ABOUT THIS PROXY STATEMENT/PROSPECTUS

This document, which forms part of a registration statement on Form S-4 filed with the SEC by Advaxis, constitutes a prospectus of Advaxis under the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of Advaxis Common Stock to be issued to Ayala stockholders pursuant to the Merger Agreement. This document also constitutes a proxy statement of Ayala under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). It also constitutes a notice of meeting with respect to the special meeting, at which Ayala stockholders will be asked to consider and vote on the adoption of the Merger Agreement and certain related matters.

Advaxis has supplied all information contained in this proxy statement/prospectus relating to Advaxis, and Ayala has supplied all information contained in this proxy statement/prospectus relating to Ayala.

You should rely only on the information contained in this proxy statement/prospectus. Advaxis and Ayala have not authorized anyone to provide you with information that is different from that contained in this proxy statement/prospectus. This proxy statement/prospectus is dated December 12, 2022, and you should not assume that the information contained in this proxy statement/prospectus is accurate as of any date other than such date. Neither the mailing of this proxy statement/prospectus to Ayala stockholders nor the issuance by Advaxis of shares of Advaxis Common Stock pursuant to the Merger Agreement will create any implication to the contrary.

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This proxy statement/prospectus contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus, including statements regarding future financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “seek,” “should,” “will” or the negative of these terms or other similar expressions.

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following:

You should not rely upon forward-looking statements as predictions of future events. Neither Advaxis nor Ayala can assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. In addition, statements that “we believe” and similar statements reflect the beliefs and opinions on the relevant subject of Advaxis, Ayala or the combined organization, as applicable. These statements are based upon information available as of the date of this prospectus, and while Advaxis, Ayala or the combined organization, as applicable, believes such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation:

If any of these risks or uncertainties materializes or any of these assumptions proves incorrect, the results of Advaxis, Ayala or the combined organization could differ materially from the forward-looking statements. All forward-looking statements in this proxy statement/prospectus are current only as of the date on which the statements were made. Advaxis and Ayala do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement is made or to reflect the occurrence of unanticipated events, except as otherwise required by the federal securities laws.

QUESTIONS AND ANSWERS ABOUT THE MERGER

The following are answers to some questions that you, as a stockholder of Ayala, may have regarding the proposed Merger between Ayala and Advaxis and the proposals to be considered at the Ayala Special Meeting. This section does not provide all the information that might be important to you with respect to the proposed Merger between Ayala and Advaxis. Ayala and Advaxis urge you to carefully read the remainder of this proxy statement/prospectus, including the annexes.

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

A: Ayala, Advaxis and Merger Sub have entered into the Merger Agreement. The Merger Agreement provides, among other things, that, upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Ayala, with Ayala surviving the Merger as a wholly owned subsidiary of Advaxis. A copy of the Merger Agreement is included in this proxy statement/prospectus as Annex A.

The Merger cannot be completed unless, among other things, Ayala’s stockholders adopt the Merger Agreement. The approval of Advaxis’ stockholders is not required for the Merger to be completed.

Ayala is using this document as a proxy statement to solicit proxies from Ayala’s stockholders in connection with proposals relating to the Merger at the Ayala Special Meeting. Advaxis is using this document as a prospectus by which Advaxis will offer and issue Advaxis Common Stock in connection with the Merger.

This proxy statement/prospectus contains important information about the Merger and the other proposals being voted on at the Ayala Special Meeting. You should read it carefully and in its entirety. The enclosed materials allow you to have your shares voted by proxy without attending the Ayala Special Meeting, which will be held virtually. Your vote is important. We encourage you to submit your proxy as soon as possible.

Q: What am I being asked to vote on?

A: At the Ayala Special Meeting, Ayala stockholders will be asked to consider and vote on the following proposals:

The approval of Advaxis’ stockholders is not required for the Merger to be completed.

Q: Why are Ayala and Advaxis proposing the Merger?

A: The boards of directors of Advaxis and Ayala believe that the Merger will provide substantial strategic and financial benefits to the companies, Advaxis’ stockholders and Ayala’s stockholders. To review the reasons for the Merger, see “The Merger—Advaxis Reasons for the Merger” and “The Merger—Ayala’s Reasons for the Merger; Recommendation of the Ayala Board” for more information.

Q: What will I receive in the Merger?

A: At the Effective Time, each share of Ayala Common Stock outstanding at that time (other than certain shares of Ayala Common Stock that may be cancelled pursuant to the terms and conditions of the Merger Agreement) will be converted into the right to receive a number of shares of Advaxis Common Stock equal to the Exchange Ratio, provided, however that such stock merger consideration is subject to further adjustment as described in this proxy statement/prospectus.

Q: What is the Exchange Ratio and how is it calculated?

A: The Exchange Ratio is 0.1874 as of the date of the Merger Agreement and is subject to adjustment at the Effective Time to reflect the following ratio (rounded to four decimal places): the quotient obtained by dividing (a) (i) $14,859,960 divided by (ii) the total number of shares of Ayala capital stock outstanding at that time on an as-exercised basis and using the treasury stock method by (b) (i) $8,915,976 divided by (ii) the total number of shares of Advaxis Common Stock outstanding at that time on an as-exercised basis and using the treasury stock method.

Q: Are Ayala stockholders guaranteed to receive exactly 0.1874 shares of Advaxis Common Stock for each share of Ayala Common Stock exchanged in the Merger?

A: No. For the reasons discussed in this proxy statement/prospectus, the overall value of the merger consideration you receive is subject to change and could vary from these numbers. As a result, you may receive more or less overall value in total merger consideration. See “Risk Factors” and “The Merger Agreement—Merger Consideration.”

Q: What equity stake will Ayala stockholders hold in Advaxis immediately following the Merger?

A: Upon the closing of the Merger, based upon the number of shares of Advaxis Common Stock expected to be issued in the Merger and an unadjusted Exchange Ratio, pre-merger Advaxis stockholders will own approximately 37.5% of the combined company and pre-merger Ayala stockholders will own approximately 62.5% of the combined company.

Q: How will the Merger affect the Ayala equity awards?

A: Stock Options. Pursuant to the Merger Agreement, at the Effective Time, each option to purchase Ayala Common Stock (each, an “Ayala Option”) granted under Ayala’s 2017 Stock Incentive Plan, as amended, that is outstanding and unexercised immediately prior to the Effective Time, will be converted into an option to purchase Advaxis Common Stock (each, an “Adjusted Option”) equal to the product obtained by multiplying (i) the number of shares of Ayala Common Stock subject to the Ayala Option immediately prior to the Effective Time, by (ii) the Exchange Ratio, with any fractional shares rounded down to the nearest whole share. Each Adjusted Option shall have an exercise price per share of Advaxis Common Stock equal to (x) the per share exercise price for shares of Ayala Common Stock subject to the corresponding Ayala Option immediately prior to the Effective Time, divided by (y) the Exchange Ratio, rounded up to the nearest whole cent. Each Adjusted Option shall otherwise be subject to the same terms and conditions applicable to the corresponding Ayala Option under Ayala’s 2017 Stock Incentive Plan, as amended, and the agreements evidencing grants thereunder, including vesting terms and provisions.

Restricted Stock Units. Pursuant to the Merger Agreement, at the Effective Time, each restricted stock unit with respect to a number of shares of Ayala Common Stock (each, an “Ayala RSU”) that is outstanding immediately prior to the Effective Time, whether or not vested, will be converted into a restricted stock unit with respect to a number of shares of Advaxis Common Stock (each, an “Adjusted RSU”) equal to the product obtained by multiplying (i) the total number of shares of Ayala Common Stock subject to such Ayala RSU immediately prior to the Effective Time by (ii) the Exchange Ratio, with any fractional shares rounded down to the nearest whole share. Each Adjusted RSU shall otherwise be subject to the same terms and conditions applicable to the corresponding Ayala RSU under, as applicable, Ayala’s 2017 Stock Incentive Plan, as amended, and the agreements evidencing grants thereunder, including vesting terms.

Restricted Stock. As outstanding shares of Ayala Common Stock, all restricted stock awards (“Ayala Restricted Stock”) that are outstanding will be substituted and converted automatically into the right to receive a number of shares of Advaxis Common Stock equal to the Exchange Ratio, provided, however that such stock merger consideration is subject to further adjustment as described in this proxy statement/prospectus. In accordance with the terms of the applicable restricted stock award agreement, these shares of Advaxis Common Stock shall be subject to the terms and conditions applicable to the corresponding Ayala Restricted Stock under, as applicable, Ayala’s 2017 Stock Incentive Plan, as amended, and the agreements evidencing grants thereunder, including vesting terms.

Q: When and where is the Ayala Special Meeting?

A: The Ayala Special Meeting will be held on January 13, 2023, at 10:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The Ayala Special Meeting will be held entirely online. You will be able to attend and participate in the Ayala Special Meeting online by visiting www.virtualshareholdermeeting.com/AYLA2023SM, where you will be able to listen to the meeting live, submit questions and vote.

Q: What do I need to do now?

A: After you have carefully read this proxy statement/prospectus and have decided how you wish to vote your shares, please vote your shares promptly so that your shares are represented and voted at the Ayala Special Meeting, even if you plan on attending. If you hold your shares in your name as a stockholder of record, you must complete, sign, date and mail your proxy card in the enclosed postage-paid return envelope as soon as possible or vote by Internet or phone, following the instructions on your proxy card. If you hold your shares in “street name” through a bank, broker or other nominee, you must direct your bank, broker or other nominee how to vote in accordance with the instructions you have received from your bank, broker or other nominee.

Q: What constitutes a quorum for the Ayala Special Meeting?

A: A quorum of stockholders is necessary to hold a valid meeting. A quorum will be present at the Ayala Special Meeting if the holders of a majority in voting power of all issued and outstanding shares of Ayala Common Stock entitled to vote as of the close of business on December 7, 2022, which is the Record Date of the Ayala Special Meeting, are present virtually at the Ayala Special Meeting or represented by proxy. As of the close of business on the Record Date, there were 14,820,727 shares of Ayala Common Stock issued and outstanding and entitled to vote. This means that at least 7,410,364 shares must be represented by stockholders present virtually at the Ayala Special Meeting or represented by proxy to have a quorum. Your shares will be counted towards the quorum if you submit a valid proxy or attend the Ayala Special Meeting. Abstentions and broker non-votes, if any, will be included in determining the number of shares present at the meeting for the purpose of determining the presence of a quorum.

Q: What is the vote required to approve each proposal?

A: Approval of the Ayala Merger Proposal requires the affirmative vote of a majority of the outstanding shares of Ayala Common Stock entitled to vote on the proposal. If you mark “ABSTAIN” on your proxy card or when voting by Internet or phone, fail to submit a proxy, fail to vote at the Ayala Special Meeting or fail to instruct your bank, broker or other nominee with respect to the Ayala Merger Proposal, it will have the same effect as a vote “AGAINST” the proposal. Approval of the Ayala Adjournment Proposal requires the affirmative vote of a majority in voting power of the votes cast affirmatively or negatively at the Ayala Special Meeting. If you mark “ABSTAIN” on your proxy card or when voting by Internet or phone, fail to submit a proxy, fail to vote at the Ayala Special meeting or fail to instruct your bank, broker or other nominee with respect to the Ayala Adjournment Proposal, it will have no effect on the proposal.

Q: How does the Ayala Board recommend that I vote at the Ayala Special Meeting?

A: The Ayala Board recommends that Ayala’s stockholders vote “FOR” the Ayala Merger Proposal and “FOR” the Ayala Adjournment Proposal.

Q: Why is my vote important?

A: The Merger will not be completed unless Ayala stockholders holding at least a majority of the shares of Ayala Common Stock outstanding as of the close of business on the Record Date vote to approve the Ayala Merger Proposal. If you do not return your proxy, it will be more difficult for Ayala to obtain the necessary quorum to hold the Ayala Special Meeting. In addition, your failure to submit a proxy or vote electronically at the Ayala Special Meeting, your failure to instruct your bank, broker or other nominee how to vote, or if you mark “ABSTAIN” on your proxy card or when voting by Internet or phone, will have the same effect as a vote “AGAINST” the Ayala Merger Proposal.

The approval of Advaxis’ stockholders is not required for the Merger to be completed.

Q: Who can vote at the Ayala Special Meeting?

A: Holders of outstanding shares of Ayala Common Stock as of the close of business on the Record Date are eligible to vote at the Ayala Special Meeting.

Q: Am I a stockholder of record or a beneficial owner? Why does this matter?

A: If on the Record Date your shares were registered directly in your name with Ayala’s transfer agent, American Stock Transfer & Trust Company, LLC, then you are a stockholder of record with respect to those shares.

If on the Record Date your shares were held in an account at a broker, bank or other similar organization as your nominee, then you are the beneficial owner of shares held in “street name” and these proxy materials are being forwarded to you by that organization. The organization holding your account is considered the stockholder of record for purposes of voting at the Ayala Special Meeting.

The form in which you own your shares affects how you vote your shares and how you can change your vote.

Q: How do I attend the Ayala Special Meeting and how can I vote my shares?

A: Ayala is conducting a virtual Special Meeting so its stockholders can participate from any geographic location with internet connectivity. Ayala has designed the format of the virtual online Ayala Special Meeting to provide stockholders the same ability to participate that they would have at an in-person meeting.

To attend, you must go to the meeting website at www.virtualshareholdermeeting.com/AYLA2023SM and enter the 16-digit control number found on your proxy card or voting instruction form sent to you by your bank, broker or other nominee. Once admitted, during the Ayala Special Meeting, you may vote, submit questions and view the list of stockholders entitled to vote at the Ayala Special Meeting by following the instructions available on the meeting website.

Access to the meeting platform will begin at 9:45 a.m. Eastern Time on January 13, 2023. If you encounter any difficulties accessing the virtual meeting during check-in or during the meeting, please call the technical support number that will be posted on the meeting website login page at www.virtualshareholdermeeting.com/AYLA2023SM. Technical support will be available beginning at 9:45 a.m. Eastern Time on January 13, 2023 and will remain available until the meeting has ended.

Rules for the conduct of the Ayala Special Meeting will be available on the meeting website. To obtain a copy of the rules of conduct for the Ayala Special Meeting in advance of the Ayala Special Meeting, please submit an email to oren.e@ayalapharma.com.

Regardless of whether you plan to participate in the Ayala Special Meeting, it is important that your shares be represented and voted at the Ayala Special Meeting. Accordingly, Ayala encourages you to vote in advance of the Ayala Special Meeting.

Q: How can I vote my shares of Ayala Common Stock?

A: For each proposal, you may vote “FOR” or “AGAINST” each proposal, or “ABSTAIN” from voting on such proposal.

If you are a stockholder of record, you may vote by proxy via telephone, over the Internet or by returning a proxy card, or you may vote online at the Ayala Special Meeting. Regardless of whether you plan to participate in the Ayala Special Meeting, we urge you to vote by proxy to ensure your vote is counted. You may still participate in the Ayala Special Meeting and vote online during the Ayala Special Meeting if you have already voted by proxy.

The deadline for receipt of a completed proxy card returned by mail at the address stated on the proxy card is 6:00 p.m. Eastern Time on January 12, 2023. The deadline for voting via the Internet or by telephone is 11:59 p.m. Eastern Time on January 12, 2023.

If you sign and return your proxy card but do not mark your card to instruct the proxies how to vote your shares of Ayala Common Stock on each proposal, your shares of Ayala Common Stock will be voted “FOR” the Ayala Merger Proposal and “FOR” the Ayala Adjournment Proposal, in accordance with the recommendation of the Ayala Board.

If you are a beneficial owner, you may vote your shares by directing the broker, bank or other similar organization that holds your shares as your nominee on how to vote the shares in your account. Please refer to the voting instructions provided by your broker, bank or other nominee. Many organizations allow beneficial owners to give voting instructions via telephone or the Internet, as well as in writing. If you are a beneficial owner and would like to vote your shares at the Ayala Special Meeting, please contact your broker, bank or other nominee for instructions and documents that may be required in order to do so.

Q: What if I return a proxy card but do not make specific choices?

A: You will only receive a proxy card if you are the record holder of your shares of Ayala Common Stock. If you return a signed and dated proxy card without marking any voting selections, your shares will be voted “FOR” the Ayala Merger Proposal and “FOR” the Ayala Adjournment Proposal, in accordance with the recommendation of the Ayala Board. If any other matter is properly presented at the meeting, your proxy (one of the individuals named on your proxy card) will vote your shares using his or her best judgment.

Q: If my shares of Ayala Common Stock are held in “street name” by my bank, broker or other nominee, will my bank, broker or other nominee automatically vote my shares for me?

A: No. If your shares of Ayala Common Stock are held in “street name,” your bank, broker or other nominee will vote your shares of Ayala Common Stock only if you provide instructions on how to vote to your bank, broker or other nominee. Under stock exchange rules, banks, brokers and other nominees who hold shares of Ayala Common Stock in “street name” for a beneficial owner of those shares typically have the authority to vote in their discretion on “routine” proposals when they have not received instructions from beneficial owners. However, banks, brokers and other nominees are not allowed to exercise their voting discretion with respect to the approval of matters determined to be “non-routine,” without specific instructions from the beneficial owner. Broker non-votes are shares held by a bank, broker or other nominee that are represented at the Ayala Special Meeting, but with respect to which the bank, broker or other nominee is not instructed by the beneficial owner of such shares to vote on the particular proposal and the bank, broker or other nominee does not have discretionary voting power on such proposal. Ayala believes that the Ayala Merger Proposal and the Ayala Adjournment Proposal are “non-routine” proposals and therefore your bank, broker or other nominee cannot vote your shares of Ayala Common Stock without your specific voting instructions. Because the only proposals for consideration at the Ayala Special Meeting are non-routine proposals, it is not expected that there will be any broker non-votes at the Ayala Special Meeting. However, if there are any broker non-votes, they will have (i) the same effect as a vote “AGAINST” the Ayala Merger Proposal and (ii) no effect on the outcome of the Ayala Adjournment Proposal.

Q: Can I change my vote?

A: Yes. If you are a record holder of Ayala Common Stock, you can revoke your proxy and change your vote at any time before the final vote at the meeting.

A revocation or later-dated proxy received by Ayala after the vote will not affect the vote.

If you are a beneficial holder (and hold your shares in “street name” through a bank, broker or other nominee), you should contact your bank, broker or other nominee to revoke your proxy or change your vote in accordance with their instructions.

Q: What happens if I fail to submit a proxy or I abstain from voting?

A: If you fail to submit a proxy or fail to instruct your bank, broker or other nominee to vote, assuming a quorum is present at the Ayala Special Meeting, it will have no effect on the outcome of the Ayala Adjournment Proposal, but it will have the same effect as a vote “AGAINST” the Ayala Merger Proposal. An abstention occurs when an Ayala stockholder returns a proxy with an “ABSTAIN” instruction or virtually attends the Ayala Special Meeting and votes to abstain from voting.

Q: What are the material U.S. federal income tax consequences of the Merger to Ayala stockholders?

A: The Merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”). The completion of the Merger is, however, not conditioned on the Merger qualifying as a “reorganization” within the meaning of Section 368(a) of the Code or upon the receipt of an opinion of counsel to that effect. No assurance can be given that the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code.

Neither Advaxis nor Ayala has sought or intends to seek a ruling from the Internal Revenue Service (the “IRS”) as to the U.S. federal income tax consequences of the Merger. If the IRS were to successfully challenge whether the Merger qualifies as a “reorganization,” the tax consequences would differ materially from those described in this proxy statement/prospectus as discussed below under “Material U.S. Federal Income Tax Consequences of the Merger—Tax Consequences if the Merger Fails to Qualify as a Reorganization.” This discussion neither binds the IRS nor precludes it from adopting a contrary position, and there can be no assurance that the IRS or a court would not disagree with or challenge any of the conclusions described in this proxy statement/prospectus.

Provided that the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code, subject to the limitations and qualifications described below under “Material U.S. Federal Income Tax Consequences of the Merger,” a U.S. Holder (as defined in the section titled “Material U.S. Federal Income Tax Consequences of the Merger”) of Ayala Common Stock will generally (i) not recognize any gain or loss upon the exchange of Ayala Common Stock for Advaxis Common Stock in the Merger (other than with respect to cash received in lieu of a fractional share of Advaxis Common Stock), (ii) have a tax basis in the Advaxis Common Stock received in the Merger (including fractional shares of Advaxis Common Stock for which cash is received) equal to the tax basis of the Ayala Common Stock surrendered in exchange therefor, and (iii) have a holding period for the Advaxis Common Stock received in the Merger (including fractional shares of Advaxis Common Stock for which cash is received) that includes its holding period for its Ayala Common Stock surrendered in exchange therefor.

For further information, see “The Merger—Material U.S. Federal Income Tax Consequences of the Merger.”

The U.S. federal income tax consequences described above may not apply to all holders of Ayala Common Stock. Your tax consequences will depend on your individual situation. Accordingly, we strongly urge you to consult your independent tax advisor for a full understanding of the particular tax consequences of the Merger to you.

Q: Are Ayala stockholders entitled to appraisal or dissenters’ rights?

A: Yes. Pursuant to Section 262 of the Delaware General Corporation Law (the “DGCL”), Ayala stockholders who do not vote in favor of adoption of the Merger Agreement, who continuously hold their shares of Ayala Common Stock through the Effective Time and who otherwise comply in all respects with the applicable requirements of Section 262 of the DGCL have the right to seek appraisal of the fair value of their shares of Ayala Common Stock, as determined by the Delaware Court of Chancery, if the Merger is consummated. See “The Merger— Appraisal Rights and Dissenters’ Rights.”

Q: Should I send in my Ayala stock certificates now?

A: No. Please do not send in your Ayala stock certificates with your proxy. After the completion of the Merger, an exchange agent mutually acceptable to Advaxis and Ayala will send you instructions for exchanging Ayala stock certificates for the merger consideration.

Q: Whom may I contact if I cannot locate my Ayala stock certificate(s)?

A: If you are unable to locate your original Ayala stock certificate(s), you should contact Ayala’s transfer agent, American Stock Transfer & Trust Company, LLC, at (800) 937-5449 (toll-free) or (718) 921-8124 (international).

Q: What should I do if I hold my shares of Ayala Common Stock in book-entry form directly with Ayala’s transfer agent, as opposed to a physical stock certificate?

A: You are not required to take any special additional actions if your shares of Ayala Common Stock are not represented by a certificate and are instead held in book-entry form with Ayala’s transfer agent. After the completion of the Merger, an exchange agent mutually acceptable to Advaxis and Ayala will contact you to provide you with details regarding the merger consideration, including shares of Advaxis Common Stock in book-entry form and any cash to be paid instead of fractional shares in the Merger.

Q: What should I do if I receive more than one set of voting materials?

A: Ayala stockholders may receive more than one set of voting materials, including multiple copies of this proxy statement/prospectus and multiple proxy cards. For example, if you hold shares of Ayala Common Stock in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold such shares. If you are a holder of record of Ayala Common Stock and your shares are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date and return each proxy card that you receive or otherwise follow the voting instructions set forth in this proxy statement/prospectus to ensure that you vote every share of Ayala Common Stock that you own.

Q: When do you expect to complete the Merger?

A: Advaxis and Ayala expect to complete the Merger during the first quarter of 2023, subject to any potential regulatory review or approval. However, neither Advaxis nor Ayala can assure you of when or if the Merger will be completed. Ayala must obtain the approval of Ayala’s stockholders for the Ayala Merger Proposal and both parties must satisfy certain closing conditions. See “The Merger Agreement—Conditions to the Completion of the Merger” for more information regarding conditions to the completion of the Merger.

Q: What happens if the Merger is not completed?

A: If the Merger is not completed, Ayala stockholders will not receive any consideration for their shares of Ayala Common Stock in connection with the Merger. Instead, Ayala will remain an independent, public company and, assuming that Ayala is able to comply with the required listing standards, Ayala Common Stock will continue to be traded on an exchange of The Nasdaq Stock Market LLC. In addition, if the Merger Agreement is terminated in certain circumstances, Advaxis or Ayala may be required to pay a termination fee. See “The Merger Agreement—Termination” for a complete discussion of the circumstances under which a termination fee will be required to be paid.

Q: Where can I find the voting results of the Ayala Special Meeting?

A: The preliminary voting results will be announced at the Ayala Special Meeting. In addition, within four business days following the Ayala Special Meeting, Ayala will disclose the preliminary or, if available, final voting results of the Ayala Special Meeting on a Current Report on Form 8-K filed with the SEC. If preliminary voting results are disclosed, Ayala will file an amended Current Report on Form 8-K with the SEC to disclose final voting results within four business days following certification of the final voting results.

Q: Is the completion of the Merger subject to a financing condition?

A: No. The completion of the Merger is not subject to any financing condition.

Q: How will I know when the other conditions to completion of the Merger have been satisfied?

A: As of the date of this proxy statement/prospectus, the parties have not satisfied the closing conditions to the Merger. If the closing conditions are satisfied, Ayala will announce the closing of the Merger via the filing of a Current Report on Form 8-K with the SEC. There is also a possibility that the closing conditions to the Merger will not be satisfied prior to the outside date of April 18, 2023, after which date either party may elect to terminate the Merger Agreement, subject to certain caveats. As a result, it is possible that factors outside the control of both companies could result in the Merger being completed at a different time or not at all.

Ayala stockholders will not know the actual Exchange Ratio or the value of the Advaxis Common Stock to be received as merger consideration until after the date of the Ayala Special Meeting. See “Risk Factors.”

Q: Are there any risks that I should consider in deciding whether to vote for the adoption of the Merger Agreement?

A: Yes. You should read and carefully consider the risk factors set forth in the “Risk Factors” section.

Q: Who can answer any questions I may have about the Merger or the Transactions contemplated by the Merger Agreement?

A: If you have any questions about the Merger or the other Transactions, or if you need additional copies of this proxy statement/prospectus, you should contact:

Ayala Pharmaceuticals, Inc.

Oppenheimer 4

Rehovot 7670104, Israel

Attn: Secretary

Tel: (857) 444-0553

RISK FACTORS

The combined company (for the purpose of this “Risk Factors” section, “we,” “us” and “our”) will be faced with a market environment that cannot be predicted and that involves significant risks and uncertainties, many of which will be beyond our control. You should carefully consider all of the information set forth in this proxy statement/prospectus. The combined company’s business, financial condition and results of operations could be materially and adversely affected by any of these risks. In that event, the trading price of our common stock would likely decline and you might lose all or part of your investment. In addition to the other information contained in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of Ayala Common Stock. You should also read and consider the other information in this proxy statement/prospectus and additional information about Ayala set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which is filed with the SEC as updated by its Quarterly Reports on Form 10-Q. Please see the section titled “Where You Can Find More Information” beginning on page 343 of this proxy statement/prospectus for further information. This proxy statement/prospectus also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described below and elsewhere in this report and our other SEC filings. See also “Cautionary Statement Concerning Forward-Looking Statements” on page 1 of this proxy statement/prospectus.

Risks Related to the Merger

The Exchange Ratio will not be adjusted based on the market price of Advaxis Common Stock, so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

At the Effective Time, outstanding Ayala Common Stock will be converted into shares of Advaxis Common Stock. Applying the Exchange Ratio, the former Ayala stockholders immediately before the Merger are expected to own approximately 62.5% of the aggregate number of shares of the combined company’s common stock following the Merger, and Advaxis stockholders immediately before the Merger are expected to own approximately 37.5% of the aggregate number of shares of the combined company’s common stock following the Merger, subject to certain assumptions.

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

If the conditions to the Merger are not satisfied or waived, the Merger may not occur.

Even if the Merger Agreement is adopted by the stockholders of Ayala and the Ayala Merger Proposal is approved by the Ayala stockholders, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 181 of this proxy statement/prospectus. Advaxis and Ayala cannot assure you that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the closing may be delayed, and Advaxis and Ayala each may lose some or all of the intended benefits of the Merger.

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

In general, neither Advaxis nor Ayla is obligated to complete the Merger if there is a material adverse effect affecting the other party between October 18, 2022, the date of the Merger Agreement, and the closing of the Merger. However, certain types of changes are excluded from the concept of a “material adverse effect.” Such exclusions include but are not limited to changes in general economic or market conditions, industry wide changes, changes in U.S. GAAP, changes in laws, rules or regulations of general applicability or interpretations thereof, natural disasters, pandemics (including the COVID-19 pandemic), outbreaks of hostilities or acts of terrorism, changes resulting from the announcement, performance or pendency of the Merger, changes in the price or trading volume of Advaxis Common Stock, and failures to meet internal or third-party guidance or forecasts. Therefore, if any of these events were to occur, impacting Advaxis or Ayala, the other party would still be obliged to consummate the closing of the Merger. If any such adverse changes occur and Advaxis and Ayala consummate the closing of the Merger, the stock price of the combined company may suffer. This in turn may reduce the value of the Merger to the stockholders of Advaxis, Ayala or both. For a more complete discussion of what constitutes a material adverse effect on Advaxis or Ayala, see the section titled “The Merger Agreement—Representations and Warranties” beginning on page 187 of this proxy statement/prospectus.

If Advaxis and Ayala complete the Merger, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations.

Additional financing may not be available to the combined company when it is needed or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of the combined company, including Advaxis’ pre-merger stockholders and Ayala’s former stockholders. It is also possible that the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company. Alternatively, in connection with the Merger, Advaxis may seek investments from outside sources to provide capital for the combined company.

Advaxis and Ayala directors and executive officers have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

Directors and executive officers of Advaxis and Ayala have interests in the Merger that are different from, or in addition to, the interests of other Advaxis stockholders generally. These interests with respect to Advaxis’ directors and executive officers may include, among others, acceleration of equity award vesting and severance payments if employment is terminated in a qualifying termination in connection with the Merger. Four current member of the Advaxis Board will continue as directors of the combined company after the Effective Time, and, following the closing of the Merger, three will be eligible to be compensated as non-employee directors of the combined company pursuant to the Advaxis non-employee director compensation policy that is expected to remain in place following the Effective Time, and current members of the Advaxis executive management team will continue with the combined company. These interests with respect to Ayala’s directors and executive officers may include, among others, that certain of Ayala’s directors and executive officers have options, subject to vesting, to purchase shares of Ayala Common Stock which, at the Effective Time, will be converted into and become fully vested options to purchase shares of the common stock of the combined company; and all of Ayala’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. Further, certain current members of Ayala’s board of directors will continue as directors of the combined company after the Effective Time, and, following the closing of the Merger, will be eligible to be compensated as non-employee directors of the combined company pursuant to the Advaxis non-employee director compensation policy that is expected to remain in place following the Effective Time. Certain directors and executive officers own options to purchase the shares of their respective companies.

The Advaxis and Ayala boards of directors were aware of and considered those interests, among other matters, in reaching their decisions to approve and adopt the Merger Agreement, approve the Merger, in the case of the Ayala board of directors, recommend the approval of the Merger Agreement to Ayala Stockholders. These interests, among other factors, may have influenced the directors and executive officers of Advaxis and Ayala to support or approve the Merger.

For more information regarding the interests of Advaxis and Ayala directors and executive officers in the Merger, please see the sections titled “The Merger—Interests of Advaxis Directors and Executive Officers in the Merger” beginning on page 169 and “The Merger—Interests of Ayala Directors and Executive Officers in the Merger” beginning on page 172 of this proxy statement/prospectus.

Advaxis stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

During the period of 2020-2022, Advaxis undertook a confidential, strategic review process, which was intended to result in an actionable plan that leverages its assets, capital and capabilities to maximize stockholder value. Following an extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, on October 18, 2022, Advaxis entered into a Merger Agreement with Ayala, under which the publicly traded Ayala will merge with a wholly-owned subsidiary of Advaxis. Pre-merger Ayala stockholders will own approximately 62.5% of the combined company and pre-merger Advaxis stockholders will own approximately 37.5% of the combined company. Both Advaxis and Ayala are devoting substantially all of their time and resources to consummating this transaction; however, there can be no assurance that such activities will result in the consummation of this transaction or that such transaction will deliver the anticipated benefits or enhance stockholder value. If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, Advaxis stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

If the Merger is not completed, Advaxis’ and Ayala’s stock price may fluctuate significantly.

The market price of Advaxis’ Common Stock is subject to significant fluctuations. During the 12-month period ended November 28, 2022, the closing sales price of Advaxis’ Common Stock on The Nasdaq Capital Market and the OTCQX, as applicable, ranged from a high of $32.02 on November 29, 2021, to a low of $1.58 on November 17, 2022 (accounting for the June 2022 reverse stock split).

The market price of Ayala’s Common Stock is subject to significant fluctuations. During the 12-month period ended November 28, 2022, the closing sales price of Ayala’s Common Stock on The Nasdaq Capital Market ranged from a high of $9.75 on November 10, 2021, to a low of $0.53 on November 21, 2022.

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

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

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

After the completion of the Merger, the current stockholders of Advaxis and stockholders of Ayala will own a smaller percentage of the combined company than their ownership of their respective companies prior to the Merger. Immediately after the Merger, Advaxis stockholders as of immediately prior to the Merger are expected to own approximately 37.5% of the outstanding shares of the combined company and former Ayala stockholders are expected to own approximately 62.5% of the outstanding shares of the combined company.

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

Covenants in the Merger Agreement impede the ability of Advaxis and Ayala to make acquisitions during the pendency of the Merger, subject to specified exceptions. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, proposing, seeking or knowingly encouraging, facilitating or supporting any inquiries, indications of interest, proposals or offers that constitute or may reasonably be expected to lead to certain transactions involving a third party, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “The Merger Agreement—No Solicitation.”

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

The terms of the Merger Agreement prohibit each of Advaxis and Ayala from soliciting or engaging in discussions with third parties regarding alternative Acquisition Proposals, except in limited circumstances when such party’s board of directors determines in good faith that an unsolicited Acquisition Proposal constitutes or could reasonably be expected to lead to a superior proposal and that failure to take such action would reasonably be expected to be inconsistent with its fiduciary duties under applicable law, as described in further detail in the section titled “The Merger Agreement—No Solicitation.” In addition, if the Merger Agreement is terminated by Advaxis or Ayala under certain circumstances, including because of a decision by either company’s board of directors to accept a superior proposal, such company would be required to pay the other a termination fee of $600,000. This termination fee may discourage third parties from submitting alternative takeover proposals to either company or its stockholders and may cause such company’s board of directors to be less inclined to recommend an alternative proposal.

The announcement and pendency of the Merger, whether or not consummated, may adversely affect the trading price of Advaxis’ Common Stock, Ayala’s Common Stock, and their business prospects.

The announcement and pendency of the Merger, whether or not consummated, may adversely affect the trading price of Advaxis’ Common Stock, Ayala’s Common Stock, and their business prospects. In the event that the Merger is not completed, the announcement of the termination of the Merger Agreement may also adversely affect the trading price of Advaxis’ Common Stock, Ayala’s Common Stock, and their business prospects.

Our efforts to have the common stock of the combined company listed on Nasdaq may not be successful.

While Advaxis intends to file an initial listing application with Nasdaq prior to the closing of the Merger, and to undertake the actions necessary to allow the stock of the combined company to be listed on The Nasdaq Capital Market as of the closing of the Merger or promptly thereafter, we may not be successful in those efforts. Because Advaxis is not currently listed on Nasdaq, the combined company will be required to meet the initial listing standards of The Nasdaq Capital Market applicable to companies seeking to uplist one or more securities from another U.S. market, such as the OTCQX. We believe that in order to achieve compliance with those listing standards, Advaxis and the combined company will need to undertake certain actions, including Advaxis obtaining the approval of its stockholders, at a special meeting, to undertake a reverse split of the Advaxis Common Stock, and the combined company raising additional capital. Any or all of these efforts may fail.

Failure to consummate the Merger may result in the terminating party paying a termination fee to the non-terminating party and could harm the terminating party’s common stock price and its future business and operations.

The Merger will not be consummated if the conditions precedent to the consummation of the transaction are not satisfied or waived, or if the Merger Agreement is terminated in accordance with its terms. If the Merger is not consummated, Advaxis and Ayala, as applicable, are subject to the following risks:

If the Merger does not close for any reason, either party’s board of directors may elect to, among other things, attempt to complete another strategic transaction, attempt to sell or otherwise dispose of such company’s various assets, dissolve or liquidate its assets, declare bankruptcy or seek to continue to operate its business. If either company seeks another strategic transaction or attempts to sell or otherwise dispose of its various assets, there is no assurance that it will be able to do so, that the terms would be equal to or superior to the terms of the Merger or as to the timing of such transaction. If either company decides to dissolve and liquidates its assets, such company would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurance as to the amount or timing of available cash left to distribute to stockholders after paying its debts and other obligations and setting aside funds for reserves.

If either party were to seek to continue its business, such company would need to determine whether to acquire one or more other product candidates. Such company would also need to raise funds to support continued operations and re-assess its workforce requirements in consideration of its reduced workforce.

If the Merger is not consummated, Advaxis and Ayala, as applicable, may be unable to retain the services of key remaining members of its management teams and, as a result, may be unable to seek or consummate another strategic transaction, properly dissolve and liquidate its assets or continue its business.

If Advaxis does not successfully consummate the transaction with Ayala, Advaxis’ and Ayala’s, as applicable, board of directors may dissolve or liquidate its assets to pursue a dissolution and liquidation. In such an event, the amount of cash available for distribution to Advaxis’ and Ayala’s stockholders will depend heavily on the timing of such transaction or liquidation.

If the Merger does not close for any reason, Advaxis’ and Ayala’s, as applicable, board of directors may elect to, among other things, dissolve or liquidate its assets, which may include seeking protection from creditors in a bankruptcy proceeding. If Advaxis and Ayala, as applicable, decides to dissolve and liquidate its assets, such company would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left to distribute to stockholders after paying its debts and other obligations and setting aside funds for reserves.

In the event of a dissolution and liquidation, the amount of cash available for distribution to Advaxis’ and Ayala’s, as applicable, stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution continues to decrease as Advaxis and Ayala, as applicable, funds its operations in preparation for the consummation of the Merger. Further, the Merger Agreement contains certain termination rights for each party, and provides that, upon termination under specified circumstances, either party may be required to pay the other a termination fee of $600,000, which would further decrease such company’s’ available cash resources. If either party board of directors were to approve and recommend, and its stockholders were to approve, a dissolution and liquidation, such company would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to its stockholders. Advaxis’ and Ayala’s, as applicable, commitments and contingent liabilities may include (i) regulatory and clinical obligations remaining under its clinical trials; (ii) obligations under its employment, separation and retention agreements with certain employees that provide for severance and other payments following a termination of employment occurring for various reasons, including a Change in Control; and (iii) potential litigation against such company, and other various claims and legal actions arising in the ordinary course of business. As a result of this requirement, a portion of Advaxis’ and Ayala’s, as applicable, assets may need to be reserved pending the resolution of such obligations. In addition, either company may be subject to litigation or other claims related to a dissolution and liquidation of such company. If a dissolution and liquidation were pursued, such company’s board of directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Advaxis and Ayala, as applicable, common stock could lose all or a significant portion of their investment in the event of its liquidation, dissolution or winding up.

Risk Factors of the Combined Company

The failure to successfully integrate the businesses and operations of Ayala and Advaxis in the expected time frame may adversely affect the combined company’s future results.

We and Advaxis have operated independently and there can be no assurances that the businesses can be integrated successfully. It is possible that the integration process could result in the loss of key Ayala or Advaxis employees, independent contractors, principal investigators, Clinical Research Organizations (“CROs”), consultants, vendors, and any other third parties, the disruption of our ongoing businesses, inconsistencies in standards, controls, procedures and policies, unexpected integration issues, higher than expected integration costs and an overall integration process that takes longer than originally anticipated. Specifically, the following issues, among others, must be addressed in integrating the operations of Ayala and Advaxis in order to realize the anticipated benefits of the Merger so the combined company performs as expected:

In addition, at times the attention our management may be focused on the integration of the businesses of the two companies and diverted from day-to-day business operations or other opportunities that may have been beneficial to us, which may disrupt our ongoing business.

Advaxis and Ayala will incur substantial direct and indirect costs as a result of the Merger and the combined company will incur substantial direct and indirect costs in connection with combining the business of Advaxis and Ayala following the Merger.

Advaxis and Ayala will incur substantial expenses in connection with and as a result of consummating the Merger, and over a period of time following the consummation of the Merger, the combined company also expects to incur substantial expenses in connection with coordinating and, in certain cases, combining the businesses, operations, policies and procedures of Advaxis and Ayala. A portion of the transaction costs related to the Merger will be incurred regardless of whether the Merger is consummated. While Advaxis and Ayala have assumed that a certain level of transaction expenses will be incurred, factors beyond Advaxis’ and Ayala’s control could affect the total amount or the timing of these expenses. These expenses may exceed the costs historically borne by Advaxis and Ayala. These expenses could adversely affect the financial condition, results of operations and cash flows of the combined company following the consummation of the Merger.

The actual financial position and results of operations of the combined company after the Merger may differ materially from the unaudited pro forma financial information included in this joint proxy statement/prospectus.

The unaudited pro forma financial information included in this joint proxy statement/prospectus is presented for informational purposes only and may not be an indication of what Ayala’s financial position or results of operations would have been had the Merger been consummated on the dates indicated. The unaudited pro forma financial information has been derived from the audited and unaudited historical financial statements of Ayala and Advaxis and certain adjustments and assumptions regarding Ayala after giving effect to the Merger. The assets and liabilities of Advaxis have been measured at fair value based on various preliminary estimates using assumptions that Ayala and Advaxis management believes are reasonable, utilizing information currently available. These fair value measurements can be highly subjective and the reasonable application of measurement principles may result in a range of alternative estimates using the same facts and circumstances. These estimates, which require extensive use of accounting estimates and management judgment, may be revised as additional information becomes available and as additional analyses are performed. Differences between preliminary estimates in the unaudited pro forma financial information and the final acquisition accounting will occur and could have a material impact on the unaudited pro forma financial information and the combined company’s financial position and future results of operations.

In addition, the assumptions used in preparing the unaudited pro forma financial information may not prove to be accurate, and other factors may affect the combined company’s financial condition or results of operations following the consummation of the Merger. Any material variance from the pro forma financial information may cause significant variations in the market price of the Advaxis Common Stock. See “Unaudited Pro Forma Condensed Combined Financial Information” beginning on page 315 of this proxy statement/prospectus.

Sales of shares of Advaxis Common Stock after the completion of the Merger may cause the market price of Advaxis Common Stock to fall.

Ayala stockholders may decide not to hold the shares of Advaxis Common Stock they receive in the Merger and other Ayala stockholders, such as funds with limitations on the amount of stock they are permitted hold in individual issuers, may be required to sell shares of Advaxis Common Stock that they receive in the Merger. Such sales, or market perception of such sales, of Advaxis Common Stock could result in higher than average trading volume following the closing of the Merger and may cause the market price for Advaxis Common Stock to decline. Such sales may take place promptly following the Merger or at other times in the future. There is no lock-up in place that would prevent institutional or larger stockholders from selling some or all of their Advaxis Common Stock after the close of the transaction.

If third parties threaten to terminate, terminate or alter existing contracts or relationships with Advaxis or Ayala, Advaxis’ and Ayala’s respective businesses may be materially harmed.

Ayala has contracts with customers, suppliers, vendors, landlords, licensors and other business partners which may require Ayala to obtain consents from these other parties in connection with the Merger. If these consents cannot be obtained, the combined company may suffer a loss of potential future revenues and may lose rights that are material to the business of the combined company. In addition, third parties with whom Ayala or Advaxis currently have relationships may terminate or otherwise reduce the scope of their relationship with either party in anticipation of the Merger. Any such disruptions could limit the combined company’s ability to achieve the anticipated benefits of the Merger. The adverse effect of such disruptions could also be exacerbated by a delay in the completion of the Merger or the termination of the Merger Agreement.

Both Ayala and Advaxis have operated with a loss and negative cash flows for the entirety of their existence and it is expected the combined company will have to raise significant capital in the future that could be dilutive to stockholders of the combined company.

Both Ayala and Advaxis have operated with a loss and negative cash flows for the entirety of their existence. Ayala and Advaxis have incurred significant net operating losses in every year since inception and expect to continue to incur significant expenses and operating losses for the foreseeable future. Ayala’s net losses were approximately $40.3 million for the year ended December 31, 2021 and $28.4 million for the nine months ended September 30, 2022. Advaxis’ net losses were approximately $17.9 million for the year ended October 31, 2021 and $10.8 million for the nine months ended July 31, 2022. Based on the combined company’s anticipated cash balances and recurring losses, there is substantial doubt about the combined company’s ability to continue as a going concern as a standalone company.

The combined company may not be able to raise capital to continue operations in the future which could result in bankruptcy or liquidation of the combined company. As a result, adequate funding may not be available to the combined company on acceptable terms, or at all.

Risks Related to the Business of Advaxis

You should carefully consider the risks described below as well as other information provided to you in this proxy statement/prospectus, including information in the section of this document entitled “Forward-Looking Statements.” The risks and uncertainties described below are not the only ones facing Advaxis. Additional risks and uncertainties not presently known to Advaxis or that it currently believes are immaterial may also impair its business operations. If any of the following risks actually occur, Advaxis’ business, financial condition or results of operations could be materially adversely affected, the value of its common stock could decline, and you may lose all or part of your investment.

Risks Related to Advaxis’ Financial Position, Capital Needs and Strategic Considerations

Advaxis has incurred significant losses since its inception and anticipate that it will continue to incur losses for the foreseeable future.

Advaxis is a clinical-stage biotechnology company. Investment in biotechnology product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. Advaxis has not generated any revenue from product sales to date, and it continues to incur significant development and other expenses related to its ongoing operations. As a result, Advaxis is not profitable and have incurred losses in each period since its inception.

Advaxis expects to continue to incur losses for the foreseeable future, and it expects these losses to increase as it continues its development of, and seek regulatory approvals for, Advaxis’ product candidates, and begin to commercialize any approved products. Advaxis may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The size of Advaxis’ future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenues. If any of Advaxis’ product candidates fail in clinical studies or do not gain regulatory approval, or if approved, fails to achieve market acceptance, Advaxis may never become profitable. Even if Advaxis achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. Advaxis’ prior losses and expected future losses have had and will continue to have an adverse effect on its stockholders’ (deficit) equity and working capital.

Advaxis will require additional capital to fund its operations and if it fails to obtain necessary financing, it will not be able to complete the development and commercialization of its product candidates.

The research and development of Advaxis’ products have consumed substantial amounts of cash since inception. Advaxis expects to continue to invest in advancing the clinical development of its product candidates and to commercialize any product candidates for which it receives regulatory approval. As of July 31, 2022, Advaxis had cash and cash equivalents of approximately $28.15 million. Advaxis will require additional capital for the further development of its product candidates. Advaxis is pursuing various ways to support its development efforts including debt and/or equity financing as well as targeting potential collaborators of its products.

Advaxis cannot be certain that additional funding will be available on acceptable terms, or at all. If Advaxis is unable to raise additional capital in sufficient amounts or on terms acceptable to it, Advaxis may have to significantly delay, scale back or discontinue the development or commercialization of one or more of its products or product candidates or one or more of its other research and development initiatives. Advaxis’ forecast of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. Advaxis has based this estimate on assumptions that may prove to be wrong, and it could utilize its available capital resources sooner than it currently expects. Advaxis’ future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

Risks Related to Advaxis’ Business, Industry and Strategy

Advaxis is 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. Advaxis’ 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. Advaxis is continuing to monitor the situation in Ukraine and globally and assessing its potential impact on Advaxis’ business.

Although, to date, Advaxis’ 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 its 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 Advaxis’ 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.

Advaxis is a clinical stage company.

Advaxis is a clinical stage biotechnology company with a history of losses and can provide no assurance as to future operating results. As a result of losses that will continue throughout Advaxis’ clinical stage, it may exhaust its financial resources and be unable to complete the development of its products. Advaxis anticipates that it will continue to incur significant operational costs as Advaxis executes its clinical development strategy. Advaxis’ deficit will continue to grow during its drug development period.

Advaxis has sustained losses from operations in each fiscal year since its inception, and it expects losses to continue for the foreseeable future due to its substantial investment in research and development. As of July 31, 2022, Advaxis had an accumulated deficit of approximately $438.4 million and stockholders’ equity of approximately $28.2 million. Advaxis expects to spend substantial additional sums on the continued administration and research and development of proprietary products and technologies with no certainty that its immunotherapies will become commercially viable or profitable as a result of these expenditures. If Advaxis fails to raise a significant amount of capital, it may need to significantly curtail operations or cease operations in the near future. If any of Advaxis’ product candidates fail in clinical trials or does not gain regulatory approval, Advaxis may never become profitable. Even if Advaxis achieves profitability in the future, it may not be able to sustain profitability in subsequent periods.

Advaxis is significantly dependent on the success of its Lm Technology platform and its product candidates based on this platform.

Advaxis is invested, and it expects to continue to invest, significant efforts and financial resources in the development of product candidates based on its Lm Technology. Advaxis’ ability to generate meaningful revenue, which may not occur for the foreseeable future, if ever, will depend heavily on the successful development, regulatory approval and commercialization of one or more of these product candidates, and such regulatory approval and commercialization may never occur.

The successful development of immunotherapies is highly uncertain.

Successful development of immunotherapies is highly uncertain and is dependent on numerous factors, many of which are beyond Advaxis’ control. Immunotherapies that appear promising in the early phases of development may fail to reach, or be delayed in reaching, the market for several reasons including:

Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to the next and may be difficult to predict.

Even if Advaxis’ product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be marketed. They may also be subject to other conditions of approval, may contain significant safety warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for successful commercialization, or may contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of risk evaluation and mitigation strategies, or REMS, to monitor the safety or efficacy of the products. If Advaxis does not receive FDA approval for, and successfully commercialize its product candidates, it will not be able to generate revenue from these product candidates in the United States in the foreseeable future, or at all. Any significant delays in obtaining approval for and commercializing Advaxis’ product candidates will have a material adverse impact on its business and financial condition.

Advaxis must rely upon third parties for manufacturing.

Advaxis currently has agreements with third party manufacturing facilities for production of many of its immunotherapies for research and development and testing purposes. Advaxis depends on third-party manufacturers to supply all of its clinical materials, but it does not have direct control over their personnel or operations. Third-party manufacturers must be able to meet Advaxis’ deadlines as well as adhere to quality standards and specifications. Advaxis’ reliance on third parties for the manufacturing of its drug substance, investigational new drugs and, in the future, any approved products, creates a dependency that could severely disrupt Advaxis’ research and development, its clinical testing, and ultimately its sales and marketing efforts if the source of such supply proves to be unreliable or unavailable. For instance, manufacturers may experience unforeseen problems, such as material or personnel shortages, temporary or permanent facility closures, or scale up challenges. If any contracted manufacturing operation is unreliable or unavailable, Advaxis may not be able to manufacture clinical drug supplies of its immunotherapies, and its preclinical and clinical testing programs may not be able to move forward and its entire business plan could fail. If Advaxis is able to commercialize its products in the future, there is no assurance that any third-party manufacturers will be able to meet commercialized scale production requirements in a timely manner.

There is also no guarantee that Advaxis’ third-party manufacturers will be able to manufacture its product candidates in accordance with current Good Manufacturing Practices, or cGMPs. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. If these third-party manufacturers are not able to comply with cGMPs, Advaxis may not be able to conduct clinical trials, may need to conduct additional studies, and may not, eventually, receive and maintain FDA approval for those products. Deviations from manufacturing requirements may also require remedial measures that may be costly and/or time-consuming for a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon or by third parties with whom Advaxis contracts could materially harm its business. A failure to comply with the applicable regulatory requirements may also result in regulatory enforcement actions against Advaxis’ manufacturers.

While Advaxis is ultimately responsible for the manufacturing of its product candidates, other than through its contractual arrangements, Advaxis has little control over its manufacturers’ compliance with these regulations and standards. If Advaxis’ manufacturers encounter manufacturing difficulties, including cGMP compliance, it may need to find alternative manufacturing facilities, which it may not be able to on favorable terms or at all, and which would significantly impact Advaxis’ ability to develop, obtain and maintain regulatory approval for or market its product candidates, if approved. Any new manufacturers would need to either obtain or develop the necessary manufacturing know-how, and obtain the necessary equipment and materials, which may take substantial time and investment. Advaxis must also receive FDA approval for the use of any new manufacturers for commercial supply.

If Advaxis is unable to establish, manage or maintain strategic collaborations in the future, its revenue and drug development may be limited.

Advaxis’ strategy includes eventual substantial reliance upon strategic collaborations for marketing and commercialization of its clinical product candidates, and it may rely even more on strategic collaborations for research, development, marketing and commercialization for some of Advaxis’ immunotherapies. To date, Advaxis has been heavily reliant upon third party outsourcing for its clinical trials execution and production of drug supplies for use in clinical trials. Establishing strategic collaborations is difficult and time-consuming. Advaxis’ discussions with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. For example, potential collaborators may reject collaborations based upon their assessment of Advaxis’ financial, clinical, regulatory or intellectual property position. Advaxis’ current collaborations, as well as any future new collaborations, may never result in the successful development or commercialization of its immunotherapies or the generation of sales revenue. To the extent that Advaxis has entered or will enter into co-promotion or other collaborative arrangements, its product revenues are likely to be lower than if it directly marketed and sold any products that Advaxis may develop.

Management of Advaxis’ relationships with its collaborators will require:

If Advaxis continues to enter into research and development collaborations at the early phases of drug development, its success will in part depend on the performance of its corporate collaborators. Advaxis will not directly control the amount or timing of resources devoted by its corporate collaborators to activities related to its immunotherapies and its collaborations may terminate at any time. Advaxis’ corporate collaborators may not commit sufficient resources to its research and development programs or the commercialization, marketing or distribution of its immunotherapies. If any corporate collaborator fails to commit sufficient resources or terminate their collaborations with Advaxis, its preclinical or clinical development programs related to this collaboration could be delayed or terminated.

Further, Advaxis’ collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with Advaxis. Collaborators may also fail to comply with the applicable regulatory requirements, which may subject them or Advaxis to regulatory enforcement actions. Finally, if Advaxis fails to make required milestone or royalty payments to its collaborators or to observe other obligations in its agreements with them, Advaxis’ collaborators may have the right to terminate those agreements.

Changes in product candidate manufacturing or formulation may result in additional costs or delay.

In an effort to optimize processes and results, it is common that various aspects of the development program, such as manufacturing methods, manufacturing sites, and formulation, are altered as product candidates are developed from preclinical studies to late-stage clinical trials toward approval and commercialization. Any of these changes could cause Advaxis’ product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, regulatory disclosure, or prior approval from the FDA. For instance, the FDA may require that Advaxis conducts a comparability study that evaluates the potential differences in the product candidate resulting from the change. Delays in designing and completing such a study to the satisfaction of the FDA could delay or preclude Advaxis’ development and commercialization plans, and the regulatory approval of its product candidates. It may also require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Advaxis’ product candidates and jeopardize its ability to commence product sales and generate revenue. Any of the foregoing could limit Advaxis’ future revenues and growth. Any changes would also require that Advaxis devotes time and resources to manufacturing development, including with third-party manufacturers, and would also likely require additional testing and regulatory actions on its part, which may delay the development of its product candidates.

Advaxis may incur significant costs complying with environmental laws and regulations.

Advaxis and its contracted third parties use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. As appropriate, Advaxis stores these materials and wastes resulting from their use at Advaxis or its outsourced laboratory facility pending their ultimate use or disposal. Advaxis contract with a third party to properly dispose of these materials and wastes. Advaxis is subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with such laws and regulations may be costly.

Additional laws and regulations governing international operations could negatively impact or restrict Advaxis’ operations.

If Advaxis further expands its operations outside of the United States, it must dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which it plans to operate. The U.S. Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring Advaxis to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If Advaxis expands its presence outside of the United States, it will require Advaxis to dedicate additional resources to comply with these laws, and these laws may preclude it from developing, manufacturing or selling certain products and product candidates outside of the United States, which could limit its growth potential and increase Advaxis’ development costs.

The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

Advaxis is subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. Advaxis can face serious consequences for violations.

Among other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, exclusion from public tenders, reputational harm and other consequences. Advaxis has direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. Advaxis plans to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and it can be held liable for the corrupt or other illegal activities of its personnel, agents or partners, even if Advaxis does not explicitly authorize or have prior knowledge of such activities.

If Advaxis uses biological materials in a manner that causes injury, it may be liable for damages.

Advaxis’ research and development activities involve the use of biological and hazardous materials. Although Advaxis believes its safety procedures for handling and disposing of these materials complies with federal, state and local laws and regulations, it cannot entirely eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of these materials. Advaxis does not carry specific biological waste or pollution liability or remediation insurance coverage, nor do its workers’ compensation, general liability, and property and casualty insurance policies provide coverage for damages and fines/penalties arising from biological exposure or contamination. Accordingly, in the event of contamination or injury, Advaxis could be held liable for damages or penalized with fines in an amount exceeding its resources, and its clinical trials or regulatory approvals could be suspended or terminated.

Advaxis needs to attract and retain highly skilled personnel; it may be unable to effectively manage growth with its limited resources.

As of October 31, 2022 Advaxis had 15 employees, 14 of which were full time employees. Advaxis’ ability to attract and retain highly skilled personnel is critical to its operations and expansion. Advaxis faces competition for these types of personnel from other technology companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than it has. Advaxis may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all. If Advaxis is not successful in attracting and retaining these personnel, or integrating them into its operations, business, prospects, financial condition and results of operations will be materially adversely affected. In such circumstances Advaxis may be unable to conduct certain research and development programs, unable to adequately manage its clinical trials and other products, unable to commercialize any products, and unable to adequately address its management needs.

Advaxis depends upon its senior management and key consultants and their loss or unavailability could put it at a competitive disadvantage.

Advaxis depends upon the efforts and abilities of its senior executives, as well as the services of several key consultants. The loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect on Advaxis’ business, prospects, financial condition and results of operations. Advaxis has not obtained, does not own, nor is it the beneficiary of, key-person life insurance.

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

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

Advaxis is aware of certain investigational new products under development or approved products by competitors that are used for the prevention, diagnosis, or treatment of certain diseases it has targeted for product development. Various companies are developing biopharmaceutical products that have the potential to directly compete with Advaxis’ immunotherapies even though their approach may be different. The biotechnology and biopharmaceutical industries are highly competitive, and this competition comes from both biotechnology firms and major pharmaceutical companies, including companies like: Gritstone, Moderna, Bristol-Myers Squibb Company (“BMS”), Merck and Neon Therapeutics, among others, each of which is pursuing cancer vaccines and/or immunotherapies. Many of these companies have substantially greater financial, marketing, and human resources than Advaxis does (including, in some cases, substantially greater experience in clinical testing, manufacturing, and marketing of pharmaceutical products). Advaxis also experiences competition in the development of its immunotherapies from universities and other research institutions and compete with others in acquiring technology from such universities and institutions.

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

Risks Related to the Development and Regulatory Approval of Advaxis Product Candidates

Advaxis can provide no assurance that its clinical product candidates will obtain regulatory approval or that the results of clinical studies will be favorable.

Advaxis is currently evaluating the safety and efficacy of its product candidates in clinical trials. However, even though the initiation and conduct of the clinical trials is in accordance with the governing regulatory authorities in each country, as with any investigational new drug (under an Investigational New Drug Application, or IND, in the United States, or the equivalent in countries outside of the United States), Advaxis is at risk of a clinical hold at any time based on the evaluation of the data and information submitted to the governing regulatory authorities.

There can be delays in obtaining FDA and/or other necessary regulatory approvals in the United States and in countries outside the United States for any investigational new drug and failure to receive such approvals would have an adverse effect on the investigational new drug’s potential commercial success and on Advaxis’ business, prospects, financial condition and results of operations. The time required to obtain approval by the FDA and non-U.S. regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. For example, the FDA or non-U.S. regulatory authorities may disagree with the design or implementation of Advaxis’ clinical trials or study endpoints; or it may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks. In addition, the FDA or non-U.S. regulatory authorities may disagree with Advaxis’ interpretation of data from preclinical studies or clinical trials or the data collected from clinical trials of its product candidates may not be sufficient to support the submission of a BLA or New Drug Application (“NDA”) or other submission or to obtain regulatory approval in the United States or elsewhere. The FDA or non-U.S. regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which Advaxis contracts for clinical and commercial supplies; and the approval policies or regulations of the FDA or non-U.S. regulatory authorities may significantly change in a manner rendering Advaxis’ clinical data insufficient for approval.

In addition to the foregoing, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Advaxis has not submitted for nor obtained regulatory approval for any product candidate in-humans (US & EU) and it is possible that none of its existing product candidates or any product candidates Advaxis may seek to develop in the future will ever obtain regulatory approval.

Drug discovery and development is a complex, time-consuming and expensive process that is fraught with risk and a high rate of failure.

Product candidates are subject to extensive pre-clinical testing and clinical trials to demonstrate their safety and efficacy in humans. Conducting pre-clinical testing and clinical trials is a lengthy, time-consuming and expensive process that takes many years. Advaxis cannot be sure that pre-clinical testing or clinical trials of any of its product candidates will demonstrate the safety, efficacy and benefit-to-risk profile necessary to obtain marketing approvals. In addition, product candidates that experience success in pre-clinical testing and early-stage clinical trials will not necessarily experience the same success in larger or late-stage clinical trials, which are required for marketing approval.

Even if Advaxis is successful in advancing a product candidate into the clinical development stage, before obtaining regulatory and marketing approvals, it must demonstrate through extensive human clinical trials that the product candidate is safe and effective for its intended use. Human clinical trials must be carried out under protocols that are acceptable to regulatory authorities and to the independent committees responsible for the ethical review of clinical studies. There may be delays in preparing protocols or receiving approval for them that may delay the start or completion of the clinical trials. In addition, clinical practices vary globally, and there is a lack of harmonization among the guidance provided by various regulatory bodies of different regions and countries with respect to the data that is required to receive marketing approval, which makes designing global trials increasingly complex. There are a number of additional factors that may cause Advaxis’ clinical trials to be delayed, prematurely terminated or deemed inadequate to support regulatory approval, such as:

Any deficiency in the design, implementation or oversight of Advaxis’ development programs could cause it to incur significant additional costs, conduct additional trials, experience significant delays, prevent it from obtaining marketing approval for any product candidate or abandon development of certain product candidates, any of which could harm its business and cause its stock price to decline.

Advaxis may face legal claims; legal disputes are expensive and it may not be able to afford the costs.

Advaxis may face legal claims involving stockholders, consumers, clinical trial subjects, competitors, regulators and other parties. Advaxis is engaged in legal proceedings. Litigation and other legal proceedings are inherently uncertain, and adverse rulings could occur, including monetary damages, or an injunction stopping Advaxis from engaging in business practices, or requiring other remedies, including, but not limited to, compulsory licensing of patents.

The costs of litigation or any proceeding, including, but not limited to, those relating to Advaxis’ intellectual property or contractual rights, could be substantial, even if resolved in its favor. Some of Advaxis’ competitors or financial funding sources have far greater resources than it does and may be better able to afford the costs of complex litigation. Also, a lawsuit, even if frivolous, will require considerable time commitments on the part of management, Advaxis’ attorneys and consultants. Defending these types of proceedings or legal actions involve considerable expense and could negatively affect Advaxis’ financial results. Legal claims may also adversely impact Advaxis in other ways, such as the withdrawal or slower enrollment in or from its clinical trials, regulatory enforcement actions, and negative media attention, any of which could materially and negatively harm Advaxis and its operations.

Advaxis can provide no assurance of the successful and timely development of new products.

Advaxis immunotherapies are at various stages of development. Further development and extensive testing will be required to determine their technical feasibility and commercial viability. Advaxis will need to complete significant additional clinical trials demonstrating that its product candidates are safe and effective to the satisfaction of the FDA and other non-U.S. regulatory authorities. The drug approval process is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials. Advaxis’ success will depend on its ability to achieve scientific and technological advances and to translate such advances into licensable, FDA-approvable, commercially competitive products on a timely basis. Failure can occur at any stage of the process. If such programs are not successful, Advaxis may invest substantial amounts of time and money without developing revenue-producing products. As Advaxis enters a more extensive clinical program for its product candidates, the data generated in these studies may not be as compelling as the earlier results.

The proposed development schedules for Advaxis immunotherapies may be affected by a variety of factors, including technological difficulties, clinical trial failures, regulatory hurdles, clinical holds, competitive products, intellectual property challenges and/or changes in governmental regulation, many of which will not be within its control. Any delay in the development, introduction or marketing of Advaxis products could result either in such products being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of Advaxis’ projects, the unproven technology involved, and the other factors described elsewhere in this section, there can be no assurance that Advaxis will be able to successfully complete the development or marketing of any new products which could materially harm its business, results of operations and prospects.

Advaxis research and development expenses are subject to uncertainty.

Factors affecting Advaxis research and development expenses include, but are not limited to:

There can be no guarantee that Advaxis research and development expenses will be consistent from period to period. Advaxis may be required to accelerate or delay incurring certain expenses depending on the results of its studies and the availability of adequate funding.

Advaxis may be required to suspend or discontinue clinical trials for a number of reasons, which could preclude approval of any of its product candidates.

Advaxis clinical trials may be suspended at any time for a number of reasons. A clinical trial may be suspended or terminated by Advaxis, an Institutional Review Board (“IRB”), the FDA or other regulatory authorities due to a failure to conduct the clinical trial in accordance with regulatory requirements or its clinical protocols, presentation or identification of unforeseen safety signals or issues, failure to demonstrate a benefit from using the investigational drug, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or for other business-related reasons. For example, in June 2019, Advaxis announced that it was closing its AIM2CERV Phase 3 clinical trial with AXAL in cervical cancer due to the delays Advaxis incurred as a result of the recent FDA partial clinical hold on the trial, as well as the estimated cost and time to completion of the trial. Furthermore, Advaxis has completed the clinical study report from Part A of the ADXS-NEO study and plans to close its ADXS-NEO program IND as next step. In addition, clinical trials for Advaxis’ product candidates could be suspended due to adverse side effects. Drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Advaxis may also voluntarily suspend or terminate its clinical trials if at any time it believes that they present an unacceptable risk to patients or do not demonstrate clinical benefit. If Advaxis elects or is forced to suspend or terminate any clinical trial of any product candidates that it develops, the commercial prospects of such product candidates will be harmed and its ability to generate product revenues from any of these product candidates will be delayed or eliminated. Any of these occurrences may significantly harm Advaxis’ business, financial condition, results of operations and prospects.

Preliminary or interim results of a clinical trial are not necessarily predictive of future or final results.

Interim or preliminary data from clinical trials that Advaxis may conduct may not be indicative of the final results of the trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Interim or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim or preliminary data. As a result, interim or preliminary data should be viewed with caution until the final data are available. Even if Advaxis’ clinical trials are completed as planned, it cannot be certain that their results will support its proposed indications.

Advaxis is subject to numerous risks inherent in conducting clinical trials.

Advaxis outsources the management of its clinical trials to third parties. Agreements with CROs, clinical investigators and medical institutions for clinical testing and data management services, place substantial responsibilities on these parties that, if unmet, could result in delays in, or termination of, Advaxis’ clinical trials. For example, if any of Advaxis’ clinical trial sites or CROs fail to comply with FDA-approved good clinical practices, Advaxis may be unable to use the data gathered at those sites. If these clinical investigators, medical institutions or other third parties do not carry out their contractual duties or regulatory obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to Advaxis’ clinical protocols or for other reasons, its clinical trials may be extended, delayed or terminated, and Advaxis may be unable to obtain regulatory approval for, or successfully commercialize, its agents. Advaxis is not certain that it will successfully recruit enough patients to complete its clinical trials nor that it will reach its primary endpoints. Delays in recruitment, lack of clinical benefit or unacceptable side effects would delay or prevent the initiation of future development of Advaxis’ agents.

While Advaxis has agreements governing the activities of such third parties and are responsible for its third-party service provider’s activities and regulatory compliance, it has limited influence and control over their actual performance and activities and cannot control whether or not they devote sufficient time and resources to Advaxis’ ongoing clinical, non-clinical, and preclinical programs and cannot control whether they maintain regulatory compliance. Advaxis’ third-party service providers may also have relationships with other entities, some of which may be its competitors, for whom they may also be conducting trials or other therapeutic development activities that could harm Advaxis’ competitive position.

Agreements with third parties conducting or otherwise assisting with Advaxis’ clinical or preclinical studies might terminate for a variety of reasons, including a failure to perform by the third parties. If any of Advaxis’ relationships with these third parties terminate, it may not be able to enter into arrangements with alternative providers or to do so on commercially reasonable terms. Switching or adding additional third parties involve additional cost and requires management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, if Advaxis needs to enter into alternative arrangements, it could delay its product development activities and adversely affect its business. Though Advaxis carefully manages its relationships with third parties, there can be no assurance that it will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on Advaxis’ business, financial condition and prospects, and results of operations.

Advaxis or its regulators may suspend or terminate its clinical trials for a number of reasons. Advaxis may voluntarily suspend or terminate its clinical trials if at any time it believes they present an unacceptable risk to the patients enrolled in its clinical trials or do not demonstrate clinical benefit. In addition, regulatory agencies may order the temporary or permanent discontinuation of Advaxis’ clinical trials, or place its products on temporary or permanent hold, at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to the patients enrolled in Advaxis’ clinical trials.

Advaxis’ clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that Advaxis or its clinical trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, it may receive reports of observations or warning letters detailing deficiencies, and it will be required to implement corrective actions. If regulatory agencies deem Advaxis’ responses to be inadequate or are dissatisfied with the corrective actions it or its clinical trial sites have implemented, Advaxis’ clinical trials may be temporarily or permanently discontinued, may be fined, Advaxis or its investigators may be precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve its marketing applications or allow it to manufacture or market its products, and Advaxis may be criminally prosecuted.

The lengthy approval process as well as the unpredictability of future clinical trial results may result in Advaxis failing to obtain regulatory approval for its product candidates, which would materially harm its business, results of operations and prospects.

Advaxis employees, independent contractors, consultants, commercial partners, principal investigators, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on its business.

Advaxis is exposed to the risk of employee and third-party fraud or other misconduct. Misconduct by employees, independent contractors, consultants, commercial partners, manufacturers, investigators, or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, comply with federal procurement rules or contract terms, report financial information or data accurately or disclose unauthorized activities to Advaxis. This misconduct could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to Advaxis’ reputation. It is not always possible to identify and deter this type of misconduct, and the precautions Advaxis takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting it from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Moreover, it is possible for a whistleblower to pursue a federal False Claims Act, or FCA, case against Advaxis even if the government considers the claim unmeritorious and declines to intervene, which could require Advaxis to incur costs defending against such a claim. Further, due to the risk that a judgment in an FCA case could result in exclusion from federal health programs or debarment from government contracts, whistleblower cases often result in large settlements. If any such actions are instituted against Advaxis, and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, financial condition, and results of operations, including the imposition of significant fines or other sanctions.

Advaxis must comply with significant government regulations.

The research and development, manufacturing and marketing of human therapeutic and diagnostic products are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things, research and development activities (including testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, distribution, advertising and promotion of the products that Advaxis is developing. If Advaxis obtains approval for any of its product candidates, its operations will be directly or indirectly through its customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statue and the FCA, and privacy laws. Advaxis, its product candidates, and its products, if it receives marketing approval are and will continue to be subject to extensive governmental regulation and regulatory authorities do and will continue to closely monitor Advaxis and its contractor’s compliance through, among other methods, inspections. Noncompliance with applicable laws and requirements can result in various adverse consequences and regulatory enforcement actions, including delay in approving or refusal to approve product licenses or other applications, suspension or termination of clinical investigations, revocation of approvals previously granted, fines, criminal prosecution, civil and criminal penalties, restitution or disgorgement of profits, recall or seizure of products, exclusion from having its products reimbursed by federal health care programs, the curtailment or restructuring of Advaxis’ operations, corporate integrity agreements or consent decrees, refusal to permit product import or export, modifications to labeling or promotional materials, issuance of corrective information, regulatory authority public statements, warning, untitled, or cyber letters, requirements for post-market studies or REMS, injunctions against shipping products and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts. Any of these events could prevent Advaxis from achieving or maintaining product approval and market acceptance of the particular product candidate, if approved, or could substantially increase the costs and expenses of developing and commercializing such product, which in turn could delay or prevent Advaxis from generating significant revenues from its sale. Any of these events could further have other material and adverse effects on Advaxis’ operations and business and could adversely impact its stock price and could significantly harm Advaxis’ business, financial condition, results of operations, and prospects.

The process of obtaining requisite FDA approval has historically been costly and time-consuming. Current FDA requirements for a new human biological product to be marketed in the United States include: (1) the successful conclusion of preclinical laboratory and animal tests, if appropriate, to gain preliminary information on the product’s safety; (2) filing with the FDA of an IND to conduct human clinical trials for drugs or biologics; (3) the successful completion of adequate and well-controlled human clinical trials to establish the safety and efficacy of the investigational new drug for its recommended use; and (4) filing by a company and acceptance and approval by the FDA of a BLA for marketing approval of a biologic, to allow commercial distribution of a biologic product. The FDA also requires that any drug or formulation to be tested in humans be manufactured in accordance with its cGMP regulations. This has been extended to include any drug that will be tested for safety in animals in support of human testing. The cGMPs set certain minimum requirements for procedures, record-keeping and the physical characteristics of the laboratories used in the production of these drugs. A delay in one or more of the procedural steps outlined above could be harmful to Advaxis in terms of getting its immunotherapies through clinical testing and to market.

Advaxis may not obtain or maintain the benefits associated with Orphan Drug Designation, including market exclusivity.

Although Advaxis has been granted a designation from the FDA under the Orphan Drug Act, or ODA, intended to treat a rare disease or condition (Orphan Drug Designation, or “ODD”) for AXAL for use in the treatment of anal cancer, HPV-associated head and neck cancer, Stage II-IV invasive cervical cancer and for ADXS-HER2 for the treatment of osteosarcoma in the United States, as well as the European Medicines Agency, or EMA, ODD for AXAL for the treatment of anal cancer and for ADXS-HER2 for the treatment of osteosarcoma in the EU, Advaxis may not receive the benefits associated with ODD. This may result from a failure to maintain orphan drug status or result from a competing product reaching the market that has an orphan designation for the same disease indication. Moreover, while ODD does provide Advaxis with certain advantages, it neither shortens the development time or regulatory review time of a product candidate nor gives the product candidate any advantage in the regulatory review or approval process.

Under U.S. rules for orphan drugs, if such a competing product reaches the market before Advaxis does, if such product is considered by FDA to be the same as Advaxis’, and if such product is intended for the same orphan indication, the competing product could potentially obtain a scope of market exclusivity that limits or precludes its product from being sold in the United States for seven years unless Advaxis can demonstrate that its product is clinically superior. Even if Advaxis obtains exclusivity, the FDA could subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior to Advaxis in that it is shown to be safer, more effective or makes a major contribution to patient care. A competitor also may receive approval of different products for the same indication for which Advaxis’ orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. Moreover, Advaxis may not be able to maintain its ODD or exclusivity and its product candidates would not be eligible for exclusivity if the approved indication is broader than the ODD.

In addition, if and when Advaxis requests ODD in Europe, the European exclusivity period is ten years but can be reduced to six years if the drug no longer meets the criteria for ODD or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Advaxis may incur substantial liabilities from any product liability claims if its insurance coverage for those claims is inadequate.

Advaxis faces an inherent risk of product liability exposure related to the testing of its immunotherapies in human clinical trials and will face an even greater risk if the approved products are sold commercially. An individual may bring a liability claim against Advaxis if one of the immunotherapies causes, or merely appears to have caused, an injury. If Advaxis cannot successfully defend itself against the product liability claim, it will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

Advaxis has product liability and clinical trial liability insurance coverage for each clinical trial. Advaxis does not have product liability insurance for sold commercial products because it does not have products on the market. Advaxis plans to expand such coverage to include the sale of commercial products if marketing approval is obtained for any of its immunotherapies. However, insurance coverage is increasingly expensive and Advaxis may not be able to maintain insurance coverage at a reasonable cost. Further, Advaxis may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise.

Advaxis may not receive Fast Track designation, Breakthrough Therapy Designation or any other designation that it may apply for from the FDA and, if granted, such designations may not actually lead to a faster development or regulatory review or approval process.

The FDA has granted a designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need (the “Fast Track” designation) for AXAL for adjuvant therapy for high-risk locally advanced cervical cancer patients, and has granted Fast Track designation for ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma. Advaxis may seek Breakthrough Therapy Designation for its product candidates or Fast Track designation for certain of its other product candidates. There is no guarantee, however, that Advaxis will be able to obtain or maintain such designations.

The FDA has broad discretion whether or not to grant any special designation, so even if Advaxis believes one of its product candidates is eligible for this designation, it cannot assure you that the FDA would decide to grant it. Additionally, even if Advaxis receives a special designation, it may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may also withdraw the designation if it believes that the designation is no longer supported by data from Advaxis’ clinical development program.

The results of clinical trials conducted at clinical trial sites outside the United States might not be accepted by the FDA, and data developed outside of a foreign jurisdiction similarly might not be accepted by such foreign regulatory authority.

Some of the clinical trials for Advaxis product candidates that are being or will be conducted through its partnerships and collaborations may be conducted outside the United States, and it intends in the future to conduct additional clinical trials outside the United States. Although the FDA, EMA or comparable foreign regulatory authorities may accept data from clinical trials conducted outside the relevant jurisdiction, acceptance of these data is subject to certain conditions. For example, the FDA requires that the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles such as IRB or ethics committee approval and informed consent, the trial population must adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to the applicable local laws, acceptance of the data by the FDA will be dependent upon its determination that the trials were conducted consistent with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the United States as adequate support of a marketing application. Similarly, Advaxis must also ensure that any data submitted to foreign regulatory authorities adheres to their standards and requirements for clinical trials and there can be no assurance a comparable foreign regulatory authority would accept data from trials conducted outside of its jurisdiction.

Advaxis’ relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose it to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute (the “AKS”) and the FCA which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the research of Advaxis’ product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. The applicable federal, state and foreign healthcare laws and regulations that may affect Advaxis’ ability to operate include, but are not limited to:

The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products. Pharmaceutical companies may also be subject to federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies continue to closely scrutinize interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time and resource-consuming and can divert a company’s attention from the business.

It is possible that governmental and enforcement authorities will conclude that Advaxis’ business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against Advaxis, and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of Advaxis’ operations, as well as additional reporting obligations and oversight if it becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the physicians or other healthcare providers or entities with whom Advaxis expects to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Any action for violation of these laws, even if successfully defended, could cause a biopharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

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

Obtaining and maintaining regulatory approval of Advaxis’ product candidates in one jurisdiction does not guarantee that it will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, the EMA or comparable foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Advaxis intends to charge for its products are also subject to approval.

Advaxis may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which it must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Advaxis and could delay or prevent the introduction of its products in certain countries. If Advaxis fails to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, its target market will be reduced and its ability to realize the full market potential of its product candidates will be harmed.

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

If any of Advaxis’ product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, distribution, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities. In addition, Advaxis will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that it conducts post-approval.

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

Any regulatory approvals that Advaxis receives for its product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. Certain endpoint data Advaxis hopes to include in any approved product labeling also may not make it into such labeling, including exploratory or secondary endpoint data such as patient-reported outcome measures. The FDA may also require a REMS program as a condition of approval of Advaxis’ product candidates, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA, EMA or a comparable foreign regulatory authority approves Advaxis’ product candidates, it will have to comply with requirements including submissions of safety and other post-marketing information and reports and registration.

The FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with Advaxis’ product candidates, including adverse events of unanticipated severity or frequency, or with its third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. The policies of the FDA, EMA and comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Advaxis’ product candidates. Advaxis cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Advaxis is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Advaxis is not able to maintain regulatory compliance, it may lose any marketing approval that it may have obtained and it may not achieve or sustain profitability.

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

The success of Advaxis’ product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors. Advaxis cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, its product candidates or assure that coverage and reimbursement will be available for any product that it may develop.

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

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

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

Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on Advaxis’ business and results of operations.

Changes in regulations, statutes or the interpretation of existing regulations could impact Advaxis’ business in the future by requiring, for example: (i) changes to its manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of its products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of Advaxis’ business.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. biopharmaceutical industry. The ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs and created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges, as well as efforts by the Trump administration to repeal or replace certain aspects of the ACA. For example, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, the Tax Reform Act includes a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” As a result of the individual mandate repeal, subsequent litigation challenged the validity of the ACA. On December 14, 2018, a U.S. District Court judge in the Northern District of Texas ruled that the individual mandate portion of the ACA is an essential and inseverable feature of the ACA, and therefore because the mandate was repealed as part of the Tax Cuts and Jobs Act, or TCJA, the remaining provisions of the ACA are invalid as well. The Trump administration and CMS have both stated that the ruling will have no immediate effect, and on December 30, 2018 the same judge issued an order staying the judgment pending appeal. A Fifth Circuit U.S. Court of Appeals hearing to determine whether certain states and the House of Representatives have standing to appeal the lower court decision was held on July 9, 2019, but it is unclear when the court will render its decision on this hearing, and what effect it will have on the status of the ACA. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. Advaxis will continue to evaluate the effect that the ACA and its possible repeal and replacement has on its business.

Since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Further, the Trump administration has concluded that cost-sharing reduction, or CSR, payments to insurance companies required under the ACA have not received necessary appropriations from Congress and announced that it will discontinue these payments immediately until those appropriations are made. The loss of the CSR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA. Bipartisan bills to appropriate funds for CSR payments were proposed in 2017 and 2018, but the proposals have not been enacted into law. Multiple state Attorneys General filed suit to stop the administration from terminating the subsidies, but their case was dismissed by a federal judge in California on July 18, 2018. Furthermore, on June 14, 2018, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor payments to third-party payors who argued were owed to them. The effects of this gap in reimbursement on third-party payors, the viability of the ACA marketplace and providers, and the potential effect on Advaxis’ business, are not yet known.

Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of Advaxis’ business may rely, which could negatively impact its business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect Advaxis’ business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process Advaxis’ regulatory submissions, which could have a material adverse effect on its business. Further, upon completion of this offering and in Advaxis’ operations as a public company, future government shutdowns could impact its ability to access the public markets and obtain necessary capital in order to properly capitalize and continue its operations.

Approval of Advaxis’ product candidates does not ensure successful commercialization and reimbursement.

Advaxis is not currently marketing its product candidates, nor can it until they are approved; however, Advaxis is seeking partnering and commercial opportunities for its products. Advaxis cannot assure you that it will be able to commercialize any of its product candidates itself or find a commercialization partner or that it will be able to agree to acceptable terms with any partner to launch and commercialize its products.

The commercial success of Advaxis’ product candidates is subject to risks in both the United States and European countries. In addition, in European countries, pricing and payment of prescription pharmaceuticals is subject to more extensive governmental control than in the United States. Pricing negotiations with European governmental authorities can take six to 12 months or longer after the receipt of regulatory approval and product launch. If reimbursement is unavailable in any country in which reimbursement is sought, limited in scope or amount, or if pricing is set at or reduced to unsatisfactory levels, Advaxis’ ability or any potential partner’s ability to successfully commercialize in such a country would be impacted negatively. Furthermore, if these measures prevent Advaxis or any potential partner from selling on a profitable basis in a particular country, they could prevent the commercial launch or continued sale in that country and could adversely impact the commercialization market opportunity in other countries.

Moreover, as a condition of approval, the regulatory authorities may require that Advaxis conduct post-approval studies. Those studies may reveal new safety or efficacy findings regarding Advaxis’ drug that could adversely impact the continued commercialization or future market opportunity in other countries.

In addition, Advaxis predominantly relies on a network of suppliers and vendors to manufacture its products. Should a regulatory authority make any significant findings on an inspection of Advaxis’ own operations or the operations of those companies, the ability for it to continue producing its products could be adversely impacted and further production could cease. Regulatory GMP requirements are extensive and can present a risk of injury or recall, among other risks, if not manufactured or labeled properly under GMPs.

Advaxis’ potential revenues from the commercialization of its product candidates are subject to these and other factors, and therefore it may never reach or maintain profitability.

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

In addition, if one of Advaxis’ products is approved for marketing, it will be subject to significant regulatory obligations regarding product promotion, the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that Advaxis’ third-party providers comply) with cGMPs, and GCPs for any clinical trials that it conducts post-approval. In addition, there is always the risk that Advaxis or a regulatory authority might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with Advaxis product candidates’ post-market approval could have a material adverse effect on its business, financial condition and results of operations.

Risks Related to Advaxis’ Intellectual Property

Advaxis relies on patents to protect its technology. Advaxis may be unable to protect its intellectual property rights and it may be liable for infringing the intellectual property rights of others.

Advaxis’ ability to compete effectively will depend on its ability to maintain the proprietary nature of its technologies, including the Lm-LLO based immunotherapy platform technology, and the proprietary technology of others with whom Advaxis has entered into collaboration and licensing agreements.

Currently, Advaxis owns or have rights to several hundred patents and applications, which are owned, licensed from, or co-owned with Penn and Merck. Advaxis has obtained the rights to all future patent applications in this field originating in the laboratories of Dr. Yvonne Paterson and Dr. Fred Frankel, at the University of Pennsylvania.

Advaxis owns or hold licenses to a number of issued patents and U.S. pending patent applications, as well as foreign patents and foreign counterparts. Advaxis’ success depends in part on its ability to obtain patent protection both in the United States and in other countries for its product candidates, as well as the methods for treating patients in the product indications using these product candidates. Such patent protection is costly to obtain and maintain, and Advaxis cannot guarantee that sufficient funds will be available. Advaxis’ ability to protect its product candidates from unauthorized or infringing use by third parties depends in substantial part on its ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, Advaxis’ ability to obtain, maintain and enforce patents is uncertain and involves complex legal and factual questions. Even if Advaxis’ product candidates, as well as methods for treating patients for prescribed indications using these product candidates are covered by valid and enforceable patents and have claims with sufficient scope, disclosure and support in the specification, the patents will provide protection only for a limited amount of time. Accordingly, rights under any issued patents may not provide Advaxis with sufficient protection for its product candidates or provide sufficient protection to afford it a commercial advantage against competitive products or processes.

In addition, Advaxis cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to Advaxis. Even if patents have issued or will issue, Advaxis cannot guarantee that the claims of these patents are or will be valid or enforceable or will provide it with any significant protection against competitive products or otherwise be commercially valuable to Advaxis. The laws of some foreign jurisdictions do not protect intellectual property rights to the same extent as in the United States and many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions. Furthermore, different countries have different procedures for obtaining patents, and patents issued in different countries offer different degrees of protection against use of the patented invention by others. If Advaxis encounters such difficulties in protecting or are otherwise precluded from effectively protecting its intellectual property rights in foreign jurisdictions, its business prospects could be substantially harmed.

The patent positions of biotechnology and pharmaceutical companies, including Advaxis’ patent position, involve complex legal and factual questions, and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated, or circumvented as a result of laws, rules and guidelines that are changed due to legislative, judicial or administrative actions, or review, which render Advaxis’ patents unenforceable or invalid. Advaxis’ patents can be challenged by its competitors who can argue that its patents are invalid, unenforceable, lack utility, sufficient written description or enablement, or that the claims of the issued patents should be limited or narrowly construed. Patents also will not protect Advaxis’ product candidates if competitors devise ways of making or using these product candidates without infringing its patents.

Advaxis will be able to protect its proprietary rights from unauthorized use by third parties only to the extent that its technologies, methods of treatment, product candidates, and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets and Advaxis has the funds to enforce its rights, if necessary.

The expiration of Advaxis’ owned or licensed patents before completing the research and development of its product candidates and receiving all required approvals in order to sell and distribute the products on a commercial scale can adversely affect Advaxis’ business and results of operations.

Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming. If Advaxis is involved in such litigation, it could cause delays in bringing product candidates to market and harm its ability to operate.

Advaxis’ success will depend in part on its ability to operate without infringing the proprietary rights of third parties. The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may obtain patents in the future and allege that the products or use of Advaxis’ technologies infringe these patent claims or that it is employing their proprietary technology without authorization.

In addition, third parties may challenge or infringe upon Advaxis’ existing or future patents. Proceedings involving Advaxis’ patents or patent applications or those of others could result in adverse decisions regarding:

Even if Advaxis is successful in these proceedings, it may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on Advaxis. If Advaxis is unable to avoid infringing the patent rights of others, it may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. Advaxis may not have sufficient resources to bring these actions to a successful conclusion. In addition, if Advaxis does not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared valid, Advaxis may:

Advaxis may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

Advaxis also relies on trade secrets to protect its proprietary technologies, especially where it does not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Advaxis relies in part on confidentiality agreements with its employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors to protect its 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 Advaxis’ trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of Advaxis’ proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect its competitive business position.

Some of Advaxis’ products are dependent upon its license agreement with Penn; if Advaxis breaches the license agreement and/or fail to make payments due and owing to Penn under its license agreement, its business may be materially and adversely affected.

Pursuant to the terms of Advaxis’ license agreement with Penn, which has been amended from time to time, it has acquired exclusive worldwide licenses for patents and patent applications related to its proprietary Listeria vaccine technology. The license provides Advaxis with the exclusive commercial rights to the patent portfolio developed at Penn as of the effective date of the license, in connection with Dr. Paterson and requires Advaxis to pay various milestone, legal, filing and licensing payments to commercialize the technology. As of July 31, 2022, Advaxis did not have outstanding payables to Penn. Advaxis can provide no assurance that it will be able to make all future payments due and owing thereunder, that such licenses will not be terminated or expire during critical periods, that it will be able to obtain licenses from Penn for other rights that may be important to Advaxis, or, if obtained, that such licenses will be obtained on commercially reasonable terms. The loss of any current or future licenses from Penn or the exclusivity rights provided therein could materially harm Advaxis’ business, financial condition and operating results.

If Advaxis is unable to obtain licenses needed for the development of its product candidates, or if it breaches any of the agreements under which Advaxis licenses rights to patents or other intellectual property from third parties, it could lose license rights that are important to its business.

If Advaxis is unable to maintain and/or obtain licenses needed for the development of its product candidates in the future, it may have to develop alternatives to avoid infringing on the patents of others, potentially causing increased costs and delays in drug development and introduction or precluding the development, manufacture, or sale of planned products. Some of Advaxis’ licenses provide for limited periods of exclusivity that require minimum license fees and payments and/or may be extended only with the consent of the licensor. Advaxis can provide no assurance that it will be able to meet these minimum license fees in the future or that these third parties will grant extensions on any or all such licenses. This same restriction may be contained in licenses obtained in the future.

Additionally, Advaxis can provide no assurance that the patents underlying any licenses will be valid and enforceable. To the extent any products developed by Advaxis are based on licensed technology, royalty payments on the licenses will reduce its gross profit from such product sales and may render the sales of such products uneconomical. In addition, the loss of any current or future licenses or the exclusivity rights provided therein could materially harm Advaxis’ business, financial condition and its operations.

Risks Related to Ownership of Advaxis’ Securities

Because Advaxis is quoted on the OTCQX instead of an exchange or national quotation system, its investors find it more difficult to trade in its stock or might experience volatility in the market price of Advaxis’ Common Stock.

Advaxis’ Common Stock is quoted on the OTCQX. The OTCQX is often highly illiquid, in part because it does not have a national quotation system by which potential investors can follow the market price of shares except through information received and generated by a limited number of broker-dealers that make markets in particular stocks. There is a greater chance of volatility for securities that are quoted on the OTCQX as compared to a national exchange or quotation system. This volatility may be caused by a variety of factors, including the lack of readily available price quotations, the absence of consistent administrative supervision of bid and ask quotations, lower trading volume, and market conditions. Investors in Advaxis’ Common Stock may experience high fluctuations in the market price and volume of the trading market for its securities. These fluctuations, when they occur, have a negative effect on the market price for Advaxis’ securities. Accordingly, Advaxis stockholders may not be able to realize a fair price from their shares when they determine to sell them or may have to hold them for a substantial period of time until the market for its Common Stock improves.

Advaxis’ stock is quoted on the OTCQX, if it fails to remain current on its reporting requirements, Advaxis could be removed from the OTCQX which would limit the ability of broker-dealers to sell its securities in the secondary market.

Companies trading on the OTCQX, must be reporting issuers under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and must be current in their reports under Section 13, in order to maintain price quotation privileges on the OTCQX. As a result, the market liquidity for Advaxis’ securities could be severely adversely affected by limiting the ability of broker-dealers to sell its securities and the ability of stockholders to sell their securities in the secondary market. In addition, it may be unable to get relisted on the OTCQX, which may have an adverse material effect on Advaxis.

Advaxis could issue additional “blank check” preferred stock without stockholder approval with the effect of diluting then current stockholder interests and impairing their voting rights, and provisions in its charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.

Advaxis’ certificate of incorporation, as amended, provides that it may authorize and issue up to 5,000,000 shares of “blank check” preferred stock with designations, rights, and preferences as may be determined from time to time by Advaxis’ Board. Advaxis’ Board is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting, or other rights, which could dilute the interest of or impair the voting power of its holders of Common Stock. The issuance of a series of preferred stock could be used as a method of discouraging, delaying, or preventing a change in control. For example, it would be possible for Advaxis’ Board to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of Advaxis.

Sales of additional equity securities may adversely affect the market price of Advaxis’ Common Stock and your rights may be reduced.

Advaxis expects to continue to incur drug development and selling, general and administrative costs, and to satisfy its funding requirements, it will need to sell additional equity securities, which may be subject to registration rights and warrants with anti-dilutive protective provisions. The sale or the proposed sale of substantial amounts of Advaxis’ Common Stock or other equity securities in the public markets may adversely affect the market price of its Common Stock and stock price may decline substantially. Advaxis shareholders may experience substantial dilution and a reduction in the price that they are able to obtain upon sale of their shares. Also, new equity securities issued may have greater rights, preferences or privileges than Advaxis’ existing Common Stock.

The price of Advaxis’ Common Stock and warrants may be volatile.

The trading price of Advaxis’ Common Stock and warrants may fluctuate substantially. The price of Advaxis’ Common Stock and warrants that will prevail in the market may be higher or lower than the price you have paid, depending on many factors, some of which are beyond Advaxis’ control and may not be related to its operating performance. These fluctuations could cause you to lose part or all of your investment in Advaxis’ Common Stock and warrants. Those factors that could cause fluctuations include, but are not limited to, the following:

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. Due to the potential volatility of Advaxis’ stock price, it may therefore be the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from its business.

The market prices for Advaxis’ Common Stock may be adversely impacted by future events.

Advaxis’ Common Stock began trading on the over-the-counter-markets on July 28, 2005 and is currently quoted on the OTCQX under the symbol ADXS. Market prices for Advaxis’ Common Stock and warrants will be influenced by a number of factors, including:

So long as Advaxis’ Common Stock continues to be quoted on the OTCQX, it could be subject to the so-called “penny stock” rules that impose restrictive sales practice requirements.

As Advaxis’ Common Stock has been de-listed from The Nasdaq Capital Market and is now quoted on the OTCQX, which is not a “national securities exchange” as defined by the Exchange Act, and thus its Common Stock will be become subject to the so-called “penny stock” rules if the shares have a market value of less than $5.00 per share. The SEC has adopted regulations that define a penny stock to include any stock that has a market price of less than $5.00 per share, subject to certain exceptions, including an exception for stock traded on a national securities exchange. The SEC regulations impose restrictive sales practice requirements on broker-dealers who sell penny stocks to persons other than established customers and accredited investors. An accredited investor generally is a person whose individual annual income exceeded $200,000, or whose joint annual income with a spouse exceeded $300,000 during the past two years and who expects their annual income to exceed the applicable level during the current year, or a person with net worth in excess of $1.0 million, not including the value of the investor’s principal residence and excluding mortgage debt secured by the investor’s principal residence up to the estimated fair market value of the home, except that any mortgage debt incurred by the investor within 60 days prior to the date of the transaction shall not be excluded from the determination of the investor’s net worth unless the mortgage debt was incurred to acquire the residence. For transactions covered by this rule, the broker-dealer must make a special suitability determination for the purchaser and must have received the purchaser’s written consent to the transaction prior to sale. This means that so long as Advaxis’ Common Stock is not listed on a national securities exchange, the ability of stockholders to sell their Common Stock in the secondary market could be adversely affected.

If a transaction involving a penny stock is not exempt from the SEC’s rule, a broker-dealer must deliver a disclosure schedule relating to the penny stock market to each investor prior to a transaction. The broker-dealer also must disclose the commissions payable to both the broker-dealer and its registered representative, current quotations for the penny stock, and, if the broker-dealer is the sole market-maker, the broker-dealer must disclose this fact and the broker-dealer’s presumed control over the market. Finally, monthly statements must be sent disclosing recent price information for the penny stock held in the customer’s account and information on the limited market in penny stocks.

Advaxis may be at an increased risk of securities litigation, which is expensive and could divert management attention.

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

Advaxis does not intend to pay cash dividends.

Advaxis has not declared or paid any cash dividends on its Common Stock, and it does not anticipate declaring or paying cash dividends for the foreseeable future. Any future determination as to the payment of cash dividends on Advaxis’ Common Stock will be at its Board of Directors’ discretion and will depend on its financial condition, operating results, capital requirements and other factors that its Board of Directors considers to be relevant.

Advaxis’ certificate of incorporation, bylaws and Delaware law have anti-takeover provisions that could discourage, delay or prevent a change in control, which may cause Advaxis’ stock price to decline.

Advaxis’ certificate of incorporation, Bylaws and Delaware law contain provisions which could make it more difficult for a third party to acquire Advaxis, even if closing such a transaction would be beneficial to its shareholders. Advaxis is authorized to issue up to 5,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by Advaxis’ Board of Directors without further action by shareholders. The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of the holders of Advaxis’ Common Stock, and therefore, reduce the value of its Common Stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict Advaxis’ ability to merge with, or sell its assets to, a third party and thereby preserve control by the present management.

Provisions of Advaxis’ certificate of incorporation, Bylaws and Delaware law also could have the effect of discouraging potential Acquisition Proposals or making a tender offer or delaying or preventing a change in control, including changes a shareholder might consider favorable. Such provisions may also prevent or frustrate attempts by Advaxis shareholders to replace or remove its management. In particular, the certificate of incorporation, Bylaws and Delaware law, as applicable, among other things; provide the Board of Directors with the ability to alter the By-laws without shareholder approval and provide that vacancies on the Board of Directors may be filled by a majority of directors in office, and less than a quorum.

These provisions are expected to discourage certain types of coercive takeover practices and inadequate takeover bids and to encourage persons seeking to acquire control of Advaxis to first negotiate with its board. These provisions may delay or prevent someone from acquiring or merging with Advaxis, which may cause the market price of its Common Stock to decline.

Risks Related to the Business of Ayala

You should carefully consider the risks and uncertainties described below and the other information included in this proxy statement/prospectus before making an investment in Ayala’s Common Stock. Ayala’s business, financial condition, results of operations, or prospects could be materially and adversely affected if any of these risks occurs, and as a result, the market price of Ayala’s Common Stock could decline and you could lose all or part of your investment. This proxy statement/prospectus also contains forward-looking statements that involve risks and uncertainties. See “Cautionary Statement Concerning Forward-Looking Statements.” Ayala’s actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.

Risks Related to Ayala’s Financial Position and Need for Additional Capital

Ayala has incurred significant losses since inception and anticipates that it will continue to incur losses for the foreseeable future. Ayala is not currently profitable, and may never achieve or sustain profitability. If Ayala is unable to achieve or sustain profitability, the market value of its common stock will likely decline.

Ayala is a clinical-stage biopharmaceutical company with a limited operating history and has incurred significant losses since its formation. Ayala had a net loss of approximately $10.2 million and $28.4 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022, Ayala had an accumulated deficit of $139.6 million. As noted below, Ayala has identified conditions and events that raise substantial doubt about its ability to continue as a going concern. Ayala has not commercialized any products and has never generated revenue from the commercialization of any product. To date, Ayala has devoted most of its financial resources to licensing product candidates and research and development, including its preclinical development activities and clinical trials.

Ayala expects to incur significant operating expenses and increasing net losses for the next several years, at least, as it advances AL101, AL102 and any future product candidate through preclinical and clinical development, seek regulatory approvals and commercialize AL101, AL102 or any other product candidate, if approved. The costs of advancing product candidates into each clinical phase tend to increase substantially over the duration of the clinical development process. Therefore, the total costs to advance any of Ayala’s product candidates to marketing approval in even a single jurisdiction will be substantial. Because of the numerous risks and uncertainties associated with pharmaceutical product development, Ayala is unable to accurately predict the timing or amount of increased expenses or when, or if, Ayala will be able to begin generating revenue from the commercialization of any products or achieve or maintain profitability. Ayala’s expenses will also increase substantially if and as Ayala:

Furthermore, Ayala’s ability to successfully develop, commercialize and license any product candidates and generate product revenue is subject to substantial additional risks and uncertainties, as described under “Risks Related to the Business of Ayala—Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval” and “Risks Related to the Business of Ayala—Risks Related to Commercialization.” As a result, Ayala expects to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on Ayala’s stockholders’ equity and working capital. The amount of Ayala’s future net losses will depend, in part, on the rate of future growth of its expenses and ability to generate revenues. If Ayala is unable to develop and commercialize one or more product candidates, either alone or through collaborations, or if revenues from any product that receives marketing approval are insufficient, Ayala will not achieve profitability. Even if Ayala does achieve profitability, Ayala may not be able to sustain profitability or meet outside expectations for its profitability. If Ayala is unable to achieve or sustain profitability or to meet outside expectations for its profitability, the value of its common stock will be materially and adversely affected.

Ayala’s recurring losses from operations raise substantial doubt regarding its ability to continue as a going concern.

Ayala has incurred significant losses since its inception and has never generated revenue or profit, and it is possible Ayala will never generate revenue or profit. As of September 30, 2022, Ayala had cash and cash equivalents and restricted bank deposits totaling $11.5 million. Based on Ayala’s current operating plans, and without additional funding, Ayala believes it will not have sufficient funds to meet its obligations within the next twelve months from the issuance of Ayala’s unaudited and audited consolidated financial statements that are included elsewhere in this proxy statement/prospectus. These factors raise substantial doubt about Ayala’s ability to continue as a going concern. Ayala will need to raise additional capital to fund its future operations and remain as a going concern. There can be no assurance that Ayala will be able to obtain additional funding on acceptable terms, if at all. To the extent that Ayala raises additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which dilution may be significant. However, Ayala cannot guarantee that it will be able to obtain any or sufficient additional funding or that such funding, if available, will be obtainable on terms satisfactory to Ayala. In the event that Ayala is unable to obtain any or sufficient additional funding, there can be no assurance that Ayala will be able to continue as a going concern, and Ayala will be forced to delay, reduce or discontinue its product development programs or commercialization efforts.

Substantial doubt about Ayala’s ability to continue as a going concern may materially and adversely affect the price per share of its common stock, and it may be more difficult for Ayala to obtain financing. If potential collaborators decline to do business with Ayala or potential investors decline to participate in any future financings due to such concerns, Ayala’s ability to increase its cash position may be limited. The perception that Ayala may not be able to continue as a going concern may cause others to choose not to deal with Ayala due to concerns about Ayala’s ability to meet its contractual obligations.

Ayala has prepared its consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Ayala’s unaudited and audited consolidated financial statements included in this proxy statement/prospectus do not include any adjustments to reflect the possible inability of Ayala to continue as a going concern within one year after the issuance of such financial statements. If Ayala is unable to continue as a going concern, you could lose all or part of your investment in Ayala.

Ayala will require additional capital to fund its operations, and if Ayala fails to obtain necessary financing, it may not be able to complete the development and commercialization of AL101 and AL102.

Ayala expects to spend substantial amounts of capital to complete the development of, seek regulatory approvals for and, if approved, commercialize AL101 and AL102. These expenditures will include costs related to Ayala’s clinical development and costs associated with its license agreement with BMS under which Ayala is obligated to make milestone payments, royalty payments in connection with the sale of resulting products and payments consisting of a portion of all consideration Ayala receives in connection with the sublicense or assignment of any patent rights Ayala licensed from BMS. For more information regarding this agreement, please see “Ayala’s Business—License Agreements.”

Ayala anticipates that it will use its cash and cash equivalents, including the net proceeds from its initial public offering, or IPO, and other issuances of common stock and short-term restricted bank deposits, to advance the clinical development of AL101 and AL102 and the remainder, if any, for working capital and general corporate purposes.

Ayala will require additional capital to enable it to complete the development and commercialization of AL101 for the treatment of R/M ACC, and R/R T-ALL, AL102 for the treatment of desmoid tumors and any other potential indications, if approved, which Ayala may obtain through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources. Adequate additional financing may not be available to Ayala on acceptable terms, or at all. Ayala’s failure to raise capital as and when needed would have a negative effect on its financial condition and its ability to pursue its business strategy. In addition, attempting to secure additional financing may divert the time and attention of Ayala’s management from day-to-day activities and harm Ayala’s development efforts.

As noted above, Ayala has identified conditions and events that raise substantial doubt about its ability to continue as a going concern. Because the length of time and activities associated with successful development of AL101 and AL102 is highly uncertain, Ayala is unable to estimate the actual funds it will require for development and any approved marketing and commercialization activities. Ayala’s future funding requirements, both near and long-term, will depend on many factors, including, but not limited to: