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GlobeNewswire·

Fate Therapeutics Reports Second Quarter 2026 Financial Results and Business Updates

  • First patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial for lupus nephritis using FT819, an iPSC-derived off-the-shelf CAR T-cell therapy, with treatment administered as an outpatient and same-day discharge.
  • FDA cleared the FT839 IND application to advance the dual CD19/CD38 targeting off-the-shelf CAR T-cell product into a Phase 1/2 basket trial for autoimmune diseases.
  • Preliminary data for FT819 in systemic sclerosis presented at ISSCR 2026 showed rCRISS25+ responses and mRSS improvements in all four treated patients with no CRS, ICANS, GvHD, or hypogammaglobulinemia.
  • Laura Hamill appointed to the Board to provide commercial expertise as the company advances its pipeline toward commercial-stage transition.
  • Quarterly cash, cash equivalents, & investments decreased by $21 million to $153.8 million, with a cash runway expected into 2028.
  • RECLAIM-LN aims to enroll 53 patients with a primary endpoint of complete renal response at Week 26, using less-intensive bendamustine conditioning & targeting completion in H1 2028.
  • FT819 Phase 1 data in SLE showed well-tolerated therapy with no dose-limiting toxicities or severe CRS/ICANS/GvHD, including 5 patients discontinuing steroids entirely.
  • FT839 utilizes 13 genetic edits & Sword & Shield™ technology to enable multi-antigen targeting without conditioning chemotherapy requirements.
  • FT836 demonstrated preliminary anti-tumor activity in KRAS wild-type metastatic colorectal cancer patients without conditioning chemotherapy.
  • Second quarter 2026 total operating expenses were $33.2 million, resulting in a net loss of $30.2 million or $0.25 per share.
  • Collaboration revenue from Ono Pharmaceutical totaled $2.1 million for the quarter.