Fate Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total operating expenses for the quarter ended September 30, 2026, were $32.2 million, a decrease from $36.5 million in the same period of 2025.
• Research and development expenses were $24.2 million for the quarter, down from $25.8 million in Q3 2025.
• General and administrative expenses were $8.0 million for the quarter, down from $10.6 million in Q3 2025.
• Net loss was $30.7 million, or $(0.25) per share, compared to a net loss of $32.3 million, or $(0.27) per share, in Q3 2025.
• Collaboration revenue was $0 for the quarter, compared to $1.7 million in Q3 2025.
• Cash, cash equivalents, and investments totaled $139.1 million as of September 30, 2026, representing a quarterly decrease of $14.7 million.
• Total operating expenses for the nine months ended September 30, 2026, decreased by $18.5 million compared to the same period in 2025, driven by an 11% reduction in R&D expenses and a 26% reduction in G&A expenses.
• Net loss for the nine months ended September 30, 2026, was $92.1 million, compared to $103.9 million in the same period of 2025.
• Shares outstanding as of September 30, 2026, included 121.5 million common shares, 3.9 million pre-funded warrants, and 2.8 million preferred shares (each convertible into five common shares).

Guidance and Future Outlook:

• Cash runway is expected to extend to mid-2028, supported by $139.1 million in cash and the newly awarded $15.0 million CIRM grant.
• The company expects to dose patients in the COMPLETE trial (FT839) by year-end 2026, including in rheumatoid arthritis.
• Management remains focused on execution to deliver milestones across multiple fronts in 2027.

Business Segments and Product Lines:

• RECLAIM-LN (FT819): Enrollment is open across 17 active sites for the Phase 2 potentially registrational trial in lupus nephritis, expected to enroll approximately 53 patients. The trial utilizes a fludarabine-free, less-intensive bendamustine conditioning regimen.
• FT819 Clinical Data: Updated Phase 1 data presented at ASN Kidney Week 2026 showed 100% renal response (CRR or PERR) in the two patients with Month 6 follow-up treated with bendamustine conditioning. Mean urine protein-to-creatinine ratio decreased by approximately 50% from baseline. Safety data across 29 autoimmune patients showed no dose-limiting toxicities, no ICANS, no GvHD, no IEC-HS, and no deaths.
• COMPLETE Trial (FT839): The FDA cleared the IND application for FT839 in July 2026. Multiple clinical sites have been activated for the Phase 1/2 basket trial in autoimmune disease, which does not require conditioning chemotherapy. FT839 is a dual CD19/CD38 targeting CAR T-cell product.
• FT836: Enrollment continues in the Phase 1 solid tumor basket study for metastatic colorectal cancer and non-small cell lung cancer, with preliminary evidence of anti-tumor activity observed. An investigator-initiated trial with daratumumab in multiple myeloma is ongoing.
• FT819 in Systemic Sclerosis: Preliminary data presented at ISSCR 2026 showed all four treatment-refractory patients achieved a rCRISS of 25 or higher with meaningful improvement in skin scores at three months.
• Commercial Leadership: Jamie Harrell was appointed to lead commercial and market development strategy across autoimmunity and oncology programs.

Market and Competitive Landscape:

• The company highlights the enthusiasm of the rheumatology community for FT839, evidenced by the early activation of multiple clinical sites.
• FT819 and FT839 are positioned as off-the-shelf, iPSC-derived therapies designed to overcome limitations of patient- and donor-sourced CAR T-cell therapies, offering uniform composition and lower cost of goods.
• The fludarabine-free conditioning regimen for FT819 addresses patient and clinician preferences regarding less intensive conditioning compared to standard CAR T-cell trials.

Risks and Challenges:

• Forward-looking statements note risks regarding the potential failure of product candidates to demonstrate requisite safety, efficacy, or attributes for regulatory approval.
• Risks include delays in clinical trial initiation, enrollment, or dosing; difficulties in manufacturing or supplying product candidates; and the possibility that preliminary clinical results may not predict outcomes in larger trials.
• Specific risks include the potential failure to receive or utilize CIRM grant funding in the anticipated timeframe and the risk of incurring operating expenses greater than anticipated.

Management Commentary and Tone:

• CEO Bob Valamehr stated the third quarter was defined by "steady execution" and that momentum is building for RECLAIM-LN.
• Management expressed excitement regarding the rollout of the COMPLETE trial and the potential of FT839 to provide comprehensive elimination of complex autoimmune disorders.
• The tone emphasized the company's progress, extended cash runway, and focus on delivering across multiple fronts in 2027.

Analyst Questions and Answers:

• No analyst questions and answers section was included in the provided press release text.

Other Key Points:

• Fate Therapeutics was awarded a $15.0 million CLIN2 grant by the California Institute for Regenerative Medicine (CIRM) to support the clinical development of RECLAIM-LN.
• The company plans to present four abstracts at the upcoming ACR Convergence 2026 covering FT819 and FT839 programs.
• FT819 data presented at CCR-West 2026 showed improvements in SLEDAI and FACIT-Fatigue scores in SLE patients, with significant reductions in urine protein-to-creatinine ratio in patients with active lupus nephritis.
• The company's iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.