Sana Biotechnology, Inc. (SANA) reported fourth-quarter financial results with an expanded net loss. But on an adjusted basis, the net loss narrowed. In addition, the firm provided details on the upcoming milestones and its cash runway.
Following the results, SANA is down 3.05% at $3.81.
For the fourth quarter, adjusted net loss narrowed to $44.74 million, or $0.16 per share, from $54.79 million, or $0.23 per share, in the prior year.
Net loss expanded to $58.83 million, from $49.07 million in the prior year. But on a per-share basis, the net loss remains flat at $0.21 per share, year-over-year.
For the full year, adjusted net loss shrank to $170.12 million or $0.67 per share from $263.08 million or $1.14 per share in the prior year.
Net loss narrowed to $244.17 million, or $0.96 per share, from $266.76 million, or $1.16 per share, in the prior year.
"Meaningful scientific and operational progress in 2025 has positioned us well to generate human proof-of-concept data over the next 12-18 months for SC451 in type 1 diabetes and SG293 in blood cancers," said Steve Harr, Sana's President and Chief Executive Officer
Pipeline, Milestones Ahead and Cash Runway
Sana's preclinical programs include SC451, a stem-cell-derived pancreatic islet cell program for type 1 diabetes and SG293, an in vivo CAR T program for B-cell-related diseases. The pipeline also includes UP421 for Type 1 diabetes, which is currently in an investigator-sponsored trial(IST).
Sana uses its Hypoimmune (HIP) platform, designed to generate ex vivo cells that can evade the patient's immune system, enabling the transplantation of allogeneic cells without immunosuppression.
SC451
Sana develops SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, as a one-time treatment for patients with Type 1 Diabetes, aiming to achieve normal blood glucose levels without insulin or immunosuppression.
Sana has had multiple interactions with regulators over the last year, including FDA INTERACT and Pre-IND meetings. Sana noted that the results increased confidence in the manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan.
The firm expects to file an IND for SC451 as early as 2026 and begin Phase 1 testing shortly thereafter.
SG293
SG293 is a CD8-targeted fusosome that generates CD19-directed CAR T Cells in vivo while avoiding potentially troublesome tissue delivery, such as to the liver. It is designed for B-cell-related diseases.
Preclinical data demonstrate that an SG293 surrogate achieves cell-specific delivery and deep B-cell depletion, as measured by depletion of circulating and lymph node B cells, and a phenotypic reset when B cells return in non-human primates, without the use of any lymphodepleting chemotherapy, according to the firm.
Sana intends to explore SG293 in both B-cell cancers and B-cell-mediated autoimmune diseases, and expects to generate first-in-human data as early as this year and to file an IND for SG293 as early as 2027.
UP421
UP421 is SANA's human pancreatic islet cell therapy, engineered with its HIP technology, and is currently under an investigator-sponsored trial in Type 1 diabetes.
A grant from The Leona M. and Harry B. Helmsley Charitable Trust supports the UP421 preclinical study.
The goal of this investigator-sponsored trial (IST) was to assess safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, in HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without immunosuppression.
In August 2025, the New England Journal of Medicine (NEJM) published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression", which discussed 12-week results from the trial, conducted at Uppsala University Hospital, evaluating the transplantation of UP421 without the use of immunosuppressive medications in a 42-year-old patient living with type 1 diabetes for over three decades.
Results of the study, conducted for 1 year after cell transplantation, demonstrate the survival and function of pancreatic beta cells, as measured by circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin.
C-peptide levels also increased during mixed-meal tolerance tests conducted throughout the study, consistent with insulin secretion in response to a meal.PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm.
The trial study identified no safety issues, and the HIP-modified islet cells evaded immune detection according to the firm.
As of the fourth quarter 2025, the firm reported a cash position of $138.4 million with an expected cash runway into late 2026.
SANA has traded between $1.26 and $6.55 in the last year. The stock closed Tuesday's trade at $3.93, down 5.30%.
(Amended: Corrects to replace "preclinical study" with "trial" under subhead "UP421"
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