reaching a consensus with regulatory agencies on trial design;

•        the FDA may not allow Morphogenesis to use the clinical trial data from a research institution to support an IND, application if Morphogenesis cannot demonstrate the comparability of its product candidates with the product candidate used by the relevant research institution in its clinical trials;

•        Morphogenesis’ INDs have been approved in a timely manner thus far, however the FDA may not agree with Morphogenesis’ approach and strategy, which could result in potential delays, and changes to its regulatory strategy;

•        Morphogenesis may be required to complete additional preclinical studies in human leukocyte antigens, before it can proceed with its INDs;

•        delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

•        delays in obtaining required Institutional Review Board (“IRB”) approval at each clinical trial site;

•        imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of Morphogenesis’ clinical trial operations or trial sites; developments on clinical trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

•        delays in recruiting suitable patients to participate in Morphogenesis’ clinical trials;

•        failure by Morphogenesis’ CROs, other third parties, or Morphogenesis to adhere to clinical trial requirements;

•        failure to perform in accordance with the FDA’s current good clinical practice regulations (“cGCPs”), requirements, or similar applicable regulatory guidelines in other countries;

•        delays in patients completing participation in a trial or returning for post-treatment follow-up;

•        patients dropping out of a trial;

•        occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

•        changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

•        changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;

•        the cost of clinical trials of Morphogenesis’ product candidates being greater than Morphogenesis anticipates;

•        clinical trials of Morphogenesis’ product candidates producing negative or inconclusive results, which may result in Morphogenesis deciding, or regulators requiring it, to conduct additional clinical trials or abandon product development programs;

•        delays in developing Morphogenesis’ manufacturing processes and transferring to new third-party facilities to support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and

•        delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of Morphogenesis’ product candidates for use in clinical trials or the inability to do any of the foregoing.

Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for Morphogenesis’ product candidates

Any inability to successfully complete preclinical and clinical development could result in additional costs to Morphogenesis or impair its ability to generate revenue. In addition, if Morphogenesis makes manufacturing or formulation changes to its product candidates, Morphogenesis may be required to, or it may elect to, conduct additional trials to bridge its modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which Morphogenesis’ products have patent protection and may allow its competitors to bring products to market before Morphogenesis does, which could impair its ability to successfully commercialize its product candidates and may harm its business and results of operations.

If Morphogenesis does not achieve its projected development and commercialization goals in accordance with its expected and announced timeframes, the commercialization of any of its product candidates may be delayed, and its business will be harmed.

Elsewhere in this proxy statement/prospectus Morphogenesis has provided timing estimates regarding the initiation of clinical trials and clinical development milestones, and the expected availability of data resulting from these trials for certain of Morphogenesis’ product candidates. Morphogenesis expects to continue to estimate the timing of these types of development milestones and its expected timing for the accomplishment of various other scientific, clinical, regulatory, and other product development objectives. From time to time, Morphogenesis may publicly announce the expected timing of some of these events. However, the achievement of many of these milestones and events may be outside of Morphogenesis’ control. These timing estimations are based on a variety of assumptions Morphogenesis makes, which may cause the actual timing of these events to differ from the timing it expects, including:

•        Morphogenesis’ available capital resources and its ability to obtain additional funding as needed;

•        the rate of progress, costs, and results of its clinical trials and research and development activities;

•        Morphogenesis’ ability to identify and enroll patients who meet clinical trial eligibility criteria;

•        Morphogenesis’ receipt of approvals by the FDA, European Medicines Agency (“EMA”), and other regulatory authorities and the timing of these approvals;

•        Morphogenesis’ ability to access sufficient, reliable, and affordable supplies of materials used in the manufacture of Morphogenesis’ product candidates;

•        the efforts with respect to the commercialization of Morphogenesis’ product candidates;

•        securing of costs related to, and timing issues associated with, manufacturing Morphogenesis’ therapeutic candidates and, if any of Morphogenesis’ product candidates are approved, sales and marketing activities and the commercial manufacture of its product candidates; and

•        circumstances arising from or relating to the COVID-19 pandemic, including potential effects on the global supply chain, Morphogenesis’ manufacturers and the availability of raw materials needed for the research and development of Morphogenesis’ product candidates.

If Morphogenesis fails to timely achieve announced milestones, the commercialization of any of its product candidates may be delayed, and its business and results of operations may be harmed.

Failure to successfully identify, develop, and commercialize additional therapeutics or product candidates could impair Morphogenesis’ ability to grow.

Although a substantial amount of Morphogenesis’ efforts will focus on the continued preclinical and clinical testing and potential approval of the product candidates in the company’s current pipeline, Morphogenesis expects to continue to innovate and potentially expand its portfolio. Research programs to identify product candidates may require substantial additional technical, financial, and human resources and may not result in any new potential product candidates being identified. Morphogenesis’ success may depend, in part, upon its ability to identify, select, and develop promising product candidates and therapeutics. Morphogenesis may expend resources and ultimately fail to discover and generate additional product candidates suitable for further development. All product candidates are prone to risks of failure typical of biotechnology product development, including the possibility that a product candidate may not be suitable for clinical development due to its harmful side effects, limited efficacy, or other characteristics indicating that it is unlikely to receive approval by the FDA, the EMA, and other comparable foreign regulatory authorities and achieve market acceptance. If Morphogenesis does not successfully develop and commercialize new product candidates it has identified and explored, Morphogenesis’ business, prospects, financial condition, and results of operations could be adversely affected.

The FDA or comparable foreign regulatory authorities may disagree with Morphogenesis’ regulatory plans and Morphogenesis may fail to obtain regulatory approval of Morphogenesis’ product candidates.

The FDA standard for regular approval of a biologic generally requires two well-controlled phase 3 studies or one large and robust, well-controlled phase 3 study in the patient population being studied that provides substantial evidence that a biologic is safe and effective for its proposed indication. Phase 3 clinical trials typically involve hundreds of patients, have significant costs, and take years to complete. Product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. If Morphogenesis’ efforts to obtain accelerated approval for IFx-2.0 or any other product candidate is not successful, then Morphogenesis may be required to conduct additional clinical trials beyond those it contemplates, which would likely result in a longer time period to potential approval and commercialization of such product candidate (if approved) and would likely increase the cost of development of such product candidate, all of which could harm the company’s competitive position in the marketplace and shorten the remaining term of applicable patent coverage after product approval.

As part of its marketing authorization process, the EMA may grant marketing authorizations on the basis of less complete data than is normally required, when, for certain categories of medicinal products, doing so may meet unmet medical needs of patients and serve the interest of public health. In such cases, it is possible for the Committee for Medicinal Products for Human Use (“CHMP”), to recommend the granting of a marketing authorization, subject to certain specific obligations to be reviewed annually, which is referred to as a conditional marketing authorization. This may apply to medicinal products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention, or the medical diagnosis of seriously debilitating diseases or life-threatening diseases and those designated as orphan medicinal products.

A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

•        the risk-benefit balance of the medicinal product is positive;

•        it is likely that the applicant will be in a position to provide the comprehensive clinical data;

•        unmet medical needs will be fulfilled; and

•        the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required

The granting of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete nonclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be used in emergency situations in response to public-health threats.

Conditional marketing authorizations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.

The granting of a conditional marketing authorization will allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case and will ensure that additional data on a product are generated, submitted, assessed, and acted upon. Although Morphogenesis may seek a conditional marketing authorization for one or more of Morphogenesis’ product candidates by the EMA, the EMA or CHMP may ultimately not agree that the requirements for such conditional marketing authorization have been satisfied.

Morphogenesis’ clinical trial results may also not support approval, whether accelerated approval, conditional marketing authorizations, or regular approval. The results of preclinical studies and clinical trials may not be predictive of the results of later-stage clinical trials, and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through preclinical studies and initial clinical trials. In addition, Morphogenesis’ product candidates could fail to receive regulatory approval for many reasons, including the following:

•        the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Morphogenesis’ clinical trials;

•        the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which Morphogenesis seeks approval;

•        Morphogenesis may be unable to demonstrate that its product candidates’ risk-benefit ratios for their proposed indications are acceptable;

•        the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•        Morphogenesis may be unable to demonstrate that the clinical and other benefits of its product candidates outweigh their safety risks;

•        the FDA or comparable foreign regulatory authorities may disagree with Morphogenesis’ interpretation of data from preclinical studies or clinical trials;

•        the data collected from clinical trials of Morphogenesis’ product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;

•        the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, Morphogenesis’ own manufacturing facilities, or a third-party manufacturer’s facilities with which Morphogenesis contracts for clinical and commercial supplies; and

•        the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering Morphogenesis’ clinical data insufficient for approval.

Further, failure to obtain approval for any of the above reasons may be made more likely due to the novel nature of Morphogenesis’ technology. Failure to obtain regulatory approval to market any of Morphogenesis’ product candidates would significantly harm its business, results of operations, and prospects.

Morphogenesis’ clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates, which would prevent or delay regulatory approval and commercialization.

The clinical trials of Morphogenesis’ product candidates are, and the manufacturing and marketing of its products will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where Morphogenesis intends to test and market its product candidates. Before obtaining regulatory approvals for the commercial sale of any of its product candidates, Morphogenesis must demonstrate through lengthy, complex, and expensive preclinical testing and clinical trials that its product candidates are both safe and effective for use in each target indication. In particular, because its product candidates are subject to regulation as biological drug products, Morphogenesis will need to demonstrate that they are safe, pure, and potent for use in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. The risk/benefit profile required for product licensure will vary depending on these factors and may include not only the ability to show tumor shrinkage, but also adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival. For example, response rates from the use of Morphogenesis’ product candidates may not be sufficient to obtain regulatory approval unless Morphogenesis can also show an adequate duration of response. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of Morphogenesis’

product candidates may not be predictive of the results of later-stage clinical trials. The results of studies in one set of patients or line of treatment may not be predictive of those obtained in another. Morphogenesis expects there may be greater variability in results for products processed and administered on a patient-by-patient basis, as anticipated for its product candidates, than for “off-the-shelf” products, like small molecule drugs which are not personalized for each patient. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

In addition, even if Morphogenesis’ clinical trials are successfully completed, Morphogenesis cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as Morphogenesis does, and more trials could be required before Morphogenesis submits its product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, Morphogenesis may be required to expend significant resources, which may not be available to it, to conduct additional trials in support of potential approval of its product candidates.

Morphogenesis’ product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.

As with most biological products, use of Morphogenesis’ product candidates could be associated with side effects or adverse events, which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects or unacceptable toxicities caused by Morphogenesis’ product candidates could cause Morphogenesis or regulatory authorities to interrupt, delay, or halt clinical trials.

The FDA or comparable foreign regulatory authorities could delay or deny approval of Morphogenesis’ product candidates for any or all targeted indications and negative side effects could result in a more restrictive label for any product that is approved. Side effects such as toxicity or other safety issues associated with the use of Morphogenesis’ product candidates could also require Morphogenesis or its collaborators to perform additional studies or halt development or sale of these product candidates.

If one or more of Morphogenesis’ product candidates receives marketing approval, and Morphogenesis or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using Morphogenesis’ products, many potentially significant negative consequences could result, including:

•        regulatory authorities may withdraw or limit their approvals of such products;

•        regulatory authorities may require the addition of labeling statements, specific warnings or a contraindications;

•        Morphogenesis may be required to create a Risk Evaluation and Mitigation Strategy (“REMS”), plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use;

•        Morphogenesis may be required to change the way such products are distributed or administered, or change the labeling of the products;

•        the FDA or a comparable foreign regulatory authority may require Morphogenesis to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products;

•        Morphogenesis may decide to recall such products from the marketplace after they are approved;

•        Morphogenesis could be sued and held liable for harm caused to individuals exposed to or taking its products; and

•        Morphogenesis’ reputation may suffer.

In addition, adverse side effects caused by any therapeutics that may be similar in nature to Morphogenesis’ product candidates could delay or prevent regulatory approval of Morphogenesis’ product candidates, limit the commercial profile of an approved label for Morphogenesis’ product candidates, or result in significant negative consequences for its product candidates following marketing approval.

Morphogenesis believes that any of these events could prevent it from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing Morphogenesis’ product candidates, if approved, and significantly impact Morphogenesis’ ability to successfully commercialize its product candidates and generate revenues.

If Morphogenesis encounters difficulties enrolling patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on Morphogenesis’ ability to enroll a sufficient number of patients who remain in the trial until its conclusion. Morphogenesis may experience difficulties in patient enrollment in its clinical trials for a variety of reasons, including:

•        the size and nature of the patient population;

•        the patient eligibility criteria defined in the protocol;

•        the size of the study population required for analysis of the trial’s primary endpoints;

•        the proximity of patients to trial sites;

•        the design of the trial;

•        Morphogenesis’ ability to recruit clinical trial investigators with the appropriate competencies and experience;

•        clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications Morphogenesis is investigating;

•        Morphogenesis’ ability to obtain and maintain patient consents; and

•        the risk that patients enrolled in clinical trials will not complete a clinical trial.

In addition, Morphogenesis’ clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as Morphogenesis’ product candidates, and this competition will reduce the number and types of patients available to Morphogenesis, because some patients who might have opted to enroll in Morphogenesis’ trials may instead opt to enroll in a trial being conducted by one of its competitors. Because the number of qualified clinical investigators is limited, Morphogenesis may conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which will reduce the number of patients who are available for Morphogenesis’ clinical trials at such clinical trial sites. Moreover, because Morphogenesis’ product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and hematopoietic cell transplantation, rather than enroll patients in any future clinical trial.

Even if Morphogenesis can enroll a sufficient number of patients in its clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect Morphogenesis’ ability to advance the development of its product candidates.

Clinical trials are expensive, time-consuming, and difficult to design and implement, and Morphogenesis’ clinical trial costs may be higher than those for more conventional therapeutic technologies or drug products.

Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because Morphogenesis’ product candidates are based on new technologies and manufactured on a patient-by-patient basis, Morphogenesis expects that they will require extensive research and

development and have substantial manufacturing costs. In addition, costs to treat patients with relapsed/refractory cancer and to treat potential side effects that may result from Morphogenesis’ product candidates can be significant. Accordingly, Morphogenesis’ clinical trial costs are likely to be significantly higher per patient than those of more conventional therapeutic technologies or drug products.

In addition, one of Morphogenesis’ early-stage product candidates that is currently in preclinical development is for a novel class of injectable biologics. Development of the underlying technology may be affected by unanticipated technical, regulatory, manufacturing, or other problems, among other research and development issues, and the possible insufficiency of funds needed to complete development of this product candidate.

Morphogenesis’ proposed personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us. Depending on the number of patients Morphogenesis ultimately enrolls in its trials, and the number of trials Morphogenesis may need to conduct, its overall clinical trial costs may be higher than for more conventional treatments.

Morphogenesis’ product candidates are biologics and the manufacture of its product candidates is complex and Morphogenesis may encounter difficulties in production, particularly with respect to process development or scaling-out of Morphogenesis’ manufacturing capabilities. If Morphogenesis or any of its third-party manufacturers encounter such difficulties, Morphogenesis’ ability to provide supply of its product candidates for clinical trials or its products for patients, if approved, could be delayed or stopped, or Morphogenesis may be unable to maintain a commercially viable cost structure.

Morphogenesis’ product candidates are biologics and the process of manufacturing its products is complex, highly regulated, and subject to multiple risks. The manufacture of Morphogenesis’ product candidates involves complex processes, and, as a result of the complexities, the cost to manufacture biologics in general is generally higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce. Morphogenesis’ manufacturing process will be susceptible to product loss or failure due to logistical issues. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. Further, as product candidates are developed through preclinical to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause Morphogenesis’ product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

In addition, the manufacturing process for any products that Morphogenesis may develop is subject to FDA and foreign regulatory authority approval process, and Morphogenesis will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an ongoing basis. If Morphogenesis or its CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, Morphogenesis may not obtain or maintain the approvals Morphogenesis needs to commercialize such products. Even if Morphogenesis obtains regulatory approval for any of its product candidates, there is no assurance that either Morphogenesis or its CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Morphogenesis’ product candidate, impair commercialization efforts, increase its cost of goods, and have an adverse effect on its business, financial condition, results of operations and growth prospects.

Morphogenesis relies on third parties to manufacture its clinical product supplies, and Morphogenesis intends to rely on third parties for at least a portion of the manufacturing process of its product candidates, if approved. Morphogenesis’ business could be harmed if those third parties fail to provide it with sufficient quantities of product or fail to do so at acceptable quality levels or prices or fail to maintain or achieve satisfactory regulatory compliance.

Morphogenesis does not currently own any facility that may be used as its clinical-scale manufacturing and processing facility and currently relies on a single source vendor to manufacture supplies and process Morphogenesis’ product candidates. Morphogenesis has not yet caused its product candidates to be manufactured or processed on a commercial scale and may not be able to do so for any of its product candidates.

Although in the future Morphogenesis does intend to develop its own manufacturing facility, it also intends to use third parties as part of its manufacturing process and may, in any event, never be successful in developing its own manufacturing facility. Morphogenesis’ anticipated reliance on a limited number of third-party manufacturers exposes it to the following risks:

•        Morphogenesis may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any manufacturers. This approval would require new testing and good manufacturing practices compliance inspections by FDA. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of Morphogenesis’ products;

•        Morphogenesis’ third-party manufacturers might be unable to timely manufacture its product or produce the quantity and quality required to meet its clinical and commercial needs, if any;

•        Contract manufacturers may not be able to execute Morphogenesis’ manufacturing procedures and other logistical support requirements appropriately;

•        Morphogenesis’ future contract manufacturers may not perform as agreed, may not devote sufficient resources to its products, or may not remain in the contract manufacturing business for the time required to supply its clinical trials or to successfully produce, store, and distribute its products;

•        Morphogenesis’ future contract manufacturers may not perform as agreed, may not devote sufficient resources to its products, or may not remain in the contract manufacturing business for the time required to supply its clinical trials or to successfully produce, store, and distribute its products;

•        Manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with current good manufacturing practices, or cGMP, current good tissue practices, or cGTP, if applicable and other government regulations and corresponding foreign standards. Morphogenesis does not have control over third-party manufacturers’ compliance with these regulations and standards;

•        Morphogenesis may not own, or may not solely own, the intellectual property rights to improvements made by its third-party manufacturers in the manufacturing process for its products;

•        Morphogenesis’ third-party manufacturers could breach or terminate their agreement with the company;

•        Raw materials and components used in the manufacturing process, particularly those for which Morphogenesis has no other source or supplier, may not be available or may not be suitable or acceptable for use due to material or component defects;

•        Morphogenesis’ contract manufacturers and critical reagent suppliers may be subject to inclement weather, as well as natural or man-made disasters; and

•        Morphogenesis’ contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.

Each of these risks could delay or prevent the completion of Morphogenesis’ clinical trials or the approval of any of its product candidates by the FDA, result in higher costs or adversely impact commercialization of Morphogenesis’ product candidates. In addition, Morphogenesis will rely on third parties to perform certain

specification tests on its product candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put at risk of serious harm and the FDA could place significant restrictions on Morphogenesis until deficiencies are remedied.

Although Morphogenesis’ agreements with its CMOs require them to perform according to certain cGMP and, if applicable, cGTP requirements such as those relating to quality control, quality assurance, and qualified personnel, Morphogenesis cannot control the conduct of its CMOs to implement and maintain these standards. If any of Morphogenesis’ CMOs cannot successfully manufacture material that conforms to its specifications and the regulatory requirements of the FDA, EMA, or other comparable foreign authorities, Morphogenesis would be prevented from obtaining regulatory approval for its drug candidates unless and until Morphogenesis engages a substitute CMO that can comply with such requirements, which it may not be able to do. Any such failure by any of Morphogenesis’ CMOs would significantly impact its ability to develop, obtain regulatory approval for, or market Morphogenesis’ drug candidates, if approved.

The manufacture of biological drug products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.

Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process (including the absence of contamination). These problems include logistics and shipping, difficulties with production costs and yields, quality control, including stability of the product, product testing, operator error, availability of qualified personnel, as well as compliance with strictly enforced federal, state, and foreign regulations. Furthermore, if contaminants are discovered in Morphogenesis’ supply of its product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period to investigate and remedy the contamination. Morphogenesis cannot assure you that any stability failures or other issues relating to the manufacture of its product candidates will not occur in the future. Additionally, Morphogenesis’ manufacturers may experience manufacturing difficulties due to resource constraints, labor disputes, or unstable political environments. If Morphogenesis’ manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, its ability to provide its product candidate to patients in clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs, and, depending upon the period of delay, require Morphogenesis to begin new clinical trials at additional expense or terminate clinical trials completely.

Morphogenesis’ third-party manufacturers may be unable to successfully scale up manufacturing of its product candidates in sufficient quality and quantity, which would delay or prevent Morphogenesis from developing its product candidates and commercializing any approved product candidates.

Morphogenesis’ manufacturing partners may be unable to successfully increase the manufacturing capacity for its product candidates in a timely or cost-effective manner, or at all, as needed for its development efforts or, if its product candidates are approved, its commercialization efforts. Quality issues may also arise during scale-up activities. If Morphogenesis, or any manufacturing partners, are unable to successfully scale up the manufacture of Morphogenesis’ product candidates in sufficient quality and quantity, the development, testing, and clinical trials of its product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting therapeutic may be delayed or not obtained, which could significantly harm Morphogenesis’ business.

Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to Morphogenesis on acceptable terms or at all. For some of these reagents, equipment, and materials, Morphogenesis relies or may rely on sole source vendors or a limited number of vendors, which could impair Morphogenesis’ ability to manufacture and supply its products.

Manufacturing Morphogenesis’ product candidates will require many reagents, which are substances used in Morphogenesis’ manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. Morphogenesis currently depends on a limited number of vendors for certain materials and equipment used in the manufacture of its product candidates. Some of these suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support Morphogenesis’ needs. Morphogenesis also

does not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, Morphogenesis may experience delays in receiving key materials and equipment to support clinical or commercial manufacturing.

For some of these reagents, equipment, and materials, Morphogenesis relies and may in the future rely on sole source vendors or a limited number of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect Morphogenesis’ ability to satisfy demand for its product candidates, which could adversely and materially affect its product sales and operating results or its ability to conduct clinical trials, either of which could significantly harm its business.

As Morphogenesis continues to develop and scale its manufacturing process, Morphogenesis expects that it will need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. Morphogenesis may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if it is unable to alter its process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on its business.

Morphogenesis relies and will rely on third parties to conduct its clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, Morphogenesis may not be able to obtain regulatory approval of or commercialize its product candidates.

Morphogenesis depends and will depend upon independent investigators and collaborators to conduct its clinical trials under agreements with universities, medical institutions, CROs, strategic partners, and others. Morphogenesis expects to have to negotiate budgets and contracts with CROs and trial sites, which may result in delays to Morphogenesis’ development timelines and increased costs.

Morphogenesis relies and will rely heavily on third parties over the course of its clinical trials, and as a result will have limited control over the clinical investigators and limited visibility into its day-to-day activities. Nevertheless, Morphogenesis is responsible for ensuring that each of its trials is conducted in accordance with the applicable protocol and legal, regulatory, and scientific standards, and Morphogenesis’ reliance on third parties does not relieve it of its regulatory responsibilities. Morphogenesis and these third parties are required to comply with good clinical practices (“GCP”), which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GCP through periodic inspections of trial sponsors, principal investigators, and trial sites. If Morphogenesis or any of these third parties fails to comply with applicable GCP regulations, the clinical data generated in Morphogenesis’ clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Morphogenesis to perform additional nonclinical or clinical trials before approving its marketing applications. Morphogenesis cannot be certain that, upon inspection, such regulatory authorities will determine that any of its clinical trials comply with the applicable GCP regulations. In addition, Morphogenesis’ clinical trials must be conducted with biologic product produced under cGMP, and likely cGTP regulations and will require a large number of test patients. Morphogenesis’ failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require Morphogenesis to repeat clinical trials, which would delay the regulatory approval process. Moreover, Morphogenesis’ business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting Morphogenesis’ clinical trials are not and will not be its employees and, except for remedies available to Morphogenesis under its agreements with such third parties, Morphogenesis cannot control whether or not they devote sufficient time and resources to its ongoing preclinical, clinical, and nonclinical programs. These third parties may also have relationships with other commercial entities, including Morphogenesis’ competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on Morphogenesis’ behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to Morphogenesis’ clinical protocols or regulatory requirements or for other reasons, Morphogenesis’ clinical trials may be extended, delayed, or terminated and Morphogenesis may not be able to complete development of, obtain regulatory approval

of or successfully commercialize its product candidates. As a result, Morphogenesis’ financial results and the commercial prospects for its product candidates would be harmed, its costs could increase, and its ability to generate revenue could be delayed.

Any agreements governing Morphogenesis’ relationships with CROs or other contractors with whom Morphogenesis currently engages or may engage in the future may provide those outside contractors with certain rights to terminate a clinical trial under specified circumstances. If any of Morphogenesis’ relationships with these third-party CROs terminate, Morphogenesis may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays occur, which can materially impact Morphogenesis’ ability to meet its desired clinical development timelines. Though Morphogenesis carefully manages its relationships with its CROs, there can be no assurance that Morphogenesis will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on its business, financial condition, and prospects.

Morphogenesis plans to seek orphan drug status for some or all of its product candidates, but Morphogenesis may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause its revenue, if any, to be reduced.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of Morphogenesis’ drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if Morphogenesis is unable to manufacture sufficient supply of its product.

Morphogenesis plans to seek orphan drug designation for some or all of its product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products, but exclusive marketing rights in the United States may be limited if Morphogenesis seeks approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. In addition, although Morphogenesis intends to seek orphan drug designation for other product candidates, Morphogenesis may never receive such designations.

The review processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable. If Morphogenesis is unable to obtain approval for its product candidates from applicable regulatory authorities, it will not be able to market and sell those product candidates in those countries or regions and Morphogenesis’ business could be substantially harmed.

The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDA in the United States and by the respective regulatory authorities in other countries where regulations differ. Morphogenesis is not permitted to market

its biological product candidates in the United States until Morphogenesis receives the respective approval of a BLA from the FDA, or in any foreign countries until Morphogenesis receives the requisite approval from the respective regulatory authorities in such countries. The time required to obtain approval, if any, by the FDA, EMA and comparable foreign authorities is unpredictable, but typically takes many years following the commencement of clinical trials, if approval is obtained at all, and depends upon numerous factors, including the substantial discretion of the regulatory authorities and the type, complexity and novelty of the product candidates involved. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that Morphogenesis’ data is insufficient for approval and require additional nonclinical studies or clinical trials. Morphogenesis has limited experience in planning and conducting the clinical trials required for marketing approvals, and Morphogenesis has and expects to continue to rely on third-party CROs to assist Morphogenesis in this process. Obtaining marketing approval requires the submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process, and in many cases the inspection of manufacturing, processing, and packaging facilities by the regulatory authorities. Morphogenesis’ product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude Morphogenesis’ obtaining marketing approval or prevent or limit commercial use, or there may be deficiencies in cGMP compliance by Morphogenesis or by its CMOs that could result in the candidate not being approved. Moreover, Morphogenesis has not obtained regulatory approval for any drug candidate in any jurisdiction and it is possible that none of its existing drug candidates or any drug candidates Morphogenesis may seek to develop in the future will ever obtain regulatory approval.

Morphogenesis’ biological product candidates could fail to receive, or could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following:

•        the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of Morphogenesis’ clinical trials;

•        Morphogenesis may be unable to demonstrate to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

•        the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or comparable foreign regulatory authorities for approval;

•        Morphogenesis may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

•        the FDA, EMA or comparable foreign regulatory authorities may disagree with Morphogenesis’ interpretation of data from preclinical studies or clinical trials;

•        the data collected from clinical trials of Morphogenesis product candidates may not be sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere;

•        upon review of Morphogenesis’ clinical trial sites and data, the FDA or comparable foreign regulatory authorities may find Morphogenesis’ record keeping or the record keeping of its clinical trial sites to be inadequate;

•        the manufacturing processes or facilities of third-party manufacturers with which Morphogenesis contracts for clinical and commercial supplies may fail to meet the requirements of the FDA, EMA or comparable foreign regulatory authorities;

•        the FDA, EMA or comparable foreign regulatory authorities may fail to approve the companion diagnostics Morphogenesis contemplates developing internally or with partners; and

•        the change of the medical standard of care or the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner that renders Morphogenesis’ clinical data insufficient for approval.

Even if Morphogenesis was able to obtain regulatory approval in one or more jurisdictions, regulatory authorities may approve any of its product candidates for fewer or more limited indications than Morphogenesis requests, may not approve prices Morphogenesis may propose to charge for its products, may grant approval contingent on the performance of costly post-marketing clinical trials (referred to as “conditional” or “accelerated” approval depending on the jurisdiction), or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing circumstances could materially harm the commercial prospects for Morphogenesis’ drug candidates.

Morphogenesis currently has no marketing and sales organization and have no experience in marketing products. If Morphogenesis is unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell its product candidates, Morphogenesis may not be able to generate product revenue.

Morphogenesis currently has no sales, marketing, or commercial product distribution capabilities and has no experience in marketing products. Morphogenesis intends to develop an in-house marketing organization and sales force, which will require significant capital expenditures, management resources, and time. Morphogenesis will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, and retain marketing and sales personnel.

If Morphogenesis is unable or decide not to establish internal sales, marketing and commercial distribution capabilities for any or all products Morphogenesis develops, it will likely pursue collaborative arrangements regarding the sales and marketing of its products. However, there can be no assurance that Morphogenesis will be able to establish or maintain such collaborative arrangements, or if Morphogenesis is able to do so, that they will have effective sales forces. Any revenue Morphogenesis receives will depend upon the efforts of such third parties, which may not be successful. Morphogenesis may have little or no control over the marketing and sales efforts of such third parties, and Morphogenesis’ revenue from product sales may be lower than if it had commercialized its product candidates itself. Morphogenesis also faces competition in ts search for third parties to assist it with the sales and marketing efforts of its product candidates.

There can be no assurance that Morphogenesis will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, Morphogenesis may not be able to generate product revenue.

Morphogenesis may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and Morphogenesis may not realize the benefits of such alliances or licensing arrangements.

Morphogenesis may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that Morphogenesis believes will complement or augment its development and commercialization efforts with respect to its product candidates and any future product candidates that Morphogenesis may develop. Any of these relationships may require Morphogenesis to incur non-recurring and other charges, increase Morphogenesis’ near and long-term expenditures, issue securities that dilute its existing stockholders, or disrupt its management and business. In addition, Morphogenesis faces significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, Morphogenesis may not be successful in its efforts to establish a strategic partnership or other alternative arrangements for Morphogenesis’ product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view Morphogenesis’ product candidates as having the requisite potential to demonstrate safety and efficacy.

Further, collaborations involving Morphogenesis’ product candidates, such as Morphogenesis’ collaborations with third-party research institutions, are subject to numerous risks, which may include the following:

•        collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

•        collaborators may not pursue development and commercialization of Morphogenesis’ product candidates or may elect not to continue or renew development or commercialization programs based on clinical

trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;

•        collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;

•        collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with Morphogenesis’ products or product candidates;

•        a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;

•        collaborators may not properly maintain or defend Morphogenesis’ intellectual property rights, or may use its intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate Morphogenesis’ intellectual property or proprietary information or expose Morphogenesis to potential liability;

•        disputes may arise between Morphogenesis and a collaborator that cause the delay or termination of the research, development or commercialization of Morphogenesis’ product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

•        collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

•        collaborators may own or co-own intellectual property covering Morphogenesis’ products that results from its collaborations with them, and in such cases, Morphogenesis would not have the exclusive right to commercialize such products.

As a result, if Morphogenesis enters into collaboration agreements and strategic partnerships or license its products or businesses, it may not be able to realize the benefit of such transactions if it are unable to successfully integrate them with Morphogenesis’ existing operations and company culture, which could delay Morphogenesis’ timelines or otherwise adversely affect its business. Morphogenesis also cannot be certain that, following a strategic transaction or license, it will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to Morphogenesis’ product candidates could delay the development and commercialization of Morphogenesis’ product candidates in certain geographies for certain indications, which would harm Morphogenesis’ business prospects, financial condition, and results of operations.

If Morphogenesis engages in future acquisitions or strategic partnerships, this may increase Morphogenesis’ capital requirements, dilute its stockholders, cause Morphogenesis to incur debt or assume contingent liabilities, and subject it to other risks.

Morphogenesis may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

•        increased operating expenses and cash requirements;

•        the assumption of additional indebtedness or contingent liabilities;

•        assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

•        Morphogenesis’ inability to achieve desired efficiencies, synergies or other anticipated benefits from such acquisitions or strategic partnerships;

•        the diversion of Morphogenesis’ management’s attention from its existing product programs and initiatives in pursuing such a strategic merger or acquisition;

•        retention of key employees, the loss of key personnel, and uncertainties in Morphogenesis’ ability to maintain key business relationships;

•        risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and

•        Morphogenesis’ inability to generate revenue from acquired technology and/or products sufficient to meet its objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

In addition, if Morphogenesis undertakes acquisitions, it may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. Moreover, Morphogenesis may not be able to locate suitable acquisition opportunities and this inability could impair Morphogenesis’ ability to grow or obtain access to technology or products that may be important to the development of its business.

If Morphogenesis, its CROs or its CMOs use hazardous and biological materials in a manner that causes injury or violates applicable law, Morphogenesis may be liable for damages.

Morphogenesis’ research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by Morphogenesis or third parties, such as CROs and CMOs. Morphogenesis and such third parties are subject to federal, state, and local laws and regulations in the United States governing the use, manufacture, storage, handling, and disposal of medical and hazardous materials. Although Morphogenesis believes that its and such third parties’ procedures for using, handling, storing, and disposing of these materials comply with legally prescribed standards, Morphogenesis cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, Morphogenesis may incur liability or local, city, state, or federal authorities may curtail the use of these materials and interrupt its business operations. In the event of an accident, Morphogenesis could be held liable for damages or penalized with fines, and the liability could exceed its resources. Morphogenesis does not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair Morphogenesis’ research, development and production efforts, which could harm its business, prospects, financial condition, or results of operations.

Morphogenesis’ internal computer systems, or those used by its third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of security measures, Morphogenesis’ internal computer systems and those of its future CROs and other contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. Although to Morphogenesis’ knowledge it has not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in Morphogenesis’ operations, it could result in a material disruption of its development programs and Morphogenesis’ business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in Morphogenesis’ regulatory approval efforts and significantly increase Morphogenesis’ costs to recover or reproduce the data. Likewise, Morphogenesis relies on its third-party research institution collaborators for research and development of its product candidates and other third parties for the manufacture of Morphogenesis’ product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on its business. To the extent that any disruption or security breach were to result in a loss of, or damage to, Morphogenesis’ data or applications, or inappropriate disclosure of confidential or proprietary information, Morphogenesis could incur liability and the further development and commercialization of its product candidates could be delayed.

Although Morphogenesis takes reasonable steps to help protect confidential and other sensitive information from unauthorized access or disclosure, Morphogenesis also could be the target of phishing attacks seeking confidential information regarding its employees. Furthermore, while Morphogenesis has implemented data privacy and security measures in an effort to comply with applicable laws and regulations relating to privacy and data protection, some PHI and other PII or confidential information may be transmitted to Morphogenesis by third parties, who may not implement adequate security and privacy measures, and it is possible that laws, rules and

regulations relating to privacy, data protection, or information security may be interpreted and applied in a manner that is inconsistent with Morphogenesis’ practices or those of third parties who transmit PHI and other PII or confidential information to Morphogenesis.

To the extent Morphogenesis or these third parties are found to have violated such laws, rules or regulations or that any disruption or security breach were to result in a loss of, or damage to, Morphogenesis’ or its third-party vendors’, collaborators’ or other contractors’ or consultants’ data or applications, or inappropriate disclosure of confidential or proprietary information, Morphogenesis could incur liability including litigation exposure, penalties and fines, Morphogenesis could become the subject of regulatory action or investigation, its competitive position could be harmed and the further development and commercialization of its product candidates could be delayed. Any of the above could have a material adverse effect on Morphogenesis’ business, financial condition, results of operations or prospects.

If product liability lawsuits are brought against Morphogenesis, it may incur substantial liabilities and may be required to limit commercialization of its product candidates.

Morphogenesis faces an inherent risk of product liability as a result of the clinical testing of its product candidates and will face an even greater risk if Morphogenesis commercializes any products. For example, Morphogenesis may be sued if its product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If Morphogenesis cannot successfully defend itself against product liability claims, Morphogenesis may incur substantial liabilities or be required to limit commercialization of its product candidates. Even successful defense would require significant financial and management resources. Product liability claims could delay or prevent completion of Morphogenesis’ development programs. If Morphogenesis succeeds in marketing any approved products, these claims could result in an FDA investigation of the safety and effectiveness of its products, its manufacturing processes and facilities (or the manufacturing processes and facilities of Morphogenesis’ third-party manufacturer) or its marketing programs, a recall of Morphogenesis’ products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in:

•        decreased demand for Morphogenesis’ products;

•        injury to Morphogenesis’ reputation;

•        withdrawal of clinical trial participants and inability to continue clinical trials;

•        initiation of investigations by regulators;

•        costs to defend the related litigation;

•        a diversion of management’s time and Morphogenesis’ resources;

•        substantial monetary awards to trial participants or patients;

•        substantial monetary awards to trial participants or patients;

•        product recalls, withdrawals or labeling, marketing or promotional restrictions;

•        loss of revenue;

•        exhaustion of any available insurance and Morphogenesis’ capital resources;

•        the inability to commercialize any product candidate; and

•        a decline in Morphogenesis’ share price.

Risks Related to Government Regulation

The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and Morphogenesis may experience significant delays in the clinical development and regulatory approval, if any, of its product candidates.

The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States. Morphogenesis is not permitted to market any biological drug product in the United States until Morphogenesis receives a Biologics License from the FDA. Morphogenesis has not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe, pure, potent, and effective for each desired indication. The BLA must also include significant information regarding the chemistry, manufacturing, and controls for the product, and the manufacturing facilities must complete a successful pre-license inspection. Morphogenesis expects the novel nature of its product candidates to create further challenges in obtaining regulatory approval. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on Morphogenesis’ ability to obtain licensure of the product candidates based on the completed clinical trials. Accordingly, the regulatory approval pathway for Morphogenesis’ product candidates may be uncertain, complex, expensive, and lengthy, and approval may not be obtained.

In addition, clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:

•        obtaining regulatory approval to begin a trial, if applicable;

•        the availability of financial resources to begin and complete the planned trials;

•        reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•        obtaining approval at each clinical trial site by an independent institutional review board (“IRB”);

•        recruiting suitable patients to participate in a trial in a timely manner;

•        having patients complete a trial or return for post-treatment follow-up;

•        clinical trial sites deviating from trial protocol, not complying with GCP, or dropping out of a trial;

•        addressing any patient safety concerns that arise during the course of a trial;

•        addressing any conflicts with new or existing laws or regulations;

•        adding new clinical trial sites; or

•        manufacturing qualified materials under cGMP for use in clinical trials.

Morphogenesis’ third-party research institution collaborators may also experience similar difficulties in completing ongoing clinical trials and conducting future clinical trials of product candidates. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of Morphogenesis’ product candidates.

Obtaining and maintaining regulatory approval of Morphogenesis’ product candidates in one jurisdiction does not mean that Morphogenesis will be successful in obtaining regulatory approval of its product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of Morphogenesis’ product candidates in one jurisdiction does not guarantee that Morphogenesis will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative

effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Morphogenesis intends to charge for its products is also subject to approval.

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Morphogenesis and could delay or prevent the introduction of its products in certain countries. If Morphogenesis fails to comply with the regulatory requirements in international markets and/or to receive applicable marketing approvals, its target market will be reduced and its ability to realize the full market potential of its product candidates will be harmed.

Even if Morphogenesis receives regulatory approval of its product candidates, it will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and Morphogenesis may be subject to penalties if it fails to comply with regulatory requirements or experience unanticipated problems with its product candidates.

If Morphogenesis’ product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, and comparable foreign regulatory authority, requirements, including ensuring that quality control and manufacturing procedures conform to current Good Manufacturing Practices, or cGMP, and in certain cases Good Tissue Practices (“cGTP”), regulations. As such, Morphogenesis and its contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and cGTp and adherence to commitments made in any BLA, other marketing application, and previous responses to inspection observations. Accordingly, Morphogenesis and others with whom it works must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

Any regulatory approvals that Morphogenesis receives for its product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS program as a condition of approval of Morphogenesis’ product candidates, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves Morphogenesis’ product candidates, Morphogenesis will have to comply with requirements including submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs, cGTP and cGCPs for any clinical trials that Morphogenesis conducts post-approval.

Later discovery of previously unknown problems with Morphogenesis’ product candidates, including adverse events of unanticipated severity or frequency, or with Morphogenesis’ third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following among other things:

•        restrictions on the manufacturing of the product, the approved manufacturers or the manufacturing process;

•        restrictions on the labeling or marketing of a product;

•        restrictions on product distribution or use;

•        requirements to conduct post-marketing studies or clinical trials;

•        withdrawal of the product from the market;

•        product recalls;

•        warning or untitled letters from the FDA or comparable notice of violations from foreign regulatory authorities;

•        refusal of the FDA or other applicable regulatory authority to approve pending applications or

•        supplements to approved applications;

•        fines, restitution or disgorgement of profits or revenues;

•        suspension or withdrawal of marketing approvals;

•        suspension of any of Morphogenesis’ ongoing clinical trials;

•        product seizure or detention or refusal to permit the import or export of products; and

•        consent decrees, injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

The policies of the FDA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Morphogenesis’ product candidates. Morphogenesis cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Morphogenesis is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Morphogenesis is not able to maintain regulatory compliance, Morphogenesis may lose any marketing approval that it may have obtained and it may not achieve or sustain profitability.

In addition, if Morphogenesis was able to obtain accelerated approval of any of Morphogenesis’ product candidates, the FDA would require Morphogenesis to conduct a confirmatory study to verify the predicted clinical benefit and additional safety studies. The results from the confirmatory study may not support the clinical benefit, which would result in the approval being withdrawn. While operating under accelerated approval, Morphogenesis will be subject to certain restrictions that it would not be subject to upon receiving regular approval.

Even if Morphogenesis obtains regulatory approval of its product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community.

Morphogenesis’ products may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, and others in the medical community. Several factors will influence whether Morphogenesis’ product candidates are accepted in the market, including:

•        the clinical indications for which Morphogenesis’ product candidates are approved;

•        physicians, hospitals, cancer treatment centers, and patients considering Morphogenesis’ product candidates as a safe and effective treatment;

•        the potential and perceived advantages of Morphogenesis’ product candidates over alternative treatments;

•        the prevalence and severity of any side effects;

•        any restrictions on concomitant Morphogenesis of other medications

•        product labeling or product insert requirements of the FDA or other regulatory authorities;

•        limitations or warnings contained in the labeling approved by the FDA;

•        the size of the market for such drug candidate, based on the size of the patient subsets that Morphogenesis is targeting, in their territories for which Morphogenesis gains regulatory approval and have commercial rights;

•        the safety of the drug candidate as demonstrated through broad commercial rights;

•        the adequacy of supply of Morphogenesis’ product candidates;

•        the timing of market introduction of Morphogenesis’ product candidates as well as competitive products;

•        the cost of treatment in relation to alternative treatments;

•        the amount of upfront costs or training required for physicians to administer Morphogenesis’ product candidates;

•        the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities;

•        the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities;

•        support from patient advocacy groups;

•        relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

•        the effectiveness of Morphogenesis’ sales and marketing efforts.

Morphogenesis’ ability to negotiate, secure and maintain third-party coverage and reimbursement for its product candidates may be affected by political, economic and regulatory developments in the United States, the European Union and other jurisdictions. Governments continue to impose cost containment measures, and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. These and other similar developments could significantly limit the degree of market acceptance of any product candidate of ours that receives marketing approval in the future.

Even if Morphogenesis’ products achieve market acceptance, Morphogenesis may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than its products, are more cost effective or render Morphogenesis’ products obsolete.

Morphogenesis is and will be subject to stringent privacy laws, cybersecurity laws, regulations, policies and contractual obligations related to privacy and security, and changes in such laws, regulations, policies or how they are interpreted or changes in related contractual obligations could adversely affect Morphogenesis’ business.

Morphogenesis is subject to data privacy and protection laws and regulations that apply to the collection, transmission, processing, storage and use of personally-identifying information including comprehensive regulatory systems in the U.S. and EU, which, among other things, impose certain requirements relating to the privacy, security and transmission of personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect Morphogenesis’ business. Failure to comply with any of these laws and regulations by Morphogenesis or third parties to whom Morphogenesis contracts certain types of work (like clinical trials) could result in enforcement action against Morphogenesis or such third parties, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to Morphogenesis’ reputation and loss of goodwill, any of which could have a material adverse effect on its business, financial condition, results of operations or prospects.

There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information. In particular, regulations promulgated pursuant to the HIPAA, establish privacy and security standards that limit the use and disclosure of individually identifiable health information, or protected health information, and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information. Determining whether protected health information has been handled in compliance with applicable privacy standards and its contractual obligations can be complex and may be subject to changing interpretation.

If Morphogenesis is unable to properly protect the privacy and security of protected health information or other personal, sensitive, or confidential information in its possession, Morphogenesis could be found to have breached its contracts. Further, if Morphogenesis fails to comply with applicable privacy laws, including applicable HIPAA privacy and security standards, Morphogenesis could face significant administrative, civil and criminal penalties. Enforcement activity can also result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal and outside resources. In addition, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents. In addition to the risks associated with enforcement activities and potential contractual liabilities, Morphogenesis’ ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to its policies, procedures and systems.

In the EU, Morphogenesis may be subject to the General Data Protection Regulation (“GDPR”) which went into effect in May 2018 and which imposes obligations on companies that operate in Morphogenesis’ industry with respect to the processing of personal data and the cross-border transfer of such data. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and policies. If Morphogenesis’ or Morphogenesis’ partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, Morphogenesis may be subject to litigation, regulatory investigations, enforcement notices requiring Morphogenesis to change the way Morphogenesis uses personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.

The GDPR may also impose additional compliance obligations relating to the transfer of data between Morphogenesis and its subsidiaries or other business partners. For example, the European Court of Justice recently invalidated the EU-U.S. Privacy Shield as a basis for transfers of personal data from the EU to the U.S. and raised questions about the continued validity of one of the primary alternatives to the EU-U.S. Privacy Shield, namely the European Commission’s Standard Contractual Clauses. Some customers or other service providers may respond to these evolving laws and regulations by asking Morphogenesis to make certain privacy or data-related contractual commitments that Morphogenesis is unable or unwilling to make. This could lead to the loss of current or prospective customers or other business relationships.

While Morphogenesis continues to address the implications of the recent changes to EU data privacy regulations, data privacy remains an evolving landscape at both the domestic and international level, with new regulations coming into effect and continued legal challenges, and Morphogenesis’ efforts to comply with the evolving data protection rules may be unsuccessful. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with Morphogenesis’ practices. Morphogenesis must devote significant resources to understanding and complying with this changing landscape. Failure to comply with laws regarding data protection would expose Morphogenesis to risk of enforcement actions taken by data protection authorities in the EU and elsewhere and carries with it the potential for significant penalties if Morphogenesis is found to be non-compliant. Similarly, failure to comply with federal and state laws in the United States regarding privacy and security of personal information could expose Morphogenesis to penalties under such laws. Any such failure to comply with data protection and privacy laws could result in government-imposed fines or orders requiring that Morphogenesis changes its practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect Morphogenesis’ business.

Even if Morphogenesis is not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm its business, financial condition, results of operations or prospects.

Coverage and reimbursement may be limited or unavailable in certain market segments for Morphogenesis’ product candidates, which could make it difficult for Morphogenesis to sell its product candidates profitably.

Successful sales of Morphogenesis’ product candidates, if approved, depend on the availability of adequate coverage and reimbursement from third-party payors. In addition, because Morphogenesis’ product candidates represent new approaches to treat cancer and other immune-related diseases, Morphogenesis cannot accurately estimate the potential revenue from its product candidates.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance.

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

a covered benefit under its health plan;

•        safe, effective and medically necessary;

•        appropriate for the specific patient;

•        cost-effective; and

•        neither experimental nor investigational.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require Morphogenesis to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of Morphogenesis’ products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if Morphogenesis obtains coverage for a given product, the resulting reimbursement payment rates might not be adequate for Morphogenesis to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of Morphogenesis’ products. Patients are unlikely to use Morphogenesis’ product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Morphogenesis’ product candidates. Because Morphogenesis’ product candidates have a higher cost of goods than conventional therapies, and may require long-term follow up evaluations, the risk that coverage and reimbursement rates may be inadequate for Morphogenesis to achieve profitability may be greater.

Morphogenesis intends to seek approval to market its product candidates in both the United States and in selected foreign jurisdictions. If Morphogenesis obtains approval in one or more foreign jurisdictions for its product candidates, Morphogenesis will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the EU, the pricing of biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of Morphogenesis’ product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for Morphogenesis’ product candidates and may be affected by existing and future health care reform measures.

Morphogenesis’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Morphogenesis is exposed to the risk of fraud, misconduct or other illegal activity by its employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with applicable laws and regulations of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; comply with manufacturing standards Morphogenesis has established; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. If Morphogenesis obtains FDA approval of any of its product candidates and begin commercializing those products in the United States, Morphogenesis’ potential exposure under such laws will increase significantly, and its costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, Morphogenesis’ current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials, which could result in significant regulatory sanctions and cause serious harm to Morphogenesis’ reputation. It is not always possible to identify and deter misconduct by employees and other parties, and the precautions Morphogenesis takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Morphogenesis from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against Morphogenesis, and Morphogenesis is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of significant fines or other sanctions.

Morphogenesis’ relationships with prescribers, purchasers, third-party payors and patients will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose Morphogenesis to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Although Morphogenesis does not currently have any products on the market, upon commercialization of its drug candidates, if approved, Morphogenesis will be subject to additional health care statutory and regulatory requirements and oversight by federal and state governments in the United States as well as foreign governments in the jurisdictions in which Morphogenesis conducts its business. Physicians, other health care providers and third-party payors will play a primary role in the recommendation, prescription and use of any product candidates for which Morphogenesis obtains marketing approval. Morphogenesis’ future arrangements with such third parties may expose Morphogenesis to broadly applicable fraud and abuse and other health care laws and regulations that may constrain Morphogenesis’ business or financial arrangements and relationships through which Morphogenesis markets, sells and distributes any products for which Morphogenesis may obtain marketing approval. Restrictions under applicable domestic and foreign health care laws and regulations include, but are not limited to, the following:

•        the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal health care program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•        U.S. federal false claims, false statements and civil monetary penalties laws, including the US False Claims Act, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the

federal government; actions may be brought by the government or a whistleblower and may include an assertion that a claim for payment by federal health care programs for items and services which results from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

•        HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any health care benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•        analogous state and foreign laws and regulations relating to health care fraud and abuse, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving health care items or services reimbursed by non-governmental third-party payors, including private insurers;

•        the FCPA and other anti-corruption laws and regulations pertaining to Morphogenesis’ financial relationships and interactions with foreign government officials;

•        the U.S. federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act,” which requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Centers for Medicare & Medicaid Services (“CMS”), information related to physician payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as the ownership and investment interests of physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year;

•        analogous state and foreign laws that require pharmaceutical companies to track, report and disclose to the government and/or the public information related to payments, gifts, and other transfers of value or remuneration to physicians and other health care providers, marketing activities or expenditures, or product pricing or transparency information, or that require pharmaceutical companies to implement compliance programs that meet certain standards or to restrict or limit interactions between pharmaceutical manufacturers and members of the health care industry;

•        the U.S. federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under federal health care programs;

•        HIPAA, which imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses and their business associates that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and

•        state and foreign laws that govern the privacy and security of health information in certain circumstances, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of Morphogenesis’ business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act (the “ACA”), among other things, amends the intent requirement of the federal Anti-Kickback Statute and criminal healthcare fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual

knowledge of these statutes or specific intent to violate them in order to have committed a violation. Moreover, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Efforts to ensure that Morphogenesis’ business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that Morphogenesis’ business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against Morphogenesis, and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Morphogenesis’ operations, any of which could adversely affect its ability to operate its business and its results of operations. In addition, the approval and commercialization of any of Morphogenesis’ product candidates outside the United States will also likely subject Morphogenesis to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. If any of the physicians or other health care providers or entities with whom Morphogenesis expects to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from federal health care programs.

Risks Related to Intellectual Property

Morphogenesis could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of its products or product candidates.

Morphogenesis anticipates that it will file additional patent applications both in the United States and in other countries, as appropriate. However, Morphogenesis cannot predict:

•        if and when any patents will issue;

•        the degree and range of protection any issued patents will afford Morphogenesis against competitors, including whether third parties will find ways to invalidate or otherwise circumvent its patents;

•        whether others will apply for or obtain patents claiming aspects similar to those covered by Morphogenesis’ patents and patent applications; or

•        whether Morphogenesis will need to initiate litigation or administrative proceedings to defend its patent rights, which may be costly whether Morphogenesis wins or loses.

For biological and pharmaceutical products, claims directed to compositions of matter are generally considered to be the strongest form of intellectual property protection. Such claims are not directed to any particular use of the product, and therefore encompass all uses. Morphogenesis cannot be certain, however, that the claims in its pending patent applications covering the composition of matter of its product candidates will be considered patentable by the United States Patent and Trademark Office (“USPTO”) or foreign patent offices, or that Morphogenesis’ issued claims will be considered valid and enforceable by U.S. or foreign courts.

Claims directed to methods of use protect the use of a product for the specified method. This type of claim does not prevent a competitor from making and marketing a product that is identical to the product for a specific use that falls outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for Morphogenesis’ targeted indications, physicians may prescribe these products “off-label” for those uses that are covered by Morphogenesis’ method claims. Although off-label prescriptions may infringe or contribute to the infringement of method claims, the practice is common and such infringement is difficult to prevent or prosecute. Many of Morphogenesis’ issued claims cover methods for making its cell therapy products.

Claims directed to methods of making a product protect the process by which a product is made. This type of claim does not prevent a competitor from marketing a product that is identical to Morphogenesis’ product, if the competitor’s product is made by a process outside the scope of the patented method.

The strength of patents in the biotechnology and pharmaceutical field can be uncertain, and evaluating the scope of such patents involves complex legal and scientific analyses. The patent applications that Morphogenesis owns or in-license may fail to result in issued patents with claims that cover its product candidates, methods of making its product candidates, or uses thereof in the United States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceability, or scope thereof, which may result in such patents being narrowed, invalidated, or held unenforceable. Furthermore, even if they are unchallenged, Morphogenesis’ patents and patent applications may not adequately protect its intellectual property or prevent others from designing their products to avoid being covered by its claims. If the breadth or strength of protection provided by the patents and patent applications Morphogenesis holds with respect to its product candidates is threatened, this could dissuade companies from collaborating with Morphogenesis to develop, and could threaten Morphogenesis’ ability to commercialize, Morphogenesis’ product candidates. Further, if Morphogenesis encounters delays in its clinical trials, the period of time during which Morphogenesis could market its product candidates under patent protection would be reduced. Because patent applications in the United States and most other countries are confidential for a period of time after filing, Morphogenesis cannot be certain that it was the first to file any patent application related to its product candidates.

Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.

In addition to the protection afforded by patents, Morphogenesis seeks to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that Morphogenesis elects not to patent, processes for which patents are difficult to enforce, and any other elements of its product discovery and development processes that involve proprietary know-how, information, or technology that is not covered by patents. Trade secrets, however, may be difficult to protect. Morphogenesis seeks to protect its proprietary processes, in part, by entering into confidentiality agreements with its employees, consultants, outside scientific advisors, contractors, and collaborators. Although Morphogenesis uses reasonable efforts to protect its trade secrets, its employees, consultants, outside scientific advisors, contractors, and collaborators might intentionally or inadvertently disclose its trade secret information to competitors. In addition, competitors may otherwise gain access to Morphogenesis’ trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, Morphogenesis may encounter significant problems in protecting and defending its intellectual property both in the United States and abroad. If Morphogenesis is unable to prevent unauthorized material disclosure of its intellectual property to third parties, or misappropriation of Morphogenesis’ intellectual property by third parties, Morphogenesis will not be able to establish or maintain a competitive advantage in its market, which could materially adversely affect its business, operating results, and financial condition.

Third-party claims of intellectual property infringement against Morphogenesis or its collaborators may prevent or delay its product discovery and development efforts.

Morphogenesis’ commercial success depends in part on it avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. Recently, due to changes in U.S. law referred to as patent reform, procedures including inter parties review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of challenge to Morphogenesis’ patents in the future.

Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which Morphogenesis is developing its product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that Morphogenesis’ product candidates may give rise to claims of infringement of the patent rights of others.

Morphogenesis may not be able to protect its intellectual property rights throughout the world.

Filing, prosecuting, maintaining, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and Morphogenesis’ intellectual property rights in some countries outside the United States can have a different scope and strength than do those in the United States. To date, in addition

to the United States, Morphogenesis has filed patent applications in Australia, Brazil, Canada, China, Europe (via European Patent Office), Hong Kong, India, Israel, Japan, Russian Federation, South Korea, Mexico, and Singapore. In addition, the laws of some foreign countries, such as China, Brazil, Russia, and India, do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, Morphogenesis may not be able to prevent third parties from practicing its inventions in all countries outside the United States, or from selling or importing products made using Morphogenesis’ inventions in and into the United States or other jurisdictions. Competitors may use Morphogenesis’ technologies in jurisdictions where Morphogenesis has not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where Morphogenesis has patent protection, but enforcement against importation of infringing products is challenging or legal remedies are insufficient. These products may compete with Morphogenesis’ products and its patents or other intellectual property rights may not be effective or adequate to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, such as China, Brazil, Russia, and India, do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult in those jurisdictions for Morphogenesis to stop the infringement or misappropriation of its patents or other intellectual property rights, or the marketing of competing products in violation of Morphogenesis’ proprietary rights. Proceedings to enforce Morphogenesis’ patent and other intellectual property rights in foreign jurisdictions could result in substantial costs and divert its efforts and attention from other aspects of its business. Furthermore, such proceedings could put Morphogenesis’ patents at risk of being invalidated, held unenforceable, or interpreted narrowly, could put its patent applications at risk of not issuing, and could provoke third parties to assert claims of infringement or misappropriation against Morphogenesis. Morphogenesis may not prevail in any lawsuits that it initiates and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Morphogenesis’ efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Morphogenesis develops or licenses.

Morphogenesis may be involved in lawsuits to protect or enforce its patents or the patents of its licensors, which could be expensive, time-consuming, and unsuccessful.

Competitors may infringe Morphogenesis’ patents or the patents of its licensors. To cease such infringement or unauthorized use, Morphogenesis may be required to file patent infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding or a declaratory judgment action against Morphogenesis, a court may decide that one or more of Morphogenesis’ patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that Morphogenesis’ patents do not cover the technology in question. An adverse result in any litigation or defense proceeding could put one or more of Morphogenesis’ patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put its patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from Morphogenesis’ business.

Interference or derivation proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to, or the correct inventorship of, Morphogenesis’ patents or patent applications or those of its licensors. An unfavorable outcome could result in a loss of Morphogenesis’ current patent rights and could require Morphogenesis to cease using the related technology or to attempt to license rights to it from the prevailing party. Morphogenesis’ business could be harmed if the prevailing party does not offer Morphogenesis a license on commercially reasonable terms. Litigation, interference, or derivation proceedings may result in a decision adverse to Morphogenesis’ interests and, even if it is successful, may result in substantial costs and distract its management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Morphogenesis’ confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Morphogenesis’ Common Stock.

Issued patents covering Morphogenesis’ product candidates could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign authority.

If Morphogenesis or one of its licensing partners initiate legal proceedings against a third party to enforce a patent covering one of Morphogenesis’ product candidates, the defendant could counterclaim that the patent covering Morphogenesis’ product candidate is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post-grant review, and equivalent proceedings in foreign jurisdictions, such as opposition or derivation proceedings. Such proceedings could result in revocation or amendment to Morphogenesis’ patents in such a way that they no longer cover and protect its product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity of Morphogenesis’ patents, for example, Morphogenesis cannot be certain that there is no invalidating prior art of which it, its patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, Morphogenesis would lose at least part, and perhaps all, of the patent protection on its product candidates. Such a loss of patent protection could have a material adverse impact on Morphogenesis’ business.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing Morphogenesis’ ability to protect its products.

As is the case with other biopharmaceutical companies, Morphogenesis’ success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves, both technological and legal complexity, and is therefore costly, time-consuming, and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Morphogenesis’ ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken Morphogenesis’ ability to obtain new patents or to enforce its existing patents and patents that Morphogenesis might obtain in the future. For example, in, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to naturally-occurring substances are not patentable. Although Morphogenesis does not believe that any of the patents owned or licensed by Morphogenesis will be found invalid based on this decision, Morphogenesis cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of its patents.

Morphogenesis may be subject to claims that its employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

Morphogenesis has received confidential and proprietary information from third parties. In addition, Morphogenesis employs individuals who were previously employed at other biotechnology or pharmaceutical companies. Morphogenesis may be subject to claims that it or its employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or Morphogenesis’ employees’ former employers. Litigation may be necessary to defend against these claims. Even if Morphogenesis is successful in defending against these claims, litigation could result in substantial cost and be a distraction to Morphogenesis’ management and employees.

Morphogenesis may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of its product candidates.

Even if Morphogenesis is successful in achieving regulatory approval to commercialize a product candidate faster than its competitors, Morphogenesis may face competition from biosimilars. The Patient Protection and Affordable Care Act, which was signed into law in March 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). The BPCIA established a regulatory scheme authorizing the FDA to approve biosimilars and interchangeable biosimilars. While certain biosimilar

products have been approved by the FDA for use in the United States, none of these have been cell therapy products and none have been interchangeable biosimilars. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars. Additional guidance is expected to be finalized by the FDA in the near term.

Under the BPCIA, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar product, it must find that the product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity, and potency. For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and, for products administered multiple times, that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date of approval of the reference product. The FDA may not approve a biosimilar product until 12 years from the date on which the reference product was approved. Even if a product is considered to be a reference product eligible for exclusivity, another company could market a competing version of that product if the FDA approves a full BLA for such product containing the sponsor’s own non-clinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity, and potency of their product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

If competitors are able to obtain marketing approval for biosimilars referencing Morphogenesis’ products, Morphogenesis’ products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

Morphogenesis may be subject to claims challenging the inventorship of its patents and other intellectual property.

Although Morphogenesis is not currently experiencing any claims challenging the inventorship of its patents or ownership of its intellectual property, it may in the future be subject to claims that former employees, collaborators, or other third parties have an interest in its patents or other intellectual property as an inventor or co-inventor. For example, Morphogenesis may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing its product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If Morphogenesis fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on Morphogenesis’ business. Even if Morphogenesis is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Risks Related to the Commercialization of Morphogenesis’ Product Candidates

Morphogenesis’ product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.

Morphogenesis’ product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials. There is no assurance that Morphogenesis’ manufacturers will be successful in establishing a larger-scale commercial manufacturing process for its product candidates that achieves its objectives for manufacturing capacity and cost of goods. Even if Morphogenesis could otherwise obtain regulatory approval for any product candidate, there is no assurance that its manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet

the requirements for the potential launch of the product or to meet potential future demand. If Morphogenesis’ manufacturers are unable to produce sufficient quantities of the approved product for commercialization, its commercialization efforts would be impaired, which would have an adverse effect on its business, financial condition, results of operations and growth prospects.

Biologics carry unique risks and uncertainties, which could have a negative impact on future results of operations.

The successful discovery, development, manufacturing, and sale of biologics is a lengthy, expensive, and uncertain process. There are unique risks and uncertainties with biologics. For example, access to and supply of necessary biological materials, such as cell lines, may be limited and governmental regulations restrict access to and regulate the transport and use of such materials. In addition, the development, manufacturing and sale of biologics is subject to regulations that are often more complex and extensive than the regulations applicable to other pharmaceutical products. Manufacturing biologics, especially in large quantities, is often complex and may require the use of innovative technologies. Such manufacturing also requires facilities specifically designed and validated for this purpose and sophisticated quality assurance and quality control procedures. Biologics are also frequently costly to manufacture because production inputs are derived from living animal or plant material, and some biologics cannot be made synthetically. Failure to successfully discover, develop, manufacture, and sell Morphogenesis’ biological product candidates would adversely impact Morphogenesis’ business and future results of operations.

Even if Morphogenesis is able to commercialize any of its product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or health care reform initiatives, which would harm Morphogenesis’ business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug and biological products vary widely from country to country. Current and future legislation may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product marketing approval is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, Morphogenesis may obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay its commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues Morphogenesis is able to generate from the sale of the product in that country. Adverse pricing limitations may hinder Morphogenesis’ ability to recoup its investment in one or more product candidates, even if its product candidates obtain marketing approval.

Morphogenesis’ ability to commercialize any product candidates successfully also will depend in part on the extent to which coverage and reimbursement for these product candidates and related treatments will be available from government authorities, private health insurers and other organizations. In the United States, reimbursement varies from payor to payor. Reimbursement agencies in Europe may be more conservative than federal health care programs or private health plans in the United States. For example, a number of cancer drugs are generally covered and paid for in the United States, but have not been approved for reimbursement in certain European countries. A primary trend in the U.S. health care industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of payments for particular products. For example, payors may limit coverage to specific drug or biological products on an approved list, also known as a formulary, which might not include all of the FDA-approved drugs or biologics for a particular indication. Payors may require use of alternative therapies or a demonstration that a product is medically necessary for a particular patient before use of a product will be covered. Additionally, payors may seek to control utilization by imposing prior authorization requirements.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for products. Morphogenesis cannot be sure that coverage will be available for any product candidate that it commercializes and, if coverage is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any product candidate for which Morphogenesis obtains marketing approval. Patients are unlikely to use Morphogenesis’ products, if they are approved for marketing, unless coverage is provided and reimbursement is adequate to cover a significant portion

of the cost of such products. If reimbursement is not available or is available only to limited levels, Morphogenesis may not be able to successfully commercialize any product candidate for which Morphogenesis obtains marketing approval.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers Morphogenesis’ costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover Morphogenesis’ costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by federal health care programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. In the European Union, reference pricing systems and other measures may lead to cost containment and reduced prices. Morphogenesis’ inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved products that Morphogenesis develops could have a material adverse effect on its operating results, its ability to raise capital needed to commercialize products and its overall financial condition.

Further, there have been, and may continue to be, legislative and regulatory proposals at the U.S. federal and state levels and in foreign jurisdictions directed at broadening the availability and containing or lowering the cost of healthcare including plans announced by the Trump Administration to reform the U.S. pharmaceutical pricing system significantly through rulemaking and executive orders. In addition, existing legislation aimed at patient affordability in the United States such as the ACA may be repealed or replaced. The continuing efforts of the government, insurance companies, managed care organizations and other third-party payors to contain or reduce costs of healthcare may adversely affect Morphogenesis’ ability to set prices for its products that would allow it to achieve or sustain profitability. In addition, governments may impose price controls on any of Morphogenesis’ products that obtain marketing approval, which may adversely affect Morphogenesis’ future profitability.

In some foreign countries, particularly the member states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can be a long and expensive process after the receipt of marketing approval for a product candidate. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, Morphogenesis may be required to conduct additional clinical trials that compare the cost-effectiveness of its product candidates to other available therapies in order to obtain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on prices or reimbursement levels within the country of publication and other countries. If reimbursement of Morphogenesis’ products is unavailable or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, Morphogenesis may be unable to achieve or sustain profitability for sales of any of its product candidates that are approved for marketing in that country and its business could be adversely affected.

Morphogenesis has no experience selling, marketing or distributing products and currently have no internal marketing and sales force. If Morphogenesis is unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell its product candidates, it may not be able to effectively market and sell its product candidates, if approved, or generate product revenues.

Morphogenesis currently has no sales, marketing or distribution capabilities and have no experience as a company in the sale or marketing of pharmaceutical products. There can be no assurance that Morphogenesis will be able to market and sell its products in the United States or overseas. In order to commercialize any product candidates, Morphogenesis must build on a territory-by-territory basis marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and

Morphogenesis may not be successful in doing so. Therefore, with respect to the commercialization of all or certain of Morphogenesis’ product candidates, Morphogenesis may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment its own sales force and distribution systems or in lieu of its own sales force and distribution systems. If so, Morphogenesis’ success will depend, in part, on its ability to enter into and maintain collaborative relationships for such capabilities, such collaborators’ strategic interest in the products under development and such collaborators’ ability to successfully market and sell any such products.

If Morphogenesis is unable to enter into such arrangements when needed on acceptable terms or at all, Morphogenesis may not be able to successfully commercialize any of its product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations. Further, to the extent that Morphogenesis depends on third parties for marketing and distribution, any revenues Morphogenesis receives will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful.

To the extent that Morphogenesis decides not to, or is unable to, enter into collaborative arrangements with respect to the sales and marketing of its products, Morphogenesis may in the future need to establish an internal sales and marketing team with technical expertise and supporting distribution capabilities to commercialize its product candidates, which could be expensive, time-consuming and requiring significant attention of its executive officers to manage. Further, Morphogenesis may not have sufficient resources to allocate to the sales and marketing of its products.

Any failure or delay in the development of sales, marketing and distribution capabilities, through collaboration with one or more third parties or through internal efforts, would adversely impact the commercialization of any of Morphogenesis’ products that Morphogenesis obtains approval to market. As a result, Morphogenesis’ future product revenue will suffer and Morphogenesis may incur significant additional losses.

General Risk Factors

Morphogenesis’ estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which Morphogenesis competes achieve the forecasted growth, its business may not grow at similar rates, or at all.

Morphogenesis’ market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. Its estimates and forecasts relating to size and expected growth of its target market may prove to be inaccurate. Even if the markets in which Morphogenesis ultimately competes meet its size estimates and growth forecasts, its business may not grow at similar rates, or at all. Morphogenesis’ growth is subject to many factors, including its success in implementing its business strategy, which is subject to many risks and uncertainties.

Morphogenesis’ revenue will depend, in part, upon the size of the markets in the territories for which Morphogenesis gains regulatory approval, the accepted price for its products, the ability to obtain coverage and reimbursement and whether Morphogenesis owns the commercial rights for that territory. If the number of its addressable patients is not as significant as Morphogenesis estimates, the indication approved by regulatory authorities is narrower than Morphogenesis expects or the treatment population is narrowed by competition, physician choice, or treatment guidelines, Morphogenesis may not generate significant revenue from sales of such products, even if approved.

Morphogenesis’ business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, such as the COVID-19 pandemic, political crises, geopolitical events, such as conflict between Russia and Ukraine, or other macroeconomic conditions, which could have a material and adverse effect on its results of operations and financial condition.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates, and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdown, and extreme volatility in the capital markets. The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again.

Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending. Similarly, the ongoing military conflict between Russia and Ukraine and rising tensions with China have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global supply chain. Any such volatility and disruptions may adversely affect its business or the third parties on whom Morphogenesis relies. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all. Increased inflation rates can adversely affect Morphogenesis by increasing its costs, including labor and employee benefit costs.

Morphogenesis may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials. Any one or a combination of these events could have a material and adverse effect on its results of operations and financial condition.

Risks Related to the Combined Company

Unless the context otherwise requires, references to “we,” “us” or “our” in this subsection generally refer to the combined company.

If any of the events described in “Risks Related to CohBar” or “Risks Related to Morphogenesis” occur, those events could cause potential benefits of the Merger not to be realized.

Following completion of the Merger, the combined company will be susceptible to many of the risks described in the sections herein entitled “Risks Related to CohBar” and “Risks Related to Morphogenesis.” To the extent any of the events in the risks described in those sections occur, the potential benefits of the Merger may not be realized and the results of operations and financial condition of the combined company could be adversely affected in a material way. This could cause the market price of the combined company’s common stock to decline.

The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.

The market price of the combined company’s common stock following the Merger could be subject to significant fluctuations. Some of the factors that may cause the market price of the combined company’s common stock to fluctuate include:

•        results of clinical trials and preclinical studies of the combined company’s product candidates, or those of the combined company’s competitors or the combined company’s existing or future collaborators;

•        failure to meet or exceed financial and development projections the combined company may provide to the public;

•        failure to meet or exceed the financial and development projections of the investment community;

•        if the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts;

•        announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by the combined company or its competitors;

•        actions taken by regulatory agencies with respect to the combined company’s product candidates, clinical studies, manufacturing process or sales and marketing terms;

•        disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain patent protection for its technologies;

•        additions or departures of key personnel;

•        significant lawsuits, including patent or stockholder litigation;

•        if securities or industry analysts do not publish research or reports about the combined company’s business, or if they issue adverse or misleading opinions regarding its business and stock;

•        changes in the market valuations of similar companies;

•        general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors;

•        sales of securities by the combined company or its securityholders in the future;

•        if the combined company fails to raise an adequate amount of capital to fund its operations or continued development of its product candidates;

•        trading volume of the combined company’s common stock;

•        announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

•        adverse publicity relating to biological product candidates, including with respect to other products in such markets;

•        the introduction of technological innovations or new therapies that compete with the products and services of the combined company; and

•        period-to-period fluctuations in the combined company’s financial results.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock. In addition, a recession, depression or other sustained adverse market event could materially and adversely affect the combined company’s business and the value of its common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies. Furthermore, market volatility may lead to increased shareholder activism if the combined company experiences a market valuation that activists believe is not reflective of its intrinsic value. Activist campaigns that contest or conflict with the combined company’s strategic direction or seek changes in the composition of its board of directors could have an adverse effect on its operating results, financial condition, and cash flows.

The combined company may incur losses for the foreseeable future and may never achieve profitability.

The combined company may never become profitable, even if the combined company is able to complete clinical development for one or more product candidates and eventually commercialize such product candidates. The combined company will need to successfully complete significant research, development, testing and regulatory compliance activities that, together with projected general and administrative expenses, is expected to result in substantial increased operating losses for at least the next several years. Even if the combined company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis.

Following the Merger, the combined company may be unable to integrate successfully the businesses of CohBar and Morphogenesis and realize the anticipated benefits of the Merger.

The Merger involves the combination of two companies which currently operate as independent companies. Following the Merger, the combined company will be required to devote significant management attention and resources to integrating its business practices and operations. The combined company may fail to realize some or all of the anticipated benefits of the Merger if the integration process takes longer than expected or is more costly than expected. Potential difficulties the combined company may encounter in the integration process include the following:

•        the inability to successfully combine the businesses of CohBar and Morphogenesis in a manner that permits the combined company to achieve the anticipated benefits from the Merger, which would result in the anticipated benefits of the Merger not being realized partly or wholly in the time frame currently anticipated or at all;

•        creation of uniform standards, controls, procedures, policies, and information systems; and

•        potential unknown liabilities and unforeseen increased expenses, delays or regulatory conditions associated with the Merger

In addition, CohBar and Morphogenesis have operated and, until the completion of the Merger, will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures, and policies, any of which could adversely affect the combined company’s ability to maintain its business relationships or the ability to achieve the anticipated benefits of the Merger, or could otherwise adversely affect the business and financial results of the combined company.

If the combined company fails to attract and retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.

The combined company’s ability to compete in the highly competitive pharmaceuticals industry depends on its ability to attract and retain highly qualified managerial, scientific, medical, legal, sales and marketing, and other personnel. The combined company will be highly dependent on its management and scientific personnel. The loss of the services of any of these individuals could impede, delay, or prevent the successful development of the combined company’s product pipeline, completion of its planned clinical trials, commercialization of its product candidates or in-licensing or acquisition of new assets and could negatively impact its ability to implement successfully its business plan. If the combined company loses the services of any of these individuals, it might not be able to find suitable replacements on a timely basis or at all, and its business could be harmed as a result. The combined company might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

The combined company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

The combined company will require substantial additional funds to conduct the costly and time-consuming clinical efficacy trials necessary to pursue regulatory approval of each potential product candidate and to continue the development of IFx-Hu2.0 and IFx-Hu3.0, Morphogenesis’ other product candidates and future product candidates. The combined company’s future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance. Raising additional capital may be costly or difficult to obtain and could, for example, through the sale of common stock or securities convertible or exchangeable into common stock, significantly dilute stockholders’ ownership interests in the combined company or inhibit the combined company’s ability to achieve its business objectives. If the combined company raises additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely the rights of its common stockholders. In addition, any debt financing may subject the combined company to fixed payment obligations and covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the combined company raises additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, the combined company may have to relinquish certain valuable intellectual property or other rights to its product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to it. Even if the combined company were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to the combined company or its stockholders.

If the assets subject to the CVR Agreement are not disposed of in a timely manner, the combined company may have to incur time and resources to wind down or dispose of such assets.

In connection with the Merger, CohBar intends to declare a dividend to each person who as of immediately prior to the Effective Time was a stockholder of record of CohBar or had the right to receive CohBar Common Stock of the right to receive one non-transferable CVR for each then outstanding share of CohBar Common Stock, each representing the non-transferable contractual right to receive certain contingent payments from CohBar upon the occurrence of certain events within agreed time periods. See the section titled “Agreements Related to the Merger — Contingent Value Rights Agreement” beginning on page 170 of this proxy statement/prospectus. Pursuant to the terms of the CVR Agreement, if the combined company is unable to sell the assets subject to the CVR Agreement within three years following the closing of the Merger, the combined company will be responsible for any wind-down costs associated with the termination of such assets within the parameters contained in the CVR Agreement. Further, pursuant to the terms of the CVR Agreement, the holders of CohBar Common Stock prior to the closing of the Merger, rather than the holders of the combined company’s common stock, are the primary recipients of any net proceeds of the disposition of the assets subject to the CVR Agreement. Absent such CVR Agreement, the combined company may have allocated such funds, time and resources to its core programs and the foregoing could be a distraction to the combined company’s management and employees. As a result, the combined company’s operations and financial condition may be adversely affected.

The combined company will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.

The combined company will incur significant legal, accounting, and other expenses as a public company that Morphogenesis did not incur as a private company, including costs associated with public company reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The combined company’s management team will consist of the executive officers of Morphogenesis prior to the Merger, some of whom have not previously managed and operated a public company. These executive officers and other personnel will need to devote substantial time to gaining expertise related to public company reporting requirements and compliance with applicable laws and regulations to ensure that the combined company complies with all these requirements. Any changes the combined company makes to comply with these obligations may not be sufficient to allow it to satisfy its obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for the combined company to attract and retain qualified persons to serve on the board of directors or on board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

Upon completion of the Merger, failure by the combined company to comply with the initial listing standards of Nasdaq will prevent its stock from being listed on Nasdaq.

Upon completion of the Merger, CohBar, under the new name “TuHURA Biosciences, Inc.” will be required to meet the initial listing requirements to maintain the listing and continued trading of its shares on Nasdaq. These initial listing requirements are more difficult to achieve than the continued listing requirements. Pursuant to the Merger Agreement, CohBar agreed to use its commercially reasonable efforts to cause the shares of CohBar Common Stock being issued in the Merger to be approved for listing on Nasdaq at or prior to the Effective Time of the Merger. Based on information currently available to CohBar, CohBar anticipates that its stock will be unable to meet the $4.00 (or, to the extent applicable, $3.00) minimum bid price initial listing requirement at the closing of the Merger unless it effects a reverse stock split. The board of directors of CohBar intends to effect a reverse stock split of the shares of CohBar Common Stock at a ratio of between 1-for-1.5 to 1-for-10. In addition, often times a reverse stock split will not result in a trading price for the affected common stock that is proportional to the ratio of the split. Following the Merger, if the combined company is unable to satisfy Nasdaq listing requirements, Nasdaq may notify the combined company that its shares of common stock will not be listed on Nasdaq.

Upon a potential delisting from Nasdaq, if the common stock of the combined company is not then eligible for quotation on another market or exchange, trading of the shares could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it is likely that there would be significantly less liquidity in the trading of the common stock

of the combined company; decreases in institutional and other investor demand for the shares, coverage by securities analysts, market making activity and information available concerning trading prices and volume; and fewer broker dealers willing to execute trades in the common stock of the combined company. Also, it may be difficult for the combined company to raise additional capital if the combined company’s common stock is not listed on a major exchange. The occurrence of any of these events could result in a further decline in the market price of the common stock of the combined company and could have a material adverse effect on the combined company.

Once the combined company is no longer a smaller reporting company or otherwise no longer qualifies for applicable exemptions, the combined company will be subject to additional laws and regulations affecting public companies that will increase the combined company’s costs and the demands on management and could harm the combined company’s operating results and cash flows.

The combined company will be subject to the reporting requirements of the Exchange Act, which requires, among other things, that the combined company file with the SEC, annual, quarterly, and current reports with respect to the combined company’s business and financial condition as well as other disclosure and corporate governance requirements. CohBar and Morphogenesis expect the combined company will qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Exchange Act, in at least the near term, which will allow the combined company to take advantage of certain exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this proxy statement/prospectus and in the combined company’s periodic reports and proxy statements. Once the combined company is no longer a smaller reporting company or otherwise no longer qualifies for these exemptions, the combined company will be required to comply with these additional legal and regulatory requirements applicable to public companies and will incur significant legal, accounting and other expenses to do so. If the combined company is not able to comply with the requirements in a timely manner or at all, the combined company’s financial condition or the market price of the combined company’s common stock may be harmed. For example, if the combined company or its independent auditor identifies deficiencies in the combined company’s internal control over financial reporting that are deemed to be material weaknesses the combined company could face additional costs to remedy those deficiencies, the market price of the combined company’s stock could decline or the combined company could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

The unaudited pro forma condensed combined financial information for CohBar and Morphogenesis included in this proxy statement/prospectus are preliminary, and the combined company’s actual financial position and operations after the Merger may differ materially from the unaudited pro forma financial information included in this proxy statement/prospectus.

The unaudited pro forma financial information for CohBar and Morphogenesis included in this proxy statement/prospectus are presented for illustrative purposes only and is not necessarily indicative of the combined company’s actual financial condition or results of operations of future periods, or the financial condition or results of operations that would have been realized had the entities been combined during the period presented. The combined company’s actual results and financial position after the Merger may differ materially and adversely from the unaudited pro forma financial information included in this proxy statement/prospectus. The Exchange Ratio reflected in this proxy statement/prospectus is preliminary. The final Exchange Ratio could differ materially from the preliminary Exchange Ratio used to prepare the pro forma adjustments. For more information see the section titled “Unaudited Pro Forma Condensed Combined Financial Information” beginning on page 288 of this proxy statement/prospectus.

The combined company’s certificate of incorporation and bylaws and provisions under Delaware law could make an acquisition of the combined company more difficult and may prevent attempts by its stockholders to replace or remove its management.

If the Merger is completed, the CohBar Bylaws and the CohBar Charter, as amended by the amendments thereto attached to this proxy statement/prospectus in the form of Annex I, assuming Proposal No. 2 is approved by CohBar’s stockholders at the CohBar special meeting, will become the combined company’s bylaws and certificate of incorporation. Provisions that will be included in the combined company’s certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of

the combined company that stockholders may consider favorable, including transactions in which its common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of the combined company’s common stock, thereby depressing the market price of its common stock. In addition, because the combined company’s board of directors will be responsible for appointing the members of the combined company’s management team, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of the combined company’s board of directors. Among other things, these provisions will include the following:

•        the authorized number of the combined company’s directors may be changed only by resolution of its board of directors and only its board of directors is authorized to fill vacant directorships, including newly created seats;

•        stockholders may not take action by written consent, but may only take action at an annual of special meeting of stockholders;

•        advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on at stockholder meetings;

•        stockholders are not entitled to the right to cumulate votes in the election of directors;

•        limitations on who may call a special meeting of stockholders; and

•        the board of directors is authorized to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by the combined company’s board of directors.

Moreover, because the combined company will be incorporated in Delaware, it is governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of the outstanding combined company voting stock from merging or combining with the combined company. Although CohBar and Morphogenesis believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with the combined company’s board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing the members of management.

The bylaws of the combined company will provide that, unless the combined company consents in writing to the selection of an alternative forum, certain designated courts will be the sole and exclusive forum for certain legal actions between the combined company and its stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with the combined company or its directors, officers, employees or agents.

The bylaws of the combined company will provide that, unless it consents in writing to an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for state law claims for (i) any derivative action or proceeding brought on its behalf, (ii) any action asserting a claim of or based on a breach of a fiduciary duty owed by any of its current or former directors, officers, or other employees to the combined company or its stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, its charter or its bylaws, or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein, which for purposes of this risk factor refers to herein as the “Delaware Forum Provision.” The combined company reserves the right to assert that the Delaware Forum Provision applies to any derivative action or proceeding to procure a judgment in the combined company’s favor, that arise under the Exchange Act. It is, however, uncertain whether a court would enforce the Delaware Forum Provision with respect to a derivative action or proceeding brought by a stockholder to enforce the combined company’s rights under the Exchange Act. The combined company will not assert that the Delaware Forum Provision applies to any direct action brought by a stockholder to enforce rights under the Exchange Act or Securities Act. The bylaws of the combined company will further provide that, unless it consents in writing to an alternative forum, federal district courts of the United States will be the

exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, which for purposes of this risk factor refers to herein as the “Federal Forum Provision.” It is, however, uncertain whether a court would enforce the Federal Forum Provision with respect to a proceeding brought by a stockholder to enforce its rights under the Securities Act. In addition, the bylaws of the combined company will provide that any person or entity purchasing or otherwise acquiring any interest in shares of its capital stock is deemed to have notice of and consented to the foregoing Delaware Forum Provision and Federal Forum Provision; provided, however, that stockholders cannot and will not be deemed to have waived its compliance with the U.S. federal securities laws and the rules and regulations thereunder.

The Delaware Forum Provision and the Federal Forum Provision may impose additional litigation costs on stockholders of the combined company in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the forum selection clauses in the bylaws of the combined company may limit its stockholders’ ability to bring a claim in a judicial forum that they find favorable for disputes with the combined company or its directors, officers or employees, which may discourage such lawsuits against the combined company and its directors, officers and employees even though an action, if successful, might benefit its stockholders.

Choice of forum. Our restated certificate of incorporation provides that, to the fullest extent permitted by law, the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the DGCL, our restated certificate of incorporation or our restated bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine. The combined company reserves the right to assert that the provision applies to any derivative action or proceeding brought to procure a judgment in the combined company’s favor that arise under the Exchange Act. It is, however, uncertain whether a court would enforce the provision with respect to a derivative action or proceeding brought by a stockholder to enforce the combined company’s rights under the Exchange Act.

CohBar and Morphogenesis do not anticipate that the combined company will pay any cash dividends in the foreseeable future.

The current expectation is that the combined company will retain its future earnings, if any, to fund the growth of the combined company’s business as opposed to paying dividends. As a result, capital appreciation, if any, of the common stock of the combined company will be your sole source of gain, if any, for the foreseeable future.

An active trading market for the combined company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all.

Prior to the Merger, there had been no public market for shares of Morphogenesis capital stock. An active trading market for the combined company’s shares of common stock may never develop or be sustained. If an active market for the combined company’s common stock does not develop or is not sustained, it may be difficult for its stockholders to sell their shares at an attractive price or at all.

Future sales of shares by existing stockholders could cause the combined company’s stock price to decline.

If existing securityholders of CohBar and Morphogenesis sell, or indicate an intention to sell, substantial amounts of the combined company’s common stock in the public market after legal restrictions on resale discussed in this proxy statement/prospectus lapse, the trading price of the common stock of the combined company could decline. Based on shares outstanding as of August 15, 2023, after giving effect to the estimated Exchange Ratio, the Stock Dividend, the Reverse Stock Split (at an assumed ratio of 1-for-3), and the issuance of shares of CohBar Common Stock to be issued in the Initial Financing and shares expected to be issued upon completion of the Merger, the combined company is expected to have outstanding a total of approximately 24,389,0202 shares of common stock immediately following the completion of the Merger. Of such outstanding shares of common stock, approximately 10,825,924 shares will be freely tradeable upon completion of the Merger and approximately 11,063,096 shares will become available for sale in the public market beginning 180 days after the closing of the Merger as a result of the expiration of lock-up agreements between CohBar and certain securityholders of Morphogenesis (and without giving effect to any restrictions on resale under securities laws). The 2,500,000 shares of common stock of the combined company purchased in the Initial Financing may be resold in the public market upon the registration for resale of such shares following the Merger in accordance with the registration rights agreement with the Investor. In addition, shares of common stock that are subject to outstanding options or warrants

of Morphogenesis will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act. If these shares are sold, the trading price of the combined company’s common stock could decline.

After completion of the Merger, the combined company’s executive officers, directors and principal stockholders will have the ability to control or significantly influence all matters submitted to the combined company’s stockholders for approval.

Upon the completion of the Merger, and giving effect to the Stock Dividend and the issuance of the shares of CohBar Common Stock pursuant to the Initial Financing, it is anticipated that the combined company’s executive officers, directors and principal stockholders will, in the aggregate, beneficially own approximately 39.6% of the combined company’s outstanding shares of common stock. As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to the combined company’s stockholders for approval, as well as the combined company’s management and affairs. For example, these stockholders, if they choose to act together, would control or significantly influence the election of directors and approval of any Merger, consolidation or sale of all or substantially all of the combined company’s assets. This concentration of voting power could delay or prevent an acquisition of the combined company on terms that other stockholders may desire.

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about the combined company, its business or its market, its stock price and trading volume could decline.

The trading market for the combined company’s common stock will be influenced by the research and reports that equity research analysts publish about it and its business. Equity research analysts may elect to not provide research coverage of the combined company’s common stock after the completion of the Merger, and such lack of research coverage may adversely affect the market price of its common stock. In the event it does have equity research analyst coverage, the combined company will not have any control over the analysts or the content and opinions included in their reports. The price of the combined company’s common stock could decline if one or more equity research analysts downgrade its stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of the combined company or fails to publish reports on it regularly, demand for its common stock could decrease, which in turn could cause its stock price or trading volume to decline.

The combined company will have broad discretion in the use of the cash and cash equivalents of the combined company and the proceeds from the Initial Financing and Second Financing and may invest or spend the proceeds in ways that may not increase the value of your investment.

The combined company will have broad discretion over the use of the cash and cash equivalents of the combined company and the proceeds from the Initial Financing and Second Financing. You may not agree with the combined company’s decisions, and its use of the proceeds may not yield any return on your investment. The combined company’s failure to apply these resources effectively could compromise its ability to pursue its growth strategy and the combined company might not be able to yield a significant return, if any, on its investment of these net proceeds. You will not have the opportunity to influence its decisions on how to use the combined company’s cash resources.

The combined company may be subject to adverse legislative or regulatory tax changes that could negatively impact its financial condition.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect the combined company or its stockholders. The combined company will assess the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where the combined company has operations to determine the potential effect on its business and any assumptions the combined company will make about its future taxable income. It cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what effect, if any, such proposals would have on its business if they were to be enacted. For example, the United States recently enacted the Inflation Reduction Act of 2022, which implements, among other changes, a 1% excise tax on certain stock buybacks. In addition, beginning in 2022, the Tax Cuts and Jobs Act, P.L. 115-97 eliminates the currently available

option to deduct research and development expenditures and requires taxpayers to amortize them generally over five years. The U.S. Congress is considering legislation that would restore the current deductibility of research and development expenditures, however, there is no assurance that the provision will be repealed or otherwise modified. Such changes, among others, may adversely affect its effective tax rate, results of operation and general business condition.

The combined company’s ability to use net operating loss carryforwards and other tax attributes may be limited, including as a result of the Merger.

Under current law, U.S. federal net operating loss carryforwards generated in taxable periods beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such net operating loss carryforwards is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform to federal law. In addition, under Sections 382 and 383 of the Code, U.S. federal net operating loss carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership. An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The combined company’s ability to utilize its net operating loss carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including in connection with the Merger or other transactions. Similar rules may apply under state tax laws. If the combined company earns taxable income, such limitations could result in increased future income tax liability to the combined company, and the combined company’s future cash flows could be adversely affected. CohBar had net operating loss carryforwards as of December 31, 2022 of approximately $74.8 million, which are subject to limitations.

Unfavorable global economic conditions could adversely affect the combined company’s business, financial condition, results of operations or cash flows.

The combined company’s results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to the combined company’s business, including, weakened demand for the combined company’s product candidates and the combined company’s ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain the combined company’s suppliers, possibly resulting in supply disruption, or cause the combined company’s customers to delay making payments for its services. Any of the foregoing could harm the combined company’s business and the combined company cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact its business.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This proxy statement/prospectus contains or incorporates statements that constitute forward-looking statements within the meaning of the federal securities laws in relation to CohBar, Morphogenesis, the Merger and the other proposed transactions contemplated thereby. Any express or implied statements that do not relate to historical or current facts or matters are forward-looking statements. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “target,” “endeavor,” “potential,” “continue” or the negative of these terms or other comparable terminology, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting CohBar, Morphogenesis or the proposed transaction will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond CohBar’s or Morphogenesis’ control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. In addition to other factors and matters contained in or incorporated by reference in this document, CohBar and Morphogenesis believe the following factors could cause actual results to differ materially from those discussed in the forward-looking statements: the risk that the conditions to the closing of the transaction are not satisfied, including the failure to obtain stockholder approval for the transaction;

•        the timing, receipt and terms and conditions of any required governmental or regulatory approvals of the Merger that could cause the parties to abandon the Merger;

•        CohBar’s and Morphogenesis’ ability to meet expectations regarding the timing and completion of the Merger;

•        the risk that the Initial Financing and Second Financing are not completed in a timely manner or at all;

•        uncertainties as to the timing of the consummation of the transaction and the ability of each of CohBar and Morphogenesis to consummate the transaction, including the Initial Financing and Second Financing;

•        risks related to CohBar’s continued listing on the Nasdaq Capital Stock Market until closing of the Merger;

•        expectations regarding the strategies, prospects, plans, expectations and objectives of management of CohBar or Morphogenesis for future operations of the combined company following the closing of the Merger;

•        the ability of the combined company to recognize the benefits that may be derived from the Merger, including the commercial or market opportunity of, the product candidates of CohBar, Morphogenesis and the combined company;

•        risks related to CohBar’s and Morphogenesis’ ability to correctly estimate their respective operating expenses and expenses associated with the transaction, uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources;

•        the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement;

•        the fact that under the terms of the Merger Agreement, CohBar is restrained from soliciting other acquisition proposals during the pendency of the Merger, except in certain circumstances;

•        the effect of the announcement or pendency of the Merger on CohBar’s or Morphogenesis’ business relationships, operating results and business generally, including disruption of CohBar’s and

Morphogenesis’ management’s attention from ongoing business operations due to the Merger and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction;

•        the risk that the Merger Agreement may be terminated in circumstances that require CohBar to pay a Termination Fee;

•        the outcome of any legal proceedings that may be instituted against CohBar, Morphogenesis or any of their respective directors or officers related to the Merger Agreement or the transactions contemplated thereby;

•        the ability of CohBar or Morphogenesis to protect their respective intellectual property rights;

•        competitive responses to the Merger;

•        legislative, regulatory, political and economic developments beyond the parties’ control;

•        the initiation, timing and success of clinical trials for CohBar’s and Morphogenesis’ product candidates;

•        CohBar’s and Morphogenesis’ reliance on third parties to conduct clinical trials for its product candidates and for its clinical product supplies;

•        the failure to achieve the market acceptance by any CohBar or Morphogenesis product candidates that receive marketing approval;

•        success in retaining, or changes required in, CohBar’s and Morphogenesis’ officers, key employees or directors;

•        CohBar’s public securities’ potential liquidity and trading;

•        regulatory actions with respect to CohBar’s and Morphogenesis’ product candidates or their respective competitors’ products and product candidates;

•        CohBar’s and Morphogenesis’ ability to manufacture its product candidates in conformity with the FDA’s requirements and to scale up manufacturing of its product candidates to commercial scale, if approved;

•        CohBar’s and Morphogenesis’ reliance on third-party contract development and manufacturer organizations to manufacture and supply CohBar’s and Morphogenesis’ product candidates;

•        CohBar’s and Morphogenesis’ ability to successfully commercialize its product candidates, if approved, and the rate and degree of market acceptance of its product candidates;

•        developments and projections relating to CohBar’s and Morphogenesis’ competitors or its industry; and

•        risks related to health, pandemics, epidemics and outbreaks, including COVID-19, which could significantly disrupt CohBar’s and Morphogenesis’ preclinical studies and clinical trials.

Should one or more of these risks or uncertainties materialize, or should any of CohBar’s or Morphogenesis’ assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. There may be additional risks that CohBar considers immaterial or which are unknown. You are urged to carefully review the disclosures CohBar and Morphogenesis make concerning these risks and other factors that may affect CohBar’s and Morphogenesis’ business and operating results under the section titled “Risk Factors” beginning on page 26 of this proxy statement/prospectus. Additional factors that could cause actual results to differ materially from those expressed in the forward-looking statements are discussed in reports filed with the SEC by CohBar and incorporated by reference herein. Please see the section titled “Where You Can Find More Information” beginning on page 320 of this proxy statement/prospectus. There can be no assurance that the Merger will be completed, or if it is completed, that it will be completed within the anticipated time period or that the expected benefits of the Merger will be realized.

If any of these risks or uncertainties materialize or any of these assumptions prove incorrect, the results of CohBar, Morphogenesis or the combined company could differ materially from the forward-looking statements. Any public statements or disclosures by CohBar and Morphogenesis following this proxy statement/prospectus that modify or impact any of the forward-looking statements contained in this proxy statement/prospectus will be deemed to modify or supersede such statements in this proxy statement/prospectus. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. CohBar and Morphogenesis do not intend, and undertake no obligation, to update any forward-looking information to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events, unless required by law to do so.

THE SPECIAL MEETING IN LIEU OF ANNUAL MEETING OF COHBAR STOCKHOLDERS

Date, Time and Place

The CohBar Special Meeting will be held on October 4, 2023, commencing at 8:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The CohBar Special Meeting will be held entirely online. CohBar is sending this proxy statement/prospectus to its stockholders in connection with the solicitation of proxies by the CohBar Board for use at the CohBar Special Meeting and any adjournments or postponements of the CohBar Special Meeting. This proxy statement/prospectus is first being mailed to CohBar stockholders on or about September 12, 2023.

Purposes of the CohBar Special Meeting

The purposes of the CohBar Special Meeting are:

1.      To approve (i) the issuance of shares of CohBar Common Stock, which will represent more than 20% of the shares of CohBar Common Stock outstanding immediately prior to the Merger, to stockholders of Morphogenesis, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A to this proxy statement/prospectus, and (ii) the change of control of CohBar resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively;

2.      To approve an amendment to the CohBar Charter at the option of the CohBar Board to effect the Authorized Share Increase;

3.      To adopt and approve an amendment to the CohBar Charter to effect the Reverse Stock Split, by a ratio of not less than 1-for-1.5 and not more than 1-for-10, such ratio and the implementation and timing of the Reverse Stock Split to be determined in the discretion of the CohBar Board;

4.      To approve, on an advisory (non-binding) basis, certain compensation payments that will or may be made by CohBar to its named executive officers in connection with the Merger;

5.      To elect a board of directors named in the accompanying proxy statement/prospectus, up to the number of directorships subject to election (being seven or two), to serve until the next annual meeting of stockholders or until their successors are duly elected and qualified;

6.      To ratify the appointment of Marcum LLP as CohBar’s independent registered public accounting firm for the year ending December 31, 2023;

7.      To approve the TuHURA Biosciences, Inc. 2023 Equity Incentive Plan, in the form attached as Annex H to the accompanying proxy statement/prospectus;

8.      To approve an adjournment of the CohBar Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals 1, 2, 3, 4 and 7; and

9.      To transact such other business as may properly come before the stockholders at the CohBar Special Meeting or any adjournment or postponement thereof.

The approval of each of Proposal Nos. 1, 2 and 3 is a condition to completion of the Merger. The issuance of CohBar Common Stock in connection with the Merger and the change of control of CohBar resulting from the Merger, or Proposal No. 1, will not take place unless Proposal No. 1 is approved by CohBar stockholders and the Merger is consummated. The amendment to the CohBar Charter to effect the Authorized Share Increase, or Proposal No. 2, will not take place unless Proposal No. 2 is approved by the requisite CohBar stockholders. The amendment to the CohBar Charter to effect a Reverse Stock Split of CohBar’s issued and outstanding common stock, or Proposal No. 3, will not take place unless Proposal No. 3 is approved by the requisite CohBar stockholders.

Recommendation of CohBar’s Board of Directors

•        The CohBar Board has determined and believes that the issuance of shares of CohBar Common Stock pursuant to the Merger Agreement is fair to, in the best interests of, and advisable to, CohBar and its stockholders and has approved such issuance. The CohBar Board recommends that CohBar stockholders vote “FOR” the Nasdaq Stock Issuance Proposal.

•        The CohBar Board has determined and believes that it is fair to, in the best interests of, and advisable to, CohBar and its stockholders to approve the amendment to the CohBar Charter to increase the number of its authorized shares, as described in this proxy statement/prospectus. The CohBar Board recommends that CohBar stockholders vote “FOR” the Authorized Share Increase Proposal.

•        The CohBar Board has determined and believes that it is fair to, in the best interests of, and advisable to, CohBar and its stockholders to approve the amendment to the CohBar Charter to effect the Reverse Stock Split, as described in this proxy statement/prospectus. The CohBar Board recommends that CohBar stockholders vote “FOR” the Reverse Stock Split Proposal.

•        The CohBar Board has determined and believes that it is advisable to, and in the best interests of, CohBar and its stockholders to approve, on an advisory (non-binding) basis, certain compensation payments that will or may be made by CohBar to its named executive officers in connection with the Merger, as described in this proxy statement/prospectus. The CohBar Board recommends that CohBar stockholders vote “FOR” the Golden Parachute’s Compensation Proposal.

•        The CohBar Board has determined and believes that it is advisable to, and in the best interests of, CohBar and its stockholders to elect each of the director nominees named in the Director Election Proposal, to serve on the CohBar Board. The CohBar Board recommends that CohBar stockholders vote “FOR” each of the director nominees named in the Director Election Proposal.

•        The CohBar Board has determined and believes that it is advisable to, and in the best interests of, CohBar and its stockholders to ratify the appointment of Marcum LLP as CohBar’s independent registered public accounting firm for the fiscal year ending December 31, 2023. The CohBar Board recommends that CohBar stockholders vote “FOR” the Auditor Ratification Proposal.

•        The CohBar Board has determined and believes that it is advisable to, and in the best interests of, CohBar and its stockholders to approve the TuHURA Biosciences, Inc. 2023 Equity Incentive Plan, in the form attached as Annex H to the accompanying proxy statement/prospectus. The CohBar Board recommends that CohBar stockholders vote “FOR” the 2023 Equity Incentive Plan Proposal.

•        The CohBar Board has determined and believes that adjourning the CohBar Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Nasdaq Stock Issuance Proposal and/or the Authorized Share Increase Proposal is fair to, in the best interests of, and advisable to, CohBar and its stockholders and has approved and adopted the proposal. The CohBar Board recommends that CohBar stockholders vote “FOR” the Adjournment Proposal, if necessary.

Record Date and Voting Power

Only holders of record of CohBar Common Stock at the close of business on the record date of August 31, 2023, are entitled to notice of, and to vote at, the CohBar Special Meeting. At the close of business on the record date, there were approximately 25 registered holders of record of CohBar Common Stock and there were 2,906,926 shares of CohBar Common Stock issued and outstanding. Each share of CohBar Common Stock entitles the holder thereof to one vote on each matter submitted for stockholder approval.

Voting and Revocation of Proxies

The proxy accompanying this proxy statement/prospectus is solicited on behalf of the CohBar Board for use at the CohBar Special Meeting.

If, as of the record date referred to above, your shares were registered directly in your name with the transfer agent for CohBar Common Stock, American Stock Transfer & Trust Company, LLC, then you are a stockholder of record. Whether or not you plan to attend the CohBar Special Meeting online, CohBar urges you to fill out and return the proxy card or vote by proxy over the telephone or on the internet as instructed below to ensure your vote is counted.

The procedures for voting are as follows:

If you are a stockholder of record, you may vote at the CohBar Special Meeting. Alternatively, you may vote by proxy by using the accompanying proxy card, over the internet or by telephone. Whether or not you plan to attend the CohBar Special Meeting, CohBar encourages you to vote by proxy to ensure your vote is counted. Even if you have submitted a proxy before the CohBar Special Meeting, you may still attend the CohBar Special Meeting and vote. In such case, your previously submitted proxy will be disregarded.

•        To vote at the CohBar Special Meeting, attend the CohBar Special Meeting online and follow the instructions posted at www.virtualshareholdermeeting.com/CWBR2023.

•        To vote using the proxy card, simply complete, sign and date the accompanying proxy card and return it promptly in the envelope provided. If you return your signed proxy card before the CohBar Special Meeting, CohBar will vote your shares in accordance with the proxy card.

•        To vote by proxy over the internet, follow the instructions provided on the Notice of Internet Availability.

•        To vote by telephone, you may vote by proxy by calling the toll free number found on the Notice of Internet Availability.

If you are a beneficial owner of shares registered in the name of your broker, bank or other agent, you should have received a voting instruction card and voting instructions with these proxy materials from that organization rather than from CohBar. Simply complete and mail the voting instruction card to ensure that your vote is counted. To vote at the CohBar Special Meeting, you must obtain a valid proxy from your broker, bank or other agent. Follow the instructions from your broker, bank or other agent included with these proxy materials, or contact your broker, bank or other agent to request a proxy form.

CohBar provides internet proxy voting to allow you to vote your shares online, with procedures designed to ensure the authenticity and correctness of your proxy vote instructions. However, please be aware that you must bear any costs associated with your internet access, such as usage charges from internet access providers and telephone companies.

If you hold shares beneficially in street name and do not provide your broker or other agent with voting instructions, your shares may constitute “broker non-votes.” A “broker non-vote” occurs when shares held by a broker that are represented at the meeting are not voted with respect to a particular proposal because the broker has not received voting instructions from its client(s) with respect to such shares on how to vote and does not have or did not exercise discretionary authority to vote on the matter. Broker non-votes, if any, will be treated as shares that are present at the CohBar Special Meeting for purposes of determining whether a quorum exists but will not have any effect for the purpose of voting on Proposal Nos. 1, 2, 3, 4, 5, 6, 7 and 8. If a CohBar stockholder does not return voting instructions to their broker on how to vote their shares of CohBar Common Stock, such broker may be prevented from voting, or may otherwise choose not to vote, such shares held by such broker, resulting in broker non-votes with respect to such shares. To make sure that your vote is counted, you should instruct your broker to vote your shares of CohBar Common Stock, following the procedures provided by your broker.

All properly executed proxies that are not revoked will be voted at the CohBar Special Meeting and at any adjournments or postponements of the CohBar Special Meeting in accordance with the instructions contained in the proxy. If a holder of CohBar Common Stock properly executes and returns a proxy and no direction or instruction is made, the shares represented by that proxy will be voted “FOR” all of the proposals in accordance with the recommendations of the CohBar Board.

If you are a stockholder of record of CohBar and you have not executed a support agreement, you may change your vote at any time before your proxy is voted at the CohBar Special Meeting in any one of the following ways:

•        You may submit another properly completed proxy with a later date by mail or via the internet.

•        You can provide your proxy instructions via telephone at a later date.

•        You may send a written notice that you are revoking your proxy over the internet, following the instructions provided on the Notice of Internet Availability.

•        You may attend the CohBar Special Meeting online and vote by following the instructions at www.virtualshareholdermeeting.com/CWBR2023. Simply attending the CohBar Special Meeting will not, by itself, revoke your proxy.

If your shares are held by your broker, bank or other agent, you should follow the instructions provided by them.

Required Vote

The presence at the CohBar Special Meeting of the holders of not less than one-third of the total voting power of the shares of CohBar Common Stock outstanding and entitled to vote at the CohBar Special Meeting is necessary to constitute a quorum at the meeting. Abstentions and broker non-votes will be counted towards the presence of a quorum. The affirmative vote of the holders of a majority of all of the shares of CohBar Common Stock present or represented by proxy at the CohBar Special Meeting and voting on such matter is required for approval of Proposal Nos. 1, 2, 3, 4, 6, 7 and 8. With respect to Proposal No. 5, directors are elected by a plurality of the votes cast by the stockholders entitled to vote on the election at the CohBar Special Meeting, and the nominees for director receiving the highest number of affirmative votes, up to the number of directorships subject to election, will be elected. The issuance of CohBar Common Stock in connection with the Merger and the change of control of CohBar resulting from the Merger, or Proposal No. 1, will not take place unless Proposal Nos. 1, 2 and 3 are approved by CohBar stockholders and the Reverse Stock Split is effected and the Merger is consummated. The amendment to the CohBar Charter to effect the Authorized Share Increase, or Proposal No. 2, will not take place unless Proposal No. 2 is approved by the requisite CohBar stockholders. The amendment to the CohBar Charter to effect a Reverse Stock Split of CohBar’s issued and outstanding common stock, or Proposal No. 3, will not take place unless Proposal No. 3 is approved by the requisite CohBar stockholders. CohBar may still elect to proceed with the Reverse Stock Split if Proposal No. 3 is approved by CohBar stockholders even if Proposal Nos. 1 and 2 are not approved, or even if approved, the Merger is not consummated.

Votes will be counted by the inspector of election appointed for the meeting, who will separately count “FOR” and “AGAINST” votes, abstentions and broker non-votes. Abstentions and broker non-votes, if any, will also be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the CohBar Special Meeting. Votes withheld, abstentions and broker non-votes will not be counted as “votes cast” and will therefore have no effect on Proposal Nos. 1, 2, 3, 4, 5, 6, 7 and 8.

As of May 22, 2023, certain officers and directors of CohBar who owned approximately 0.8% of the outstanding shares of CohBar Common Stock entered into support agreements with CohBar and Morphogenesis, pursuant to which each of them has agreed to vote all shares of CohBar Common Stock owned by him or her in favor of the issuance of shares of CohBar Common Stock that represent (or are convertible into or exercisable for) more than 20% of the voting shares of CohBar Common Stock outstanding immediately prior to the Merger to the stockholders of Morphogenesis in connection with the Merger and the change of control of CohBar resulting from the Merger, in each case pursuant to Nasdaq listing rules 5635(a) and 5635(b), and against any competing “Acquisition Proposal.”

Solicitation of Proxies

In addition to solicitation by mail, the directors, officers, employees and agents of CohBar may solicit proxies from CohBar stockholders by personal interview, telephone, email, fax or otherwise. CohBar and Morphogenesis will share equally the costs of printing and filing this proxy statement/prospectus and proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of CohBar Common Stock for the forwarding of solicitation materials to the beneficial owners of CohBar Common Stock. CohBar will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out of pocket expenses they incur in connection with the forwarding of solicitation materials. CohBar has retained Morrow to assist it in soliciting proxies using the means referred to above. CohBar will pay the fees of Morrow, which CohBar expects to be approximately $40,000, plus reimbursement of out-of-pocket expenses.

Other Matters

As of the date of this proxy statement/prospectus, the CohBar Board does not know of any business to be presented at the CohBar Special Meeting other than as set forth in the notice accompanying this proxy statement/prospectus. If any other matters should properly come before the CohBar Special Meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.

THE MERGER

This section and the section titled “The Merger Agreement” beginning on page 148 of this proxy statement/prospectus describe the material aspects of the Merger and the Merger Agreement. While CohBar and Morphogenesis believe that this description covers the material terms of the Merger and the Merger Agreement, it may not contain all of the information that is important to you. You should read carefully this entire proxy statement/prospectus for a more complete understanding of the Merger and the Merger Agreement and the other documents to which you are referred in this proxy statement/prospectus. See the section titled “Where You Can Find More Information” beginning on page 320 of this proxy statement/prospectus.

Background of the Merger

The following chronology is a summary description of the background of the negotiations and the proposed merger and does not purport to catalogue every conversation among representatives of CohBar, Morphogenesis and other parties. In addition to formal meetings of the CohBar Board, CohBar management had informal discussions with the CohBar Board throughout the process and CohBar management held weekly calls with advisors, and ultimately with Morphogenesis and its advisors. The terms of the Merger Agreement are the result of extensive arm’s-length negotiations among CohBar’s and Morphogenesis’s management and members of CohBar’s and Morphogenesis’s board of directors, along with CohBar’s and Morphogenesis’s financial advisor and their respective legal counsel.

In an effort to enhance stockholder value, the CohBar Board and management regularly review and discuss CohBar’s near and long-term operating and strategic priorities. Among other things, these reviews and discussions focus on the opportunities and risks associated with CohBar’s development programs, financial condition and its strategic relationships and potential long-term strategic options.

On March 29, 2022, CohBar announced that it had observed injection site reactions (“ISRs”) in preclinical studies of its CB5138-3 product candidate that it was developing for the treatment of idiopathic pulmonary fibrosis and other fibrotic diseases. At that time, CohBar announced a delay of approximately one year in its planned IND filing for this program, to the second half of 2023, to enable CohBar to develop alternative formulations of CB5138-3 to mitigate the ISRs.

On July 11, 2022, the CohBar Board held an in person meeting to discuss strategic options for CohBar in the event that the alternative formulations under development for CB5138-3 were not successful. The strategic options discussed at the July 2022 board meeting included mergers, taking-private transactions, partnering, fundraising and in-licensing of a later stage asset. Based on such discussions, in August and September 2022, CohBar management (including Dr. Joseph J. Sarret, the President and Chief Executive Officer of CohBar and Mr. Jeffrey F. Biunno, the Chief Financial Officer of CohBar) met with potential strategic advisors, including Ladenburg, to advise on potential strategic options.

On September 9, 2022, the CohBar Board held a virtual meeting at which CohBar management proposed certain criteria to determine whether or not to continue the development of CB5138-3 based on data expected during the fourth quarter of 2022 (the “CB5138-3 Criteria”).

On October 5, 2022, the CohBar Board held a virtual meeting to discuss strategic alternatives in the event that the CB5138-3 Criteria were not achieved. At that time, the CohBar Board authorized CohBar management to formally engage Ladenburg as an advisor to explore such strategic alternatives in more detail. Such potential strategic alternatives included a potential merger, business combination, investment into CohBar, asset sale or other strategic transaction. At this time, the CohBar Board had not set a timetable for the conclusion of this review of potential strategic alternatives, nor had it made any definitive decisions related to any further actions or potential strategic options.

Beginning in October 2022 and continuing until May 22, 2023, CohBar management, at the direction of the CohBar Board, engaged in discussions with various third parties with respect to a potential strategic transaction in the form of a reverse merger. During this process, CohBar management and the CohBar Board also considered alternatives to a strategic transaction in the form of the reverse merger but decided none of those alternatives would deliver greater value to its stockholders as such alternatives were determined to be unfeasible or would have resulted in substantial dilution to CohBar’s stockholders. For example, CohBar did not succeed in finding a partner for the development of CB4211, CB5138 or any of the other peptides and was unable to identify a suitable asset for CohBar

to enter into an in-licensing arrangement. In addition, a group of investors offered to fund CohBar at $10.0 million, but the CohBar Board determined that such funding amount would be insufficient to fund the development of CohBar’s product candidates through value inflection points. The same group later offered to fund CohBar at $20.0 million on the condition that CohBar would market such funding as a fully-marketed offering and file a registration statement on Form S-1 with the SEC. The CohBar Board determined that such a transaction would have little chance of success given the general condition of the capital equity markets and CohBar’s business prospects.

On October 6, 2022, CohBar entered into an engagement letter with Ladenburg. Once engaged, Ladenburg began its outreach on a “no names” basis to potential target companies and other sources. At the direction of CohBar, Ladenburg prioritized its outreach to companies that were life sciences companies with later stage assets, had sufficient capitalization and milestones within the next 18 to 24 months and were public-company ready. A total of more than 290 companies were contacted as part of this initial outreach process. A subset of those companies expressed interests and CohBar signed a non-disclosure agreement (which contained customary standstill provisions) with 41 companies, including one with Company A on October 20, 2022 and one with Morphogenesis on October 13, 2022. Beginning on October 14, 2022, at the direction of the CohBar Board, Ladenburg sent a process letter to those 39 companies seeking preliminary, non-binding indications of interest for a potential strategic transaction. The process letter instructed that all such indications of interest should be submitted by November 2, 2022.

In total, 17 companies, including Company A and Morphogenesis, submitted non-binding indications of interest to CohBar. The non-binding indication of interest submitted by Morphogenesis on November 2, 2022 contemplated a simultaneous sign-and-close reverse merger with CohBar and included a valuation for CohBar of $35 million (assuming that CohBar’s net cash at closing would equal $10 million) and a valuation for Morphogenesis of $180 million, with an implied ownership interest in the combined company of approximately 15% for existing CohBar stockholders. In addition, the non-binding term sheet provided for a concurrent financing in CohBar resulting in gross proceeds to CohBar of not less than $15 million.

On November 8, 2022, the CohBar Board held a virtual meeting at which members of management and certain advisors, including Gibson, Dunn & Crutcher LLP (“Gibson Dunn”) were present. CohBar management presented to the CohBar Board information regarding the Ladenburg outreach and bidding process. With the assistance of Ladenburg and CohBar management, the CohBar Board reviewed each of the top five candidates that submitted the non-binding indications of interest, including Company A, as determined by CohBar management based on the proposed valuations of each company, as well as assessments of each company’s (i) science and technology, (ii) public-company readiness, (iii) management, board and investor syndicate, (iv) ability to conduct a concurrent financing and (v) near term inflection points. Of the top five candidates that submitted non-binding indications of interest, four of the candidates proposed a traditional reverse merger structure (a transaction structure where parties would first sign definitive transaction documents relating to the reverse merger and consummate the reverse merger at a later date) and one of the candidates proposed a simultaneous sign-and-close reverse merger structure. Representatives of Gibson Dunn reviewed the structure and key features of the potential business combination transaction involving a simultaneous sign-and-close reverse merger structure. During this discussion, Albion J. Fitzgerald, a member of the CohBar Board, expressed concerns with the simultaneous sign-and-close structure because he believed it was unconventional and the structure foreclosed the possibility of raising funds and continuing development of CohBar’s legacy assets.

From November 10, 2022 to November 14, 2022, the five merger candidates discussed at the November 8 board meeting presented to Ladenburg, CohBar management and the CohBar Board.

On November 15, 2022, the CohBar Board held a virtual meeting at which CohBar management, representatives of Ladenburg and representatives of Gibson Dunn were present to discuss and consider the status of a potential strategic transaction. Representatives of Ladenburg and CohBar management reported to the CohBar Board regarding CohBar’s meetings and initial due diligence review of the top five candidates and thereafter presented a summary of key findings from these meetings, including risks and opportunities of each of the potential merger candidates. The CohBar Board directed CohBar management to prepare and distribute term sheets to the top three merger candidates as determined by the CohBar Board and to continue exploring a potential strategic transaction.

CohBar management did not identify Morphogenesis as one of the top candidates during both the November 8 and November 15 CohBar Board meetings because at that time CohBar management believed that other candidates were better aligned with the criteria identified at the November 8 meeting including (i) stage of development of the most advanced product or product candidate, (ii) management, board and investor syndicate, (iii) ability to conduct a concurrent financing and (iv) near term inflection points.

On November 17, 2022, at the direction of CohBar management, representatives of Ladenburg sent initial term sheets to the top three merger candidates, including Company A.

On November 30, 2022, CohBar formally engaged Gibson Dunn to serve as legal counsel in connection with a potential strategic transaction.

On December 1, 2022, the CohBar Board held a virtual meeting at which CohBar management and certain advisors, including Gibson Dunn were present to discuss, among other things, the status of a potential transaction, as well as CohBar’s pre-clinical candidate CB5138-3. At such meeting, representatives of CohBar management provided an update on the status of a potential transaction, including the results of CohBar’s meetings with the top three merger candidates, as well as the merits and drawbacks of a potential transaction with each of such merger candidates. In addition, representatives of CohBar management discussed key findings from pre-clinical activities related to the CB5138-3 formulation work, including that the CB5138-3 Criteria had not been met. Based on these results, CohBar management reassessed the feasibility of developing an analog of CB5138-3 that would be suitable for further development, including the feasibility, projected timelines and anticipated costs necessary to generate clinical data from such an analog, as well as the feasibility of raising sufficient capital to support such activities. In light of that review, as well as the challenges in the capital equity markets at that time, the CohBar Board and CohBar management further reviewed CohBar’s development activities and pipeline programs in an effort to reduce its capital expenditures and extend its projected cash runway. Following discussion among the CohBar Board and CohBar management, the CohBar Board recommended that CohBar management publicly announce a suspension of IND-enabling work with respect to the CB5138-3 program. On December 7, 2022, CohBar filed a Current Report on Form 8-K announcing such decision and its intention to explore development and/or partnership opportunities within CohBar’s peptide library and technology platform, while simultaneously exploring other strategic alternatives.

Between November 30, 2022 to December 7, 2022, CohBar received the initial comments to the term sheet from the top three merger candidates.

On December 6, 2022, the CohBar Board held a virtual meeting at which representatives of CohBar management, representatives of Ladenburg and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction. CohBar management reviewed the three proposals for a potential reverse merger transaction with the top three merger candidates (including Company A), including the key considerations with respect to each of such candidates and anticipated next steps for each. In addition, representatives of CohBar management reviewed revisions to the term sheet from two of the top three merger candidates that had been received at that time and discussed the ability of each candidate to conduct a concurrent financing necessary to consummate a potential reverse merger transaction.

From December 6, 2022 to December 13, 2022, CohBar management and Ladenburg met virtually with the management team of each of the top three merger candidates, including Company A, to discuss outstanding issues related to the draft term sheet and the general timeline to consummate a reverse merger. Following those meetings, CohBar management decided to proceed with negotiating the term sheet with Company A because one of the other merger candidates expressed its inability to secure the necessary commitments for a concurrent financing and the other merger candidate was not ready to move forward on a timeline to consummate a reverse merger that would be suitable for CohBar. As a result, on December 14, 2022, at the direction of CohBar, Ladenburg sent Company A a revised draft of the term sheet.

On December 19, 2022, the CohBar Board held a virtual meeting at which CohBar management and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction. Representatives of CohBar management presented the recommendation of management to enter into a non-binding term sheet for a reverse merger transaction with Company A and reviewed the key terms of such term sheet and Company A’s proposal including valuation, capital needs, planned concurrent financing, closing certainty and exclusivity. Company A provided CohBar access to a virtual data room on November 11, 2022, and representatives of CohBar management also discussed at the board meeting its preliminary due diligence findings on Company A. Following such discussion, the CohBar Board approved the entry into a non-binding term sheet with Company A.

From December 20, 2022 to December 23, 2022, CohBar management and the management team of Company A negotiated and finalized the terms of the non-binding term sheet. As authorized by the CohBar Board, on December 23, 2022, CohBar and Company A entered into a non-binding term sheet providing for a traditional reverse merger transaction. The non-binding term sheet valued CohBar at $17.8 million and Company A at

$165 million, plus the proceeds of a concurrent financing to Company A of at least $40 million. In addition, the non-binding term sheet provided for adjustment of CohBar’s valuation up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing was in excess of $8.3 million or below $7.2 million.

On December 28, 2022, representatives of CohBar, Ladenburg, Gibson Dunn, Company A and Company A’s outside counsel met virtually to discuss execution of a potential transaction, including the responsibility and timeline for preparation of draft documentation.

On January 4, 2023, Gibson Dunn provided an initial draft of a merger agreement to Company A’s outside counsel. The initial draft included the following terms, (i) a traditional reverse merger structure, (ii) a mechanism for contingent payments to CohBar’s stockholders via a contingent value rights agreement, (iii) a collar for net cash of CohBar at closing, (iv) typical reciprocal representations and warranties and interim operating covenants with respect to CohBar and Company A, and (v) termination fees for CohBar and Company A upon termination for certain specific conditions, as well as reciprocal expense reimbursement for termination for specific conditions.

On January 5, 2023 and January 7, 2023, Dr. Sarret met telephonically with the chief executive officer of Company A to discuss the status of Company A’s planned concurrent financing. On January 9, 2023, CohBar and Company A terminated discussions regarding a potential transaction and released each other from the exclusivity provisions of the term sheet due to Company A’s inability to secure the necessary commitments for its planned concurrent financing.

CohBar, with the assistance of Ladenburg, resumed its exploration of a potential transaction with other counterparties after such mutual release, including discussing a potential transaction with three merger candidates. The three merger candidates were Morphogenesis and Company B (each of which were one of the 17 companies that submitted non-binding indications of interests to CohBar in November 2022) and Company C (one other company that was new to the process and identified by Ladenburg). On February 3, 2023, CohBar management and Ladenburg met with Morphogenesis management and H.C. Wainwright, the financial advisor to Morphogenesis. CohBar management and Ladenburg met with management team of Company B and Company C on January 25, 2022 and January 31, 2023, respectively.

On February 7, 2023, the CohBar Board held a virtual meeting at which CohBar management, representatives of Ladenburg and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction, including an update with respect to Morphogenesis’ status and certain improvements with respect to the criteria identified at the November 8 meeting. CohBar management provided an update and presented the recommendation to the CohBar Board to authorize CohBar management to engage in further negotiations with Morphogenesis, Company B, and Company C regarding a potential transaction. During the meetings with Morphogenesis, CohBar management conducted a wide range of diligence including scientific diligence on the Morphogenesis clinical pipeline, diligence on the management and board of directors, as well as diligence on the Morphogenesis cash requirements over the next 12-24 months.

Following the meeting with the CohBar Board, at the direction of CohBar management, on February 8, 2023, representatives of Ladenburg provided draft non-binding term sheets relating to a potential reverse merger to the three merger candidates. The draft non-binding term sheet sent to Morphogenesis contemplated a traditional reverse merger with CohBar and included a valuation for CohBar of $31.4 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $6.9 million or below $5.9 million) and a valuation for Morphogenesis of $180 million, with an implied ownership interest in the combined company of approximately 14.9% for existing CohBar stockholders. In addition, the non-binding term sheet provided for a concurrent financing in CohBar resulting in gross proceeds to CohBar of not less than $15 million.

During the negotiation of the non-binding term sheet, Morphogenesis expressed an openness to a simultaneous sign-and-close reverse merger structure and asked CohBar management to provide a revised non-binding term sheet with such structure. On February 10, 2023, at the direction of CohBar management, representatives of Ladenburg provided such revised non-binding term sheet to Morphogenesis with a simultaneous sign-and-close structure. The draft non-binding term sheet included a valuation for CohBar of $36.2 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million) and a valuation for Morphogenesis of $180 million, with an implied ownership interest in the combined company of approximately 16.7% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet.

On February 13, 2023, Morphogenesis provided CohBar with certain requested diligence items and, on February 14, 2023, CohBar management, Morphogenesis management and representatives of Ladenburg and H.C. Wainwright met virtually to discuss certain diligence items. Also on February 14, 2023, CohBar management and Morphogenesis management and their respective legal counsel held a separate virtual meeting where such legal counsel discussed the differences between a traditional reverse merger structure and a simultaneous sign-and-close reverse merger structure and the features associated with each of the structures. The material differences include that a simultaneous sign-and-close reverse merger structure involves the issuance of a non-controlling stake of common stock (not to exceed 16.7% of the shares outstanding at closing), with the remainder of the merger consideration being issued in the form of non-voting stock. As a result, a stockholder vote is not required to consummate the merger and the merger and concurrent financing are able to close on an accelerated basis. In contrast, a traditional reverse merger involves issuing a controlling interest in voting common stock at closing, which necessitates a stockholder vote prior to closing. During the February 14 meeting, both CohBar management and Morphogenesis management agreed to continue to discuss whether to structure the reverse merger as simultaneous sign-and-close merger structure in order to accelerate the closing of the merger and the anticipated concurrent financing, thereby increasing CohBar’s value due to the higher anticipated cash balance at closing.

Also on February 14, 2023, CohBar management, Company B management and representatives of Ladenburg and Gibson met to discuss potential deal structures.

On February 15, 2023, Dr. Sarret met telephonically with Dr. James Bianco, the chief executive officer of Morphogenesis, to discuss the proposed terms and structure of the transaction, as well as the anticipated staffing needs of the combined company.

On February 17, 2023, Morphogenesis provided a revised non-binding term sheet to Ladenburg. The revised draft non-binding term sheet retained the simultaneous sign-and-close structure unchanged and included a valuation for CohBar of $35 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million), with an implied ownership interest in the combined company of approximately 16.28% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet.

Also on February 17, 2023, the CohBar Board held a virtual meeting at which CohBar management and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction. CohBar management informed the CohBar Board that the proposed structure of a potential transaction with Morphogenesis was being revised from a traditional reverse merger structure to a simultaneous sign-and-close structure. Mr. Fitzgerald again raised concerns about the simultaneous sign-and-close reverse merger structure because he believed it was unconventional and the structure foreclosed the possibility of raising funds and continuing development of CohBar’s legacy assets. During this meeting, CohBar management also discussed certain logistical challenges related to a potential transaction with Company B because Company B was a foreign entity that was publicly listed on a foreign stock exchange.

On February 21, 2023, Morphogenesis management met telephonically with the Investor’s principal, Vijay Patel, and the Investor’s representatives to discuss a potential reverse merger (but without CohBar being named at that point) and to discuss a potential additional investment in Morphogenesis or the combined company in connection with the proposed reverse merger. Mr. Patel, through another entity named K&V Investment One, LLC, had in June and August 2022 previously made an investment in an aggregate of 25,863,637 shares of Series A Preferred Stock and common stock purchase warrants of Morphogenesis for an aggregate of $15.0 million. During the February 21, 2023 meeting, Morphogenesis management discussed with Investor that the completion of a reverse merger would require an additional investment of $15.0 million concurrently or in advance of the merger transaction. Following the meeting, Morphogenesis gave Investor and its representatives access to relevant clinical, regulatory, and manufacturing data related to Morphogenesis’ drug candidates.

On February 22, 2023, CohBar management met with Dr. Bianco to discuss the clinical data and development plans and timelines for Morphogenesis’ IFx-Hu2.0 product candidate.

On February 22, 2023, at the direction of CohBar management, representatives of Ladenburg provided a revised non-binding term sheet to Morphogenesis. The draft non-binding term sheet continued to contemplate the simultaneous sign-and-close structure and included a valuation for CohBar of $35 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million)

and a valuation for Morphogenesis of $180 million, with an implied ownership interest in the combined company of approximately 16.28% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet.

On February 23, 2023, representatives of Morphogenesis provided a revised non-binding term sheet to Ladenburg. The draft non-binding term sheet continued to contemplate the simultaneous sign-and-close structure and included a valuation for CohBar of $30 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million) and a valuation for Morphogenesis of $150 million, with an implied ownership interest in the combined company of approximately 16.7% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet.

On February 24, 2023, the CohBar Board held a virtual meeting at which CohBar management, representatives of Ladenburg and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction. Representatives of Ladenburg provided a preliminary valuation analysis of Morphogenesis for discussion and reviewed reverse merger stock performance trends and the valuation methodology utilized by Ladenburg in valuing Morphogenesis and CohBar. Representatives of Ladenburg also reviewed public company comparable valuations and discussed market comparisons and the estimates and assumptions underlying the Ladenburg analysis. Thereafter, representatives of CohBar management reviewed the most recent valuation proposals for Morphogenesis, Company B and Company C.

During this board meeting, CohBar management also discussed the revised draft term sheet submitted by Company B on February 22, 2023, which valued CohBar at $15 million and Company B at $53.5 million, without contemplating a concurrent financing. The CohBar Board had concerns that the Company B proposal included additional complexity and transactional costs, and had a higher risk of successfully closing since Company B was a foreign entity that was publicly listed on a foreign stock exchange. CohBar management continued to discuss a potential transaction with Company C, which included a valuation for CohBar of $26.2 million and a valuation for Company C of $100 million (which included a $5 million bridge financing). The CohBar Board believed that the combined company would have a limited cash runway and had concerns about the public company readiness of Company C. After reviewing the relative merits of the three proposals of Morphogenesis, Company B and Company C, the CohBar Board authorized CohBar management to execute a non-binding term sheet with Morphogenesis.

Also on February 24, 2023, Dr. Sarret met virtually with Dr. Bianco to discuss the valuations of CohBar and Morphogenesis and the anticipated staffing needs of the combined company. On February 28, 2023, Morphogenesis proposed a valuation for CohBar of $25 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million) and a valuation for Morphogenesis of $125 million, with an implied ownership interest in the combined company of approximately 16.7% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet. This proposal included a stock dividend for pre-merger CohBar stockholders.

On March 2, 2023, CohBar and Morphogenesis executed a final version of the non-binding term sheet, which provided for a simultaneous sign-and-close reverse merger between CohBar and Morphogenesis and valued CohBar at $25 million (adjusted up or down on a dollar-for-dollar basis in the event CohBar’s net cash at closing is in excess of $11.3 million or below $11.1 million) and Morphogenesis at $125 million, with an implied ownership interest in the combined company of approximately 16.7% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the non-binding term sheet. The final non-binding term sheet also provided for a concurrent financing in CohBar resulting in gross proceeds to CohBar of not less than $15 million.

On March 7, 2023, Morphogenesis management met in person with Mr. Patel and a Morphogenesis director to further discuss a $15.0 million concurrent financing for a reverse merger transaction in the form of a “PIPE investment”, and Mr. Patel agreed in principle that the Investor was willing to move forward with such an investment pending the completion of due diligence and pending learning more about the potential transaction. During this meeting, CohBar had not yet been identified as the reverse merger candidate. On the following date (March 8, 2023), Morphogenesis management met with Investor’s investment and diligence team at their office in New Port Richey, Florida to discuss how a PIPE transaction works and the general timeline to a closing on a reverse merger and the concurrent investment.

On March 8, 2023, Morphogenesis provided CohBar access to a virtual data room.

On March 8, 2023, Dr. Sarret and Dr. Bianco met telephonically and discussed certain issues related to the fact that Morphogenesis was incorporated in Florida.

On March 12, 2023, Gibson Dunn provided an initial draft of the merger agreement to Foley & Lardner LLP (“Foley”), Morphogenesis’ outside legal counsel. The initial draft included the following terms, (i) a simultaneous sign-and-close reverse merger structure, (ii) a collar for net cash of CohBar at closing with a net cash target of $11.2 million, (iii) a dividend of CohBar Common Stock to the CohBar stockholders as of immediately prior to closing of the merger and (iv) typical reciprocal representations and warranties and covenants with respect to CohBar, the Merger Sub and Morphogenesis.

On March 15, 2023, CohBar management, representatives of Ladenburg, representatives of Gibson Dunn, Morphogenesis management, representatives of H.C. Wainwright and representatives of Foley met virtually to discuss a potential transaction between Morphogenesis and CohBar. Gibson Dunn and Foley discussed a reincorporation of Morphogenesis, then a Florida corporation, in Delaware to facilitate a potential transaction, given the prominence, predictability and flexibility of Delaware corporate law and Delaware’s well-established principles of corporate governance.

On March 22, 2023, Foley provided to Gibson Dunn an initial draft of the stock purchase agreement for the concurrent financing contemplated by the final non-binding term sheet. The initial draft included the following terms, (i) a concurrent investment of $15 million in CohBar concurrently with the closing of the merger, (ii) the option for the Investor to make an additional investment of up to $5 million in CohBar, with such option exercisable within 90 days after the closing of the initial investment and (iii) typical representations and warranties and covenants on the part of CohBar and the Investor.

On March 23, 2023, Morphogenesis management met with Investor and a Morphogenesis director to discuss the concurrent financing and the principal terms thereof, and Investor at that time orally comitted to an investment of $15 million at $4.00 per share of the combined company together with a right to purchase an additional $7.5 million in shares at the same price during the 6-months following closing. Following that meeting in March, under an executed confidentiality agreement, the identity of CohBar was disclosed to Investor, at which time Morphogenesis management and Investor and Investor’s management engaged in various communications regarding CohBar, the capital structure of CohBar and Morphogenesis (both before and after the reverse merger), and the respective valuations of CohBar and Morphogenesis in the transaction.

On March 30, 2023, Foley provided a revised draft of the merger agreement to Gibson Dunn. This revised draft included the following terms, (i) agreement with respect to the simultaneous sign-and-close reverse merger structure, (ii) revised definitions for the calculation of CohBar’s net cash and the responsibility for certain transaction expenses and (iii) typical reciprocal representations and warranties and covenants with respect to CohBar, the Merger Sub and Morphogenesis.

On March 28, 2023, Dr. Sarret spoke with Dr. Bianco via phone and discussed whether CohBar’s severance payment obligations should be included in the net cash calculation under the merger agreement. Dr. Sarret and Dr. Bianco agreed to include such obligations in the net cash calculation. And as such, the net cash target for CohBar would be reduced from $11.2 million to $10 million and the valuation of CohBar would remain the same in the draft merger agreement.

On April 7, 2023, Gibson Dunn provided revised drafts of the merger agreement and stock purchase agreement to Foley. The revised draft of the merger agreement included the following terms, (i) a net cash target for CohBar of $10 million (reduced from $11.2 million) and (ii) allocation of expenses incurred in connection with the engagement of an exchange agent and all filing and other fees paid to the SEC in connection with the merger to be shared equally by Morphogenesis and CohBar.

Between April 7, 2023 through May 4, 2023, representatives of Gibson Dunn and Foley negotiated the remaining terms of the merger agreement, including finalizing the calculation of the exchange ratio and the calculation of Morphogenesis’ outstanding share count for purposes thereof, the treatment of the outstanding Morphogenesis warrants, including any related adjustments to the exchange ratio following the closing and prior to the issuance of CohBar capital stock to the Morphogenesis stockholders to account for exercise or expiration thereof, the allocation of expenses incurred in connection with the engagement of an exchange agent and all filing and other fees paid to the SEC in connection with the merger, the terms of the forms of support agreement and lock-up agreement, the stock purchase agreement for the concurrent financing, the registration rights agreement providing for registration of the CohBar Common Stock issued or issuable in the transaction, and the contingent value

rights agreement providing for contingent payments to CohBar’s stockholders in the event of a sale of CohBar’s legacy assets following the closing and the other transaction documents. During that same period, Morphogenesis management and Investor continued to discuss the concurrent financing and the terms thereof, including the purchase price per share of CohBar Common Stock. During the course of communications during the weeks of April 9 and 16, 2023, Investor expressed that it was not willing to purchase CohBar shares at $4.00 per share and would only pay $2.00 per share because CohBar Common Stock was trading at below $2.00 at that time.

On April 13, 2023, Gibson Dunn sent an initial draft of the contingent value rights agreement to Foley, which draft provided that pre-merger common stockholders would receive, within three years of the closing of the Merger, (i) 100% of cash payment actually paid to the combined company pursuant to any legacy asset disposition agreement(s) entered into 6 months following the closing of the Merger and (ii) 80% of cash payment actually paid to the combined company pursuant to any other legacy asset disposition agreement(s). On April 20, 2023, Foley sent a revised draft to Gibson Dunn. This revised draft included, among others, the following changes, (i) set the record date for the CVR holders to be the 10th calendar days after the date of the merger agreement (or the immediately subsequent business day if such 10th day is not a business day), (ii) revised that any pre-merger common stockholders would receive, within three years of the closing of the Merger, 80% of cash payment actually paid to the combined company pursuant to any legacy asset disposition agreement(s), (iii) identified CohBar’s CB4211 candidate and CB5138 Analog therapeutics as the “Legacy Assets” and (iv) added fees that might be incurred in connection with a certain advisory agreement to the “Permitted Deductions” definition. On May 7, 2023, Gibson Dunn sent a further revised draft to Foley to reflect the change of a simultaneous sign-and-close transaction to a traditional reverse merger one. In addition, Gibson Dunn added back that 100% of cash payment actually paid to the combined company pursuant to any legacy asset disposition agreement(s) entered into 6 months following the closing of the Merger, which Foley subsequently accepted. Between May 7, 2023 through May 18, 2023, representatives of Gibson Dunn and Foley exchanged a few drafts with immaterial changes and finalized the terms of the CVR Agreement, a form of which is included as Annex F to this proxy statement/prospectus.

On April 12, 2023, the CohBar Board held a virtual meeting at which CohBar management, representatives of Gibson Dunn and representatives of Ladenburg were present. During the meeting, representatives of CohBar management led a discussion regarding potential amendments to Mr. Biunno’s employment agreement to provide for 12 months (rather than six months) of severance payments given Mr. Biunno’s length of service at CohBar, the substitution of severance payments that would be due to Dr. Sarret and Mr. Biunno upon a change of control and subsequent termination for a retention bonus (subject to repayment to CohBar under certain circumstances) and the provision of COBRA to Dr. Sarret and Mr. Biunno for a period of 12 months and six months, respectively, if either of them resigns from CohBar within a certain time period given the important role each of them plays in securing a potential strategic transaction for CohBar. Following such discussion, the representatives of CohBar management in attendance exited the meeting and the CohBar Board determined to formally approve such matters at a future meeting or through a unanimous written consent.

On April 21, 2023, the CohBar Board held a virtual meeting at which CohBar management, representatives of Gibson Dunn and representatives of Ladenburg were present to discuss, among other things, the status of a potential transaction. Representatives of CohBar management reviewed the current terms of the transaction, including the status of Morphogenesis’s reincorporation in Delaware and the pricing and terms of the concurrent financing. In addition, the CohBar Board reviewed the various potential alternative courses of action available to maximize stockholder value, including seeking to raise capital to fund legacy programs, reverse merger transactions and a potential liquidation of CohBar. Representatives of Gibson Dunn reviewed with the CohBar Board their fiduciary duties in the context of each of these alternatives. Following discussion, the CohBar Board determined that while further discussion regarding alternative strategic options was warranted, CohBar management should continue to pursue a potential transaction with Morphogenesis.

On April 26, 2023, the CohBar Board held a virtual meeting at which CohBar management and representatives of Gibson Dunn were present to discuss various potential courses of action available to maximize stockholder value, including seeking to raise capital to fund legacy programs, reverse merger transactions and a potential liquidation of CohBar. Following discussion, the CohBar Board determined that CohBar management should continue to pursue a potential transaction with Morphogenesis.

Also on April 26, 2023, Dr. Bianco informed CohBar management that Morphogenesis had received stockholder approval of the reincorporation of Morphogenesis from Florida to Delaware, which the Morphogenesis board of directors had already unanimously approved on March 27, 2023. On April 27, 2023, representatives of Foley informed representatives of Gibson Dunn that the reincorporation of Morphogenesis became effective.

On May 3, 2023, Dr. Sarret and Mr. Fitzgerald met telephonically. During this meeting, Mr. Fitzgerald told Dr. Sarret that he would not vote in favor of a potential transaction with Morphogenesis and would not resign from the CohBar Board at closing of such a potential transaction. During this conversation, Mr. Fitzgerald expressed to Dr. Sarret his concerns regarding the contemplated transaction, including that the original transaction structure contemplated a simultaneous sign-and-close reverse merger structure because he believed it was unconventional and the structure foreclosed the possibility of raising funds and continuing development of CohBar’s legacy assets, notwithstanding that the CohBar and Morphogenesis teams both initially sought to complete a simultaneous sign-and-close transaction due to a range of factors including expedited closing, decreased transaction expenses and increased net cash to be delivered at closing. Prior to May 3, 2023, Mr. Fitzgerald had expressed objections to the proposed transaction structure of a simultaneous sign-and-close reverse merger transaction with Morphogenesis in meetings of the CohBar Board, but management was not yet aware of his conclusion that he would not support a transaction with such structure. Following this meeting, Dr. Sarret updated the CohBar Board regarding Dr. Sarret’s meeting with Mr. Fitzgerald.

On May 4, 2023, Dr. Sarret spoke via telephone with Dr. Bianco regarding Dr. Sarret’s meeting with Mr. Fitzgerald. Dr. Bianco communicated that Morphogenesis would be unwilling to proceed with the potential transaction as structured and Dr. Sarret and Dr. Bianco discussed revising the structure of the potential transaction from a simultaneous sign-and-close reverse merger transaction to a traditional reverse merger transaction, with the intent being to address Mr. Fitzgerald’s concerns about the deal structure by submitting a proposal to CohBar stockholders to approve a potential transaction with Morphogenesis by stockholder vote. Under the traditional reverse merger structure, it was anticipated that CohBar would deliver approximately $5 million less in net cash due to the later timing of the closing and higher transaction costs, Dr. Sarret and Dr. Bianco agreed to discuss the impact, if any, on the relative valuations of CohBar or Morphogenesis after further consideration.

Also on May 4, 2023, Dr. Sarret updated the CohBar Board regarding Dr. Sarret’s meeting with Dr. Bianco regarding a potential restructuring of the transaction from a simultaneous sign-and-close structure to a traditional reverse merger structure.

On May 5, 2023, representatives of CohBar, Morphogenesis, Ladenburg, H.C. Wainwright, Gibson Dunn and Foley met virtually to discuss a revised traditional reverse merger transaction. During this meeting, CohBar and Morphogenesis agreed to explore the revised transaction structure and agreed that Gibson Dunn and Foley would revise the documentation to reflect the new traditional reverse merger structure.

On May 8, 2023, the CohBar Board held a virtual meeting at which CohBar management and representatives of Gibson Dunn were present to discuss, among other things, the status of a potential transaction. Representatives of CohBar management provided an update to the CohBar Board regarding the transition to a traditional reverse merger transaction. The CohBar Board authorized management to continue exploring a transaction with Morphogenesis with the revised transaction structure. The modified transaction structure satisfied Mr. Fitzgerald’s concern regarding allowing CohBar stockholders the ability to approve the transaction before its consummation, but Mr. Fitzgerald continued to express concerns about exploring a strategic transaction because he believed that CohBar should continue as a stand-alone company and develop its legacy mitochondria assets; however, the CohBar Board did not believe a plan or proposal to pursue such a course would be feasible, including a plan to raise sufficient capital to allow CohBar to reach a value inflection point.

On May 10, 2023, Morphogenesis proposed two potential approaches to account for the fact that CohBar would deliver approximately $5 million less net cash under the traditional reverse merger structure. Under the first approach, CohBar’s valuation would be decreased by $5 million, to $20 million, with no change in the Morphogenesis valuation. Under the second approach, Morphogenesis’ valuation would be increased from $125 million to $130.6 million with no change to the CohBar valuation. The reduction in net cash (approximately $5 million) accounts for multiple expenses CohBar would need to account for in a traditional reverse merger that are excluded in the sign-and-close structure including incremental burn associated with the post-announcement but pre-closing corporate expenses and incremental cash spent on items such as D&O policy and increased legal fees. The structural change resulted in an increase in the Morphogenesis valuation as opposed to a decrease in the CohBar valuation due to a desire to preserve the $25 million of value for the CohBar stockholders as previously negotiated. By increasing the Morphogenesis valuation by $5.6 million (rather than lowering the CohBar valuation by $5 million), CohBar shareholders receive a sizeable premium to cash while maintaining a similar ownership split to the previously negotiated values, as opposed to substantially lowering the CohBar ownership of the pro-forma company. Also on May 10, 2023, Dr. Sarret spoke via telephone with Mr. Fitzgerald. Mr. Fitzgerald communicated to Dr. Sarret that he was unwilling to vote in favor of the proposed transaction with Morphogenesis.

On May 11, 2023, Foley shared a revised draft of the stock purchase agreement for the concurrent financing with Gibson Dunn. The revised draft had a traditional reverse merger structure and included the following terms, (i) a concurrent investment of $15 million in CohBar concurrently with the closing of the merger, (ii) the option for the Investor to make an additional investment of up to $15 million in CohBar, with such option exercisable within six months after the closing of the initial investment and (iii) typical representations and warranties and covenants on the part of CohBar, the Merger Sub and the Investor.

On May 12, 2023, Dr. Sarret and Dr. Bianco spoke via telephone and Dr. Sarret informed Dr. Bianco that Mr. Fitzgerald planned to vote against the proposed transaction with Morphogenesis. During that call, Dr. Sarret and Dr. Bianco agreed on the second approach proposed by Morphogenesis on May 10, 2023 — a valuation of $25 million for CohBar with no net cash target or adjustment and a valuation of $130.6 million for Morphogenesis with an implied ownership interest in the combined company of approximately 15% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the merger agreement. Dr. Sarret updated the CohBar Board on these changes on the same date.

Also on May 12, 2023, Gibson Dunn shared a revised draft of the merger agreement with Foley. The revised draft included the following terms, (i) a traditional reverse merger structure, (ii) a valuation of $25 million for CohBar with no net cash target or adjustment and a valuation of $130.6 million for Morphogenesis, with an implied ownership interest in the combined company of approximately 15% for existing CohBar stockholders after giving effect to all of the transactions contemplated by the merger agreement, (iii) typical reciprocal representations and warranties and interim operating covenants with respect to CohBar, the Merger Sub and Morphogenesis and (iv) termination fees for CohBar and Morphogenesis upon termination for certain specific conditions, as well as reciprocal expense reimbursement for termination for specific conditions.

Between May 12, 2023 through May 22, 2023, representatives of Gibson Dunn and Foley negotiated the remaining terms of the merger agreement, including the representations and warranties and operating covenants of each party, the treatment of the outstanding Morphogenesis warrants, the requirement that no less than sixty percent of the holders of Morphogenesis’ fully-diluted common stock (on an as-converted to Morphogenesis Common Stock basis) as of immediately prior to the effectiveness of the merger execute lock-up agreements, the requirement that CohBar have a minimum amount of cash at the closing of the transaction, and the amount of the termination fees and expense reimbursement payable to each party in the event of termination. During that period, representatives of Gibson Dunn and Foley also negotiated the terms of the forms of support agreements and lock-up agreement, the stock purchase agreement for the concurrent financing, the form of registration rights agreement providing for registration of the CohBar Common Stock issued in the concurrent financing and issuable to certain former holders of warrants to acquire Morphogenesis Common Stock, and the contingent value rights agreement providing for contingent payments to CohBar’s stockholders in the event of a sale of CohBar’s legacy assets following the closing and the other transaction documents.

On May 15, 2023, following various communications between Morphogenesis and Investor and Investor’s representatives regarding the negotiation of the terms of the concurrent financing, the parties agreed in principle that the concurrent financing would be for $15.0 million at a purchase price of $2.00 per CohBar common share, with an option by Investor to purchase up to an additional $15.0 million of CohBar common shares at the same price during the six months following the closing of the reverse merger. The form of the Stock Purchase Agreement was thereupon revised by Foley and circulated to the parties. Investor also agreed to escrow the initial $15.0 investment amount pending the completion of the reverse merger.

In addition, between May 19, 2023 to May 20, 2023, representatives of Gibson Dunn and Foley negotiated the terms of the amendment to Mr. Biunno’s employment agreement and certain letter agreements with each of Dr. Sarret and Mr. Biunno that were discussed at the April 12, 2023 board meeting.

On May 22, 2023, the CohBar Board held a virtual meeting, at which representatives of CohBar management, Gibson Dunn and Ladenburg were present. The participants discussed the status of the transaction. During the meeting, representatives of Gibson Dunn reviewed the key terms of the revised transaction documents, including certain updates that resulted from the change from a simultaneous sign-and-close transaction to a traditional reverse merger transaction. Gibson Dunn also presented to the CohBar Board its key legal due diligence findings on Morphogenesis based on its review of Morphogenesis’s incorporation documents, lien and litigation search results, material contracts, intellectual property matters and other legal matters and documents posted to a virtual data room. CohBar management had previously presented to the CohBar Board its findings

on the Morphogenesis technology and Morphogenesis’ clinical and regulatory development plans for its IFx-2.0 program after review of the correspondence between FDA and Morphogenesis, discussions with Morphogenesis management and review of clinical and regulatory materials posted to a virtual data room.

During the May 22 meeting, representatives of Ladenburg then reviewed and discussed with the CohBar Board Ladenburg’s financial analyses with respect to CohBar, Morphogenesis and the proposed merger. Thereafter, at the request of the CohBar Board, Ladenburg orally rendered its opinion to the CohBar Board (which was subsequently confirmed in writing by delivery of Ladenburg’s written opinion dated May 22, 2023 addressed to the CohBar Board), as to, as of such date, the fairness, from a financial point of view, to the CohBar stockholders of the Exchange Ratio provided for in the Merger pursuant to the Merger Agreement. After further discussion, based on the factors cited in “— CohBar’s Reasons for the Merger; Recommendation of the CohBar Board,” the CohBar Board considered the due diligence findings on Morphogenesis and with the exception of Mr. Fitzgerald, who voted against the Merger and the related transactions, (i) determined that the Merger and the other transactions contemplated by the merger agreement are advisable and in the best interests of CohBar and its stockholders; (ii) determined that the concurrent financing and related issuance of shares to the Investor is advisable and in the best interests of CohBar and its stockholders, (iii) approved the merger agreement, the stock purchase agreement and the other transaction documents and the transactions contemplated thereby, including the issuance of shares of CohBar Common Stock pursuant to the merger agreement and pursuant to the concurrent financing and (iv) recommended that CohBar’s stockholders vote in favor of the Proposals.

Also on May 22, 2023, the CohBar Board approved (i) the amendment to Mr. Biunno’s employment agreement, which increases the aggregate gross amount of severance payable to Mr. Biunno upon a termination without cause from 50% to 100% of his base salary, and (ii) the letter agreements, which provide for, subject to certain adjustments or conditions, payment of a retention bonus in the amount of $803,250 to Dr. Sarret and $393,300 to Mr. Biunno in exchange for, among other things, waiver by Dr. Sarret and Mr. Biunno of their entitlement to certain severance benefits. Neither Dr. Sarret nor Mr. Biunno will join the management team or the board of directors of the combined company. Please see the section titled “Management Following the Merger” beginning on page 280 of this proxy statement/prospectus for a more detailed discussion.

Subsequently, on May 22, 2023, CohBar and Morphogenesis entered into the Merger Agreement and CohBar entered into the Stock Purchase Agreement for the Initial Financing and Second Financing.

On May 23, 2023, before opening of the Nasdaq for trading that day, CohBar and Morphogenesis issued a joint press release announcing the proposed Merger between the two companies. CohBar also filed a Current Report on Form 8-K with the SEC announcing, among other things, the proposed Merger and the execution of the Merger Agreement and the Stock Purchase Agreement.

CohBar’s Reasons for the Merger; Recommendation of the CohBar Board

The CohBar Board, in consultation with financial and legal advisors and management, evaluated the terms of the Merger Agreement and the related transactions contemplated thereby and (i) determined that the Merger and the related transactions contemplated by the Merger Agreement are fair to, advisable and in the best interests of CohBar and its stockholders; (ii) approved and declared advisable the Merger Agreement and the related transactions contemplated by the Merger Agreement, including the issuance of shares of CohBar Common Stock in connection with the Merger; and (iii) recommends that CohBar’s stockholders vote in favor of the Proposals.

During the course of its evaluation of the Merger Agreement and the transactions contemplated by the Merger Agreement, the CohBar Board held numerous meetings, consulted with CohBar’s senior management, CohBar’s legal counsel and financial advisors, and reviewed and assessed a significant amount of information. In reaching its decision to approve the Merger Agreement and the transactions contemplated by the Merger Agreement, the CohBar Board considered a number of factors and scenarios that it viewed as supporting its decision to approve the Merger Agreement, including:

•        the financial condition and prospects of CohBar and the risks associated with continuing to operate CohBar on a stand-alone basis, including in light of:

•        CohBar’s decision, announced in December 2022, to suspended IND-enabling work on its pre-clinical candidate CB5138-3, a potential treatment of idiopathic pulmonary fibrosis and other fibrotic diseases that CohBar had been developing, which was driven in large part by the completed non-clinical studies seeking to identify a formulation suitable for clinical development;

•        CohBar’s belief that the formulation of CB4211 used in the Phase 1b stage of its trial is not suitable for further development, and efforts to develop an improved formulation have not been successful;

•        investor interest and value perception for possible further development of its programs, the product candidates’ tolerability profiles, difficulty in formulating, stage of development, the lack of clarity on the mechanism of action for CB5138-3, and probability of success in relation to the requisite time and costs; and

•        difficulties encountered in CohBar’s related business development efforts to license, sell or otherwise partner its assets that could result in meaningful new capital or shared future development costs;

•        the CohBar Board and CohBar’s financial advisor undertook a comprehensive and thorough process of reviewing and analyzing potential strategic alternatives and merger partner candidates and the CohBar Board’s view that no alternatives to the Merger (including remaining a standalone company, a liquidation or dissolution of CohBar to distribute any available cash, and alternative strategic transactions) were reasonably likely to create greater value to CohBar’s stockholders;

•        the CohBar Board’s conclusion that the Merger would provide the existing CohBar stockholders with (i) a significant opportunity to participate in the potential growth of the combined company following the Merger with a risk diversified development pipeline with a late-stage clinical program, including Morphogenesis’ plan for its lead product candidate, IFx-Hu2.0, to be developed under the FDA’s accelerated approval pathway for the treatment of an aggressive form of skin cancer and expected initiation of a Phase 2/3 registration study early next year, (ii) the potential to receive shares of CohBar Common Stock pursuant to the Stock Dividend and potentially certain cash payments following the closing of the Merger pursuant to the CVR Agreement, and (iii) the potential to extend the cash runway of the combined company from the proceeds of the Initial Financing and Second Financing;

•        the CohBar Board’s belief that the $25 million equity value ascribed to CohBar (which is comprised of CohBar’s $5 million of net cash and an appropriate premium valuation of $20 million based on the valuations of certain comparable precedent reverse merger transactions since 2018) would provide the existing CohBar stockholders significant value for CohBar’s public listing, and afford the CohBar stockholders a significant opportunity to participate in the potential growth of the combined company following the Merger at the negotiated Exchange Ratio, and the CohBar Board’s determination that the premium valuation of $20.0 million received by CohBar as a public vehicle (net of cash) in the Merger compared favorably to the valuations for the public vehicle (net of cash) for the Selected Precedent Reverse Merger Transactions, as more fully described below under the caption “The Merger — Opinion of Ladenburg to the CohBar Board,” beginning on page 125 in this proxy statement/prospectus;

•        the CohBar Board’s belief, after a thorough review of strategic alternatives, such as attempting to further advance the development of its internal programs, raising additional capital through the issuance of equity or debt securities, entering into a licensing, sale or other strategic agreement related to certain assets sufficient to fund operations, combining with other potential strategic transaction candidates, and discussions with CohBar’s senior management, financial advisors and legal counsel, that the Merger is more favorable to CohBar stockholders than the potential value that might have resulted from other strategic alternatives available to CohBar;

•        the CohBar Board’s belief, after thorough discussions with CohBar’s management, financial advisors and legal counsel, that a potential liquidation and dissolution was not reasonably likely to create greater value for CohBar stockholders than the Merger based on, among other things, the need to hold back a potentially meaningful amount of CohBar’s current cash balance to cover current and potential unknown future liabilities;

•        the CohBar Board’s belief that, as a result of arm’s length negotiations with Morphogenesis, CohBar and its representatives negotiated the most favorable exchange ratio for CohBar’s stockholders to which Morphogenesis was willing to agree, and that the terms of the Merger Agreement include the most favorable terms to CohBar in the aggregate that were achievable and consistent with other similar transactions;

•        the CohBar Board’s view that Morphogenesis’ product candidates have the potential to create meaningful value for the stockholders of the combined company and an opportunity for CohBar’s stockholders to participate in the growth of the combined company, based on the business, scientific, regulatory, intellectual property, financial, accounting and legal due diligence conducted by CohBar management and advisors (which included numerous diligence calls and a comprehensive review of Morphogenesis’ due diligence materials) regarding:

•        the regulatory pathway for, and market opportunity of, Morphogenesis’ product candidates, including in light of the stage of development of Morphogenesis’ product candidates;

•        the quality and scope of the preclinical and clinical results available for Morphogenesis;

•        the expectation that Morphogenesis would start enrolling patients in early 2024 for a single Phase 2/3 registration trial for IFx-Hu2.0 utilizing the FDA’s accelerated approval pathway, with the potential for a Biologics License Application (BLA) filing in the second half of 2026;

•        Morphogenesis’ plans to expand the utility of its cancer vaccine technology to blood-related cancers, which are not amenable to intratumoral administration, such as by developing IFx-Hu3.0, its mRNA cancer vaccine for intravenous or autologous whole cell administration;

•        Morphogenesis having additional product candidates in the preclinical stages, providing possible additional pathways to regulatory approval; and

•        the likelihood of experiencing value inflection milestones relating to Morphogenesis’ product candidates prior to the time in which the combined company would need to raise additional financing;

•        the CohBar Board’s consideration on May 22, 2023 of the expected cash balances of the combined company as of the closing of the Merger resulting from the approximately $20.8 million of net cash expected to be held by CohBar upon completion of the Merger, including the $15 million of expected gross proceeds from the Initial Financing and together with the cash Morphogenesis currently holds;

•        the CohBar Board’s view, following a review with CohBar’s management and advisors of Morphogenesis’ current development and clinical trial plans, of the likelihood that the combined company would possess sufficient cash resources at the closing of the Merger to fund development of Morphogenesis’ product candidates through upcoming value inflection points, including the initiation of Morphogenesis’ anticipated Phase 2/3 registration trial for IFx-Hu2.0;

•        the expected operations, management structure, operating plans and cash burn rate of the combined company, and the expected cash resources of the combined company (including the ability to support the combined company’s current and planned clinical trials and operations);

•        the ability of Morphogenesis to take advantage of the potential benefits resulting from becoming a public reporting company listed on Nasdaq, should it be required to raise additional capital in the future through the sale of equity or debt securities;

•        the prospects of and risks associated with the other strategic candidates that had made proposals for a strategic transaction with CohBar based on the business, scientific, regulatory, intellectual property, financial, accounting and legal due diligence conducted by CohBar’s management and advisors;

•        the CohBar Board’s view that the combined company will be led by (i) an experienced senior management team from Morphogenesis, many members of which have extensive experience in drug development, research and development, business and regulatory expertise and (ii) a board of directors of the combined company with representation from each of the current boards of directors of CohBar and Morphogenesis;

•        the current financial market conditions and historical market prices, volatility and trading information with respect to CohBar Common Stock, as well as the unfavorable state of the capital raising environment for biotechnology companies in general which made it challenging for CohBar to raise sufficient additional capital;

•        the CohBar Board’s view that the combined company post-Merger would have projected net cash sufficient to achieve several anticipated data read-outs and possible value-driving events; and

•        the financial analysis reviewed by Ladenburg with the CohBar Board as well as the oral opinion of Ladenburg rendered to the CohBar Board on May 22, 2023 (which was subsequently confirmed in writing by delivery of Ladenburg’s written opinion dated May 22, 2023 addressed to the CohBar Board), as to, as of May 22, 2023, the fairness, from a financial point of view, to the CohBar stockholders of the Exchange Ratio provided for in the Merger pursuant to the Merger Agreement, after giving effect to the transactions contemplated by the Merger Agreement, as more fully described below under the caption “The Merger — Opinion of Ladenburg to the CohBar Board,” beginning on page 125 in this proxy statement/prospectus.

The CohBar Board also reviewed the terms of the Merger Agreement and related transaction documents, as well as the safeguards and protective provisions included therein intended to mitigate risks, including those described below, and concluded that the terms of the Merger Agreement and related transaction documents, in the aggregate, were reasonable under the circumstances:

•        the calculation of the Exchange Ratio and the estimated number of shares of CohBar Common Stock to be issued in the Merger;

•        a dividend to the holders of CohBar Common Stock as of the Record Date equal to approximately 3.3 shares of CohBar Common Stock per each share of CohBar Common Stock issued and outstanding as of the Record Date;

•        the number and nature of the conditions to Morphogenesis’ and CohBar’s respective obligations to complete the Merger and the likelihood that the Merger will be completed on a timely basis, including that Morphogenesis’ obligation to complete the Merger would be conditioned on CohBar having at least $4 million cash as of the Effective Time, as more fully described below under the caption “The Merger Agreement — Conditions to the Completion of the Merger,” beginning on page 161 in this proxy statement/prospectus;

•        the respective rights of, and limitations on, CohBar and Morphogenesis under the Merger Agreement to consider and engage in discussions regarding unsolicited acquisition proposals under certain circumstances, and the limitations on the board of directors of each party to change its recommendation in favor of the Merger, as more fully described below under the caption “The Merger Agreement — Non-Solicitation,” beginning on page 157 in this proxy statement/prospectus;

•        the potential termination fee of $1 million, in the case of the fee payable by CohBar, or $3 million, in the case of the fee payable by Morphogenesis, and related reimbursement of certain transaction expenses of up to $1.5 million, which could become payable by either CohBar or Morphogenesis to the other party if the Merger Agreement is terminated in certain circumstances, as more fully described below under the caption “The Merger Agreement — Termination and Termination Fees,” beginning on page 165 in this proxy statement/prospectus;

•        the lock-up agreements, pursuant to which certain stockholders of Morphogenesis representing approximately 36% of the fully-diluted Morphogenesis Common Stock have, subject to certain exceptions, agreed not to transfer their shares of CohBar Common Stock during the period of 180 days following the completion of the Merger, as more fully described below under the caption “Agreements Related to the Merger — Lock-Up Agreements,” beginning on page 169 in this proxy statement/prospectus;

•        the support agreements, pursuant to which certain stockholders of Morphogenesis and certain directors and officers of CohBar, respectively, have agreed, solely in their capacities as stockholders, to vote all of their shares of CohBar Common Stock or Morphogenesis Common Stock in favor of the proposals submitted to them in connection with the Merger and against any alternative acquisition proposals, as more fully described below under the caption “Agreements Related to the Merger — Support Agreements,” beginning on page 169 in this proxy statement/prospectus;

•        the Stock Purchase Agreement, pursuant to which (i) CohBar will issue, subject to adjustments contained therein, a certain number of shares of CohBar Common Stock for an aggregate purchase price of $15 million immediately prior to the Effective Time and (ii) CohBar has agreed to sell, at the election of the Investor within six months after the Initial Closing of the Financing and subject to the satisfaction

or waiver of the conditions set forth therein, a certain number of shares of CohBar Common Stock for an aggregate purchase price of up to $15 million, as more fully described below under the caption “Agreements Related to the Merger — Stock Purchase Agreement,” beginning on page 168 in this proxy statement/prospectus;

•        the CVR Agreement, pursuant to which CohBar stockholders and certain warrant holders of record as of a date agreed to by CohBar and Morphogenesis prior to the Effective Time will receive a CVR for each outstanding share of CohBar Common Stock held by such CohBar stockholders representing the contractual right to receive contingent cash payments upon the receipt of CohBar of certain net proceeds payable by the combined company during a certain period following closing, as more fully described below under the caption “Agreements Related to the Merger — CVR Agreement,” beginning on page 170 in this proxy statement/prospectus;

•        the expectation that the Merger will qualify as a reorganization within the meaning of Section 368(a) of the Code, and will constitute a “plan of reorganization” within the meaning of Treasury Regulations Section 1.368-2(g), with the result that Morphogenesis stockholders will generally not recognize taxable gain or loss for U.S. federal income tax purposes upon the exchange of Morphogenesis Common Stock for CohBar Common Stock pursuant to the Merger Agreement, as more fully described below under the caption “The Merger — Material U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of Morphogenesis Common Stock,” beginning on page 140 in this proxy statement/prospectus; and

•        the belief that the terms of the Merger Agreement, including the parties’ representations, warranties and covenants, and the conditions to their respective obligations, are reasonable under the circumstances.

In the course of its deliberations, the CohBar Board also considered a variety of risks and other countervailing factors related to entering into the Merger, including:

•        the potential effect of the $1 million termination fee payable by CohBar and CohBar’s expense reimbursement obligations upon the occurrence of certain events in deterring other potential acquirors from proposing an alternative acquisition proposal that may be more advantageous to CohBar stockholders;

•        the prohibition on CohBar to solicit alternative acquisition proposals during the pendency of the Merger;

•        the substantial expenses to be incurred by CohBar in connection with the Merger;

•        the likelihood of disruptive stockholder litigation following announcement of the Merger;

•        the possible volatility of the trading price of the CohBar Common Stock resulting from the announcement, pendency or completion of the Merger;

•        the scientific, technical, regulatory and other risks and uncertainties associated with development and commercialization of Morphogenesis’ product candidates;

•        various risks impacting the financial condition, results of operations and prospects for CohBar, including:

•        the risks and challenges associated with pursuing any strategic alternative to the Merger available to CohBar, including the discussions that CohBar’s management and the CohBar Board previously conducted with other potential transaction partners, and the time to negotiate and complete an alternative strategic transaction and anticipated cash burn;

•        the risks and delays associated with, and uncertain value and costs to CohBar stockholders of, liquidating CohBar, including the uncertainties of continuing cash burn while contingent liabilities are resolved, uncertainty of timing of release of cash until contingent liabilities are resolved, and the risks and costs associated with being a shell company prior to cash distribution;

•        the risks and challenges of attempting to continue to operate CohBar on a stand-alone basis, including, without limitation, (i) the considerable time and resources that would have been required to develop suitable formulation of its product candidates and/or novel analogs of its product candidate that would be more easily formulated, (ii) the inability to sufficiently finance CohBar’s continuing operations through the sale of securities in the capital markets due to, among other

things, the lack of near term data catalysts and the general downturn in the U.S. capital markets for biotechnology companies and (iii) CohBar’s other product candidate profiles, stage of development, and probability of success in relation to the requisite time and costs required, and (iv) that status of management’s related business development efforts to license, sell or otherwise partner the assets;

•        the challenges of retaining or rebuilding staff with limited cash runway; and

•        the challenges of maintaining CohBar’s Nasdaq listing without completing the Merger and the transactions contemplated in the Merger Agreement, including the reverse stock split;

•        the risk to CohBar’s business, operations and financial results in the event that the Merger is not consummated, including the diminution of CohBar’s cash and the significant challenges associated with the need to raise additional capital through the public or private sale of equity securities; and

•        the various other risks associated with the combined company and the Merger, including those described in the sections entitled “Risk Factors” and “Cautionary Statement Concerning Forward-Looking Statements” in this proxy statement/prospectus.

Concerns of the Dissenting Director

As discussed further in the section titled “Background of the Merger”, the CohBar Board also considered the views of director Albion J. Fitzgerald, who was the sole CohBar director who voted against the adoption and approval of the Merger Agreement. On May 3, 2023, Mr. Fitzgerald told Dr. Sarret, the President and Chief Executive Officer of CohBar, that he would not vote in favor of a potential transaction with Morphogenesis and would not resign from the CohBar Board at closing of such a potential transaction. During this conversation, Mr. Fitzgerald expressed to Dr. Sarret his concerns regarding the contemplated transaction, including his belief that the structure was unconventional and that it foreclosed the possibility of raising funds and continuing development of CohBar’s legacy assets. Prior to May 3, 2023, Mr. Fitzgerald had expressed objections to the proposed transaction structure of a simultaneous sign-and-close reverse merger transaction with Morphogenesis in meetings of the CohBar Board, but management was not yet aware of his conclusion that he would not support a transaction with such structure.

After discussions between Morphogenesis and CohBar, the parties agreed to revise the proposed transaction structure from a simultaneous sign-and-close reverse merger transaction to a traditional reverse merger transaction thereby allowing CohBar stockholders a chance to approve the potential transaction before the consummation of the Merger. The modified transaction structure satisfied Mr. Fitzgerald’s concern regarding allowing CohBar stockholders the ability to approve the transaction before its consummation, but Mr. Fitzgerald continued to express concerns about exploring a strategic transaction because he believed that CohBar should continue as a stand-alone company and develop its legacy mitochondria assets; however, the CohBar Board did not believe a plan or proposal to pursue such a course would be feasible, including a plan to raise sufficient capital to allow CohBar to reach a value inflection point. Ultimately, Mr. Fitzgerald decided to vote against the approval of the Merger Agreement, the Merger and the transactions contemplated by the Merger Agreement for the foregoing reasons.

The other six members of the CohBar Board considered Mr. Fitzgerald’s concerns over the course of several meetings of the CohBar Board. In particular, the CohBar Board reviewed: (1) in consultation with its legal advisors, the process undertaken by the CohBar Board in considering the various strategic alternatives available to CohBar, including the proposed Merger, continuing as a stand-alone company and other potential business combination, merger or acquisition transactions, and (2) in consultation with its financial advisors, the strategic, financial and other considerations described above. After weighing these various factors, the other six directors determined to vote in favor of the board approvals and recommendations described above because they believed that, taking all relevant factors into account, the Merger Agreement and the Merger were in the best interests of CohBar and its stockholders.

Recommendation of the CohBar Board

For the reasons discussed, a majority of the CohBar Board has determined that the Merger Agreement, the Merger and the transactions contemplated by the Merger Agreement are in the best interests of CohBar and its stockholders, and the CohBar Board has adopted and approved the Merger Agreement and the consummation of the Merger and the transactions contemplated by the Merger Agreement, and recommends that stockholders vote “FOR” approval of the Proposals.

The foregoing information and factors considered by the CohBar Board are not intended to be exhaustive but are believed to include all of the material factors considered by the CohBar Board. In view of the wide variety of factors considered in connection with its evaluation of the Merger and the complexity of these matters, the CohBar Board did not find it useful, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of the CohBar Board may have given different weight to different factors. The CohBar Board conducted an overall analysis of the factors described above, including thorough discussions with, and questioning of, the CohBar management team and CohBar’s legal and financial advisors, and considered the factors overall to be favorable to, and to support, its determination.

Morphogenesis’ Reasons for the Merger

In the course of reaching its decision to approve the Merger, the Merger Agreement, and the other transactions contemplated by the Merger Agreement, the Morphogenesis Board held numerous meetings; consulted with Morphogenesis’ senior management, legal counsel and financial advisors; and reviewed and considered a wide variety of factors. Ultimately, the Morphogenesis Board concluded that a merger with CohBar, together with the Initial Financing and Second Financing, was the best option to generate capital resources to support the advancement of Morphogenesis’ product pipeline and to fund the organization.

The Morphogenesis Board also considered the following additional factors (which are not necessarily presented in any order of relative importance):

•        the expectation that the Merger would be a more time- and cost-effective means than other available options, including an initial public offering or additional rounds of private financing, in order to finance the continued development and regulatory approval process with respect Morphogenesis’ products candidates and technology platforms;

•        the view that the range of options available to the combined company to access private and public equity markets will likely be greater as a public company than Morphogenesis continuing as a privately held company;

•        the potential benefits from increased public market awareness of Morphogenesis and its pipeline;

•        the historical and current information concerning Morphogenesis’ business, including its financial performance and condition, operations, management and preclinical and clinical data;

•        the competitive nature of the industry in which Morphogenesis operates;

•        the fiduciary duties of the Morphogenesis Board to Morphogenesis stockholders;

•        the Morphogenesis Board’s expectation that the Merger, together with the Initial Financing and the potential for the completion of the Second Financing (which would be at the option of the Investor in the Initial Financing), would be a higher probability and more cost-effective means to access capital than other options considered, including an initial public offering;

•        the Morphogenesis Board’s belief that the Second Financing, although at the option of the Investor in the Initial Financing, might represent a higher probability and more cost-effective means to access additional capital during the six-month period immediately following the completion of the Merger in light of the relatively short time period during which the Investor would have to exercise the right to complete the Second Financing and in light of the Investor’s then-existing interest in the combined company after giving effect to the Initial Financing;

•        the projected financial position, operations, management structure, operating plans, cash burn rate and financial projections of the combined company, and the expected cash resources of the combined company (including the ability to support the combined company’s current and planned clinical trials and operations);

•        the business, history, operations, financial resources, assets, technology and credibility of CohBar;

•        the likelihood that the Merger would be consummated on a reasonably timely basis, including the likelihood that the Merger would receive all necessary approvals;

•        the availability of appraisal rights under the DGCL to holders of Morphogenesis capital stock who comply with the required procedures under the DGCL, which allow such holders to seek appraisal of the fair value of their shares of Morphogenesis capital stock as determined by the Delaware Court of Chancery;

•        the terms and conditions of the Merger Agreement, including the following:

•        the determination that the expected relative percentage ownership of CohBar stockholders and Morphogenesis stockholders in the combined organization was appropriate, based on the Morphogenesis Board’s judgment and assessment of the approximate valuations Morphogenesis and CohBar (including the value of the net cash CohBar is expected to provide to the combined organization);

•        the expectation that the Merger will be treated as a reorganization for U.S. federal income tax purposes, with the result that in the Merger the Morphogenesis stockholders will generally not recognize taxable gain or loss for U.S. federal income tax purposes;

•        the limited number and nature of the conditions of the obligation of CohBar to consummate the Merger;

•        the rights of Morphogenesis under the Merger Agreement to consider certain unsolicited acquisition proposals under certain circumstances should Morphogenesis receive a superior proposal;

•        the minimum amount of unrestricted cash of CohBar expected to be on hand immediately following the Effective Time of the Merger

•        the conclusion of the Morphogenesis Board that the potential termination fees and/or expenses reimbursements payable by Morphogenesis or CohBar to the other party, and the circumstances when such fees or expenses may be payable, were reasonable; and

•        the belief that the other terms of the Merger Agreement, including the parties’ representations, warranties and covenants, and the conditions to their respective obligations, were reasonable in light of the entire transaction;

•        the shares of CohBar Common Stock issued to Morphogenesis stockholders will be registered on a Form S-4 registration statement and will become freely tradable for Morphogenesis stockholders who are not affiliates of Morphogenesis and who are not parties to lock-up agreements;

•        the ability to obtain a Nasdaq listing and the change of the combined organization’s name to TuHURA Biosciences, Inc. upon the closing of the Merger; and

•        the likelihood that the Merger will be consummated on a timely basis.

The Morphogenesis Board also considered a number of uncertainties and risks in its deliberations concerning the Merger and the other transactions contemplated by the Merger Agreement, including the following:

•        the possibility that the Merger might not be completed and the potential adverse effect of the public announcement of the Merger on the reputation of Morphogenesis and the ability of Morphogenesis to obtain financing in the future in the event the Merger is not completed;

•        the possibility that the Initial Financing and Second Financing might not be completed or completed in accordance with the terms of the Stock Purchase Agreement and the impact of the Investor’s right under the Stock Purchase Agreement to purchase additional shares of CohBar Common Stock under a Second Financing Closing;

•        the possibility that the anticipated benefits of the Merger may not be realized or that they may be lower than expected;

•        the risk that future sales of CohBar Common Stock by existing CohBar stockholders may cause the price of CohBar Common Stock or the combined company’s common stock to fall, thus reducing the potential value of CohBar Common Stock received by Morphogenesis stockholders following the Merger;

•        the Exchange Ratio used to establish the number of aggregate shares of CohBar Common Stock to be issued to Morphogenesis equity holders in the Merger is fixed, and thus the relative percentage ownership of Morphogenesis equity holders and CohBar equity holders in the combined organization immediately following the completion of the Merger is similarly fixed;

•        the termination fee payable by Morphogenesis to CohBar upon the occurrence of certain events and/or Morphogenesis’ expense reimbursement obligations under certain specified circumstances pursuant to the Merger Agreement, and the potential effect of such termination fee and/or expense reimbursement obligations in deterring other potential acquirers from proposing an alternative transaction that may be more advantageous to Morphogenesis stockholders;

•        the potential reduction of CohBar’s net cash prior to the closing of the Merger;

•        the possibility that CohBar could, under certain circumstances, consider unsolicited acquisition proposals if superior to the Merger or change its recommendation to approve the Merger upon certain events;

•        the risk that the Merger might not be consummated in a timely manner or at all, for a variety of reasons, such as the failure of CohBar to obtain the required stockholder vote, and the potential adverse effect on the reputation of Morphogenesis and the ability of Morphogenesis to obtain financing in the future in the event the Merger is not completed;

•        the time, effort and substantial costs involved in connection with entering into the Merger Agreement and consummating the Merger and the related disruptions to the operation of Morphogenesis’ business and development activities, including the risk of diverting management’s attention from other strategic priorities to the Merger, and the risk that the operations of Morphogenesis would be disrupted by employee concerns or departures or by changes to or termination of Morphogenesis’ relationships with its vendors, contractors, and other third parties;

•        the restrictions on the conduct of Morphogenesis’ business during the pendency of the Merger, which may delay or prevent Morphogenesis from undertaking potential business opportunities that may arise or may negatively affect Morphogenesis’ ability to attract, retain and motivate key personnel;

•        the additional expenses and obligations to which Morphogenesis’ business will be subject following the Merger that Morphogenesis has not previously been subject to, and the operational changes to Morphogenesis’ business, in each case that may result from being a public company;

•        the fact that the representations and warranties of CohBar in the Merger Agreement do not survive the closing of the Merger and the potential risk of liabilities that may arise post-closing; and

•        various other risks associated with the combined organization and the Merger, including the risks described in the section titled “Risk Factors” in this proxy statement/prospectus.

The foregoing information is not intended to be exhaustive but is believed to include a summary of all of the material factors considered by the Morphogenesis Board in its consideration of the Merger Agreement and the transactions contemplated thereby. After conducting an overall analysis of these and other factors, including thorough discussions with, and questioning of, CohBar’s senior management, the Morphogenesis Board concluded that the benefits, advantages, and opportunities of a potential transaction outweighed the uncertainties and risks described above. Based on this overall analysis of the factors described above, the Morphogenesis Board unanimously approved the Merger Agreement, the Merger and the other transactions contemplated by the Merger Agreement.

Opinion of CohBar’s Financial Advisor

As stated above, pursuant to an engagement letter dated October 6, 2022 (the “Ladenburg Engagement Letter”), CohBar retained Ladenburg to act as its financial advisor in connection with the Merger and to render the Opinion to the CohBar Board as to the fairness of the Exchange Ratio, from a financial point of view, to the holders of CohBar Common Stock. On May 22, 2023, at the request of the CohBar Board, Ladenburg rendered its oral opinion to the CohBar Board, subsequently confirmed in writing (the “Opinion”), that as of the date of such Opinion and based upon the various assumptions and limitations set forth therein, and such other factors that Ladenburg deemed relevant, the Exchange Ratio (assumed, at the time, to be 0.3114) was fair, from a financial point of view, to the holders of CohBar Common Stock.

The full text of the Opinion is attached as Annex G to this proxy statement/prospectus and is incorporated herein by reference. CohBar encourages its stockholders to read the Opinion in its entirety for the assumptions made, procedures followed, other matters considered and limits of the review by Ladenburg. The summary of the Opinion set forth herein is qualified by reference to the full text of the Opinion. Ladenburg provided its Opinion for the benefit and use by the CohBar Board in its consideration of the financial terms of the Merger. The Opinion is not a recommendation to the CohBar Board of whether or not to approve the Merger or to any holder of CohBar Common Stock or any other person as to how to vote with respect to the proposed Merger or to take any other action in connection with the Merger or otherwise.

In connection with the Opinion, Ladenburg took into account an assessment of general economic, market and financial conditions as well as its experience in connection with similar transactions and securities valuations generally and, among other things:

•        Reviewed a draft of the Merger Agreement, dated May 19, 2023, which would be delivered in connection with the consummation of the Merger. The Merger Agreement was the most recent draft made available to Ladenburg prior to the delivery of the Opinion;

•        Reviewed and analyzed certain publicly available financial and other information for each of CohBar and Morphogenesis, respectively, including equity research on comparable companies and on CohBar, and certain other relevant financial and operating data furnished to Ladenburg by the management of each of CohBar and Morphogenesis, respectively;

•        Reviewed and analyzed certain relevant historical financial and operating data concerning Morphogenesis furnished to Ladenburg by the management of Morphogenesis;

•        Discussed with certain members of the management of CohBar the historical and current business operations, financial condition and prospects of CohBar and Morphogenesis;

•        Reviewed and analyzed certain operating results of Morphogenesis as compared to operating results and the reported price and trading histories of certain publicly traded companies that Ladenburg deemed relevant;

•        Reviewed and analyzed certain financial terms of the Merger Agreement as compared to the publicly available financial terms of certain selected business combinations that Ladenburg deemed relevant;

•        Reviewed and analyzed certain financial terms of completed initial public offerings for certain companies that Ladenburg deemed relevant;

•        Reviewed certain pro forma financial effects of the Merger;

•        Reviewed and analyzed certain internal financial analyses including the cash burn model over the next year, projections as to cost and expenses and whether concurrent capital raised would sufficiently cover select programs, reports, preliminary internal market opportunity assumptions and other information concerning Morphogenesis prepared by Morphogenesis, which were further revised by CohBar and utilized per the instruction of the CohBar management team. Such internal financial analyses were not utilized in connection with the three principal financial analyses that Ladenburg conducted which focused on a range of valuations of Morphogenesis. Such internal financial analyses were instead considered by the CohBar Board and management team in determining the viability of the combined company to successfully operate in the public markets; and

•        Reviewed and analyzed such other information and such other factors, and conducted such other financial studies, analyses and investigations, as Ladenburg deemed relevant for the purposes of the Opinion.

In conducting its review and arriving at its Opinion, Ladenburg, with the consent of the CohBar Board, assumed and relied upon, without independent verification or investigation, the accuracy and completeness of all financial and other information provided to or discussed with Ladenburg by CohBar and Morphogenesis, respectively (or their respective employees, representatives or affiliates), or which was publicly available or was otherwise made available to it by CohBar or Morphogenesis, respectively. Ladenburg did not undertake any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. Ladenburg relied upon, without independent verification, the assessment of CohBar management and Morphogenesis management as to the viability of, and risks associated with, the current and future products and services of Morphogenesis (including without limitation, the development, testing and marketing of such products and services, the receipt of all necessary governmental and other regulatory approvals for the development, testing

and marketing thereof, and the life and enforceability of all relevant patents and other intellectual and other property rights associated with such products and services). In addition, Ladenburg did not conduct, nor did it assume any obligation to conduct, any physical inspection of the properties or facilities of CohBar or Morphogenesis. Ladenburg, with the CohBar Board’s consent, relied upon the assumption that all information provided to it by CohBar and Morphogenesis was accurate and complete in all material respects. To the extent that such information included estimates and forecasts of future financial performance prepared by or reviewed with the management of CohBar or Morphogenesis, as applicable, Ladenburg assumed such estimates and forecasts had been reasonably prepared on bases reflecting the best currently available estimates and judgements of such management.

In its Opinion, Ladenburg expressly disclaimed any undertaking or obligation to advise any person of any change in any fact or matter affecting its Opinion of which it becomes aware after the date of its Opinion. For purposes of its Opinion, Ladenburg assumed there were no material changes in the assets, liabilities, financial condition, results of operations, business or prospects of CohBar or Morphogenesis since the date of the last financial statements made available to it. Ladenburg did not obtain any independent evaluations, valuations or appraisals of the assets or liabilities of CohBar or Morphogenesis, nor was Ladenburg furnished with such materials. In addition, Ladenburg did not evaluate the solvency or fair value of CohBar or Morphogenesis under any state or federal laws relating to bankruptcy, insolvency or similar matters. Ladenburg’s Opinion does not address any legal, tax or accounting matters related to the Merger, as to which it assumed that CohBar and the CohBar Board had received such advice from legal, regulatory, tax and accounting advisors as each had determined appropriate. The Opinion addresses only the fairness of the Exchange Ratio, from a financial point of view, to the holders of CohBar Common Stock. Ladenburg expressed no view as to any other aspect or implication of the Merger or any other agreement or arrangement entered into in connection with the Merger. The Opinion was necessarily based upon financial, economic and market conditions and other circumstances as they existed and could be evaluated by Ladenburg on the date of its Opinion. Ladenburg cautioned that it should be understood that although subsequent developments may affect its Opinion, Ladenburg does not have any obligation to update, revise or reaffirm its Opinion and Ladenburg expressly disclaimed any responsibility to do so.

Ladenburg did not consider any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the Securities and Exchange Commission, the Financial Accounting Standards Board, or any similar foreign regulatory body or board. For purposes of rendering its Opinion, Ladenburg assumed in all respects material to its analysis, that the representations and warranties of each party contained in the Merger Agreement were true and correct, that each party would perform all of the standards of the covenants and agreements required to be performed by it under the Merger Agreement and that all conditions to the consummation of the Merger would be satisfied without waiver or amendment of any term or condition thereof. Ladenburg also assumed that all governmental, regulatory and other consents and approvals contemplated by the Merger Agreement or otherwise required for the transactions contemplated thereby would be obtained and that in the course of obtaining any of those consents no restrictions would be imposed or waivers made that would have an adverse effect on CohBar, Morphogenesis or the contemplated benefits of the Merger. Ladenburg assumed that the Merger would be consummated in a manner that complied with the applicable provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and all other applicable federal and state statutes, rules and regulations. Ladenburg noted that the CohBar Board had informed it, and it had assumed, that the Merger was intended to constitute a reorganization within the meaning of Section 368(a) of the Code and the Treasury Regulations promulgated thereunder.

Ladenburg’s Opinion was intended for the benefit and use of the CohBar Board in its consideration of the financial terms of the Merger and, except as set forth in the Ladenburg Engagement Letter, could not be used for any other purpose or reproduced, disseminated, quoted or referred to at any time, in any manner or for any purpose without Ladenburg’s prior written consent, unless pursuant to applicable law or regulations or required by other regulatory authority by the order or ruling of a court or administrative body, except that Ladenburg agreed that the Opinion could be included in its entirety in any filing related to the Merger to be filed with the SEC and the proxy statement/prospectus to be mailed to the holders of CohBar Common Stock.

Ladenburg’s Opinion does not constitute a recommendation to the CohBar Board of whether or not to approve the Merger or to any holder of CohBar Common Stock or any other person as to how to vote with respect to the Merger or to take any other action in connection with the Merger or otherwise. The Opinion does not address

CohBar’s underlying business decision to proceed with the Merger or the relative merits of the Merger compared to other alternatives available to CohBar. Ladenburg expressed no opinion as to the prices or ranges of prices at which shares or the securities of any person, including CohBar and Morphogenesis, will trade at any time, including following the announcement or consummation of the Merger. Ladenburg was not requested to opine as to, and the Opinion does not in any manner address, the fairness in amount or nature of compensation to any of the officers, directors or employees of any party to the Merger, or any class of such persons, relative to the compensation to be received by the holders of CohBar Common Stock in connection with the Merger pursuant to the Merger Agreement. The Opinion was reviewed and approved by Ladenburg’s fairness opinion committee.

Principal Financial Analyses

The following is a summary of the principal financial analyses performed by Ladenburg to arrive at its Opinion. Some of the summaries of financial analyses include information presented in tabular format. In order to fully understand the financial analyses, the tables must be read together with the text of each summary. The tables alone do not constitute a complete description of the financial analyses. Considering the data set forth in the tables without considering the full narrative description of the financial analyses, including the methodologies and assumptions underlying the analyses, could create a misleading or incomplete view of the financial analyses. Ladenburg performed certain procedures, including each of the financial analyses described below and reviewed with the CohBar Board the assumptions on which such analyses were based and other factors, including the historical and projected financial results of CohBar and Morphogenesis.

Transaction Overview as of the Date of the Opinion

Based upon the Exchange Ratio of 0.3114 at the time of the signing of the Merger Agreement, Ladenburg estimated that at the closing of the Merger: (a) Morphogenesis equity holders as of immediately prior to the Merger would own approximately 83.9% of the fully-diluted shares of CohBar Common Stock at the closing of the Merger, and (b) the existing CohBar equity holders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money CohBar options) would own approximately 16.1% of the fully-diluted shares of CohBar Common Stock at the closing of the Merger. Shares issued in connection with the Initial Financing and Second Financing are not included in the calculation of the Exchange Ratio.

Implied Morphogenesis Valuation

The Morphogenesis valuation of $130.6 million represents an implied price per share of Morphogenesis Common Stock of $0.62 (calculated by dividing $130.6 million by 209,684,773 shares of Morphogenesis Common Stock on a fully diluted basis). The number of fully-diluted Morphogenesis Common Stock includes 68,013,861 shares of Morphogenesis Common Stock outstanding as well as 61,054,669 shares of Morphogenesis Common Stock underlying Morphogenesis outstanding options and warrants and 80,616,243 shares of Morphogenesis Common Stock underlying outstanding Morphogenesis preferred shares.

CohBar Equity Value

CohBar’s equity value was based upon an agreed valuation of $25.0 million, which is comprised of CohBar’s $5.0 million of net cash and an appropriate premium valuation of $20.0 million based on the valuations of certain comparable precedent reverse merger transactions since 2018.

Exchange Ratio

The Exchange Ratio was calculated by dividing (a) the Company Merger Shares by (b) the Company Outstanding Shares, which is the product of the following items:

(i)     0.6228 as the numerator, calculated by dividing the equity value of Morphogenesis ($130,600,000) by 209,684,773 shares of Morphogenesis Common Stock on a fully-diluted basis; and

(ii)    2.0000 as the denominator, calculated by dividing the equity value of CohBar ($25,000,000) by 12,500,000 shares of CohBar Common Stock.

Analysis of the Selected Precedent Reverse Merger Transactions

Ladenburg reviewed the financial terms, to the extent the information was publicly available, of the 66 most recent reverse-merger transactions of companies in the biopharmaceutical industry (referred to as the “Selected Precedent Reverse Merger Transactions”). Following the selection of the Selected Precedent Reverse Merger Transactions based on the foregoing criteria, in its evaluation, Ladenburg did not exercise any judgment or exclusionary practices to add or remove relevant companies that fit within such parameters. Although the companies referred to below were used for comparison purposes, none of those companies were directly comparable to CohBar. Ladenburg reviewed the total premium to cash delivered to each target, along with other quantitative metrics. These Selected Precedent Reverse Merger Transactions, including the date each was closed, were as follows below:

The Selected Precedent Reverse Merger Transactions had a mean and median value delivered for the public vehicle (net of cash) of $13 million and $10 million, respectively. These values were calculated by subtracting the cash of the acquired company from the total value attributed to the surviving company in the merger. As noted above, the CohBar Board determined that the premium valuation of $20.0 million received by CohBar in the Merger compared favorably to the Selected Precedent Reverse Merger Transactions.

Analysis of Selected Publicly Traded Companies

Based on its experience and professional judgment and using financial screening sources and databases to find companies that share similar business characteristics to Morphogenesis within the biopharmaceutical industry, Ladenburg selected financial data of 34 publicly traded companies (referred to as the “Selected Publicly Traded Companies”). Each of the Selected Publicly Traded Companies had a lead candidate in Phase II through Phase III of clinical development and focused on oncology/solid tumors and did not recently experience a lead asset clinical failure or have a pipeline of similar stage products in which only one asset met the criteria described. Following the selection of the Selected Publicly Traded Companies based on the foregoing criteria, in its evaluation, Ladenburg did not exercise any judgement or exclusionary practices to add or remove relevant companies that fit within such parameters. Although the companies referred to below were used for comparison purposes, none of those companies were directly comparable to Morphogenesis. The total enterprise values are based on closing stock prices on May 19, 2023. The Selected Publicly Traded Companies were: