SEC Info℠

Home

Search

My Interests

Help

Sign In

Please Sign In

Acesis Holdings Corp. – IPO: ‘S-1’ on 9/14/23

On:  Thursday, 9/14/23, at 5:52pm ET   ·   As of:  9/15/23   ·   Accession #:  1575872-23-1447   ·   File #:  333-274523

in

this entire Filing. an “Entity” Search.

Show

Documents searched

and

each “hit”. the 1st “hit”.

↓↑Hints

 Text Wildcards:  ? (any letter/digit),  * (many).  Search Logic:  for Documents:  & (and),  | (or);  for Text:  | (anywhere),  "(&)" (near).  Details... 

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 9/15/23  Acesis Holdings Corp.             S-1         9/14/23   29:9.9M                                   DataTracks Svcs Ltd./FA

Document/Exhibit                   Description                      Pages   Size 

 1: S-1         Registration Statement (General Form)               HTML   1.80M 
 2: EX-2.1      Plan of Acquisition, Reorganization, Arrangement,   HTML     50K 
                Liquidation or Succession                                        
 3: EX-3.1      Articles of Incorporation/Organization or Bylaws    HTML      9K 
 4: EX-3.2      Articles of Incorporation/Organization or Bylaws    HTML     22K 
 5: EX-3.3      Articles of Incorporation/Organization or Bylaws    HTML    121K 
 6: EX-4.1      Instrument Defining the Rights of Security Holders  HTML     76K 
 7: EX-5.1      Opinion of Counsel re: Legality                     HTML     19K 
 8: EX-10.1     Material Contract                                   HTML     55K 
17: EX-10.10    Material Contract                                   HTML     95K 
18: EX-10.11    Material Contract                                   HTML     12K 
19: EX-10.12    Material Contract                                   HTML     51K 
20: EX-10.13    Material Contract                                   HTML     47K 
21: EX-10.14    Material Contract                                   HTML     46K 
22: EX-10.15    Material Contract                                   HTML     47K 
23: EX-10.16    Material Contract                                   HTML     46K 
24: EX-10.17    Material Contract                                   HTML     28K 
25: EX-10.19    Material Contract                                   HTML     54K 
 9: EX-10.2     Material Contract                                   HTML     34K 
26: EX-10.20    Material Contract                                   HTML     20K 
10: EX-10.3     Material Contract                                   HTML     40K 
11: EX-10.4     Material Contract                                   HTML    296K 
12: EX-10.5     Material Contract                                   HTML    148K 
13: EX-10.6     Material Contract                                   HTML     27K 
14: EX-10.7     Material Contract                                   HTML     82K 
15: EX-10.8     Material Contract                                   HTML    119K 
16: EX-10.9     Material Contract                                   HTML     95K 
27: EX-21.1     Subsidiaries List                                   HTML      9K 
28: EX-23.1     Consent of Expert or Counsel                        HTML     11K 
29: EX-FILING FEES  Filing Fees                                     HTML     32K 

As filed with the Securities and Exchange Commission on September 14, 2023

Registration No. [*]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

ACESIS HOLDINGS CORPORATION

(Exact name of registrant as specified in its charter)

9233 Park Meadows Dr., Ste. 108

Lone Tree, CO 80124

(720) 389-0650

(Address, including zip code, and telephone number, including area code,

of registrant’s principal executive offices)

Konstantinos Karatzas

Chief Executive Officer

9233 Park Meadows Dr., Ste. 108

Lone Tree, CO 80124

(720) 389-0650

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box. x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please 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(c) 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, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting 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 to Section 7(a)(2)(B) of the Securities Act. ¨

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

This Registration Statement contains two prospectuses, as set forth below.

The Resale Prospectus is substantively identical to the Public Offering Prospectus, except for the following principal points:

The registrant has included in this registration statement a set of alternate pages after the back cover page of the Public Offering Prospectus, which we refer to as the “Alternate Pages”, to reflect the foregoing differences in the Resale Prospectus as compared to the Public Offering Prospectus. The Public Offering Prospectus will exclude the Alternate Pages and will be used for the public offering by the Registrant. The Resale Prospectus will be substantively identical to the Public Offering Prospectus except for the addition or substitution of the Alternate Pages and will be used for the resale offering by the selling stockholders.

The information in this preliminary 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 preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Subject to Completion, dated September 14, 2023

PRELIMINARY PROSPECTUS

Acesis Holdings Corporation

1,300,000 Shares of Common Stock

This is an initial public offering of 1,300,000 shares of Acesis Holdings Corporation common stock, par value, $0.001 per share, (“Common Stock”) at an assumed offering price of $5.00 per share, the midpoint of a range between $4.00 and $6.00 per share. The actual number of shares of Common Stock we will offer will be determined based on the actual public offering price. In addition to the underwritten offering of our Common Stock by us pursuant to this Public Offering Prospectus, [*] of our shareholders (“Selling Stockholders”) are offering 1,700,000 shares of our Common Stock pursuant to the Resale Prospectus to be used in connection with the potential distribution of such shares by such shareholders. These [*] shares of Common Stock include [[*] shares of Common Stock underlying warrants issued to the placement agent in connection with a private placement of our Common Stock as described herein under “Prospectus Summary-Recent Developments—Equity Private Placements.”]  

Prior to this offering, there has been no public market for our common stock. We have applied to have our common stock listed on The Nasdaq Capital Market, or Nasdaq under the symbol “ACSB”. We believe that upon completion of this offering, we will meet the standards for listing, and the closing of this offering is contingent upon such listing.

We intend to use the proceeds from this offering as described under “Use of Proceeds”.

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 27 of this prospectus for a discussion of information that should be considered in connection with an investment in our common stock.

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012, and we have elected to comply with certain reduced public company reporting requirements.

This offering is being underwritten on a firm commitment basis. We have granted the representative an option, exercisable for 45 days from the date of this prospectus, to purchase up to an additional fifteen percent (15%) of the shares of common stock on the same terms as the other shares being purchased by the underwriters from us.

The underwriters expect to deliver the shares against payment to the investors in this Offering on [*], 2023.

Sole Book-Running Manager

BOUSTEAD SECURITIES, LLC

The date of this prospectus is [*], 2023.

Table of Contents

Through and including [*], 2023 (the 25^th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

You should rely only on the information contained in this prospectus or any prospectus supplement or amendment. Neither we, nor the underwriters, have authorized any other person to provide you with information that is different from, or adds to, that contained in this prospectus. If anyone provides you with different or inconsistent information, you should not rely on it. Neither we nor the underwriters take responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. You should assume that the information contained in this prospectus, or any free writing prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date. We are not making an offer of any securities in any jurisdiction in which such offer is unlawful.

For investors outside the United States: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our common stock and the distribution of this prospectus outside of the United States.

No person is authorized in connection with this prospectus to give any information or to make any representations about us, our common stock offered hereby, or any matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

Copies of some of the documents referred to herein have been filed as exhibits to the registration statement of which this prospectus forms a part, and you may obtain copies of those documents as described in this prospectus under the heading “Where You Can Find More Information.”

BASIS OF PRESENTATION

The consolidated financial statements include the accounts of Acesis Holdings Corporation, and its wholly-owned subsidiaries Acesis Biomed Ltd. and Acesis Biomed US Inc., which are affiliated by virtue of common management and ownership. All intercompany transactions and accounts have been eliminated. Numerical figures included in this prospectus have been subject to rounding adjustments. Accordingly, numerical figures shown as totals in various tables may not be arithmetic aggregations of the figures that precede them. 

MARKET DATA

Market data and certain industry data and forecasts used throughout this prospectus were obtained from internal company surveys, internal estimates, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications and surveys. We believe that industry surveys, publications, consultant surveys and forecasts referred to herein have been obtained from reliable sources. To our knowledge, third-party industry data that includes projections for future periods does not take into account all potential factors that could affect such projections. Accordingly, those third-party projections should not be given undue weight. We have not independently verified any of the data from third party sources, nor have we ascertained the underlying economic assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry, have not been independently verified. Statements as to our market position are based on the most currently available data. Our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus.

TRADEMARKS

The logos, and other trade names, trademarks, and service marks of Acesis Holdings Corporation and its subsidiaries appearing in this prospectus are the property of Acesis Holdings Corporation and its subsidiaries. Other trade names, trademarks, and service marks appearing in this prospectus are the property of their respective holders. Trade names, trademarks, and service marks contained in this prospectus may appear without the “®” or “™” symbols. Such references are not intended to indicate, in any way, that we, or the applicable owner or licensor, will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable owner or licensor to those trade names, trademarks, and service marks.  

ABOUT THIS PROSPECTUS

Throughout this prospectus, unless otherwise designated or the context suggests otherwise,

GLOSSARY OF CERTAIN TERMS

As a biotechnology company, describing our business involves several technical terms and acronyms. We are providing the following glossary to assist readers with certain technical terms and acronyms that are frequently used herein.

“14-3-3” means small acidic proteins (27 to 32-kDa), that are highly conserved across species. They are adapter proteins implicated in the regulation of a large spectrum of both general and specialized signaling pathways. They bind to partners, usually by recognition of a phosphoserine or phosphothreonine motif. Binding generally results in the modulation of the activity of the binding partner. 14-3-3ɛ is part of the 14-3-3 family and identified as negative regulator of androgen formation in the Leydig cells.

“ACE-167” means a tetrapeptide which is the Company’s lead candidate for a number of Low-T related indications.

“black box warning” also called “boxed warnings”, means warnings required by the US Food & Drug Administration (the “FDA”) for certain medications that carry serious safety risks. Often these warnings communicate potentially rare but dangerous side effects, or they may be used to communicate important instructions for safe use of the drug.

“Cachexia” means a disorder that causes extreme weight loss and muscle wasting and can include loss of body fat. This syndrome affects people who are in the late stages of serious diseases including cancer and HIV.

“clinical trials” means studies carried out in humans to find out whether a drug candidate is as effective as a therapeutic. Clinical trials are segmented into at least three phases (and often four – latter is usually post-approval and a condition of approval; also used for marketing studies).

“comorbidities” means the presence of two or more diseases in the same person.

“contract research organization” or “CRO” means a company that provides support to the pharmaceutical, biotechnology and medical device industries in the form of research services outsourced on a contract basis.

“endogenous” means having internal cause or origin.

“estradiol” means an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.

“estrogen” means a category of sex hormones responsible for the development and regulation of the female reproductive system and secondary sex characteristics.

“exogenous” means having external cause or origin.

“first-in-class” means drugs that use a new and unique method of action for treating a medical condition. (Note that this term as used herein is not intended to and does not imply that a drug or treatment has been approved by the FDA or any other domestic or foreign regulatory authority).

“functional hypogonadism” or “FH” means hypogonadism present in the absence of organic pathology and often associated with obesity, comorbidities and medications.

“fusion peptides” or “TVS167” means peptides made by the fusion of two or more peptides originating from different protein encoding nucleotide sequences. Fusion peptides were used to facilitate entry of peptides into cells (fused to HIV TAT protein) or elucidate a peptide sequence blocking mechanism (fused to VDAC1 mimic sequence for best blocking effect).

“gonadotropin” means any hormones that stimulate the gonads, or sex glands, to carry out their reproductive or endocrine functions.

“gonadotrophin releasing hormone” or “GnRH” means a hormone responsible for the release of follicle-stimulating hormone and luteinizing hormone from the anterior pituitary. GnRH is a tropic peptide hormone synthesized and released from GnRH neurons within the hypothalamus.

“gonads” means the primary reproductive organs, the testes in the male and the ovaries in the female.

“hypogonadism” or “testosterone deficiency syndrome” or “TDS” means a condition in which the male testes produce little or no sex hormones.

“hypogonadotropic” or “secondary hypogonadism” means a form of hypogonadism that indicates a problem in the hypothalamus or the pituitary gland, the parts of the brain that signal the testes to produce testosterone.

“hypothalamic-pituitary-gonadal axis” or “HPG axis” means the hypothalamus, pituitary gland, and gonadal glands as if these individual endocrine glands were a single entity.

“hypothalamus” means a part of the brain that has a vital role in controlling many bodily functions including the release of hormones from the pituitary gland.

“in vitro” means studies that are performed with microorganisms, cells or biological molecules outside their normal biological context.

“in vivo” means studies in which the effects of various biological entities are tested on whole, living organisms or cells, usually animals, including humans.

“IND-enabling studies” means studies which are conducted to evaluate new drugs prior to human studies and to estimate starting doses for human clinical trials.

“Indications: Low-T” means together, the Low-T indications of primary hypogonadism and secondary hypogonadism being progressed by the Group, through ACE-167.

“Investigational New Drug” or “IND” means a drug substance that has been tested in the laboratory and has been approved by the FDA for testing in people. An IND application is filed with the FDA to begin clinical testing.

“Kallmann Syndrome” means a condition characterized by delayed or absent puberty and an impaired sense of smell. This disorder is a form of hypogonadotropic hypogonadism, which is a condition resulting from a lack of production of certain hormones that direct sexual development.

“Klinefelter Syndrome” means a rare genetic condition where boys are born with an extra X chromosome and the condition is associated with hypogonadism.

“lead candidate” means a drug candidate which following high-throughput screening and lead generation stages is the compound entering the optimization process which aims to generate the molecule for pre-clinical (and, potentially, clinical) studies.

“mitochondria” means membrane-bound cell organelles (mitochondrion, singular) that generate most of the chemical energy needed to power the cell’s biochemical reactions.

“mechanism of action” or “mode of action” or “MOA” means also known as mechanism of action; the mechanism by which a pharmacologically active substance produces an effect on a living organism or in a biochemical system.

“non-alcoholic fatty liver disease” or “NAFLD” is a chronic clinicopathological condition associated with significant lipid deposition in hepatocytes and an increased risk of liver injury. NAFLD encompasses a wide histological spectrum of diseases ranging from simple steatosis (SS) without inflammation or fibrosis to non-alcoholic steatohepatitis (“NASH”) with inflammation, and eventually cirrhosis and ultimately hepatocellular carcinoma (HCC), strong association with obesity, insulin resistance or type 2 diabetes mellitus, and dyslipidemia.

“peptide” means molecules that consist of between 2 and 50 amino acids.

“phase 1 clinical trial” means the phase that occurs directly after lab testing. Based on the lab testing, researchers have determined that the drug may provide a benefit to humans. However, at this point, it has not yet been determined how the drug will affect or react to a human’s biology, or whether it is safe or even effective. Phase 1 usually consists of a very small number of participants — either mostly healthy subjects or patients, such as terminal cancer patients — and is conducted to evaluate the drug’s overall safety and determine the safest dose of the drug.

“phase 2 clinical trials” means after appropriate dosing is established in phase 1, the clinical trial moves on to phase 2. In this phase, the experimental drug or treatment is tested on a larger group of people (up to several hundred), to see if it’s effective and safe.

“phase 3 clinical trials” means larger scale studies carried out in humans to gather confirming data on a drug’s safety and efficacy before applying for regulatory approval for marketing.

“pituitary gland” means a small, bean-shaped gland situated at the base of the brain. The gland influences nearly every part of the body. The hormones it produces help regulate important functions, such as growth, blood pressure and reproduction.

“pre-clinical” means pre-clinical development and encompasses the studies / activities that link drug discovery in the laboratory to initiation of human clinical trials.

“selective estrogen receptor modulators” or “SERMs” block the effects of estrogen in the breast tissue. SERMs work by sitting in the estrogen receptors in breast cells. If a SERM is in the estrogen receptor, there is no room for estrogen and it cannot attach to the cell.

“serum testosterone” means a blood test called a serum testosterone test that is used to determine one’s level of circulating testosterone.

“steroidogenesis” means the multistep process for biosynthesis of steroid hormones from cholesterol. Primary organs for steroidogenesis in the male are the testes and adrenal glands.

“testosterone” or “T” means the male sex hormone that is made in the testes.

“testosterone replacement therapy” or “TRT” means a form of hormone therapy in which testosterone is supplemented or replaced exogenously.

“T-inducer” means a molecule/factor that induces testosterone production by cells in the testes.

“translocator protein” or “TSPO” means an outer mitochondrial membrane protein shown to bind cholesterol and various classes of chemicals and drugs with high affinity. It has been implicated in many mitochondrial and cell functions including steroid production in steroid producing cells.

“type 2 diabetes” or “T2D” means an impairment in the way the body regulates and uses sugar (glucose) as a fuel and the chronic high blood sugar levels can lead to disorders of the circulatory, nervous and immune systems.

“voltage-dependent anion channel 1” or VDAC1 means a protein which is an important regulator of mitochondrial function located in the outer mitochondrial membrane, which makes VDAC1 ideally placed to interact with over 100 proteins, and to orchestrate the interaction of mitochondrial and cellular activities.

RISK FACTORS

Our business is subject to many risks and uncertainties, which may affect our future financial performance. If any of the events or circumstances described below occur, our business and financial performance could be adversely affected, our actual results could differ materially from our expectations, and the price of our stock could decline. The risks and uncertainties discussed below are not the only ones we face. There may be additional risks and uncertainties not currently known to us or that we currently do not believe are material that may adversely affect our business and financial performance. You should carefully consider the risks described below, together with all other information included in this prospectus including our financial statements and related notes, before making an investment decision. The statements contained in this prospectus that are not historic facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. If any of the following risks actually occurs, our business, financial condition or results of operations could be harmed. In that case, the trading price of our common stock could decline, and investors in our securities may lose all or part of their investment.

Risks Related to our Business and Industry

We are an early, pre-clinical, development-stage company with a limited operating history.

We were incorporated in the State of Nevada on October 3, 2022. The Company acts as the holding company for its wholly-owned subsidiary Acesis UK and its operating subsidiary, ABI, a research and development company within the life sciences and biotech sector and focused on the research and development of novel treatments for Low–T in males since its incorporation in the State of Colorado, on March 11, 2015. The Company is at an early stage of development and does not have an established record. There can be no guarantee that the Company will be able, or that it will be commercially advantageous for the Company, to continue to develop its product candidates, nor is there any guarantee that any of its product candidates will prove to be efficacious treatments and will reach commercialization.

We have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future.

We have no products approved for commercial sale and have not generated any revenue to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred significant losses in each period since our inception in March 2015. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development and seek regulatory approvals for our product candidate.

The Company has limited historical financial data upon which to base its projected revenue (of which there is none currently). The Company also has limited historical financial data upon which to base its planned operating expense or upon which investors may evaluate its business and prospects. Based on the Company’s limited experience in developing and marketing new products, it may not be able to effectively:

There can be no assurance that we will ever generate meaningful revenues or be profitable. If we cannot achieve our business objectives, investors in our shares will likely suffer a loss of their entire investment.

The Company is currently only developing one product, ACE-167.

The Company is currently only developing one product, ACE-167. This product is being developed for several indications, as a platform product, where there is scientific evidence linking low testosterone to the indication, with the Low-T indications of primary and secondary hypogonadism in males being at the most advanced development stage as at the date of this document. There is no guarantee that this product will be successfully brought through pre-clinical and clinical studies for any of the indications for which it is currently being developed. Furthermore, the ACE-167 development path for male hypogonadism treatment may incur delays, funding and/or technical issues and/or may altogether fail in safety and efficacy trials which may have a material adverse effect on the timings and viability for the additional indications set out in this document. If this product is found to be defective in any way, is found to be unsuitable as a treatment for the indications for which it is being developed or fails to reach commercialization for any reason this would have a material adverse effect on the viability of the Company and on its ability to generate revenues and continue to operate.

We will need additional funding to fund our operations.

While the Company has sufficient funding available for its current requirements, the Company will need to raise additional funding to complete pre-clinical studies on ACE-167 (for additional low-T Indications) as well as commence in the future early-stage clinical trials Phase I for the male hypogonadism indication and on several other indications including Klinefelter Syndrome, NAFLD and type 2 diabetes and take advantage of future opportunities.

Currently expected net proceeds from this private placement offering will be insufficient for the Company to complete IND-enabling studies on its lead indications of primary hypogonadism and secondary hypogonadism for ACE-167. We will need to raise additional funds in order to manufacture the clinical product supply required to progress to phase 1 clinical trial.

We will need additional funding to fund our operations, but additional funds may not be available to us on acceptable terms on a timely basis, if at all. We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt offerings. If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation, or asset sale transactions. Any future debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Furthermore, we cannot be certain that additional funding will be available on acceptable terms, if at all. If we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need to curtail planned activities to reduce costs, which will harm our ability to execute on our business plan and continue operations.

No assurance can be given that any such additional funding will be available or, if available, that it will be on terms that are favorable to the Company or its shareholders. If the Company is unable to obtain additional funding as required, it may be required to cease operations or reduce the scope of its operations or anticipated business expansion.

We and our contract manufacturers are subject to extensive governmental regulation both in the United States and abroad, and failure to comply with applicable requirements could cause our business to suffer.

The Company, its contract manufacturers and its potential customers are subject to regulatory requirements in all countries where the Company operates and intends to introduce its products and technologies. The development and commercialization of the Company’s proprietary technology and operations, which are at an early stage, are likely, in part or in whole, to be exposed to research and development risks and to require differing and varied forms of regulatory approval.

The biotechnology and pharmaceutical industries are regulated extensively by governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies. The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, difficulties achieving new product clearances, higher than anticipated costs or lower than anticipated sales.

The Company is a pre-revenue, research and development stage company and has a relatively limited operating history on which to assess the business. The products will require significant additional research and development efforts prior to any commercial use, including extensive pre-clinical and clinical testing as well as lengthy regulatory approval under the FDA drug approval process. There can be no assurances that the Company’s research and development efforts will be successful (or completed in a timely manner if at all), that the potential products will prove to be safe and effective in future clinical trials or that the Company will develop any commercially successful products. The Company currently has no approved products on the market and has not received any commercial revenues from the sale or license of any diagnostic or therapeutic products.

Any delay in, or failure to receive or maintain, clearance or approval for our product candidates under development could prevent us from generating revenue from these products or achieving profitability.

In addition, even after we have obtained the proper regulatory clearance or approval to market a product, the FDA has the power to require us to conduct post-market surveillance on our product. These studies can be very expensive and time consuming to conduct. Failure to comply with those studies in a timely manner could result in the revocation of clearance for a product that is subject to such surveillance and the recall or withdrawal of the product, which could prevent us from generating sales from that product in the United States.

The FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some clinicians from using our product and adversely affect our reputation and the perceived safety and effectiveness of our product.

Failure to comply with applicable regulations could jeopardize our ability to sell our product and result in enforcement actions such as:

Adverse action by an applicable regulatory agency the FDA could result in inability to produce our product in a cost-effective and timely manner, or at all, decreased sales, higher prices, lower margins, additional unplanned costs or actions, damage to our reputation, and could have material adverse effect on our reputation, business, results of operations, and financial condition.

We may become dependent on a limited number of contract manufacturers, some of them single-source and some of them in single locations, for our product, and the loss of any of these contract manufacturers, or their inability to provide us with an adequate supply of products in a timely and cost-effective manner, could materially adversely affect our business.

If approved, there is no guarantee that the Company’s proposed products can be manufactured in commercial quantities, will comply with regulatory requirements, or will be produced at an acceptable cost. Similarly, licensing of the treatment process technology will require licensing and technology transfer, and there is no guarantee that the final licensed process will comply with regulatory requirements or can be completed at an acceptable cost.

All entities involved in the development of product candidates for clinical trials or commercial sale, including the Company’s contract manufacturers, are subject to extensive regulation. The Company may experience production problems and delays in obtaining regulatory approval of the Company’s manufacturing processes, which could result in delays in the development of the Company’s product candidates. The manufacturing process the Company uses to produce its products is likely to be complex and has not yet been validated for commercial use. The Company, and the Company’s elected contract manufacturer, will both be subject to significant regulation with respect to manufacturing products.

The Company intends to outsource the manufacture of products and treatment process design and optimization that will be required in connection with the research and development of its proposed products and process and, as such, will be dependent upon third parties to provide adequate supplies and facilities.

Furthermore, where the Company is dependent on third parties for product manufacture and process optimization, its ability to obtain both in accordance with regulatory requirements may be constrained, and its ability to develop and deliver both for patient treatment on a timely and competitive basis (along with the operational costs incurred by the business) may be adversely affected.

We will rely on contract manufacturers to supply our clinical supplies to perform clinical trials. For us to be successful, any contract manufacturers must be able to provide us with product in substantial quantities, in compliance with regulatory requirements, in accordance with agreed upon specifications, at acceptable prices, and on a timely basis. The inability to find the required contract manufacturers or the time required to switch contract manufacturers could adversely affect sales.

In addition, our anticipated growth could strain the ability of our contract manufacturers to deliver an increasingly large supply of product. Contract manufacturers often experience difficulties in scaling up production, including financial issues, or problems with production yields and quality control and assurance.

We will use a small number of sole sourced component manufacturers. Upon FDA approval and commercialization of our product, we may use a single-source manufacturer for many components of our product. Our dependence on such a limited number of manufacturers exposes us to risks, including, among other things:

If any one or more of these risks materialize, it could significantly increase our costs and impact our ability to meet demand for our product. If we are unable to satisfy commercial demand for our product in a timely manner, our ability to generate revenue would be impaired, market acceptance of our product could be adversely affected, and customers may instead purchase or use our competitors’ products. Additionally, we could be forced to seek alternative sources of supply.

Because of the nature of our internal quality control requirements, regulatory requirements, and the custom and proprietary nature of our product, we may not be able to quickly engage additional or replacement contract or component manufacturers for our product and accessories. We may also be required to assess any potential new manufacturer’s compliance with all applicable regulations and guidelines, which could further impede our ability to obtain our product in a timely manner. As a result, we could incur increased product costs, experience delays in deliveries of our product, suffer damage to our reputation, and experience an adverse effect on our business and financial results. Failure of any of our contract manufacturers to meet our product demand level would limit our ability to meet our sales commitments to our customers and could have a material adverse effect on our business.

We may also have difficulty obtaining similar product from other contract manufacturers that are acceptable to the FDA and the failure of our contract manufacturers to comply with strictly enforced regulatory requirements could expose us to delays in obtaining clearances or approvals, regulatory action including warning letters, product recalls, termination of distribution, product seizures, civil, administrative, or criminal penalties. We could incur delays while we locate and engage qualified alternative contract manufacturers, and we may be unable to engage alternative contract manufacturers on favorable terms or at all. Any such disruption or increased expenses could harm our commercialization efforts and adversely affect our ability to generate sales.

In addition, we expect that most of our contract manufacturers may operate at a facility in a single location and substantially all their inventory of component supplies and finished goods may be held at these locations. We, and we presume our contract manufacturer(s), will take precautions to safeguard facilities, including acquiring insurance, adopting health and safety protocols, and utilizing off-site storage of computer data. However, vandalism, terrorism, or a natural or other disaster, such as an earthquake, fire, or flood, could damage or destroy equipment or component supplies or finished product, cause substantial delays in our operations, result in the loss of key information, and cause us to incur additional expenses. Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our or our contract manufacturers’ facilities could harm our business, financial condition, and operating results.

As our sales grow, our contract manufacturers may encounter problems or delays in the manufacturing of our product or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results.

To become profitable, our contract and component manufactures must manufacture our product in adequate quantities in compliance with regulatory requirements and at an acceptable cost. Increasing their capacity to manufacture and inspect our product may require them to improve internal efficiencies or require us to re-design or change the specifications of our product. Our manufacturers may encounter several difficulties in increasing this capacity, including:

If we are unable to satisfy commercial demand for our product due to our contract manufacturer’s inability to manufacture and inspect our product, our ability to generate revenue would be impaired, market acceptance of our product could be adversely affected, and customers may instead purchase or use our competitors’ products.

We may be unable to drive adoption of our products by its target audience and market, which might have a material adverse effect on the Company, its business, financial situation, growth, and prospects.

If the Company is unable to drive adoption of its products to its target audience and market, or there is a slower than expected adoption of its products, there could be weak penetration of the market, which might have a material adverse effect on the Company, its business, financial situation, growth, and prospects. The slow adoption of its products and technologies could result in timeframes being longer than anticipated by the Company for commercialization.

Public opinion, perception, and acceptance of the use of therapies for hypogonadal treatment, whether by hormonal, or non-hormonal, methods, and the knowledge of Black Box warnings on certain competitor products, may affect the adoption of any products commercialized by the Company.

The results of our future clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

If our anticipated clinical trials are initiated and completed as planned, we cannot be certain that their results will support our product marketing claims or third party reimbursors will agree with our conclusions regarding them. The clinical trial process may fail to demonstrate efficacy and cost effectiveness of our product and may hinder the adoption of our product or ability to obtain payor coverage. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

The possible side effects and full efficacy and safety of the technologies that the Company intends to produce are not yet fully understood. There are therefore risks that potentially serious side effects of the technology could occur or that such technology fails future efficacy or safely testing, none of which the Company can rule out and, if so, this could have serious implications on the viability of the technology and the business of the Company.

Severe side effects, failures or complications in clinical trials, or post-approval could also, in addition to having an impact on the commercial products, may result in financial claims and losses against the Company as well as a high probability of significant reputational damage to the Company.

If we encounter delays or difficulties in the development of these product candidates, as well as any other product candidates, the Company’s business prospects would be significantly harmed.

The future success of our Company is significantly dependent on the timely and successful development and commercialization of the lead product candidate ACE-167 (Indications: Low-T) for the treatment of low testosterone levels (hypogonadism) in men. If the Company encounters delays or difficulties in the development of these product candidates, as well as any other product candidates, the Company’s business prospects would be significantly harmed.

The Company is dependent upon the successful development, approval, and commercialization of the product candidate. Before receiving regulatory approval for the product candidate, extensive pre-clinical studies and clinical trials will need to be completed demonstrating their safety and efficacy in humans. The lead product candidate is in early stages of development and the Company must first complete IND-enabling studies prior to phase 1 clinical trial.

IND-enabling studies and pre-clinical testing is expensive, difficult to design and implement and can take many months to complete. Importantly, delays and/or a failure of one or more of these or any other pre-clinical studies can occur at any stage of testing. The Company may experience numerous unforeseen events during, or as a result of pre-clinical studies that could delay or prevent the ability to receive regulatory approval to proceed with clinical studies and thus commercialize the product candidates, including the following:

Any inability to successfully complete pre-clinical development could result in additional costs to the Company or impair its ability to generate revenue. In addition, if the Company makes manufacturing or formulation changes to the product candidates, the Company may be required to, or may elect to, conduct additional studies to bridge the modified product candidates to earlier versions (“bridging studies”). Pre-clinical study delays could also shorten any periods during which the products have patent protection and may allow the Company’s competitors to bring products to the clinic before they do, which could impair the Company’s ability to successfully commercialize its product candidates and may harm the Company’s business and results of operations.

Cost of our research and development process may change, and as a result, approval of our product may be delayed, and we might need to raise additional funding to continue our operations.

The Company operates through a virtual drug development model whereby it contracts out IND-enabling activities and preliminary peptide production and formulation studies. There can be no guarantee of costs remaining flat and/or stable and since it is not always possible to predict the timings of approval stages, the timelines may be at risk of delay which can impact costs. Therefore, approval stages and studies could take longer than what we presently expect and, if such delays occur, the Company may require additional working capital sooner than anticipated. Our need for additional funding due to delays or increased costs may have a material adverse effect on the Company’s ability to complete pre-IND enabling studies and obtain FDA approval or, more generally, progress its research activities to reach commercialization and hence, the ability to generate revenues.

We may not be able to obtain an orphan drug designation for ACE-167 or we may experience significant delays in doing so.

Dr. Papadopoulos intends to test ACE-167 in cells collected from Klinefelter patients with the initial aim for the Company to submit an orphan drug designation request to the FDA or the European Medicines Agency (EMA) Orphan drugs present numerous development and manufacturing challenges and there are often long development times associated with them.

Rare diseases that affect limited patient populations and have not been extensively studied can pose significant research and development challenges for companies looking to identify new drugs to treat them. A key factor is the difficulty in establishing clinical trials for very small patient populations. However, the Klinefelter Syndrome and subsets of this genetic disease collectively is one of the most common of the orphan diseases. Although in general it takes time to recruit patients for orphan disease indications, and those who do participate are often highly geographically dispersed, so managing the trials can be complex, this may not be the case for a subset of patients with Klinefelter Syndrome. Orphan drugs are in many cases administered to limited patient populations, leading to the need, even for commercial products, to manufacture much smaller quantities than have been traditionally required. However, because it is expected that the ACE-167 product candidate will be the same product to be used across several disease indications including Klinefelter syndrome patients, there will be no need for manufacturing smaller quantities, only different strength, and formulation.

Accordingly, there is a risk that the Company will not be able to obtain an orphan drug designation or that it will experience significant delays in doing so.

We rely on the expertise and resources of third parties to complete the development, pre-clinical testing, regulatory process, manufacturing, marketing, and commercialization of product candidates.

The Company does not possess “in-house” all the resources necessary to complete the development, pre-clinical testing, regulatory process, manufacturing, marketing, and commercialization of product candidates and will need to obtain such resources from third parties. In order to obtain such resources, the Company will need to enter into collaborations with corporate partners, licensors, licensees and possibly relationships with third parties from whom the Company will outsource the necessary expertise and resources. The Company’s success will depend on securing such relationships. This business strategy would utilize the expertise and resources of third parties in several areas including:

The Company faces intense competition for qualified employees and consultants, including personnel with a high level of scientific and technical expertise in the industry. Pharmaceutical companies, specialist pharmaceutical and biotechnology companies and other competitors, which may have greater resources and experience than the Company has, likely offer superior compensation packages to attract and retain skilled personnel. As a result, the Company may have difficulty retaining such employees and consultants because it may not be able to match the packages offered by such competitors and may have difficulty attracting suitable replacements.

The Company expects that the potential expansion into areas and activities requiring additional expertise, such as regulatory, pre-clinical, preparing submissions for engaging with regulatory agencies, governmental approvals, contract, and manufacturing, will be done by working with outside contractors who have the appropriate expertise or by utilizing collaborators and partners. The management of these processes may require an increase in staff and the development of additional expertise by existing management personnel. The failure to attract and retain such personnel or to develop such expertise could have a material adverse effect on the prospects for the Company’s success.

There is a risk that the parties with whom the Company trades or has other business or collaborative relationships, including partnerships or licensing arrangements, may become insolvent. In the event that a party with whom the Company trades becomes insolvent, this could have a material adverse impact on the financial performance and prospects of the Company.

If any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

Any contract manufacturers and suppliers we engage are subject to numerous federal, state, and local environmental, health, and safety laws, regulations, and permitting requirements, including those governing laboratory procedures and those governing the generation, handling, use, storage, treatment, and disposal of hazardous and regulated materials and wastes.

Compliance by our manufacturing partners with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research and product development efforts if our partners cannot deliver the supply of material (ACE-167) for our programs. In addition, we cannot eliminate the risk of accidental injury or contamination from these materials or wastes.

Liabilities incurred pursuant to these laws and regulations could result in significant costs or an interruption in operations, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

The effect of the COVID-19 pandemic or other pandemics on our operations, and the operations of our partners has had, and is expected to continue to have an impact on our business, financial condition, cash flows and results of operations.

In December 2019, a novel coronavirus disease, or COVID-19, was initially reported and on March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. COVID-19 has had a widespread and detrimental effect on the global economy as a result of the continued increase in the number of cases and affected countries and actions by public health and governmental authorities, businesses, other organizations, and individuals to address the outbreak, including travel bans and restrictions, quarantines, shelter in place, stay at home or total lock-down orders and business limitations and shutdowns.

Despite recent developments of vaccines, the duration and severity of COVID-19, mutations and possible additional mutations and the degree of their impact on our business is uncertain and difficult to predict. We may face increased competition; increased risk in collectability of accounts receivable; lost or reduced productivity due to illness and/or illness of family members; inability to hire key roles; adverse effects on our strategic partners businesses; impairment charges; extreme currency exchange-rate fluctuations; inability to recover costs from insurance carriers; increased risk of vulnerability to cybersecurity attacks or breaches resulting from a greater number of our employees working remotely for extended periods of time; and challenges with Internet infrastructure due to high loads. Our inability to respond to and manage the potential impact of such events effectively could have a material adverse effect on our business, financial condition, and results of operations.

Our efforts to help mitigate the negative impact of the outbreak on our business may not be effective, and we may be affected by a protracted economic downturn. Furthermore, while many governmental authorities around the world have and continue to enact legislation to address the impact of COVID-19, including measures intended to mitigate some of the more severe anticipated economic effects of the virus, we may not benefit from such legislation, or such legislation may prove to be ineffective in addressing COVID-19’s impact on our and our customer’s businesses and operations. Even after the COVID-19 outbreak has subsided, we may continue to experience impacts to our business as a result of COVID-19’s global economic impact and any recession that has occurred or may occur in the future. Further, as the COVID-19 situation is unprecedented and continuously evolving, COVID-19 may also affect our operating and financial results in a manner that is not presently known to us or in a manner that we currently do not consider that may present significant risks to our operations.

The ongoing nature and uncertainty of the pandemic in many countries including the measures and restrictions put in place, such as travel bans and quarantining, continue to have the ability to impact the Company’s business continuity, workforce, business development, ability to progress pre-clinical studies and may also impact the Company’s partners and potential future partners and collaborators and, consequently, future revenues. It is currently difficult to predict the effect of the COVID-19 pandemic on the pre-clinical and clinical development of our products and our future revenues.

In addition, the overall uncertainty regarding the economic impact of the COVID-19 pandemic and the impact on our revenue growth, could impact our cash flows from operations and liquidity. To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

We cannot assure you that we will effectively manage our growth.

The growth and expansion of our business, personnel, and customer base, create significant challenges for our management, including managing multiple relationships with our partners, and other third parties, and constrained operational and financial resources. If our operations or the number of third-party relationships continues to grow, our information-technology systems and our internal controls and procedures may not adequately support our operations. In addition, some members of our management do not have significant experience managing large global business operations, so our management may not be able to manage such growth effectively. To effectively manage our growth, we must continue to improve our operational, financial, and management processes and systems and effectively expand, train, and manage our employee base. However, the actions we take to achieve such improvements may not have the intended effect and may instead result in disruptions, employee turnover, declines in revenue, and other adverse effects.

We are vulnerable to competition and technological change, and also to resistance from physicians and health care providers to using new therapies.

The industry in which we operate is intensely competitive and rapidly evolving. The Company is vulnerable to competition and technological change, and also to resistance from physicians, health care providers and payers to using new therapies.

We will compete with a wide and diverse array of companies. The Company will compete with domestic and foreign companies in developing technology and products, including biotechnology and pharmaceutical companies. Many current and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources. There is no assurance that competitors will not succeed in developing alternative products and/or services that are more effective, easier to use, or more economical than those which the Company may develop, or that would render the Company’s products and/or services obsolete and non-competitive. In general, the Company may not be able to prevent others from developing and marketing competitive products and/or services similar to or which perform similar functions, or which are marketed before the Company’s products.

Competitors may have greater experience in developing products, therapies, conducting clinical trials, obtaining regulatory clearances or approvals, manufacturing, and commercialization. It is possible that competitors may obtain patent protection, approval or clearance from the FDA or achieve commercialization earlier than the Company can, any of which could have a substantial negative effect on the Company’s business.

Physicians and health care providers may resist implementing new therapies due to their prior experience in treating existing conditions. As a result, they may not initiate therapy despite recognition of the problem or the best intervention for a disease status. In particular, they may resist prescribing new treatments, such as the Company’s future therapeutic peptide, to treat hypogonadal males, which would cause our operating results to suffer.

Our ability to protect our intellectual property and proprietary technology is uncertain. If we cannot protect our intellectual property, it will negatively affect our business, financial condition, cash flows and results of operations.

The Company relies on intellectual property laws and third-party non-disclosure agreements to protect its patents and other proprietary rights. We rely primarily on patent, copyright, trademark, and trade secret laws, as well as confidentiality and non-disclosure agreements and other methods to protect our proprietary technologies and know-how. The Company’s business is based upon a combination of patent applications and confidential business know-how. No assurance can be given that any currently pending patent applications or any future patent applications will result in patents being granted or that any pending or granted patent will not be challenged. In addition, there can be no guarantee that the patents will be granted on a timely basis, that the scope of any patent protection will exclude competitors or provide competitive advantages to the Company, that any of the Company’s patents will be held valid if challenged, or that third parties will not claim rights in, or ownership of, the patents and other proprietary rights held by the Company.

Unauthorized third parties may attempt to copy or obtain and use the Company’s intellectual property rights and other technology that are incorporated into its pharmaceutical products. In addition, alternative technological solutions similar to the Company’s products may become available to competitors or prospective competitors of the Company. Once granted, a patent can be challenged both in the relevant patent office and in the courts by third parties. Third parties can bring material and arguments which the patent office granting the patent may not have seen at the time of granting the patent. Therefore, while a patent may be granted to the Company it could in the future be found by a court of law or by the patent office to be invalid or unenforceable or in need of further restriction.

The Company’s priorities are to protect its intellectual property and seek to avoid infringing other companies’ intellectual property. The Company engages reputable legal advisers to mitigate the risk of patent infringement and to assist with the protection of the Company intellectual property. However, no guarantee can be made that infringement proceedings will not be initiated against the Company. Should the Company be required to assert its intellectual property rights, including any patents, against third parties it is likely to use a significant amount of the Company’s resources as patent litigation can be both costly and time consuming. No assurance can be given that the Company will be able to devote sufficient resources to pursue such litigation. In addition, a defendant could counterclaim that the patent covering the Company's intellectual property rights is invalid or unenforceable. Any unfavorable outcomes in respect of patent litigation could limit the Company' intellectual property rights and activities moving forward. Any claims made against the Company’s intellectual property rights by a third party, even without merit, could be time consuming and expensive to defend and could have a materially detrimental effect on the Company's resources.

A patent is limited territorially to the country or economic area in which it was granted. There are countries in which the Company has not filed patent applications. Some territories have patent applications pending and not all patent applications filed by the Company have yet been approved. There is no guarantee that any pending patents or future patent applications will be granted.

We also rely on trade secrets, know-how, and technology, which are not protected by patents, to maintain our competitive position. We try to protect this information by entering into confidentiality and intellectual property assignment agreements with parties that develop intellectual property for us and/or have access to it, such as our officers, employees, consultants, contract research organizations, contract manufacturers and advisors. However, in the event of unauthorized use or disclosure or other breaches of such agreements, we may not be provided with meaningful protection for our trade secrets or other proprietary information. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our commercial partners, collaborators, employees, and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. If any of our trade secrets, know-how or other technologies not protected by a patent were to be disclosed to or independently developed by a competitor, our business, financial condition, and results of operations could be materially adversely affected.

In the future, we may enter into licensing agreements to maintain our competitive position. If we enter into in-bound intellectual property license agreements, we may not be able to fully protect the licensed intellectual property rights or maintain those licenses. Future licensors could retain the right to prosecute and defend the intellectual property rights licensed to us, in which case we would depend on the ability of our licensors to obtain, maintain, and enforce intellectual property protection for the licensed intellectual property. These licensors may determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would. Further, entering into such license agreements could impose various diligence, commercialization, royalty, or other obligations on us. Future licensors may allege that we have breached our license agreement with them, and accordingly seek damages or to terminate our license, which could adversely affect our competitive business position and harm our business prospects.

Further, the Company’s operations rely on the significant experience and know-how of its management and staff. The Company takes precautionary measures to protect its proprietary rights and information, including the use of confidentiality agreements with its employees and consultants, as well as with its academic and commercial relationships. There is no guarantee that agreements will not be violated or that there will be an adequate remedy available for a violation of an agreement.

Our failure to maintain our patents may have significant adverse effects on the Company’s financial position, prospects, and results of operations.

Maintenance of patents through prompt payment of renewal and other fees by third parties will allow the Company to prosecute its patent estate. Conversely, non-payment of those fees would prevent the Company enforcing its intellectual property rights and those rights licensed to it. In that position, the Company may be vulnerable to third parties bringing patent infringement proceedings and the Company may also be unable to assert its intellectual property rights against third parties infringing the rights licensed to it. If a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and other rights may be difficult and time consuming. Even if successful, litigation to defend our patents or other intellectual property rights against challenges or to enforce our intellectual property rights could be expensive and time consuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents or trademarks against challenges or to enforce our intellectual property rights. In addition, if third parties infringe any intellectual property that is not material to the products that we make, have made, use, or sell, it may be impractical for us to enforce this intellectual property against those third parties. Such events may have significant adverse effects on the Company’s financial position and prospects.

An effective system for monitoring and paying renewal fees will be required to ensure prompt payment of renewal and other fees and achieve third-party effectiveness.

If the Company fails to perform any of its obligations under the license agreements, license agreements could be terminated, the intellectual property could revert to the licensor and the Company’s operation can be negatively affected.

In the future, the Company may enter into licensing agreements as a result of its development activities as an extension to its current intellectual property portfolio and, as a result, the Company may have obligations under such license agreements. If the Company fails to perform any of its obligations under the license agreements, it may be in breach. Upon such a breach, license agreements could be terminated, and the intellectual property could revert to the licensor and the Company may be unable to use or further develop related products in those circumstances.

We may be subject to damages resulting from claims that we, our employees, or our contractors have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

Our employees might have been previously employed at other pharmaceutical companies, including our competitors or potential competitors, in some cases until recently. Our contractors might in the past have partnered with our competitors. We may be subject to claims that we, our employees, or our contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of these former employers or competitors. In addition, we have been and may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Even if we are successful in defending against these claims, litigation could result in substantial costs, divert the attention of management from our core business and harm our reputation. If our defense to those claims fails, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. There can be no assurance that this type of litigation will not continue, and any future litigation or the threat thereof may adversely affect our ability to hire additional direct sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product candidates, which could have an adverse effect on our business, results of operations, and financial condition.

We have not obtained formal FTO opinions on our intellectual property portfolio.

The right conferred by a patent is an exclusory right, meaning that the owner can prevent others from carrying out the invention of the patent. However, patents do not provide the owner with the freedom to operate. If aspects of the invention are covered by other patents, permission will be required from the owner of those patents to carry out the invention. If an invention can be exploited without requiring permission from third party patent owners, it is said that there is “freedom to operate” (“FTO”). The Company has not obtained formal FTO opinions on its intellectual property portfolio. FTO analysis is not always practical where a product or process is at the research stage or in early-stage development. This is because the scope of any such search would have to be impractically broad in view of the uncertainty inherent in a product or process that has yet to be finalized. FTO searching and analysis of the search results usually becomes more practical at the stage, prior to commercialization, when a project (method or product) can be specified sufficiently to focus the search to relevant third-party rights.

The Company had instructed its Canadian patent advisers), to conduct a patent landscape analysis. Unlike an FTO analysis, which seeks to identify if an invention potentially infringes at least one claim of a patent owned by a third party, a patent landscape analysis seeks to determine if published documents disclose a technology and, if so, if the disclosure of the published documents could destroy the novelty of the inventive step of claims concerning such technology. The adviser conducted a patent landscape analysis to determine if the Company’s current lead peptide-based compound (ACE-167) as well as two additional potential back-up peptide-based compounds (“Compounds”) were disclosed in the documents considered and if so, if claims to the Compounds would still be considered novel and inventive in view of the disclosure of these documents. As Canadian patent agents, the adviser’s analysis considered novelty and an inventive step from the perspective of the Patent Act (Canada) only and therefore other jurisdictions may apply the concepts of novelty and an inventive step differently.

The patent landscape analysis conducted by the adviser did not identify any published patent applications disclosing the Compounds. However, as noted above, a patent landscape analysis differs from a FTO analysis. The Company is unaware of any FTO issues under its patent families. However, it is possible that a third-party patent might exist, of which the Company is currently unaware, which could impact upon the Company’s freedom to operate.

Patent terms are limited, and we may not be able to effectively protect our product and business.

Patents have a limited lifespan. In the U.S., the natural expiration of a patent is generally 20 years after it is filed. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. In addition, upon issuance in the U.S., the patent term may be extended based on certain delays caused by the applicant(s) or the U.S. Patent and Trademark Office (“USPTO”). Even if we obtain effective patent rights for all our current patent applications, we may not have sufficient patent terms or regulatory exclusivity to protect our product, and our business and results of operations would be adversely affected.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product.

As is the case with other pharmaceutical and biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in our industry involves both technological and legal complexity. Therefore, obtaining and enforcing patents is costly, time-consuming, and inherently uncertain. In addition, the U.S. 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 regarding our 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 future actions 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 our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These products may compete with our product and our patents or other intellectual property rights may not be effective or sufficient 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, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.

In addition to patent protection, we also rely upon copyright and trade secret protection, as well as non-disclosure agreements and invention assignment agreements with our employees, consultants, contract research organizations, contract manufacturers and third parties, to protect our confidential and proprietary information. In addition to contractual measures, we intend to protect the confidential nature of our proprietary information using commonly accepted physical and technological security measures. Such measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our product that we consider proprietary. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable. Trade secret violations are often a matter of state law, and the criteria for protection of trade secrets can vary among different jurisdictions. In addition, trade secrets may be independently developed by others in a manner that could prevent legal recourse by us. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our business and competitive position could be harmed.

Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We employ individuals who previously worked with other companies, including our competitors or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third party. Litigation may be necessary to defend against these claims. If we fail in defending any such claims or settling those claims, in addition to paying monetary damages or a settlement payment, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may incur future product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.

Our business exposes us to potential product candidate liability claims that are inherent in the testing, design, manufacture, and sale of pharmaceutical products.

In its contractual dealings with third parties, it is not always possible for the Company to limit its potential exposure to products liability claims and, in any event, such contractual dealings may be of limited (if any) effect as a result of existing or future laws or regulations or unfavorable judicial decisions The distribution, sale and support of the Company’s future products may entail the risk of such claims, which is likely to be substantial in light of the use of its products in the treatment of medical conditions.

We could become the subject of product liability lawsuits alleging that product defects, or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to patients. Product liability lawsuits and claims, safety alerts, or product recalls, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation, our ability to attract and retain customers and our results of operations or financial condition.

A successful product liability claim could result in significant monetary liability and could seriously harm the Company’s business, operations, financial position and/or reputation.

It is possible that claims against us may exceed the coverage limits of our third-party product liability insurance policies or cause us to record a self-insured loss. Even if any product liability loss is covered by an insurance policy, these policies typically have substantial retentions or deductibles that we are responsible for. Product liability claims in excess of applicable insurance coverage could have a material adverse effect on our business, results of operations, and financial condition.

In addition, any future product liability claim brought against us, with or without merit, could result in an increase of our product liability insurance rates. Insurance coverage varies in cost and can be difficult to obtain, and we cannot guarantee that we will be able to obtain insurance coverage in the future on terms acceptable to us or at all.

If we do not successfully make, integrate, and maintain acquisitions and investments, our business could be adversely impacted.

We have entered into a strategic relationship with the University of Southern California to become effective upon the listing of the Company’s common stock on Nasdaq. Although we have identified the contract research organizations and contract manufacturing organizations we hope to work with, we have not yet signed contracts with any of them. We may acquire, invest in, or enter into strategic relationships with additional companies to complement our existing business and the breadth of our offerings. These transactions are inherently risky and expose us to risks which include:

Future acquisitions or investments could also result in potential dilutive issuances of equity securities, use of significant cash balances or the incurrence of debt, any of which could adversely affect our stock price, financial condition, and results of operations. Further, our acquisitions or investments could result in significant impairments related to goodwill and amortization expenses related to other intangible assets and exposure to undisclosed or potential liabilities of the acquired companies. To the extent that the goodwill arising from the acquisitions carried on the financial statements does not pass a goodwill impairment test, excess goodwill will be impaired and will reduce future earnings.

Adverse market and economic conditions may exacerbate certain risks associated with commercializing the Company’s products.

Future sales of the Company’s products will be dependent on purchasing decisions of, and reimbursement from government health administration authorities, distributors, and other organizations. As a result of adverse conditions affecting the global economy and credit and financial markets, including disruptions due to political instability, global pandemics and diseases such as the COVID-19 pandemic, or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement obligations, or may delay payment for any of the Company’s products which may have a material adverse effect on the financial condition of the Company.

If alternative technology or products are developed, the results of our operations may be negatively affected.

Demand for the Company’s products could be adversely impacted by the development of alternative technology and products. There can be no assurance that the technology and products currently being developed by the Company will not be rendered obsolete either before or following commercialization. As a result, there is the possibility that new technology or products may be superior to, or render obsolete, the technology and products that the Company is currently developing. Any failure of the Company to ensure that its products remain up to date with the latest advances may have a material adverse impact on the Company’s competitiveness and financial performance. The Company’s success will depend, in part, on its ability to develop and adapt to these technological changes and industry trends.

We rely on information technologies and systems to operate our business and maintain our competitiveness, and any failures in our technology infrastructure could harm our reputation and brand and adversely affect our business.

We may not be able to maintain our existing systems or replace our current systems or introduce new technologies and systems quickly or cost effectively. Failure to invest in and adapt to technological developments and industry trends may have a material adverse effect on our business, results of operations, financial condition, and prospects.

The Company uses a cloud-based computing platform which also provides cloud-based data storage and back-up solutions. The service agreement with the relevant service provider allows the provider to terminate or suspend the Company’s access to the services in certain defined circumstances including breach of the provider’s terms and conditions. In the event of termination or suspension, the Company has a period of time to request access to its content. However, the provider may refuse access if the termination arose because of the Company violating the provider’s terms and conditions or acceptable use policy. In those circumstances, if the Company is unable to access its cloud-based data and migrate it to a new platform, there could be a material disruption of the Company’s product development programs.

We rely upon third-party service providers, such as cloud service providers, and we are dependent on these third parties to provide continuous power, cooling, internet connectivity and physical security for computing storage resources, and our reliance on these third parties can be expected to increase as we expand our infrastructure in the future. If these third-party providers experience any interruption in operations or cease business for any reason, or if we are unable to agree on satisfactory terms for continued hosting relationships, our business could be harmed, and we could be forced to enter into a relationship with other service providers or assume respective responsibilities ourselves. A system disruption at a third-party service provider could result in a noticeable disruption and performance degradation to our infrastructure.

Further, our technology infrastructure may be vulnerable to damage or interruption from natural disasters, power loss, telecommunication failures, terrorist attacks, computer intrusions, vulnerabilities, and malware, including viruses and malicious software, software errors, computer denial-of-service attacks and other events. Our technology infrastructure may fail or be vulnerable to damage or interruption because of actions by third parties or employee error or malfeasance. We may not carry business interruption insurance sufficient to protect us from any and all losses that may result from interruptions in our services as a result of technology infrastructure failures or to cover all contingencies.

Despite the implementation of security measures, any of the internal computer systems belonging to the Company or its third-party service providers and collaborators are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failure. Any system failure, accident or security breach that causes interruptions in its own or in third-party service providers’ and collaborators’ operations could result in a material disruption of its product development programs.

The loss of key personnel, an inability to attract and retain additional personnel or difficulties in the integration of new members of our management team into our Company could affect our ability to successfully grow our business.

Our future success depends in large part upon the continued service of the members of our executive management team and key employees. The success of the Company, in common with other businesses of a similar size, will be highly dependent on the expertise and experience of a small number of key individuals comprising the directors, key senior management and scientific advisers of the Company. Of particular importance is Dr. Papadopoulos given he is leading the research and development conducted by the Company and is the scientist who discovered the technology which the Company is progressing. The retention of such key personnel, their services and knowledge cannot be guaranteed. Should key personnel leave, the Company’s business, prospects, financial condition, or results of operations may be materially adversely affected.

In addition, our success also depends on our ability to attract and retain qualified clinical, sales and marketing, administrative, financial, and accounting, legal, and other managerial personnel. The competition for skilled personnel in the industries in which we operate is intense. Our personnel generally may terminate their employment at any time for any reason. Departing personnel are required to maintain confidentiality. We may incur significant costs to attract and retain highly skilled personnel, and we may lose new employees to our competitors before we realize the benefit of our investment in recruiting them. As we move into new geographies, we will need to attract and recruit skilled personnel across functional areas. If we fail to attract new personnel or if we suffer increases in costs or business operations interruptions as a result of a labor dispute, or fail to retain and motivate our current personnel, we might not be able to operate our businesses effectively or efficiently, serve our users properly or maintain the quality of our content and services.

Failure to protect or enforce our intellectual property rights or the costs involved in such enforcement could harm our business, financial condition, and results of operations.

We may from time to time seek to enforce our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of the intellectual property. If we choose to enforce our intellectual property rights against a party, then that individual or company has the right to ask the court to rule that such rights are invalid or should not be enforced. These lawsuits and proceedings are expensive and would consume time and resources and divert the attention of managerial and operational personnel even if we were successful in stopping the infringement of such rights. In addition, there is a risk that the court will decide that such rights are not valid and that we do not have the right to stop the other party from using the inventions.

Further, our competitors have been granted patents protecting various products and solutions. If our products and solutions employ these processes, or other subject matter that is claimed under our competitors’ patents, or if other companies obtain patents claiming subject matter that we use, those companies may bring infringement actions against us. The question of whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. In addition, because patent applications can take many years to issue, there may be applications now pending of which we are unaware, which might later result in issued patents that our products and solutions may infringe. There can be no assurance that our products will not be determined to have infringed upon an existing third-party patent. If any of our products and solutions infringes a valid patent, we may be required to discontinue offering certain products or systems, pay damages, purchase a license to use the intellectual property in question from its owner, or redesign the product in question to avoid infringement. A license may not be available or may require us to pay substantial royalties, which could in turn force us to attempt to redesign the infringing product or to develop alternative technologies at a considerable expense. Additionally, we may not be successful in any attempt to redesign the infringing product or to develop alternative technologies, which could force us to withdraw our products or services from the market.

We may also infringe other intellectual property rights belonging to third parties, such as trademarks, copyrights, and confidential information. As with patent litigation, the infringement of trademarks, copyrights and confidential information involve complex legal and factual issues and our products, branding or associated marketing materials may be found to have infringed existing third-party rights. When any third-party infringement occurs, we may be required to stop using the infringing intellectual property rights, pay damages and, if we wish to keep using the third-party intellectual property, purchase a license or otherwise redesign the product, branding or associated marketing materials to avoid further infringement. Such a license may not be available or may require us to pay substantial royalties.

The success of our business depends on our continued ability to use our trade names in order to increase our brand awareness. The unauthorized use or other misappropriation of any of the trademarks or trade names we will register could diminish the value of our business, which would have a material adverse effect on our financial condition and results of operation.

If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.

We rely on trade secrets to protect our proprietary technologies. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

Changes in tax laws or exposure to additional income tax liabilities could affect our future profitability.

Factors that could materially affect our future effective tax rates include but are not limited to:

Because we do not have a long history of operating at our present scale and we have significant expansion plans, our effective tax rate may fluctuate in the future. Future effective tax rates could be affected by operating losses in jurisdictions where no tax benefit can be recorded under United States generally accepted accounting principles, changes in the composition of earnings in countries with differing tax rates, changes in deferred tax assets and liabilities, or changes in tax laws.

Our failure to adequately protect personal information in compliance with evolving legal requirements could harm our business.

In the ordinary course of our business, we plan to collect and store sensitive data, including legally protected personally identifiable information. We may collect this kind of information during the course of future clinical trials and for possible post-marketing safety vigilance, helping enable clinicians and their patients to pursue claims for reimbursement for treatment using our products.

There are a number of state, federal, and international laws protecting the privacy and security of health information and personal data. These data protection and privacy-related laws and regulations are evolving and may result in ever-increasing regulatory and public scrutiny of companies’ data practices and escalating levels of enforcement and sanctions. As part of the American Recovery and Reinvestment Act 2009, or ARRA, Congress amended the privacy and security provisions of the Health Insurance Portability and Accountability Act, or HIPAA. HIPAA imposes certain requirements regarding the privacy, security, use, and disclosure of an individual’s protected health information, or PHI, by certain health care providers, health care clearinghouses, and health insurance plans, collectively referred to as “covered entities,” and their “business associates,” or subcontractors who provide services to covered entities that involve the creation, use, maintenance, or disclosure of PHI. ARRA included significant increases in the penalties for improper use or disclosure of an individual’s PHI under HIPAA and extended enforcement authority to state attorneys general. The amendments also created notification requirements applicable to covered entities and business associates in certain cases when PHI in their control has been inappropriately accessed or disclosed. In the case of a breach of unsecured PHI, covered entities may be required to provide notification to individuals affected by the breach, federal regulators, and, in some cases, local and national media. In addition to HIPAA, most states have laws requiring notification of affected individuals and state regulators in the event of a breach of “personal information,” which is a broader class of information than the PHI protected by HIPAA. Certain states also have data privacy requirements applicable to individually identifiable health information. Privacy laws in different states may contain different requirements, and such laws may not be pre-empted by HIPAA, which could complicate our efforts to comply.

In addition, even when HIPAA does not apply, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the FTCA, 15 U.S.C § 45(a). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Medical data is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to what is required by the HIPAA Security Rule.

Our failure to comply with applicable laws and regulations, or to protect such data, could result in enforcement actions against us, including fines, imprisonment of Company officials and public censure, claims for damages by end-customers, and other affected individuals, and the imposition of integrity obligations and agency oversight, damage to our reputation, and loss of goodwill, any of which could harm our operations, financial performance, and business. Evolving and changing definitions of personal data and personal information, within the United States, and elsewhere, may limit or inhibit our ability to operate or expand our business, including limiting strategic partnerships that may involve the sharing of data. Moreover, if the relevant laws and regulations change, or are interpreted and applied in a manner that is inconsistent with our data practices or the operation of our product, or if we expand into new regions and are required to comply with new requirements, we may need to expend resources in order to change our business operations, data practices, or the manner in which our product operates. Even the perception of privacy concerns, whether or not valid, may harm our reputation and inhibit adoption of our product.

Our operations may be adversely affected by the risks outside of our control.

The Company’s operations now or in the future may be adversely affected by risks outside the control of the Company such as labor unrest, civil disorder, war, hostilities, terrorist attacks, subversive activities or sabotage, fires, floods, explosions or other catastrophes, pandemics (including the COVID-19 pandemic) or quarantine restrictions.

Even if we are able to commercialize any product candidates in the future, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, and reimbursement for new medicines vary widely from country to country. Some countries require approval of the sale price of a medicine before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a medicine in a particular country, but then be subject to price regulations that delay or might even prevent our commercial launch of the medicine, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the medicine in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates we may develop, even if any product candidates we may develop obtain marketing approval.

Our ability to commercialize any medicines successfully also will depend in part on the extent to which reimbursement for these medicines and related treatments will be available from government authorities or healthcare program, private health plans, and other organizations. Government authorities and third-party payors, such as private health plans, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are challenging the prices charged for medical products and requiring that drug companies provide them with predetermined discounts from list prices. Novel medical products, if covered at all, may be subject to enhanced utilization management controls designed to ensure that the products are used only when medically necessary.

Risks Related to this Offering and Ownership of our Common Stock

Our management will have broad discretion over the use of any net proceeds from this offering and you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

Our management will have broad discretion as to the use of any net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard to the use of any proceeds from this offering and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return for you. If we do not use the net proceeds that we receive in this offering effectively, our business, financial condition, results of operations, and prospects could be harmed, and the market price of our common stock could decline.

Investors in this offering may experience future dilution as a result of future equity offerings.

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock. Investors purchasing our shares or other securities in the future could have rights superior to existing common stockholders, and the price per share at which we sell additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price per share in this offering.

Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock.

Sales of a substantial number of shares of our common stock in the public markets could depress the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities. We cannot predict the effect that future sales of our common stock would have on the market price of our common stock.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If no or too few securities or industry analysts provide coverage or if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, the price of our stock would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our stock could decrease, which might cause the price of our stock and trading volume to decline.

There is no existing market for our common stock, and we cannot assure you that a market will develop for our common stock or what the market price of our common stock will be.

Prior to this offering, there has been no public market for our common stock. We cannot predict the extent to which investor interest in our Company will lead to the development of an active trading market on the Nasdaq or otherwise or how liquid that market might become. If an active trading market does not develop, you may have difficulty selling any shares of our common stock that you purchase, and the value of such shares might be materially impaired.

In addition, we cannot predict the prices at which our common stock will trade. The initial public offering price for our common stock will be determined by negotiations between us and the representatives of the underwriters and may not be indicative of prices that will prevail in the open market following this initial public offering. Consequently, you may not be able to sell shares of our common stock at prices equal to or greater than the price you paid in this initial public offering.

The market price of our stock may be highly volatile, and you could lose all or part of your investment.

The market for our common stock may be characterized by significant price volatility when compared to the shares of larger, more established companies that have large public floats, and we expect that our stock price will be more volatile than the shares of such larger, more established companies for the indefinite future. The stock market in general has recently been highly volatile. Furthermore, there have been recent instances of extreme stock price run-ups followed by rapid price declines and stock price volatility following a number of recent initial public offerings, particularly among companies with relatively smaller public floats. We may also experience such volatility, including stock run-ups, upon completion of this offering, which may be unrelated to our actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.

The market price of our common stock is likely to be volatile due to a number of factors. First, as noted above, our common stock is likely to be more sporadically and thinly traded compared to the shares of such larger, more established companies. The price for our common stock could, for example, decline precipitously in the event that a large number of shares is sold on the market without commensurate demand. Secondly, we are a speculative or “risky” investment due to our lack of profits to date. As a consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a larger, more established company that has a large public float. Many of these factors are beyond our control and may decrease the market price of our common stock regardless of our operating performance. The market price of our common stock could also be subject to wide fluctuations in response to a broad and diverse range of factors, including the following:

In addition, if the market for biotechnology and pharmaceutical stocks or the stock market, in general, experience a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, results of operations, or financial condition. The trading price of our common stock might also decline in reaction to events that affect other companies in our industry even if these events do not directly affect us. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. If our stock price is volatile, we may become the target of securities litigation. Securities litigation could result in substantial costs and divert our management’s attention and resources from our business. This could have a material adverse effect on our business, results of operations, and financial condition.

The public offering price of our common stock has been determined by negotiations between us and the underwriters based upon many factors and may not be indicative of prices that will prevail following the closing of this offering. Volatility in the market price of our common stock may prevent investors from being able to sell their shares at or above the initial public offering price. As a result, you may suffer a loss on your investment.

Because the initial public offering price of our common stock will be substantially higher than the pro forma net tangible book value per share of our outstanding common stock following this offering, new investors will experience immediate and substantial dilution.

The initial public offering price of our common stock is substantially higher than the pro forma as adjusted net tangible book value per share of our common stock immediately following this offering based on the total value of our tangible assets less our total liabilities. Therefore, if you purchase shares of our common stock in this offering, you will experience immediate dilution of $[*] per share, the difference between the assumed limited public offering price of [*] per share, which is the midpoint of the range as set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, and the pro forma net tangible book value per share of our common stock of $[*], immediately after giving effect to the issuance of shares of our common stock in this offering. See “Dilution.”

Sales of substantial amounts of our common stock in the public markets, including when the “lock-up” or “market standoff” period ends [or when outstanding warrants or options are exercised], or the perception that sales might occur, could reduce the price of our common stock and may dilute your voting power and your ownership interest in us.

Sales of a substantial number of shares of our common stock in the public market after this offering, or the perception that these sales could occur, could adversely affect the market price of our common stock, and may make it more difficult for you to sell your common stock at a time and price that you deem appropriate. In connection with this offering, we and our officers, directors and holders of 5% or greater of our outstanding common stock have agreed to be locked up for a period of twelve months from the date on which the trading of our common stock commences. [Holders of 1-4.99% of our outstanding common stock agreed to be locked up for a period of six months from the date on which the trading of our common stock commences, provided that if the aggregate of such holders’ shares were to equal or exceed 20% of our outstanding common stock on a fully diluted basis prior to the completing of this offering, then their lock up period shall be for twelve months from the date of trading of our common stock commences. Holders of less than 1% of our outstanding common stock are not subject to any lock up, provided that if the aggregate of such holders’ shares were to equal or exceed 5% of our outstanding common stock on a fully diluted basis prior to the completing of this offering, then their lock up period shall be for six months from the date of trading of our common stock commences.] See “Underwriting.” When the lock-up period expires [or when outstanding warrants or options are exercised], our security holders will be able to sell shares in the public market subject to any restrictions under the securities laws. In addition, the representative of the underwriters may, in its discretion, release all or some portion of the shares subject to lock-up agreements prior to the expiration of the lock-up period. See “Shares Eligible for Future Sale” for more information. Sales of a substantial number of such shares upon expiration, or the perception that such sales may occur, or early release of the lock-up [or exercise of outstanding warrants or options], could cause our share price to fall, or make it more difficult for you to sell your common stock at a time and price that you deem appropriate.

We also may register the offer and sale of all shares of common stock that we may issue under our equity compensation plans.

We may issue our shares of common stock or securities convertible into our common stock from time to time in connection with a financing, acquisition, investments or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline. 

We may be subject to securities litigation, which is expensive and could divert our management’s attention.

The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns.

We may not be able to satisfy listing requirements of Nasdaq to maintain a listing of our common stock.

If our common stock is listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain such listing. If we violate the maintenance requirements for continued listing of our common stock, our common stock may be delisted. In addition, our board of directors may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A delisting of our common stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock. In addition, the delisting of our common stock could significantly impair our ability to raise capital.

The offering price of the primary offering and resale offering could differ.

The offering price of our Common Stock in the primary offering (the initial public offering) has been determined by negotiations between the Company and the underwriters based upon several factors, including prevailing market conditions, our historical performance, estimates of our business potential and earnings prospects, and the market valuations of similar companies. The offering price in the primary offering bears no relationship to our assets, earnings or book value, or any other objective standard of value. Additionally, the estimated offering price in the primary offering of $5.00 per share is substantially higher than the prices at which the Selling Stockholders acquired their shares ($1.00 per share), and we recently sold stock at prices ($1.00 per share) substantially less than the primary offering price. Our recent share issuances at prices substantially less than the primary offering price occurred while we were a non-public company, and the shares we issued were subject to transfer restrictions imposed by the Securities Act of 1933, as amended, and by lock-up restrictions, whereas shares issued in the primary offering will be issued after we are a public company and will be issued without restriction.

The Selling Stockholders may sell the resale shares at prevailing market prices or privately negotiated prices after close of the primary offering and listing of our Common Stock on the Nasdaq. Therefore, the offering prices of our Common Stock in the primary offering and the resale offering could differ. As a result, purchasers in the resale offering could pay more or less than the offering price in the primary offering.

The resale by the Selling Stockholders may cause the market price of our Common Stock to decline; research report impacts.

The resale of shares of our Common Stock by the Selling Stockholders in the resale offering could result in resales of our Common Stock by our other shareholders concerned about selling volume. In addition, the resale by the Selling Stockholders after expiration of the lock-up period could have the effect of depressing the market price for our Common Stock.

If securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our Common Stock could be negatively affected.

Any trading market for our Common Stock may be influenced in part by any research reports that securities industry analysts publish about us. We do not currently have and may never obtain research coverage by securities industry analysts. If no securities industry analysts commence coverage of us, the market price and market trading volume of our Common Stock could be negatively affected. In the event we are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage of us, the market price and market trading volume of our Common Stock could be negatively affected.

Our failure to maintain effective internal controls over financial reporting could have an adverse impact on us.

We will be required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment of our internal controls over financial reporting or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. In addition, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be relative to their costs. Because of the inherent limitations in all control systems, no system of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Further, controls can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.

At present, management has identified some material weaknesses in its internal controls. Management has taken initial steps to remedy this weakness by hiring a Chief Financial Officer, a senior accountant and external financial consultants, and plans to continue to add additional resources, technology and headcount as warranted by the growth of the Company and our plans to become a public company. We are also in the process of putting proper policies and procedures in place to ensure proper documentation is established and maintained for transactions that the Company enters into. While we believe these efforts will improve our internal controls and address the underlying causes of the material weaknesses, such material weaknesses will not be remediated until our remediation plan has been fully implemented and we have concluded that our controls are operating effectively for a sufficient period of time. We cannot be certain that the steps we are taking will be sufficient to remediate the control deficiencies that led to our material weaknesses in our internal control over financial reporting or prevent future material weaknesses or control deficiencies from occurring. While we are working to remediate the material weaknesses as timely and efficiently as possible, at this time we cannot provide an estimate of costs expected to be incurred in connection with the implementation of this remediation plan, nor can we provide an estimate of the time it will take to complete this remediation plan. Even if management does establish effective remedial measures, we cannot guarantee that those internal controls and disclosure controls that we put in place will prevent all possible errors, mistakes or all fraud.

Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm our stock price.

We will require significant financial resources to maintain our public reporting status. We cannot assure you we will be able to maintain adequate resources to ensure that we will not have any future material weakness in our system of internal controls. The effectiveness of our controls and procedures may in the future be limited by a variety of factors including:

Our internal control over financial reporting will be a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States of America. Our internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.

Despite these anticipated controls, because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives. Furthermore, smaller reporting companies like us face additional limitations. Smaller reporting companies employ fewer individuals and can find it difficult to employ resources for complicated transactions and effective risk management. Additionally, smaller reporting companies tend to utilize general accounting software packages that lack a rigorous set of software controls.

If we fail to have effective controls and procedures for financial reporting in place, we could be unable to provide timely and accurate financial information and be subject to investigation by the SEC and civil or criminal sanctions.

We must implement additional and expensive procedures and controls in order to grow our business and organization and to satisfy new reporting requirements, which will increase our costs and require additional management resources.

Upon becoming a fully public reporting company, we will be required to comply with the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) and the related rules and regulations of the SEC, including the requirements that we maintain disclosure controls and procedures and adequate internal control over financial reporting. Compliance with the Sarbanes-Oxley Act and other SEC and national exchange requirements will increase our costs and require additional management resources. We plan to begin the process of upgrading our procedures and controls and will need to begin implementing additional procedures and controls as we grow our business and organization and to satisfy new reporting requirements. If we are unable to complete the required assessment as to the adequacy of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act or if we fail to establish and maintain internal control over financial reporting, our ability to produce timely, accurate and reliable periodic financial statements could be impaired.

If we do not establish and maintain adequate internal control over financial reporting, investors could lose confidence in the accuracy of our periodic reports filed under the Exchange Act. Additionally, our ability to obtain additional financing could be impaired or a lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

We are an “emerging growth company” under the JOBS Act of 2012 as well as a “smaller reporting company" under the rules and regulations of the Securities and Exchange Commission and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) as well as a “smaller reporting company” under the rules and regulations of the Securities and Exchange Commission, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” and “smaller reporting companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933 (the “Securities Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition period for complying with new or revised accounting standards.

We will remain an “emerging growth company” until the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act, although we will lose that status sooner if our revenues exceed $1.235 billion, if we issue more than $1 billion in non-convertible debt in a three year period, or if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last day of our most recently completed second fiscal quarter.

We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter.

Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.

Because of the exemptions from various reporting requirements provided to us as an “emerging growth company” and because we will have an extended transition period for complying with new or revised financial accounting standards, we may be less attractive to investors, and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry. If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

Our management team has limited experience managing a public company.

Our management team has limited experience managing a publicly traded company, interacting with public company investors and securities analysts, and complying with the increasingly complex laws pertaining to public companies. These new obligations and constituents require significant attention from our management team and could divert their attention away from the day-to-day management of our business, which could harm our business, results of operations, and financial condition.

We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future. We currently intend to retain any future earnings to support the development of our business and do not anticipate paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our board of directors after taking into account various factors, including, but not limited to, our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. In addition, our ability to pay dividends on our common stock may be limited by Nevada state law. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize a return on their investment. Investors seeking cash dividends should not purchase our common stock.

The elimination of personal liability against our directors and officers under Nevada law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses.

Our articles of incorporation and our bylaws eliminate the personal liability of our directors and officers to us and our stockholders for damages for breach of fiduciary duty as a director or officer to the extent permissible under Nevada law. Further, our articles of incorporation and our bylaws provide that we are obligated to indemnify each of our directors or officers to the fullest extent authorized by Nevada law and, subject to certain conditions, advance the expenses incurred by any director or officer in defending any action, suit or proceeding prior to its final disposition. Those indemnification obligations could expose us to substantial expenditures to cover the cost of settlement or damage awards against our directors or officers, which we may be unable to afford. Further, those provisions and resulting costs may discourage us or our stockholders from bringing a lawsuit against any of our current or former directors or officers for breaches of their fiduciary duties, even if such actions might otherwise benefit our stockholders.

Provisions in Nevada law may have an anti-takeover effect.

Nevada corporate statutes contain provisions designed to protect Nevada corporations and employees from the adverse effects of hostile corporate takeovers. These statutory provisions reduce the possibility that a third party could effect a change in control without the support of our incumbent directors and may also strengthen the position of current management by restricting the ability of shareholders to change the composition of the Board, to affect its policies generally and to benefit from actions that are opposed by the Board.

You should consult your own independent tax advisor regarding any tax matters arising with respect to the securities offered in connection with this offering.

Participation in this offering could result in various tax-related consequences for investors. All prospective purchasers of the resold securities are advised to consult their own independent tax advisors regarding the U.S. federal, state, local and non-U.S. tax consequences relevant to the purchase, ownership and disposition of the resold securities in their particular situations.

IN ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT THE COMPANY’S BUSINESS OPERATIONS AND THE VALUE OF THE COMPANY’S SECURITIES.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this prospectus, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this prospectus relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

USE OF PROCEEDS

We estimate that our net proceeds from the sale of our common stock that we are offering will be approximately $5,941,000 million (or approximately $6,832,150 million if the underwriters’ option to purchase additional shares of our common stock from us is exercised in full), assuming an initial public offering price of $5.00 per share, the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The principal purposes of this offering are to increase our capitalization and financial flexibility, increase our visibility in the marketplace and create a public market for our common stock. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. However, we currently intend to use the net proceeds we receive from this offering during the next 18 months as follows:

The research program at USC is designed to evaluate the use of ACE-167 for Low–T indications such as Klinefelter Syndrome, NAFLD and type 2 diabetes.

Proceeds from this offering may be used to accelerate the listed R&D activities and potentially for exploring and in-licensing other programs which align with the Company’s strategy in the field of low-T. Our expected use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. As a result, we will retain broad discretion in the allocation of the net proceeds from this offering and could utilize the proceeds in ways that do not necessarily improve our results of operations or enhance the value of our common stock.  

DIVIDEND POLICY

We have not declared any cash dividends since inception, and we do not anticipate paying any dividends in the foreseeable future. Instead, we anticipate that all of our earnings will be used to provide working capital, to support our operations, and to finance the growth and development of our business, including potentially the investment in research and development, technologies or services that complement our existing business. The payment of dividends is within the discretion of the Board and will depend on our earnings, capital requirements, financial condition, prospects and applicable Nevada law. There are no restrictions that currently limit our ability to pay dividends on our common stock other than those generally imposed by applicable state law.

CAPITALIZATION

The following table sets forth our consolidated cash and capitalization, as of September [*], 2023. Such information is set forth on the following basis:

You should read the following table in conjunction with “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included in this prospectus. The following table sets forth our cash and cash equivalents and capitalization as of [*], 2023:

⁽¹⁾ Does not include: (a) shares issuable upon the exercise of the underwriter’s option to purchase up to 195,000 additional shares of common stock; and (b) 91,000 shares of our common stock issuable upon exercise of the representative’s warrant (or 104,650 shares of common stock issuable upon exercise of the representative’s warrants shares if the over-allotment option is exercised in full).

DILUTION

Purchasers of our common stock in this offering will experience an immediate and substantial dilution in the as adjusted net tangible book value of their shares of our common stock. Dilution in as adjusted net tangible book value represents the difference between the public offering price per share and the as adjusted net tangible book value per share of our common stock immediately after this offering.

Our historical net tangible book value as of June 30, 2023, was $(1,045,495) or $(0.07) per share. Historical net tangible book value per share of our common stock represents our total tangible assets (total assets less intangible assets) less total liabilities divided by the number of shares of our common stock outstanding as of that date. After giving effect to the sale of 1,300,000 shares (or 1,495,000 shares if the overallotment option is exercised in full) in this offering at an assumed initial public offering price of $5.00 per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, for net proceeds of approximately $5,941,000 (or $6,832,150 if the overallotment option is exercised in full) as if this offering and such share issuances had occurred on June 30, 2023, our pro forma net tangible book value as of June 30, 2023, would have been $4,895,505 (or $5,786,655 if the overallotment option is exercised in full) or approximately $0.30 (or $0.35 if the overallotment option is exercised in full) per share of our common stock. This represents an immediate increase in pro forma, net tangible book value per share of $5,941,000 (or $6,832,150 if the overallotment option is exercised in full) to the existing stockholders and an immediate dilution in pro forma net tangible book value per share of $4.70 (or $4.65 if the overallotment option is exercised in full) to new investors who purchase shares of our common stock in this offering. The following table illustrates this per share dilution to new investors:

After completion of this offering, our existing stockholders would own approximately 92% and our new investors would own approximately 8% of the total number of shares of our common stock outstanding after this offering.

To the extent that outstanding options or warrants are exercised, you will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities may result in further dilution to our stockholders.

The following table sets forth the total number of shares of common stock previously issued and sold to existing investors, the total consideration paid for the foregoing and the average price per share of common stock paid, or to be paid, by existing owners and by the new investors. The calculation below is based on the assumed initial public offering price of $5.00 per share, which is the midpoint of the estimated offering range set forth on the cover page of this prospectus, before deducting estimated underwriter commissions and offering expenses, in each case payable by us, and assumes no exercise of the over-allotment option. 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with “Selected Consolidated Financial Data” and our consolidated financial statements and related notes included elsewhere in this prospectus. This discussion and other parts of this prospectus contain forward-looking statements that involve risks, uncertainties, and assumptions, such as our plans, objectives, expectations, intentions, and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Some of the numbers included herein have been rounded for convenience of presentation. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section “Risk Factors” included elsewhere in this prospectus.

Overview

AHC and its subsidiaries, Acesis UK and ABI, is an emerging pre-phase 1 biotechnology company focused on men’s health. Acesis UK was incorporated in England and Wales on February 4, 2021. ABI was incorporated as a C-corporation in the state of Colorado on March 11, 2015. On April 7, 2021, Acesis UK entered into various share exchange agreements with each shareholder of ABI pursuant to which Acesis UK agreed to issue new ordinary shares in the Acesis UK to the shareholders of ABI, in consideration for shares of common stock of ABI, constituting 100% of the common stock of ABI. Following this share exchange, ABI became a wholly owned subsidiary of Acesis UK. Acesis UK has its primary place of business in London, England and ABI has its primary place of business in Denver, Colorado.  

AHC was incorporated in the State of Nevada on October 3, 2022. Pursuant to a Share Exchange Agreement, dated as of November 15, 2022, among AHC, Acesis UK and all the shareholders of Acesis UK, the Company exchanged shares of its common stock for all the ordinary shares of Acesis UK held by such shareholders, at a ratio of 1 share of AHC’s common stock for each 20 ordinary shares of Acesis UK with the result being that (i) all the ordinary shares of Acesis UK will be held by AHC and (ii) ABI will become an indirect wholly-owned subsidiary of AHC. AHC was established for the sole purpose of acquiring Acesis UK and is jointly controlled by five parties, including the Company’s Directors. The same five parties are deemed to have control of the Company prior to the acquisition and as such, the transaction is deemed to have taken place under common control. As such, the acquisition has been accounted for under merger accounting and no goodwill has been recognized.

Our Historical Performance

We have not generated any revenue to date, and we do not currently have a product ready for sale.

At December 31, 2022, the Company had cash of $150,628. It also had a working capital deficit of $1,407,595 and an accumulated deficit of $17,975,050. This raises substantial doubt about the Company’s ability to continue as a going concern. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the date of the issuance of the Company’s financial statements. The Company received $223,705 in net cash proceeds for the sale of 250,000 shares of its common stock for the year ended December 31, 2022. Additionally, the Company received $200,000 for convertible notes and $100,000 from a note payable. Sales of the Company’s equity instruments will continue as the Company seeks a private placement offering of its common stock, as well as a contemplated public offering. These fundraising efforts may not be successful. While there can be no assurances, management believes that these actions will enable the Company to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

At June 30, 2023, the Company had cash of $247,582, a working capital deficit of $1,045,495 and an accumulated deficit of $18,538,131. This raises substantial doubt about the Company’s ability to continue as a going concern. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the date of the issuance of the Company’s financial statements. The Company received $1,015,285 in net cash proceeds for the sale of 1,110,000 shares of its common stock for the six months ended June 30, 2023. Sales of the Company’s equity instruments will continue as the Company seeks a private placement offering of its common stock, as well as this contemplated public offering. These fundraising efforts may not be successful. While there can be no assurances, management believes that these actions will enable the Company to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

If we are unable to obtain additional financing on a timely basis including further equity offerings as necessary, we may have to curtail our development, and business activities, which would have a material adverse effect on our business, financial condition and results of operations, and ultimately, we could be forced to discontinue our operations and liquidate. See “Liquidity and Capital Resources” below.

Recent Developments

In December 2022 and in 2023, the Company completed four closings as a part of the Company’s pre-IPO financing. AHC has sold a total of 1,402,289 shares at $1.00 per share and received net proceeds of $1,238,990 after fees and commissions. As a part of this sale, the Company issued warrants to the broker for 95,200 shares exercisable for five years at $1.00 per share.

In February 2023, the Company signed an agreement with Freemind Group LLC (“Freemind”) to provide consulting services in identifying grants and assisting the Company in writing the grants. The Company agreed to pay a monthly retainer of $5,000, plus 5% of any award received with the assistance of Freemind. The Company is obligated to pay 12 months of the retainer but may terminate the agreement by providing 30 days written notice.

In May 2023, the Company signed a Master Services Agreement with KreaMedica Inc. (“KreaMedica”) to provide research and development services. The agreement is for 2 years but may be terminated by either party with a 30-day written notice. The Company also signed a Commercial Agreement with KreaMedica for R&D services to complete pre-IND and IND services in order to take advantage of eligible Canadian Tax Credits. The services related to the contract with KreaMedica will be sub-contracted to CROs. This agreement expires June 30, 2024. This agreement is aimed at using KreaMedica’s network to identify and negotiate the optimum pricing and services by CROs, in addition to the Company having support of a project manager and a toxicologist pro-bono. As a result of taking advantage of certain Scientific Research and Experimental Development tax credits, the Company will be reimbursed by KreaMedica as follows, once Study Charges and/or Study Material Costs exceed $600,000:

Also, in May 2023 the Company completed a closing as a part of the Company’s pre-IPO financing. AHC sold 100,000 shares to KreaMedica Holdings Inc. at $1.00 per share and received net proceeds of $91,435 after fees and commissions. As a part of this sale, the Company issued warrants to the broker for 7,000 shares exercisable for five years at $1.00 per share at a fair value of $6,003.

In August 2023, certain officers, directors, founders and Scientific Advisory Board members agreed to forgive certain accrued and unpaid amounts payable to them totaling $934,719. The amounts forgiven will be reflected as a reduction in liabilities and an increase in other income in the financial statements for the nine-month period ending September 30, 2023.

Emerging Growth Company

We qualify as an “emerging growth company” under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

We will remain an emerging growth company for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed $1,235,000,000, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.

Results of Operations

For the year ended December 31, 2022 compared to the year ended December 31, 2021

The following table sets forth key components of our results of operations during the years ended December 31, 2022 and 2021, both in dollars and as a percentage of our revenues.

For the six months ended June 30, 2023 compared to the six months ended June 30, 2022

The following table sets forth key components of our results of operations during the six months ended June 30, 2023 and 2022, both in dollars and as a percentage of our revenues.

Revenues

The Company has no revenues to-date and has no products ready for sale.

General and Administrative and Professional and Consulting Expenses, Related Party

General and administrative expenses for the years ended December 31, 2022 and 2021 consist primarily of professional, legal and accounting fees related to the preparation and filing of a potential public stock offering in the UK (2021) and US (2022), including significant share-based compensation in 2021. General and administrative expenses totaled $702,887 in 2022 and $9,445,681 in 2021, a decrease of $8,742,794. The largest decline was a result of share-based compensation of $72,369 in 2022 compared to $8,354,155 in 2021, a decrease of $8,281,786. We incurred $501,068 in related party professional and consulting expenses in the year ended December 31, 2022 compared to $365,764 in 2021. We expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure and incur additional costs to support the execution of our business plan.

General and administrative expenses for the six months ended June 30, 2023 and 2022 consist primarily of employee compensation and professional, legal and accounting fees related to the preparation and filing of a potential public stock offering in the UK (2022) and US (2023). General and administrative expenses totaled $272,593 in 2023 and $226,453 in 2022, an increase of $46,140. This increase is largely due to legal, audit, accounting, and filing fees for the purpose of completing this initial public offering of our Common Stock and listing such shares on the Nasdaq. We incurred $249,999 in related party professional and consulting expenses in the six months ended June 30, 2023 compared to $250,696 in 2022. Patent-related costs are expensed in general and administrative expenses because there is uncertainty as to the future economic benefit of the asset. We expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure and incur additional costs to support the execution of our business plan.

Research and Development

As noted in General and Administrative section above, the Company’s primary efforts and expenditures for the years ended December 31, 2022 and 2021 were preparing for the filing of potential public stock offerings. Accordingly, expenditures for research and development costs that are charged to operations in the period incurred were limited but expected to increase significantly in the next year. For the years ended December 31, 2022 and 2021, total research and development expenses were $248,952 and $87,500, respectively. In 2022, these expenses included Scientific Advisory Board (“SAB”) fees, and expenses for the Company’s sponsored research agreement with USC. In 2022, these expenses included accrued SAB fees of $100,000, $73,952 recorded for stock issuances to the SAB (a total of $173,952 for the SAB), and $75,000 for the Company’s agreement with USC. In the year ended December 31, 2021, the expenses incurred were only for the accrued SAB fees.

As noted in the General and Administrative section above, the Company’s primary efforts and expenditures in 2023 and 2022 were preparing for the filing of potential public stock offerings. Accordingly, expenditures for research and development costs that are charged to operations in the period incurred were limited but expected to increase significantly in the next year. For the six months ended June 30, 2023 and 2022, total research and development expenses were $126,770 and $50,000 respectively. In 2023, these expenses included accrued SAB fees of $50,000, $21,250 for the Company’s agreement with the Freemind Group, and $55,520 for its agreement with Ardena. In the six months ended June 30, 2022, the expenses were only for the accrued SAB fees.

Interest Expense

For the years ended December 31, 2022 and 2021, the Company recorded interest expense of $127,184 and $46,757, respectively. This included $124,964 and $37,671, respectively, for amortization of debt discount on convertible notes.

For the six months ended June 30, 2023 and 2022, the Company recorded interest expense of $1,480 and $0 related to a note that was repaid.

Other Income (Loss)

As a result of a derivative liability related to a convertible note, the Company recorded a gain of $4,913 in 2022 and a loss of $24,580 on the change in fair value of the derivative liability in 2021.

In March 2021, $224,465 principal of related party notes were converted into 975,935 shares of ABI common stock at $0.23 per share (146,390 shares of AHC). As a result, the Company recognized a loss on debt extinguishment, related party of $238,157. Similarly, a founder converted a $67,950 note payable resulting in a $72,094 loss on debt extinguishment.

In 2021, the Company recorded a gain on debt forgiveness of $314,083 as the result of certain employees and consultants agreeing to forgive accrued amounts due them for previous periods.

The Company recorded a foreign exchange gain of $87,760   in the six months ended June 30, 2023 compared to a foreign exchange loss of $55,842 in the six months ended June 30, 2022. The increase in other income was due to changes in the GBP and USD exchange rates from 2022 to 2023.

Liquidity and Capital Resources

We measure our liquidity in a number of ways, including the following: 

Since our inception, we have not generated any revenues and have funded our operations through the sale of our equity securities and through notes payable. The implementation of our business plan, as discussed in “Business,” will require the receipt of sufficient grant, equity and/or debt financing to purchase necessary technology and materials, fund our research and development efforts, and otherwise fund our operations. We anticipate our business plan will require approximately $5.5 to $7.5 million to fund our anticipated operations for the next 18 to 24 months.

Cash Flow

Net Cash Used in Operating Activities

For the years ended December 31, 2022 and 2021, we experienced negative cash flows from operating activities of $856,703 and $1,250,224, respectively. This is due primarily to a net loss of $1,566,191 and $9,993,899 respectively, in 2022 and 2021. The loss for the years ended December 31, 2022 and 2021 included non-cash expense for share-based compensation of $72,369 and $8,354,155 as a result of stock issued as compensation in 2022 and 2021, a significant decrease.

In January 2022 Acesis UK issued a total of 1,200,000 ordinary shares of its £0.0002 nominal value stock (60,000 shares of AHC) to its independent SAB members including 300,000 shares (15,000 shares of AHC) to each of the four independent SAB members upon execution of new advisory board agreements with these individuals. The shares were valued at £60,000 ($72,369) or £0.05 per share (the price of the most recent third-party share sale in the UK).

The share-based compensation in 2021 was the result of several transactions. In January 2021, the Board of Directors issued 1,000,000 shares of ABI common stock (150,000 shares of AHC) to one of its founding stockholders, SMW, LLC, in compensation recorded at $300,000 (or $0.30 per share that was the price of the most recent third-party stock sale). In March 2021, ABI issued a total of 10,000 shares to a consultant for services rendered (1,500 shares of AHC). The company also issued a total of 15,000 shares to two current stockholders as compensation (2,250 shares of AHC). ABI recorded compensation expense of $7,500 related to these issuances (or $0.30 per share that was the price of the most recent third-party stock sale). In April 2021, ABI issued an aggregate of 26,480,383 shares of common stock to advisors pursuant to services performed in connection with the Exchange Agreement (3,972,062 shares of AHC). The fair value recorded was $7,944,115, or $0.30 per share (the price of the most recent third-party stock sale). In October 2021, Acesis UK issued 1,500,000 ordinary shares (75,000 shares of AHC) to a third-party consultant for services. The fair value of $102,540, or approximately $0.07 (or £0.05) per share (the price of the most recent third-party share sale in the UK).

As of January 1, 2021 there were warrants to purchase 11,740,000 shares of ABI common stock at exercise prices from $0.01 per share to $0.75 per share. In April 2021, ABI warrant holders entered into a Cancellation and Exchange Agreement whereby the ABI warrant holders cancelled their outstanding warrants to purchase 11,740,000 shares of ABI common stock and in exchange received three shares of Acesis UK ordinary shares, or a total of 35,200,000 shares (or 1,761,000 shares of AHC common stock). Accordingly, the only warrants outstanding at December 31, 2022 were warrants to purchase 17,500 shares of AHC common stock issued to the underwriter with an exercise price of $1.00 per share for a period of five (5) years.

In 2021, a loss on debt extinguishment totaling $353,051 was offset by debt forgiveness of $314,083. Prepaid expenses decreased by $80,460 to $4,416 in 2022 from $84,876 in 2021 as prepaid patent legal fees were used during 2022. An increase in accounts payable of $372,575 to $779,853 in 2022 versus $407,278 in 2021 increased due to an increase in general and administrative and research and development costs, this increase reduced the cash used in operating activities in 2022 as compared to 2021. Accrued board fees were $402,471 in 2022 compared to $284,333 in 2021.

For the six months ended June 30, 2023 and 2022, we experienced negative cash flows from operating activities of $728,226 and $352,807, respectively. This is due primarily to a net loss of $563,082 and $582,991 respectively, in the six months ended June 30, 2023 and 2022. The loss for the six months ended June 30, 2023 and 2022 included non-cash expense for share-based compensation of $0 and $72,369, respectively, as a result of stock issued as compensation.

Changes in operating assets and liabilities were ($165,144) in the six months ended June 30, 2023 as compared to $157,815 in 2022. In 2023, the changes in operating assets and liabilities were primarily due to a decrease in accrued salaries of $108,282, a decrease in related parties of $63,528, and a decrease in other current liabilities of $26,825 offset by an increase in accrued SAB fees of $31,862 and accounts payable of $20,447. In 2022, the changes in operating assets and liabilities were primarily due to an increase in accrued salaries of $73,718, an increase in accounts payable of $72,369, and an increase in accrued SAB fees of $50,995, partially offset by a decrease in other current liabilities of $45,644.

We anticipate we will continue to use cash in operating activities in 2023 and for the foreseeable future.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the year ended December 31, 2022 and 2021 totaled $573,705 and $1,631,711, respectively. During the year ended December 31, 2022 AHC sold $300,000 shares of common stock in a private placement for net cash proceeds of $273,705. During 2022, the Company also received $200,000 in convertible note proceeds. These were converted to common stock during the year. The Company also received $100,00 from a note payable that remained outstanding at December 31, 2022 and was repaid in 2023. During the year ended December 31, 2021, Acesis UK sold, in a private placement, issuing 25,641,580 shares of ordinary shares at for net proceeds of $1,729,711. This was offset by payment of a related party note payable balance of $98,000 in 2021. We will continue to seek additional funding through private placements and other funding sources for the foreseeable future.

Net cash provided by financing activities for the six months ended June 30, 2023 totaled $1,015,285 in net cash proceeds for the sale of 1,110,000 shares of its common stock. During the six months ended June 30, 2023 the Company repaid its $100,000 note payable. We will continue to seek additional funding through private placements and other funding sources for the foreseeable future.

Contractual Obligations

Effective April 2018, the Company signed an amended and restated license agreement for intellectual property with The Royal Institution for the Advancement of Learning/McGill University (“McGill”) in Canada covering the Company’s potential products. The Company had previously executed an assignment agreement with McGill University pursuant to which the Company acquired the entire right, title, interest, property and benefit in and for Canada, and all other countries in the world, in and to the inventions held by McGill for the subject matter of Patent Families I and II. The payment obligations below commenced in April 2018 and will terminate on the twentieth anniversary therefrom.

The Company must pay minimum royalties of $5,000 per year beginning on the date of the first commercialization of the first product developed using the patents covered by the license/assignment agreement. If the Company is required to obtain a license from a third party for the commercialization of a product using Family I or II patents the royalty will be reduced by the rate paid for the their-party license up to an amount not exceeding 50% of the royalty paid to McGill. Additionally, for each of the Company’s potential products, it must pay 3% of annual net revenues, with a minimum royalty of CAD $5,000 per year starting on the date of commercialization of the first product developed using the intellectual property covered by the license/assignment agreement (patent Families I & II); or a 12% payment for any licensing revenue in the event the Company licenses its products to a third party.

ABI must pay milestone payments for the androgen replacement treatment as follows:

ABI must also pay milestone payments as follows for an in-vitro test to identify Alzheimer’s disease as follows, should it be developed or licensed out in the future:

ABI has no plans currently to perform any research and development or use any funds related to this Alzheimer’s agreement. In addition, ABI issued 5% of the total number of issued and outstanding shares in the Company’s Series A financing to the same institution, or 1,652,632 shares in March 2016 (247,895 shares of AHC). This agreement, payable in Canadian dollars, exposes ABI to foreign exchange transaction gains and losses. In August 2016, ABI issued an additional 300,000 shares of ABI common stock (45,000 shares of AHC) to McGill in lieu of the pre-existing anti-dilution provision. As of March 31, 2023, none of the milestones have been hit so no additional amounts have been earned or are payable.

Scientific Advisory Board – Our scientific advisory board (SAB) further strengthens our experience base and includes key contributors as well as thought leaders providing complementary expertise to our current preclinical and future clinical research efforts. Members of the SAB are involved in the following top-level activities in relation to the advancement of Acesis product candidate pipeline in the field of low-T and related co-morbidities. 

More specifically SAB members will: