(RTTNews) – Sana Biotechnology, Inc. (SANA) has reported its financial results for the fourth quarter, revealing an expanded net loss. However, on an adjusted basis, the net loss has shown improvement. The company also outlined key upcoming milestones and its cash runway.
Following the announcement, SANA shares have decreased by 3.05%, now trading at $3.81.
For the fourth quarter, the adjusted net loss narrowed to $44.74 million, or $0.16 per share, compared to $54.79 million, or $0.23 per share, in the previous year. The net loss widened to $58.83 million, up from $49.07 million in the prior year. Nevertheless, the per-share net loss remained consistent at $0.21 year-over-year.
Over the course of the full year, the adjusted net loss decreased to $170.12 million, or $0.67 per share, compared to $263.08 million, or $1.14 per share, in the previous year. The overall net loss also narrowed to $244.17 million, or $0.96 per share, from $266.76 million, or $1.16 per share, in the prior year.
Steve Harr, Sana’s President and Chief Executive Officer, stated, “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.”
Pipeline, Milestones Ahead, and Cash Runway
Sana’s preclinical pipeline includes SC451, a stem-cell-derived pancreatic islet cell program for type 1 diabetes, and SG293, an in vivo CAR T program targeting B-cell-related diseases. Additionally, UP421 for type 1 diabetes is currently undergoing an investigator-sponsored trial (IST).
The company employs its Hypoimmune (HIP) platform, which is designed to generate ex vivo cells capable of evading the patient’s immune system, thereby allowing for the transplantation of allogeneic cells without the need for immunosuppression.
SC451
Sana is developing SC451, a HIP-modified, iPSC-derived pancreatic islet cell therapy, as a one-time treatment for patients with type 1 diabetes, targeting normal blood glucose levels without the need for insulin or immunosuppression. The company has engaged in multiple discussions with regulators over the past year, including FDA INTERACT and Pre-IND meetings, which have bolstered confidence in the manufacturing processes and clinical trial plans.
Sana anticipates filing an IND for SC451 as early as 2026, with Phase 1 testing expected to commence shortly thereafter.
SG293
SG293 is a CD8-targeted fusosome that generates CD19-directed CAR T Cells in vivo, thus avoiding complex tissue delivery challenges, such as to the liver. It is intended for B-cell-related diseases. Preclinical data indicate that an SG293 surrogate achieves cell-specific delivery and significant B-cell depletion, as demonstrated by the depletion of circulating and lymph node B cells without the use of lymphodepleting chemotherapy.
Sana plans to investigate SG293 in both B-cell cancers and B-cell-mediated autoimmune diseases, with expectations to generate first-in-human data as early as this year and to file an IND for SG293 as early as 2027.
UP421
UP421 represents SANA’s human pancreatic islet cell therapy, enhanced with its HIP technology, and is currently undergoing an investigator-sponsored preclinical study in type 1 diabetes. This study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust.
The objective of the IST is to evaluate safety, immune evasion, islet cell survival, and beta cell function, as assessed 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 study detailing 12-week results from this trial, which was conducted at Uppsala University Hospital. This study explored the transplantation of UP421 without immunosuppressive medications in a patient with over three decades of type 1 diabetes.
Results indicated the survival and function of pancreatic beta cells, with C-peptide levels increasing during mixed-meal tolerance tests throughout the study. Imaging of the transplant site demonstrated the presence of islet cells, and no safety issues were reported, with the HIP-modified islet cells successfully evading immune detection.
As of the end of the fourth quarter in 2025, Sana reported a cash position of $138.4 million, with an anticipated cash runway extending into late 2026. Over the past year, SANA shares have fluctuated between $1.26 and $6.55, closing Tuesday’s trade at $3.93, a decrease of 5.30%.
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.