Every 8-K that Fate Therapeutics, Inc. (FATE) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow FATE and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full FATE filings page.
Fate Therapeutics (FATE) said the California Institute for Regenerative Medicine awarded it a $15.0 million grant on September 25, 2026, to support FT819’s Phase 2, potentially registrational trial in lupus nephritis.
The trial is expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus and Class III or IV lupus nephritis, with or without concomitant Class V, after at least two prior systemic immunosuppressive therapies. Its primary endpoint is the proportion of participants achieving complete renal response at Week 26. FT819 has FDA Regenerative Medicine Advanced Therapy designation and was selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.
Fate Therapeutics reported second-quarter 2026 results and highlighted progress across its iPSC-derived off-the-shelf CAR T-cell pipeline. The first lupus nephritis patient was dosed in -LN, a Phase 2 potentially registrational trial of FT819, treated as an outpatient with same-day discharge, and the FDA cleared an IND for dual CD19/CD38 CAR T-cell FT839 for a Phase 1/2 basket trial in autoimmune disease.
Preliminary FT819 data in systemic lupus erythematosus and systemic sclerosis showed favorable tolerability with no CRS, ICANS, GvHD, or hypogammaglobulinemia and encouraging clinical activity, while FT836 demonstrated early anti-tumor signals in KRAS wild-type metastatic colorectal cancer without conditioning chemotherapy. Cash, cash equivalents, and investments were $153.8 million at June 30, 2026, a quarterly decrease of $21 million, and operating runway is expected into 2028.
Second-quarter collaboration revenue was $2.1 million, total operating expenses were $33.2 million, and net loss was $30.2 million, or $(0.25) per share, improving from a $(34.1) million loss a year earlier. For the first half of 2026, total operating expenses fell by $14.3 million versus 2025, reflecting 13% lower R&D and 27% lower G&A.
Fate Therapeutics, Inc. reported results of its Annual Meeting of Stockholders held on June 12, 2026. Stockholders approved a third amendment and restatement of the company’s 2022 Stock Option and Incentive Plan, increasing the maximum number of shares available under the plan by an additional 7,000,000 shares.
All three Class I director nominees were elected to serve until the 2029 annual meeting or until successors are elected and qualified. Stockholders also ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, and approved on a non-binding advisory basis the compensation of the named executive officers as described in the company’s proxy statement.
A total of 116,281,693 shares of common stock were entitled to vote as of the record date, and 87,134,422 shares were present or represented by proxy at the meeting, so all proposals received sufficient support to pass.
Fate Therapeutics, Inc. updated its corporate presentation, highlighting progress in its off-the-shelf cell therapy pipeline for autoimmune diseases and cancer. Lead asset FT819, an anti-CD19 CAR T-cell, showed encouraging Phase 1 safety and activity in systemic lupus erythematosus, including outpatient dosing and deep B-cell depletion with less-intensive or no conditioning chemotherapy.
The company plans a potentially registrational Phase 2 FT819-201 trial in lupus nephritis, targeting 53 patients and aiming to start enrollment in 2H 2026 under RMAT and CDRP programs. Next-generation candidate FT836, a MICA/B-targeting CAR T-cell, demonstrated preliminary anti-tumor activity and tolerability in heavily pretreated KRAS wild-type colorectal cancer without conditioning chemotherapy. Fate also introduced FT839 and other engineered products leveraging its iPSC platform and immune-evasion technologies.
Financially, Fate reported about $174.8 million in cash, cash equivalents, and investments as of March 31, 2026, a cash runway into 2028, and roughly 20% lower operating expenses year over year in Q1 2026, reflecting tighter R&D and G&A spending.
Fate Therapeutics reported first quarter 2026 results and highlighted major advances in its iPSC-derived cell therapy pipeline. Collaboration revenue was $1.3 million, while total operating expenses fell to $34.3 million, about a 20% year-over-year reduction, leading to a narrower net loss of $31.2 million (or $0.26 per share). The company ended March 31, 2026 with $174.8 million in cash, cash equivalents and investments, which it expects to fund operations into 2028.
Clinically, FT819, an off-the-shelf CD19 CAR T-cell for autoimmune disease, advanced with FDA selection into the CMC Development and Readiness Pilot program and continued enrollment in a Phase 1 trial across multiple autoimmune indications. A Phase 2 potentially registrational lupus nephritis study of FT819 is planned to start dosing in the second half of 2026. Next-generation programs FT839 and FT836 also progressed, with FT839 nearing IND submission for a Phase 1 autoimmune basket trial and FT836 showing early safety in a Phase 1 solid tumor study.
Fate Therapeutics, Inc. reported fourth-quarter and full-year 2025 results and highlighted progress in its off-the-shelf CAR T-cell pipeline. For 2025, collaboration revenue was $6.6 million, down from $13.6 million in 2024, reflecting lower partnered activity. Total operating expenses fell sharply to $154.4 million from $223.9 million, driven by lower research and development and general and administrative costs, including reduced stock-based compensation and the absence of prior-year impairment.
The company’s 2025 net loss narrowed to $136.3 million from $186.3 million, with basic and diluted net loss per share improving to $1.15 from $1.64. As of December 31, 2025, Fate held $205.1 million in cash, cash equivalents, and investments, and common shares outstanding were 115.4 million. Management projects an operating runway through year-end 2027, supported by this cash position and an expected 30% reduction in 2025 operating expenses versus 2024, which they believe will enable key clinical and collaboration milestones.
Operationally, the company advanced FT819, its off-the-shelf CD19 CAR T-cell program for autoimmune diseases, including outpatient treatment and enrollment across 16 sites, and reported early clinical activity for FT836 in colorectal cancer without conditioning chemotherapy, alongside preclinical progress for FT839.
Fate Therapeutics, Inc. (FATE) furnished an 8-K announcing it issued a press release with financial results for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1.
The disclosure was provided under Item 2.02 (Results of Operations and Financial Condition) and is being furnished, not filed, under the Exchange Act. The report was signed by President and Chief Executive Officer Bahram Valamehr.
Fate Therapeutics (FATE) reported an early clinical update for FT819, its off-the-shelf, CD19-targeted CAR T-cell candidate, in moderate-to-severe systemic lupus erythematosus. As of the September 25, 2025 data cut-off, 10 patients received a single FT819 dose in a Phase 1 study and data were highlighted at ACR Convergence 2025.
The trial evaluates FT819 with either less‑intensive conditioning (cyclophosphamide or bendamustine) or no conditioning. In the less‑intensive arm, the company observed rapid, sustained CD19+ B‑cell depletion that correlated with dose, followed by emergence of naïve B cells beyond baseline, consistent with an immune reset and reduction in disease burden. Without conditioning, reductions in CD19+ B cells and expanded B‑cell clones were seen, alongside improvements in disease activity scores.
Fate also initiated independent dose‑expansion cohorts in AAV, IIM, and SSc, and is engaging the FDA under its RMAT designation to align on a registrational study design with a goal to start a pivotal study in 2026.
Fate Therapeutics (FATE) reported board and leadership changes. On October 10, 2025, John D. Mendlein and Neelufar Mozaffarian notified the company of their resignations from the Board, effective October 13, 2025. The company stated both resignations were voluntary and not due to any disagreement on operations, practices, or policies. Following these changes, the Board size was reduced from 10 to 8 directors, effective October 13, 2025.
On October 13, 2025, the Board approved the appointment of Kamal Adawi, M.S., M.B.A., as Chief Financial Officer, effective October 20, 2025. He was also designated principal financial officer and principal accounting officer, replacing Bahram Valamehr in those roles; Dr. Valamehr continues as Director and as President and Chief Executive Officer. The company furnished a press release on October 14, 2025 announcing Mr. Adawi’s appointment.
Fate Therapeutics (FATE) reported that on August 7, 2025 its Board approved a corporate restructuring to streamline operations, reduce operating expenses and extend the company’s cash runway. The company committed to a reduction in total workforce of approximately 12% and informed affected employees on August 12, 2025.
The company expects the reduction-in-force to complete in the third quarter of 2025 and estimates it will incur charges of approximately $0.9 million to $1.2 million for severance and other employee termination-related costs. A press release with the quarter-end results is attached as Exhibit 99.1, and the information is furnished, not filed, under the Exchange Act.