Sana edits plans again, retreating from in vivo CAR-T delivery and laying off 29% of staff to cut costs

Sana Biotechnology is restructuring and narrowing its focus for the second time in less than a year. With its stock in the doldrums, the cell engineering biotech is pulling back from its in vivo delivery platform and reducing its head count by 29% to stretch its cash runway deeper into 2025.

Seattle-based Sana went public just as the biotech stock market peaked in February 2021, enabling it to raise $587.5 million before entering the clinic. The stock has followed the broader market down ever since, sliding from its early peak of almost $40 per share to below $4 today. Plans to get in vivo and ex vivo therapies into humans as early as 2022 slipped, and Sana narrowed its focus and laid off 15% of its staff late last year.

Eleven months later, and weeks after confirming cuts “within a single area of research,” the biotech has revealed it is reducing its head count by 29%. Sana ended June with 424 full-time employees, suggesting the layoffs will affect more than 100 people.

The cuts come as the biotech narrows its focus again. Last year, Sana dropped a heart failure program but kept investing in ex vivo candidates targeting CD19, CD22 and BCMA, an in vivo CD19-targeted CAR-T and a stem-cell-derived pancreatic islet cell therapy for patients with Type 1 diabetes. Now, the biotech has abandoned plans to take its in vivo CAR-T candidate into the clinic.

Pulling back from in vivo delivery represents a major pivot from Sana’s early ambition. When the biotech went public, in vivo programs made up the top half of its pipeline and were scheduled to enter human testing around the same time as the ex vivo assets. Sana pitched in vivo delivery as a way to avoid the cost and complexity of ex vivo CAR-T production and eliminate the need for conditioning regimens. 

Around 30 months later, Sana has abandoned plans to study its in vivo candidate in humans and has a pipeline led by an ex vivo, allogeneic CAR-T that requires patients to receive conditioning chemotherapy. 

The biotech will continue “focused research” on its in vivo platform, but the priority is now getting a set of ex vivo assets to clinical data drops. Sana began a phase 1 trial of the CD19-directed CAR-T SC291 in B-cell malignancies in May and aims to start delivering data this year. Submissions to study SC291 in autoimmune disorders, islet cells in diabetes and a CD22 CAR-T in leukemias are planned for this year.

Sana’s submission schedule positions it to deliver clinical data on three candidates in multiple settings next year. The latest restructuring extended the biotech’s cash runway “further into 2025,” suggesting it has time to deliver data that could renew investor enthusiasm for its assets—or report underwhelming results that send it deeper into the mire.