More than a year after Gamida Cell slimmed down its workforce, the biotech has again resorted to laying off staff to keep the long-delayed plans for its blood cancer treatment omidubicel on the road.
The company suffered a blow last November when the FDA revealed it was unlikely to make an approval decision before May 1, three months later than previously suggested. A rough funding environment meant Gamida had been unable to gather the extra resources needed to finally get the off-the-shelf bone marrow stem cell transplant for blood cancer patients to market as originally planned, according to a full-year earnings report issued Monday.
“We believe we have a clear path to approval and are preparing for the commercial launch of omidubicel if approved,” CEO Abbey Jenkins explained in the report. “Given the challenging economic environment, to date, we have not been able to raise adequate funding to support our full pipeline and enable a more robust launch of omidubicel.”
As a result, Gamida made the “difficult” decision to deprioritize the company’s preclinical work on natural killer (NK) cell therapies, including GDA-301, GDA-501 and GDA-601, which Jenkins said “have demonstrated encouraging preclinical data that differentiate them from other NK cell therapy approaches.”
“The science is promising, but these changes are economically necessary to ensure omidubicel reaches as many patients as possible,” the CEO added. The company will, however, continue to enroll patients in the phase 1 trial of its NK therapy GDA-201 in non-Hodgkin lymphoma.
The efforts to “reduce expense across the board” also include trimming back head count by a further 17%. Most of the cuts are roles tied to the NK pipeline. Gamida will also close its operations in Jerusalem and consolidate its Israel operations at its manufacturing facility in Kiryat Gat.
Even with these changes and a $25 million loan taken out in December 2022, Gamida only expects its cash to last through to the third quarter of the year. The “vast majority” of the company’s resources will be funneled into launching omidubicel, but the limited cash means the biotech now expects “more limited investment and slower ramp than previously planned.”
The new strategy means the biotech is betting all its chips on a positive FDA decision for omidubicel, despite the drug having had a rocky journey with the regulator to date. In November 2021, the FDA requested more data on Gamida’s manufacturing facility before it agreed to move the submission forward, with the company jettisoning 10% of its staff two months later to eke out available cash.
A January 2023 approval deadline was later set, but, last November, the FDA extended the review deadline by roughly three months to May 1, 2023, after the agency apparently considered that the new information it had received from the company constituted a major amendment to the rolling submission.