Core Viewpoint - A class action lawsuit has been filed against Sana Biotechnology, Inc. for allegedly misleading investors regarding its financial stability and the potential of its product candidates [1][2]. Group 1: Allegations Against Sana Biotechnology - The lawsuit claims that Sana was at significant risk of having insufficient funds to maintain operations and advance its product candidates [2]. - Specific product candidates, including SC291 in oncology, SC379, and SG299, were reportedly less promising than what the company had communicated to investors [2]. - To conserve cash and focus on more promising candidates, Sana was likely to reduce funding for or discontinue certain projects and significantly cut its workforce [2]. - As a result, the company allegedly overstated its financial capacity to sustain operations and advance its product pipeline [2]. Group 2: Class Action Participation - Shareholders interested in serving as lead plaintiffs must file their papers with the court by May 20, 2025 [3]. - Participation in the class action is not required to be eligible for recovery; shareholders can remain absent class members if they choose [3]. Group 3: About Robbins LLP - Robbins LLP is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses and improve corporate governance since 2002 [4].

NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Sana Biotechnology, Inc. (NASDAQ: SANA) between March 17, 2023 and November 17, 2024, inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 20, 2025. SO WHAT: If you purchased Sana securities during the Class Period ...

NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Sana Biotechnology, Inc. (NASDAQ: SANA). Shareholders who purchased shares of SANA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/sana-biotechnology-inc-loss-submission-form/?id=138493&from=3 CLASS PERI ...

Core Viewpoint - A class action lawsuit has been filed against Sana Biotechnology, Inc. for misleading statements regarding its financial health and product candidates during the specified Class Period from March 17, 2023, to November 17, 2024 [1][5]. Group 1: Lawsuit Details - The lawsuit claims that Sana was at significant risk of insufficient funds to maintain operations and advance product candidates [5]. - It alleges that the product candidates SC291, SC379, and SG299 were less promising than represented, and that funding for these candidates would likely be decreased or discontinued [5]. - Defendants are accused of overstating Sana's financial capacity, leading to materially false and misleading public statements [5]. Group 2: Participation Information - Investors who purchased Sana securities during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To join the class action, interested parties must act before May 20, 2025, to serve as lead plaintiff [3][6]. - The Rosen Law Firm encourages investors to select qualified counsel with a successful track record in securities class actions [4].

Core Viewpoint - A class action lawsuit has been filed against Sana Biotechnology, Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 17, 2023, to November 4, 2024, seeking damages for affected investors [1]. Company Overview - Sana Biotechnology, Inc. is a biotechnology company focused on developing ex vivo and in vivo cell engineering programs aimed at addressing unmet treatment needs in various therapeutic areas, including oncology, diabetes, CNS disorders, and autoimmune diseases [3]. Financial and Operational Claims - Throughout the Class Period, company officials claimed that Sana had the financial capacity to maintain operations and advance product candidates, including SC291, SC379, and SG299, highlighting promising preclinical and clinical results [4]. - The complaint alleges that the company misrepresented its financial health, stating that it was at significant risk of insufficient funds to support operations and product development, and that the product candidates were less promising than claimed [5]. Recent Developments - On October 10, 2023, Sana announced a reduction in spending on its fusogen platform and a 29% headcount reduction, aiming to keep its 2024 operating cash burn below $200 million, which led to an 8.95% drop in stock price [6]. - On November 4, 2024, the company announced the suspension of development for SC291 and SC379, reallocating resources to its type 1 diabetes program, which resulted in a 9.84% decline in stock price [7][8].

Core Viewpoint - A class action lawsuit has been filed against Sana Biotechnology, Inc. for alleged violations of securities laws, claiming the company made false and misleading statements regarding its financial health and product candidates [1][4]. Group 1: Lawsuit Details - The lawsuit is based on violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 [1]. - Investors who purchased securities between March 17, 2023, and November 4, 2024, are encouraged to participate in the lawsuit [2]. - The class has not yet been certified, meaning potential participants are not currently represented by an attorney [3]. Group 2: Allegations Against the Company - The complaint alleges that Sana Biotechnology made false and misleading statements about its funding and product candidates [4]. - The company reportedly faced significant risks regarding insufficient funding to maintain operations and advance product candidates [4]. - It is claimed that several product candidates were less promising than represented, leading to potential funding cuts and layoffs to preserve cash for more promising candidates [4]. - The company's public statements were deemed false and materially misleading, resulting in investor damages when the truth emerged [4].

Company Overview - Sana Biotechnology, Inc. (NASDAQ: SANA) is a biotechnology company focused on producing engineered cells to repair or replace damaged cells that cause diseases [1] - The company explores both ex vivo and in vivo approaches to develop new therapies [1] Technology and Research - For ex vivo applications, Sana leverages its proprietary technology [1]

SAN DIEGO, March 24, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of all persons and entities that purchased or otherwise acquired Sana Biotechnology, Inc. (NASDAQ: SANA) securities between March 17, 2023 and November 4, 2024. Sana is a biotechnology company that develops ex vivo and in vivo cell engineering programs to purportedly revolutionize treatment across a broad array of therapeutic areas with unmet treatment needs, including, inter alia, oncology, di ...

ATLANTA, March 24, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Sana Biotechnology, Inc. (“Sana” or the “Company”) (NASDAQ: SANA). The lawsuit alleges that Defendants made false and/or misleading statements and/or failed to disclose material facts regarding Sana’s business, operations, and prospects, including allegations that: (i) Sana was at significant risk of having insufficient funds to maintain its current operations and advance one or more of its product candidat ...

Product Development and Clinical Trials - The company is developing UP421, a HIP-modified allogeneic primary islet cell product, which was transplanted into a patient with type 1 diabetes (T1D) in December 2024, with positive results showing survival and function of pancreatic beta cells at four weeks post-transplant [27]. - Approximately 9 million people suffer from T1D globally, and the company is developing SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy, aiming for euglycemia without exogenous insulin injections or immunosuppression, with an IND filing expected as early as 2026 [28]. - The GLEAM study, a Phase 1 clinical trial for SC291, has received Fast Track designation from the FDA for relapsed/refractory systemic lupus erythematosus, indicating the potential for expedited development due to unmet medical needs [32]. - Preliminary twelve-week clinical results for UP421 showed that all primary and secondary endpoints were met, with no drug product-related adverse events reported, indicating a significant milestone in cell therapy [28]. - The company has three ongoing clinical trials targeting T1D, B cell mediated autoimmune diseases, and B cell malignancies, demonstrating a broad therapeutic focus [26]. - SC291, targeting B cell mediated autoimmune diseases, is currently in a Phase 1 dose escalation study, with data expected to be shared in 2025 [48]. - SC262, a hypoimmune-modified CD22-directed CAR T program, has received FDA clearance for a Phase 1 clinical study, with data anticipated in 2025 [50]. - The company received IND clearance for SC291, a CD19-directed allogeneic CAR T therapy, in November 2023, with data expected in 2025 [150]. - SC262, a CD22-directed allogeneic CAR T therapy, received IND clearance in January 2024, with data also expected in 2025 [150]. - The GLEAM trial is expected to report progress in 2025, evaluating SC291 for LN, ERL, and ANCA-associated vasculitis [173]. Technology and Innovation - The HIP technology allows for the engineering of allogeneic cells that can evade the immune system, which is crucial for the success of cell therapies [25]. - The company’s hypoimmune technology is designed to enable cells to evade immune detection, which is critical for the success of allogeneic therapies [47]. - The company’s ex vivo cell engineering platform aims to overcome challenges related to engraftment, function, persistence, and manufacturing of desired cells [53]. - The company is developing hypoimmune technology to enable allogeneic cell transplantation without the need for systemic immune suppression [67]. - Current clinical hypoimmune technology involves three gene modifications: disruption of MHC class I and II expression, and overexpression of CD47 [71]. - The hypoimmune technology seeks to address both adaptive and innate immune responses, enhancing the potential for successful allogeneic therapies [65]. - The fusosome technology enables targeted delivery of genetic payloads to specific T cell populations, achieving up to 20% gene delivery in CD8+ T cells at the highest dose level in non-human primate studies [204]. - The fusosome approach allows for in vivo generation of CAR T cells without the complexities and delays associated with ex vivo manufacturing, potentially improving efficacy and safety profiles [201]. - The company is focusing on selecting fusogens that the general population does not have pre-existing immunity to, reducing the risk of immunogenicity [190]. - The fusosome technology has shown the ability to deliver a variety of payloads, including DNA, RNA, and proteins, enhancing flexibility in genome modification [191]. Market Potential and Unmet Needs - The global diabetes population is estimated to be approximately 540 million, highlighting the significant market potential for innovative treatments [43]. - Current T1D treatments, primarily insulin injections, result in a life expectancy approximately 15 years shorter than those without diabetes, highlighting the unmet need for better therapies [114]. - B cell-mediated autoimmune diseases affect over 5 million patients in the U.S., highlighting a significant market opportunity [151]. - Approximately 20% of patients in large trials still experience severe disease flares despite treatment, indicating an unmet need in the market [156]. - Only about 50% of patients treated with approved CD19-directed CAR T therapy achieve a complete response, with one-third relapsing quickly [165]. Manufacturing and Scalability - The company is investing in scalable manufacturing capabilities, including a pilot manufacturing plant in South San Francisco and a long-term lease in Bothell, Washington [56]. - The company is investing in improving manufacturing scale, costs, consistency, and product quality through partnerships with contract development manufacturing organizations (CDMO) [199]. - The non-GMP pilot plant has a bioreactor scale of up to 200L, supporting process development and production for GLP toxicology studies [218]. - The company has established a long-term lease for a GMP manufacturing facility to support the production of allogeneic T cells [218]. - The company aims to enhance patient access to cell and gene therapies by improving manufacturing processes and product characterization [215]. Safety and Efficacy - Hypoimmune primary islets have demonstrated the ability to mediate insulin independence in diabetic NHPs without immunosuppression [73]. - Human hypoimmune cells transplanted into MHC mismatched humanized mice survived without eliciting an immune response, confirming their immune evasion capabilities [77]. - The administration of anti-CD47 antibody resulted in rapid clearance of hypoimmune NHP iPSCs, demonstrating a potential safety mechanism [104]. - In vitro studies showed that hypoimmune NHP iPSCs do not induce NK cell killing, but become susceptible when treated with anti-CD47 antibody [105]. - The preliminary clinical findings from the first-in-human transplantation of UP421 validate that HIP-modified islet cells can function without immunosuppression [101]. - Long-term blood glucose control was maintained for over 64 weeks following transplantation of HIP-modified PSC islet cells, with no observed tumor formation or histological abnormalities [136]. - Positive results from the IST at four weeks post-cell transplantation showed survival and function of pancreatic beta cells, indicated by circulating C-peptide levels [137]. - At twelve weeks, all primary and secondary endpoints were met, with no drug-related adverse events reported, demonstrating the safety of the UP421 transplant [137]. Intellectual Property and Competitive Landscape - As of January 2025, the company holds approximately 45 licensed or owned U.S. issued patents and 57 pending patent applications in the U.S. [221]. - The patent portfolio includes approximately 263 licensed patent applications pending in jurisdictions outside the U.S., primarily in Europe, Canada, China, Japan, and Australia [221]. - The company plans to rely on data exclusivity, market exclusivity, and patent term extensions to protect its proprietary technology [220]. - The expected expiration dates for patents range from 2028 to 2045, depending on the filing dates and regulatory extensions [222]. - The company recognizes the competitive landscape, noting that competitors may have greater financial resources and established marketing capabilities [219].