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Sana Biotechnology Reports Second Quarter 2025 Financial Results and Business Updates
Globenewswire· 2025-08-11 20:05
Presented positive 6-month clinical results of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome immune recognition, while continuing to function and persist with stable C-peptide New England Journal of Medicine published positive 12-week clinical results of the type 1 diabetes study Recent FDA INTERACT meeting increases confidence in moving forward with GMP master cell bank for SC451 and in filing SC451 Investigational New ...
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]
INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Sana Biotechnology
Newsfilter· 2025-04-09 15:40
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Sana Biotechnology, Inc. for alleged violations of federal securities laws, particularly regarding misleading statements about the company's financial health and product development [3][5]. Group 1: Legal Investigation and Claims - The firm is encouraging investors who suffered losses in Sana between March 17, 2023, and November 4, 2024, to discuss their legal rights [1][3]. - A federal securities class action has been filed against Sana, with a deadline of May 20, 2025, for investors to seek the role of lead plaintiff [3][9]. - The complaint alleges that Sana and its executives made false statements about the company's financial capacity and the potential of its product candidates [5]. Group 2: Company Financials and Operations - On October 10, 2023, Sana announced a strategic shift to reduce spending on its fusogen platform and focus on its ex vivo cell therapy platform, resulting in a 29% headcount reduction [6][7]. - Following this announcement, Sana's stock price fell by $0.34 per share, or 8.95%, closing at $3.46 per share on October 11, 2023 [7]. - On November 4, 2024, Sana suspended development of SC291 and SC379, reallocating resources to its type 1 diabetes program, which extended its cash runway into 2026 [8]. - After this announcement, Sana's stock price dropped by $0.37 per share, or 9.84%, closing at $3.39 per share on November 5, 2024 [8].