GDA 301

Nasdaq-listed Gamida will have to become a private company wholly owned by Highbridge Capital. With the search for a partner for an approved stem cell therapy coming up short, cash-strapped Gamida Cell has accepted that the only way to remain a going concern is to allow its principal lender to acquire the company. The agreement will see Highbridge Capital Management convert $75 million of existing unsecured convertible senior notes into equity in the company as well as supply $30 million of new capital to Gamida. These combined funds should allow the biotech to continue to commercialize its stem cell therapy Omisirge, which was FDA approved a year ago. But in return, Nasdaq-listed Gamida will have to become a private company wholly owned by Highbridge, the biotech explained in a March 27 release. While Omisirge’s approval for reducing the risk of infection in blood cancer patients should have been a moment of triumph for Gamida, the Israeli company has struggled with limited resources for a while. A wave of layoffs in 2022 was followed by another round in March 2023, with the company also making the “difficult” decision to deprioritize preclinical work on natural killer (NK) cell therapies, including GDA-301, GDA-501 and GDA-601. In January, Gamida announced that it was “actively pursuing strategic alternatives in order to maximize value for all stakeholders, focusing on an asset sale, merger or other strategic transaction.” “In March 2023, Gamida Cell embarked on an extensive strategic process to address its capital structure and liquidity constraints by partnering Omisirge with a third party,” Gamida’s CEO Abbey Jenkins explained in today’s release. “Unfortunately, that process did not yield any actionable alternatives.” “This restructuring will enable Gamida Cell to remain as a going concern and will support our ongoing efforts to make Omisirge available to more transplant centers and their patients as a potentially lifesaving donor source option,” Jenkins added. Gamida entered 2024 with $46.6 million on hand in cash and equivalents, which it said would not be enough to fund operations even as far as July. Jonathan Segal, co-chief investment officer at Highbridge, said that “despite Gamida Cell’s financial struggles,” the investment firm “believes in the potential of Omisirge to fulfill an important unmet need in stem cell transplant.” “Subject to an approved budget from the company’s new board of directors, we intend to provide the company with additional capital to fund this potentially life-saving therapy,” Segal added. “We are hopeful that our continued support of the company will allow Omisirge to be available for those who need it.”

Gamida ended September with $60.4 million in cash and equivalents, which is only expected to last into the second quarter of this year. Despite finally getting an off-the-shelf bone marrow stem cell transplant for blood cancer patients to market last year, cash-strapped Gamida Cell is continuing to search for a financial life raft. The Israel-based biotech is “actively pursuing strategic alternatives in order to maximize value for all stakeholders, focusing on an asset sale, merger or other strategic transaction,” according to a Jan. 29 release. Resources have been tight at Gamida for a while now, with layoffs in 2022 followed by another round in March last year in order to eke out finances until the FDA made a decision on the blood cancer treatment omidubicel. At the same time, Gamida made the “difficult” decision to deprioritize preclinical work on natural killer (NK) cell therapies, including GDA-301, GDA-501 and GDA-601. While searching for strategic alternatives, Gamida will “continue to put its focus and resources behind the commercialization” of omidubicel, now known as Omisirge. The allogeneic cell therapy secured FDA approval in April 2023 to reduce the risk of infection in blood cancer patients, with the first individuals receiving the approved therapy in the third quarter. Omisirge works by speeding the recovery of neutrophils, a type of white blood cells that combat infection. Specifically, the drug is approved for patients 12 and older who are undergoing umbilical cord blood transplantation following radiation or chemotherapy. The single-dose therapy is administered intravenously and is made up of donor stem cells from umbilical cord blood that are processed with nicotinamide, a form of vitamin B3. The approval didn’t immediately solve the company’s money troubles, however. Gamida ended September with $60.4 million in cash and equivalents, which is only expected to last into the second quarter of this year. When the financial situation was outlined in a third-quarter earnings release in November 2023, Gamida explained that it was already on the hunt for a “strategic partner.” The biotech had “received considerable interest from multiple potential partners during the process … which has resulted in oral and written proposals.” “However … it has not identified a partnership that will adequately address strategic needs,” the company said at the time.