Sana Biotechnology Reports First Quarter 2025 Financial Results and Business Updates

Presented positive 4- and 12-week 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 production post-transplant

Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025

Presented preclinical data in non-human primates showing safety and deep B-cell depletion using a surrogate for SG299, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR

Expect to file investigational new drug applications (INDs) for SC451 in type 1 diabetes and for SG299 in B-cell related diseases as early as 2026

Q1 2025 cash position of $104.7 million; expected cash runway into 2026

SEATTLE, May 08, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the first quarter 2025.

"Type 1 diabetes (T1D) remains a large, unmet need, impacting the lives of over 9 million people, and we have made significant progress in 2025 toward a functional cure of this disease," said Steve Harr, Sana's President and Chief Executive Officer. "We recently presented 12-week clinical data for UP421, showing that hypoimmune-modified pancreatic islets transplanted without any immunosuppression continue to evade immune detection and function three months after transplant, a result that we expect to continue over time and to be broadly generalizable across the population. Additionally, we have established the foundation for a genomically stable, gene-modified master cell bank, a difficult and essential step that clears the path toward an IND as early as 2026 and makes a scalable solution for people with T1D a realistic possibility."

Recent Corporate Highlights

Announced positive initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform $(HIP.AU)$ technology, into a patient with type 1 diabetes without the use of any immunosuppression.

   -- UP421 is a primary human HIP-modified pancreatic islet cell therapy for 
      patients with type 1 diabetes. The goal of this investigator-sponsored 
      trial (IST) is to understand safety, immune evasion, islet cell survival, 
      and beta cell function, as measured by C-peptide production, of 
      HIP-modified pancreatic islet cells in type 1 diabetics without any 
      immunosuppression. The trial is being conducted under a clinical trial 
      authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as 
      the principal investigator. 
 
   -- Results of the study through 12-weeks after cell transplantation 
      demonstrate the survival and function of pancreatic beta cells as 
      measured by the presence of circulating C-peptide, a biomarker indicating 
      that transplanted beta cells are producing insulin. C-peptide levels also 
      increase with a mixed meal tolerance test during testing at these 
      timepoints, consistent with insulin secretion in response to a meal. 
      Magnetic resonance imaging scanning also demonstrates a sustained signal 
      at the site of transplanted cells over time, which is consistent with 
      graft survival. The study identified no safety issues, and the 
      HIP-modified islet cells evaded immune detection. 
   -- Sana presented 12-week data at the New York Stem Cell Foundation (NYSCF) 
      conference and expects to report additional data from this study, 
      including longer-term follow-up, as the year progresses at scientific 
      conferences and/or in a peer-reviewed publication. 

Advancing our pipeline across multiple indications and modalities:

   -- Type 1 Diabetes -- Sana continues the clinical development of 
      gene-modified primary islet cells (UP421) and the pre-clinical 
      development of SC451, a HIP-modified, stem cell-derived pancreatic islet 
      cell therapy. In addition to the human data for UP421 outlined above, 
      Sana shared data for SC451 showing 15-month durability of glycemic 
      control, with no histologic abnormalities, in a mouse model. Sana expects 
      to share additional data in 2025 and file an IND for SC451 as early as 
      2026. 
 
          -- Allogeneic CAR T cells -- The GLEAM study is a Phase 1 study 
             evaluating SC291, a HIP-modified CD19-directed allogeneic CAR T 
             cell therapy, in patients with B-cell mediated autoimmune diseases, 
             including refractory systemic lupus erythematosus and 
             antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. 
             The VIVID study is a Phase 1 clinical trial evaluating SC262, a 
             HIP-modified CD22-directed allogeneic CAR T cell therapy, in 
             patients with relapsed and/or refractory B-cell malignancies who 
             have received prior CD19-directed CAR T therapy. 
 
                 -- Data from the suspended ARDENT trial evaluating SC291 in 
                    relapsed or refractory non-Hodgkin lymphoma (NHL) and 
                    chronic lymphocytic leukemia (CLL) demonstrated the ability 
                    to safely dose SC291 with the desired deep B-cell 
                    depletion. The goal in the GLEAM study is to demonstrate 
                    similar deep B-cell depletion with subsequent clinical 
                    benefit for patients with B-cell mediated autoimmune 
                    diseases. 
 
          -- Sana is enrolling patients in both the GLEAM and VIVID trials and 
             expects to share data in 2025. 
 
          -- in vivo CAR T cells -- SG299, which uses our fusogen platform, 
             allows for cell-specific, in vivo delivery of various payloads. 
             SG299 is a CD8-targeted fusosome that delivers to CD8+ T cells the 
             genetic material to make CD19-directed CAR T cells while avoiding 
             potentially troublesome delivery to tissues such as the liver and 
             gonadal tissue. Sana shared data showing that an SG299 surrogate 
             with another component can lead to deep B-cell depletion in 
             non-human primates without the use of any lymphodepleting 
             chemotherapy. Sana expects to file an IND for SG299 as early as 
             2026, and we look forward to developing it in a range of B-cell 
             cancers and B-cell mediated autoimmune diseases. 

First Quarter 2025 Financial Results

GAAP Results

   -- Cash Position: Cash, cash equivalents, and marketable securities as of 
      March 31, 2025 were $104.7 million compared to $152.5 million as of 
      December 31, 2024. The decrease of $47.8 million was primarily driven by 
      cash used in operations of $48.7 million. 
 
   -- Research and Development Expenses: For the three months ended March 31, 
      2025, research and development expenses, inclusive of non-cash expenses, 
      were $37.2 million compared to $56.4 million for the same period in 
      2024.The decrease of $19.3 million was primarily due to lower 
      personnel-related, laboratory, and research costs due to a decrease in 
      headcount and the portfolio prioritization announced in the fourth 
      quarter of 2024, a decrease in clinical development costs primarily 
      related to the suspension of the ARDENT trial in the fourth quarter of 
      2024 and clinical development milestones recorded in the first quarter of 
      2024 that did not recur in 2025, and a decrease in facility and other 
      allocated costs primarily due to the portfolio prioritization announced 
      in the fourth quarter of 2024. These decreases were partially offset by 
      increased costs for third-party manufacturing. Research and development 
      expenses include non-cash stock-based compensation of $4.6 million and 
      $5.8 million for the three months ended March 31, 2025 and 2024, 
      respectively. 
 
   -- Research and Development Related Success Payments and Contingent 
      Consideration: For the three months ended March 31, 2025, Sana recognized 
      a non-cash expense of $2.0 million compared to $38.0 million for the same 
      period in 2024, in connection with the change in the estimated fair value 
      of the success payment liabilities and contingent consideration in 
      aggregate. The value of these potential liabilities fluctuates 
      significantly with changes in Sana's market capitalization and stock 
      price. 
 
   -- General and Administrative Expenses: General and administrative expenses 
      for the three months ended March 31, 2025, inclusive of non-cash expenses, 
      were $11.5 million compared to $16.3 million for the same period in 2024. 
      The decrease of $4.8 million was primarily due to lower personnel-related 
      costs, including non-cash stock-based compensation, due to a decrease in 
      headcount, and decreased legal and consulting fees. General and 
      administrative expenses include non-cash stock-based compensation of $2.4 
      million and $3.2 million for the three months ended March 31, 2025 and 
      2024, respectively. 
 
   -- Net Loss: Net loss for the three months ended March 31, 2025 was $49.4 
      million, or $0.21 per share, compared to $107.5 million, or $0.49 per 
      share, for the same period in 2024. 

Non-GAAP Measures

   -- Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three 
      months ended March 31, 2025 was $46.6 million compared to $58.7 million 
      for the same period in 2024. Non-GAAP operating cash burn is the decrease 
      in cash, cash equivalents, and marketable securities, excluding cash 
      inflows from financing activities, costs related to the portfolio 
      prioritizations in the fourth quarters of 2024 and 2023, and the purchase 
      of property and equipment. 
 
   -- Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 
      2025 was $47.4 million, or $0.20 per share, compared to $69.5 million, or 
      $0.32 per share, for the same period in 2024. Non-GAAP net loss excludes 
      non-cash expenses and gains related to the change in the estimated fair 
      value of contingent consideration and success payment liabilities. 

A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

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, South San Francisco, CA and Bothell, WA.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about Sana Biotechnology, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the company's vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs and potential indications for its product candidates; the potential ability of HIP-modified cells to evade immune detection and function over time across the population; expectations with respect to development of a genomically stable, gene-modified cell bank, including the potential impact thereof; expectations regarding the timing, substance, significance, and impact of data from clinical trials of the Company's product candidates and technologies and an IST utilizing HIP-modified primary islet cells in patients with type 1 diabetes across multiple disease settings, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology, including expectations for reporting of additional data from the IST at scientific conferences and/or in peer-reviewed publications; the potential ability of SC291 to be safely dosed and demonstrate deep B-cell depletion and to translate into clinical benefit for patients with B-cell mediated autoimmune diseases; and expectations regarding the Company's cash runway. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company's strategy, expectations, cash runway and 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. The Company 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 risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's Securities and Exchange Commission $(SEC.UK)$ reports, including but not limited to its Quarterly Report on Form 10-Q dated May 8, 2025. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Investor Relations & Media:

Nicole Keith

investor.relations@sana.com

media@sana.com

 
 
                         Sana Biotechnology, Inc. 
            Unaudited Selected Consolidated Balance Sheet Data 
                                    March 31, 2025     December 31, 2024 
                                   ----------------  --------------------- 
                                              (in thousands) 
Cash, cash equivalents, and 
 marketable securities              $       104,701    $         152,497 
Total assets                                445,470              501,020 
Contingent consideration                    110,832              108,968 
Success payment liabilities                   4,649                4,556 
Total liabilities                           236,391              250,516 
Total stockholders' equity                  209,079              250,504 
 
 
 
                          Sana Biotechnology, Inc. 
              Unaudited Consolidated Statements of Operations 
                                    Three Months Ended March 31, 
                            --------------------------------------------- 
                                     2025                     2024 
                            -----------------------  ----------------------- 
                                (in thousands, except per share data) 
Operating expenses: 
   Research and 
    development               $          37,189       $            56,448 
   Research and 
    development related 
    success payments and 
    contingent 
    consideration                         1,957                    38,007 
   General and 
    administrative                       11,484                    16,269 
                            ---  --------------          ---------------- 
     Total operating 
      expenses                           50,630                   110,724 
                            ---  --------------          ---------------- 
Loss from operations                    (50,630)                 (110,724) 
Interest income, net                        992                     3,034 
Other income, net                           249                       215 
                            ---  --------------          ---------------- 
Net loss                      $         (49,389)      $          (107,475) 
                            ===  ==============          ================ 
Net loss per common share 
 -- basic and diluted         $           (0.21)      $             (0.49) 
                            ---  --------------          ---------------- 
Weighted-average number of 
 common shares -- basic 
 and diluted                            237,578                   217,290 
                            ===  ==============          ================ 
 
 
 
                      Sana Biotechnology, Inc. 
      Changes in the Estimated Fair Value of Success Payments 
                    and Contingent Consideration 
                                                    Total Success 
                                                       Payment 
                                                    Liability and 
             Success Payment       Contingent         Contingent 
               Liability((1)    Consideration((2)   Consideration 
             ----------------  -------------------  -------------- 
                                (in thousands) 
Liability 
 balance as 
 of 
 December 
 31, 2024     $         4,556   $          108,968  $      113,524 
   Changes 
    in fair 
    value 
    -- 
    expense                93                1,864           1,957 
                 ------------      ---------------   ------------- 
Liability 
 balance as 
 of March 
 31, 2025     $         4,649   $          110,832  $      115,481 
                 ============      ===============   ============= 
Total 
 change in 
 fair value 
 for the 
 three 
 months 
 ended 
 March 31, 
 2025         $            93   $            1,864  $        1,957 
                 ============      ===============   ============= 
 
 

(1) Cobalt Biomedicine, Inc. (Cobalt) and the President and Fellows of Harvard College (Harvard) are entitled to success payments pursuant to the terms and conditions of their respective agreements. The success payments are recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in research and development related success payments and contingent consideration on the statement of operations.

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