As filed with the U.S. Securities and Exchange Commission on June 30,July 26, 2023

Registration No. 333-271826

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 12

to

FORM S-4

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

Vascular Biogenics Ltd.

(Exact name of registrant as specified in its charter)

8 HaSatat St.

Modi’in

Israel 7178106

+972-8-9935000

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Sam Backenroth

Chief Financial Officer

VBL, Inc.

1 Blue Hill Plaza, Suite 1509

Pearl River, NY 10965

+1-845-474-8411

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

Copies to:

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

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

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

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

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

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

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

Exchange Act Rule 13(e)-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.

The information in this proxy statement/prospectus/information statement is not complete and may be changed. VBL may not sell its securities pursuant to the proposed transactions until the Registration Statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus/information statement is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Subject to completion, dated June 30,July 26, 2023

PROPOSED MERGER

YOUR VOTE IS VERY IMPORTANT

To the Shareholders of Vascular Biogenics Ltd. and the Stockholders of Notable Labs, Inc.:

Vascular Biogenics Ltd. (“VBL”) is holding a special meeting, which will be held at       , Eastern Time, on       , 2023 (the “VBL special meeting”). The VBL special meeting will be a virtual shareholder meeting, conducted solely through remote audio access via a webcast at                     . In order to attend the virtual VBL special meeting and vote online,             ... This is an important special meeting that affects your investment in VBL.

VBL, Notable Labs, Inc. (“Notable”), and Vibrant Merger Sub, Inc., a wholly-owned subsidiary of VBL (“Merger Sub”) have entered into an Agreement and Plan of Merger, dated February 22, 2023, and as may be amended from time to time (the “Merger Agreement”), pursuant to which Merger Sub will merge with and into Notable, with Notable surviving as a wholly owned subsidiary of VBL (the “Merger”).

At the effective time of the Merger (the “Effective Time”), each share of Notable’s common stock, par value $0.001 per share, (“Notable Common Stock”), outstanding immediately prior to the Effective Time will be converted into the right to receive approximately 2.2482 ordinary shares, of a nominal value of NIS 0.01 each, of VBL (“VBL Ordinary Shares”), subject to adjustment to account for the effect of a reverse share split of VBL Ordinary Shares, at a ratio mutually agreed to by VBL and Notable in the range of one new share for every 10 to 50 shares, inclusive, outstanding (or any whole number in between), to be implemented immediately prior to and contingent upon the consummation of the Merger as discussed in this proxy statement/prospectus/information statement, and further adjusted based on VBL’s Net Cash (as defined in the Merger Agreement) relative to Target Net Cash immediately prior to the closing of the Merger, and other adjustments described in this proxy statement/prospectus/information statement.

Under the terms of the Merger Agreement, the number of VBL Ordinary Shares to be issued to Notable’s stockholders, at the closing of the Merger will be determined based on an exchange ratio, which will be calculated based on the total number of outstanding VBL Ordinary Shares and Notable Common Stock, each on a fully-diluted basis, and the respective deemed valuations of VBL and Notable, as of immediately prior to the closing of the Merger (the “Exchange Ratio”). As of the effective date of the Merger Agreement, the closing date valuation of Notable (the “Notable Valuation”) is anticipated to be $110,000,000, and the closing date valuation of VBL (the “VBL Valuation”) is anticipated to be $35,000,000, but the Notable Valuation and the VBL Valuation are subject to adjustment as described in the section titled “The Merger — Merger Consideration” in this proxy statement/prospectus/information statement. Accordingly, if the closing of the Merger occurred and there is no adjustment to the Notable Valuation or the VBL Valuation as described below, then immediately following the Effective Time, Notable’s stockholders will own or hold rights to acquire 76% of the combined organization, on a fully-diluted basis as set forth in the Merger Agreement, and VBL’s shareholders will own or hold rights to acquire 24% of the combined organization, on a fully-diluted basis as set forth in the Merger Agreement. Without giving effect to the proposed reverse share split of VBL Ordinary Shares described elsewhere in this proxy statement/prospectus/information statement, and based on the foregoing percentages and VBL’s and Notable’s capitalization as of June 26,July 19, 2023, the Exchange Ratio for the Notable Common Stock would be approximately 2.2482 shares of VBL Ordinary Shares for each share of Notable Common Stock (approximately 249,857,511 total VBL Ordinary Shares would be issued to Notable’s stockholders, on a fully diluted basis). There will be no adjustment to the number of shares of VBL Ordinary Shares to be issued to Notable’s stockholders based on the market value of VBL Ordinary Shares, and the market value of VBL Ordinary Shares as of the date of the closing of the Merger may vary significantly from the market value as of the date of this proxy statement/prospectus/information statement. For a complete description of how the ownership percentages and Exchange Ratio will be determined at the Effective Time of the Merger, please see the section entitled “The Merger Agreement — Merger Consideration” beginning on page 133 of this proxy statement/prospectus/information statement.

VBL Ordinary Shares are currently listed on The Nasdaq Capital Market under the symbol “VBLT”. After completion of the Merger, VBL will be renamed “Notable Labs, Ltd.” and is expected to trade on The Nasdaq Capital Market under the symbol “NTBL”. On June 28,July 21, 2023, the closing sale price of VBL Ordinary Shares was $0.27$0.29 per share.

At the VBL special meeting, VBL will ask its shareholders to:

Notable stockholders (as applicable) are being asked to adopt the Merger Agreement and vote in favor of any other matter necessary to consummate the transactions contemplated by the Merger Agreement.

Promptly following the registration statement on Form S-4 (the “Registration Statement”), of which this proxy statement/prospectus/information statement is a part, being declared effective by the U.S. Securities and Exchange Commission (the “SEC”), and in no event later than five business days thereafter and pursuant to the conditions of the Merger Agreement, Notable shall obtain the approval by written consent pursuant to Section 228 of the Delaware General Corporation Law (“DGCL”) from Notable stockholders sufficient to approve the transactions contemplated by the Merger Agreement, referred to as the written consent, for purposes of (i) adopting and approving the Merger Agreement and the transactions contemplated by the Merger Agreement, (ii) acknowledging that the approval given thereby is irrevocable and that such stockholder is aware of its rights to demand appraisal for its shares pursuant to Section 262 of the DGCL, a copy of which will be attached thereto, and that such stockholder has received and read a copy of Section 262 of the DGCL, and (iii) acknowledging that by its approval of the Merger it is not entitled to appraisal rights with respect to its shares in connection with the Merger and thereby waives any rights to receive payment of the fair value of its capital stock under the DGCL. Therefore, absent termination of the Merger Agreement, holders of a sufficient number of shares of Notable capital stock required to adopt the Merger Agreement will have agreed to adopt the Merger Agreement, and no meeting of Notable stockholders to adopt the Merger Agreement and approve the Merger will be held. Nevertheless, all Notable stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions by signing and returning to Notable a written consent.

After careful consideration, each of the VBL and Notable boards of directors has approved the Merger Agreement and the Merger, and each of the VBL and Notable boards of directors has determined that it is advisable to enter into the Merger Agreement and related transactions. The VBL board of directors has approved the respective proposals referred to above and recommends that its shareholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus/information statement, and the board of directors of Notable recommends that its securityholders sign and return the written consent indicating their approval of the Merger and adoption of the Merger Agreement and related transactions to Notable described in the accompanying proxy statement/prospectus/information statement.

More information about VBL, Notable and the proposed transaction is contained in this proxy statement/prospectus/information statement. VBL and Notable urge you to read the accompanying proxy statement/prospectus/information statement, carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 10.

VBL and Notable are excited about the opportunities the Merger brings to both VBL and Notable securityholders and thanks you for your consideration and continued support.

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

The accompanying proxy statement/prospectus/information statement is dated            , 2023, and is first being mailed to VBL and Notable securityholders on or about            , 2023.

VASCULAR BIOGENICS LTD.

NOTICE OF SPECIAL MEETING OF SHAREHOLDERS
TO BE HELD ON              , 2023

Dear Shareholders of VBL:

On behalf of the board of directors of Vascular Biogenics Ltd., an Israeli corporation (“VBL”), we are pleased to deliver this proxy statement/prospectus/information statement for the proposed transaction between VBL and Notable Labs, Inc., a Delaware corporation (“Notable”), pursuant to an Agreement and Plan of Merger, dated February 22, 2023, and as may be amended from time to time (the “Merger Agreement”), under which Vibrant Merger Sub, Inc., a wholly owned subsidiary of VBL (“Merger Sub”) will merge with and into Notable, with Notable surviving as a wholly owned subsidiary of VBL (the “Merger”). The special meeting of shareholders of VBL (the “VBL special meeting”) will be held in a virtual-only format via live audio webcast on                       , 2023 at                       , Eastern Time, at                       , for the following matters:

Following such increase, the registered share capital of VBL shall be up to NIS 12,000,000.

The VBL board of directors has fixed                    , 2023, as the record date for the determination of shareholders entitled to notice of, and to vote at, the VBL special meeting and any adjournment or postponement thereof. Only holders of record of VBL Ordinary Shares at the close of business on the record date are entitled to notice of, and to vote at, the VBL special meeting. At the close of business on the record date, there were                     VBL Ordinary Shares outstanding and entitled to vote.

Your vote is important.

The affirmative vote of a majority of the voting power present and voting in person or by proxy at the VBL special meeting (not counting “abstentions” or “broker non-votes” as votes cast) is required for approval of each of Proposal Nos. 1 through 4, 6 (other than with respect to the Chief Executive Officer), 8, 10 and 11. The approval of Proposal Nos. 5, 6 (with respect to the Chief Executive Officer), 7, and 9 also require such affirmative majority, plus either (i) a simple majority of shares voted at the VBL special meeting, excluding the shares of controlling shareholders, if any, and of shareholders who have a personal interest in the approval of the resolution (for Proposal No. 9 – other than personal interest not deriving from a relationship with a controlling shareholder), or (ii) the total number of shares of non-controlling shareholders and of shareholders who do not have a personal interest in the resolution voting against approval of the resolution does not exceed 2% of the outstanding voting power in VBL. A shareholder that possesses a personal interest or is a controlling shareholder is qualified to participate in the vote; however, the vote of such shareholder may not be counted towards the majority requirement described in clause (i) above and will not count towards the 2% threshold described in clause (ii) above. We encourage you to read this proxy statement/prospectus/information statement carefully. If you have any questions or need assistance voting your shares, please call our proxy solicitor, Mediant Communications Inc., at 866-551-3850.

Even if you plan to attend the VBL special meeting via live audio webcast, VBL requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the VBL special meeting if you are unable to attend.

By Order of the VBL Board of Directors,

Dror Harats, M.D.

Chief Executive Officer

Modi’in, Israel

                                , 2023

THE VBL BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, VBL AND ITS SHAREHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. THE VBL BOARD OF DIRECTORS RECOMMENDS THAT VBL SHAREHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.

REFERENCES TO ADDITIONAL INFORMATION

This proxy statement/prospectus/information statement incorporates important business and financial information about VBL that is not included in or delivered with this document. You may obtain this information without charge through the SEC’s website (http://www.sec.gov) or upon your written or oral request by contacting the Secretary of Vascular Biogenics Ltd., 8 HaSatat St., Modi’in, Israel 7178106, or by calling +972-8-9935000.

To ensure timely delivery of these documents, any request should be made no later than                    , 2023 to receive them before the VBL special meeting.

For additional details about where you can find information about VBL, please see the sections titled “Where You Can Find More Information” in this proxy statement/prospectus/information statement.

Table of Contents

QUESTIONS AND ANSWERS ABOUT THE MERGER

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus/information statement does not give effect to the proposed VBL ordinary share reverse share split at a ratio of one (1) new share for every 10 to 50 shares of outstanding VBL Ordinary Shares, inclusive, with a nominal value of NIS 0.01 per share (“VBL Ordinary Shares”), of VBL (as defined below) described in VBL Proposal No. 2 (the “VBL Reverse Share Split”) in this proxy statement/prospectus/information statement. If the Merger (as defined below) and the VBL Reverse Share Split (as defined below) are approved, the VBL Reverse Share Split will be effected immediately prior to the closing of the Merger (the “Closing”) at a ratio to be determined by the VBL board of directors.

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

The VBL Valuation of $35,000,000 is based on a projected net cash balance (or cash, cash equivalents, investments and other assets settled in cash minus outstanding liabilities) at the Closing of $15,000,000, plus an additional $20,000,000 of enterprise value. If VBL’s Net Cash (as defined in the Merger Agreement, see the section entitled “The Merger Agreement — Merger Consideration.”) as of the close of business on the last business day prior to the anticipated closing date as agreed upon by VBL and Notable (referred to as the “determination date”) is less than Target Net Cash (as defined in the Merger Agreement), the ownership percentage of former Notable stockholders in the combined organization will be increased based on the difference between VBL’s Net Cash and the VBL Target Net Cash. If VBL’s Net Cash is greater than Target Net Cash, the ownership percentage of former Notable stockholders in the combined organization will be decreased based on the difference between VBL’s Net Cash and the Target Net Cash. Additionally, the Notable Valuation of $110,000,000 is based on the sum of a $100,000,000 pre-money valuation as set forth in the Stock Purchase Agreement, entered into on February 22, 2023 with the Noble Pre-Closing Financing investors (the “Stock Purchase Agreement”), pursuant to which the Notable Pre-Closing Financing investors have collectively subscribed for approximately $10.3 million of Series D SAFEs (as defined below) and shares of preferred stock of Notable, par value $0.001 per share (“Notable Preferred Stock”, and the financing, the “Notable Pre-Closing Financing”), plus the expected aggregate net cash proceeds from the Notable Pre-Closing Financing. If (i) the pre-money valuation set forth in the Stock Purchase Agreement is other than $100,000,000 or (ii) the aggregate net cash proceeds from the Notable Pre-Closing Financing are less than $8,000,000 or more than $12,000,000, the Notable Valuation will be adjusted as agreed by the investors in the Notable Pre-Closing Financing.

Without giving effect to the proposed VBL Reverse Share Split, and based on the foregoing percentages as of June 26,July 19, 2023, and VBL’s and Notable’s capitalization as of June 26,July 19, 2023, the Exchange Ratio for the Notable Common Stock would be approximately 2.2482 VBL Ordinary Shares for each share of Notable Common Stock (approximately 249,857,511 total shares of VBL common stock would be issued to former Notable stockholders, on a fully diluted basis).

In the Merger, VBL will be issuing approximately 249,857,511 VBL Ordinary Shares on a fully diluted basis, and VBL Ordinary Shares to be issued pursuant to the Merger Agreement will represent greater than 20% of its voting shares. Accordingly, VBL is seeking shareholder of approval of the issuance pursuant to the Merger Agreement under the Nasdaq rules.

In addition to the requirement of obtaining such shareholder approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

Under Notable’s Fifth Amended and Restated Certificate of Incorporation, which will be filed prior to the consummation of the Merger, the approval of the Merger and the adoption of the Merger Agreement requires the affirmative consent of the holders of at least a majority of the issued and outstanding shares of Notable Common Stock and Notable Preferred Stock, voting together on an as-converted basis and the approval of the conversion of outstanding Notable Preferred Stock into Notable Common Stock and the consummation of the Pre-Closing Financing requires the affirmative consent of the holders of at least: (i) a majority of the Notable’s outstanding Series A Preferred Stock, (ii) 55% of the Notable’s outstanding Series B Preferred Stock, (iii) a majority of the Notable’s outstanding Series C Preferred Stock, and (iv) a majority of the Notable’s outstanding Series D Preferred Stock. Notable has obtained Support Agreements from stockholders owning in excess of the aforementioned thresholds necessary to approve the Merger and adopt the Merger Agreement and related transactions.

Directors and executive officers of Notable and certain stockholders of Notable, who own approximately 63% of the outstanding shares of Notable Common Stock, and certain VBL shareholders, including certain directors, executive officers and former executive officers, of VBL who in the aggregate own approximately 2.5% of the outstanding VBL Ordinary Shares able to vote, are parties to support agreements with VBL and Notable. The VBL shareholders who are party to such support agreements have agreed to vote their shares (a) in favor of the VBL shareholder proposals and any other matter necessary to consummate the transactions contemplated by the Merger Agreement and voted on by the VBL shareholders and to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the issuances of the VBL Ordinary Shares by virtue of the Merger on the date on which such meeting is held and (b) against any “acquisition proposal,” as defined in the Merger Agreement. The Notable stockholders who are party to such support agreements have agreed to vote their shares (a) in favor of (i) adoption and approval of the Merger Agreement and the approval of any related transactions contemplated by the Merger Agreement and (ii) any matter that could reasonably be expected to facilitate the Merger and any related transactions contemplated by the Merger Agreement; (b) against any “acquisition proposal,” as defined in the Merger Agreement, or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger and all of the other related transactions contemplated by the Merger Agreement; (c) to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which such meeting is held and (d) where applicable, in favor of an election to convert all of the Notable Preferred Stock held by such Notable stockholder into Notable Common Stock. Nevertheless, all Notable stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions by signing and returning to Notable a written consent.

For a more complete description of the closing conditions under the Merger Agreement, VBL and Notable urge you to read the section titled “The Merger Agreement — Conditions to the Completion of the Merger” in this proxy statement/prospectus/information statement.

For a more complete description of what Notable stockholders, warrantholders and optionholders will receive in the Merger, please see the sections titled “Market Price and Dividend Information” and “The Merger Agreement — Merger Consideration” in this proxy statement/prospectus/information statement.

Tax matters are very complicated, and the tax consequences of the Merger to a particular Notable stockholder will depend on such stockholder’s circumstances. Accordingly, each Notable stockholder is strongly urged to consult with his, her or its tax advisor for a full understanding of the tax consequences of the Merger to that stockholder, including the applicability and effect of federal, state, local and non-U.S. income and other tax laws. For more information, please see the section titled “Certain Material U.S. Federal Income Tax Considerations” in this proxy statement/prospectus/information statement.

Though VBL does not believe it was a passive foreign investment company (“PFIC”) for its 2022 taxable year, if VBL is a PFIC for its current taxable year, proposed U.S. Treasury Regulations under Section 1291(f) of the Code (which have a retroactive effective date), if finalized in their current form, generally would require a VBL U.S. Holder (as defined in the section titled “Certain Material U.S. Federal Income Tax Considerations”) to recognize gains as a result of the Deemed Domestication unless the U.S. Holder makes (or has made) certain elections discussed further under “Certain Material U.S. Federal Income Tax Considerations — U.S. Federal Income Taxation of U.S. Holders — Passive Foreign Investment Company Rules.” The tax on any such gain would be imposed at the rate applicable to ordinary income and an interest charge would apply based on a complex set of rules. It is difficult to predict whether such proposed regulations will be finalized and whether, in what form, and with what effective date, other final U.S. Treasury Regulations under Section 1291(f) of the Code will be adopted.

For a discussion of the material U.S. federal income tax considerations applicable to VBL shareholders with respect to the Merger, see the section titled “Certain Material U.S. Federal Income Tax Considerations”.

The tax consequences to you of the VBL Reverse Share Split will depend on if the VBL Reverse Share Split is treated as a tax deferred “recapitalization” for U.S. federal income tax purposes. If the VBL Reverse Share Split qualifies as a recapitalization, then a VBL U.S. Holder generally will not recognize gain or loss on the VBL Reverse Share Split. In general, the aggregate tax basis of the post-split shares received will be equal to the aggregate tax basis of the pre-split shares exchanged therefor and the holding period of the post-split shares received will include the holding period of the pre-split shares exchanged. Treasury regulations promulgated under the Code provide detailed rules for allocating the tax basis and holding period of the shares of VBL Ordinary Shares surrendered to the shares of VBL Ordinary Shares received pursuant to the VBL Reverse Share Split. VBL U.S. Holders of shares of VBL Ordinary Shares acquired on different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares.

A VBL U.S. holder whose fractional shares resulting from the VBL Reverse Share Split are rounded up to the nearest whole share may recognize gain for U.S. federal income tax purposes equal to the value of the additional fractional share. The treatment of the exchange of a fractional share for a whole share in the VBL Reverse Share Split is not clear. VBL intends to treat the issuance to a holder of a whole share in exchange for a fractional share as a non-recognition event, but there can be no assurance that the Internal Revenue Service (“IRS”) or a court would not successfully assert otherwise.

The tax consequences to you of the VBL Reverse Share Split will depend on your particular facts and circumstances. You should consult your tax advisors as to the specific tax consequences to you.

For example, the employment agreements of certain VBL executive officers provide for post-employment compensation arrangements. On January 20, 2022, VBL entered into a restated executive employment agreement and consulting agreement with Prof. Harats pursuant to which he provides services as VBL’s Chief Executive Officer (the “Harats agreements”). Pursuant to Prof. Harats’ agreements with VBL, VBL can terminate Prof. Harats’ employment (as can he) for any reason by giving nine months prior written notice of termination. However, in the event that Prof. Harats’ employment is terminated other than for “cause” or if Prof. Harats resigns for “good reason” (each as defined in the Harats Agreements), Prof. Harats will be entitled to receive an aggregate of 15 months of salary and benefits continuation under the Harats Agreements. In connection with the Merger, we anticipate providing Prof. Harats with such 15-month salary and benefits continuation as set forth in the Harats Agreements.

On October 4, 2021, VBL entered into an offer letter with Mr. Backenroth for his services as our Chief Financial Officer (the “Backenroth Offer Letter”). The Backenroth Offer Letter provides that if Mr. Backenroth is terminated by us without cause or Mr. Backenroth resigns for good reason (defined generally as a reduction in his salary amongst similarly-situated employees, relocation, or a material diminution in title, duties or responsibilities) regardless of whether such termination or resignation was a result of a change of control, then, subject to Mr. Backenroth’s execution and delivery of a general release of all claims, his then outstanding, unvested options and VBL RSUs, if any, will vest and be exercisable as to all of the covered shares and Mr. Backenroth shall be additionally entitled to (1) severance pay at a rate equal to one hundred percent (100%) of his base salary for a period of 12 months from the date of termination, and (2) reimbursement of 12 months of health benefits (COBRA subsidization) in accordance with our standard expense reimbursement procedures. In connection with the Merger, we anticipate providing Mr. Backenroth with such 12-month salary and benefits continuation as set forth in the Backenroth Offer Letter.

In addition, in August 2022, VBL awarded Prof. Harats and Mr. Backenroth each a grant of 700,000 VBL RSUs as a retention incentive to remain employed with VBL through the Merger. The award vests 75% at March 31, 2023, with the remainder on the two year anniversary of the grant, subject to acceleration upon change of control (such as completion of the Merger). The VBL RSU award for Prof. Harats is subject to VBL shareholder approval (see VBL Proposal No. 5: Approval of the Grant of 700,000 VBL RSUs to Prof. Dror Harats) and therefore did not vest on March 31, 2023.

Additionally, pursuant to the terms of the Merger Agreement, Michael Rice, who is currently a director of VBL, will continue as a director of the combined organization after the Closing and will be eligible for certain compensation as a non-employee director.

Furthermore, on June 30, 2023, VBL entered into an exclusivea non-binding term sheet for the sale of the VB-601 Asset with Wellbeing Group Ltd. (“Wellbeing”), or one of their assignees, for total cash consideration of up to $5 million plus royalties. On July 25, 2023, VBL and Wellbeing executed an amendment to the non-binding term sheet to clarify certain terms, which amendment was initiated by and negotiated by Mr. Kozin on behalf of VBL and without the Interested Parties (as defined below) to clarify certain terms from the term sheet executed on June 30, 2023, which is attached as Annex D to this proxy statement/prospectus/information statement. Wellbeing has advised VBL that it intends to form a new company to acquire the VB-601 Asset and proposes to recruit Prof. Harats, Dr. Feige, and Mr. Backenroth as investors and partners to manage the new company and develop the VB-601 Asset due to their historical knowledge of the program. Due to the proposed involvement of Prof. Harats, Dr. Feige and Mr. Backenroth who are current executive officers and/or employees of VBL and also potentially investors and partners (together, the Interested Parties in“Interested Parties”) of the entity that will be moving forward withproposes to acquire and developingfurther develop the VB-601 Asset, the transactionproposed VB-601 Asset Sale is considered a related party transaction, and requires audit committee approval and approval of the VBL board of directors approval,under Israeli law. Such proposed VB-601 Asset Sale continues to be subject to the negotiation and execution of definitive documentation. Although the circumstances of the VB-601 Asset Sale do not require the approval of the shareholders under Israeli law, because of the related party nature of the transaction, and to provide VBL’s shareholders the opportunity to have a say in the disposition of the VB-601 Asset, VBL’s board of directors also resolved that the closing of the VB-601 Asset Sale would be subject to the separate approval of the VBL shareholders at the Special Meeting. Thespecial meeting. Further, the Interested Parties recused themselves from discussions and negotiations between VBL and Wellbeing regarding the proposed VB-601 Offer.Asset Sale, the terms of which are being negotiated by Mr. Kozin (VBL’s Chairman of the board) for VBL.

Discussions between Wellbeing and the Interested Parties are also ongoing. There are no definitive agreements with respect to the Interested Parties’ participation as investors or partners in the company proposed to be formed by Wellbeing to acquire and further develop the VB-601 Asset.

As of June 26,July 19, 2023, the directors and executive officers of VBL owned, in the aggregate, approximately 2.5% of the outstanding voting VBL Ordinary Shares. Each of VBL’s executive officers and directors have entered into support agreements and lock-up agreements in connection with the Merger. The support agreements and lock-up agreements are discussed in greater detail in the section titled “Agreements Related to the Merger” in this proxy statement/prospectus/information statement.

The VBL board of directors 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 VBL Directors and Executive Officers in the Merger” in this proxy statement/prospectus/information statement.

A: Yes. In considering the recommendation of Notable’s board of directors with respect to approving the Merger and related transactions by written consent, Notable stockholders should be aware that certain members of the board of directors and executive officers of Notable have interests in the Merger that may be different from, or in addition to, interests they have as Notable stockholders. For example, certain of Notable’s executive officers and certain of its directors have options, subject to vesting, to purchase shares of Notable that will convert into options to purchase a number of VBL Ordinary Shares determined by the Exchange Ratio. Certain directors of Notable are affiliated with entities that own shares and warrants to purchase shares of Notable that will be exchanged for a number of VBL Ordinary Shares determined by the Exchange Ratio and the warrants will convert into warrants to purchase a number of VBL Ordinary Shares determined by the Exchange Ratio. Additionally, certain of Notable’s directors and all its executive officers are expected to become directors and executive officers of VBL upon the consummation of the Merger; and all of Notable’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.

As of June 26,July 19, 2023, the directors and executive officers of Notable beneficially owned, in the aggregate, approximately 49.1% of the outstanding shares of Notable Common Stock. Each of Notable’s executive officers and directors have entered into support agreements and lock-up agreements in connection with the Merger. The support agreements and lock-up agreements are discussed in greater detail in the section titled “Agreements Related to the Merger” in this proxy statement/prospectus/information statement.

The Notable board of directors were aware of these interests and considered them, among other matters, in its decision to approve the Merger Agreement. For more information, please see the section titled “The Merger — Interests of the Notable Directors and Executive Officers in the Merger” of this proxy statement/prospectus/information statement.

Abstentions (as described below) will be counted towards the quorum requirement. If within half an hour from the time appointed for the meeting, a quorum is not present, without there being an obligation to notify the shareholders to that effect, the meeting shall be adjourned to the same day, in the following week, at the same hour and at the same place or to a later time and date if so specified in the notice of the meeting, unless such day shall fall on a statutory holiday (either in Israel or in the United States), in which case the meeting will be adjourned to the first business day afterwards which is not a statutory holiday.

If you are a VBL shareholder, you may provide your proxy instructions in one of two different ways. First, you can mail your signed proxy card in the enclosed return envelope. You may also provide your proxy instructions via the Internet by following the instructions on your proxy card or voting instruction form. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the VBL special meeting of VBL shareholders.meeting.

If you are a Notable stockholder, you may execute and return your written consent to Notable in accordance with the instructions provided.

If you are a shareholder of record and do not vote by telephone, through the Internet, by completing the enclosed proxy card or in person at the VBL special meeting, your shares will not be voted.

Beneficial Owner: Shares Registered in the Name of a Broker or Bank

Proposals Nos. 1 through 11 are non-discretionary matters. As a result, banks, brokers and other nominees will not have discretion to vote on Proposals Nos. 1 through 11.

Shareholders of Record

If your VBL Ordinary Shares are registered directly in your name with the VBL transfer agent, you are considered to be the shareholder of record with respect to those shares, and the proxy materials and proxy card are being sent directly to you by VBL.

If you are a VBL shareholder of record, you may register to attend the VBL special meeting and by accessing the meeting center at             and entering the control number on the proxy card previously received. You will need to register to attend the VBL special meeting at              by no later than             , 2023 at             Eastern Time. You will be emailed an individual link to attend the virtual VBL special meeting. Instructions on how to connect to the VBL special meeting and participate via the Internet, including how to demonstrate proof of stock ownership, are posted at                    ...

Even if you plan to attend the VBL special meeting via live audio webcast, VBL requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the VBL special meeting if you are unable to attend.

Beneficial Owners

If your VBL Ordinary Shares are held in a brokerage account or by another nominee, you are considered the beneficial owner of shares held in “street name,” and the proxy materials are being forwarded to you by your broker or other nominee together with a voting instruction card. As the beneficial owner, you are also invited to attend the VBL special meeting via live audio webcast. Because a beneficial owner is not the shareholder of record, you may not vote these shares at the VBL special meeting unless you obtain a proxy from the broker, trustee or nominee that holds your shares, giving you the right to vote the shares at the meeting.

VBL has been advised by             that beneficial shareholders as of the record date who want to attend the VBL special meeting virtually must register in advance at             using the control number found on the proxy card previously received by no later than             , 2023 at             Eastern Time. VBL shareholders will then receive a confirmation of registration and an individual link to access the virtual VBL special meeting.

To vote at the VBL special meeting, beneficial owners must obtain a legal proxy from the holder of record and submit proof of legal proxy reflecting the number of VBL Ordinary Shares held as of the record date.

Even if you plan to attend the VBL special meeting via live audio webcast, VBL requests that you sign and return the proxy materials provided by your broker or other nominee together with a voting instruction to ensure that your shares will be represented at the VBL special meeting if you are unable to attend.

If you are a beneficial owner of shares, you may submit new voting instructions by contacting the record holder, or, if you have obtained a legal proxy from the record holder giving you the right to vote your shares, by attending the VBL special meeting and voting in person.

If you are a VBL shareholder of record or a shareholder who owns VBL shares in “street name” and instructed a broker to vote your VBL Ordinary Shares, you must follow directions received from your broker to change those instructions.

Vascular Biogenics Ltd.

8 HaSatat St.

Modi’in

Israel 7178106

+972-8-9935000

Attn: Secretary

sam@vblrx.com

If you have questions about the Merger, including the procedures for voting your shares, please contact:

Mediant

200 Regency Forest Drive, Suite 200

Cary, NC 27518

Stockholders may call toll-free: 866-551-3850

Banks and Brokers may call collect: 919-809-6675

If you are a Notable stockholder, and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:

Notable Labs, Inc.

320 Hatch Drive

Foster City, CA 94404

(415) 851-2410

Attention: Thomas Bock

RISK FACTORS

The combined organization will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/information statement, you should carefully consider the material risks described below and those described in the section of this proxy statement/prospectus/information statement titled “Forward-Looking Statements” before deciding how to vote your shares. In addition, you should read and consider the risks associated with the business of VBL because these risks may also affect the combined organization. You should also read and consider the other information in this proxy statement/prospectus/information statement. Please see the sections titled “Where You Can Find More Information” in this proxy statement/prospectus/information statement.

Risks Related to the Merger

The Exchange Ratio is not adjustable based on the market price of VBL Ordinary Shares so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed.

The estimated Exchange Ratio calculation contained herein is based upon VBL’s and Notable’s capitalization immediately prior to the date of this proxy statement/prospectus/information statement, and will be adjusted based on the amount of VBL Net Cash, the terms and net proceeds from the Notable Pre-Closing Financing, and changes in the capitalization of VBL or Notable prior to the Closing, not taking into account the VBL Reverse Share Split, as described in the section titled “The Merger — Merger Consideration and Adjustment” of this proxy statement/prospectus/information statement. Any changes in the market price of VBL Ordinary Shares before the completion of the Merger will not affect the number of shares Notable securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger the market price of VBL Ordinary Shares declines from the market price on the date of the Merger Agreement, then Notable securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the Merger the market price of VBL Ordinary Shares increases from the market price on the date of the Merger Agreement, then, Notable securityholders could receive merger consideration with considerably more value for their shares of Notable capital stock than the parties had negotiated for in the establishment of the Exchange Ratio. The Merger Agreement does not include a price-based termination right. Because the Exchange Ratio does not adjust as a result of changes in the value of VBL Ordinary Shares, for each one percentage point that the market value of VBL Ordinary Shares rises or declines, there is a corresponding one percentage point rise or decline, respectively, in the value of the total merger consideration issued to Notable securityholders.

Failure to complete the Merger may result in VBL or Notable paying a termination fee or reimbursing expenses to the other party and could harm the price of VBL Ordinary Shares and future business and operations of each company.

If the Merger is not completed, VBL and Notable are subject to the following risks:

In addition, if the Merger Agreement is terminated and the VBL board of directors or the Notable board of directors determines to seek another business combination, there can be no assurance that either VBL or Notable will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the Merger on a timely basis, or at all. VBL’s or Notable’s collaborators and other business partners and investors in general may also view the failure to complete the Merger as a poor reflection on its business or prospects, which could adversely affect their respective businesses.

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

In general, either VBL or Notable can refuse to complete the Merger if there is a material adverse change affecting the other party between February 22, 2023, the date of the Merger Agreement, and the Closing. However, certain types of changes do not permit either party to refuse to complete the Merger, even if such change could be said to have a material adverse effect on VBL or Notable, including:

If adverse changes occur and VBL and Notable still complete the Merger, the combined organization stock price may suffer. This in turn may reduce the value of the Merger to the stockholders of VBL, Notable or both.

Some VBL and Notable 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.

Certain officers and directors of VBL and Notable participate in arrangements that provide them with interests in the Merger that are different from yours, including, among others, the continued service as an officer or director of the combined organization, severance benefits, the acceleration of RSU and stock option vesting, continued indemnification and the potential ability to sell an increased number of ordinary shares of the combined organization in accordance with Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”), and anticipated interests in a new entity to be formed to acquire and pursue further development of the VB-601 Asset. For additional information, please see the sections titled “VBL Executive Compensation — Executive Employment and Other Compensation Arrangements” and “Notable Executive Compensation — Narrative Disclosure to Summary Compensation Table — Agreements with Notable’s Named Executive Officers” below.

Based on the terms of their respective employment agreements, VBL’s executive officers will be entitled to receive a total value of approximately $1.28 million (collectively, not individually) in connection with the consummation of the Merger, the associated termination of their employment from VBL, and accelerated vesting of VBL RSUs, and not including the value associated with the acceleration of their outstanding equity awards.

Additionally, the directors and officers of VBL are parties to the VBL support agreements and lock-up agreements with VBL and Notable.

The VBL board of directors 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 VBL Directors and Executive Officers in the Merger” of this proxy statement/prospectus/information statement.

Certain of Notable’s executive officers and certain of its directors have options, subject to vesting, to purchase shares of Notable that will convert into options to purchase a number of VBL Ordinary Shares; certain of Notable’s directors and all its executive officers are expected to become directors and executive officers of VBL upon the consummation of the Merger; and all of Notable’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. In addition, certain of Notable’s executive officers and directors and affiliates of Notable’s directors currently hold shares of common stock of Notable and warrants to purchase capital stock of Notable that will convert into VBL Ordinary Shares and warrants exercisable to purchase VBL Ordinary Shares.

These interests, among others, may influence the officers and directors of VBL and Notable to support or approve the Merger. For more information concerning the interests of VBL and Notable executive officers and directors, see the sections titled “The Merger — Interests of the VBL Directors and Executive Officers in the Merger” and “The Merger — Interests of the Notable Directors and Executive Officers in the Merger” in this proxy statement/prospectus/information statement.

The market price of the combined organization’s ordinary shares following the Merger may decline as a result of the Merger.

The market price of the combined organization’s ordinary shares may decline as a result of the Merger for a number of reasons including if:

VBL shareholders and Notable stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

If the combined organization is unable to realize the full strategic and financial benefits currently anticipated from the Merger, VBL shareholders and Notable stockholders will have experienced substantial dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined organization is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

During the pendency of the Merger, VBL and Notable may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

Covenants in the Merger Agreement impede the ability of VBL and Notable to make acquisitions or dispositions or complete other transactions that are not in the ordinary course of business, subject to certain exceptions, pending completion of the Merger. 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, among other things, soliciting, initiating, knowingly encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets or other business combination outside the ordinary course of business, with any third party. Any such transactions could be favorable to such party’s stockholders.

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

The terms of the Merger Agreement prohibit each of VBL and Notable from soliciting alternative takeover proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when, among other things, such party’s board of directors determines in good faith that an unsolicited acquisition proposal constitutes or would reasonably be expected to result in, a superior offer and that failure to cooperate with the proponent of the proposal would reasonably be expected to be inconsistent with the fiduciary duties of the board of directors of such party under applicable law. In addition, if VBL or Notable terminate the Merger Agreement under certain circumstances, including terminating because of a decision of a board of directors to recommend a superior proposal, VBL or Notable would be required to pay to the other party a termination fee equal to $2,500,000. This termination fee may discourage third parties from submitting alternative takeover proposals to VBL or its shareholders or Notable or its stockholders and may cause the respective boards of directors to be less inclined to recommend an alternative proposal.

Because the lack of a public market for Notable shares makes it difficult to know the fair market value of Notable, the stockholders of Notable may receive consideration in the Merger that is less than the fair market value of the Notable shares.

The outstanding capital stock of Notable is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Notable. Because the percentage of VBL equity to be issued to Notable stockholders was determined based on negotiations between the parties, it is possible that the value of the VBL Ordinary Shares to be received by Notable stockholders will be less than the fair market value of Notable, or VBL may pay more than the aggregate fair market value for Notable.

The combined organization will incur significant transaction costs as a result of the Merger, including investment banking, legal and accounting fees. In addition, the combined organization will incur significant operating expenses which cannot be accurately estimated at this time. Actual transaction costs may substantially exceed VBL and Notable’s estimates and may have an adverse effect on the combined organization’s financial condition and operating results.

If the conditions to the Merger are not met, the Merger will not occur.

Even if the Merger is approved by the shareholders of VBL and the stockholders of Notable, 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” in this proxy statement/prospectus/information statement. VBL and Notable cannot assure you that all of the conditions will be satisfied. If the conditions are not satisfied or waived, the Merger will not occur or will be delayed, and VBL and Notable each may lose some or all of the intended benefits of the Merger.

As a result of the Deemed Domestication, VBL is expected to be treated as a U.S. domestic corporation for U.S. federal income tax purposes.

Although VBL is incorporated under the laws of Israel, it is expected to be treated as a U.S. domestic corporation for U.S. federal income tax purposes under Section 7874(b) of the Code as a result of the Merger because the Merger is expected to result in an 80% Inversion (as defined in “Certain Material U.S. Federal Income Tax Considerations” below). As a result, VBL is expected to be deemed to convert from a non-U.S. corporation to a U.S. corporation in an F Reorganization that occurs at the end of the day immediately preceding the Merger. Consequently, VBL will be subject to U.S. federal income tax on its worldwide taxable income following the Deemed Domestication. See the section titled “Certain Material U.S. Federal Income Tax Considerations – Tax Residency of VBL for U.S. Federal Income Tax Purposes” for a more complete discussion.

Certain investors may be required to recognize gain for U.S. federal income tax purposes as a result of the Deemed Domestication or may be subject to U.S. withholding tax.

As discussed more fully under the section “Certain Material U.S. Federal Income Tax Considerations — U.S. Federal Income Taxation of U.S. Holders,” VBL will, as a result of the Deemed Domestication, for U.S. federal income tax purposes, convert from a non-U.S. corporation to a U.S. corporation in an F Reorganization. Therefore, VBL U.S. Holders will be subject to Section 367(b) of the Code and, as a result:

In addition, as discussed further under “Certain Material U.S. Federal Income Tax Considerations — U.S. Federal Income Taxation of U.S. Holders — Passive Foreign Investment Company Rules” below, if VBL is a PFIC, proposed U.S. Treasury Regulations under Section 1291(f) of the Code (which have a retroactive effective date), generally would require a VBL U.S. Holder to recognize gain as a result of the Deemed Domestication unless the U.S. Holder makes (or has made) certain elections discussed further under “Certain Material U.S. Federal Income Tax Considerations — U.S. Federal Income Taxation of U.S. Holders — Passive Foreign Investment Company Rules.”

The tax on any such gain would be imposed at the rate applicable to ordinary income and an interest charge would apply based on a complex set of rules. It is difficult to predict whether such proposed regulations will be finalized and in what form, and as a result, the impact of such proposed regulations is unclear. For a more complete discussion of the potential application of the PFIC rules to VBL U.S. Holders as a result of the Deemed Domestication, see the section titled “Certain Material U.S. Federal Income Tax Considerations — U.S. Federal Income Taxation of U.S. Holders — Passive Foreign Investment Company Rules.”

The tax consequences of the Deemed Domestication are complex and will depend on a Holder’s particular circumstances. All Holders are strongly urged to consult their tax advisor for a full description and understanding of the tax consequences of the Deemed Domestication, including the applicability and effect of U.S. federal, state, local and non-U.S. income and other tax laws. For a more complete discussion of the U.S. federal income tax considerations of the Deemed Domestication, see the section below titled “Certain Material U.S. Federal Income Tax Considerations.”

If the Merger does not qualify as a “reorganization” for U.S. federal income tax purposes, U.S. Holders of Notable Common Stock will be required to recognize gain or loss for U.S. federal income tax purposes upon the exchange of their Notable Common Stock for VBL Ordinary Shares in the Merger.

The U.S. federal income tax consequences of the Merger to U.S. Holders (as defined in the section titled “Certain Material U.S. Federal Income Tax Considerations”) will depend on whether the Merger qualifies as a “reorganization” for U.S. federal income tax purposes. If the Merger fails to qualify as a reorganization within the meaning of Section 368(a) of the Code, a U.S. Holder of Notable Common Stock would recognize gain or loss for U.S. federal income tax purposes on each share of Notable Common Stock surrendered in the Merger for VBL Ordinary Shares. For a more complete discussion of the material U.S. federal income tax consequences of the Merger, please carefully review the information set forth in the section titled “Certain Material U.S. Federal Income Tax Considerations” in this proxy statement/prospectus/information statement.

Certain shareholders could attempt to influence changes within VBL which could adversely affect VBL’s operations, financial condition and the value of VBL Ordinary Shares.

VBL shareholders may from time-to-time seek to acquire a controlling stake in VBL, engage in proxy solicitations, advance shareholder proposals or otherwise attempt to effect changes. Campaigns by shareholders to effect changes at publicly-traded companies are sometimes led by investors seeking to increase short-term shareholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the entire company. Responding to proxy contests and other actions by activist shareholders can be costly and time-consuming and could disrupt VBL’s operations and divert the attention of the VBL board of directors and senior management from the pursuit of the Merger. These actions could adversely affect VBL’s operations, financial condition, ability to consummate the Merger and the VBL Ordinary Share value.

VBL and Notable may become involved in litigation in connection with the Merger, which could divert the attention of VBL and Notable management and harm the combined organization’s business, and insurance coverage may not be sufficient to cover all related costs and damages.

Litigation frequently follows the announcement of certain significant business transactions, such as a business combination transaction. VBL and Notable may become involved in additional matters in connection with the Merger, and the combined organization may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect the business of VBL, Notable and the combined organization. At present, VBL is unable to estimate potential losses, if any, related to any future lawsuit.

Risks Related to VBL

Risks Related to the Proposed VBL Reverse Share Split

The proposed VBL Reverse Share Split may not increase the combined organization’s stock price over the long-term.

The principal purpose of the proposed VBL Reverse Share Split is to increase the per-share market price of VBL Ordinary Shares. It cannot be assured, however, that the per-share market price of VBL Ordinary Shares will remain at such increased level for any meaningful period of time. While the reduction in the number of outstanding VBL Ordinary Shares should proportionally increase the market price of VBL Ordinary Shares, it cannot be assured that the proposed VBL Reverse Share Split will increase the market price of VBL Ordinary Shares by a multiple of the proposed VBL Reverse Share Split ratio, or result in any permanent or sustained increase in the market price of VBL Ordinary Shares, which is dependent upon many factors, including the combined organization’s business and financial performance, general market conditions and prospects for future success. Therefore, while the stock price of the combined organization might meet the continued listing requirements for The Nasdaq Stock Market initially, it cannot be assured that it will continue to do so.

The proposed VBL Reverse Share Split may decrease the liquidity of the combined organization’s ordinary shares.

Although the VBL board of directors believes that the anticipated increase in the market price of the combined organization’s ordinary shares could encourage interest in its ordinary shares and possibly promote greater liquidity for its shareholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the proposed VBL Reverse Share Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for VBL Ordinary Shares.

The proposed VBL Reverse Share Split may lead to a decrease in the combined organization’s overall market capitalization.

Should the market price of the combined organization’s ordinary shares decline after the proposed VBL Reverse Share Split, the percentage decline may be lower, due to the higher per share value of the shares outstanding, than it would have been prior to the proposed VBL Reverse Share Split. A reverse share split may be viewed negatively by the market and, consequently, can lead to a decrease in the combined organization’s overall market capitalization. If the per share market price does not increase in proportion to the proposed VBL Reverse Share Split ratio, then the value of the combined organization, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse share splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of VBL Ordinary Shares will remain the same after the proposed VBL Reverse Share Split is effected, or that the proposed VBL Reverse Share Split will not have an adverse effect on the stock price of VBL Ordinary Shares due to the reduced number of shares outstanding after the proposed VBL Reverse Share Split.

Risks Related to VBL’s Capital Requirements, Finances and Operations if the Merger is Not Completed

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

VBL is an early stage biotechnology company, and it has not yet generated any regular revenue streams. VBL has incurred losses in each year since its inception in 2000, including net losses of $32.3 million and $29.9 million for the years ended December 31, 2022, and 2021, respectively and $2.6 million for the three months ended March 31, 2023. As of March 31, 2023, VBL had an accumulated deficit of $297.0 million.

Historically, VBL has devoted most of its financial resources to research and development, including its clinical and preclinical development activities. To date, VBL has financed its operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental agencies. The amount of VBL’s future net losses will depend, in part, on the rate of its future expenditures and its ability to obtain funding through equity or debt financings, strategic collaborations or additional grants. VBL has never successfully completed a pivotal clinical trial for any of its product candidates. Ofra-vec, VBL’s former product candidate, did not meet the primary endpoint in its Phase 3 OVAL trial and accordingly, VBL ceased development of ofra-vec in August 2022. VBL’s current product candidate, VB-601, an early-stage program and it will be a few years, if ever, before VBL has a product candidate ready for commercialization. Even if VBL decided to pursue future clinical trials of VB-601 or any other product candidates and they are successful such that VBL obtains regulatory approval to market a product, VBL’s future revenues will depend upon the size of any markets in which such product receives approval, and VBL’s ability to achieve sufficient market acceptance, reimbursement from third-party payers and adequate market share for any approved product in those markets.

VBL expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. VBL anticipates that its expenses will increase substantially if and as it:

The net losses VBL incurs may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of VBL’s results of operations may not be a good indication of its future performance. In any particular quarter or quarters, VBL’s operating results could be below the expectations of securities analysts or investors, which could cause its share price to decline.

VBL has never generated any revenue from product sales and may never be profitable.

VBL’s ability to generate revenue and achieve profitability depends on its ability, alone or with strategic collaboration partners, to successfully complete the development of, obtain the regulatory approvals of, and commercialize a product candidate. VBL does not anticipate generating revenues from product sales for the foreseeable future, if ever. VBL’s ability to generate future revenues from product sales depends heavily on its success in:

Even if one or more of VBL’s product candidates are approved for commercial sale, VBL anticipates incurring significant costs associated with commercializing any approved product candidate. VBL’s expenses could increase beyond expectations if VBL is required by the FDA, the European Medicines Agency (“EMA”), or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that VBL currently anticipates. Even if VBL is able to generate revenues from the sale of any approved product, VBL may not become profitable and may need to obtain additional funding to continue operations.

VBL is not in compliance with Nasdaq’s minimum bid price requirement and if VBL fails to regain compliance with Nasdaq’s continued listing requirements, the VBL Ordinary Shares could be delisted, which could adversely affect the liquidity of the VBL Ordinary Shares and its ability to raise additional capital or complete the Merger. The Merger is a “change of control” and the combined organization will need to satisfy all of Nasdaq’s initial listing criteria to remain listed on Nasdaq.

On August 31, 2022, VBL received a deficiency letter from the Listing Qualifications Department of Nasdaq, notifying it that its listed securities did not maintain the minimum bid price requirement of $1.00 per ordinary share for continued listing on The Nasdaq Global Market for a period of 30 consecutive business days as required under Nasdaq Listing Rule 5450(a)(1). Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

In accordance with Nasdaq Listing Rule 5810(c), VBL had a period of 180 calendar days, or until February 27, 2023 (the “Compliance Period”), to regain compliance with the minimum closing bid price requirement. If at any time during the Compliance Period, the VBL Ordinary Shares had a closing bid price of at least $1.00 for 10 consecutive business days, Nasdaq would have provided it a written confirmation of compliance and the matter would have been closed. However, VBL did not regain compliance by February 27, 2023, requested a transfer of its listing to The Nasdaq Capital Market, and received an additional 180-day period to regain compliance. If compliance with the minimum closing bid price requirement cannot be demonstrated by the end of this second compliance period, or August 28, 2023, Nasdaq will provide written notification that the VBL Ordinary Shares will be delisted. At that time, VBL may appeal Nasdaq’s determination to a Hearings Panel. VBL intends to monitor the closing bid price of the VBL Ordinary Shares and may, if appropriate, consider available options to regain compliance with the minimum bid price requirement. If VBL completes the proposed Merger, this will be deemed a “change in control” under Nasdaq’s rules, and the combined organization will need to satisfy all of Nasdaq’s initial listing criteria. If the Merger is consummated and the combined organization fails to either qualify for listing or timely complete Nasdaq’s initial listing process prior to consummation, this could also result in a suspension of trading and possible delisting.

VBL has undergone a significant workforce reduction to reduce operating expenses and extend its cash runway, but such efforts may not yield the anticipated benefits, which could have a material effect on VBL’s operations.

On August 2, 2022, VBL announced an organizational streamlining designed to reduce operating expenses and preserve capital. As a result, to date, VBL has significantly reduced its workforce and currently has only seven full-time employees. As part of the organizational streamlining, Dr. Ron Cohen, Dr. Bennett Shapiro and Ms. Alison Finger resigned from VBL’s board of directors, effective August 1, 2022, reducing the number of members of VBL’s board of directors from nine to six. The reduction in workforce is expected to reduce operating expenses and extend VBL’s cash runway, but the reduction in workforce may not have as significant a benefit as anticipated. As a result, VBL may need to raise additional capital or take additional measures to be able to continue its operations as expected and consummate any strategic transaction, including the Merger or any transaction involving VB-601.

VBL is exploring strategic alternatives to enhance shareholder value, including the proposed Merger with Notable, transactions involving VB-601 and the recently completed sale of its Modi’in facility lease rights. VBL may not be successful in consummating the Merger or any other strategic transaction or they may not deliver the value to VBL’s shareholders that VBL anticipates.

Based on the results of the Phase 3 OVAL clinical trial, VBL began exploring strategic alternatives to enhance shareholder value and engaged Chardan as its exclusive financial advisor to assist in this process. The strategic alternatives that VBL explored included some or all of the following: license, divestiture, or monetization of current assets; license or acquisition of additional assets; merger, reverse merger, joint venture, partnership, or other business combination with another entity, public or private.

Following this review process, on February 15, 2023, VBL entered into an Asset Purchase Agreement providing for the sale of its rights to lease the Modi’in facility and certain related assets (which sale closed on March 9, 2023). Further, on February 22, 2023, VBL entered into the Merger Agreement, pursuant to which, and subject to the satisfaction or waiver of the conditions set forth therein, Notable will become VBL’s wholly-owned subsidiary and Notable’s management and stockholders will control the company and Notable’s financial statements will become VBL’s financial statements under applicable accounting rules. In addition, on June 30, 2023, VBL entered into an exclusivea non-binding term sheet, as amended on July 25, 2023, for the sale of the VB-601 Asset.Asset, the form of which is attached as Annex D to this proxy statement/prospectus/information statement. There can be no assurance that VBL will be able to successfully consummate the proposed Merger on a timely basis or at all, or that any transaction VBL may pursue for VB-601, will be successfully consummated or enhance shareholder value. If VBL is unable to execute on this or other strategic alternatives, VBL may be forced to liquidate.

The process of pursuing these or any other strategic alternatives could adversely impact VBL’s business, financial condition and results of operations and VBL has incurred and will continue to incur substantial expenses associated with these processes, including those related to equity compensation, severance pay and insurance, legal, accounting and financial advisory fees. In addition, the process is time consuming and may be disruptive to VBL’s business operations, could divert the attention of management and the board of directors from VBL’s business, has led to additional resignations from VBL’s workforce and could interfere with VBL’s ability to retain its remaining employees, and could expose VBL to potential litigation in connection with this process or any resulting transaction. Further, speculation regarding any developments related to the consummation of VBL’s strategic alternatives and perceived uncertainties related to VBL’s future could cause its stock price to fluctuate significantly.

VBL may need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force VBL to delay, limit or terminate its product development efforts or other operations.

Developing pharmaceutical products is expensive and tends to increase substantially in connection with any expanded activities, particularly when advancing any product candidate in clinical trials.

As of March 31, 2023, VBL’s cash and cash equivalents, restricted cash, and short-term bank deposits were $26.5 million. VBL estimates that the balance of cash, cash equivalents, restricted cash, and short-term bank deposits will be sufficient to fund its operations for at least 12 months from the date of this filing and, together with the proceeds from the sale of rights to the Modi’in facility and certain related assets, meet its minimum cash requirements in the Merger Agreement. However, VBL’s operating plan may change as a result of many factors including VBL’s ability to consummate the Merger or the VB-601 Asset Sale, and VBL may need to seek additional funds sooner than planned through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. In any event, even if VBL can complete the Merger and sale of its rights, VBL will require additional capital to obtain regulatory approval for any product candidate, and to commercialize and market any product that receives regulatory approval. Raising funds in the current economic environment may present additional challenges. Global health concerns resulting from the outbreak of the coronavirus and worldwide macroeconomic turmoil may have long-term lasting effects on VBL’s ability to raise capital, many of which are difficult for VBL to predict at this time. Even if VBL believes it has sufficient funds for its current or potential future operating plans, VBL may seek additional capital if market conditions are favorable or if it has specific strategic considerations.

Any additional fundraising efforts may divert VBL’s management from their day-to-day activities, which may compromise VBL’s ability to develop and commercialize any product candidate. In addition, VBL cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to it, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of VBL’s shareholders, and the issuance of additional securities, whether equity or debt, by it, or the possibility of such issuance, may cause the market price of VBL Ordinary Shares to decline. The sale of additional equity or convertible securities would dilute all of VBL’s shareholders. The incurrence of indebtedness would result in increased fixed payment obligations, and VBL may be required to agree to certain restrictive covenants such as limitations on VBL’s ability to incur additional debt, limitations on VBL’s ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact its ability to conduct its business. VBL could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than would be desirable, and VBL may be required to relinquish rights to its technology or product candidate or otherwise agree to terms unfavorable to it.

If VBL is unable to obtain funding on a timely basis, VBL may be required to significantly curtail, delay or discontinue its research or development program or the commercialization of any product candidate, and VBL may be unable to expand its operations or otherwise capitalize on its business opportunities, as desired. VBL may also need to curtail or cease operations.

VBL has received Israeli governmental grants to assist in funding a portion of its research and development activities. If VBL monetizes the programs funded by these grants, it would owe royalties and other payments which could harm VBL’s operating results.

Through March 31, 2023 VBL had received an aggregate of $29.4 million in grants from the Israeli Innovation Authority (“IIA”). Under the Israel Encouragement of Research and Development in Industries (“Research Law”), royalties of 3% to 3.5% on the revenues derived from sales of products or services developed in whole or in part using these IIA grants are payable to the Israeli government. The maximum aggregate royalties paid for each technology or program separately, generally cannot exceed 100% of the grants made to VBL for such technology or program, plus annual interest. VBL developed ofra-vec and another previously developed program utilizing IIA funds, neither of which VBL expects to be able to commercialize, and therefore does not expect to be liable for repayment of such grants. While VBL does not believe it will be required to make any significant repayments of grant funding to the IIA for previous programs and monetization activities arising from the strategic process, it remains possible that such payments, including the potential repayment of a portion of the grants supporting certain equipment included in the Facility Sale, will be mandated by the IIA. VBL may elect to dispute the IIA’s repayment decision, however, it may not be successful in reducing or eliminating the IIA repayment decision. In addition, VBL is in the process of closinghas closed out the IIA grant programs. ToAlthough the extent this occurs,programs have been closed, VBL shall still remainremains subject to the provisions of the Research Law as it relates to the historical programs it received grant funding for. It is unclear when this will occur, if at all. As of March 31, 2023, the balance of the principal and interest in respect of VBL’s commitments for these potential future payments to the IIA totaled approximately $38.4 million. To date, VBL has paid the IIA in relation to its license agreement, royalties of approximately $0.6 million. If VBL monetizes the programs funded by these grants, it would owe royalties and other payments, which could harm VBL’s operating results.

The Israeli government grants VBL has received for research and development expenditures restrict its ability to manufacture product candidates and transfer technologies outside of Israel and require it to satisfy certain conditions. If VBL fails to satisfy these conditions, it may be required to refund grants previously received together with interest and penalties.

Under the Research Law, VBL is required to manufacture the majority of any product candidate developed using these grants in the State of Israel or otherwise ask for special approvals. VBL may not receive the required approvals for any proposed transfer of manufacturing activities outside of Israel. Even if VBL does receive approval to manufacture a product candidate developed with government grants outside of Israel, the royalty rate may be increased and VBL may be required to pay up to 300% of the grant amounts plus interest, depending on the manufacturing volume that is performed outside of Israel. This restriction may impair VBL’s ability to outsource manufacturing or engage in VBL’s own manufacturing operations for those product candidates or technologies. See “VBL’s Management’s Discussion and Analysis of Financial Condition and Results of Operations” for additional information.

Additionally, under the Research Law, VBL is prohibited from transferring, including by way of license, the IIA-financed technologies and related intellectual property rights and know-how outside of the State of Israel, except under limited circumstances and only with the approval of the IIA Research Committee. VBL may not receive the required approvals for any proposed transfer and, even if received, VBL may be required to pay the IIA a portion, to be set by the IIA upon their approval of such transaction, of the consideration or milestone and royalties payments that it receives upon any sale or out licensing of such technology to a non-Israeli entity, up to 600% of the grant amounts plus interest. The scope of the support received, the royalties that VBL has already paid to the IIA, the amount of time that has elapsed between the date on which the know-how or the related intellectual property rights were transferred and the date on which the IIA grants were received and the sale price and the form of transaction will be taken into account in order to calculate the amount of the payments to the IIA. For Israeli entities, approval of the transfer of technology to residents of the State of Israel is required, and may be granted in specific circumstances only if the recipient abides by the provisions of applicable laws, including the restrictions on the transfer of know-how and the obligation to pay royalties. No assurance can be made that approval to any such transfer, if requested, will be granted.

These restrictions may impair VBL’s ability to sell its technology assets or to perform or outsource manufacturing outside of Israel, engage in change of control transactions or otherwise transfer VBL’s know-how outside of Israel and may require it to obtain the approval of the IIA for certain actions and transactions and pay additional royalties and other amounts to the IIA. In addition, any change of control and any change of ownership of VBL Ordinary Shares that would make a non-Israeli citizen or resident an “interested party,” as defined in the Research Law, requires prior written notice to the IIA, and VBL’s failure to comply with this requirement could result in criminal liability.

These restrictions will continue to apply even after VBL has repaid the full amount of royalties on the grants. For the years ended December 31, 2022, 2021 and 2020, VBL recorded grants totaling $0.05 million, $0.5 million and $1.5 million from the IIA, respectively. If VBL fails to satisfy the conditions of the Research Law, VBL may be required to refund certain grants previously received together with interest and penalties, and may become subject to criminal charges.

Risks Related to the Discovery and Development of VBL’s Product Candidate and Platform Technology

VBL is highly dependent on the success of VB-601 in inflammatory indications, and its platform technology in general, and VBL cannot be certain that either will receive regulatory approval or be commercialized. Any failure to successfully develop, obtain regulatory approval for and commercialize VB-601 for inflammatory indications, or any other product candidates, independently or in cooperation with a third party collaborator, or the experience of significant delays in doing so, would compromise VBL’s ability to generate revenue and become profitable.

VBL has spent time, money and effort on the development of its platform technology and product candidate VB-601. To date, VBL has not received regulatory approval for any current and historical product candidates. Positive results obtained during early development do not necessarily mean later development will succeed or that regulatory approvals will be obtained.

VBL’s ability to generate product revenue from any product candidate depends heavily on the successful development and commercialization of its product candidate, which, in turn, depends on several factors, including the following:

VBL’s product candidate is based on novel technology, which makes it difficult to predict the time and cost of product candidate development and potential regulatory approval.

VBL has historically concentrated its product research and development efforts on its distinct platform technologies, and VBL’s future success depends on the successful development of its technology. VBL could experience development problems in the future related to its technology, which could cause significant delays or unanticipated costs, and it may not be able to solve such development problems. VBL may also experience delays in developing sustainable, reproducible and scalable manufacturing processes or transferring those processes to commercial partners, if VBL decides to do so, which may prevent it from completing its clinical trials or commercializing its product, if approved, on a timely or profitable basis, if at all. If an issue is identified in VBL’s platform technology, it may cause it to cease development of the product candidate that utilizes the underlying technology.

In addition, the clinical trial requirements of the FDA, the EMA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products. The regulatory approval process for a novel product candidate such as VBL’s can be more expensive and take longer than for other, better known or extensively studied pharmaceutical or other product candidates. Approvals by the FDA may not be indicative of what the EMA or other regulatory agencies may require for approval, and vice versa.

In addition, adverse developments in clinical trials of pharmaceutical products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any product candidate.

These regulatory agencies and review committees and the new requirements and guidelines they promulgate may lengthen the regulatory review process, require VBL to perform additional studies, increase VBL’s development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of a treatment candidate or lead to significant post-approval limitations or restrictions. As VBL advances its product candidate, it will be required to consult with these regulatory groups, and comply with applicable requirements and guidelines. If VBL fails to do so, it may be required to delay or discontinue development of its product candidate. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product candidate to market could impair VBL’s ability to generate product revenue and to become profitable.

VBL may find it difficult to enroll patients in its clinical trials, and patients could discontinue their participation in VBL’s clinical trials, which could delay or prevent clinical trials of VBL’s product candidate.

Identifying and qualifying patients to participate in clinical trials of VBL’s product candidate is critical to its success. The timing of VBL’s clinical trials depends on the speed at which it can recruit patients to participate in testing its product candidates. VBL has experienced delays in some of its previous clinical trials, and VBL may experience similar delays in the future. If patients are unwilling to participate in VBL’s clinical trials because of negative publicity from adverse events in the biotechnology or pharmaceutical industries or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing VBL’s product development, delays in testing the effectiveness of VBL’s technology or termination of the clinical trials altogether.

VBL may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a trial, to complete VBL’s clinical trials in a timely manner. Patient enrollment is affected by factors including:

In particular, some of the indications VBL may develop its candidates for may be for rare disorders with limited patient pools from which to draw for clinical trials. The eligibility criteria of VBL’s clinical trials will further limit the pool of available trial participants. Additionally, the process of finding and diagnosing patients may prove costly.

VBL plans to seek initial marketing approval in established global markets, in addition to the United States. VBL may not be able to initiate or continue clinical trials if it cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by the EMA or other foreign regulatory agencies. VBL’s ability to successfully initiate, enroll and complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries, including:

If VBL has difficulty enrolling a sufficient number of patients to conduct its clinical trials, it may need to delay, limit or terminate ongoing or planned clinical trials.

In addition, patients enrolled in VBL’s clinical trials may discontinue their participation at any time during the trial as a result of a number of factors, including withdrawing their consent or experiencing adverse clinical events, which may or may not be judged related to VBL’s product candidate under evaluation. The discontinuation of patients in any one of VBL’s trials may cause it to delay or abandon its clinical trial, or cause the results from that trial not to be positive or sufficient to support a filing for regulatory approval of the applicable product candidate.

VBL may encounter substantial delays in its clinical trials or VBL may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining marketing approval from regulatory authorities for the sale of a product candidate, VBL must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome. VBL cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, and that the trial will result in a positive outcome. For example, VBL’s Phase 3 clinical trial of ofra-vec in platinum-resistant ovarian cancer did not successfully meet either primary endpoint, progression-free survival (“PFS”), or overall survival (“OS”), and VBL made the decision to cease development of ofra-vec in August 2022. VBL also cannot guarantee that it will receive regulatory approval if VBL achieves statistical significance absent clinically meaningful benefit in a confirmatory trial. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

Any inability to successfully complete preclinical and clinical development could result in additional costs to VBL or impair its ability to generate revenue from product sales. In addition, if VBL makes manufacturing or formulation changes to its product candidate, VBL may need to conduct additional studies to bridge its modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which VBL may have the exclusive right to commercialize its product candidate or allow its competitors to bring products to market before it does, which could impair VBL’s ability to successfully commercialize its product candidates.

If the results of VBL’s clinical trials are inconclusive or if there are safety concerns or adverse events associated with any product candidate, VBL may:

Any of these events could prevent VBL from achieving or maintaining market acceptance of its product candidate and impair its ability to commercialize its product candidate.

Side effects may occur following treatment with VBL’s product candidate, which could make it more difficult for VBL’s product candidate to receive regulatory approval.

Treatment with VBL’s product candidate may cause side effects or adverse events. In addition, because VBL’s product candidate may in some cases be administered in combination with other therapies, patients or clinical trial participants may experience side effects or other adverse events that are unrelated to VBL’s product candidate, but may still impact the success of VBL’s clinical trials. Additionally, VBL’s product candidates could potentially cause other unforeseen adverse events that it cannot predict. The inclusion of critically ill patients in VBL’s clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using or the severity of the medical condition treated. The experience of side effects and adverse events in VBL’s clinical trials could make it more difficult to achieve regulatory approval of its product candidate, if at all, or could negatively impact the market acceptance of such products, if approved.

Success in early and prior clinical trials may not be indicative of results obtained in later trials.

There is a high failure rate for drugs and biologics proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later stage clinical trials even after achieving promising results in earlier stage and prior clinical trials. The results of nonclinical and preclinical studies and clinical trials may not be predictive of the results of later-stage clinical trials, and interim results of a clinical trial do not necessarily predict final results. The results of preclinical studies and clinical trials in one set of patients or disease indications may not be predictive of those obtained in another. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures and timing of such procedures as set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and the rate of dropout among clinical trial participants, among other factors. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through nonclinical studies and initial clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, regulatory delays or rejections may be encountered as a result of many factors, including changes in regulatory policy during the period of product development.

The results from VBL’s future clinical trials may not be sufficiently robust to support the submission for marketing approval for its product candidate. Before VBL submits any product candidate for marketing approval, the FDA and the EMA may require it to conduct additional clinical trials or evaluate subjects for an additional follow-up period.

It is possible that, even if VBL achieves favorable results in its clinical trials, the FDA or the EMA may require it to conduct additional clinical trials, possibly involving a larger sample size or a different clinical trial design, particularly if the FDA or the EMA does not find the results from VBL’s completed clinical trials to be sufficiently persuasive to support a Biologics License Application (“BLA”) or a New Drug Application (“NDA”). For example, achieving statistical significance is no guarantee of approval if there is no clinically meaningful benefit.

It is also possible that the FDA or the EMA may not consider the results of VBL’s clinical trials to be sufficient for approval of its product candidate for its target indications. If the FDA or the EMA requires additional studies for any reason, VBL would incur increased costs and delays in the marketing approval process, which may require it to expend more resources than it has available. In addition, it is possible that the FDA and the EMA may have divergent opinions on the elements necessary for a successful NDA or BLA and Marketing Authorisation Application, which is the equivalent of an NDA and BLA, respectively, which may cause it to alter its development, regulatory or commercialization strategies.

Even if VBL completes the necessary preclinical studies and clinical trials, it cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or the approval may be for a more narrow indication than VBL expects.

VBL cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if VBL’s product candidate demonstrates safety and efficacy in clinical trials, the regulatory agencies may not complete their review processes in a timely manner, or VBL may not be able to obtain regulatory approval. Additional delays may result if an FDA advisory committee or other regulatory authority recommends non-approval or restrictions on approval, or if the FDA is unable to conduct a timely inspection of VBL’s third party manufacturing facility. In addition, VBL may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory agency policy during the period of product development, clinical trials and the review process. Regulatory agencies also may approve a treatment candidate for fewer or more limited indications than requested or may grant approval subject to the performance of post-marketing studies. In addition, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of VBL’s treatment candidates.

Even if VBL obtains regulatory approval for a product candidate, its product will remain subject to regulatory scrutiny.

Even if VBL obtains regulatory approval in a jurisdiction, the regulatory authority may still impose significant restrictions on the indicated uses or marketing of its product candidate or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. For example, the holder of an approved BLA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the BLA. The FDA may also impose a REMS which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The holder of an approved BLA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product sponsors and their manufacturers and manufacturing facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP and other regulatory requirements, such as product tracking and tracing, and adherence to commitments made in the BLA as the case may be. If VBL or a regulatory agency discover previously unknown problems with a product such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If VBL fails to comply with applicable regulatory requirements following approval of any product candidate, a regulatory agency may:

Any government investigation of alleged violations of law could require VBL to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit VBL’s ability to commercialize its product candidate and generate revenues.

VBL has only limited experience in regulatory affairs and intends to rely on consultants and other third parties for regulatory matters, which may affect its ability or the time VBL requires to obtain necessary regulatory approvals.

VBL has limited experience in filing and prosecuting the applications necessary to gain regulatory approvals for investigational product candidates. VBL intends to rely on independent consultants for purposes of its regulatory compliance and product development and approvals in the United States and elsewhere. Any failure by VBL’s consultants to properly advise it regarding, or properly perform tasks related to, regulatory compliance requirements could compromise VBL’s ability to develop and seek regulatory approval of its product candidate.

In addition to the level of commercial success of VBL’s product candidate, if approved, VBL’s future prospects are also dependent on its ability to successfully develop a pipeline of additional product candidates, and VBL may not be successful in its efforts in using its platform to identify or discover additional product candidates.

The success of VBL’s business depends primarily upon its ability to identify, develop and commercialize product candidates based on its platform technology. VBL’s research programs may fail to identify other potential product candidates for clinical development for a number of reasons. VBL’s research methodology may be unsuccessful in identifying potential product candidates or its potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval. VBL may also be limited in its ability to pursue multiple indications with any one product candidate, due to financial or other resource constraints, development issues or regulatory obstacles.

If any of these events occur, VBL may be forced to abandon its development efforts for a program or programs. For example, VBL ceased development of ofra-vec in August 2022 after its Phase 3 trial in platinum-resistant ovarian cancer did not meet its primary endpoints. Research programs to identify new product candidates require substantial technical, financial and human resources. VBL may focus its efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

Risks Related to VBL’s Reliance on Third Parties

VBL expects to rely on third parties to conduct some or all aspects of its product manufacturing, protocol development, research and preclinical and clinical testing, and these third parties may not perform satisfactorily.

VBL does not expect to independently conduct all aspects of its product manufacturing, protocol development, research and preclinical and clinical testing. VBL currently relies, and expects to continue to rely, on third parties with respect to these items.

VBL does not have the ability to independently conduct clinical trials. VBL relies and expects to continue to rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, to conduct or otherwise support clinical trials for its product candidate. VBL may also rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to a product candidate. VBL will not control the design or conduct of any investigator-sponsored trials, and it is possible that the FDA or non-U.S. regulatory authorities will not view these investigator-sponsored trials as providing adequate support for future clinical trials, whether controlled by VBL or third parties, for any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results. Such arrangements will likely provide VBL certain information rights with respect to the investigator-sponsored trials, including access to and the ability to use and reference the data, including for VBL’s own regulatory filings, resulting from the investigator-sponsored trials. However, VBL would not have control over the timing and reporting of the data from investigator-sponsored trials, and it may not own the data from certain investigator-sponsored trials. If VBL is unable to confirm or replicate the results from the investigator-sponsored trials or if negative results are obtained, it would likely be further delayed or prevented from advancing further clinical development of its product candidate. Further, if investigators or institutions breach their obligations with respect to the clinical development of VBL’s product candidate, or if the data proves to be inadequate compared to the first-hand knowledge VBL might have gained had the investigator-sponsored trials been sponsored and conducted by it, then VBL’s ability to design and conduct any future clinical trials itself may be adversely affected.

Any of these third parties may terminate their engagements with VBL at any time. If VBL needs to enter into alternative arrangements, it could delay VBL’s product development activities. VBL’s reliance on these third parties for research and development activities will reduce its control over these activities but will not relieve VBL of its responsibility to ensure compliance with all required regulations and study protocols. For example, for a product candidate that VBL develops and commercializes on its own, VBL will remain responsible for ensuring that each of its investigational new drug application (“IND”)-enabling studies and clinical trials are conducted in accordance with the study plan and protocols. For any violations of laws and regulations during the conduct of its clinical trials, VBL could be subject to warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct VBL’s studies in accordance with regulatory requirements or VBL’s stated study plans and protocols, VBL will not be able to complete, or may be delayed in completing, the preclinical studies and clinical trials required to support future IND submissions and approval of its product candidates.

Reliance on third-party manufacturers entails risks to which VBL would not be subject if it manufactured the product candidate itself, including:

Any of these events could lead to clinical trial delays or failure to obtain regulatory approval, or impact VBL’s ability to successfully commercialize future products. Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production.

VBL and its Contract Development and Manufacturing Organizations (“CDMOs”) are subject to significant regulation with respect to manufacturing its product candidate. The manufacturing facilities on which VBL relies may not continue to meet regulatory requirements and have limited capacity.

VBL currently has relationships with a limited number of suppliers for the manufacturing of its product candidate. Each supplier may require licenses to manufacture components of VBL’s product candidate or to utilize certain processes for the manufacture of VBL’s product candidate. If such components or licenses are not owned by the supplier or in the public domain, VBL may be unable to transfer or sublicense the intellectual property rights VBL may have with respect to such activities.

All entities involved in the preparation of therapeutics for clinical trials or commercial sale, including VBL’s existing contract manufacturers for VBL’s product candidate, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP requirements. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants, or to inadvertent changes in the properties or stability of VBL’s product candidate that may not be detectable in final product testing. VBL or its contract manufacturers must supply all necessary documentation in support of a BLA on a timely basis and must adhere to the FDA’s cGMP regulations enforced by the FDA through its facilities inspection program. Information requests from the FDA or failure to meet FDA requirements can result in delays in clinical trials and any future commercial supply. The facilities and controls of some or all of VBL’s third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of VBL’s product candidate or any of VBL’s other potential products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of VBL’s product candidate or VBL’s other potential products or the associated controls for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA or other regulatory authority approval of the product candidate will not be granted.

The regulatory authorities also may, at any time following approval of a product for sale, audit VBL’s manufacturing facilities or those of VBL’s third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or VBL’s product specifications, or if a violation of applicable regulations, including a failure to comply with the product specifications, occurs independent of such an inspection or audit, VBL or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for VBL or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility.

If VBL or any of its third-party manufacturers fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new product, or revocation of a pre-existing approval.

If any manufacturer with whom VBL contracts fails to perform its obligations, VBL may be forced to manufacture the materials itself, for which it may not have the capabilities or resources, or enter into an agreement with a different manufacturer, which it may not be able to do on reasonable terms, if at all. In either scenario, VBL’s clinical trial supply could be delayed significantly as it establishes alternative supply sources. In some cases, the technical skills required to manufacture VBL’s product or product candidate may be unique or proprietary to the original manufacturer and VBL may have difficulty, or there may be contractual restrictions prohibiting it from, transferring such skills to a back-up or alternate supplier, or VBL may be unable to transfer such skills at all. In addition, if VBL is required to change manufacturers for any reason, VBL will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations. VBL will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce VBL’s product candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new manufacturer could negatively affect VBL’s ability to develop a product candidate or commercialize a product in a timely manner or within budget. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that VBL conduct bridging studies between VBL’s prior clinical supply used in its clinical trial and that of any new manufacturer. VBL may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conducting of additional clinical trials. Additionally, if VBL’s product candidate receives regulatory approval and supply from a manufacturer is interrupted, there could be a significant disruption in commercial supply. An alternative manufacturer would need to be qualified through a BLA supplement which could result in further delay. The regulatory agencies may also require comparability studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in VBL’s desired clinical and commercial timelines.

In addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others, supplier delays, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with cGMP requirements, lot consistency and timely availability of raw materials. Even if VBL obtains marketing approval for any product candidate or any future product candidates, there is no assurance that VBL or its manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential future demand. If VBL or its manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, VBL’s development and commercialization efforts would be impaired, which would have an adverse effect on VBL’s business, financial condition, results of operations and growth prospects.

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of a product candidate, cause VBL to incur higher costs and prevent it from commercializing its product successfully. Furthermore, if VBL’s suppliers fail to meet contractual requirements, and VBL is unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, its clinical trials and potential commercialization may be delayed or VBL could lose potential revenue.

VBL has relied, and expects to continue to rely, on third parties to conduct, supervise and monitor VBL’s clinical trials, and if these third parties perform in an unsatisfactory manner, it may harm VBL’s business.

VBL has relied, and expects to continue to rely, on CROs and clinical trial sites, including clinical investigators, to ensure VBL’s clinical trials are conducted properly and on time. While VBL will have agreements governing their activities, it will have limited influence over their actual performance. VBL will control only some aspects of its CROs’ activities. Nevertheless, VBL will be responsible for ensuring that each of its clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific requirements and standards, and VBL’s reliance on the CROs does not relieve VBL of its regulatory responsibilities.

VBL and its CROs are required to comply with the FDA’s GCP requirements for conducting, recording and reporting the results of clinical trials to assure that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. The FDA enforces these GCP requirements through periodic inspections of study sponsors, principal investigators and clinical trial sites. If VBL or its CROs fail to comply with applicable GCP requirements, the clinical data generated in VBL’s clinical trials may be deemed unreliable and the FDA may require VBL to perform additional clinical trials before approving any marketing applications. Upon inspection, the FDA may determine that VBL’s clinical trials did not comply with GCP requirements. In addition, VBL’s clinical trials will require a sufficient number of test subjects to evaluate the safety and effectiveness of a product candidate. Recruitment in rare diseases may be challenging and require the performance of trials in a significant number of sites which may be harder to monitor. Accordingly, if VBL’s CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, VBL may be required to repeat such clinical trials, which would result in significant additional costs and delay the regulatory approval process.

VBL’s CROs are not VBL’s employees, and VBL is therefore unable to directly monitor whether or not they devote sufficient time and resources to VBL’s clinical and nonclinical programs. These CROs may also have relationships with other commercial entities, including parties developing potentially competitive products, for whom they may also be conducting clinical trials or other drug development activities that could harm VBL’s competitive position. If VBL’s CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to VBL’s clinical protocols or regulatory requirements, or for any other reason, VBL’s clinical trials may be extended, delayed or terminated, and VBL may not be able to obtain regulatory approval for, or successfully commercialize its product candidates. As a result, the commercial prospects for VBL’s product candidate would be harmed, VBL’s costs could increase, and VBL’s ability to generate revenues could be delayed.

VBL also expects to rely on other third parties to store and distribute its product candidate for any clinical trials that it may conduct. Any performance failure on the part of VBL’s distributors could delay clinical development or marketing approval of its product candidate or commercialization of VBL’s product candidate, if approved, producing additional losses and depriving VBL of potential product revenue.

VBL’s reliance on third parties requires VBL to share its trade secrets, which increases the possibility that a competitor will discover them or that its trade secrets will be misappropriated or disclosed.

Because VBL relies on third parties to manufacture its product candidate, and because VBL collaborates with various organizations and academic institutions on the advancement of its technology, VBL must, at times, share trade secrets with them. VBL seeks to protect its proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with its collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose VBL’s confidential information, such as trade secrets. Despite these contractual provisions, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by potential competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that VBL’s proprietary position is based, in part, on VBL’s know-how and trade secrets, discovery by a third party of VBL’s trade secrets or other unauthorized use or disclosure would impair VBL’s intellectual property rights and protections in any product candidate.

In addition, these agreements typically restrict the ability of VBL’s collaborators, advisors, employees and consultants to publish data potentially relating to VBL’s trade secrets. VBL’s academic collaborators typically have rights to publish data, provided that VBL is notified in advance and may delay publication for a specified time in order to secure VBL’s intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by VBL, although in some cases VBL may share these rights with other parties. Despite VBL’s efforts to protect its trade secrets, VBL’s competitors may discover VBL’s trade secrets, either through breach of these agreements, independent development or publication of information including VBL’s trade secrets in cases where VBL does not have proprietary or otherwise protected rights at the time of publication.

Risks Related to VBL’s Business Operations

VBL’s future success depends on its ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

VBL is highly dependent on the principal members of its executive team, including Prof. Dror Harats, VBL’s chief executive officer, the loss of whose services may adversely impact the achievement of VBL’s objectives. While VBL has entered into employment agreements with each of its named executive officers and has provided for additional retention benefits, such as the grant of VBL RSUs in August 2022 in lieu of a cash retention, as it pursues strategic alternatives, any of them could leave VBL’s employment at any time, as all of VBL’s employees are “at will” employees. Recruiting and retaining other qualified employees, consultants and advisors for VBL’s business, including scientific and technical personnel, will also be critical to VBL’s success. There is currently a shortage of skilled executives in VBL’s industry, which is likely to continue. As a result, competition for skilled personnel is intense and the turnover rate can be high. VBL’s recent reduction in force and uncertainty around VBL’s pursuit of strategic alternatives has resulted in significant employee turnover and difficulty retaining staff. VBL may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets and greater financial resources than it. In addition, failure to succeed in preclinical studies or clinical trials may make it more challenging to recruit and retain qualified personnel. The inability to recruit or loss of the services of any executive, key employee, consultant or advisor may impede the progress of VBL’s research, development and strategic objectives.

VBL’s collaborations with outside scientists and consultants may be subject to restriction and change.

VBL works with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist VBL in its research, development and regulatory efforts, including the members of VBL’s scientific advisory board. In addition, these scientists and consultants have provided, and VBL expects that they will continue to provide, valuable advice regarding VBL’s programs and regulatory approval processes. These scientists and consultants are not VBL’s employees and may have other commitments that would limit their future availability to VBL. If a conflict of interest arises between their work for VBL and their work for another entity, VBL may lose their services. In addition, VBL is limited in its ability to prevent them from establishing competing businesses or developing competing products. For example, if a key scientist acting as a principal investigator in any of VBL’s clinical trials identifies a potential product or compound that is more scientifically interesting to his or her professional interests, his or her availability to remain involved in VBL’s clinical trials could be restricted or eliminated.

VBL is experiencing difficulties retaining employees, which could disrupt its operations.

As of June 26,July 19, 2023, VBL had seven employees. VBL’s recent reduction in force and uncertainty around VBL’s pursuit of strategic alternatives has resulted in significant employee turnover and difficulty retaining staff. VBL’s management may need to divert a disproportionate amount of its attention away from VBL’s day-to-day activities and devote a substantial amount of time retaining employees. VBL may not be able to effectively manage its operations, which may result in weaknesses in its infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. If VBL’s management is unable to effectively manage its staff, VBL’s expenses may increase more than expected, VBL’s ability to generate or grow revenue could be compromised, and VBL may not be able to implement its business strategy. VBL’s future financial performance and its ability to and compete effectively will depend, in part, on its ability to effectively manage any future operational growth.

VBL’s employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

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

VBL’s business was negatively impacted by the ongoing COVID-19 pandemic and may in the future be impacted by any future pandemics. In addition, this pandemic may continue to, and any future pandemics may, adversely impact economies worldwide, which could result in adverse effects on VBL’s business and operations.

VBL experienced disruptions in its business as VBL and its CROs navigated the initial outbreak and subsequent governmental restrictions imposed due to the ongoing COVID-19 pandemic. Although VBL’s employees have returned to work, there are a number of vaccines available, and many restrictions have been lifted, there is still uncertainty about the overall impact of COVID-19 on VBL’s business, as well as its continuing impact on economies worldwide. Future pandemics may arise, and they, like the COVID-19 pandemic, could impact VBL and its CDMOs and CROs, creating disruptions that affect VBL’s ability to initiate and complete preclinical studies or clinical trials, disrupt VBL’s supply chain for its research and development activities, and disrupt any planned or ongoing clinical trials for any number of reasons. Any future pandemics could similarly impact patient recruitment or retention for clinical trials or result in resources being redirected in a way that adversely impacts VBL’s ability to progress regulatory approvals and protect its intellectual property. In addition, as with the COVID-19 pandemic, VBL may face impediments to regulatory meetings and approvals due to recommended safety measures intended to limit in-person interactions in any future pandemic.

The ongoing COVID-19 pandemic already caused significant disruptions in the financial markets, and it may continue to, and any future pandemic could similarly, cause such disruptions, which could impact VBL’s ability to raise additional funds through public offerings and may also impact the volatility of VBL’s stock price and trading in VBL Ordinary Shares. VBL cannot be certain what the overall impact of the ongoing COVID-19 pandemic or any future pandemic will be on its business. The extent of the impact of COVID-19 and any future pandemic on VBL’s business, financial condition, results of operations and prospects will depend on future developments that are uncertain.

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

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect VBL’s business. In addition, government funding of the SEC and other government agencies on which VBL’s operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Separately, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold due to the COVID-19 pandemic, the FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed. During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities. If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to timely review and process VBL’s regulatory submissions, which could have a material adverse effect on VBL’s business. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact VBL’s business by delaying review of its public filings, to the extent such review is necessary, and VBL’s ability to access the public markets.

VBL faces potential product liability, and, if successful claims are brought against it, VBL may incur substantial liability and costs. If the use of VBL’s product candidate harms patients, or is perceived to harm patients even when such harm is unrelated to VBL’s product candidate, VBL’s regulatory approvals could be revoked or otherwise negatively impacted and VBL could be subject to costly and damaging product liability claims.

The use of VBL’s product candidates in clinical trials and the sale of any products for which VBL obtains marketing approval exposes VBL to the risk of product liability claims. Product liability claims might be brought against VBL by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with VBL’s product candidate. There is a risk that VBL’s product candidate may induce adverse events. If VBL cannot successfully defend against product liability claims, it could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

VBL carries combined public and products liability (including human clinical trials extension) insurance. VBL believes its product liability insurance coverage is sufficient in light of its current status; however, VBL may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect it against losses due to liability. If VBL obtains marketing approval for any product candidate, it intends to expand its insurance coverage to include the sale of commercial products, but VBL may not be able to obtain product liability insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. A successful product liability claim or series of claims brought against VBL could cause its share price to decline and, if judgments exceed VBL’s insurance coverage, could materially and adversely affect VBL’s financial position.

Patients with the diseases targeted by some of VBL’s product candidates are often already in severe and advanced stages of disease and have both known and unknown significant pre-existing and potentially life-threatening health risks. During the course of treatment, patients may suffer adverse events, including death, for reasons that may be related to VBL’s product candidates. Such events could subject VBL to costly litigation, require VBL to pay substantial amounts of money to injured patients, delay, negatively impact or end VBL’s opportunity to receive or maintain regulatory approval to market its products, or require VBL to suspend or abandon its commercialization efforts. Even in a circumstance in which VBL does not believe that an adverse event is related to its product candidate, the investigation into the circumstance may be time-consuming or inconclusive. These investigations may harm VBL’s reputation, delay its regulatory approval process, limit the type of regulatory approvals VBL’s product candidates receive or maintain, and compromise the market acceptance of any of its product candidates that receive regulatory approval. As a result of these factors, a product liability claim, even if successfully defended, could hurt VBL’s business and impair its ability to generate revenue.

VBL may use its financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

Because VBL has very limited resources, it may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential. VBL’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. VBL’s spending on current and future research and development programs for product candidates may not yield any commercially viable products. For example, VBL devoted significant time and effort, as well as capital, on the development of ofra-vec, only to not meet the primary endpoint in the OVAL trial and VBL ceased development of the program. If VBL does not accurately evaluate the commercial potential or target market for a particular product candidate, VBL may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for VBL to retain sole development and commercialization rights to such product candidate, or VBL may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement.

VBL will continue to incur significant increased costs as a result of operating as a public company, and its management will continue to be required to devote substantial time to new compliance initiatives.

As a public company, VBL will continue to incur significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies. On January 1, 2023, VBL ceased to be a “foreign private issuer” and is now required to comply with U.S. reporting requirements and subject to additional obligations due to its change in status. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which VBL operates its business in ways it cannot currently anticipate. VBL’s management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase VBL’s legal and financial compliance costs and will make some activities more time-consuming and costly. For example, VBL expects these rules and regulations, as well as the increase in the number of class actions and other securities litigation filed against publicly traded life sciences companies, to make it more difficult and more expensive for VBL to obtain director and officer liability insurance and VBL may be required to incur substantial costs to maintain its current levels of such coverage. While compliance with these additional requirements and the transition from being a foreign private issuer will result in increased costs to VBL, VBL cannot accurately predict or estimate at this time the amount of additional costs it may incur as a public company under both U.S. and Israeli laws.

Additionally, VBL is no longer an “emerging growth company,” as defined in the JOBS Act, and is now required to comply with additional disclosure and reporting requirements even though it now also qualifies as a “smaller reporting company” due to the loss of foreign private issuer status. These additional reporting requirements may increase VBL’s legal and financial compliance costs and cause management and other personnel to divert attention from operational and other business matters to devote substantial time to these public company requirements.

As a “smaller reporting company,” VBL is permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure; and reduced disclosure obligations regarding executive compensation. VBL has taken advantage of reduced reporting burdens in this proxy statement/prospectus/information statement. VBL cannot predict whether investors will find VBL Ordinary Shares less attractive if VBL relies on these exemptions. If some investors find VBL Ordinary Shares less attractive as a result, there may be a less active trading market for VBL Ordinary Shares and VBL’s share price may be more volatile.

Moreover, as a smaller reporting company, VBL is not required to include an auditor attestation regarding its internal control over financial reporting assessment. If VBL identifies material weaknesses in its internal control over financial reporting, or if VBL is unable to assert that its internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of VBL’s financial reports and the trading price of VBL Ordinary Shares could be negatively affected. VBL could also become subject to investigations by the stock exchange on which its securities are listed, the SEC or other regulatory authorities, which could require additional financial and management resources.

Irrespective of compliance with Sections 404(a) and 404(b) of the Sarbanes-Oxley Act, any failure of VBL’s internal control could have a material adverse effect on its stated results of operations and harm its reputation. In order to implement changes to VBL’s internal control over financial reporting triggered by a failure of those controls, VBL could experience higher than anticipated operating expenses, as well as higher independent auditor fees during and after the implementation of these changes.

VBL is subject to foreign currency exchange risk, and fluctuations between the U.S. dollar and the NIS, the Euro and other non-U.S. currencies may negatively affect VBL’s earnings and results of operations.

VBL operates in a number of different currencies. While the dollar is VBL’s functional and reporting currency and investments in VBL’s share capital have been denominated in dollars, VBL’s financial results may be adversely affected by fluctuations in currency exchange rates as a significant portion of its operating expenses, including its salary-related and manufacturing expenses, are denominated in the NIS.

VBL is exposed to the risks that the NIS may appreciate relative to the dollar, or, if the NIS instead devalues relative to the dollar, that the inflation rate in Israel may exceed such rate of devaluation of the NIS, or that the timing of such devaluation may lag behind inflation in Israel. In any such event, the dollar cost of VBL’s operations in Israel would increase and VBL’s dollar-denominated results of operations would be adversely affected. VBL cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation (if any) of the NIS against the dollar. Market volatility and currency fluctuations may limit VBL’s ability to cost-effectively hedge against its foreign currency exposure and, in addition, its ability to hedge its exposure to currency fluctuations in certain emerging markets may be limited. Hedging strategies may not eliminate VBL’s exposure to foreign exchange rate fluctuations and may involve costs and risks of their own, such as devotion of management time, external costs to implement the strategies and potential accounting implications. Foreign currency fluctuations, independent of the performance of VBL’s underlying business, could lead to materially adverse results or could lead to positive results that are not repeated in future periods.

Under applicable employment laws, VBL may not be able to enforce covenants not to compete.

VBL generally enters into non-competition agreements with its employees. These agreements prohibit VBL’s employees, if they cease working for VBL, from competing directly with VBL or working for its competitors or clients for a limited period. VBL may be unable to enforce these agreements under the laws of the jurisdictions in which its employees work and it may be difficult for VBL to restrict its competitors from benefitting from the expertise its former employees or consultants developed while working for VBL. For example, Israeli labor courts have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the employer which have been recognized by the courts, such as the protection of a company’s trade secrets or other intellectual property. VBL has expanded operations into the United States and entered into U.S. employment agreements. As employment law varies from U.S. state to state, VBL may not be able to enforce non-compete rights in such agreements if U.S. employees reside in states that do not recognize such rights.

VBL’s internal information technology systems, or those of its third-party CROs, contractors, consultants or others who process sensitive information on VBL’s behalf, may fail or suffer security incidents, loss or leakage of data and other compromises, any of which could result in a material disruption of VBL’s product candidate’s development program, compromise sensitive information related to VBL’s business or prevent VBL from accessing such information, expose VBL to liability or otherwise adversely affect VBL’s business.

In the ordinary course of its business, VBL may collect, store and transmit confidential information, including intellectual property, proprietary business information and personal information (including health information). It is critical that VBL does so in a secure manner to maintain the confidentiality, integrity and availability of such information. VBL also has outsourced certain of its operations to third parties, and as a result VBL manages a number of third parties who have access to its information. Despite the implementation of security measures, VBL’s internal computer systems, and those of its CROs and other third parties on which VBL relies, are vulnerable to damage from computer viruses, unauthorized access, cyberattacks by sophisticated nation-state and nation-state supported actors or by malicious third parties (including the deployment of harmful malware (such as malicious code, viruses and worms), natural disasters, global pandemics, fire, terrorism, war and telecommunication and electrical failures, fraudulent activity, as well as security incidents from inadvertent or intentional actions (such as error or theft) by VBL’s employees, contractors, consultants, business partners, and/or other third parties, phishing attacks, ransomware, denial-of-service attacks, social engineering schemes and other means that affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise VBL’s system infrastructure as well as lead to unauthorized access, disclosure or acquisition of information. Cyberattacks are increasing in their frequency, sophistication and intensity. The techniques used to sabotage or to obtain unauthorized access to VBL’s information technology systems or those upon whom VBL relies on to process its information change frequently, and VBL may be unable to anticipate such techniques or implement adequate preventative measures or to stop security incidents in all instances. The recovery systems, security protocols, network protection mechanisms and other security measures that VBL has integrated into its information technology systems, which are designed to protect against, detect and minimize security breaches, may not be adequate to prevent or detect service interruption, system failure or data loss.

Significant disruptions of VBL’s information technology systems or security incidents could adversely affect its business operations and/or result in the loss, misappropriation, and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property, proprietary business information and personal information including health information), and could result in financial, legal, business and reputational harm to VBL. If such disruptions were to occur and cause interruptions in VBL’s operations, it could result in a material disruption of VBL’s product development programs. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in VBL’s regulatory approval efforts and significantly increase VBL’s costs to recover or reproduce the data. To the extent that any disruption or security incident results in a loss of, or damage to, VBL’s data or applications, or inappropriate disclosure of confidential or proprietary information, VBL could incur liability and the further development of its future product candidates could be delayed.

VBL may also be required to comply with laws, regulations, rules, industry standards, and other legal obligations that require it to maintain the security of personal data. VBL may also have contractual and other legal obligations to notify collaborators, its clinical trial participants, or other relevant stakeholders of security incidents. Failure to prevent or mitigate cyberattacks could result in unauthorized access to data, including personal data. Most jurisdictions have enacted laws requiring companies to notify individuals, regulatory authorities, and others of security breaches involving certain types of data. Such disclosures are costly, could lead to negative publicity, may cause VBL’s collaborators or other relevant stakeholders to lose confidence in the effectiveness of VBL’s security measures and require it to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security breach. In addition, the costs to respond to a cybersecurity event or to mitigate any identified security vulnerabilities could be significant, including costs for remediating the effects of such an event, paying a ransom, restoring data from backups, and conducting data analysis to determine what data may have been affected by the breach. In addition, VBL’s efforts to contain or remediate a security incident or any vulnerability exploited to cause an incident may be unsuccessful, and efforts and any related failures to contain or remediate them could result in interruptions, delays, harm to VBL’s reputation, and increases to VBL’s insurance coverage.

In addition, litigation resulting from security breaches may adversely affect VBL’s business. Unauthorized access to VBL’s information technology systems could result in litigation with VBL’s collaborators, its clinical trial participants, or other relevant stakeholders. These proceedings could force VBL to spend money in defense or settlement, divert management’s time and attention, increase VBL’s costs of doing business, or adversely affect VBL’s reputation. VBL could be required to fundamentally change its business activities and practices in response to such litigation, which could have an adverse effect on its business. If a security breach were to occur and the confidentiality, integrity or availability of VBL’s data or the data of its collaborators were disrupted, VBL could incur significant liability, which could negatively affect VBL’s business and damage its reputation.

Furthermore, VBL may not have adequate insurance coverage or otherwise protect it from, or adequately mitigate, liabilities or damages. The successful assertion of one or more large claims against VBL that exceeds its available insurance coverage, or results in changes to VBL’s insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have an adverse effect on VBL’s business. In addition, VBL cannot be sure that its existing insurance coverage and coverage for errors and omissions will continue to be available on acceptable terms or that VBL’s insurers will not deny coverage as to any future claim.

Risks Related to VBL’s Intellectual Property

If VBL is unable to obtain or protect intellectual property rights related to its product candidates, VBL may not be able to obtain exclusivity for its product candidates or prevent others from developing similar competitive products.

VBL relies upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to its product candidates. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that VBL owns or in-licenses may fail to result in issued patents with claims that cover its product candidates in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to VBL’s patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents cover VBL’s product candidates, third parties may challenge their validity, enforceability or scope, which may result in the patent claims being narrowed or invalidated. Furthermore, even if they are unchallenged, VBL’s patents and patent applications may not adequately protect VBL’s intellectual property, provide exclusivity for VBL’s product candidates or prevent others from designing around VBL’s claims. Any of these outcomes could impair VBL’s ability to prevent competition from third parties and materially affect its operations and financial condition.

If the patent applications VBL holds with respect to its programs or product candidates fail to issue, if the breadth or strength of its patent protection is threatened, or if its patent portfolio fails to provide meaningful exclusivity for VBL’s product candidates, it could dissuade companies from collaborating with VBL to develop product candidates and threaten VBL’s ability to commercialize future products. Several patent applications covering VBL’s product candidates have been filed recently. VBL cannot offer any assurances about which, if any, applications will issue as patents, the breadth of any such issued patent claims or whether any issued claims will be found invalid and unenforceable or will be threatened by third parties. Any successful opposition to these patents or any other patents owned by or licensed to VBL could deprive it of rights necessary for the successful commercialization of any product candidates that VBL may develop. Further, if VBL encounters delays in regulatory approvals, the period of time during which it could market a product candidate under patent protection could be reduced. Because patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, VBL cannot be certain that it or its licensors were the first to file any patent application related to a product candidate. Furthermore, if third parties have filed such patent applications, an interference proceeding in the United States can be initiated by a third party to determine who was the first to invent any of the subject matter covered by the patent claims of VBL’s applications. In addition, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering VBL’s product candidates are obtained, once the patent life has expired for a product, VBL may be open to competition from generic medications. This risk is material in light of the length of the development process of VBL’s products and lifespan of VBL’s current patent portfolio.

In addition to the protection afforded by patents, VBL relies on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that it elects not to patent, processes for which patents are difficult to enforce and any other elements of VBL’s product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. VBL seeks to protect its proprietary technology and processes, in part, by entering into confidentiality agreements with its employees, consultants, scientific advisors and contractors. VBL also seeks to preserve the integrity and confidentiality of its data and trade secrets by maintaining physical security of its premises and physical and electronic security of its information technology systems. Security measures may be breached, and VBL may not have adequate remedies for any breach. In addition, VBL’s trade secrets may otherwise become known or be independently discovered by competitors. Although VBL expects all of its employees and consultants to assign their inventions to VBL, and all of VBL’s employees, consultants, advisors and any third parties who have access to VBL’s proprietary know-how, information or technology to enter into confidentiality agreements, VBL cannot provide any assurances that all such agreements have been duly executed or that its trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to its trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of VBL’s trade secrets could impair VBL’s competitive position and may have a material adverse effect on its business. Additionally, if the steps taken to maintain VBL’s trade secrets are deemed inadequate, VBL may have insufficient recourse against third parties for misappropriating the trade secret. In addition, others may independently discover VBL’s trade secrets and proprietary information. For example, the FDA, as part of its Transparency Initiative, is currently considering whether to make additional information publicly available on a routine basis, including information that VBL may consider to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change in the future, if at all.

Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, VBL may encounter significant problems in protecting and defending its intellectual property both in the United States and abroad. If VBL is unable to prevent material disclosure of the non-patented intellectual property related to its technologies to third parties, and there is no guarantee that VBL will have any such enforceable trade secret protection, VBL may not be able to establish or maintain a competitive advantage in its market.

Third-party claims of intellectual property infringement may prevent or delay VBL’s development and commercialization efforts.

VBL’s commercial success depends in part on its avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and inter partes review proceedings before the U.S. Patent and Trademark Office (“U.S. PTO”) and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which VBL is pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that VBL’s product candidates may be subject to claims of infringement of the patent rights of third parties.

Third parties may assert that VBL is employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of VBL’s product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that VBL’s product candidates may be accused of infringing. In addition, third parties may obtain patents in the future and claim that use of VBL’s technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of VBL’s product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block VBL’s ability to commercialize such product candidate unless VBL obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of VBL’s formulations, processes for manufacture or methods of use, the holders of any such patents may be able to block VBL’s ability to develop and commercialize the applicable product candidate unless VBL obtained a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms or at all.

Parties making claims against VBL may obtain injunctive or other equitable relief, which could effectively block VBL’s ability to further develop and commercialize one or more of its product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from VBL’s business. In the event of a successful claim of infringement against it, VBL may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign its infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

VBL may not be successful in obtaining or maintaining necessary rights to pharmaceutical product components and processes for its development pipeline through acquisitions and in-licenses.

Presently VBL has rights to the intellectual property, through licenses from Janssen Vaccines & Prevention B.V. and under patents that VBL owns, to develop its product candidates. Because VBL’s programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of its business may depend in part on its ability to acquire, in-license or use these proprietary rights. In addition, VBL’s product candidates may require specific formulations to work effectively and efficiently and these rights may be held by others. VBL may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that VBL identifies. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that VBL may consider attractive. These established companies may have a competitive advantage over VBL due to their size, cash resources and greater clinical development and commercialization capabilities. In addition, companies that perceive VBL to be a competitor may be unwilling to assign or license rights to it. VBL also may be unable to license or acquire third-party intellectual property rights on terms that would allow it to make an appropriate return on its investment.

VBL may enter into license agreements with third parties, and if it fails to comply with its obligations in such agreements under which it licenses intellectual property rights from third parties or otherwise experiences disruptions to its business relationships with its licensors, VBL could lose license rights that are important to its business.

VBL may need to obtain licenses from third parties to advance its research or allow commercialization of its product candidates, and VBL has done so from time to time. VBL may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, VBL may be required to expend significant time and resources to develop or license replacement technology. If VBL is unable to do so, it may be unable to develop or commercialize the affected product candidates.

In many cases, patent prosecution of VBL’s in-licensed technology is controlled solely by the licensor. If VBL’s licensors fail to obtain and maintain patent or other protection for the proprietary intellectual property VBL licenses from them, VBL could lose its rights to the intellectual property or its exclusivity with respect to those rights, and its competitors could market competing products using the intellectual property. In some cases, VBL controls the prosecution of patents resulting from licensed technology. In the event VBL breaches any of its obligations related to such prosecution, VBL may incur significant liability to its licensing partners. Licensing of intellectual property is of critical importance to VBL’s business and involves complex legal, business and scientific issues and is complicated by the rapid pace of scientific discovery in VBL’s industry. Disputes may arise regarding intellectual property subject to a licensing agreement, including:

If disputes over intellectual property that VBL has licensed prevent or impair its ability to maintain its current licensing arrangements on acceptable terms, VBL may be unable to successfully develop and commercialize the affected product candidates.

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

Competitors may infringe VBL’s patents or the patents of its licensors. To counter infringement or unauthorized use, VBL may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of VBL’s or its licensors is not valid, is unenforceable or is not infringed, or may refuse to stop the other party from using the technology at issue on the grounds that VBL’s patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of VBL’s patents at risk of being invalidated or interpreted narrowly and could put VBL’s patent applications at risk of not issuing.

Interference proceedings provoked by third parties or brought by VBL may be necessary to determine the priority of inventions with respect to VBL’s patents or patent applications or those of its licensors. An unfavorable outcome could require VBL to cease using the related technology or to attempt to license rights to it from the prevailing party. VBL’s business could be harmed if the prevailing party does not offer it a license on commercially reasonable terms. VBL’s defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract VBL’s management and other employees. VBL may not be able to prevent, alone or with its licensors, misappropriation of VBL’s intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

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

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of VBL’s patent applications and the enforcement or defense of its issued patents.

Patent reform legislation continues to increase the uncertainties and costs surrounding the prosecution of VBL’s patent applications and the enforcement or defense of its issued patents. The Leahy-Smith Act introduced a number of significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted and patent litigation is conducted. The U.S. PTO continues to develop regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated therewith, in particular, the inter partes review proceedings. It remains to be seen what impact the Leahy-Smith Act will have on the operation of VBL’s business. However, its implementation increases the uncertainties and costs surrounding the prosecution of VBL’s patent applications and the enforcement or defense of VBL’s issued patents, all of which could have a material adverse effect on VBL’s business and financial condition.

VBL may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that its employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Certain of VBL’s key employees and personnel are or were previously employed at universities, medical institutions or other biotechnology or pharmaceutical companies, including VBL’s competitors or potential competitors.

Although VBL tries to ensure that its employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for VBL, VBL may be subject to claims that VBL or its employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of VBL’s employee’s former employer or other third parties. Litigation may be necessary to defend against these claims. If VBL fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights or personnel. Even if VBL is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Furthermore, universities or medical institutions who employ some of VBL’s key employees and personnel in parallel to their engagement by VBL may claim that intellectual property developed by such person is owned by the respective academic or medical institution under the respective institution intellectual property policy or applicable law.

VBL may become subject to claims for remuneration or royalties for assigned service invention rights by its employees, which could result in litigation and adversely affect its business.

A significant portion of VBL’s intellectual property has been developed by its employees in the course of their employment for VBL. Under the Israeli Patent Law, 5727-1967 (the “Patent Law”), inventions conceived by an employee during the term and as part of the scope of his or her employment with a company are regarded as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee (the “Committee”), a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his inventions. Recent decisions by the Committee (which have been upheld by the Israeli Supreme Court on appeal) have created uncertainty in this area, as it held that employees may be entitled to remuneration for their service inventions despite having specifically waived any such rights. Further, the Committee has not yet determined the method for calculating this remuneration nor the criteria or circumstances under which an employee’s waiver of his right to remuneration will be disregarded. VBL generally enters into assignment-of-invention agreements with its employees pursuant to which such individuals assign to VBL all rights to any inventions created in the scope of their employment or engagement with it. Although VBL’s employees have agreed to assign to VBL service invention rights, VBL may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims, VBL could be required to pay additional remuneration or royalties to its current or former employees, or be forced to litigate such claims, which could negatively affect VBL’s business.

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

VBL may be subject to claims that former employees, collaborators or other third parties have an ownership interest in its patents or other intellectual property. VBL may have, in the future, ownership disputes arising, for example, from conflicting obligations of consultants or others who are involved in developing its product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If VBL fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on VBL’s business. Even if VBL is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Obtaining and maintaining VBL’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and VBL’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be paid to the U.S. PTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and applications. The U.S. PTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. There are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Issued patents covering VBL’s product candidates could be found invalid or unenforceable if challenged in court. Changes in U.S. patent law could diminish the value of patents in general, thereby impairing VBL’s ability to protect its products.

As is the case with other biotechnology companies, VBL’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnology industry involves both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in some situations. In addition to increasing uncertainty with regard to VBL’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the U.S. PTO, the laws and regulations governing patents could change in unpredictable ways that would weaken VBL’s ability to obtain new patents or to enforce its existing patents and patents that it might obtain in the future.

VBL has not yet registered trademarks for a commercial trade name for some of its product candidates and failure to secure such registrations could adversely affect its business.

VBL has not yet registered trademarks for a commercial trade name for some of its product candidates. During trademark registration proceedings, VBL may receive rejections. Although VBL would be given an opportunity to respond to those rejections, it may be unable to overcome such rejections. In addition, in the U.S. PTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against VBL’s trademarks, and VBL’s trademarks may not survive such proceedings. Moreover, any name VBL proposes to use with its product candidates in the United States must be approved by the FDA, regardless of whether VBL has registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA objects to any of VBL’s proposed proprietary product names, VBL may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.

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

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and VBL’s intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, VBL may not be able to prevent third parties from practicing its inventions in all countries outside the United States, or from selling or importing products made using its inventions in and into the United States or other jurisdictions. Potential competitors may use VBL’s technologies in jurisdictions where it has not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where VBL has patent protection, but enforcement is not as strong as that in the United States. These products may compete with VBL’s product candidates, if approved, and VBL’s patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

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

Risks Related to Ownership of VBL Ordinary Shares

The market price of VBL Ordinary Shares may be highly volatile, and you may not be able to resell your shares at the purchase price.

An active trading market for VBL Ordinary Shares may not be available. You may not be able to sell your shares quickly or at the market price if trading in VBL Ordinary Shares is not active.

The market price of VBL Ordinary Shares has been and is likely to remain volatile. VBL’s share price could be subject to wide fluctuations in response to a variety of factors, including the following:

In addition, companies trading in the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of VBL Ordinary Shares, regardless of VBL’s actual operating performance.

There has been limited trading volume for VBL Ordinary Shares.

Even though VBL Ordinary Shares have been listed on Nasdaq, there has been limited liquidity in the market for the VBL Ordinary Shares, which could make it more difficult for holders to sell their VBL Ordinary Shares. There can be no assurance that an active trading market for VBL Ordinary Shares will be sustained. In addition, the stock market generally has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors may negatively affect the market price of VBL Ordinary Shares, regardless of its actual operating performance. The market price and liquidity of the market for VBL Ordinary Shares that will prevail in the market may be higher or lower than the price you pay and may be significantly affected by numerous factors, some of which are beyond VBL’s control.

VBL’s principal shareholders and management own a significant percentage of its shares and will be able to exert significant control over matters subject to shareholder approval.

As of June 26,July 19, 2023, to the best of VBL’s information, its executive officers, key management, directors, 5% shareholders and their affiliates beneficially owned approximately 17.2% of VBL’s voting shares. Therefore, these shareholders have the ability to influence VBL through their ownership positions. These shareholders may be able to determine all matters requiring shareholder approval. For example, these shareholders, if they were to act together, may be able to control elections of directors, amendments of VBL’s organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for VBL Ordinary Shares that you may believe are in your best interest as one of VBL’s shareholders.

Future sales and issuances of VBL Ordinary Shares or rights to purchase VBL Ordinary Shares, including pursuant to VBL’s equity incentive plans and at-the-market offering, could result in additional dilution of the percentage ownership of VBL’s shareholders and could cause its share price to fall.

Additional capital will be needed in the future to continue VBL’s planned operations. To the extent VBL raises additional capital by issuing equity securities, its shareholders may experience substantial dilution. VBL may sell ordinary shares, convertible securities or other equity securities in one or more transactions at prices and in a manner VBL determines from time to time, including pursuant to the at-the-market facility with Jefferies LLC (the “Jefferies ATM”). If VBL sells ordinary shares, convertible securities or other equity securities in one or more transactions, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to VBL’s existing shareholders, and new investors could gain rights superior to VBL’s existing shareholders.

VBL also has equity plans that provide for the grant of share options and other equity-based awards to VBL’s employees, directors and consultants, and has issued warrants. The exercise of any of these RSUs, options and warrants would result in additional share issuances and may be dilutive. As these securities are registered, many are available for resale into the public market. Sales of a substantial number of shares of VBL Ordinary Shares by its existing shareholders in the public market, or the perception that these sales might occur, could depress the market price of VBL Ordinary Shares and could impair its ability to raise capital through the sale of additional equity securities. VBL is unable to predict the effect that such sales may have on the prevailing market price of VBL Ordinary Shares.

VBL could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for VBL because pharmaceutical companies have experienced significant share price volatility in recent years. In July 2022, VBL announced the OVAL Phase 3 trial did not meet its primary endpoint, which resulted in a significant reduction in VBL’s share price and increase the volatility of VBL Ordinary Shares. VBL is also now pursuing the Merger and sale of VB-601 Asset, and recently completed the sale of its rights to lease the Modi’in facility, which transactions may not maximize shareholder value as intended. If VBL faces any such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm VBL’s business.

VBL does not intend to pay dividends on VBL Ordinary Shares in the foreseeable future, so any returns will be limited to the value of its shares.

VBL has never declared or paid any cash dividends on its share capital. VBL currently anticipates that it will retain future earnings for the development, operation and expansion of its business and does not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to shareholders will therefore be limited to the appreciation of their shares. In addition, Israeli law limits VBL’s ability to declare and pay dividends and may subject VBL’s dividends to Israeli withholding taxes. Furthermore, VBL’s payment of dividends (out of tax-exempt income) may retroactively subject it to certain Israeli corporate income taxes, to which VBL would not otherwise be subject.

If equity research analysts do not publish research reports about VBL’s business or if they issue unfavorable commentary or downgrade VBL Ordinary Shares, the price of VBL Ordinary Shares could decline.

The trading market for VBL Ordinary Shares relies in part on the research and reports that equity research analysts publish about VBL and its business. The price of VBL Ordinary Shares could decline if it does not obtain research analyst coverage, or one or more securities analysts downgrade the VBL Ordinary Shares, or if those analysts issue other unfavorable commentary or expectations that VBL is unable to meet or cease publishing reports about VBL or its business.

Risks Related to VBL’s Incorporation and Operations in Israel

VBL has lost its foreign private issuer status, which requires it to comply with the domestic reporting regime under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and cause it to incur significant legal, accounting and other expenses.

As a foreign private issuer, VBL was permitted by the SEC to file an annual report on Form 20-F and copies of certain home country materials on Form 6-K in lieu of filing annual, quarterly and current reports on Forms 10-K, 10-Q and 8-K. VBL was exempt from SEC proxy statement requirements and certain SEC tender offer requirements and its affiliates were exempt from Section 16 of the Exchange Act.

VBL ceased to be a foreign private issuer and ceased to be eligible for the foregoing exemptions and privileges effective January 1, 2023. VBL is required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers as of January 1, 2023, which are more detailed and extensive than the requirements for foreign private issuers. VBL may also be required to make changes in its corporate governance practices in accordance with various SEC and Nasdaq rules. Although VBL already reports under U.S. GAAP and voluntarily publishes quarterly financial information, the regulatory and compliance costs to VBL once it is required to comply with the reporting requirements applicable to a U.S. domestic issuer may be significantly higher than the cost VBL incurs as a foreign private issuer even though VBL is able to qualify as a “smaller reporting company.”

As a result, VBL expects that its recent loss of foreign private issuer status will increase its legal and financial compliance costs and may make some activities highly time consuming and costly. It will also impose additional burdens on holders of VBL’s securities, which may make an investment in VBL less attractive. VBL expects that complying with the rules and regulations applicable to United States domestic issuers may make it more difficult and expensive for it to obtain director and officer liability insurance, and VBL may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for VBL to attract and retain qualified members of its board of directors.

Potential political, economic and military instability in the State of Israel, where the majority of VBL’s senior management and employees are located, may adversely affect VBL’s results of operations.

VBL is incorporated under Israeli law and VBL’s offices and core operations are located in the State of Israel, with a small operational base in the United States. In addition, most of VBL’s remaining key employees and officers and three of VBL’s directors are residents of Israel. Accordingly, political, economic and military conditions in Israel directly affect VBL’s business. Since the State of Israel was established in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries.

Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or a significant downturn in the economic or financial condition of Israel, could affect adversely VBL’s operations. Since October 2000, there have been increasing occurrences of terrorist violence. Ongoing and revived hostilities or other Israeli political or economic factors could harm VBL’s operations, product development and results of operations.

In addition, Israel faces threats from more distant neighbors, in particular, Iran. VBL’s insurance policies do not cover it for the damages incurred in connection with these conflicts or for any resulting disruption in VBL’s operations. The Israeli government, as a matter of law, provides coverage for the reinstatement value of direct damages that are caused by terrorist attacks or acts of war; however, the government may cease providing such coverage or the coverage might not be enough to cover potential damages. In the event that hostilities disrupt the ongoing operation of VBL’s facilities or the airports and seaports on which VBL depends to import and export its supplies and products, VBL’s operations may be materially adversely affected.

In addition, numerous acts of protest and civil unrest have taken place in several countries in the Middle East and North Africa, many of which involved significant violence, including Egypt and Syria, which border Israel. The ultimate effect of these developments on the political and security situation in the Middle East and on Israel’s position within the region is not clear at this time. Such instability may lead to deterioration in the political and trade relationships that exist between the State of Israel and certain other countries.

Popular uprisings in various countries in the Middle East and North Africa are affecting the political stability of those countries. Such instability may lead to deterioration in the political and trade relationships that exist between the State of Israel and these countries. Several countries, principally in the Middle East, still restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or increases. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or significant downturns in the economic or financial condition of Israel, could adversely affect VBL’s operations and product development and adversely affect its share price. Similarly, Israeli companies are limited in conducting business with entities from several countries. For instance, in 2008, the Israeli legislature passed a law forbidding any investments in entities that transact business with Iran.

Additionally, the Israeli government is currently advancing significant changes in Israeli legislation concerning judiciary nomination and oversight. If such proposals will be enacted by the Israeli Knesset, they will change the current balance between the three branches of government in Israel in a manner that is expected to add significant power to the executive and the legislative branches. Such changes may have actual or perceived effects regarding the risks associated with conducting business or investing in Israel. Since the proposals have not yet been enacted as law, the uncertainty of their effect on VBL and its business may not be estimated at this time.

VBL’s operations may be disrupted by the obligations of personnel to perform military service.

As of June 26,July 19, 2023, VBL had seven employees, six of whom were based in Israel. Israeli employees may be called upon to perform up to 36 days (and in some cases more) of annual military reserve duty until they reach the age of 40 (and in some cases, up to 45 or older) and, in emergency circumstances, could be called to immediate and unlimited active duty. In the event of severe unrest or other conflict, individuals could be required to serve in the military for extended periods of time. Since September 2000, in response to increased tension and hostilities, there have been occasional call-ups of military reservists and it is possible that there will be additional call-ups in the future. Although VBL’s current streamlined workforce does not include any employees subject to this obligation, if VBL’s Israeli workforce grows and becomes subject to this duty, it could impact VBL’s operations, which disruptions could materially adversely affect the business and results of operations. Additionally, the absence of a significant number of the employees of VBL’s Israeli suppliers and contractors related to military service or the absence for extended periods of one or more of their key employees for military service may disrupt their operations.

The tax benefits that are available to VBL if and when it generates taxable income require it to meet various conditions and may be prevented or reduced in the future, which could increase VBL’s costs and taxes.

If and when VBL generates taxable income, it would be eligible for certain tax benefits provided to “Benefited Enterprises” under the Israeli Law for the Encouragement of Capital Investments, 1959, as amended (the “Investment Law”). In order to remain eligible for the tax benefits for “Benefited Enterprises” VBL must continue to meet certain conditions stipulated in the Investment Law and its regulations, as amended. In addition, VBL informed the Israeli Tax Authority of its choice of 2012 as a “Benefited Enterprise” election year, all under the Investment Law. The benefits available to VBL under this tax regulation are subject to the fulfillment of conditions stipulated in the regulation. Further, in the future these tax benefits may be reduced or discontinued. If these tax benefits are reduced, cancelled or discontinued, VBL’s Israeli taxable income would be subject to regular Israeli corporate tax rates. The standard corporate tax rate for Israeli companies is 23% for 2018 and thereafter. Additionally, if VBL increases its activities outside of Israel through acquisitions, for example, its expanded activities might not be eligible for inclusion in future Israeli tax benefit programs.

It may be difficult to enforce a U.S. judgment against VBL, its officers and directors and the Israeli experts named in this document in Israel or the United States, or to assert U.S. securities laws claims in Israel or serve process on VBL’s officers and directors and these experts.

VBL was incorporated in Israel, and its corporate headquarters and substantially all of its operations are located in Israel. Most of VBL’s executive officers and three of VBL’s directors, and the Israeli experts named in this document, are located in Israel. The majority of VBL’s assets and the assets of these persons are located outside the United States. Therefore, it may be difficult for an investor, or any other person or entity, to enforce a U.S. court judgment based upon the civil liability provisions of the U.S. federal securities laws against VBL or any of these persons in a U.S. or Israeli court, or to effect service of process upon these persons in the United States. Additionally, it may be difficult for an investor, or any other person or entity, to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws against VBL or its officers and directors on the grounds that Israel is not the most appropriate forum in which to bring such a claim. Even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel addressing the matters described above.

Your rights and responsibilities as VBL’s shareholder will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.

Because VBL is incorporated under Israeli law, the rights and responsibilities of its shareholders are governed by VBL’s articles of association and Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders of U.S. corporations. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and other shareholders and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting of shareholders on certain matters, such as an amendment to the company’s articles of association, an increase of the company’s authorized share capital, a merger of the company and approval of related party transactions that require shareholder approval. A shareholder also has a general duty to refrain from discriminating against other shareholders. In addition, a controlling shareholder or a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of an officer of the company has a duty to act in fairness towards the company with regard to such vote or appointment. However, Israeli law does not define the substance of this duty of fairness. There is limited case law available to assist VBL in understanding the nature of this duty or the implications of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on VBL’s shareholders that are not typically imposed on shareholders of U.S. corporations. See “Related Party Transactions of Directors and Executive Officers of the Combined Organization — Related Party Transactions Under Israeli Law — Approval of Related Party Transactions Under Israeli Law.”

Provisions of Israeli law and VBL’s amended and restated articles of association could make it more difficult for a third party to acquire VBL or increase the cost of acquiring VBL, even if doing so would benefit VBL’s shareholders.

Israeli law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to such types of transactions. For example, a tender offer for all of a company’s issued and outstanding shares can only be completed if the acquirer receives positive responses from the holders of at least 95% of the issued share capital. Completion of the tender offer also requires approval of a majority of the offerees that do not have a personal interest in the tender offer, unless at least 98% of the company’s outstanding shares are tendered. Furthermore, the shareholders, including those who indicated their acceptance of the tender offer (unless the acquirer stipulated in its tender offer that a shareholder that accepts the offer may not seek appraisal rights), may, at any time within six months following the completion of the tender offer, petition an Israeli court to alter the consideration for the acquisition. See “Description of VBL’s Share Capital” for additional information.

Further, Israeli tax considerations may make potential transactions undesirable to VBL or to some of its shareholders whose country of residence does not have a tax treaty with Israel granting tax relief to such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no disposition of the shares has occurred.

Certain U.S. shareholders may be subject to adverse tax consequences if VBL is characterized as “Controlled Foreign Corporation.”

Each “Ten Percent Shareholder” in a non-U.S. corporation that is classified as a “controlled foreign corporation” (“CFC”) for U.S. federal income tax purposes generally is required to include in income for U.S. federal tax purposes such Ten Percent Shareholder’s pro rata share of the CFC’s “Subpart F income” and investment of earnings in U.S. property, even if the CFC has made no distributions to its shareholders. A non-U.S. corporation generally will be classified as a CFC for U.S. federal income tax purposes if Ten Percent Shareholders own, directly or indirectly, more than 50% of either the total combined voting power of all classes of stock of such corporation entitled to vote or of the total value of the stock of such corporation. A “Ten Percent Shareholder” is a U.S. person (as defined by the Code), who owns or is considered to own 10% or more of the total combined voting power of all classes of stock entitled to vote of such corporation. The determination of CFC status is complex and includes attribution rules, the application of which is not entirely certain.

VBL does not believe that it was a CFC for the taxable year ended December 31, 2022, or that VBL is currently a CFC. It is possible, however, that a shareholder treated as a U.S. person for U.S. federal income tax purposes will acquire, directly or indirectly, enough shares to be treated as a Ten Percent Shareholder after application of the constructive ownership rules and, together with any other Ten Percent Shareholders of the company, cause VBL to be treated as a CFC for U.S. federal income tax purposes. VBL believes that certain of its shareholders are Ten Percent Shareholders for U.S. federal income tax purposes. Holders should consult their own tax advisors with respect to the potential adverse U.S. federal income tax consequences of becoming a Ten Percent Shareholder in a CFC.

VBL might be classified as a PFIC in future years, and its U.S. shareholders may suffer adverse tax consequences as a result.

Generally, if, for any taxable year, at least 75% of VBL’s gross income is passive income, or at least 50% of the value of VBL’s assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, VBL would be characterized as a PFIC for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest, and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. If VBL is characterized as a PFIC, VBL’s U.S. shareholders may suffer adverse tax consequences, including having gains realized on the sale of VBL Ordinary Shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on VBL Ordinary Shares by individuals who are U.S. Holders, and having interest charges apply to distributions by VBL and the proceeds of share sales.

Because PFIC status depends on the composition of VBL’s income and the composition and value of its assets (which may be determined in part by reference to the market value of VBL Ordinary Shares, which may be volatile) from time to time, there can be no assurance that VBL will not be considered a PFIC for any taxable year. VBL believes that it was not a PFIC for its 2022 taxable year. However, the determination of whether VBL is a PFIC is a fact-intensive determination made on an annual basis applying principles and methodologies that in some circumstances are unclear and subject to varying interpretation. As a result, Goodwin Procter LLP cannot provide an opinionVBL’s PFIC status depends on the composition of its income and the composition and value of its assets (which may be determined in part by reference to the market value of VBL Ordinary Shares, which may be volatile) between the start and end of VBL’s current taxable year (which should end on the day immediately preceding the yet to be determined closing date of the Merger), VBL cannot determine its current PFIC status until after the closing date of any entity under the PFIC rulesMerger and there can be no assurance that VBL will not be treated asconsidered a PFIC for the current or any future taxable year.

Risks Related to Notable

Unless the context indicates or suggests otherwise, reference to “it”, “its”, “their”, and “Notable” in this section refers to Notable Labs, Inc.

Risks Related to Notable’s Business, Financial Position and Capital Requirements

Notable has a limited operating history that you can use to evaluate it, and the likelihood of Notable’s success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered by a small developing company.

Notable is clinical-stage precision therapeutics company that was incorporated in June 2014 and has a limited operating history. Since inception, Notable’s operations have been primarily limited to acquiring and licensing intellectual property rights, undertaking research and conducting preclinical studies and clinical trials for Notable’s PPMP, and its current drug candidates Volasertib and Fosciclopirox. Notable has not yet obtained regulatory approval for any product candidates. Consequently, any predictions about Notable’s future success or viability, or any evaluation of Notable’s business and prospects, may not be accurate. The likelihood of Notable’s success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered by a small developing company starting a new business enterprise and the highly competitive environment in which Notable will operate.

Notable expects its financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond its control. Notable will need to eventually transition from a company with a research and development focus to a company capable of undertaking commercial activities. Notable may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in such a transition. Since Notable has a limited operating history, Notable cannot assure you that its business will be profitable or that it will ever generate sufficient revenues to meet its expenses and support Notable’s anticipated activities. In addition, there is no guarantee that any of Notable’s product candidates will ever receive FDA approval.

Notable has incurred significant losses since its inception and anticipates that it will continue to incur significant losses for the foreseeable future and Notable’s management’s conclusions based on the required assessment by management per GAAP have raised substantial doubt about Notable’s ability to continue as a going concern.

Notable has devoted most of its financial resources to research and development, including Notable’s preclinical and clinical development activities. To date, Notable has funded its operations primarily through research funding, and through the sale of equity and convertible securities. Notable expects to continue to incur substantial and increased expenses, losses and negative cash flows as it expands its development activities and advances its preclinical programs. If Notable’s product candidates are not successfully developed or commercialized, including because of a lack of capital, or if Notable does not generate enough revenue following marketing approval, it will not achieve profitability and its business may fail. Even if Notable successfully obtains regulatory approval to market a product candidate, its revenues will also depend upon the size of any markets in which its product candidates receive market approval and its ability to achieve sufficient market acceptance and adequate market share for its products.

Notable expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses Notable incurs may fluctuate significantly from quarter to quarter. Notable anticipates that its expenses will increase substantially if and as it:

To become and remain profitable, Notable must develop and eventually commercialize one or more drug candidates with significant market potential or license one or more of its drug candidates to an industry partner. This will require Notable to be successful in a range of challenging activities, including completing clinical trials of its drug candidates, publishing its data and findings on its drug candidates with peer reviewed publications, developing commercial scale manufacturing processes, obtaining marketing approval, manufacturing, marketing and selling any current and future drug candidates for which Notable may obtain marketing approval, and satisfying any post-marketing requirements. Notable is only in the preliminary stages of most of these activities and, in some cases, has not yet commenced certain of these activities. Notable may never succeed in any or all of these activities and, even if it does, it may never generate sufficient revenue to achieve profitability.

Because of the numerous risks and uncertainties associated with drug development, Notable is unable to accurately predict the timing or amount of expenses or when, or if, Notable will obtain marketing approval to commercialize any of its drug candidates. If Notable is required by the FDA, or other regulatory authorities such as the EMA, to perform studies and trials in addition to those currently expected, or if there are any delays in the development, or in the completion of any planned or future preclinical studies or clinical trials of its current or future drug candidates, its expenses could increase and profitability could be further delayed.

Even if Notable does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Notable’s failure to become and remain profitable would decrease its value and could impair its ability to raise capital, maintain its research and development efforts, expand its business or continue its operations. A decline in the value of Notable also could cause investors to lose all or part of their investment in the company.

As a result, management has included disclosures in Note 1 of the financial statements and Notable’s independent auditor included an explanatory paragraph in its report on its financial statements for the year ended December 31, 2022 with respect to this uncertainty. Notable’s 2022 financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

Notable has generated only limited revenue since inception, and may never be profitable.

Notable’s ability to generate revenue and achieve profitability depends on its ability, alone or with strategic alliance partners, to successfully complete the development of, obtain the necessary regulatory approvals for and commercialize the PPMP and Notable’s product candidates. Notable does not anticipate generating significant revenues from sales of its products for the foreseeable future, if ever. Notable’s ability to generate future revenues from product sales depends heavily on its success in:

Because of the numerous risks and uncertainties associated with predictive medicine and pharmaceutical product development, Notable is unable to predict the timing or amount of increased expenses and when it will be able to achieve or maintain profitability, if ever. In addition, Notable’s expenses could increase beyond expectations if it is required by the FDA or foreign regulatory agencies to perform studies and trials in addition to those that it currently anticipates.

Even if one or more of the product candidates that Notable licenses or develops is approved for commercial sale, it anticipates incurring significant costs associated with commercializing any approved product. Even if Notable is able to generate revenues from the sale of any approved products, it may not become profitable and may need to obtain additional funding to continue operations.

Notable has identified material weaknesses in its internal control over financial reporting. If Notable’s remediation of the material weaknesses is not effective, or if Notable experiences additional material weaknesses or otherwise fails to maintain an effective system of internal controls in the future, Notable may not be able to produce timely and accurate financial statements, and Notable or its independent registered public accounting firm may conclude that Notable’s internal control over financial reporting is not effective, which could adversely affect Notable’s investors’ confidence and the valuation of its common stock.

Notable has identified material weaknesses in its internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of Notable’s annual or interim financial statements will not be prevented or detected on a timely basis. In preparing Notable’s consolidated financial statements as of and for the year ended December 31, 2022, management of Notable identified the following material weaknesses in its internal control over financial reporting:

Notable did not fully maintain components of the COSO framework, including elements of the control environment, risk assessment, monitoring activities, information and communication, and control activities components, relating to: (i) Notable’s commitment to attract, develop, and retain competent individuals; (ii) identifying, assessing, and communicating appropriate objectives, (iii) identifying and analyzing risks to achieve these objectives; (iv) selecting, developing, and performing ongoing evaluation to ascertain whether the components of internal controls are present and functioning; (v) communicating accurate information internally and externally, including providing information pursuant to objectives, responsibilities, and functions of internal control; (vi) selecting and developing control activities that contribute to the mitigation of risks and support achievement of objectives and (vii) deploying control activities through policies that establish what is expected and procedures that put policies into action.

These material weaknesses resulted in adjustments to Notable’s consolidated financial statements.

To remediate these material weaknesses, Notable is actively recruiting additional accounting personnel with appropriate experience, certification, education and training. Notable is in the process of implementing additional measures and risk assessment procedures designed to improve Notable’s disclosure controls and procedures and internal control over financial reporting to address the underlying causes of these material weaknesses, including the implementation of appropriate segregation of duties, formalization of accounting policies and controls, and implementation of accounting systems to automate manual processes. Notable has engaged financial consultants to assist with the implementation of internal controls over financial reporting and are actively recruiting an audit committee and financial expert. In March 2023 Notable also hired a Chief Financial Officer. To the extent that Notable is not able to hire and retain such individuals or is unable to successfully design and implement such controls, the material weaknesses identified may not be remediated and management may be required to record additional adjustments to its financial statements in the future or otherwise not be able to produce timely or accurate financial statements. If Notable’s management concludes that Notable’s internal control over financial reporting is not effective, such a determination could adversely affect Notable’s investors’ confidence and the valuation of its common stock.

Notable expects that it will need to raise additional capital, which may not be available on acceptable terms, or at all.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. Notable anticipates that its expenses will increase substantially as it continues to develop and begin and continues clinical trials with respect to Volasertib and Fosciclopirox and any additional drug candidates; seek to identify and develop additional drug candidates; acquire or in-license other drug candidates or technologies; seek regulatory and marketing approvals for its drug candidates that successfully complete clinical trials, if any; establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various drugs for which Notable may obtain marketing approval, if any; require the manufacture of larger quantities of drug candidates for clinical development and, potentially, commercialization; maintain, expand and protect its intellectual property portfolio; develop, maintain, and expand the PPMP; hire and retain additional personnel, such as clinical, quality control and scientific personnel; add operational, financial and management information systems and personnel, including personnel to support its drug development and help it comply with its obligations as a public company; and add equipment and physical infrastructure to support its research and development programs.

Notable will be required to expend significant funds in order to advance the development of the PPMP, Volasertib, Fosciclopirox and any other drug candidate(s). In addition, while Notable may seek one or more collaborators for future development of its current drug candidates or any future drug candidates that it may develop for one or more indications, Notable may not be able to enter into a partnership or out-license for any of its drug candidates for such indications on suitable terms, on a timely basis or at all. In any event, Notable’s existing cash, cash equivalents and other capital resources will not be sufficient to fund all of the efforts that it plans to undertake or to fund the completion of development of its drug candidates or its other preclinical studies. Accordingly, Notable will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources. Notable does not have any committed external source of funds. Further financing may not be available to Notable on acceptable terms, or at all. Notable’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategy.

Notable expects its research and development expenses to substantially increase in connection with its ongoing activities, particularly as it advances its product candidates, Volasertib and Fosciclopirox, through clinical trials. Notable may need to raise additional capital to support its operations and such funding may not be available to it on acceptable terms, or at all. Notable cannot provide assurances that its plans will not change or that any change in circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. For example, Notable’s preclinical or clinical trials may encounter technical or other difficulties. Any of these events may increase Notable’s development costs more than it expects. In order to support Notable’s long-term plans, it may need to raise additional capital or otherwise obtain funding through additional strategic alliances if it chooses to initiate preclinical or clinical trials for new product candidates. In any event, Notable will require additional capital to obtain regulatory approval for, and to commercialize, its current and future product candidates.

Any additional fundraising efforts may divert Notable’s management from its day-to-day activities, which may adversely affect Notable’s ability to develop and commercialize current and future product candidates. In addition, Notable cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to it, if at all. If Notable is unable to raise additional capital when required or on acceptable terms, it may be required to:

Notable’s future funding requirements, both short-term and long-term, will depend on many factors, including:

Notable faces significant competition from other biopharmaceutical companies, and Notable’s operating results will suffer if it fails to compete effectively.

The biopharmaceutical industry is characterized by intense competition and rapid innovation. Notable’s competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Notable’s potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of Notable’s competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly as they develop novel approaches to treating disease indications that Notable’s product candidates are also focused on treating. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel therapeutics or to in-license novel therapeutics that could make the product candidates that Notable develops obsolete. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Notable’s competitors, either alone or with collaboration partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than its product candidates or may develop proprietary technologies or secure patent protection that it may need for the development of its technologies and products. Notable believes the key competitive factors that will affect the development and commercial success of its product candidates are efficacy, safety, tolerability, reliability, convenience of use, price and reimbursement.

Even if Notable obtains regulatory approval of drug products, the availability and price of its competitors’ products could limit the demand and the price it is able to charge for its product candidates. Notable may not be able to implement its business plan if the acceptance of its product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to Notable’s product candidates, or if physicians switch to other new drug or biologic products or choose to reserve its product candidates for use in limited circumstances.

Notable’s product candidates, Volasertib and Fosciclopirox, are in the early stages of clinical development and their commercial viability remains subject to current and future clinical trials, regulatory approvals and the risks generally inherent in the development of a drug candidate. If Notable is unable to successfully advance or develop its product candidates, its business will be materially harmed.

In the near-term, failure to successfully advance the development of Notable’s product candidates, Volasertib and Fosciclopirox, may have a material adverse effect on the company. To date, Notable has not successfully or commercially marketed, distributed or sold any product candidate. The success of Notable’s business depends primarily upon its ability to successfully advance the development of its product candidate clinical trials, have the product candidate approved for sale by the FDA or regulatory authorities in other countries, and ultimately have the product candidates successfully commercialized by Notable or a strategic partner. Notable cannot assure you that the results of its ongoing clinical trials will support or justify the continued development of its product candidates, or that it will receive approval from the FDA, or similar regulatory authorities in other countries, to advance the development of its product candidates.

Notable’s product candidates must satisfy rigorous regulatory standards of safety and efficacy before it can advance or complete its clinical developments or it can be approved for sale. To satisfy these standards, Notable must engage in expensive and lengthy clinical trials, develop acceptable manufacturing processes, and obtain regulatory approval of its product candidates. Despite these efforts, Notable’s product candidates may not:

A number of companies in the pharmaceutical and biopharmaceutical industries have experienced significant delays, setbacks and failures in all stages of development, even after achieving promising results in clinical trials. Furthermore, even if the data collected from preclinical studies and clinical trials involving Notable’s product candidates demonstrate a favorable safety and efficacy profile, such results may not be sufficient to support the submission of an NDA or a BLA to obtain regulatory approval from the FDA in the United States, or other similar regulatory agencies in other jurisdictions, which is required to market and sell the product.

Notable’s product candidates will require significant additional research and development efforts, the commitment of substantial financial resources, and regulatory approvals prior to advancing into further clinical development or being commercialized by Notable or collaborators. Notable cannot assure you that its product candidates will successfully progress through the drug development process or will result in commercially viable products. Notable does not expect its product candidates to be commercialized by Notable or collaborators for at least several years.

Risks Related to the Discovery and Development of Notable’s Drug Candidates

Notable has limited experience in drug discovery and drug development and may not receive regulatory approval to market its drug candidates.

Prior to the acquisition of its drug candidates, Notable was not involved in and had no control over their preclinical and clinical development. In addition, Notable relies upon the parties from whom it has acquired its drug candidates to have conducted such research and development in accordance with the applicable protocol, legal, regulatory and scientific standards, have accurately reported the results of all clinical trials conducted prior to its acquisition of the applicable drug candidate, and have correctly collected the data from these studies and trials. To the extent any of these has not occurred, Notable’s expected development time and costs may be increased, which could adversely affect its prospects for marketing approval of, and receiving any future revenue from, these drug candidates.

In the near term, Notable is dependent on its ability to advance the development of Volasertib and Fosciclopirox. If Notable is unable to initiate or complete the clinical development of, obtain marketing approval for or successfully commercialize Volasertib and Fosciclopirox and its other drug candidates, either alone or with a collaborator, or if it experiences significant delays in doing so, Notable’s business could be substantially harmed. In addition, Notable may not continue the development of Volasertib in the United States until it completes the transfer of the Volasertib IND from Oncoheroes Biosciences, Inc. (“Oncoheroes”). Any delay of such IND transfer may delay Notable’s planned clinical trials of Volasertib.

Notable currently does not have any drugs that have received regulatory approval and may never be able to develop marketable drug candidates. Notable is investing a significant portion of its efforts and financial resources in the advancement of its drug candidates and in the development of the PPMP. Notable’s prospects are substantially dependent on its ability, or those of any future collaborator, to develop, obtain marketing approval for and successfully commercialize drug candidates in one or more disease indications.

The success of Volasertib and Fosciclopirox and Notable’s other drug candidates will depend on several factors, including the following: