Sana Biotechnology, Inc. (NASDAQ: SANA) has announced its financial results for the third quarter of 2024, alongside key business updates. The company, which specializes in creating and delivering engineered cells as medicines, is strategically focusing on immunologic diseases, particularly type 1 diabetes and B-cell mediated autoimmune disorders. This repositioning aims to accelerate development and extend the company's capital runway.
Financial Overview
Sana Biotechnology reported a net loss of $59.9 million, or $0.25 per share, for the third quarter of 2024. As of September 30, 2024, the company's cash, cash equivalents, and marketable securities totaled $199.0 million, providing a financial runway into 2026. Research and development expenses for the quarter were $53.2 million, a decrease from $65.6 million in the same period in 2023. The company's strategic shift and ongoing clinical programs are expected to yield multiple clinical data readouts in 2024 and 2025.
Clinical Program Advancements
Sana Biotechnology is currently advancing three clinical programs across five indications:
- Type 1 Diabetes: UP421, a HIP-modified primary human pancreatic islet cell therapy, is being evaluated in an investigator-sponsored trial. 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 preclinical development of SC451, a HIP-modified, stem cell-derived pancreatic islet cell program.
- B-cell Mediated Autoimmune Diseases: The GLEAM trial is evaluating SC291, a HIP-modified CD19-directed allogeneic CAR T therapy, in patients with lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis. Initial data is anticipated in 2024 or 2025.
- Oncology: The VIVID trial is assessing SC262, a HIP-modified CD22-directed allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have previously received CD19-directed CAR T therapy. Data is expected in 2025.
Leadership and Strategic Focus
In a significant move, Sana Biotechnology appointed Dhaval Patel, M.D., Ph.D., as Executive Vice President and Chief Scientific Officer. Dr. Patel brings extensive experience in research, drug discovery, and clinical care, having contributed to the development of 10 approved drugs across multiple indications. His expertise is expected to strengthen the company's scientific leadership as it advances its clinical programs.
Steve Harr, Sana’s President and Chief Executive Officer, stated, “Early clinical data with our hypoimmune technology suggest HIP-modified cells evade immune detection, and we look forward to sharing data in 2024 and 2025 across multiple clinical settings, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology.”
Financial Position and Outlook
Sana Biotechnology's cash position of $199.0 million is expected to provide a cash runway into 2026. However, payments related to ongoing activities and the strategic repositioning may increase the 2024 operating cash burn above the prior guidance of less than $200 million.
The company's strategic focus on immunologic diseases and the advancement of its clinical programs, combined with the appointment of Dr. Patel, positions Sana Biotechnology for potential growth and success in the coming years. The anticipated clinical data readouts in 2024 and 2025 will be crucial in validating the company's hypoimmune technology and allogeneic CAR T therapies.
