Fate Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates

Outpatient treatment enabled under FT819-102 autoimmune basket protocol with patients now treated with FT819 off-the-shelf CAR T-cell therapy as same-day hospital discharge

Four systemic sclerosis patients and the first idiopathic inflammatory myopathy patient treated with FT819; First systemic sclerosis patient reaching 3-month evaluation timepoint shows meaningful disease improvement using less-intensive conditioning chemotherapy

FT819 Phase 1 enrollment expanded across 16 clinical sites in the U.S., U.K. and EU, with 15 systemic lupus erythematosus patients enrolled to date, supported by increased interest in FT819 safety, efficacy and on-demand accessibility profile

Colorectal cancer patient shows greater than 50% reduction in CEA levels with tumor reduction across all target lesions after treatment with FT836, a MICA/B-targeted off-the-shelf CAR T-cell therapy with Sword and Shield™ technology, highlighting early activity at DL1 without the use of conditioning chemotherapy

Projected operating runway through year-end 2027, supported by $205 million in cash, cash equivalents, and investments, and driven by a 30% reduction in operating expenses in 2025 compared to 2024, enabling the achievement of key clinical and collaboration milestones

SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc.(NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics,” said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. “I’m also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the Phase 1 basket study of FT819 across the U.S., U.K. and E.U., with the ultimate goal to advance FT819 to commercialization in various autoimmune diseases. Last year’s accomplishments are further highlighted by strong fourth-quarter clinical site activation, accelerated patient enrollment, expansion of FT819 into additional autoimmune diseases, the advancement of our next generation CAR T-cell programs, and continuation of our scientific leadership through quality conference presentations and manuscript publications. Importantly, additional clinical signals across autoimmune disease and in oncology without the use of conditioning chemotherapy are further validating the breadth of our platform. We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation.”

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population.

Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819, and the Company’s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono Pharmaceutical, and the Company’s expectations regarding the receipt of funding under the collaboration. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, risks relating to regulatory interactions and the outcome of such interactions, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono Pharmaceutical, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.