Fate Therapeutics reports Q3 2026 financial results

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Fate Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026.^{1 1}A copy of the press release is attached as Exhibit 99.1.¹

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934², as amended ("Exchange Act") or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1³

Press release dated November 5, 2026³

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

FATE THERAPEUTICS, INC.

Date:

November 5, 2026

By:³

/s/ Bahram Valamehr³

Bahram Valamehr, Ph.D., MBA³

President and Chief Executive Officer³

Fate Therapeutics Reports Third Quarter 2026 Financial Results and Business Updates

San Diego, CA – November 5, 2026 – Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disease, today reported financial results and a business update for the third quarter ended September 30, 2026.

"The third quarter was defined by steady execution across our portfolio, bringing us closer to our goal of delivering off-the-shelf, master cell bank derived cell therapies to the patients who need them most," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Momentum continues to build for RECLAIM-LN, and the updated Phase 1 data presented at ASN Kidney Week further supports the Phase 2 study design, including updated safety and efficacy data that reinforces the unique and encouraging product profile of FT819 in lupus. We are also excited to roll out the Phase 1/2 COMPLETE trial, with the recently cleared IND application for FT839, our first-of-kind, dual CAR T-cell co-targeting CD19 and CD38 for the comprehensive elimination of complex autoimmune disorders. At the upcoming ACR Convergence, our four presentations across FT819 and FT839 will give the rheumatology community an additional look at our clinical programs in autoimmune disease. Our progress this year, together with continued extension of our cash runway, positions us well for important milestones ahead, and we remain focused on execution as we work to deliver across multiple fronts in 2027."

Clinical Development & Program Updates

RECLAIM-LN, FT819 Phase 2 potentially registrational trial in lupus nephritis

The Company continues to advance RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis (LN), with enrollment currently open across 17 active sites⁶. In August, the study was initiated and the first patient was treated in an outpatient setting. New Phase 1 efficacy and safety data presented at American Society of Nephrology (ASN) further supports the design and advancement of RECLAIM-LN.

The RECLAIM-LN trial is an open-label, single-arm study developed following interactions with the FDA under the Company's Regenerative Medicine Advanced Therapy (RMAT) designation. The Phase 2 potentially registrational clinical trial is expected to enroll approximately 53 patients.⁶ Patients will receive a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is fludarabine-free and less-intensive than other CAR T-cell clinical trials, which typically incorporate up to three days of co-administration of cyclophosphamide and fludarabine, a combination that was observed as less desirable to patients and clinicians, in part because of the potential increase in serious adverse events.

Encouraging safety data demonstrated across all 29 autoimmune patients treated with a single dose of FT819 and less-intensive fludarabine-free conditioning as of a data cutoff date of August 18, 2026⁷

• No dose-limiting toxicities and no immune effector cell-associated neurotoxicity syndrome (ICANS), no graft-versus-host disease (GvHD), no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), and no deaths were reported.

• No cytokine release syndrome (CRS) above Grade 2 was observed; Grade 1–2 CRS occurred in 5 patients (17.2%).⁷

• Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%).

The Company believes this encouraging safety profile reflects the distinct molecular design and manufacturing features of FT819, including a tuned CAR motif with targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and a well-vetted clonal master iPSC bank that serves as a consistent and uniform starting point for manufacture of drug product for broad patient availability. Additionally, the use of a less-intensive, fludarabine-free conditioning approach is intended to significantly reduce the possibility for adverse events, and the avoidance of fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, is particularly relevant for patients with LN.

Updated Phase 1 lupus n