Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material
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
