On August 10, 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 second quarter 2026.
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"Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma," said Steve Harr, President and Chief Executive Officer. "Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT (Free ASGCT Whitepaper) meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress."
Corporate Highlights
Continued progress toward beginning clinical trials for SC451 and SG293
SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology 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 is conducting activities to prepare for SC451 investigational new drug application (IND) submission and Phase 1/2 trial start, including near-term completion of GLP toxicology studies, advancement of SC451 technology transfer to the contract manufacturer, and clinical trial readiness. Sana expects to file an IND and begin a Phase 1/2 clinical trial for SC451 as early as this year.
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 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 expects to generate first-in-human data for SG293 in non-Hodgkin lymphoma as early as this year. 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.
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.
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.
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.
14-month data from the study were presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in July 2026, and additional data from the IST will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2.
Announced strategic collaboration with Mayo Clinic to advance development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.
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.
In connection with the collaboration, Mayo Clinic made a $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes.
Advanced preclinical pipeline
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 mid-2027, contingent upon the early clinical profile of SG293.
Raised aggregate net proceeds of $93.3 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and Mayo Clinic investment in the second quarter; expected cash runway into mid-2027.
Raised net proceeds of $93.3 million in the second quarter from sales of common stock through Sana’s ATM and equity financing.
Second Quarter 2026 Financial Results
GAAP Results
Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2026 were $160.5 million compared to $138.4 million as of December 31, 2025. The increase of $22.1 million was primarily due to net proceeds from equity financings of $93.3 million, partially offset by cash used in operations of $70.2 million and cash used for the purchase of property and equipment of $1.9 million.
Research and Development Expenses: For the three and six months ended June 30, 2026, research and development expenses, inclusive of non-cash expenses, were $30.7 million and $59.4 million, respectively, compared to $29.8 million and $67.0 million for the same periods in 2025. The increase of $0.9 million for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased research, laboratory, and clinical development costs for our SC451 and SG293 programs and increased third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs, partially offset by lower personnel and other facility and allocated costs. The decrease of $7.6 million for the six months ended June 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 decreased third-party manufacturing costs at CDMOs due to costs incurred in the first half of 2025 for the suspended allogeneic CAR T programs that did not recur in 2026. These decreases were partially offset by increased third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $6.3 million for the three and six months ended June 30, 2026, respectively, compared to $4.2 million and $8.8 million for the same periods in 2025.
Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2026, Sana recognized non-cash expenses of $23.9 million and $32.3 million, respectively, compared to $10.3 million and $12.2 million for the same periods in 2025, 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 may fluctuate significantly with changes to the probabilities of achieving clinical development or regulatory milestones with respect to a fusosome product candidate, and Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2026, inclusive of non-cash expenses, were $10.8 million and $22.2 million, respectively, compared to $10.3 million and $21.8 million for the same periods in 2025. The increases for each of the three and six months ended June 30, 2026 and 2025 were primarily due to increases in facility and other allocated costs. General and administrative expenses include non-cash stock-based compensation of $2.2 million and $4.7 million for the three and six months ended June 30, 2026, respectively, compared to $2.4 million and $4.8 million for the same periods in 2025.
Impairment of Long-Lived Assets: For each of the three and six months ended June 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 six months ended June 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.
Net Loss: Net loss for the three and six months ended June 30, 2026 was $63.6 million, or $0.22 per share, and $110.8 million, or $0.39 per share, respectively, compared to $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, for the same periods in 2025.
(Press release, Sana Biotechnology, AUG 10, 2026, View Source [SID1234669911])