UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

SCHEDULE 14A

 

Proxy Statement Pursuant to Section 14(a) of

the Securities and Exchange Act of 1934

 

Filed by the Registrant ☒

Filed by a Party other than the Registrant ☐

Check the appropriate box:

 

Preliminary Proxy Statement
   
Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))
   
Definitive Proxy Statement      
   
Definitive Additional Materials      
   
Soliciting Material Pursuant to § 240.14a-12  

 

Gamida Cell Ltd.

 

(Name of Registrant as Specified in Its Charter)

 

 

 

(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

 

Payment of Filing Fee (Check the appropriate box):

 

No fee required
   
Fee paid previously with preliminary materials
   
Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11

 

 

 

 

 

 

On September 29, 2023, Gamida Cell Ltd. (the “Company”) mailed to its shareholders of record as of the close of business on September 11, 2023 the following materials relating to the Company’s 2023 annual general meeting of shareholders (the “Annual Meeting”):

 

 

September 29, 2023

 

Important Shareholder Meeting

 

Dear Fellow Shareholders,

 

As you probably already know, Gamida Cell’s annual general meeting of shareholders is scheduled to be held on Thursday, October 19, 2023, at 10:00am ET. We encourage you to read the proxy statement, vote your shares and attend the meeting as described therein. We’ve included another form of proxy with this letter which will make it easier for you to vote your shares at this very important annual general meeting.

 

Included among the six ballot items, under Proposal 6 we are seeking approval of an increase in the number of our ordinary shares authorized for issuance in our share reserve, which we believe will provide us with certain flexibility to continue financing the business prudently in order to achieve our two-pronged corporate strategy. Your Board of Directors recommends that you vote in favor of all six of the proposed resolutions and believes we have the right combination of skills and experience to capitalize on the significant opportunity that Omisirge’s recent FDA marketing approval presents.

 

We would like this opportunity to update you on the progress of our two-pronged approach, which was announced at the end of March 2023 relating to (i) the targeted launch of Omisirge (omidubicel-onlv) in the United States, and (ii) pursuing a strategic partnership or transaction with a bio-pharmaceutical company to expand transplant center onboarding and accelerate patient access to Omisirge.

 

Targeted Launch of Omisirge

 

This week we announced that the first patient has received a stem cell transplant with Omisirge. This is a significant milestone for Gamida Cell, marking the advancement of our mission of delivering potentially curative therapies to patients with cancer. We believe this patient is just the first of many who have new hope for a cure, thanks to the availability of Omisirge as a new stem cell transplant donor source.

 

As we also shared this week, we are pleased with the progress we are making with the launch of Omisirge to date, especially in light of our need to launch with a limited investment and field footprint in order to appropriately manage our cash. Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. We are actively engaged with more than 90% of the top 70 transplant centers, which perform approximately 80% of transplants. Transplanters are identifying patients for whom they intend to use Omisirge as their donor source, with an increasing number of patients being enrolled in Gamida Cell Assist, which indicates the transplanter’s intention to use Omisirge as the donor source.

 

We have conducted multiple market research studies that confirm the unmet need in the market and associated market share potential of Omisirge with a fully resourced launch. These studies showed that Omisirge has the potential to capture approximately 20% market share at peak, which we estimate could drive over $600 million in net sales within 5 years.

 

 

 

 

Pursuing a Strategic Partnership or Transaction

 

We continue to actively engage with potential strategic partners to identify the best strategic and commercial fit to support the early launch of Omisirge and its long-term potential to address critical unmet needs in stem cell transplantation. To ensure that we maintain early launch momentum while pursuing strategic alternatives, we were pleased to share at our second quarter earnings call that we have strengthened our balance sheet significantly, extending our cash runway into Q2 of 2024. 

 

In the spirit of creating value, we continue to be laser focused on successfully executing both prongs of our corporate strategy, and believe it is critical to maintain financial strength and liquidity in order to effectively position the company in a potential transaction. While we are sensitive to shareholder dilution, raising capital through the issuance of shares may be necessary from time to time. As we strive to successfully complete a strategic transaction, we must continue to invest in the launch of Omisirge and our ongoing operations.

 

We continue to work on your behalf to create shareholder value and appreciate your support.

 

Sincerely,

 

Shawn Tomasello  
Shawn C. Tomasello  
Chairwoman of the Board of Directors  

 

Cautionary Note Regarding Forward Looking Statements

 

This letter contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge™ (omidubicel-onlv), including statements regarding Omisirge’s potential to capture market share and potential Omisirge sales revenue. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

 

 

 

 

 

 

 

 

 

 

 

Additional Information and Where to Find It

 

On September 13, 2023, the Company filed the definitive proxy statement (the “Proxy Statement”) with the Securities and Exchange Commission (the “SEC”) in connection with its solicitation of proxies for its Annual Meeting. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND OTHER DOCUMENTS THE COMPANY FILES WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Proxy Statement (including any amendments or supplements thereto) and other documents filed or that will be filed with the SEC through the web site maintained by the SEC at www.sec.gov. In addition, the documents filed by the Company may be obtained free of charge from the Company’s website at www.athersys.com or by written request to the Company at 116 Huntington Avenue, 7th Floor, Boston, Massachusetts 02116, Attention: Josh Patterson, General Counsel & Chief Compliance Officer, or by e-mail to legalnotices@gamida-cell.com.

 

No Offer or Solicitation

 

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

 

Participants in the Solicitation

 

The Company and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from the Company’s stockholders in connection with the Annual Meeting. For information regarding the Company’s directors and executive officers, please see the Proxy Statement, the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2023, the Company’s subsequent Quarterly Reports on Form 10-Q, and the other documents filed (or to be filed) by the Company from time to time the SEC. Additional information regarding the interests of those participants and other persons who may be deemed participants may be obtained by reading the definitive Proxy Statement and other relevant documents filed with the SEC. Free copies of these documents may be obtained free of charge from the Company’s website at www.gamida-cell.com or by written request to the Company at 116 Huntington Avenue, 7th Floor, Boston, Massachusetts 02116, Attention: Josh Patterson, General Counsel & Chief Compliance Officer, or by e-mail to legalnotices@gamida-cell.com.

 

 

 

 

 


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