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Sana Biotechnology Announces Pricing of Public Offering
Globenewswire· 2025-08-07 03:24
Group 1 - Sana Biotechnology, Inc. has priced its underwritten public offering of 20,895,522 shares of common stock at $3.35 per share and pre-funded warrants to purchase 1,492,537 shares at $3.3499 per warrant [1] - The gross proceeds from the offering are expected to be approximately $75.0 million before deducting underwriting discounts and commissions [1] - The offering is expected to close on or about August 8, 2025, subject to customary closing conditions [1] Group 2 - Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the offering [2] - The offering is being made pursuant to a Registration Statement on Form S-3, which has been declared effective by the SEC [3] - A final prospectus supplement and accompanying prospectus will be filed with the SEC [3] Group 3 - Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients [5] - The company has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA [5]
Sana Biotechnology Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-08-06 20:38
Core Viewpoint - Sana Biotechnology, Inc. has announced a public offering of $75 million in common stock and pre-funded warrants, with an additional option for underwriters to purchase up to $11.25 million more [1][2]. Group 1: Offering Details - The public offering consists of $75 million in shares of common stock and pre-funded warrants for certain investors [1]. - The underwriters will have a 30-day option to purchase an additional $11.25 million in shares [1]. - All shares and warrants will be sold by Sana, and the offering is subject to market conditions [1]. Group 2: Underwriters - Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the offering [2]. Group 3: Regulatory Information - The offering is made under a Registration Statement on Form S-3, which has been declared effective by the SEC [3]. - A preliminary prospectus supplement will be filed to describe the terms of the offering, available through the SEC's website [3]. Group 4: Company Overview - Sana Biotechnology focuses on creating engineered cells as medicines for patients, with operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA [5].
Sana Biotechnology Announces Publication in New England Journal of Medicine of Groundbreaking Clinical Data from Transplantation Without Immunosuppression of Hypoimmune-Modified, Insulin-Producing Islet Cells in Patient with Type 1 Diabetes
GlobeNewswire· 2025-08-04 15:35
Core Insights - The study demonstrates that Sana's hypoimmune (HIP)-modified pancreatic islet cells can be transplanted without immunosuppression, showing persistence and insulin production over time in a patient with type 1 diabetes [1][2][6] - The results indicate a significant advancement towards a functional cure for type 1 diabetes, as the patient was able to produce insulin independently for the first time in over 35 years [2][3] - The company plans to file an Investigational New Drug application for SC451, a HIP-modified stem cell-derived therapy, as early as 2026 [1][2] Study Findings - The study involved the transplantation of HIP-modified pancreatic islet cells into a 42-year-old patient, with results showing that these cells evade immune detection and continue to function [1][9] - Six-month follow-up results confirmed the survival and function of the transplanted cells, indicated by the presence of circulating C-peptide, a biomarker for insulin production [7][9] - MRI scans showed consistent signals at the transplant site, confirming graft survival [9] Technology and Development - Sana's HIP platform is designed to create cells that can evade the immune system, allowing for the transplantation of allogeneic cells without the need for immunosuppression [8][10] - The company is developing multiple therapeutic candidates using this platform, including stem cell-derived pancreatic islet cells and CAR T cells for various diseases [8][10] - The ongoing study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, emphasizing the significance of the research [5]
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 Announces Positive Six-Month Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
Globenewswire· 2025-06-23 14:05
Core Insights - The study demonstrates the potential of Sana's hypoimmune (HIP) technology to treat type 1 diabetes by transplanting insulin-secreting cells without the need for immunosuppression, showing promising results over a six-month follow-up period [1][2][5] - The results indicate that transplanted pancreatic islet cells are safe, well-tolerated, and continue to produce insulin, as evidenced by consistent levels of circulating C-peptide [1][5] - The study is a collaboration with Uppsala University Hospital and aims to develop a one-time treatment for type 1 diabetes that achieves normal blood glucose levels without insulin or immunosuppression [1][4] Study Results - Six-month follow-up results show that the transplanted islet cells survived and functioned effectively, indicated by the presence of circulating C-peptide, a biomarker for insulin production [1][5] - C-peptide levels increased during a mixed meal tolerance test (MMTT), confirming insulin secretion in response to meals [1][5] - MRI scans indicated signals consistent with graft survival six months post-transplantation [1] Technology and Development - Sana's HIP technology is designed to enable the transplantation of allogeneic cells without immunosuppression, addressing the challenge of immune rejection in type 1 diabetes [3][6] - The company plans to incorporate findings from the UP421 trial into the development of SC451, a HIP-modified, stem cell-derived therapy for type 1 diabetes, with an investigational new drug application (IND) expected to be filed next year [2][6] - The HIP platform has shown proof-of-concept in humans, demonstrating the ability to evade immune recognition while retaining cell activity [5][6] Industry Impact - Type 1 diabetes affects over nine million people globally, and advancements in treatment options are crucial for improving patient outcomes [2][3] - The potential to administer insulin-producing cells could transform diabetes management, reducing reliance on lifelong insulin injections and immunosuppressive drugs [3][4] - The study's findings may lead to broader applications of cellular and transplant medicine, making these therapies more accessible to patients [2][3]
Sana Biotechnology (SANA) FY Conference Transcript
2025-06-10 13:40
Summary of Sana Biotechnology (SANA) FY Conference Call - June 10, 2025 Company Overview - **Company**: Sana Biotechnology (SANA) - **Industry**: Biotechnology - **Focus**: Development of cell-based therapies, particularly for type one diabetes and CAR T cell therapies Key Points and Arguments Portfolio Strategy and Pipeline - The company is focused on using cells as medicines, specifically through two technologies: hypoimmune technology and in vivo gene modification [3][4] - The majority of capital is allocated towards the hypoimmune platform, which aims to hide cells from immune system recognition, particularly in type one diabetes [5][12] - Type one diabetes affects approximately 9 million people globally, with about 2 million in the U.S., and has seen little meaningful progress in treatment over the past century [6][7] - The goal is to provide a single treatment that results in normal blood sugar levels for life without the need for insulin or immunosuppression [8][12] Type One Diabetes Program - The lead program, SC451, is a hypoimmune iPSC-derived islet cell therapy expected to file an IND in 2026 [15] - Investigator-sponsored trials have shown promising results, including a patient making insulin without immunosuppression for over 35 years [21][22] - The therapy aims to be scalable and consistent, addressing the limitations of current treatments that require lifelong immunosuppression [24][53] Risks and Challenges - Major risks identified include capital and time constraints, safety concerns, and the need for scalable manufacturing [56][57] - The company is focused on ensuring product purity to avoid tumor emergence, which is critical for long-term patient safety [56] CAR T Cell Programs - The company is also developing allogeneic CAR T therapies for oncology and autoimmune diseases, facing competition and investor fatigue in the CAR T space [9][10][11] - The allogeneic CAR T program aims to provide off-the-shelf therapies that do not require patient-specific modifications [61][64] - The company is optimistic about achieving deep B cell depletion in autoimmune settings based on oncology data [62][64] Competitive Landscape - The company differentiates itself by eliminating the need for immunosuppression in its therapies, which is a significant advantage over competitors [52][53] - The market for type one diabetes treatments is vast, with potential for significant revenue if successful [51] Financial Strategy and Partnerships - The company acknowledges the need for additional funding to support its various programs and is exploring partnerships as a non-dilutive option [74][75] - There is a strong commitment to protect the type one diabetes franchise while seeking capital for other programs [75][76] Upcoming Data and Expectations - The company plans to present updated data at the American Diabetes Association meeting, with expectations for stable C peptide levels and glucose-sensitive insulin secretion [35][36] - The focus remains on ensuring that the therapy meets safety and efficacy standards before moving forward with broader applications [66][67] Additional Important Content - The company has made significant progress in developing a master iPSC cell bank, which is crucial for scaling production [41][49] - The challenges of scaling production to meet the needs of millions of patients are acknowledged, with ongoing efforts to ensure genomic stability [46][47] This summary encapsulates the key points discussed during the conference call, highlighting Sana Biotechnology's strategic focus, challenges, and future expectations in the biotechnology sector.
Sana Biotechnology Announces Invited Oral Presentation at the 85th Annual American Diabetes Association Scientific Sessions
Globenewswire· 2025-06-09 20:05
Core Insights - Sana Biotechnology, Inc. is set to present updated six-month clinical results of a hypoimmune-modified primary pancreatic islet cell therapy for type 1 diabetes at the upcoming American Diabetes Association (ADA) Scientific Sessions [1] - The presentation will focus on the first-in-human study of UP421, an allogeneic primary islet cell therapy utilizing Sana's hypoimmune (HIP) technology, which does not require immunosuppression [1] Presentation Details - The presentation titled "Hypoimmune Pancreatic Islet Transplantation in Adult Subjects with Type 1 Diabetes" will take place on June 23, 2025, from 9:00 to 9:20 a.m. CT at the joint ADA/IPITA symposium [2] - The symposium is themed "Outpacing the Immune System—Sprinting Towards Immune Protection for Cell Replacement Therapy" [2] Company Overview - Sana Biotechnology, Inc. is dedicated to creating engineered cells as medicines, aiming to repair and control genes, and replace missing or damaged cells [3] - The company operates in multiple locations including Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA [3]
Sana Biotechnology (SANA) 2025 Conference Transcript
2025-06-04 19:37
Summary of Sana Biotechnology (SANA) Conference Call Company Overview - **Company**: Sana Biotechnology (SANA) - **Focus**: Development of innovative therapies for type one diabetes and autoimmune disorders through gene modification and hypoimmune platforms [4][5][6] Key Points and Arguments Hypoimmune Platform - **Objective**: To hide cells from immune recognition to overcome allogeneic and autoimmune rejection [5][10] - **Significant Achievement**: Successful transplantation of gene-modified beta cells into a type one diabetic patient without the need for immunosuppression, marking a potential breakthrough in treatment [6][20][66] - **Core Product**: SC451, a gene-modified stem cell-derived pancreatic islet aimed at providing a functional cure for type one diabetes with a single injection [7][66] Type One Diabetes - **Market Need**: Approximately 10 million people globally suffer from type one diabetes, with a significantly reduced life expectancy and no disruptive therapies developed in over a century [15][16] - **Current Treatments**: Traditional methods involve lifelong insulin therapy or cadaveric islet transplants, which are not scalable and require immunosuppression [17][18] - **Clinical Trial**: An investigator-sponsored trial in Sweden demonstrated that gene-modified islet cells can function without immunosuppression, with promising early results [20][22][68] Efficacy and Safety - **Key Outcomes**: The patient in the trial is producing insulin for the first time in over 30 years, with stable C-peptide levels indicating functional beta cells [23][24][66] - **Immunological Response**: The hypoimmune cells showed no T cell or antibody response, indicating successful evasion of the immune system [35][66] Future Developments - **IND Filing**: Plans to file an Investigational New Drug (IND) application next year, with ongoing work to scale production and ensure safety [38][41][65] - **Additional Programs**: Exploration of allogeneic CAR T cell therapies for autoimmune disorders, with a focus on scalability and efficacy [46][50][54] Other Important Content - **Financial Considerations**: The company acknowledges the need for additional capital to support ongoing and future studies [10][41] - **Upcoming Data Releases**: Anticipation of data presentations at the American Diabetes Association meeting, with a focus on the six-month results from the clinical trial [22][68] - **Comparative Analysis**: The company positions its hypoimmune platform as a significant advancement over existing therapies, likening it to the evolution from electric cars needing to be plugged in to those with functional batteries [66][67] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Sana Biotechnology's innovative approaches and the potential impact on treating type one diabetes and autoimmune disorders.
Sana Biotechnology to Present at June 2025 Investor Conferences
Globenewswire· 2025-05-28 20:05
Core Viewpoint - Sana Biotechnology, Inc. is set to present at two major investor conferences in June 2025, providing a business overview and updates on its operations [1][5]. Group 1: Company Overview - Sana Biotechnology focuses on creating engineered cells as medicines, aiming to repair and control genes, and replace missing or damaged cells [3]. - The company operates in multiple locations including Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA [3]. Group 2: Upcoming Events - Sana will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 2:35 p.m. ET [5]. - The company will also present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 8:40 a.m. ET [5]. Group 3: Investor Relations - Webcasts of the presentations will be available on the Investor Relations page of Sana's website, with replays accessible for 30 days post-conference [2].
Sana: HIP-Modified Islet Cells To Possibly Change Scope Of Type 1 Diabetes Treatment
Seeking Alpha· 2025-05-19 19:10
Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is priced at $49 per month, with a discounted annual plan available for $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the importance of deep analysis for informed investment decisions in the healthcare sector [2]. - The article does not indicate any personal investment positions in the companies discussed, ensuring an unbiased perspective [3].