Sana Biotechnology, Inc. (NASDAQ: SANA) announced its third quarter 2024 financial results and business updates, highlighting a strategic focus on immunologic diseases and the advancement of its clinical programs. The company is enrolling patients in trials for type 1 diabetes, B-cell mediated autoimmune diseases, and oncology, with data expected in 2024 and 2025.
Strategic Repositioning and Pipeline Focus
Sana Biotechnology is increasing its focus on type 1 diabetes and B-cell mediated autoimmune diseases. According to Steve Harr, Sana’s President and Chief Executive Officer, this strategic repositioning aims to accelerate development and prolong the company's capital runway. The company anticipates multiple clinical data readouts with its current balance sheet, projecting a cash runway into 2026.
Clinical Program Updates
Sana is advancing three clinical programs across five indications, utilizing its hypoimmune (HIP) technology. These programs include:
- Type 1 Diabetes: UP421, an investigator-sponsored trial (IST), is evaluating a HIP-modified pancreatic islet cell therapy in patients with type 1 diabetes. The trial aims to assess immune evasion, islet cell survival, and beta cell function without immunosuppression. Initial data is expected in 2024 or 2025. The company is also progressing with pre-clinical development of SC451, a HIP-modified, stem cell-derived pancreatic islet cell program.
- B-cell Mediated Autoimmune Diseases: The GLEAM trial is assessing SC291, a HIP-modified CD19-directed allogeneic CAR T therapy, in patients with B-cell mediated autoimmune diseases, including lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis. Initial data is anticipated in 2024 or 2025.
- Oncology: The VIVID trial is evaluating SC262, a HIP-modified CD22-directed allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy. Data is expected in 2025.
Leadership and Financial Highlights
Dhaval Patel, M.D., Ph.D., has been appointed as Executive Vice President and Chief Scientific Officer, bringing extensive experience in research, drug discovery, and clinical care. As of September 30, 2024, Sana's cash, cash equivalents, and marketable securities totaled $199.0 million, compared to $205.2 million at the end of 2023. Research and development expenses for the third quarter were $53.2 million, and the net loss was $59.9 million, or $0.25 per share.
Financial Position
The company's cash position was $199.0 million as of September 30, 2024, compared to $205.2 million as of December 31, 2023. The decrease of $6.2 million was primarily driven by cash used in operations of $176.0 million and cash used for the purchase of property and equipment of $33.0 million, partially offset by net proceeds from equity financings of $181.0 million, proceeds from stock option exercises and the employee stock purchase plan of $10.3 million, and net proceeds of $7.8 million from a loan to fund tenant improvements for our manufacturing facility in Bothell, Washington during the nine months ended September 30, 2024.
Sana Biotechnology is focused on creating and delivering engineered cells as medicines, with a vision of repairing and controlling genes and replacing damaged cells to make therapies broadly available.
