Sana Biotechnology Announces Increased Focus on Type 1 Diabetes and B-cell Mediated Autoimmune Diseases with the Potential to Deliver Clinical Proof of Concept Data Across Multiple Studies in 2024 and 2025

Strategic Focus and Development Priorities - The company prioritizes clinical and preclinical development on type 1 diabetes (UP421 and SC451), B-cell mediated autoimmune diseases (SC291), refractory B-cell malignancies (SC262), and the fusogen platform for generating in vivo CAR T cells [1] - The modified strategy extends the expected cash runway into 2026, with potential for multiple data readouts in 2024 and 2025 [1] - The company will suspend development of SC291 in oncology and SC379 (glial progenitor cell program) while seeking partnerships for these programs [1] - Increased investment in the type 1 diabetes program is planned, utilizing cash savings from the strategic changes [1] Clinical Data and Therapeutic Potential - Early clinical data with the hypoimmune platform (HIP) suggest that HIP-modified cells evade immune detection, indicating potential across multiple therapeutic areas [2] - The company expects to present robust clinical data for type 1 diabetes, SC291 in autoimmune diseases, and SC262 in refractory blood cancers over the next 12 to 18 months [2] - SC291 in B-cell mediated autoimmune diseases shows early clinical data indicating deep B cell depletion, which may drive an immune "reset" and significant clinical benefit in conditions like lupus [3] Program Updates and Expectations - UP421 (HIP-modified primary pancreatic islet cells) in type 1 diabetes: An investigator-sponsored trial is active, with proof of concept data expected in 2024 and/or 2025 [3] - SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases: Enrollment continues in the Phase 1 GLEAM trial, with clinical data expected in 2024 and/or 2025 [4] - SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology: Enrollment continues in the Phase 1 VIVID study, with data expected in 2025 [4] - SC451 (HIP-modified stem cell-derived pancreatic islet cells) in type 1 diabetes: Preclinical development continues [5] - SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Preclinical development continues, with potential in both autoimmune diseases and oncology [5] Pipeline Adjustments and Partnerships - SC291 in oncology: Enrollment and further internal investment in the Phase 1 ARDENT trial are halted due to alternative opportunities and increased competition in blood cancers The company is seeking a licensing partner [6] - SC379 (stem-cell derived glial progenitor cells) in CNS diseases: The company is actively seeking a partner or opportunity to spin out this program into a new company [7] Financial and Operational Impact - The modified strategy extends the expected cash runway into 2026, though 2024 operating cash burn may exceed prior guidance of less than $200 million due to ongoing activities and workforce reductions [2]