As filed with the Securities and Exchange Commission on December 8, 2022
Registration No. 333-268586
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
President and Chief Executive Officer
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to: | ||||
Justin W. Chairman Morgan, Lewis & Bockius LLP 1701 Market Street New York, New York 19103 (215) 963-6000 |
Roni Mamluk, Ph.D. Ayala President and Chief Executive Officer Ayala Pharmaceuticals, Inc. Oppenheimer 4 Rehovot 7670104, Israel (857) 444-0553 |
Peter N. Handrinos Joshua M. Dubofsky Elisabeth M. Martin Latham & Watkins LLP 200 Clarendon Street Boston, MA 02116 (617) 948-6000 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.
If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box: ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer) ☐
Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) ☐
The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
DATED December 8, 2022
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PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT
To the Stockholders of Ayala Pharmaceuticals, Inc.,
Ayala Pharmaceuticals, Inc., a Delaware corporation (“Ayala”), Advaxis, Inc., a Delaware corporation (“Advaxis”), and Doe Merger Sub, Inc. (“Merger Sub”), a direct, wholly-owned subsidiary of Advaxis, entered into an Agreement and Plan of Merger (the “Merger Agreement”), on October 18, 2022, pursuant to which Merger Sub will merge with and into Ayala, with Ayala surviving as a wholly owned subsidiary of Advaxis, and the surviving company of the merger, which transaction is referred to herein as the Merger. Advaxis following the Merger is referred to herein as the combined company.
At the effective time of the Merger (the “Effective Time”) each share of Ayala’s Common Stock, par value $0.01 per share, (the “Ayala Common Stock”), issued and outstanding immediately prior to the Effective Time (other than shares held in treasury, if any) will be converted into the right to receive a number of shares of Advaxis’ Common Stock, par value $0.001 per share (the “Advaxis Common Stock”), equal to the exchange ratio, which was initially 0.1874 shares as of October 18, 2022 and may be adjusted at the closing of the Merger based on the formula set forth in the Merger Agreement (the “Exchange Ratio”) described in more detail in the section titled “The Merger Agreement—Merger Consideration” beginning on page 181 of the accompanying proxy statement/prospectus.
In addition, each outstanding option to purchase shares of the Ayala Common Stock (each, an “Ayala Option”) unexercised immediately before the Effective Time, automatically and without any action on the part of the holder thereof, shall be assumed by Advaxis and converted into an option for Advaxis Common Stock (each, an “Advaxis Replacement Option”) with the number of shares subject to, and the per share exercise price of, such option adjusted to reflect the Exchange Ratio. Each such substituted Advaxis Replacement Option shall continue to have, and shall be subject to, the same terms and conditions (including the applicable time-vesting and/or performance-vesting conditions) as applied to the Ayala Option immediately prior to the Effective Time. Further, each warrant to purchase shares of Ayala Common Stock (the “Ayala Common Warrants”), shall, upon the effective time of the Merger, become warrants to purchase Advaxis Common Stock (the “Advaxis Replacement Warrants”). The Holders of the Ayala Common Warrants shall have the right to receive, upon exercise of their Ayala Replacement Warrants, the number of shares subject to the warrant to be adjusted to reflect the Exchange Ratio. Ayala’s pre-funded warrants to purchase common stock shall be automatically net exercised in accordance with their terms immediately prior to the Effective Time and the holders of the pre-funded warrants will hold Ayala Common Stock at the Effective Time as a result of such exercise. All other securities of Ayala shall be cancelled and shall be of no further force and effect from the Effective Time of the Merger and shall not be assumed or converted into a right to receive any shares of Advaxis Common Stock.
Each share of Advaxis Common Stock and option to purchase Advaxis Common Stock that is issued and outstanding at the Effective Time of the Merger will remain issued and outstanding, and such shares and options will be unaffected by 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.
Shares of Advaxis Common Stock are currently quoted on OTCQX under the symbol “ADXS.” On December 7, 2022 the last trading day before the date of the accompanying proxy statement/prospectus, the closing sale price of Advaxis Common Stock on the OTCQX was $1.49 per share. After completion of the Merger, it is expected that the common stock of the combined company will be quoted on the OTCQX under the symbol “ADXS”. Advaxis intends to file an initial listing application with The Nasdaq Stock Market LLC (“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. However, 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. While Ayala and Advaxis intend to use their best commercially practicable efforts to have the stock of the combined company approved for listing on Nasdaq as of the closing of the Merger or promptly thereafter, no assurance can be made that these efforts will be successful.
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Ayala stockholders are cordially invited to attend the special meeting of Ayala stockholders. Ayala is holding its special meeting of stockholders, or the Ayala Special Meeting, on January 13, 2023, at 10:00 a.m. Eastern Time, unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the Merger and related matters. The Ayala Special Meeting will be held entirely as a virtual meeting. Ayala stockholders will be able to attend and participate in the Ayala Special Meeting online by visiting www.virtualshareholdermeeting.com/AYLA2023SM where they will be able to listen to the meeting live, submit questions and vote. At the Ayala Special Meeting, Ayala will ask its stockholders to:
● | approve the adoption of the Merger Agreement, which is further described in the section titled “The Merger Agreement” and a copy of which is attached to this proxy statement/prospectus as Annex A (the “Ayala Merger Proposal”); and |
● | approve the adjournment of the Ayala Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes to approve the Ayala Merger Proposal. |
As described in the accompanying proxy statement/prospectus, certain Ayala stockholders who in the aggregate own approximately 42.5% of the Ayala Common Stock as of October 31, 2022, are parties to voting and support agreements with Advaxis (the “Voting Agreements”), whereby such stockholders have agreed to vote in favor of, and to adopt and approve, the Merger Agreement, the Merger and the related transactions at any meeting of Ayala’s stockholders, as applicable (or any adjournment or postponement thereof), subject to the terms of the Voting Agreements.
After careful consideration, the Ayala board of directors (the “Ayala Board”) has approved the Merger Agreement and has determined that it is advisable to consummate the Merger. The Ayala Board has approved the proposals described in the accompanying proxy statement/prospectus and unanimously recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.
More information about Advaxis, Ayala, the Merger Agreement and the transactions contemplated thereby (collectively the “Transactions”), and the foregoing proposals is contained in the accompanying proxy statement/prospectus. Ayala urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 25 OF THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS.
Ayala is excited about the opportunities the Merger brings to Ayala’s stockholders and thanks you for your consideration and continued support.
Sincerely,
/s/ Roni Mamluk
Roni Mamluk, Ph.D.
President and Chief Executive Officer
Ayala Pharmaceuticals, Inc.
Neither the U.S. Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the accompanying proxy statement/prospectus. Any representation to the contrary is a criminal offense.
The accompanying proxy statement/prospectus is dated December 8, 2022 and is first being mailed to Ayala stockholders on or about December 12, 2022.
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AYALA PHARMACEUTICALS, INC.
Oppenheimer 4
Rehovot 7670104, Israel
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD JANUARY 13, 2023
To the Stockholders of Ayala Pharmaceuticals, Inc.:
NOTICE IS HEREBY GIVEN that Ayala Pharmaceuticals, Inc. (“Ayala”) will hold a virtual special meeting of stockholders (the “Ayala Special Meeting”), 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 as a virtual meeting. 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.
The Ayala Special Meeting will be held for the following purposes:
1. | To consider and vote upon the proposal to adopt the Agreement and Plan of Merger (the “Merger Agreement”), dated as of October 18, 2022, as amended or supplemented from time to time, by and among Ayala, Advaxis, Inc. (“Advaxis”) and Doe Merger Sub, Inc. (“Merger Sub”), a direct, wholly-owned subsidiary of Advaxis, pursuant to which Merger Sub will merge with and into Ayala, with Ayala surviving as a wholly-owned subsidiary of Advaxis, as more fully described in the attached proxy statement/prospectus (the “Ayala Merger Proposal”); and | |
2. | To consider and vote upon the proposal to approve the adjournment of the Ayala Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Ayala Merger Proposal (the “Ayala Adjournment Proposal”). |
Record Date: |
Ayala’s board of directors has fixed December 7, 2022 as the record date for the determination of stockholders entitled to notice of, and to vote at, the Ayala Special Meeting and any adjournment or postponement thereof (the “Record Date”). Only holders of record of shares of Ayala Common Stock at the close of business on the Record Date are entitled to notice of, and to vote at, the Ayala Special Meeting. At the close of business on the Record Date, Ayala had 14,820,727 shares of common stock outstanding and entitled to vote. |
Your vote is important. The affirmative vote of the holders of a majority of the outstanding shares of Ayala Common Stock entitled to vote at the Ayala Special Meeting is required for approval of the Ayala Merger Proposal. Approval of the Ayala Merger Proposal is a condition to the completion of the Merger. Therefore, the Merger cannot be consummated without the approval of the Ayala Merger Proposal. The Ayala Merger Proposal is described in more detail in the section titled “The Merger Agreement” in the accompanying proxy statement/prospectus, which you should read carefully in its entirety before you vote. A copy of the Merger Agreement is attached as Annex A to the accompanying proxy statement/prospectus.
Even if you plan to virtually attend the Ayala Special Meeting, Ayala requests that you sign and return the enclosed proxy card or vote by mail or online to ensure that your shares will be represented at the Ayala Special Meeting if you are unable to virtually attend. You may change or revoke your proxy at any time before it is voted at the Ayala Special Meeting.
After careful consideration, the Ayala Board has approved the Merger Agreement and has determined that it is advisable to consummate the Merger. The Ayala Board has approved the proposals described in the accompanying proxy statement/prospectus and unanimously recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.
By Order of Ayala’s Board of Directors,
/s/ Yossi Maimon
Yossi Maimon
Chief Financial Officer, Secretary and Treasurer
Rehovot, Israel
December 8, 2022
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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 8, 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.
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TABLE OF CONTENTS
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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:
● | the plans, strategies and objectives of management for future operations, including the execution of integration and restructuring plans and the anticipated timing of filings; | |
● | plans to develop and commercialize products; | |
● | the plans, strategies and objectives of management with respect to the approval and consummation of the Merger; | |
● | the expected benefits of and potential value created by the Merger for the stockholders of Advaxis and Ayala; | |
● | the satisfaction of certain conditions to the completion of the Merger and whether and when the Merger will be consummated; | |
● | Advaxis’ ability to control and correctly estimate its operating expenses and its expenses associated with the Merger; | |
● | the attraction and retention of highly qualified personnel; | |
● | the ability to protect and enhance the combined organization’s products, product candidates and intellectual property; | |
● | expectations concerning Ayala’s relationships and actions with third parties; | |
● | the ability of the combined company to list on the Nasdaq; and | |
● | future regulatory, judicial and legislative changes in Ayala’s industry. |
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:
● | the risk that the conditions to the closing are not satisfied, including the failure to timely, or at all, obtain stockholder approval for the Merger; | |
● | uncertainties as to the timing of the consummation of the Merger; risks related to Advaxis’ ability to correctly estimate its operating expenses and its expenses associated with the Merger; | |
● | the ability of Advaxis, Ayala or the combined organization to protect its intellectual property rights; competitive responses to the Merger; | |
● | unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; | |
● | legislative, regulatory, political and economic developments; and | |
● | the risks set forth in the section titled “Risk Factors” in this proxy statement/prospectus. |
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.
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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:
1. | To approve the adoption of the Merger Agreement, pursuant to which Merger Sub will merge with and into Ayala, with Ayala surviving as a wholly-owned subsidiary of Advaxis (the “Ayala Merger Proposal”); and | |
2. | To approve the adjournment of the Ayala Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Ayala Merger Proposal (the “Ayala Adjournment Proposal”). |
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.
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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.
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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.
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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.
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● | You may vote your shares by proxy over the Internet, by telephone or by returning your proxy card by mail in the envelope provided. Instructions to vote over the Internet or by telephone are printed on your proxy card. To vote using the proxy card, please complete, sign and date the enclosed proxy card and return it promptly to Broadridge as provided on the proxy card. If you vote by proxy via telephone, over the Internet or by returning your signed proxy card to Broadridge before the Ayala Special Meeting, we will vote your shares as you direct. | |
● | To vote online during the Ayala Special Meeting, you must go to the meeting website at www.virtualshareholdermeeting.com/AYLA2023SM. Once admitted, during the Ayala Special Meeting, you may vote by following the instructions available on the meeting website. |
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.
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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.
● | You may return by mail another properly completed proxy card with a later date, which must be received at the address stated on the proxy card no later than 6:00 p.m., Eastern Time on January 12, 2023. | |
● | You may submit another properly completed proxy with a later date via the Internet or by telephone before the closing of those voting facilities at 11:59 p.m., Eastern Time on January 12, 2023. | |
● | You may participate in the virtual online Ayala Special Meeting and vote at the meeting. Simply participating in the virtual online meeting will not, by itself, revoke your proxy. | |
● | You may send a written notice that you are revoking your proxy to our Corporate Secretary at Ayala Pharmaceuticals, Inc., Oppenheimer 4, Rehovot 7670104, Israel, Attn: Corporate Secretary. |
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.
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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).
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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.
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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
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PROSPECTUS SUMMARY
This summary highlights selected information from this proxy statement/prospectus and may not contain all of the information that is important to you. To better understand the Merger and the proposals being considered at the Ayala Special Meeting, you should read this entire proxy statement/prospectus carefully, including the Merger Agreement and the other annexes to which you are referred in this proxy statement/prospectus. For more information, please see the section titled “Where You Can Find More Information” beginning on page 344 of this proxy statement/prospectus.
Overview of the Companies
Advaxis, Inc.
9 Deer Park Drive, Suite K-1
Monmouth Junction, New Jersey 08852
Telephone: (609) 452-9813
Advaxis is a clinical-stage biotechnology company focused on the development and commercialization of proprietary antigen delivery products, or Lm Technology™, based on a platform technology that utilizes live attenuated Listeria monocytogenes, or Lm, bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate anti-tumor T cell immunity, stimulate and activate the innate immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the Tumor Microenvironment, or TME, to enable the T cells to attack tumor cells.
Advaxis believes that Lm Technology™ immunotherapies can complement and address significant unmet needs in the current oncology treatment landscape. Specifically, our product candidates ADXS-PSA and ADXS-504 have the potential to enhance performance of other oncology treatments, while having a generally well-tolerated safety profile. Advaxis is currently winding down or has wound down clinical studies of Lm Technology™ immunotherapies in four program areas:
● | Non-small cell lung cancer (“ADXS-503”) | |
● | Human Papilloma Virus (“HPV”)-associated cancers (“AXAL”) | |
● | Personalized neoantigen-directed therapies | |
● | Human epidermal growth factor receptor-2 (“HER-2”) associated cancers |
All these clinical program areas are anchored in Advaxis’ Lm Technology™, a unique platform designed for its ability to safely and effectively target various cancers in multiple ways. While we are currently winding down clinical studies of Lm Technology™ immunotherapies in these four program areas, our license agreements continue with OS Therapies, LLC for ADXS-HER2 and with Global BioPharma, or GBP, for the exclusive license for the development and commercialization of AXAL in Asia, Africa, and the former USSR territory, exclusive of India and certain other countries.
Ayala Pharmaceuticals, Inc.
Oppenheimer 4
Rehovot 7670104
Israel
Telephone: (857) 444-0553
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Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including adenoid cystic carcinoma (“ACC”) and desmoid tumors. AL102 has received a designation from the U.S. Food and Drug Administration (the “FDA”) 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) and is currently in the Phase 2 portion of a pivotal study for patients with desmoid tumors (RINGSIDE). AL101 has received Fast Track designation and Orphan Drug Designation, or ODD, a designation from the FDA under the Orphan Drug Act, or ODA, intended to treat a rare disease or condition, and is currently in a Phase 2 clinical trial for patients with ACC (“ACCURACY”) bearing Notch activating mutations. For more information, visit www.ayalapharma.com.
Doe Merger Sub, Inc.
9 Deer Park Drive, Suite K-1
Monmouth Junction, New Jersey 08852
(609) 452-9813
Merger Sub is a direct, wholly owned subsidiary of Advaxis. Merger Sub was incorporated in the State of Delaware on October 14, 2022 solely for the purpose of carrying out the Merger. Merger Sub has not carried on any activities to date, except for activities incidental to its formation and activities undertaken in connection with the Merger.
The Merger (see page 140)
On October 18, 2022, Ayala entered into the Merger Agreement with Advaxis and Merger Sub, pursuant to which Merger Sub will merge with and into Ayala, with Ayala as the surviving corporation and becoming a wholly-owned subsidiary of Advaxis. If the Merger is completed, Merger Sub will merge with and into Ayala, with Ayala being the surviving entity as a wholly-owned subsidiary of Advaxis (collectively with the other transactions contemplated by the Merger Agreement, the “Transactions”).
Subject to the terms and conditions of the Merger Agreement, at the closing of the Merger, (i) each share of the common stock, par value $0.01 per share, of Ayala (the “Ayala Common Stock”) issued and outstanding immediately prior to the Merger (including restricted stock issued by Ayala under its 2017 Stock Incentive Plan) shall be automatically converted into the right to receive 0.1874 shares (as such amount may be adjusted as provided in the Merger Agreement, the “Exchange Ratio”) of the common stock, par value $0.001 per share, of Advaxis (the “Advaxis Common Stock”); (ii) each outstanding option to purchase shares of Ayala Common Stock (each, an “Ayala Option”) will be substituted and converted automatically into an option (each, a “Advaxis Replacement Option”) to purchase the number of shares of Advaxis Common Stock equal to the product obtained by multiplying (a) the number of shares of Ayala Common Stock subject such Ayala Option immediately prior to the Effective Time, by (b) the Exchange Ratio, with any fractional shares rounded down to the nearest whole share, with each such Advaxis Replacement Option to have an exercise price per share of Advaxis Common Stock equal to (x) the per share exercise price for the 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, and (iii) each restricted stock unit of Ayala (each, an “Ayala RSU”) outstanding immediately prior to the Effective Time, whether or not vested, will be substituted and converted automatically into a restricted stock unit award of Advaxis (each, an “Adjusted RSU”) with respect to a number of shares of Advaxis Common Stock 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 of the Merger by (ii) the Exchange Ratio, with any fractional shares rounded down to the nearest whole share.
Under the Exchange Ratio formula in the Merger Agreement, upon the closing of the Merger, on a pro forma basis and based upon the number of shares of Advaxis Common Stock expected to be issued in the Merger, 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.
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Each share of Advaxis Common Stock and option to purchase Advaxis Common Stock that is issued and outstanding at the Effective Time of the Merger will remain issued and outstanding, and such shares will be unaffected by the Merger.
For a more complete description of the Merger and the Exchange Ratio, please see the section titled “The Merger Agreement” in this proxy statement/prospectus.
The Merger will be completed as promptly as practicable, but in no event later than the three (3) business days after all of the conditions to consummation of the Merger set forth in the Merger Agreement are satisfied or waived (save and except for those conditions that by their nature are to be satisfied at the closing, but subject to the satisfaction or waiver of each of such conditions), including the adoption of the Merger Agreement by the Ayala stockholders and the approval by the Advaxis stockholders of the issuance of Advaxis Common Stock in the Merger. The Merger is anticipated to close promptly after the Ayala Special Meeting scheduled to be held on January 13, 2023. However, Advaxis and Ayala cannot predict the exact timing of the completion of the Merger because it is subject to the satisfaction or waiver of various conditions.
Reasons for the Merger (see pages 151 and 153)
Advaxis Reasons for the Merger
After consideration and consultation with its senior management and its financial and legal advisors, the Advaxis board of directors unanimously determined that the Merger Agreement, the Merger and other transactions contemplated thereby are advisable, fair to and in the best interests of Advaxis and its stockholders. The Advaxis board of directors considered various reasons to reach its determination. For example:
● | During its evaluation of the Merger Agreement and other Transactions, the Advaxis Board considered several factors in its decision to approve the Merger Agreement with Ayala. | |
● | The Advaxis Board assessed the financial condition and prospects of Advaxis and risks associated with continued operations; considered the expected cash resources of the combined company and the likelihood the combined company would possess sufficient cash resources to fund future product development; and analyzed the potential strategic alternatives of other merger partner candidates. Further, Advaxis management conducted scientific, regulatory, and technical due diligence of the regulatory pathway for, and market opportunity of, Ayala’s product candidates. The current financial market conditions and historical market prices, volatility, and trading information for Advaxis Common Stock was considered by the Advaxis Board as well. | |
● | The Advaxis Board considered that the combined company would be led by a board of directors with representation from each of the current boards of directors of Advaxis and Ayala. | |
● | The Advaxis Board’s consideration of the financial analyses of Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), including its opinion to the Advaxis Board, to the effect that, as of such date and based on and subject to various assumptions, matters considered and limitations, conditions and qualifications described in its opinion, the Exchange Ratio was fair, from a financial point of view, to Advaxis, as more fully described below under the caption “The Merger—Opinion of Advaxis’ Financial Advisor—Cantor Fitzgerald.” |
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● | The Advaxis Board also considered, in its deliberations, the variety of risks and other countervailing factors related to entering into the Merger Agreement, including the potential effect of the termination fee; substantial expense incurred in connection with the Merger; the scientific, technical, regulatory and other risks and uncertainties associated with the development and commercialization of Ayala’s product candidates; the risk of a lack of available sources of financing necessary to fund product development; and various other risks. | |
● | The Advaxis Board considers the factors overall to be favorable to, and to support, its determination of approval of the Merger Agreement. |
Ayala’s Reasons for the Merger
After consideration the Ayala board of directors (the “Ayala Board”), by a unanimous vote of all directors at its meeting on October 18, 2022, approved and declared advisable the Merger Agreement and the Merger, and recommended that Ayala stockholders vote to approve the Merger Agreement.
In the course of evaluating the Merger Agreement and the Transactions, the Ayala Board held numerous meetings and consulted with Ayala management and Ayala’s legal and financial advisors and considered a number of factors in reaching its decision to approve the Merger Agreement, the Merger and the other Transactions, which included the following (not in order of relative importance):
● | Consideration of Alternatives. The Ayala Board pursued several strategic and financing transactions for Ayala in 2022 and considered alternatives to the Merger and determined that entering into the Merger Agreement was more favorable to Ayala stockholders than other alternatives available to Ayala. | |
● | Challenges that Ayala Would Face on a Standalone Basis. The challenges facing Ayala if it were to continue on a standalone basis, including Ayala’s financial condition and prospects, including Ayala’s limited cash runway and the fact that Ayala’s management believed that Ayala’s cash and cash equivalents would not be sufficient to meet its obligations past the middle of the first quarter of 2023 (in contrast to Ayala’s pro forma cash runway through the fourth quarter of 2023 upon completion of the Merger), and Ayala’s inability to raise additional capital on reasonable terms; | |
● | Advaxis Net Cash. The expected cash resources of the combined company as of the closing of the Merger, resulting from the approximately $20 million of net cash expected to be held by Advaxis upon completion of the Merger that would be available to be invested in the combined company’s programs; | |
● | Participation in Potential Appreciation. After giving effect to the Merger, Ayala stockholders will own approximately 62.5% of the combined company’s outstanding common stock, and as a result, Ayala stockholders would participate in the future growth of the combined company after the consummation of the Merger; | |
● | Voting Agreements. The Voting and Support Agreements (the “Voting Agreements”), pursuant to which Israel Biotech Fund I, L.P. (“IBF I”), which owned approximately 22.24% of the outstanding shares of Ayala Common Stock as of the date of the Merger Agreement, and aMoon 2 Fund Limited Partnership (“aMoon”), which owned approximately 20.3% of the outstanding shares of Ayala Common Stock as of the date of the Merger Agreement, agreed to support the transaction and vote in favor of the adoption of the Merger Agreement, demonstrating strong support for a combination with Advaxis; | |
● | Financial Analyses of Torreya; Receipt of Fairness Opinion. The financial analyses of Torreya Capital, LLC (“Torreya”) and its oral opinion (which was subsequently confirmed in its written opinion, dated October 16, 2022) (the “Torreya Opinion”) to the Ayala Board to the effect that, as of that date and based upon and subject to certain assumptions, factors and qualifications, set forth in the Torreya Opinion, the Exchange Ratio was fair, from a financial point of view, to Ayala. |
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● | Terms of the Merger Agreement. The terms and conditions of the Merger Agreement, including: | ||
● | Ownership Split. The determination that the expected relative percentage ownership of Ayala’s stockholders (62.5%) and Advaxis’ stockholders (37.5%) in the combined company was appropriate, based on the Ayala Board’s judgment and assessment of the approximate valuations of Advaxis (including the value of the net cash Advaxis is expected to provide to the combined company) and Ayala; | ||
● | Tax Treatment. The expectation that the Merger will be treated as a “reorganization” within the meaning of Section 368(a) of the Code for U.S. federal income tax purposes, with the result that in the Merger the holders of Ayala Common Stock will generally not recognize taxable gain or loss for U.S. federal income tax purposes (other than with respect to cash received in lieu of a fractional share of Advaxis Common Stock); | ||
● | Reciprocity. The review by the Ayala Board, in consultation with Ayala’s advisors, of the structure of the Merger and the terms and conditions of the Merger Agreement, including certain reciprocal provisions that may have the effect of discouraging alternative Acquisition Proposals involving Ayala or Advaxis and their ability to terminate the Merger Agreement; | ||
● | Conditions to Consummation of the Merger. The limited number and nature of the conditions to the parties’ obligations to complete the Merger and the belief of the Ayala Board of the likelihood of satisfying such conditions; | ||
● | Right to Withdraw Recommendation to Ayala Stockholders. The right of Ayala under the Merger Agreement to consider certain unsolicited Acquisition Proposals should Ayala receive a superior proposal, and the right of the Ayala Board under certain circumstances to withdraw its recommendation to Ayala stockholders that they adopt the Merger Agreement; | ||
● | Opportunity to Vote. The opportunity of the Ayala stockholders to vote on the adoption of the Merger Agreement; and | ||
● | Termination Fee. The conclusion of the Ayala Board that the potential termination fees payable by Ayala or Advaxis to the other party, and the circumstances when such fee may be payable, were reasonable. | ||
● | The Ayala Board also considered various risks and other potentially negative factors concerning the Merger Agreement, the Merger and the other Transactions, which included the following factors: | ||
● | the challenges inherent in combining the businesses, operations and regulatory compliance systems of Ayala and Advaxis; | ||
● | the expectation that the combined company will need to raise substantial additional capital in the future, which could result in further dilution to stockholders; | ||
● | the fact that forecasts of future results of operations and synergies are necessarily estimates based on assumptions; |
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● | the possibility that the Merger might not be completed, or that completion might be unduly delayed, including as a result of Ayala’s stockholders failing to grant the requisite approvals to consummate the Merger, and the potential negative impact that may have on Ayala’s business and stockholders; | |
● | the risk to Ayala’s business, operations and financial results in the event that the Merger is not consummated, including the diminution of Ayala’s cash and the significant challenges associated with the need to raise additional capital through the public or private sale of equity securities; | |
● | the substantial costs to be incurred in connection with the Merger, including the cash and other costs of integrating the businesses of Ayala and Advaxis, as well as the transaction expenses arising from the Merger; | |
● | the terms of the Merger Agreement, including generally reciprocal covenants relating to (i) the two companies’ conduct of their respective businesses during the period between the signing of the Merger Agreement and the completion of the Merger, and (ii) the restrictions on the two companies’ ability to solicit alternative transaction proposals; | |
● | the likely detrimental effect on Ayala’s cash position, stock price and ability to initiate another process and to successfully complete an alternative transaction should the Merger not be completed; | |
● | the likelihood of disruptive stockholder litigation following announcement of the Merger; | |
● | the strategic direction of the combined company following the completion of the Merger; and | |
● | various other risks associated with the combined organization and the Merger, including those described in the section entitled “Risk Factors”, the matters described under “Cautionary Statement Concerning Forward-Looking Statements” and the matters described under “Certain Prospective Financial Information for Ayala” beginning on pages 25, 1 and 168, respectively, of this proxy statement/prospectus. |
For a more complete description of the reasons for the Merger, please see the sections titled “The Merger—Advaxis Reasons for the Merger” and “The Merger—Ayala’s Reasons for the Merger; Recommendation of the Ayala Board” beginning on pages 151 and 153, respectively, of this proxy statement/prospectus.
Opinion of Advaxis’ Financial Advisor (see page 156)
Advaxis retained Cantor Fitzgerald & Co. (“Cantor Fitzgerald”) to act as its financial advisor in connection with the Merger. In connection with the Merger, Cantor Fitzgerald rendered its opinion to the Advaxis Board on October 18, 2022, to the effect that, as of that date and based on and subject to various assumptions, matters considered and limitations, conditions and qualifications described in its opinion, the Exchange Ratio was fair, from a financial point of view, to Advaxis.
The full text of Cantor Fitzgerald’s opinion describes the assumptions made, procedures followed, matters considered and limitations on the review undertaken by Cantor Fitzgerald. This opinion is attached as Annex C and is incorporated herein by reference. Cantor Fitzgerald’s opinion was provided for the benefit and use of the Advaxis Board (in its capacity as such) in connection with its consideration of the Merger. Cantor Fitzgerald’s opinion did not constitute a recommendation to the Advaxis Board in connection with the Merger, nor did the opinion constitute a recommendation to any holders of common stock of Advaxis or Ayala as to how they should vote or act with respect to the Merger or any related matter. Cantor Fitzgerald’s opinion did not address Advaxis’ underlying business decision to pursue the Merger, the relative merits of the Merger as compared to any alternative business or financial strategies that might exist for Advaxis or the effects of any other transaction in which Advaxis might engage. For a description of the opinion that the Advaxis Board received from Cantor Fitzgerald, see the section entitled “The Merger—Opinion of Advaxis’ Financial Advisor—Cantor Fitzgerald.”
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Opinion of Ayala’s Financial Advisor (see page 162)
Torreya rendered the Torreya Opinion to the Ayala Board that, as of October 16, 2022, based on and subject to the factors and assumptions set forth in the Torreya Opinion, the Exchange Ratio was fair, from a financial point of view to the holders of shares of Ayala. For a more complete description of the Torreya Opinion, please see the section titled “The Merger—Opinion of Ayala’s Financial Advisor—Torreya Capital, LLC ” beginning on page 162.
Interests of Certain Directors, Officers and Affiliates of Advaxis and Ayala (see page 169)
Interests of Advaxis Directors and Executive Officers in the Merger
In considering the recommendation of the Advaxis Board with respect to issuing shares of Advaxis Common Stock pursuant to the Merger Agreement and the other matters to be acted upon by Ayala stockholders at the Ayala Special Meeting, Ayala stockholders should be aware that certain members of the Advaxis Board and executive officers of Advaxis have interests in the Merger that may be different from, or in addition to, interests they have as Ayala stockholders.
Under the terms of Advaxis’ President and Chief Executive Officer’s employment agreement, Mr. Kenneth Berlin is entitled to severance payments if his employment were terminated without Just Cause or he terminated his employment for Good Reason during the period three months prior and 18 months following a Change of Control (such period, the “CIC Protection Period”) (as such terms are defined in Mr. Berlin’s employment agreement). Mr. Berlin would receive a cash severance payment equal to 2.0 times his base salary and target bonus, payable in a single lump sum within 60 days of the termination, as well as an amount equal to his target bonus for the year in which his employment is terminated, prorated for the portion of the year prior to the termination, payable within 45 days of the termination. Mr. Berlin would receive 24 months of continued health and welfare benefits. In the event Mr. Berlin’s employment were terminated without Just Cause, or he has terminated his employment for Good Reason, other than during the CIC Protection Period, he would receive equal monthly installments of 1.25 times his applicable base salary for 15 months, plus a one-time target bonus. Additionally, Mr. Berlin would receive continued health and welfare benefits in this circumstance for 15 months. In addition, Mr. Berlin is also entitled to full accelerated vesting of all outstanding equity awards upon a Change in Control regardless of whether he is terminated.
Mr. Andres Gutierrez, Advaxis’ Chief Medical Officer, is also contractually entitled to severance payments, including a cash severance payment equal to 1.0 times the base salary paid in equal monthly installments of 12 months, plus a target bonus for the fiscal year in which the termination occurs, along with health and welfare benefits up to 12 months if terminated by the Company without Just Cause or by Mr. Gutierrez for Good Reason or by reason of disability.
Based on the terms of their respective employment agreements, Advaxis’ current executive officers would be entitled to receive a total value of approximately $3.4 million (collectively, not individually) in connection with the consummation of the Merger (under certain conditions) which includes the value associated with the acceleration of outstanding equity awards.
Additionally:
● | Kenneth A. Berlin, Dr. David Sidransky, Dr. Samir Khleif, and Ronni Appel, members of the Advaxis Board, will continue as directors after the Merger, and, following the closing of the Merger, Dr. Sidransky, Dr. Khleif and Mr. Appel will be eligible to be compensated as directors of Advaxis pursuant to the Advaxis compensation policy that is expected to remain in place following the Merger. Under the Merger Agreement, Ayala’s directors and executive officers are entitled to continued indemnification, expense advancement and insurance coverage. |
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● | Kenneth A. Berlin, Andres Gutierrez, and Igor Gitelman will continue as executive officers of the combined company after the Merger. |
As of November 16, 2022, the directors and executive officers of Advaxis owned, in the aggregate, less than 1% of the outstanding voting shares of Advaxis Common Stock. The Advaxis Board was aware of these interests and considered them, among other matters, in the decision to approve the Merger Agreement. For more information, please see the section titled “The Merger—Interests of the Advaxis Directors and Executive Officers in the Merger” of this proxy statement/prospectus.
Dr. Sidransky’s Interests in the Merger
Dr. David Sidransky, a member of the Advaxis Board and the Ayala Board, is a co-founder and owner of IBF I. IBF I is an owner of Ayala Common Stock. IBF I owns an aggregate of 3,315,119 of Ayala’s Common Stock, which represent, in the aggregate, ownership of approximately 22.37% of Ayala’s outstanding shares. Additionally, Dr. Sidransky introduced the parties of the Merger. “Certain Relationships and Related-Party Transactions of the Combined Company” of this proxy statement/prospectus.
Interests of Ayala Directors and Executive Officers in the Merger
In considering the recommendation of the Ayala Board with respect to the proposal for the adoption of the Merger Agreement (the “Ayala Merger Proposal”), Ayala stockholders should be aware that the executive officers and directors of Ayala have certain interests in the Merger that may be different from, or in addition to, the interests of Ayala stockholders generally. The Ayala Board was aware of these interests and considered them, among other matters, in approving the Merger Agreement and the other Transactions and making its recommendation that Ayala stockholders vote in favor of the Ayala Merger Proposal.
These interests include, among others:
● | As of October 31, 2022, all current directors and executive officers of Ayala, together with their affiliates, owned approximately 68.75% of Ayala’s outstanding stock capital which will, at the Effective Time, be automatically converted into the right to receive an amount of registered shares of Advaxis Common Stock equal to the Exchange Ratio; certain Ayala affiliates have also entered into support agreements in connection with the Merger. The support agreements are discussed in greater detail in the section titled “Agreements Related to the Merger — Support Agreements” in this proxy statement/prospectus; | |
● | Ayala’s current executive officers and directors are entitled to certain liability insurance coverage pursuant to the terms of the tail insurance policy of Advaxis; and | |
● | Each of Ayala’s executive officers has entered into an employment agreement under which the executive officer is entitled to severance benefits upon a qualifying termination of employment as further described in the section title “Interests of Ayala Directors and Executive Officers in the Merger—Executive Officer Employment Agreements” in this proxy statement/prospectus beginning on page 172. |
Management Following the Merger (see page 306)
Effective as of the closing of the Merger, the combined company’s executive officers are expected to be:
Name | Title | |
Kenneth Berlin | President and Chief Executive Officer | |
Igor Gitelman | Interim Chief Financial Officer | |
Andres Gutierrez, M.D., Ph.D. | Chief Medical Officer |
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The Merger Agreement and Agreements Related to the Merger Agreement (see page 181)
The terms and conditions of the Merger Agreement are contained in the Merger Agreement, which is attached to this proxy statement/prospectus as Annex A and is incorporated by reference herein in its entirety. Ayala encourages you to read the Merger Agreement carefully, as it is the legal document that governs the business combination. For more information on the Merger Agreement, see the section entitled “The Merger Agreement.”
Ancillary Agreements Related to the Merger (see page 201)
In connection with execution of the Merger Agreement, Advaxis entered into the Voting Agreements with each of (a) IBF I, and (b) aMoon, pursuant to which each such party agreed, among other things, to vote their respective beneficially owned shares of Ayala Common Stock (i) in favor of (1) the adoption of the Merger Agreement and the approval of the Merger and the other Transactions, and (2) any proposal to adjourn or postpone the stockholders meeting of Ayala called to approve such matters (the “Ayala Adjournment Proposal”) to the extent permitted or required under the Merger Agreement; and (ii) against (1) any Advaxis Acquisition Proposal (as defined in the Merger Agreement), except as expressly permitted by the Merger Agreement, (2) any merger agreement or merger (other than the Merger Agreement and the Merger), consolidation, combination, sale of substantial assets, reorganization, recapitalization, dissolution, liquidation or winding up of or by Advaxis, in each case except as expressly permitted by the Merger Agreement and (3) any proposal, action or agreement that would reasonably be expected to (1) materially delay or postpone, prevent or otherwise impair the Merger or the other Transactions, (2) result in a breach in any respect of any covenant, representation, warranty or any other obligation or agreement of Ayala under the Merger Agreement, (3) result in a breach in any respect of any covenant, representation, warranty or any other obligation or agreement of such party under the Voting Agreements, (4) result in any of the conditions set forth in Section 6 of the Merger Agreement not being fulfilled or (5) except as expressly contemplated by the Merger Agreement, change in any manner the dividend policy or capitalization of, including the voting rights of any class of capital stock of Ayala. The Voting Agreements will terminate upon the earliest to occur of (a) the mutual agreement of Advaxis and the stockholder party to such Voting Agreement; (b) Ayala Special Meeting at which a vote upon the Ayala Merger Proposal and the other Transactions is taken; and (c) the date on which the Merger Agreement is terminated in accordance with its terms. The Voting Agreements provide that, in the event of an Advaxis Change in Recommendation (as defined in the Merger Agreement), the number of shares of capital stock of Ayala subject to the Voting Agreements shall only be 30% of the total current outstanding voting power of Ayala, and the number of shares of capital stock of Ayala of each of IBF I and aMoon subject to the Voting Agreements shall be reduced proportionately based on the number of shares of capital stock of Ayala subject thereto.
Voting by Ayala’s Directors and Executive Officers (see page 133)
As of the Record Date for the Ayala Special Meeting, directors and executive officers of Ayala and their affiliates owned and were entitled to vote 3,709,106 shares of Ayala Common Stock, representing approximately 25% of the shares of Ayala Common Stock outstanding on that date. Ayala currently expects that Ayala’s directors and executive officers will vote their shares of Ayala Common Stock in favor of the Ayala Merger Proposal and the Ayala Adjournment Proposal, although none of them has entered into any agreement obligating them to do so. 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. 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.
Conditions to the Completion of the Merger (see page 185)
The consummation of the Merger is subject to, and will take place within three business days of, the satisfaction or waiver of certain customary closing conditions, including, without limitation: (i) the registration statement on Form S-4 (which will include a prospectus of Advaxis and a proxy statement of Ayala) (the “Registration Statement”), to be filed by Advaxis with the U.S. Securities and Exchange Commission (“SEC”) to register the public offering and sale of Advaxis’ Common Stock to some or all holders of the shares of Ayala Common Stock in connection with the Merger, must have become effective and not subject to any stop order or proceeding seeking a stop order; (ii) Ayala must have obtained the approval of its stockholders for the Merger and the other Transactions (the “Ayala Stockholder Approval”); (iii) receipt of all required state securities or “blue sky” authorizations for the issuance of such shares of Advaxis’ Common Stock, except for such authorizations the lack of receipt of which would not reasonably be expected to have a material adverse impact on any of the parties to the Merger Agreement or their respective affiliates; (iv) the absence of any law or judgment of a governmental entity of competent jurisdiction that is in effect and restrains, enjoins, or otherwise prohibits consummation of the Merger; (v) the absence of a material adverse effect on the business, financial condition or results of operations of, respectively, (a) Ayala and its subsidiaries, taken as a whole or (b) Advaxis and its subsidiaries, taken as a whole; (vi) the accuracy of Ayala’s and Advaxis’ representations and warranties, subject to specified materiality qualifications; (vii) compliance by Ayala and Advaxis with its respective covenants in the Merger Agreement in all material respects; and (viii) delivery of customary closing documents, including a customary officer certificate from Ayala and Advaxis.
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No Solicitation (see page 188)
Each of Advaxis and Ayala agreed that, subject to limited exceptions, Advaxis and Ayala and any of their respective subsidiaries will not, and each party will not authorize or permit any of its officers, directors, employees, investment bankers, attorneys, accountants, representatives, consultants or other agents retained by it or any of its subsidiaries to, directly or indirectly:
● | solicit, initiate, induce, encourage or facilitate any inquiries or the making of any proposal or offer that constitutes, or could reasonably be expected to lead to, an Acquisition Proposal (as defined below); | |
● | participate in any discussions or negotiations or cooperate in any way with any person regarding any proposal or offer the consummation of which would constitute an Acquisition Proposal; | |
● | provide any non-public information or data concerning it or any of its subsidiaries to any person in connection with any proposal, the consummation of which would constitute an Acquisition Proposal or for the purpose of soliciting, initiating, inducing, encouraging or facilitating an Acquisition Proposal; | |
● | enter into any binding or nonbinding letter of intent, term sheet, memorandum of understanding, merger agreement, acquisition agreement, agreement in principle, option agreement, joint venture agreement, partnership agreement, lease agreement or other similar agreement with respect to an Acquisition Proposal or any proposal or offer that could reasonably be expected to lead to an Acquisition Proposal; | |
● | adopt, approve or recommend or make any public statement approving or recommending any inquiry, proposal or offer that constitutes, or could reasonably be expected to lead to, an Acquisition Proposal (including by approving any transaction, or approving any person becoming an “interested stockholder,” for purposes of Section 203 of the DGCL); take any action or exempt any person (other than the other party and its subsidiaries) from the restriction on “business combinations” or any similar provision contained in applicable takeover laws or its organizational or other governing documents; or | |
● | resolve, publicly propose or agree to do any of the foregoing actions. |
Termination (see page 199)
The Merger Agreement may be terminated under certain customary and limited circumstances at any time prior to the closing, including without limitation: (i) by mutual written consent of Advaxis and Ayala; (ii) by either Advaxis or Ayala, if (a) if a governmental authority shall have issued a final and non-appealable permanent restraining order, permanent injunction or other similar permanent order which has the effect of enjoining or otherwise prohibiting consummation of the Transactions, (b) the closing has not occurred on or before April 18, 2023, or (c) the Ayala Stockholder Approval has not been obtained at the Ayala Special Meeting, in each of (a), (b) and (c) where the terminating party’s material breach of the Merger Agreement is not the cause of, or has resulted in, the failure of such condition; (iii) by Ayala if (a) Advaxis breaches or fails to perform any of its representations, warranties or covenants contained in the Merger Agreement such that any of Ayala’s conditions to closing the Transactions would not be satisfied, and such breach or failure, if curable, is not cured in accordance with the Merger Agreement, (b) Advaxis has materially breached or failed to perform its non-solicitation covenant, or entered into a Parent Acquisition Proposal (as defined in the Merger Agreement), (c) the Ayala’s board of directors authorizes Ayala to enter into a Parent Acquisition Proposal constituting a Parent Superior Proposal (as such terms are defined in the Merger Agreement); and (iv) by Advaxis if (a) Ayala breaches or fails to perform any of its representations, warranties or covenants contained in the Merger Agreement such that any of Advaxis’ conditions to closing the Transactions would not be satisfied, and such breach or failure, if curable, is not cured in accordance with the Merger Agreement, (b) Ayala has materially breached or failed to perform its non-solicitation covenant, or entered into a Company Acquisition Proposal (as defined in the Merger Agreement), (c) Advaxis’ board of directors authorizes Advaxis to enter into a Company Acquisition Proposal constituting a Company Superior Proposal (as such terms are defined in the Merger Agreement).
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Termination Fee (see page 200)
If the Merger Agreement is terminated under certain circumstances, Advaxis or Ayala, as applicable, will be required to pay the other party a termination fee equal to $600,000.
Material U.S. Federal Income Tax Consequences of the Merger (see page 178)
It is intended that, subject to customary assumptions, caveats, exceptions and exclusions, the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code and the Treasury Regulations promulgated thereunder. In general, and subject to the exceptions, qualifications and limitations set forth in the section titled “Material U.S. Federal Income Tax Consequences of the Merger,” assuming the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code and the Treasury Regulations promulgated thereunder, the material U.S. federal income tax consequences to 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 be as follows:
● | each such U.S. Holder will not recognize gain or loss upon the exchange of Ayala Common Stock for Advaxis Common Stock pursuant to the Merger (other than with respect to cash received in lieu of a fractional share of Advaxis Common Stock); | |
● | such U.S. Holder’s aggregate tax basis for the shares of Advaxis Common Stock received in the Merger will equal the U.S. Holder’s aggregate tax basis in the shares of Ayala Common Stock surrendered in the Merger; and | |
● | the holding period of the shares of Advaxis Common Stock received by such U.S. Holder in the Merger will include the holding period of the shares of Ayala Common Stock surrendered in exchange therefor. |
Determining the actual U.S. federal income tax consequences of the Merger to you may be complex and will depend on the facts of your own situation. You should consult your tax advisors to fully understand the tax consequences to you of the Merger, including the estate, gift, state, local or non-U.S. tax consequences of the Merger.
Potential Listing of Common Stock of Combined Company (see page 175)
Shares of Advaxis Common Stock are currently quoted on OTCQX under the symbol “ADXS.” 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. However, 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. While Ayala and Advaxis intend to use their best commercially practicable efforts to have the stock of the combined company approved for listing on Nasdaq as of the closing of the Merger or promptly thereafter, no assurance can be made that these efforts will be successful. If the listing application is accepted, Advaxis anticipates that the common stock of the combined company will be listed on The Nasdaq Capital Market following the closing of the Merger under the trading symbol “AYRX.” There can be no assurance that these efforts to uplist will be successful.
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Anticipated Accounting Treatment (see page 314)
The Merger will be accounted for as a reverse acquisition in accordance with U.S. GAAP. Under this method of accounting, Ayala will be deemed to be the accounting acquirer for financial reporting purposes. As a result of the Merger, the net assets of Advaxis will be recorded at their acquisition-date fair value in the financial statements of Ayala and the reported operating results prior to the Merger will be those of Ayala.
Appraisal Rights and Dissenters’ Rights (see page 175)
Under the Delaware General Corporation Law (the “DGCL”), Ayala stockholders are entitled to appraisal rights in connection with the Merger.
Comparison of Rights of Holders of Shares (see page 329)
Advaxis and Ayala, respectively, are incorporated under the laws of the State of Delaware. If the Merger is completed, Ayala stockholders will become holders of Advaxis Common Stock and will have different rights as holders of Advaxis Common Stock than they had as holders of Ayala Common Stock. The differences between the rights of these respective holders result from the differences of the respective governing documents of Ayala and Advaxis, as the same may be amended in connection with the Merger. For additional information, see the section titled “Comparison of Rights of Holders of Advaxis Capital Stock and Ayala Capital Stock” beginning on page 330 of this proxy statement/prospectus.
Risk Factors of the Combined Company (see page 26)
Both Advaxis and Ayala are subject to various risks associated with their businesses and their industries. In addition, the Merger, including the possibility that the Merger may not be completed, poses a number of risks to each company and its respective securityholders, including, without limitation, the following risks:
● | 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; | |
● | Failure to complete the Merger may result in Advaxis or Ayala paying a termination fee Advaxis or Ayala, as applicable, which could harm the price of Advaxis Common Stock and the future business and operations of each company; | |
● | If the conditions to the Merger are not satisfied or waived, the Merger will not occur; | |
● | The Merger may be completed even though material adverse effects may result from the announcement of the Merger, changes in or affecting the industries in which Advaxis or Ayala operate and other causes; | |
● | If Advaxis and Ayala complete the Merger, the combined company will need to raise additional capital by issuing equity securities or incurring additional debt or by entering into licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations; | |
● | Some Advaxis and Ayala executive officers and directors 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; | |
● | Advaxis’ stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger; | |
● | Efforts to have the common stock of the combined company listed on The Nasdaq Capital Market may not be successful; and | |
● | If the Merger is not completed, Advaxis’ stock price may fluctuate significantly. |
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These risks and other risks are discussed in greater detail under the section titled “Risk Factors” beginning on page 25 of this proxy statement/prospectus. Advaxis and Ayala both encourage you to read and consider all of these risks carefully.
Risks Related to the Merger (see page 26)
● | 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. | |
● | If the conditions to the Merger are not satisfied or waived, the Merger may not occur. | |
● | 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. | |
● | 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. | |
● | 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. | |
● | Advaxis and Ayala stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger. | |
● | If the Merger is not completed, Advaxis’ and Ayala’s stock price may fluctuate significantly. | |
● | 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. | |
● | 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. | |
● | Efforts to have the common stock of the combined company listed on The Nasdaq Capital Market may not be successful. |
Advaxis’ Summary of Risk Factors (see page 34)
Below is a summary of the principal factors that make an investment in Advaxis’ Common Stock speculative or risky. This summary does not address all of the risks that Advaxis faces. Additional discussion of the risks summarized in this risk factor summary, and other risks that Advaxis faces, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this proxy statement/prospectus and Advaxis’ other filings with the SEC, before making an investment decision regarding Advaxis’ Common Stock.
● | Advaxis has incurred significant losses since its inception and anticipate that it will continue to incur losses for the foreseeable future. | |
● | 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. | |
● | Advaxis is significantly dependent on the success of its Lm Technology™ platform and its product candidates based on this platform. | |
● | If Advaxis is unable to establish, manage or maintain strategic collaborations in the future, its revenue and drug development may be limited. | |
● | Advaxis is subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations (“Trade Laws”). Advaxis can face serious consequences for violations. | |
● | Advaxis depends upon its senior management and key consultants and their loss or unavailability could put it at a competitive disadvantage. | |
● | 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. | |
● | Advaxis can provide no assurance that its clinical product candidates will obtain regulatory approval or that the results of clinical studies will be favorable. | |
● | Drug discovery and development is a complex, time-consuming and expensive process that is fraught with risk and a high rate of failure. | |
● | Advaxis may face legal claims; legal disputes are expensive and Advaxis may not be able to afford the costs. | |
● | Advaxis can provide no assurance of the successful and timely development of new products. | |
● | Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on Advaxis’ business and results of operations. | |
● | 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. | |
● | The price of Advaxis’ Common Stock and warrants may be volatile. |
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Ayala’s Summary of Risk Factors (see page 64)
Below is a summary of the principal factors that make an investment in Ayala’s Common Stock speculative or risky. This summary does not address all of the risks that Ayala faces. Additional discussion of the risks summarized in this risk factor summary, and other risks that Ayala faces, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this proxy statement/prospectus and Ayala’s other filings with the SEC, before making an investment decision regarding Ayala’s Common Stock.
● | 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’s recurring losses from operations raise substantial doubt regarding its ability to continue as a going concern; | |
● | Ayala has a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for its future viability; | |
● | Ayala is heavily dependent on the success of AL101 and AL102, its most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, Ayala’s business may be harmed; | |
● | Due to Ayala’s limited resources and access to capital, it must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect Ayala’s business; | |
● | The outbreak of COVID-19, may adversely affect Ayala’s business, including its clinical trials; | |
● | Ayala’s ability to use its net operating loss carryforwards to offset future taxable income may be subject to certain limitations; | |
● | Ayala’s product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach Ayala is taking to discover and develop product candidates is novel and may never lead to marketable products; | |
● | Ayala was not involved in the early development of its lead product candidates; therefore, Ayala is dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for its product candidates; | |
● | Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Ayala’s control; | |
● | If Ayala does not achieve its projected development and commercialization goals in the timeframes it announces and expects, the commercialization of Ayala’s product candidates may be delayed and Ayala’s business will be harmed; | |
● | Ayala’s product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; | |
● | The market opportunities for AL101 and AL102, if approved, may be smaller than Ayala anticipates; | |
● | Ayala may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; | |
● | Ayala has never obtained marketing approval for a product candidate and Ayala may be unable to obtain, or may be delayed in obtaining, marketing approval for any of its product candidates; | |
● | Even if Ayala obtains approval from the FDA for its product candidates in the United States, Ayala may never obtain approval for or commercialize them in any other jurisdiction, which would limit Ayala’s ability to realize their full market potential; | |
● | Ayala has been granted ODD for AL101 for the treatment of ACC and may seek ODD for other indications or product candidates, and Ayala may be unable to maintain the benefits associated with ODD, including the potential for market exclusivity, and may not receive ODD for other indications or for its other product candidates; | |
● | Although Ayala has received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; | |
● | Ayala faces significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if Ayala fails to compete effectively; | |
● | Ayala is dependent on a small number of suppliers for some of the materials used to manufacture its product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of its product candidates; | |
● | Enacted and future healthcare legislation may increase the difficulty and cost for Ayala to obtain marketing approval of and commercialize its product candidates, if approved, and may affect the prices Ayala may set; | |
● | If Ayala is unable to obtain, maintain, protect and enforce patent and other intellectual property protection for its technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, Ayala’s competitors could develop and commercialize products and technology similar or identical to Ayala’s, and Ayala may not be able to compete effectively in its markets; | |
● | Ayala may engage in acquisitions or in-licensing transactions that could disrupt its business, cause dilution to its stockholders or reduce its financial resources; and | |
● | Risks related to Ayala’s operations in Israel could materially adversely impact its business, financial condition and results of operations. |
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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.
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● | Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the Transactions. | |
● | 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 respective business prospects. | |
● | 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. | |
● | If Advaxis does not successfully consummate the transaction with Ayala, the Advaxis Board and the Ayala Board, as applicable, 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. | |
● | Efforts to have the common stock of the combined company listed on The Nasdaq Capital Market may not be successful. |
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.
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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.
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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:
● | the initiation of, material developments in, or conclusion of litigation to enforce or defend its intellectual property rights or defend against claims involving the intellectual property rights of others; |
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● | the entry into, or termination of, key agreements, including commercial partner agreements; | |
● | announcements by commercial partners or competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments; | |
● | the introduction of technological innovations or new therapies that compete with its future products; | |
● | the loss of key employees; | |
● | future sales of its common stock; | |
● | general and industry-specific economic conditions that may affect its research and development expenditures; | |
● | the failure to meet industry analyst expectations; and | |
● | period-to-period fluctuations in financial results. |
Moreover, the stock markets in general have 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.”
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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 Agreement is terminated under certain circumstances, the terminating party will be required to pay the non-terminating party a termination fee of $600,000; and | |
● | the price of the terminating party’s common stock may decline and remain volatile. |
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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.
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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:
● | combining the companies’ operations and corporate functions; | |
● | combining the businesses of Ayala and Advaxis and meeting the capital requirements of the combined company, in a manner that permits the combined company to achieve any cost savings or other synergies anticipated to result from the Merger, the failure of which would result in the anticipated benefits of the Merger not being realized in the time frame currently anticipated or at all; | |
● | integrating personnel from the two companies, especially in the COVID-19 environment which has required many people to work remotely in many locations; | |
● | integrating and unifying Ayala’s and Advaxis’ pipeline of product candidates in development; | |
● | identifying and eliminating redundant and underperforming functions and assets; | |
● | harmonizing the companies’ operating practices, employee development and compensation programs, internal controls and other policies, procedures and processes; | |
● | maintaining existing agreements with employees, independent contractors, principal investigators, CROs, consultants, vendors, and any other third parties, avoiding delays in entering into new agreements with prospective employees, independent contractors, principal investigators, CROs, consultants, vendors, and any other third parties, and leveraging relationships with such third parties for the benefit of the combined company; | |
● | addressing possible differences in business backgrounds, corporate cultures and management philosophies; | |
● | consolidating the companies’ administrative and information technology infrastructure; | |
● | coordinating research, commercialization, and marketing efforts; | |
● | coordinating geographically dispersed organizations; and | |
● | effecting actions that may be required in connection with obtaining regulatory or other governmental approvals. |
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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.
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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.
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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:
● | The progress, timing, costs and results of the clinical studies underway; | |
● | future clinical development plans it establishes for Advaxis’ product candidates; | |
● | the number and characteristics of product candidates that Advaxis develops or may in-license; | |
● | the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or the FDA, and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that Advaxis performs more studies than those that it currently expects; | |
● | the cost of filing, prosecuting, defending and enforcing Advaxis’ patent claims and other intellectual property rights; | |
● | the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against Advaxis or its product candidates; | |
● | the effect of competing technological and market developments; |
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● | the cost and timing of completion of commercial-scale outsourced manufacturing activities; and | |
● | the cost of establishing sales, marketing and distribution capabilities for any product candidates for which Advaxis may receive regulatory approval in regions where it chooses to commercialize its products on its own. |
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.
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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:
● | preclinical study results that may show the immunotherapy to be less effective than desired (e.g., the study failed to meet its primary objectives) or to have harmful or problematic side effects; | |
● | clinical study results that may show the immunotherapy to be less effective than expected (e.g., the study failed to meet its primary endpoint) or to have unacceptable side effects; | |
● | failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, delays in receiving the necessary products or supplies for the conduct of clinical or pre-clinical trials, additional time requirements for data analysis, or Biologics License Application (“BLA”) preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data, FDA delays in inspecting manufacturing establishments, failure to receive FDA approval for manufacturing processes or facilities, or unexpected safety or manufacturing issues; | |
● | manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical; and | |
● | the proprietary rights of others and their competing products and technologies that may prevent the immunotherapy from being commercialized. |
Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to the next and may be difficult to predict.