Gamida Cell Announces Commitment Letter with Highbridge for $25 Million Funding
BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM cell therapies for patients with hematological and solid cancers and other serious diseases, announced that it has entered into a Letter of Engagement with certain funds managed by Highbridge Capital Management, LLC (“Highbridge”), pursuant to which Highbridge has agreed to provide a $25 million senior secured convertible term loan (the “Term Loan”).
The Commitment Letter does not represent a definitive credit facility and is subject to certain conditions, including the completion of an offering of shares of Gamida Cell raising gross proceeds of at least $20 million. The Commitment Letter provides, among other things, for: (i) a maturity date of 24 months from the closing date of the Term Loan; and (ii) an annual interest rate of 7.50%, which may increase to 12.00% upon the occurrence of certain events, payable quarterly and, under certain conditions, payable in ordinary shares of Gamida Cell which will be valued at 95% of the volume weighted average price over a period to be agreed. The obligations under the term loan will be secured by substantially all of our assets and the assets of our subsidiaries.
Subject to certain limitations, the Lenders will have the right to convert the Term Loan, together with a set-off premium, equal to all accrued and unpaid Coupons, and remaining due to the Maturity Date (the “Amount total compensation”), into Gamida of the ordinary shares of Cell at a conversion price equal to a premium of 35% over the arithmetic average of the volume-weighted average price of the ordinary shares of Gamida Cell for the three-day period beginning September 28, 2022, which price is subject to adjustment in the event of common stock dividends, reclassifications and certain other fundamental transactions affecting the common stock. Subject to certain conditions, the term loan will be immediately repayable at 100% of the principal amount plus accrued and unpaid interest to the date of repayment, plus the set-off amount, plus a redemption premium of 5%. Beginning four months after the Term Loan Closing Date, Gamida Cell will commence monthly repayments on the Term Loan of principal and accrued but unpaid interest on such amount together with the Set-off Amount. These installment payments can be paid to Highbridge in cash or in shares.
Gamida Cell expects to pay certain fees and expenses of Highbridge and to enter into a registration rights agreement with Highbridge, pursuant to which Gamida Cell will be required to file a registration statement recording the resale by Highbridge of any common stock of Gamida Cell issuable in accordance with the terms of the term loan within 30 days of the closing date of the term loan.
Omidubicel is an advanced cell therapy candidate developed as a potentially life-saving allogeneic hematopoietic (bone marrow) stem cell transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in neutrophil engraftment time compared to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT0273029) in patients with hematological malignancies undergoing allograft of bone marrow. The phase 3 study also showed a reduction in platelet transplant time, a reduction in infections and fewer days of hospitalization. One-year post-transplant data showed durable clinical benefits with omidubicel, as evidenced by a significant reduction in infectious complications as well as a reduction in relapse-free mortality and no significant increase in relapse rates or increase in rate of graft versus host disease (GvHD). Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational stem cell therapy candidate, and its safety and effectiveness have not been established by the FDA or any other health authority. For more information on omidubicel, please visit https://www.gamida-cell.com.
Gamida Cell has applied the capabilities of its nicotinamide-activated cell expansion (NAM) technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematological and solid tumors in combination with therapies for standard antibody. GDA-201, the lead candidate in the NAM-compatible NK cell pipeline, has demonstrated promising initial clinical study data. Preclinical studies have shown that GDA-201 can address major NK cell limitations by increasing cytotoxicity and live retention and proliferation in bone marrow and lymphoid organs. Additionally, these data suggest that GDA-201 may enhance antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.
GDA-201 is an investigational candidate for cell therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM technology is designed to improve the number and functionality of targeted cells, allowing us to pursue a healing approach that goes beyond what is possible with existing therapies. By taking advantage of the unique properties of NAM (nicotinamide), we can grow and metabolically modulate multiple cell types – including stem cells and natural killer cells – with appropriate growth factors to maintain the active phenotype of cells and improve their Powerful. Additionally, our NAM technology improves the metabolic fitness of cells, allowing continued activity throughout the expansion process.
About the Gamida cell
Gamida Cell is at the forefront of a diverse immunotherapy portfolio of potentially curative cell therapy candidates for patients with solid tumors, blood cancers and other serious blood diseases. We apply a proprietary expansion platform exploiting the properties of NAM to allogeneic cell sources, including umbilical cord blood-derived cells and NK cells, to create therapeutic candidates that have the potential to redefine the standard of care. These include omidubicel, an investigational product with the potential to save the lives of patients in need of bone marrow transplants, and a modified and unmodified NAM-activated NK cell line targeted to solid tumors and hematological malignancies. For more information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the ability of Gamida Cell and Highbridge to agree to mutually acceptable loan terms, if Gamida Cell will offer common stock or making a stock offering, the timing of initiation and progress of clinical trials of Gamida Cell’s product candidates (including omidubicel), and data reported therefrom, regulatory filings submitted to the FDA (including the potential timing of FDA review of the BLA for omidubicel), marketing planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omibidicel), and Gamida Cell’s expectations regarding the planned clinical development milestones set forth herein. Any statement describing Gamida Cell’s objectives, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. These statements are subject to a number of risks, uncertainties and assumptions, including those relating to the impact the COVID-19 pandemic may have on our business, and including the scope, progress and expansion of Gamida Cell’s clinical trials and their ramifications for cost. whose ; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for human therapeutic use, and the effort of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties 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 15, 2022, as amended, and other documents filed by Gamida Cell with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in these forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, such statements are based solely on facts and factors currently known to Gamida Cell. Accordingly, you are cautioned not to rely on these forward-looking statements.
1CIBMTR 2019 – allogeneic transplants in patients aged 12 and over with hematological malignancies.
2Gamida Cell Market Research