Fate Therapeutics, Inc.

What they do

Fate engineers human induced pluripotent stem cells (iPSCs) to incorporate synthetic controls of cell function, then generates clonal master iPSC lines used as a renewable starting material to mass-produce off-the-shelf T-cell and NK cell therapies. Its pipeline consists of iPSC-derived, CAR-targeted T-cell and NK cell product candidates. The company was incorporated in Delaware in 2007 and is headquartered in San Diego, California.

Revenue drivers

• Collaboration and license agreements — Fate earns revenue from research collaborations and license agreements with pharmaceutical companies and academic institutions, including a September 2018 collaboration and option agreement with Ono Pharmaceutical for iPSC-derived CAR T-cell and CAR NK cell products for solid tumors.
• Grants — The company has historically funded operations partly through revenues from grants and collaboration activities, alongside equity and debt financings.
• No product revenue — Fate has no approved products and has never been profitable; all product candidates remain in research or early clinical development.

Recent performance

Second quarter 2026 revenue was $2.1 million, up from $1.3 million in the first quarter of 2026 and $1.4 million in the fourth quarter of 2025. Annual revenue has declined sharply from $96.3 million in 2022 to $63.5 million in 2023, $13.6 million in 2024 and $6.6 million in 2025. Net loss was $136.3 million in 2025, an improvement from $186.3 million in 2024, with diluted EPS of -$1.15 in 2025 versus -$1.64 in 2024. Operating cash outflow was $106.1 million in 2025. Quarterly cash, cash equivalents and investments decreased by $21 million in the second quarter of 2026.

Strategy

Fate is advancing FT819, an iPSC-derived off-the-shelf CAR T-cell therapy, in RECLAIM-LN, a Phase 2 potentially registrational trial in lupus nephritis expected to enroll approximately 53 patients, with CRR at Week 26 as the primary endpoint. The first patient was dosed and treated as an outpatient with same-day discharge. The company received FDA clearance of the FT839 IND for a dual CD19/CD38 targeting CAR T-cell candidate entering a Phase 1/2 basket trial in autoimmune disease, and is developing FT836 targeting MICA/B for pan-tumor treatment. It reported preliminary clinical data in systemic sclerosis showing rCRISS25 or greater responses and mRSS improvement in all four treated patients, with no CRS, ICANS, GvHD, or hypogammaglobulinemia. The company appointed Laura Hamill to its board and states it is preparing for a transition to a commercial-stage organization.

Risks

• No approved products — All product candidates are in research or early clinical development, and Fate has not completed clinical development of or obtained regulatory approval for any candidate.
• Limited autoimmune experience — Fate has historically focused on cancer cell therapies and has limited prior experience developing treatments for autoimmune diseases, where no cell therapies are approved in the United States.
• Clinical and manufacturing delays — Ongoing and planned trials may be delayed, paused or cancelled due to difficulties optimizing dose and dosing schedule, or manufacturing and distributing product candidates in sufficient quantity or cost-effectively.
• Persistent losses and cash burn — Fate has never been profitable, incurred a $136.3 million net loss in 2025 and negative operating cash flow of $106.1 million, and expects to continue incurring operating losses for at least the foreseeable future.

Outlook

Management expects a cash runway into 2028, supported by the second-quarter 2026 decrease in cash, cash equivalents and investments of $21 million. The company points to multiple activated clinical sites and pivotal FT819 drug product inventory in distribution depots ready for on-demand shipment to clinical sites. It describes FT839 advancing to first patient treatment in rheumatoid arthritis and other autoimmune diseases, and FT836 showing early anti-tumor activity in colorectal cancer without conditioning chemotherapy.