On November 5, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter 2026.

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"We continue to make meaningful progress toward initiating clinical studies of SC451 later this year and SG293 in 1Q 2027," said Steve Harr, Sana’s President and Chief Executive Officer. "We aim to share data from both of these programs in 2027 and anticipate both have the potential for relatively rapid proof of concept. In particular, SC451 in type 1 diabetes may provide a rapid signal, similar to what was seen with UP421, on whether the therapy can evade immune detection and function in patients."

Corporate Highlights

Continued progress toward beginning clinical trials for SC451 and SG293

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SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP gene modifications as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana expects to file an investigational new drug application (IND) and begin a Phase 1/2 clinical trial for SC451 as early as this year.
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SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. SG293 has been designed to minimize potential toxicities related to in vivo CAR T cells, including peri-infusion reactions and off-target delivery to tissues such as the liver. Preclinical data presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting demonstrate that a SG293 surrogate, which is active in non-human primates, achieves cell-specific delivery and deep B cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana has the potential to share first-in-human data for SG293 in non-Hodgkin lymphoma as early as the first half of 2027. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

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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 transplanted into a type 1 diabetes patient without the use of 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.

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Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells in a patient as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 were comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection.
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Announced that The New England Journal of Medicine published a peer-reviewed Letter to the Editor titled "Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression" (DOI: 10.1056/NEJMc2604408), which discusses 14-month results from this study.
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14-month data from the study were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026.

Advanced strategic collaboration with Mayo Clinic for the development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

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The purpose of the collaboration is to 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.

Advanced preclinical pipeline

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SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. Sana is preparing to begin clinical testing as early as 2027, contingent upon the early clinical profile of SG293.

Third Quarter 2026 Financial Results

GAAP Results

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Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2026 were $121.7 million compared to $138.4 million as of December 31, 2025. The decrease of $16.7 million was primarily due to cash used in operations of $108.9 million and cash used for the purchase of property and equipment of $2.7 million, partially offset by net proceeds from equity financings of $93.3 million.
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Research and Development Expenses: For the three and nine months ended September 30, 2026, research and development expenses, inclusive of non-cash expenses, were $33.9 million and $93.4 million, respectively, compared to $30.1 million and $97.1 million for the same periods in 2025. The $3.8 million increase for the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to higher third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs and higher laboratory costs related to our SC451 program. These increases were partially offset by third-party manufacturing costs at CDMOs and clinical trial costs associated with the suspended allogeneic CAR T programs incurred in the prior-year period that did not recur in 2026. The $3.7 million decrease for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, lower facility and other allocated costs, and third-party manufacturing costs at CDMOs associated with the suspended allogeneic CAR T programs incurred in the prior-year period that did not recur in 2026. These decreases were partially offset by higher laboratory costs related to our SC451 program and higher third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.0 million and $9.3 million for the three and nine months ended September 30, 2026, respectively, compared to $3.2 million and $12.0 million for the same periods in 2025.

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Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2026, Sana recognized non-cash gains of $63.4 million and $31.0 million, respectively, compared to non-cash expenses of $3.1 million and $15.3 million for the same periods in 2025, related to changes in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. Of the gains recognized during the three and nine months ended September 30, 2026, $55.5 million and $28.4 million, respectively, related to changes in the estimated fair value of the Cobalt contingent consideration (Cobalt Contingent Consideration), primarily reflecting the impact of the August 2026 amendment to the Cobalt acquisition agreement. The fair value of these potential liabilities may fluctuate significantly based on changes in the timing and probability of achieving specified development milestones, the estimated amount, timing, and probability of potential payments to Sana from business development transactions involving the fusogen technology, and Sana’s market capitalization and stock price.
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General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2026, inclusive of non-cash expenses, were $10.9 million and $33.2 million, respectively, compared to $10.3 million and $32.1 million for the same periods in 2025. The increases for each of the three and nine months ended September 30, 2026 compared to the same periods in 2025 were primarily due to higher facility and other allocated costs. General and administrative expenses include non-cash stock-based compensation of $2.3 million and $7.0 million for the three and nine months ended September 30, 2026, respectively, compared to $2.3 million and $7.1 million for the same periods in 2025.
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Impairment of Long-Lived Assets: For the nine months ended September 30, 2025, non-cash impairment of long-lived assets was $44.6 million. There was no impairment of long-lived assets for the three and nine months ended September 30, 2026. The non-cash impairment in 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. In the second quarter of 2025, because of increased availability of manufacturing capacity at third-party CDMOs for cell and gene therapy products, together with progress in understanding our near-term manufacturing needs, we determined that CDMOs could meet our manufacturing requirements. Accordingly, we suspended further build-out of our internal manufacturing capabilities and continue to rely on CDMOs to meet our manufacturing needs at present.
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Net Income (Loss): Net income for the three months ended September 30, 2026 was $20.4 million, or $0.07 per share, and net loss for the nine months ended September 30, 2026 was $90.4 million, or $0.31 per share, compared to net losses of $42.2 million, or $0.16 per share, and $185.3 million, or $0.75 per share, for the same periods in 2025.

(Press release, Sana Biotechnology, NOV 5, 2026, View Source [SID1234674327])