Fate Therapeutics (FATE) Q4 2025 earnings summary

Executive summary

• Achieved outpatient treatment for autoimmune patients with FT819 off-the-shelf CAR T-cell therapy, enabling same-day hospital discharge and broader patient access.

• Expanded FT819 Phase 1 enrollment to 16 sites across the U.S., U.K., and EU, with 15 SLE patients, 4 systemic sclerosis, and 1 idiopathic inflammatory myopathy patient treated.

• FT836, a MICA/B-targeted CAR T-cell therapy, showed >50% CEA reduction and tumor shrinkage in colorectal cancer without conditioning chemotherapy.

• Projected operating runway through year-end 2027, supported by $205 million in cash and investments and a 30% reduction in 2025 operating expenses compared to 2024.

Financial highlights

• Cash, cash equivalents, and investments totaled $205.1 million as of December 31, 2025.

• Q4 2025 revenue was $1.4 million, primarily from a collaboration with Ono Pharmaceutical.

• Q4 2025 operating expenses were $36.1 million, including $25.4 million R&D and $10.7 million G&A expenses.

• Net loss for Q4 2025 was $32.4 million; full-year 2025 net loss was $136.3 million.

• Operating expenses decreased by 30% in 2025 compared to 2024.

Outlook and guidance

• Operating runway projected through year-end 2027, enabling achievement of key clinical and collaboration milestones.

• Plans to provide clinical, regulatory, and operational updates for FT819 and FT836 in the second half of 2026.

• IND-enabling activities for FT839 to support initial clinical investigation in 2026.