On May 8, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2025 (Press release, Sana Biotechnology, MAY 8, 2025, View Source [SID1234652761]).

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"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) 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.