Fate Therapeutics Cuts Third-Quarter Loss to 25 Cents a Share
Cash and investments were $139.1 million as of September 30, 2026, and a $15.0 million CIRM grant is expected to extend the runway to mid-2028.
Fate Therapeutics (FATE), a clinical-stage biopharmaceutical company developing iPSC-derived off-the-shelf cellular immunotherapies, reported a net loss of $30.7 million, or $(0.25) a share, for the third quarter of 2026, compared with $32.3 million, or $(0.27) a share, a year earlier.
Total operating expenses were $32.2 million, including research and development of $24.2 million and general and administrative costs of $8.0 million. Collaboration revenue was zero for the three months ended September 30, 2026, versus $1.741 million a year earlier. Interest income was $1.409 million.
Cash, cash equivalents, and investments were $139.1 million as of September 30, 2026, a quarterly decrease of $14.7 million. That cash position does not include the $15.0 million CLIN2 grant recently awarded by the California Institute for Regenerative Medicine to support RECLAIM-LN. Together with the grant, the company said the cash runway is expected to mid-2028. Common shares outstanding were 121.5 million, with 3.9 million pre-funded warrants and 2.8 million preferred shares, each convertible into five common shares.
RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis, was initiated in August, and the first patient was treated in an outpatient setting. Enrollment is open across 17 active sites. The open-label, single-arm study is expected to enroll approximately 53 patients, with a single dose of FT819 at 900 million cells following bendamustine conditioning and complete renal response at Week 26 as the primary endpoint.
Safety data as of an August 18, 2026 cutoff covered 29 autoimmune patients treated with a single dose of FT819 and fludarabine-free conditioning. The company said there were no dose-limiting toxicities, ICANS, GvHD, IEC-HS, or deaths. Grade 1–2 cytokine release syndrome occurred in 5 patients (17.2%). Grade 3 or higher infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade 3 or higher cytopenias in 6 patients (20.7%).
Updated Phase 1 lupus nephritis data presented at ASN Kidney Week 2026 showed that in the bendamustine conditioning cohort selected for RECLAIM-LN, patients with Month 6 follow-up (n=2) achieved a complete renal response or primary efficacy renal response, and mean urine protein-to-creatinine ratio decreased by approximately 50% from baseline. Complete renal response was sustained through Month 24 in the single patient to reach that timepoint.
Encore systemic lupus erythematosus data at CCR–West 2026 covered 16 patients on Regimen A, 13 of whom had at least one month of follow-up as of May 14, 2026. In patients with active lupus nephritis at baseline, Month 6 UPCr decreased by 1.15 g/g across Regimen A and by 1.8 g/g in the bendamustine subset. As of a June 12, 2026 cutoff, all four treatment-refractory systemic sclerosis patients treated with FT819 achieved an rCRISS of 25 or higher and meaningful Modified Rodnan Skin Score improvement at three months post-treatment.
The FDA cleared the IND application for FT839 in July 2026. Multiple sites for COMPLETE (FT839-101), a Phase 1/2 basket trial of the dual CD19/CD38 CAR T-cell candidate, have been activated. The company said it expects to dose patients by year-end, including in rheumatoid arthritis, and that the FT839 manufacturing campaign is complete.
The company appointed Jamie Harrell to a newly created role leading commercial and market development strategy across autoimmunity and oncology programs.
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