SAN DIEGO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (the “Company” or “Fate Therapeutics”) (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that the Company will present at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 in New York, New York. Company management wil ...

Core Insights - Fate Therapeutics reported a quarterly loss of $0.27 per share, which is better than the Zacks Consensus Estimate of a loss of $0.29, and an improvement from a loss of $0.40 per share a year ago [1][2] - The company achieved a revenue of $1.74 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 104.82%, although this is a decline from $3.07 million in the same quarter last year [3] Financial Performance - The earnings surprise for the quarter was +6.90%, and over the last four quarters, the company has consistently surpassed consensus EPS estimates [2] - Fate Therapeutics has also topped consensus revenue estimates four times in the last four quarters [3] Stock Performance - Since the beginning of the year, Fate Therapeutics shares have declined by approximately 37%, contrasting with a 16.5% gain in the S&P 500 [4] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [7] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $0.85 million, and for the current fiscal year, it is -$1.14 on revenues of $4.38 million [8] - The outlook for the Medical - Biomedical and Genetics industry is relatively strong, ranking in the top 35% of over 250 Zacks industries, which may positively influence stock performance [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to . Commission File Number 001-36076 Delaware 65-1311552 (State or other jurisdiction of incorporation or organization) FATE THERAPEUTICS, INC. (Exact name of registrant ...

Financial Performance - Fate Therapeutics reported total revenue of $1.7 million for Q3 2025, derived from preclinical development activities[12] - Collaboration revenue for Q3 2025 was $1.741 million, down from $3.074 million in Q3 2024, representing a decrease of 43.4%[17] - Total operating expenses for Q3 2025 were $36.5 million, including R&D expenses of $25.8 million and G&A expenses of $10.6 million[12] - Total operating expenses for Q3 2025 were $36.476 million, a reduction of 34.2% compared to $55.451 million in Q3 2024[17] - Net loss for Q3 2025 was $32.250 million, compared to a net loss of $47.678 million in Q3 2024, indicating an improvement of 32.3%[17] - The company reported total other income of $2.485 million for Q3 2025, compared to $4.699 million in Q3 2024, a decrease of 47.2%[17] - Comprehensive loss for the nine months ended September 30, 2025, was $104.056 million, down from $133.289 million in 2024, indicating a reduction of 21.9%[17] Cash and Assets - Cash, cash equivalents, and investments as of September 30, 2025, were $225.7 million, providing a projected operating runway through year-end 2027[12] - Cash and cash equivalents increased to $40.622 million as of September 30, 2025, up from $36.056 million at the end of 2024[19] - Total assets decreased to $343.671 million as of September 30, 2025, down from $440.694 million at the end of 2024, reflecting a decline of 22%[19] Research and Development - FT819, an off-the-shelf CAR T-cell product, has shown promising clinical activity in treating systemic lupus erythematosus (SLE), with a mean SLEDAI-2K score decrease of 10.7 points at 3 months and 14 points at 6 months for patients on Regimen A[5] - The first patient with systemic sclerosis was treated in a Phase 1 study, demonstrating the potential for FT819 to address significant unmet medical needs in autoimmune diseases[5] - The company received regulatory authorization from the UK and EU to initiate clinical trials for FT819, marking a significant step in international expansion[4] - FT836, a MICA/B-targeted CAR T-cell, was administered to the first patient without conditioning chemotherapy, showcasing the potential for broad accessibility in solid tumor treatments[8] - The ongoing Phase 1 study for FT825/ONO-8250 in advanced solid tumors is currently at the third dose level of 900 million cells, with no dose-limiting toxicities observed[7] - The company plans to present data on FT836's applicability against multiple myeloma at the upcoming ASH Annual Meeting, supported by a $4 million award from CIRM[8] - Research and development expenses for the nine months ended September 30, 2025, were $82.404 million, down from $101.392 million for the same period in 2024, a decrease of 18.7%[17] - General and administrative expenses for the nine months ended September 30, 2025, were $35.856 million, compared to $58.907 million in 2024, a reduction of 39.1%[17] Leadership Changes - Kamal Adawi was appointed as Chief Financial Officer, bringing over 20 years of financial leadership experience in the life sciences industry[10] Share Information - The weighted-average common shares used to compute basic and diluted net loss per share for Q3 2025 were 118,998,693, compared to 117,769,161 in Q3 2024[17]

Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an Off-the-Shelf CD19-targeted CAR T-cell Product Candidate that Utilizes Less-intensive or No Conditioning, Enabling Broad Patient Accessibility First Systemic Sclerosis Patient treated in Phase 1 Study of FT819 Following Fludarabine-free Conditioning; Dose Expansion Designed to Evaluate Patient Outcome with Less-intensive or No Conditioning First Patient Treated wit ...

Core Viewpoint - Fate Therapeutics (FATE) is anticipated to report a year-over-year increase in earnings despite lower revenues, which could significantly influence its stock price depending on the actual results compared to estimates [1][3]. Financial Expectations - The upcoming earnings report is expected to show a quarterly loss of $0.29 per share, reflecting a year-over-year change of +27.5% [3]. - Revenues are projected to be $0.85 million, down 72.3% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 3.57% lower in the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Fate Therapeutics is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -7.02% [12]. Earnings Surprise Prediction - A positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [10]. - Fate Therapeutics currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [12]. Historical Performance - In the last reported quarter, Fate Therapeutics was expected to post a loss of $0.35 per share but actually reported a loss of -$0.29, resulting in a surprise of +17.14% [13]. - Over the past four quarters, the company has beaten consensus EPS estimates four times [14]. Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Arcturus Therapeutics (ARCT) is expected to report a loss of $1.25 per share, indicating a year-over-year change of -380.8% [18]. - Arcturus Therapeutics' revenue is expected to be $11.39 million, down 72.7% from the previous year [18].

Industry Overview - The global cancer treatment market is undergoing a transformative phase due to rising cancer incidence and rapid scientific advancements, with the U.S. projected to report 2.04 million new cancer cases and over 618,000 deaths in 2025 [1] - An aging population and lifestyle-related risks are increasing global cancer prevalence, leading to higher oncology spending by healthcare systems [1] Innovation in Cancer Treatment - Advances in immunotherapies, targeted drugs, and personalized vaccines are expanding treatment options beyond traditional chemotherapy and radiation [2] - Immune-based approaches, such as checkpoint inhibitors and CAR-T therapies, enhance the body's defenses against tumors, while targeted therapies focus on specific genetic mutations to improve precision and reduce side effects [2] - Emerging technologies like genomic sequencing, AI, and machine learning are accelerating biomarker discovery and improving early detection, contributing to better survival rates and quality of life across many cancer types [3] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, Johnson & Johnson, Pfizer, AbbVie, Merck, Bristol Myers Squibb, and Eli Lilly, are aggressively investing in new oncology pipelines, including antibody-drug conjugates and next-generation immuno-oncology agents [4] - Smaller biotech firms are key sources of innovation, driving collaborations, licensing deals, and acquisitions as larger companies seek novel assets [4] Investment Opportunities - The oncology segment is positioned as one of the most attractive and resilient areas for long-term investors due to continued innovation and favorable reimbursement trends [5] - Stocks such as Relay Therapeutics, Fate Therapeutics, and Verastem Oncology are highlighted as potential investment opportunities in the rising cancer treatment trend [6] Company Highlights - **Relay Therapeutics** is developing RLY-2608, a mutant-selective PI3Kα inhibitor, showing potential benefits in clinical studies for advanced breast cancer [7][8] - **Fate Therapeutics** focuses on universal, off-the-shelf cell products and is co-developing FT825/ONO-8250, a CAR T-cell product candidate, with promising safety profiles in early studies [9][10][11] - **Verastem Oncology** received FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, generating $2.1 million in sales shortly after launch [12][13]

Core Insights - Fate Therapeutics has reported promising initial clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), demonstrating significant clinical activity and a favorable safety profile [2][3] - The company aims to accelerate patient enrollment in its Phase 1 trial and is in discussions with the FDA regarding a registrational study design, with plans to initiate a pivotal study in 2026 [2][8] Clinical Data Summary - As of September 25, 2025, 10 patients have been treated with FT819, with 5 patients showing significant reductions in SLE Disease Activity Index (SLEDAI-2K) scores and improvements in renal response [1][3] - Patients treated with a less-intensive conditioning regimen exhibited notable reductions in SLEDAI-2K scores, with one patient achieving complete renal response and remaining in drug-free remission at 15 months [1][4] - In the conditioning-free regimen, patients on maintenance therapy also showed meaningful reductions in disease activity scores, with one patient achieving low lupus disease activity state by 3 months [5] Safety Profile - The safety profile of FT819 is favorable, with no dose-limiting toxicities observed and a low incidence of low-grade cytokine release syndrome [6][8] - All patients were discharged on the same day post-infusion, supporting the potential for outpatient administration [6][8] Mechanistic Insights - FT819 treatment led to rapid CD19+ B cell depletion and immune remodeling towards a naïve B-cell repertoire, correlating with reductions in disease activity [8] - The unique ability of FT819 to remodel the B-cell compartment without intensive conditioning chemotherapy highlights its transformative potential in treating autoimmune diseases [8] Program Expansion and Future Outlook - Fate Therapeutics is expanding its clinical program to include additional cohorts for other autoimmune diseases and is preparing for a pivotal study in 2026 [8][9] - The company currently has approximately 600 cryopreserved drug product bags of FT819 available for patient treatment [9]

Core Insights - Fate Therapeutics has reported promising initial clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), showing significant clinical activity and a favorable safety profile [2][3] - The company aims to accelerate patient enrollment in its Phase 1 trial and is in discussions with the FDA for a registrational study design, targeting a pivotal study initiation in 2026 [2][10] Clinical Data Summary - A total of 10 patients with treatment-refractory moderate-to-severe SLE have been treated with FT819, with 5 patients surpassing the 3-month post-treatment evaluation showing significant reductions in SLE Disease Activity Index (SLEDAI-2K) scores [1][3] - Patients with lupus nephritis achieved complete renal response (CRR) at 6 months, with one patient maintaining drug-free remission at 15 months [1][4] Treatment Regimens - The study includes two regimens: a less-intensive conditioning regimen and a conditioning-free regimen, with patients showing meaningful improvements in disease activity scores and renal function [3][6] - In the less-intensive conditioning regimen, patients demonstrated significant reductions in SLEDAI-2K scores, with one patient achieving a 16-point reduction and maintaining remission [4][5] Safety Profile - FT819 has shown a favorable safety profile, with no dose-limiting toxicities reported and low incidence of cytokine release syndrome (CRS) among treated patients [9] - All patients were discharged on the same day post-infusion, indicating potential for outpatient administration [9] Program Expansion and Future Outlook - The company is expanding its clinical program to include additional cohorts for other autoimmune diseases, with over 60 patients treated across various indications [9] - Fate Therapeutics has approximately 600 cryopreserved drug product bags of FT819 available for patient treatment [10]

Core Insights - Fate Therapeutics has appointed Kamal Adawi as Chief Financial Officer effective October 20, 2025, bringing over 20 years of financial leadership experience in the life sciences industry [1][2][3] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on developing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies [4] - The company aims to create off-the-shelf cellular immunotherapies that are broadly accessible and require less intensive or no conditioning chemotherapy, potentially transforming treatment for autoimmune diseases and cancer [3][4] Leadership Appointment - Kamal Adawi's previous experience includes serving as CFO for Mindera Health and Exagen Inc., where he led Exagen through a successful IPO [2][3] - His expertise includes financial strategy, capital formation, and operational growth, which will support the company's clinical programs, particularly the development of FT819 for systemic lupus erythematosus (SLE) [2][3] Stock Options and Awards - As part of his employment, Mr. Adawi will receive an option to purchase 375,000 shares of common stock, vesting over four years, and an award of 75,000 restricted stock units, also subject to vesting conditions [3]