Gamida steps up search for 'strategic alternatives' despite stem cell therapy reaching market

2024-01-29
细胞疗法上市批准加速审批免疫疗法
Gamida steps up search for 'strategic alternatives' despite stem cell therapy reaching market
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来源: FierceBiotech
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.
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