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Sana Biotechnology (SANA) Earnings Call Presentation
2025-07-04 09:46
Type 1 Diabetes (T1D) Program - Sana's hypoimmune platform (HIP) overcomes allogeneic rejection in people, which is confirmed by 4-week and 12-week data[4] - Type 1 diabetes affects 94 million children and adults, and is projected to affect 164 million by 2040[12, 13] - Type 1 diabetes leads to 201600 deaths per year and costs $81 billion worldwide annually[17] - SC451, a HIP-modified stem cell-derived pancreatic islet therapy, is advancing toward the clinic with an expected IND filing as early as 2026[114] - HIP-modified PSC differentiated islet cells transplanted into muscle persist & control blood glucose in mice for >15 months[64] Autoimmune Disease Program - B-cell mediated autoimmune diseases affect >5 million patients[68] - SC291, a HIP-modified CD19 CAR T, leads to deep B-cell depletion and has significant potential in B-cell mediated autoimmune diseases, with an ongoing GLEAM study[114] - Sana's T cell manufacturing process provides ~85% full knock-out of MHC class I and II, >995% TCR negative cells[79] - Fusogen platform offers the potential to treat B-cell mediated autoimmune diseases and B-cell cancers with NO lymphodepletion with an expected IND filing as early as 2026[114] Oncology Program - SC262, a HIP-modified CD22 CAR T, has meaningful potential in treating CD19 CAR T relapsed patients, with an ongoing VIVID study[114] - Estimated ~12000 B cell malignancy patients treated with CD19 CAR T in 2027, with ~35-40% durable complete responses, leading to ~7500 CAR T failures annually[106]
Sana Biotechnology Reports First Quarter 2025 Financial Results and Business Updates
Globenewswire· 2025-05-08 20:05
Core Insights - Sana Biotechnology, Inc. has made significant progress in developing therapies for type 1 diabetes, with promising clinical results indicating that hypoimmune-modified pancreatic islet cells can function without immunosuppression and maintain stable C-peptide production post-transplant [1][2][5] - The company is advancing its pipeline with ongoing trials for SC291 and SC262 targeting B-cell mediated autoimmune diseases and relapsed/refractory B-cell malignancies, respectively, with data expected in 2025 [1][7] - Financially, Sana reported a cash position of $104.7 million as of Q1 2025, with a cash runway expected to extend into 2026 [1][6] Clinical Developments - The ongoing UP421 trial has shown that hypoimmune-modified pancreatic islets can evade immune detection and continue to function three months post-transplant, which is a critical step towards a functional cure for type 1 diabetes [2][5] - Preclinical data for SC451 demonstrated 15-month durability of glycemic control in a mouse model, with no histological abnormalities, supporting its potential for future clinical application [4] - The GLEAM and VIVID trials are currently enrolling patients, with expectations to report clinical data in 2025 [1][7] Financial Performance - For Q1 2025, the company reported a net loss of $49.4 million, or $0.21 per share, a significant reduction from a net loss of $107.5 million, or $0.49 per share, in Q1 2024 [6][14] - Research and development expenses decreased to $37.2 million in Q1 2025 from $56.4 million in the same period in 2024, primarily due to lower personnel-related and clinical development costs [6][14] - The company’s non-GAAP operating cash burn for Q1 2025 was $46.6 million, down from $58.7 million in Q1 2024, indicating improved cash management [10][19]