Sana Biotechnology — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $121.7 million as of September 30, 2026, a decrease of $16.7 million from $138.4 million as of December 31, 2025.
• Net income for the three months ended September 30, 2026, was $20.4 million ($0.07 per share), compared to a net loss of $42.2 million ($0.16 per share) in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $90.4 million ($0.31 per share), compared to a net loss of $185.3 million ($0.75 per share) in the same period in 2025.
• Research and development expenses were $33.9 million for the three months ended September 30, 2026 (up from $30.1 million in 2025) and $93.4 million for the nine months ended September 30, 2026 (down from $97.1 million in 2025).
• General and administrative expenses were $10.9 million for the three months ended September 30, 2026 (up from $10.3 million in 2025) and $33.2 million for the nine months ended September 30, 2026 (up from $32.1 million in 2025).
• The company recognized non-cash gains of $63.4 million for the three months and $31.0 million for the nine months ended September 30, 2026, related to changes in the estimated fair value of success payment liabilities and contingent consideration, compared to non-cash expenses of $3.1 million and $15.3 million in the same periods in 2025.
• Non-GAAP operating cash burn for the nine months ended September 30, 2026, was $103.4 million, compared to $108.0 million for the same period in 2025.
• Non-GAAP net loss was $43.0 million ($0.14 per share) for the three months and $121.5 million ($0.41 per share) for the nine months ended September 30, 2026, compared to $39.0 million ($0.15 per share) and $125.4 million ($0.51 per share) respectively in 2025.
• Total liabilities decreased to $195.8 million as of September 30, 2026, from $256.0 million as of December 31, 2025.
• Total stockholders' equity increased to $180.4 million as of September 30, 2026, from $160.9 million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects to file an investigational new drug application (IND) and begin a Phase 1/2 clinical trial for SC451 as early as 2026.
• Sana anticipates sharing first-in-human data for SG293 in non-Hodgkin lymphoma as early as the first half of 2027.
• The company expects to begin a clinical study for SG227 as early as 2027, contingent upon the early clinical profile of SG293.
• Management aims to share data from SC451 and SG293 programs in 2027.
• The company expects its cash position to provide a runway into mid-2027.

Business Segments and Product Lines:

• SC451: An O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy for type 1 diabetes; progress continues toward initiating clinical trials.
• SG293: A CD8-targeted fusosome delivering genetic material for CD19-directed CAR T cells; preclinical data in non-human primates demonstrated cell-specific delivery and deep B cell depletion without lymphodepleting chemotherapy.
• UP421: An investigator-sponsored trial in a type 1 diabetes patient showed survival and function of pancreatic beta cells for 14 months without immunosuppression, with C-peptide levels comparable to the first six months of the study.
• SG227: A CD8-targeted fusosome delivering genetic material for BCMA-directed CAR T cells for multiple myeloma; development is advancing with clinical testing expected as early as 2027.
• Mayo Clinic Collaboration: Strategic collaboration advanced to accelerate development, validation, and standardization of protocols for SC451.
• Cobalt Contingent Consideration: An August 2026 amendment to the Cobalt acquisition agreement restructured contingent consideration triggers and reduced or deferred certain milestone payments until a change of control.

Market and Competitive Landscape:

• The company focuses on creating and delivering engineered cells as medicines, aiming to repair and control genes and replace damaged cells.
• SG293 is designed to minimize toxicities associated with in vivo CAR T cells, such as peri-infusion reactions and off-target delivery to the liver.
• The company plans to expand SG293 clinical development into B cell-mediated autoimmune diseases if successful in non-Hodgkin lymphoma.

Risks and Challenges:

• Drug development risks include uncertainties regarding the initiation, cost, timing, progress, and results of current and future research and development programs.
• IND acceptance and clinical trial initiation are subject to FDA discretion and are not predictive of clinical results.
• Preclinical data may not be predictive of clinical trial results.
• The collaboration with Mayo Clinic may not achieve anticipated benefits.
• Economic, market, and social conditions could cause delays in business plans or impede access to capital.

Management Commentary and Tone:

• CEO Steve Harr stated the company is making meaningful progress toward initiating clinical studies of SC451 later in 2026 and SG293 in the first quarter of 2027.
• Management anticipates both SC451 and SG293 have the potential for relatively rapid proof of concept.
• SC451 is expected to provide a rapid signal on immune evasion and function, similar to observations with UP421.

Other Key Points:

• The company announced a follow-on publication in The New England Journal of Medicine (NEJM) highlighting 14-month data on the durability of hypoimmune-modified islet cell transplantation with UP421 without immunosuppression.
• 14-month data from the UP421 study were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026.
• Preclinical data for SG293 was presented at the American Society for Gene and Cell Therapy (ASGCT) 2026 Annual Meeting.
• In the second quarter of 2025, the company suspended further build-out of its internal manufacturing facility in Bothell, Washington, and determined to rely on third-party CDMOs for manufacturing needs.
• A non-cash impairment of long-lived assets totaling $44.6 million was recorded in the nine months ended September 30, 2025, related to the Bothell facility and Seattle office space; no such impairment occurred in 2026.
• Net proceeds from equity financings were $93.3 million during the three months ended September 30, 2026.