Announcement • Jun 12

Fate Therapeutics, Inc. Announces Updated Clinical Data for Ft819 Off-The-Shelf Car T-Cell Product Candidate Demonstrating Durability of Drug-Free Remission for Severe Lupus Nephritis at EULAR 2025 Congress

Fate Therapeutics, Inc. announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain. The Company is currently conducting a multi-center, Phase 1 clinical trial of FT819, its off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate, for the treatment of patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus (NCT06308978). The study is designed to evaluate the safety, pharmacokinetics, and activity of a single dose of FT819 administered to relapsed /refractory patients either (i) with a fludarabine (flu)-free conditioning regimen, consisting of either cyclophosphamide alone or bendamustine alone (Flu-free Conditioning Regimen) or (ii) in the absence of conditioning to patients on standard-of-care maintenance therapy (Conditioning-free Regimen). As of the data cut-off date of May 15, 2025, five patients have been treated with FT819 with sufficient follow-up to be evaluable, providing the following key insights: Flu-free Conditioning Regimen: Active Lupus Nephritis. Three relapsed /refractory patients with active lupus nephritis (median prior therapies = 8 [7-8], with all patients having received prior B-cell targeted therapy; median baseline SLEDAI-2K = 20 [14-20]) were treated with a single dose of FT819 at 360 million cells in the less-intensive Flu-free Conditioning Regimen. All three patients achieved primary efficacy renal response (PERR), with a 10-point or greater reduction in SLE disease activity index (SLEDAI-2K) from baseline (SLEDAI-2K best response; Patient 1: 20 to 4 at 12 months; Patient 2: 20 to 8 at 6.5 months; Patient 3: 14 to 4 at 1 month). The first patient to reach 12-month follow-up continues on-study in drug-free DORIS (definition of remission in SLE). Extrarenal Lupus. One relapsed /refractory patient with extrarenal lupus (prior therapies = 6, including cyclophosphamide; SLEDAI-2K = 18) was treated with a single dose of FT819 at 900 million cells in the less-intensive Flu-free Conditioning Regimen consisting of cyclophosphamide alone. The patient was evaluable for 1-month follow-up, demonstrating improvement across multiple disease-specific scores including an 8-point reduction in SLEDAI-2K from baseline and a 1-point reduction in PGA. The initial kinetics of improvement observed at 1-month following administration of FT819 appear to be generally consistent with those patients treated for active lupus nephritis. Conditioning-free Regimen: Add-on to Maintenance Therapy. One patient with extrarenal lupus (prior therapies = 5, including mycophenolate mofetil), who was on a stable dose of mycophenolate mofetil (1500mg twice daily) and 5 mg /day of steroids as maintenance therapy, was treated with a single dose of FT819 at 360 million cells in the Conditioning-free Regimen as an add-on to maintenance therapy. At 3-months following administration of FT819 in the absence of conditioning, the patient achieved low lupus disease activity state (LLDAS), which was maintained at the most recent follow-up at 6 months. The SLEDAI-2K reduced to 2 from 8 at baseline, Physician’s Global Assessment to 0.5 from 2 at baseline, and tapering of steroid dose to less than 5 mg /day. B-cell Remodeling Patients in the Flu-free Conditioning Regimen showed rapid and deep B-cell depletion in the periphery within the first month of treatment, with the repopulating B-cell compartment demonstrating a shift toward a non-switched, naïve repertoire with reduction of pathogenic double-negative B cell subset within the first 60 days following administration of FT819. The first patient in the Conditioning-free Regimen also showed a reduction of B cell population in the periphery, with remodeling of the B-cell compartment towards a non-switched, naïve repertoire also within the first 60 days following administration of FT819. In 59 patients treated with FT819 across autoimmunity and oncology, a favorable safety profile continues to be observed with low incidence of low-grade cytokine release syndrome (CRS), no events of immune effector cell-associated neurotoxicity (ICANS), and no events of graft-versus-host disease (GvHD). Specifically, in the five evaluable patients treated with FT819 for SLE as of the data cut-off date: there have been no events of ICANS, no events of GvHD, and one event of low-grade cytokine release syndrome (Grade 2); no dose-limiting toxicities were observed in any patient; and with no FT819 related severe adverse events (SAEs) observed, all patients were discharged following an initial short-duration hospitalization stay of three days (as mandated per the clinical protocol), supporting the potential for outpatient administration Program Expansion The Company has reached agreement with the U.S. Food and Drug Administration (FDA) to allow for clinical investigation of multiple B cell-mediated autoimmune diseases under its current Phase 1 clinical trial of FT819, establishing the basis for conduct of a single Phase 1 basket study across autoimmune indications. The Company plans to initiate independent dose-expansion cohorts in each of anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc) in the second half of 2025. In addition, the Company plans to discuss novel registrational strategies with the FDA for FT819 to treat moderate-to-severe SLE under its Regenerative Medicine Advanced Therapy (RMAT) designation at its upcoming meeting in August. The Company currently has approximately 450 cryopreserved drug product bags of FT819 in inventory available for treatment of patients. Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

Announcement • Mar 06

Fate Therapeutics, Inc. Announces Phase 1 Dose Expansion Initiated for FT819 Off-The-Shelf CAR T-Cell Product Candidate with Fludarabine-Free Conditioning in Moderate-To-Severe SLE

Fate Therapeutics, Inc. provided business updates. FT819 iPSC-derived 1XX CAR T-cell Program Phase 1 Dose Expansion Initiated for SLE using Flu-free Conditioning Regimen. Based on clinical data from the first three patients treated with FT819 in its ongoing multi-center, Phase 1 clinical trial for moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978), the Company has initiated dose expansion in up to 10 patients at 360 million cells. The dose expansion stage is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, followed by a single dose of FT819. The Company is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. FT819 is the Company’s off-the-shelf CD8aß+ T-cell product candidate that incorporates a CD19-targeted chimeric antigen receptor (CAR) with a novel 1XX costimulatory domain into the T-cell receptor alpha constant (TRAC) locus. Clinical Data from First Three SLE Patients Presented at ASH. In December 2024, the Company highlighted clinical and translational data from the first three patients treated with FT819 for SLE at the American Society of Hematology (ASH) Annual Meeting. Each patient presented with active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies and received flu-free conditioning followed by a single dose of FT819 at 360 million cells. As of a data cutoff date of December 4, 2024, there were no dose-limiting toxicities (DLTs), and no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). All three patients showed rapid, deep, and sustained elimination of CD19+ B cells in the periphery during the first month of treatment. The first and only patient eligible for disease assessment at six-month follow-up as of the data cutoff date achieved DORIS (Definition Of Remission In SLE) clinical remission and was free of all immunosuppressive therapy. First Patient Treated with FT819 as Add-on to Maintenance Therapy. The Company amended the clinical protocol of its FT819 Phase 1 study to include a new treatment arm to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. The first patient in the new arm was on a stable dose of oral mycophenolate mofetil (MMF) and was treated with a single dose of FT819 at 360 million cells without administration of any conditioning chemotherapy. There were no DLTs and no events of CRS, ICANS, or GvHD. The patient remains on-study. Completed Type D Meeting with FDA for Inclusion of Additional Diseases in FT819 Phase 1 Study. In December 2024, the Company reached an agreement with the U.S. Food and Drug Administration (FDA) to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under current Phase 1 clinical trial of FT819. As a follow-up to the meeting, the Company has submitted an amended clinical protocol to the FDA that enables the conduct of independent dose-expansion cohorts for SLE as well as anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The Company plans to initiate dose-expansion cohorts in one or more of AAV, IIM, and SSc in 2025. Additionally, the FDA agreed to allow for investigation of a multi-dose treatment cycle as well as for re-treatment upon disease progression, making the treatment dosing paradigm more aligned with traditional biological therapies. The FDA also permitted the expansion of study eligibility criteria, including the inclusion of patients between the ages of 12 and 17. FT825 /ONO-8250 iPSC-derived CAR T-cell ProgramFirst Patient Treated with FT825 /ONO-8250 in Combination with Monoclonal Antibody Therapy. Under its collaboration with Ono Pharmaceutical Co. Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 /ONO-8250, a multiplexed-engineered CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2), in patients with advanced solid tumors (NCT06241456). Enrollment is currently ongoing at the third dose level of 900 million cells as monotherapy and at the second dose level of 300 million cells in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy. Initial Phase 1 Clinical Data Presented at 2024 SITC. At the 2024 Society of Immunotherapy of Cancer (SITC) in November, the Company presented initial clinical data from three heavily pre-treated patients, all of whom were previously treated with at least five prior lines of therapy including HER2-targeted therapy. Each patient was administered conditioning chemotherapy and a single dose of FT825 /ONO-8250 as monotherapy at the first dose level of 100 million cells. As of a data cutoff date of October 25, 2024, FT825 /ONO-8250 demonstrated a favorable safety profile with no DLTs and no events of any grade of CRS, ICANS, or GvHD. FT522 is the Company’s off-the-shelf, CD19-targeted CAR NK cell product candidate and first product candidate to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In November 2024, the Company presented initial translational data from its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed /refractory B-cell lymphoma (BCL) (NCT05950334). The presentation illustrated that live FT522 cells with anti-B cell activity were detected in the patients’ peripheral blood through Day 15, demonstrating the potential of FT522 to persist and function in the presence of an unmatched, fully-intact immune system. The Company intends to assess any further clinical development of FT522 in relapsed /refractory BCL upon completion of dose escalation at the second dose level of 900 million cells. Unique Clinical Development Opportunities for FT522 in Autoimmunity under Evaluation. The FDA has allowed the Company’s Investigational New Drug (IND) application to assess the safety, pharmacokinetics, and activity of FT522 across a basket of B cell-mediated autoimmune diseases. The Phase 1 clinical protocol allows for treatment of patients with up to four weekly doses of FT522, without administration of conditioning chemotherapy, as an add-on to rituximab induction therapy (Regimen A) and as an add-on to maintenance therapy in combination with rituximab (Regimen B). The Company is currently evaluating opportunities and timelines for the clinical development of FT522 in autoimmunity.

Total Shareholder Yield	-0.1%
Future Dividend Yield	0%
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (FATE)	n/a
Market Bottom 25% (US)	1.4%
Market Top 25% (US)	4.2%
Industry Average (Biotechs)	2.2%
Analyst forecast (FATE) (up to 3 years)	0%

Data	Last Updated (UTC time)
Company Analysis	2026/09/16 16:41
End of Day Share Price	2026/09/16 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Jack Allen	Baird
Tazeen Ahmad	BofA Global Research
Amanda Murphy	BTIG

Fate Therapeutics Dividends and Buybacks

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Key information

Recent dividend and buyback updates

Recent updates

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President recently sold US$108k worth of stock

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Consensus revenue estimates increase by 32%

Price target decreased by 7.7% to US$7.20

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Fate Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $79.999997 million.

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New minor risk - Shareholder dilution

Consensus revenue estimates decrease by 21%, EPS upgraded

Price target increased by 19% to US$7.53

Full year 2023 earnings: EPS exceeds analyst expectations

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Founder recently sold US$63k worth of stock

Founder notifies of intention to sell stock

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Price target decreased by 11% to US$6.50

General Counsel & Corporate Secretary notifies of intention to sell stock

Price target decreased by 8.8% to US$6.63

Third quarter 2023 earnings: EPS and revenues exceed analyst expectations

Fate Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

New minor risk - Share price stability

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Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

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