SEC Info - Advaxis, Inc. - ‘10-Q’ for 7/31/22

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		Alternative Formats (Word, et al.) Condensed Consolidated Balance Sheets Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Operations Controls and Procedures Exhibits Financial Information Financial Statements (unaudited) Legal Proceedings Management's Discussion and Analysis of Financial Condition and Results of Operations Notes to the Condensed Consolidated Financial Statements Other Information Quantitative and Qualitative Disclosures About Market Risk Risk Factors Signatures
1	1st Page – Filing Submission
"	Financial Information
"	Financial Statements (unaudited)
"	Condensed Consolidated Balance Sheets
"	Condensed Consolidated Statements of Operations
"	Condensed Consolidated Statements of Cash Flows
"	Notes to the Condensed Consolidated Financial Statements
"	Management's Discussion and Analysis of Financial Condition and Results of Operations
"	Quantitative and Qualitative Disclosures About Market Risk
"	Controls and Procedures
"	Other Information
"	Legal Proceedings
"	Risk Factors
"	Exhibits
"	Signatures

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i ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

i ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such fling requirements for the past 90 days. i Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). i Yes ☒ No ☐

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ i No ☒

The number of shares of the registrant’s Common Stock, $0.001 par value, outstanding as of September 9, 2022 was i 1,815,951.

This quarterly report on Form 10-Q (“Form 10-Q”) of Advaxis, Inc. (the “Company”) includes statements that are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, these forward-looking statements can be identified by the use of such terms as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or the negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this Form 10-Q and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned discovery and development of drug candidates, the strength and breadth of our intellectual property, our ongoing and planned preclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree of clinical utility of our product candidates, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, our available cash, liquidity, prospects, growth and strategies, impacts of the ongoing coronavirus (“COVID-19”) pandemic, the ongoing conflict in the Ukraine, inflation and the Federal Reserve’s responses thereto, including increasing interest rates, the length of time that we will be able to continue to fund our operating expenses and capital expenditures, our expected financing needs and sources of financing, the industry in which we operate and the trends that may affect our industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to the occurrence and timing of events or circumstances, many of which are beyond the control of the Company. As a result of these, we cannot assure you that the forward-looking statements in this Form 10-Q will prove to be accurate. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this Form 10-Q. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate, are consistent with the forward-looking statements contained in this Form 10-Q, they may not be predictive of results or developments in future periods.

Some of the material factors that we believe could cause actual results to differ from those anticipated or predicted include:

You should also read carefully the factors described in the “Risk Factors” section of the 2021 Annual Report on Form 10-K. Any forward-looking statements that we make in this Form 10-Q speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Form 10-Q except as required by the federal securities laws.

This Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data.

The accompanying notes should be read in conjunction with the financial statements.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results indicated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in Part I Item 1A. “Risk Factors” in our 2021 Annual Report on Form 10-K, below in Part II Item 1A. “Risk Factors” of this Form 10-Q and in the “Cautionary Note Regarding Forward-Looking Statements” set forth at the beginning of this report.

You should read the following discussion and analysis in conjunction with the unaudited financial statements, and the related footnotes thereto, appearing elsewhere in this Form 10-Q, and in conjunction with management’s discussion and analysis and the audited financial statements included in our Annual Report on Form 10-K. In addition, we intend to use our media and investor relations website (www.advaxis.com/investor-relations), SEC filings, press releases, public conference calls and webcasts to communicate with the public about Advaxis, its services and other issues.

Advaxis, Inc. (“Advaxis” or the “Company”) is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm Technology antigen delivery products based on a platform technology that utilizes live attenuated Listeria monocytogenes, or Lm, bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate anti-tumor T cell immunity, stimulate and activate the innate immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the Tumor Microenvironment, or TME, to enable the T cells to attack tumor cells.

The Company believes that Lm Technology immunotherapies can complement and address significant unmet needs in the current oncology treatment landscape. Specifically, our product candidates (i.e., ADXS-PSA, ADXS-503 and ADXS-504) have the potential to optimize, enhance checkpoint performance of other oncology treatments, while having a generally well-tolerated safety profile.

Advaxis is currently winding down or has wound down clinical studies of Lm Technology immunotherapies in three program areas:

All these clinical program areas are anchored in the Company’s Lm Technology^TM, a unique platform designed for its ability to safely and effectively target various cancers in multiple ways. While we are currently winding down clinical studies of Lm Technology immunotherapies in these three program areas, our license agreements continue with OS Therapies, LLC for ADXS-HER2 and with Global BioPharma, or GBP, for the exclusive license for the development and commercialization of ADXS-HPV, or AXAL, in Asia, Africa, and the former USSR territory, exclusive of India and certain other countries.

In response to the ongoing novel coronavirus (“COVID-19”) pandemic, the Company implemented remote working and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development or drug production of our drug candidates by third parties. We continue to monitor the COVID-19 pandemic and take steps intended to mitigate the potential risks to our workforce and our operations. The COVID-19 pandemic has, and may continue to, directly or indirectly affect the pace of enrollment in our clinical trials as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no longer get to the clinic. Nonetheless, thus far, the COVID-19 pandemic has not had a significant impact on our business or results of operations. However, we remain in contact with the clinical sites in our study and are in discussion with additional sites to combat any potential impact in enrollment. We are unable to determine or predict the extent, duration or scope of the overall impact of the COVID-19 pandemic on our business, operations, financial condition or liquidity.

Revenue was $0 for the three months ended July 31, 2022 compared to $250,000 for the three months ended July 31, 2021. In the prior period, we received the annual licensing fee from GBP.

We invest in research and development to advance our Lm technology through our pre-clinical and clinical development programs. Research and development expenses for the three months ended July 31, 2022 and July 31, 2021 were categorized as follows (in thousands):

Research and development costs associated with our hotspot mutation-based therapy for the three months ended July 31, 2022 increased approximately 133% to $1,271,000 compared to the same period in 2021. The increase is attributable to patient recruitment costs and manufacturing costs pertaining to the ADXS-503 study incurred in the current period.

Research and development costs associated with our prostate cancer therapy for the three months ended July 31, 2022 decreased 72% to $32,000 compared to the same period in 2021. The study has been completed and we do not anticipate that we will continue to incur significant costs associated with the wind down of the study.

The majority of the HPV-associated research and development costs include clinical trial and other related costs associated with our AXAL programs in cervical and head and neck cancers. HPV-associated costs for the three months ended July 31, 2022 decreased approximately $173,000, or 41%, compared to the same period in 2021. The decrease is attributable to wind down costs associated with the closure of our Phase 3 AIM2CERV study in high-risk locally advanced cervical cancer. We do not anticipate that we will continue to incur significant costs associated with the wind down of our Phase 3 AIM2CERV study.

Research and development costs associated with personalized neoantigen-directed therapies for the three months ended July 31, 2022 decreased approximately $7,000 compared to the same period in 2021. The study has been completed and we do not anticipate that we will continue to incur significant costs associated with the wind down of the study.

General and administrative expenses primarily include salary and benefit costs and stock-based compensation expense for employees included in our finance, legal and administrative organizations, outside legal and professional services, and facilities costs. General and administrative expenses for the three months ended July 31, 2022 and July 31, 2021 were as follows (in thousands):

General and administrative expenses for the three months ended July 31, 2022 decreased approximately $625,000, or 23%, compared to the same period in 2021. This decrease primarily relates to (1) legal and consulting fees related to the Previously Proposed Merger in the prior period and (2) the annual meeting proxy solicitation fees in the prior period. Those decreases were partially offset by an increase in amounts paid in settlement of shareholder demand letters in the current period.

During the three months ended July 31, 2022, the Company recorded an impairment charge under ASC 350 for its patents owned and in-licensed intellectual property of approximately $3,005,000.

For the three months ended July 31, 2022, we recorded non-cash income from changes in the fair value of derivative liabilities of approximately $276,000. The decrease in the derivative liabilities is attributable to a decrease in our share price from $6.56 at April 30, 2022 to $3.73 at July 31, 2022.

For the three months ended July 31, 2021, we recorded non-cash income from changes in the fair value of the warrant liability of approximately $0.8 million. The decrease in the fair value of liability warrants resulted from resulted from a decrease in our share price from $0.49 at April 30, 2021 to $0.41 at July 31, 2021.

Revenue was $250,000 for the nine months ended July 31, 2022 compared to $3,240,000 for the nine months ended July 31, 2021. In the prior period, we recognized royalty payments from OST.

We invest in research and development to advance our Lm technology through our pre-clinical and clinical development programs. Research and development expenses for the nine months ended July 31, 2022 and July 31, 2021 were categorized as follows (in thousands):

Research and development costs associated with our hotspot mutation-based therapy for the nine months ended July 31, 2022 increased approximately 22% to $3,076,000 compared to the same period in 2021. The increase is attributable to patient recruitment costs and manufacturing costs pertaining to the HOT-503 study incurred in the current period.

Research and development costs associated with our prostate cancer therapy for the nine months ended July 31, 2022 decreased approximately $122,000, or 59%, compared to the same period in 2021. The study has been completed and we do not anticipate that we will continue to incur significant costs associated with the wind down of the study.

The majority of the HPV-associated research and development costs include clinical trial and other related costs associated with our AXAL programs in cervical and head and neck cancers. HPV-associated costs for the nine months ended July 31, 2022 decreased approximately $1,533,000, or 82%, compared to the same period in 2021. The decrease is attributable to wind down costs associated with the closure of our Phase 3 AIM2CERV study in high-risk locally advanced cervical cancer. We do not anticipate that we will continue to incur significant costs associated with the wind down of our Phase 3 AIM2CERV study.

Research and development costs associated with personalized neoantigen-directed therapies for the nine months ended July 31, 2022 decreased approximately $392,000, or 98%, compared to the same period in 2021. The study has been completed and we do not anticipate that we will continue to incur significant costs associated with the wind down of the study.

Other expenses include salary and benefit costs, stock-based compensation expense, professional fees, laboratory costs and other internal and external costs associated with our research & development activities. Other expenses for the nine months ended July 31, 2022 decreased approximately $1,743,000, or 48%, compared to the same period in 2021. The decrease is attributable to (1) prior period losses on disposal of property and equipment in connection with the termination of our office lease at our former location, (2) decrease in personnel costs due to decreases in headcount, stock compensation and bonus accruals, and (3) decrease in depreciation expense.

General and administrative expenses primarily include salary and benefit costs and stock-based compensation expense for employees included in our finance, legal and administrative organizations, outside legal and professional services, and facilities costs. General and administrative expenses for the nine months ended July 31, 2022 and July 31, 2021 were as follows (in thousands):

General and administrative expenses for the nine months ended July 31, 2022 decreased approximately $2,707,000, or 30%, compared to the same period in 2021. This decrease primarily relates to (1) legal and consulting fees related to the Previously Proposed Merger in the prior period, (2) prior period losses on disposal of property and equipment in connection with the termination of our office lease at our former location, (3) prior period sublicense fees paid to the University of Pennsylvania for the OST milestones reached, (4) decrease in personnel costs due to decreases in stock compensation and bonus accruals, and (5) decreases in rent, utilities and depreciation due to the termination of our office lease at our former location. These decreases were partially offset by (1) an increase in proxy solicitation fees related to the Previously Proposed Merger and the reverse stock split and (2) an increase in amounts paid in settlement of shareholder demand letters in the current period.

During the nine months ended July 31, 2022, the Company recorded an impairment charge under ASC 350 for its patents owned and in-licensed intellectual property of approximately $3,005,000.

For the nine months ended July 31, 2022, we recorded non-cash income from changes in the fair value of derivative liabilities of approximately $4,685,000. The decrease in the derivative liabilities was attributable to a decrease in our share price from $38.80 at October 31, 2021 to $3.73 at July 31, 2022.

For the nine months ended July 31, 2021, we recorded non-cash income from changes in the fair value of the warrant liability of approximately $1,814,000. The decrease in the fair value of liability warrants resulted primarily from the issuance of warrants in the April 2021 Private Placement. The warrants issued in the April 2021 Private Placement had a decrease in fair value of approximately $1,821,000 from date of issuance to July 31, 2021, which resulted from a decrease in our share price from $45.60 at April 14, 2021 to $32.80 at July 31, 2021.

Similar to other development stage biotechnology companies, our products that are being developed have not generated significant revenue. As a result, we have historically suffered recurring losses and we have required significant cash resources to execute our business plans. These losses are expected to continue for the foreseeable future.

Historically, the Company’s major sources of cash have comprised proceeds from various public and private offerings of its securities (including common stock), debt financings, clinical collaborations, option and warrant exercises, income earned on investments and grants, and interest income. From October 2013 through July 31, 2022, the Company raised approximately $339.4 million in gross proceeds from various public and private offerings of our common stock. The Company has sustained losses from operations in each fiscal year since our inception, and we expect losses to continue for the indefinite future. As of July 31, 2022 and October 31, 2021, the Company had an accumulated deficit of approximately $438.4 million and $428.6 million, respectively, and stockholders’ equity of approximately $28.2 million and $38.9 million, respectively.

The COVID-19 pandemic has created significant volatility and disruption of financial markets. An extended period of economic disruption could negatively affect the Company’s business, financial condition, and access to sources of liquidity. As of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents. The actual amount of cash that the Company will need to continue operating is subject to many factors.

The Company recognizes that it will need to raise additional capital in order to continue to execute its business plan in the future. There is no assurance that additional financing will be available when needed or that the Company will be able to obtain financing on terms acceptable to it or whether the Company will become profitable and generate positive operating cash flow. If the Company is unable to raise sufficient additional funds, it will have to further scale back its operations. The Company believes it has sufficient capital to fund its obligations, as they become due, in the ordinary course of business into the third fiscal quarter of 2024. The Company based this estimate on assumptions that may prove to be incorrect, and we could use available capital resources sooner than currently expected.

Net cash used in operating activities includes spending associated with our clinical trial programs and general and administrative activities. Net cash used in operating activities was approximately $12,307,000 for the nine months ended July 31, 2022 compared to $11,703,000 for the nine months ended July 31, 2021. The variance is due to fluctuations in cash collected from revenue generated, as well as timing of disbursements relating to accounts payable and accrued expenses.

Net cash used in investing activities was approximately $201,000 for nine months ended July 31, 2022 compared to $104,000 for the nine months ended July 31, 2021. The decrease is the result of proceeds on a prior period disposal of property and equipment partially offset by reductions in purchases for intangible assets.

Net cash used in financing activities was approximately $956,000 for the nine months ended July 31, 2022 compared to net cash provided by financing activities of $31,886,000 for the nine months ended July 31, 2021. On January 31, 2022, the Company closed on an offering with certain institutional investors for the private placement of 1,000,000 shares of Series D Preferred Stock. The shares sold had an aggregate stated value of $5,000,000. Each share of the Series D Preferred Stock was sold for a purchase price of $4.75, representing an original issue discount of 5% of the stated value. Total net proceeds from the offering, after deducting the financial advisor’s fees and other estimated offering expenses, were approximately $4.3 million. The Series D preferred stock also had a liquidation preference over the shares of common stock, and could be redeemed by the investors, in accordance with certain terms, for a redemption price equal to 105% of the stated value, or in certain circumstances, 110% of the stated value. On April 6, 2022, the holders of all 1,000,000 outstanding shares of the Series D Preferred Stock exercised their right to cause the Company to redeem all of such shares at a price per share equal to 105% of the stated value per share of $5.00, and such shares were redeemed accordingly.

In November 2020, the Company closed on a public offering of 383,333 shares of its common stock at a public offering price of $24.00 per share. After deducting the underwriting discounts and commissions and other offering expenses, the net proceeds from the offering were approximately $8.5 million. In addition, the Company also undertook a concurrent private placement of warrants to purchase up to 191,667 shares of common stock. The warrants have an exercise price per share of $28.00, are exercisable immediately and will expire five years from the date of issuance.

On April 12, 2021, the Company completed an offering of (i) 219,718 shares of common stock, (ii) 95,899 pre-funded warrants to purchase 95,899 shares of common stock and (iii) registered common share purchase warrants to purchase 140,552 shares of common stock with two healthcare focused, institutional investors. The Company also issued to the investors, in a concurrent private placement, unregistered common share purchase warrants to purchase 175,065 shares of the Company’s common stock. We received gross proceeds of approximately $20 million, before deducting the fees and expenses payable by us in connection with the offering.

During the nine months ended July 31, 2021, warrant holders from the Company’s November 2020 and April 2021 offerings exercised 230,343 warrants in exchange for 230,343 shares of the Company’s common stock. Pursuant to these warrant exercises, the Company received aggregate proceeds of approximately $3.8 million.

The preparation of condensed financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and income and expenses during the periods reported. Actual results could materially differ from those estimates. We have identified the following critical accounting estimates:

We account for our warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for liability classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

Some of our warrants meet the criteria as liability classified derivative instruments and are recorded at fair value on the grant date and re-valued at each reporting date, with changes in the fair value reported in the statements of operations. Warrant liabilities are classified on the balance sheet as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date. Volatility in our common stock may result in significant changes in the value of the warrant liabilities and resulting gains and losses on our condensed consolidated statement of operations.

Intangible assets primarily consist of legal and filing costs associated with obtaining patents and licenses and are amortized on a straight-line basis over their remaining useful lives which are estimated to be twenty years from the effective dates of the University of Pennsylvania (Penn) License Agreements, beginning in July 1, 2002. These legal and filing costs are invoiced to the Company through Penn and its patent attorneys.

Management reviews its long-lived assets for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. Net assets are recorded on the balance sheet for patents related to ADXS-HPV (AXAL), ADXS-HOT, ADXS-PSA, ADXS-HER2 and other products that are in development, and the Lm technology licensed from the University of Pennsylvania. There are various scenarios under which an impairment charge may be recorded, which include if a competitor were to gain FDA approval for a similar treatment before the Company, if future clinical trials fail to meet the targeted endpoints, or if a drug application is rejected or fails to be issued. Lastly, if the Company is unable to raise enough capital to continue funding its studies and developing its intellectual property, the Company would likely record an impairment to these assets.

Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying condensed consolidated financial statements.

At July 31, 2022, we had approximately $28.2 million in cash and cash equivalents, which consisted primarily of bank deposits and money market funds. Our investment policy and strategy are focused on preservation of capital and supporting our liquidity requirements. We use a combination of internal and external management to execute our investment strategy and achieve our investment objectives. We typically invest in highly-rated securities (such as money market funds), and our investment policy generally limits the amount of credit exposure to any one issuer. The policy requires investments generally to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations of interest income have not been significant.

We have not been exposed nor do we anticipate being exposed to material risks due to changes in interest rates. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our financial statements.

As of the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of our chief executive officer and interim principal financial officer of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (“the Exchange Act”). Based upon this evaluation, our chief executive officer and principal financial officer concluded that our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is: (1) accumulated and communicated to our management, including our chief executive officer, as appropriate to allow timely decisions regarding required disclosure; and (2) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.

During the quarter ended July 31, 2022, there were no changes in our internal control over financial reporting that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Our management, including our Principal Executive, Financial and Accounting Officers, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent all errors and all fraud. 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. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected.

The Company is from time to time involved in legal proceedings in the ordinary course of our business. The Company does not believe that any of these claims or proceedings against us is likely to have, individually or in the aggregate, a material adverse effect on the financial condition or results of operations. For more information regarding legal proceedings involving the Company, please see Note 8 – Commitments and Contingencies to our condensed consolidated financial statements.

We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, an ongoing military conflict between Russia and Ukraine, and record inflation. Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine, geopolitical tensions, or record inflation.

U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. On February 24, 2022, a full-scale military invasion of Ukraine by Russian troops was reported. Although the length and impact of the ongoing military conflict is highly unpredictable, the conflict in Ukraine has led to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions, which has caused record inflation globally. We are continuing to monitor the situation in Ukraine and globally and assessing its potential impact on our business.

Although, to date, our business has not been materially impacted by the ongoing military conflict between Russian and Ukraine, geopolitical tensions, or record inflation, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which the conflict in Ukraine, geopolitical tensions, or record inflation may impact our business. The extent and duration of the conflict in Ukraine, geopolitical tensions, record inflation and resulting market disruptions are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in our 2021 Annual Report.

All terms not defined herein shall have the meanings ascribed in Mr. Berlins Employment Agreement, dated as of April 10, 2018 (the “Employment Agreement”).

On September 12, 2022, the Company and Mr. Berlin entered into Amendment No. 1 to his Employment Agreement. Under the terms of Amendment No. 1, the multiplier applicable to his annual Base Salary and target Bonus Percentage that Mr. Berlin would receive if his employment were terminated without Just Cause, or he terminated his employment for Good Reason during the period three months prior and 18 months following a Change of Control (such period, the “CIC Protection Period”), is being increased from 1.75 to 2, with such amount to be payable in a single lump sum within sixty (60) days of the termination. In addition, the number of months for which he would receive continued health and welfare benefits is increased from 21 months to 24 months. Amendment No. 1 further provides, that in the event Mr. Berlin’s employment were terminated without Just Cause, or he terminated his employment for Good Reason, other than during the CIC Protection Period, he would receive equal monthly installments of 1.25 times his applicable Base Salary (increased from 1.0 times), and that he would receive this amount for 15 months rather than 12. In addition, the number of months for which he would receive continued health and welfare benefits in this circumstance is increased from 12 months to 15 months.

A copy of Amendment No. 1 is filed herewith as Exhibit 10.1 and the foregoing description of the Amendment No. is qualified in its entirety by reference thereto and the Employment Agreement filed as Exhibit 10.1 on to the Form 8-K filed on April 23, 2018.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereto duly authorized.

i Delaware		i 02-0563870
(State or other jurisdiction		(IRS Employer
of incorporation or organization)		Identification No.)

i 9 Deer Park Drive, i Suite K-1, i Monmouth Junction, i NJ		i 08852
(Address of principal executive offices)		(Zip Code)

	●	the success and timing of our clinical trials, including patient accrual;

	●	our ability to obtain and maintain regulatory approval or reimbursement of our product candidates for marketing;

	●	our ability to obtain the appropriate labeling of our products under any regulatory approval;

	●	our ability to develop and commercialize our products;

	●	the successful development and implementation of our sales and marketing campaigns;

	●	the change of key scientific or management personnel;

	●	the size and growth of the potential markets for our product candidates and our ability to serve those markets;

	●	our ability to successfully compete in the potential markets for our product candidates, if commercialized;

	●	regulatory developments in the United States and foreign countries;

	●	new products, product candidates or new uses for existing products or technologies introduced or announced by our competitors and the timing of these introductions or announcements;

	●	market conditions in the pharmaceutical and biotechnology sectors;

	●	our available cash;

	●	the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

	●	our ability to obtain additional funding;

	●	any outcomes from our review of strategic transactions and options to maximize stockholder value;

	●	the ability of our product candidates to successfully perform in clinical trials and to resolve any clinical holds that may occur;

	●	our ability to obtain and maintain approval of our product candidates for trial initiation;

	●	the performance of third-party manufacturers;

	●	our ability to identify license and collaboration partners and to maintain existing relationships;

	●	the performance of our clinical research organizations, clinical trial sponsors, clinical trial investigators and collaboration partners for any clinical trials we conduct;

	●	our ability to successfully implement our strategy;

	●	our ability to maintain the listing of our common stock on the OTCQX® Best Market (“OTCQX”); and

	●	the factors described in the “Risk Factors” section of the Company’s annual report on Form 10-K for the fiscal year ended October 31, 2021 (the “2021 Annual Report on Form 10-K”), as updated and amended in other filings by the Company with the Securities and Exchange Commission (the “SEC”).

	July 31, 2022			October 31, 2021
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	i 28,150		$	i 41,614
Prepaid expenses and other current assets		i 1,667			i 1,643
Total current assets		i 29,817			i 43,257

Property and equipment (net of accumulated depreciation)		i 73			i 118
Intangible assets (net of accumulated amortization)		i 181			i 3,354
Operating right-of-use asset (net of accumulated amortization)		i 19			i 40
Other assets		i 11			i 11
Total assets	$	i 30,101		$	i 46,780

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	i 90		$	i 87
Accrued expenses		i 1,510			i 2,836
Current portion of operating lease liability		i 19			i 28
Common stock warrant liability		i 287			i 4,929
Total current liabilities		i 1,906			i 7,880

Operating lease liability, net of current portion		-			i 12
Total liabilities		i 1,906			i 7,892

Contingencies – Note 8		-			-

Series D convertible preferred stock- $ i i 0.001 / par value; i i 0 / shares authorized, i i i i 0 / / / shares issued and outstanding at July 31, 2022 and October 31, 2021.		-			-

Stockholders’ equity:
Preferred stock, $ i i 0.001 / par value; i i 5,000,000 / shares authorized, i i i i 0 / / / shares issued and outstanding at July 31, 2022 and October 31, 2021.		-			-
Common stock - $ i i 0.001 / par value; i i 170,000,000 / shares authorized, i i 1,815,951 / and i i 1,820,452 / shares issued and outstanding at July 31, 2022 and October 31, 2021.		i 2			i 2
Additional paid-in capital		i 466,561			i 467,486
Accumulated deficit		( i 438,368	)		( i 428,600	)
Total stockholders’ equity		i 28,195			i 38,888
Total liabilities and stockholders’ equity	$	i 30,101		$	i 46,780

	2022			2021
	Nine Months Ended July 31,
	2022			2021

OPERATING ACTIVITIES
Net loss	$	( i 9,768	)	$	( i 12,418	)
Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation		i 74			i 511
Gain on change in value of warrants		( i 4,642	)		( i 1,814	)
Gain on change in value of preferred stock redemption liability		( i 43	)		-
Loss on disposal of property and equipment		-			i 1,530
Abandonment of intangible assets		i 159			i 90
Impairment charges on intangible assets		i 3,005			-
Depreciation expense		i 45			i 366
Amortization expense of intangible assets		i 210			i 203
Amortization of right-of-use asset		i 21			i 327
Net gain on write-off of right-of-use asset and lease liability		-			( i 116	)
Change in operating assets and liabilities:
Prepaid expenses, other current assets and deferred expenses		( i 24	)		i 488
Other assets		-			i 171
Accounts payable and accrued expenses		( i 1,323	)		i 513
Deferred revenue		-			( i 165	)
Operating lease liabilities		( i 21	)		( i 1,389	)
Net cash used in operating activities		( i 12,307	)		( i 11,703	)

INVESTING ACTIVITIES
Proceeds from disposal of property and equipment		-			i 219
Cost of intangible assets		( i 201	)		( i 323	)
Net cash used in investing activities		( i 201	)		( i 104	)

FINANCING ACTIVITIES
Net proceeds of issuance of Series D preferred stock		i 4,312			-
Net proceeds of issuance of common stock and warrants		-			i 28,115
Fractional shares cashed out		( i 18	)		-
Redemption of Series D preferred stock		( i 5,250	)		-
Warrant exercises		-			i 3,771
Net cash (used in) provided by financing activities		( i 956	)		i 31,886

Net (decrease) increase in cash and cash equivalents		( i 13,464	)		i 20,079
Cash and cash equivalents at beginning of period		i 41,614			i 25,178
Cash and cash equivalents at end of period	$	i 28,150		$	i 45,257

SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for taxes	$	i 50		$	i 50

SUPPLEMENTAL DISCLOSURE OF NON-CASH AND FINANCING ACTIVITIES
Reclassification of preferred stock redemption liability into equity upon redemption of preferred stock		i 44			-
Accretion of discount and redemption feature of convertible preferred stock		i 1,025			-

Advaxis, Inc. – ‘10-Q’ for 7/31/22

On: Monday, 9/12/22, at 6:25pm ET · As of: 9/13/22 · For: 7/31/22 · Accession #: 1493152-22-25666 · File #: 1-36138

Previous ‘10-Q’: ‘10-Q’ on 6/8/22 for 4/30/22 · Next: ‘10-Q’ on 5/23/23 for 3/31/23 · Latest: ‘10-Q’ on 11/20/23 for 9/30/23 · 4 References:

Quarterly Report — Form 10-Q

Filing Table of Contents

‘10-Q’ — Quarterly Report

Document Table of Contents

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Dates Referenced Herein and Documents Incorporated by Reference

4 Subsequent Filings that Reference this Filing

Large Accelerated Filer	☐	Accelerated Filer	☐
i Non-accelerated Filer	☒	Smaller Reporting Company	i ☒
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		Page No.

PART I	FINANCIAL INFORMATION	5

Item 1.	Financial Statements (unaudited)	5

	Condensed Consolidated Balance Sheets	5

	Condensed Consolidated Statements of Operations	6

	Condensed Consolidated Statements of Cash Flows	7

	Notes to the Condensed Consolidated Financial Statements	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	28

PART II	OTHER INFORMATION	29

Item 1.	Legal Proceedings	29

Item 1A.	Risk Factors	29

Item 5.	Other Information	29

Item 6.	Exhibits	29

SIGNATURES		30

	●	Alerting and training the immune system by activating multiple pathways in Antigen-Presenting Cells (“APCs”) with the equivalent of multiple adjuvants;

	●	Attacking the tumor by generating a strong, cancer-specific T cell response; and

	●	Breaking down tumor protection through suppression of the protective cells in the tumor microenvironment (“TME”) that shields the tumor from the immune system. This enables the activated T cells to begin working to attack the tumor cells.

	2022		2021
	As of July 31,
	2022		2021
Warrants		i 377,818		i 377,818
Stock options		i 11,118		i 12,892
Total		i 388,936		i 390,710

	July 31, 2022			October 31, 2021
Laboratory equipment	$	i 179		$	i 179
Computer equipment		i 241			i 241
Total property and equipment		i 420			i 420
Accumulated depreciation		( i 347	)		( i 302	)
Net property and equipment	$	i 73		$	i 118

	July 31, 2022			October 31, 2021

Patents	$	i 275		$	i 4,836
License		i 44			i 777
Software		i 98			i 98
Total intangibles		i 417			i 5,711
Accumulated amortization		( i 236	)		( i 2,357	)
Intangible assets	$	i 181		$	i 3,354

	●	Adverse changes in the business climate for biotechnology companies, particularly raising capital; and
	●	A significant reduction in the Company’s market capitalization during the nine months ended July 31, 2022.

	Fiscal year ending October 31,

2022 (Remaining)	$	i 24
2023		i 94
2024		i 63
Total	$	i 181

	July 31, 2022		October 31, 2021

Salaries and other compensation	$	i 116	$	i 55
Vendors		i 851		i 1,968
Professional fees		i 343		i 613
Other		i 200		i 200
Total accrued expenses	$	i 1,510	$	i 2,836

	July 31, 2022		October 31, 2021
Operating leases:
Operating lease right-of-use assets	$	i 19	$	i 40

Operating lease liability	$	i 19	$	i 28
Operating lease liability, net of current portion		-		i 12
Total operating lease liabilities	$	i 19	$	i 40

Lease Cost (in thousands)	Statements of Operations Classification	For the Three Months Ended July 31, 2022		For the Nine Months Ended July 31, 2022
Operating lease cost	General and administrative	$	i 7	$	i 22
Variable lease cost	General and administrative		i 17		i 36
Total lease expense		$	i 24	$	i 58

	July 31, 2022			October 31, 2021
Weighted-average remaining lease term	i 0.7 years			i 1.4 years
Weighted-average discount rate		i 3.79	%		i 3.79	%

Exercise Price		Number of Shares Underlying Warrants		Expiration Date	Type of Financing
$	i i 20.00 /		i i 879 /	i i September 2024 /	i i September 2018 Public Offering /
$	i i 224.00 /		i i 4,092 /	i i July 2024 /	i i July 2019 Public Offering /
$	i i 28.00 /		i i 57,230 /	i i November 2025 /	i i November 2020 Public Offering /
$	i i 56.00 /		i i 140,552 /	i i April 2026 /	i i April 2021 Registered Direct Offering (Accompanying Warrants) /
$	i i 56.00 /		i i 175,065 /	i i 5 years after the date such warrants become exercisable, if ever /	i i April 2021 Private Placement (Private Placement Warrants) /
	Grand Total		i i 377,818 /

	April 6, 2022			January 31, 2022
Exercise Price	$	i 20.00		$	i 20.00
Stock Price	$	i 9.04		$	i 10.88
Volatility %		i 96	%		i 105	%
Risk Free Rate		i 1.25	%		i 1.00	%

	●	Human Papilloma Virus (“HPV”)-associated cancers
	●	Personalized neoantigen-directed therapies
	●	Human epidermal growth factor receptor-2 (HER-2) associated cancers

	Three Months Ended July 31,				Increase (Decrease)
	2022		2021		$			%

Hotspot/Off-the-Shelf therapies	$	1,271	$	546	$	725			133	%
Prostate cancer		32		113		(81	)		(72	)%
HPV-associated cancers		247		420		(173	)		(41	)%
Personalized neoantigen-directed therapies		-		7		(7	)		(100	)%
Other expenses		683		617		66			11	%
Total research & development expense	$	2,233	$	1,703	$	530			31	%

Stock-based compensation expense included in research and development expense	$	12	$	29	$	(17	)		(59	)%

	Nine Months Ended July 31,				Increase (Decrease)
	2022		2021		$			%

Hotspot/Off-the-Shelf therapies	$	3,076	$	2,531	$	545			22	%
Prostate cancer		85		207		(122	)		(59	)%
HPV-associated cancers		332		1,865		(1,533	)		(82	)%
Personalized neoantigen-directed therapies		8		400		(392	)		(98	)%
Other expenses		1,870		3,613		(1,743	)		(48	)%
Total research & development expense	$	5,371	$	8,616	$	(3,245	)		(38	)%

Stock-based compensation expense included in research and development expense	$	36	$	142	$	(106	)		(75	)%

	Nine Months Ended July 31,				Increase (Decrease)
	2022		2021		$			%

General and administrative expense	$	6,331	$	9,038	$	(2,707	)		(30	)%

Stock-based compensation expense included in general and administrative expense	$	38	$	369	$	(331	)		(90	)%

Exhibit No.		Description

10.1*		Amendment No. 1 to the employment agreement between Advaxis, Inc. and Kenneth A. Berlin, dated September 12, 2022.

31.1*		Certification of Principal Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

31.2*		Certification of Principal Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

32.1*		Certification of Principal Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002

32.2*		Certification of Principal Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002

101.INS		Inline XBRL INSTANCE DOCUMENT

101.SCH		Inline XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT

101.CAL		Inline XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT

101.DEF		Inline XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT

101.LAB		Inline XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT

101.PRE		Inline XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

	ADVAXIS, INC.

	By:	/s/ Igor Gitelman
	Name:	Igor Gitelman
	Title:	Interim Chief Financial Officer and VP of Finance