SAN DIEGO, CA — November 13, 2025 — Leads & Copy — Fate Therapeutics, Inc. (NASDAQ: FATE) reported its third-quarter financial results, highlighting regulatory authorizations and clinical trial updates for its induced pluripotent stem cell (iPSC)-derived cellular immunotherapies.
The company received authorization from regulatory bodies in the UK and EU to activate clinical trial sites outside the US, supporting patient enrollment for FT819. FT819 is an off-the-shelf, CD19-targeted CAR T-cell product candidate designed for broad patient accessibility using less-intensive or no conditioning.
A systemic sclerosis patient was treated in a Phase 1 study of FT819 after receiving fludarabine-free conditioning. The dose expansion aims to evaluate patient outcomes with less-intensive or no conditioning.
The first patient was treated with FT836, a MICA/B-targeted off-the-shelf CAR T cell that uses Sword and Shield™ Technology for conditioning-free treatment of various solid tumors. These advancements are intended to offer effective therapies with improved safety profiles.
As of September 30, Fate Therapeutics has $225.7 million in cash, cash equivalents, and investments, projecting an operating runway through year-end 2027. This is expected to enable the company to achieve key clinical and collaboration milestones.
Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics, noted the potential transformative impact of FT819, emphasizing its therapeutic and safety profile. Valamehr said that the company remains focused on driving enrollment and expanding access for patients with lupus and other autoimmune diseases, anticipating a planned registration study in 2026.
The company presented data at the American College of Rheumatology (ACR) Convergence 2025, demonstrating clinical activity and sustained B-cell depletion following FT819 treatment. Updated Phase 1 data included 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) treated with FT819, showing reductions in disease activity and improvements in fatigue.
The first systemic sclerosis (SSc) patient was treated in a Phase 1 autoimmunity study. The clinical trial assesses FT819’s safety and activity in autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and idiopathic inflammatory myositis (IIM) (NCT06308978).
Dose escalation continues for FT825 / ONO-8250, a HER2-targeted CAR T-cell candidate, in a Phase 1 study for advanced solid tumors (NCT06241456). Also, the first solid tumor patient was treated in a Phase 1 basket trial for the FT836 MICA/B-targeted CAR T-cell program (NCT07216105).
Additionally, Fate Therapeutics has started Investigational New Drug (IND) application activities for its FT839 dual-CAR T-cell program. The company also appointed Kamal Adawi, M.S., M.B.A., as Chief Financial Officer.
Third quarter 2025 financial results reported total revenue of $1.7 million and total operating expenses of $36.5 million. As of September 30, 2025, common shares outstanding were 115.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million.
Fate Therapeutics’ iPSC product platform leverages human induced pluripotent stem cells (iPSCs) for engineered cell products, addressing limitations of patient- and donor-sourced cell therapies.
Christina Tartaglia
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com
Source: Fate Therapeutics, Inc.
