FDA selects FT819 into the CDRP (CMC Development and Readiness Pilot) program enabling early and enhanced communication with the FDA to ensure CMC readiness for accelerated clinical timelines
Clinical data presented at Pediatric Rheumatology Symposium 2026 and Congress of Clinical Rheumatology, East 2026 highlights safety and efficacy of single dose of FT819 with reduced conditioning in SLE
Preclinical data presented at the American Association for Cancer Research 2026 demonstrates the unique ability of FT839 for comprehensive targeting of hematological malignancies and autoimmune diseases without the use of conditioning chemotherapy
Operating runway extended into 2028, driven by a 20% reduction in operating expenses in the first quarter of 2026 compared to the first quarter of 2025
SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.
"We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Our acceptance into the FDA's highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics."
Clinical Development & Program Updates
RECLAIM-LN, Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis
The Company anticipates commencing patient dosing in FT819-201, RECLAIM, LN (NCT07570862), a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis, in the second half of 2026. The planned open-label, single-arm study was developed during interactions with the FDA under the RMAT designation for FT819, and is expected to enroll approximately 53 patients, evaluating a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at six months as the primary endpoint. The conditioning regimen selected for RECLAIM, LN is unique and less-intensive than most CAR T-cell clinical trials that incorporate up to 3 days of co-administration of cyclophosphamide and fludarabine, a combination that was perceived as less desirable to patients and clinicians during the Company's Phase 1 clinical study. Based on enrollment cadence in the Phase 1 clinical trial and current clinical site engagement, the unique on-demand availability of FT819, and the option for outpatient treatment with reduced conditioning chemotherapy requirements, the Company aims to complete the enrollment of the RECLAIM, LN clinical study approximately 15 months from commencement.
CDRP program selection for FT819 to align CMC plans with the FDA early in the development process
FT819 has been selected for participation in the FDA's Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program, a highly selective initiative designed to accelerate development of investigational therapies for serious diseases with unmet medical need through enhanced FDA engagement on CMC-related activities. Participation in the program enables increased interaction with the Agency, including additional CMC-focused Type B meetings with FDA review staff intended to help clarify development strategies, address key manufacturing questions, align CMC readiness and support a more efficient regulatory review process. The Company believes participation in the CDRP Program, in addition to its previously received Regenerative Medicine Advanced Therapy (RMAT) designation, has the potential to accelerate the registration pathway of FT819 in SLE.
FT819-102 Phase 1 clinical trial now enrolling in 18 clinical sites globally
The Company's ongoing multi-center Phase 1 clinical trial of FT819 (NCT06308978) evaluates the safety, pharmacokinetics, and efficacy of FT819 administered under either Regimen A, a fludarabine-free less-intensive conditioning regimen consisting of bendamustine or cyclophosphamide, or Regimen B, where FT819 is added to background maintenance therapy without conditioning chemotherapy. The study is enrolling patients across four autoimmune disease indications: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). As of May 5, 2026, enrollment stands at:
Nineteen SLE patients across the two regimens have been treated
Eight patients have been treated across SSc, IIM and AAV
Of these 27 patients, 8 have been treated in an outpatient setting
Clinical enrollment across the study indications continues to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers, and advancing the clinical development of various autoimmune indications and study cohorts, including Regimen B of SLE, where FT819 is uniquely demonstrating meaningful reduction in lupus disease activity and improvement in quality of life without the use of conditioning chemotherapy. This week at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, the Company showed in Regimen B of the FT819-102 Phase 1 study that a single dose of FT819 without the use of conditioning chemotherapy demonstrated meaningful clinical responses at dose level 1 (360 million cells) in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS) (data cutoff of April 9, 2026). The Company is now treating patients at dose level 2 (900 million cells) in Regimen B and exploring a repeat-dose paradigm without the use of conditioning chemotherapy.
The Company anticipates providing further updates on its clinical progress at European Alliance of Associations for Rheumatology (EULAR) Annual Congress in June of 2026 as well as in other scientific conferences in the second half of 2026.
Clinical Data Presented at Pediatric Rheumatology Symposium (PRSYM) and Congress of Clinical Rheumatology CCR-East continue to demonstrate meaningful and durable clinical responses, broad accessibility, and a favorable emerging safety profile of FT819 in SLE
Highlights of the presentation included clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of December 23, 2025, with data showing clinically meaningful improvements in disease activity and patient-reported outcome measures following treatment with FT819 using less-intensive conditioning chemotherapy in Regimen A. These responses were observed early and were maintained over time, as demonstrated by i) SLEDAI-2K: Scores decreased by 13 points (mean) from baseline at Month 6, ii) PGA: Scores decreased by 1.75 points (mean) from baseline at Month 6 ; iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg (mean) from baseline at Months 3 and 6, respectively, and iv) FACIT-Fatigue: Scores improved by 23.4 points (mean) from baseline at Month 3 with continued meaningful improvement over time. The data presented continue to support the clinical advancement of FT819.
The Company believes the strength of its FT819 Phase 1 clinical data, combined with two significant regulatory recognitions, provides a compelling foundation for the RECLAIM, LN study and future pivotal programs. FT819 has demonstrated progressive and durable reductions in disease activity, clinically meaningful reductions in urine protein-to-creatinine ratio in patients with lupus nephritis, effective B-cell depletion with immune remodeling, a notable drop in FACIT-Fatigue score resulting in profound improvements in quality of life for treated patients, and a favorable tolerability profile.
FT839: Next-generation Off-the-Shelf CAR T-cell Program Designed to co-target CD19 and CD38 and Armed with Novel Sword & Shield™ Technology Designed to Eliminate the Need for Conditioning Chemotherapy
The Company plans to submit an Investigational New Drug (IND) application to the FDA to support a Phase 1 basket autoimmune study to evaluate FT839 in combination with standard of care therapies across SLE, SSc, AAV, IIM, and rheumatoid arthritis (RA), including without the use of conditioning chemotherapy, and expects to commence enrollment in the Phase 1 study in the second half of 2026. Preclinical data for FT839 was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, highlighting the ability of FT839 to simultaneously target and eliminate multiple pathogenic immune cell types across a broad range of autoimmune diseases and hematologic malignancies. FT839 preclinical data in autoimmune disease are expected to be presented at the 2026 American Society of Gene and Cell Therapy Annual Meeting and at the 2026 EULAR Annual Congress, further discussing the scientific rationale for the differentiated dual-CAR approach of FT839 in conditions where complex, multi-compartment immune dysregulation has resulted in hard-to-treat diseases.
The breadth of the therapeutic potential of FT839 is reflected in the range of clinical collaboration opportunities in discussion with leading academic centers, including in autoimmune disease and in hematological malignancies, including multiple myeloma and diffuse large B-cell lymphoma. The Company believes this growing network of academic partnerships underscores the scientific community's recognition of the potential of FT839 to address serious diseases across both autoimmune and oncology settings.
The Company will provide further updates on FT839 at American Society of Gene and Cell Therapy Annual Meeting in May of 2026.
FT836 Next-generation Off-the-Shelf CAR T-cell Program Designed to Uniquely Target Broadly Expressed Stress Cancer Antigens MICA/B and Armed with Novel Sword & Shield™ Technology
The Company is currently enrolling patients in a Phase 1 study of FT836, its multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. The Phase 1 study is designed to assess the tolerability and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors. As of April 20, 2026, nine patients have been treated with FT836 in the Phase 1 basket solid tumor study, including patients in the cetuximab combination (Regimen C) and trastuzumab combination (Regimen E) arms. To date, FT836 has been well-tolerated with no ICANS, GvHD, CRS, or dose-limiting toxicities at dose level 1 of Regimen C, supporting its potential as a broadly accessible treatment with a favorable emerging safety profile. The Company expects to present updated FT836 clinical data across a larger patient cohort at the American Society of Clinical Oncology Annual Meeting in June 2026. Additionally, the FDA has cleared an IND for an investigator-initiated trial for FT836 in combination with daratumumab for a novel treatment strategy in multiple myeloma to be conducted at the Medical College of Wisconsin. Patient treatment in this IIT is expected to commence in mid-2026.
The Company plans to provide further updates on FT836 at American Society of Gene and Cell Therapy Annual Meeting and at American Society of Clinical Oncology in May of 2026.
First Quarter 2026 Financial Results
Cash & Investment Position: Cash, cash equivalents, and investments as of March 31, 2026 were $174.8 million.
Total Revenue: Revenue was $1.3 million for the first quarter of 2026, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company's collaboration with Ono Pharmaceutical.
Total Operating Expenses: Total operating expenses were $34.3 million for the first quarter of 2026, including research and development expenses of $24.7 million and general and administrative expenses of $9.6 million. Such amount included $3.9 million of non-cash stock-based compensation expense.
Shares Outstanding: As of March 31, 2026, common shares outstanding were 116.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.
Financial Guidance
Operating runway into 2028, supported by $174.8 million in cash, cash equivalents, and investments.
About FT819
FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)
About FT839
FT839 is ...
