Sana Biotechnology and Mayo Clinic Announce Strategic Collaboration Focused on Improving Care in Type 1 Diabetes and Accelerating Development of SC451

Sana and Mayo Clinic to collaborate across multiple areas with goal of accelerating development of and access to potentially curative therapies for patients with type 1 diabetes

Initial efforts will include processes and protocols to improve handling of and clinical care involving SC451, a cell replacement therapy being developed for patients with type 1 diabetes, with a system that can be utilized at Mayo Clinic facilities and other sites around the world

Motivated by patient-centric values, collaboration includes Mayo equity investment in Sana

SEATTLE and ROCHESTER, Minn., April 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on changing the possible for patients through engineered cells, and Mayo Clinic today announced a strategic collaboration to advance development of SC451, Sana's investigational hypoimmune-modified pancreatic islet cell therapy for type 1 diabetes. SC451 is designed to allow a single administration of pancreatic islet cells to support long-term glucose control without the need for ongoing insulin therapy or immunosuppression for patients with type 1 diabetes.

The collaboration will draw on Mayo Clinic's multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments. These areas include:

• End-to-end clinical and operational insight to optimize workflows, including product handling and delivery of SC451, and post-treatment care to enable broader adoption across Mayo Clinic and global care settings.
• Surgical expertise, including refining procedural techniques.
• Standardizing handling, delivery and post-treatment management.
• Leadership in clinical trial design, including biomarker identification to guide patient selection and longitudinal monitoring.
  
  
  
  

Mayo Clinic will also look to advance its capabilities in the delivery of investigational islet cell therapies, further strengthening its leadership in innovative, multidisciplinary treatment approaches.

In connection with the collaboration, Mayo Clinic will make an equity investment in Sana Biotechnology, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional equity investment under the terms of the agreement.

"We are pleased to collaborate with Mayo Clinic as we advance SC451 toward a clinical trial that we are aiming to start this year," said Steve Harr, Sana President and Chief Executive Officer. "Mayo Clinic's longstanding commitment to patient-centered care, combined with a depth of expertise in transplant medicine and immunology, will help guide the development and delivery of SC451. Recently presented data, showing that transplanted pancreatic islets modified with Sana's hypoimmune platform technology survive and function without any immunosuppression for over a year in a patient with type 1 diabetes, make us optimistic about the potential for SC451 to transform the treatment of this disease."

"Mayo Clinic is committed to advancing innovative therapies that address significant unmet patient needs, and through this collaboration, we seek to advance potential treatment options for patients with type 1 diabetes," said Vijay Shah, MD, Mr. and Mrs. Ronald F. Kinney Executive Dean of Research, Mayo Clinic. "By bringing together complementary expertise in cell therapy development and transplant immunology, we aim to thoughtfully and rigorously evaluate this investigational approach with the goal of improving the lives of those living with the condition."

About SC451 - Sana's Therapeutic Candidate for Type 1 Diabetes

SC451 is an investigational, gene-modified, stem-cell derived pancreatic islet cell therapy that Sana is advancing toward the clinic as a potential single treatment for patients with type 1 diabetes (T1D) that leads to euglycemia without the need for exogenous insulin or immunosuppression. SC451 is a potentially scalable solution, manufactured from cells that have been modified to overcome both allogeneic and autoimmune rejection through Sana's proprietary hypoimmune (HIP) technology. An investigator-sponsored clinical study evaluating the transplantation of donor-derived, HIP-modified pancreatic islet cells into a patient with T1D show these cells are well-tolerated, survive, evade detection by the immune system, and continue to produce insulin in the patient through 14 months of follow-up to date. The company expects to file an Investigational New Drug application and initiate a Phase 1 clinical study of SC451 as early as this year.

About Sana

Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA.

About Mayo Clinic

Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news. 

Cautionary note regarding forward-looking statements of Sana

This press release contains forward-looking statements about Sana Biotechnology, Inc. (Sana) within the meaning of the federal securities laws, including those related to the potential benefits of, plans for, and activity under the strategic collaboration between Sana and Mayo Clinic, including the ability to achieve safe, scalable, and consistent delivery of SC451 across diverse clinical environments; Mayo Clinic's equity investments in Sana; expectations for Sana's SC451 program, including its clinical and regulatory development plans and timing expectations, including with respect to a potential investigational new drug (IND) application and clinical trial; the potential advantages of SC451, including with respect to scalability and the potential to be a single treatment for patients with T1D that leads to long-term glucose control without the need for exogenous insulin or immunosuppression; Sana's vision and business plans; the potential significance and impact of data from an investigator-sponsored clinical trial evaluating the transplantation of donor-derived, HIP-modified pancreatic islet cells into a patient with T1D; and statements made by Sana's President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding Sana's strategy, expectations, future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Sana has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the: risk that the collaboration with Mayo Clinic may not result in improved protocols and processes for SC451 or improvements in delivery of investigational islet cell therapies; risks inherent in drug development such as those associated with the initiation, cost, timing, progress, and results of Sana's current and future research and development programs, preclinical and clinical trials, including that the timing of an IND submission for SC451 is subject to change, IND acceptance is subject to the discretion of the U.S. Food and Drug Administration, and acceptance of an IND and initiation of a Phase 1 clinical trial for SC451 are not predictive of clinical trial results or whether Sana will successfully enroll patients; and risks associated with economic, market, and social disruptions, which could cause delays in Sana's business plans, impede Sana's access to additional capital, and impede the clinical development of SC451, among other things. For a detailed discussion of the risk factors that could affect Sana's actual results, please refer to the risk factors identified in Sana's Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated March 3, 2026. Except as required by law, Sana undertakes no obligation to update publicly any forward-looking statements for any reason.

Media contacts:

Sana Biotechnology

Nicole Keith

[email protected]

[email protected]

Mayo Clinic

Tom Millikin

[email protected]