SAN DIEGO, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE) (the Company), a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today announced the appointment of Kamal Adawi, M.S., M.B.A., to the role of Chief Financial Officer (CFO) effective October 20, 2025. Mr. Adawi brings to the Company more than 20 years of financial leadership experience in the life scie ...

Fate Therapeutics Conference Call Summary Company Overview - **Company**: Fate Therapeutics (FATE) - **Industry**: Biotechnology, specifically focusing on CAR T cell therapies for oncology and autoimmune diseases - **Tagline**: "Making transformative medicine accessible to all" [2] Key Points and Arguments CAR T Cell Technology - Fate Therapeutics is pioneering CAR T cell therapies, emphasizing the unique ability of CAR T to expand upon antigen engagement, making it a "living drug" [3] - The company utilizes stem cells to produce nearly unlimited amounts of CAR T cells, aiming for an "off the shelf" solution that enhances accessibility [3][4] Competitive Landscape - The company acknowledges competition in the autoimmune space, particularly with CD19 CAR T therapies and other modalities like T cell engagers (TCEs) [5] - Fate's FT819 is positioned as superior due to its accessibility and unique mechanism, which does not rely on the patient's immune system as heavily as other therapies [6][8] Efficacy and Safety - FT819 has shown promising preclinical results, with a 40% complete response (CR) rate in aggressive lymphoma patients [13] - The company aims to balance safety and efficacy, with a focus on operational feasibility, including reducing hospitalization requirements to potentially none by year-end [16][29] Treatment Regimens - Two treatment regimens are being explored: - **Regimen A**: Light conditioning with cyclophosphamide, which is familiar to rheumatologists [18][20] - **Regimen B**: Administering FT819 on top of maintenance therapy, with ongoing dose-finding studies [22][24] - The company has received RMAT designation from the FDA for both regimens, indicating a collaborative relationship with regulatory bodies [27] Enrollment and Site Activation - Fate has activated eight sites within four months, with expectations to reach around 20 sites by year-end, significantly improving patient enrollment rates [30][34] - The company is experiencing a shift from low patient enrollment per site to a more traditional model of higher patient numbers per site [32] Future Data and Trials - Upcoming data presentations are expected at ACR, with a focus on the efficacy and safety of FT819 and the removal of hospitalization requirements [37] - The company is also expanding its pipeline to include other autoimmune diseases beyond lupus, with positive discussions with the FDA regarding additional indications [39] Manufacturing and Capacity - Fate has established a master cell bank capable of producing 400 vials, each yielding trillions of CAR T cells, indicating a robust manufacturing capability [42][44] - The company can produce approximately 50,000 doses per year and is exploring options for increased production without additional capital investment [44][45] Financial Position - Fate has extended its cash runway to 2027, with a focus on prioritizing the FT819 program while also advancing next-generation products [59] - The company is strategically managing its resources to ensure successful completion of pivotal studies and continued development of its pipeline [59] Additional Important Insights - The CEO emphasized the importance of operational feasibility and patient experience, aiming to minimize the burden on patients undergoing treatment [15][16] - The company is leveraging its unique manufacturing capabilities to differentiate itself from competitors in the CAR T space [45][46]

Core Insights - Fate Therapeutics has made significant progress in its clinical programs, particularly with the FT819 CAR T-cell product candidate for autoimmune diseases, showing promising data in systemic lupus erythematosus (SLE) and lupus nephritis (LN) [2][5] - The company is working closely with the FDA under the Regenerative Medicine Advanced Therapy (RMAT) designation to establish a registrational study for FT819 in SLE and LN, aiming to commence this study in 2026 [2][5] - Financially, the company reported a cash position of $248.9 million as of June 30, 2025, and total revenue of $1.9 million for the second quarter of 2025 [17][19] Clinical Developments - The first patient treated with FT819 achieved a durable response and drug-free remission at the 12-month follow-up, indicating the potential effectiveness of the therapy [1] - The Phase 1 clinical trial of FT819 continues to enroll patients, with interim data showing that patients with refractory active LN achieved objective renal responses [5][6] - The company has expanded its Phase 1 study to include additional B cell-mediated autoimmune diseases, with plans to initiate independent dose-expansion cohorts in the second half of 2025 [10] Financial Performance - For the second quarter of 2025, total operating expenses were $38.9 million, with research and development expenses accounting for $27.4 million [17][19] - The net loss for the second quarter was $34.1 million, compared to a net loss of $38.4 million in the same quarter of the previous year [19] - The company has implemented measures to extend its cash runway through the end of 2027, including a 12% reduction in employee headcount [12] Partnerships and Collaborations - Fate Therapeutics has extended its collaboration with Ono Pharmaceuticals for the development of a second solid tumor CAR T-cell product candidate [9] - The company is conducting a Phase 1 study for FT825/ONO-8250, targeting HER2 in advanced solid tumors, with a favorable safety profile reported [7] Regulatory Developments - The FDA has allowed the IND application for FT836, a CAR T-cell program targeting MICA/B for the treatment of solid tumors without conditioning chemotherapy [4][11] - The RMAT designation for FT819 was granted in April 2025, aimed at expediting the development of therapies for serious diseases [5]

Core Insights - Fate Therapeutics announced promising clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), showing all five patients treated achieved significant disease improvement [2][3] - The first patient reached a 12-month follow-up and continues in drug-free remission, indicating the potential for durable treatment effects [2][4] - The company is expanding its clinical trials to include multiple B cell-mediated autoimmune diseases, with plans for independent dose-expansion cohorts in various conditions [8] Clinical Data Summary - A multi-center, Phase 1 clinical trial is evaluating FT819's safety and efficacy in patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus [3] - As of May 15, 2025, five patients have been treated, with all showing significant improvements in disease activity scores [3][4] - Three patients with active lupus nephritis achieved primary efficacy renal response, with reductions in SLEDAI-2K scores of 10 points or more [4][5] Treatment Regimens - FT819 was administered under two regimens: a fludarabine-free conditioning regimen and a conditioning-free regimen [3][6] - In the fludarabine-free regimen, three patients with active lupus nephritis showed significant reductions in SLEDAI-2K scores, with one patient achieving a score reduction from 20 to 4 at 12 months [4] - One patient with extrarenal lupus on maintenance therapy achieved low lupus disease activity state (LLDAS) at 3 months, maintained at 6 months, with a reduction in SLEDAI-2K from 8 to 2 [6] B-cell Remodeling - Patients treated with FT819 exhibited rapid B-cell depletion and a shift towards a non-switched, naïve B-cell repertoire within the first 60 days [7] - This remodeling was observed in both treatment regimens, indicating a potential mechanism of action for FT819 [7] Safety Profile - The treatment demonstrated a favorable safety profile, with low incidence of cytokine release syndrome and no events of neurotoxicity or graft-versus-host disease [8][10] - All patients were discharged after a short hospitalization, supporting the potential for outpatient administration [10] Regulatory and Development Plans - Fate Therapeutics has reached an agreement with the FDA to investigate multiple autoimmune diseases under its Phase 1 trial for FT819 [8] - The company plans to discuss registrational strategies with the FDA for FT819 in SLE under its RMAT designation [8]

Core Insights - Fate Therapeutics is presenting clinical data from its Phase 1 study of FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE) at the EULAR 2025 conference [1][2] - The study evaluates the safety and efficacy of FT819 with a fludarabine-free conditioning regimen, aiming to enhance patient access and therapeutic outcomes [2][4] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on developing induced pluripotent stem cell (iPSC)-derived cellular immunotherapies [5][6] - The company has established a leadership position in creating multiplexed-engineered master iPSC lines and manufacturing off-the-shelf iPSC-derived cell products [6] Product Platform - The iPSC product platform allows for unlimited self-renewal and differentiation into all cell types, enabling the creation of well-defined and uniform engineered cell products [4][6] - The platform is supported by over 500 issued patents and 500 pending patent applications, highlighting its innovative approach and potential for broad patient application [4]

Financial Performance - Fate Therapeutics reported a loss of 32 cents per share for Q1 2025, which is narrower than the Zacks Consensus Estimate of a loss of 39 cents, and an improvement from a loss of 47 cents per share in the same period last year [1] - The company earned collaboration revenues of $1.6 million, exceeding the Zacks Consensus Estimate of $1 million, although revenues declined by 15.8% year-over-year [1] - Research and development (R&D) expenses decreased by 9.3% to $29.1 million, while general and administrative (G&A) expenses decreased by approximately 34% to $13.8 million [4] - As of March 31, 2025, cash, cash equivalents, and investments totaled $272.7 million, which is expected to sustain operations through the first half of 2027 [4] Stock Performance - Shares of Fate Therapeutics increased by 5% in after-hours trading on May 13, following the better-than-expected earnings announcement [2] - Year-to-date, the stock has declined by 39.4%, compared to the industry's decline of 6.4% [3] Pipeline Development - Fate Therapeutics is focused on developing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform, which includes iPSC-derived natural killer (NK) cells and T-cell product candidates [5] - A phase I study of FT819, a T-cell product candidate for systemic lupus erythematosus (SLE), is ongoing, with dose expansion initiated in up to 10 patients at 360 million cells [6][8] - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819 for treating active moderate to severe SLE, including lupus nephritis [9] - Fate Therapeutics is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical, and is conducting a phase I study for advanced solid tumors [9][10]

Core Insights - Fate Therapeutics is advancing its FT819 off-the-shelf CAR T-cell product candidate for moderate-to-severe systemic lupus erythematosus (SLE), with new Phase 1 data to be presented at the EULAR 2025 Congress in June [1][2] - The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for FT819, which will expedite its development and review process [5] - The company has $273 million in cash and investments, providing a projected operating runway through the first half of 2027 [1][11] Company Developments - The ongoing Phase 1 study of FT819 is designed to evaluate safety, pharmacokinetics, and efficacy, with patient enrollment at two dose levels: 360 million cells and 900 million cells [5] - The company plans to expand the Phase 1 study to include additional B cell-mediated autoimmune diseases, such as anti-neutrophilic cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis [5] - Fate Therapeutics is also conducting a Phase 1 study for FT825, a CAR T-cell product candidate targeting HER2 in advanced solid tumors, which has shown a favorable safety profile [6] Financial Performance - For the first quarter of 2025, the company reported total revenue of $1.6 million, primarily from preclinical development activities [11] - Total operating expenses for the same period were $42.9 million, with research and development expenses accounting for $29.1 million [11][17] - The net loss for the first quarter was $37.6 million, compared to a net loss of $48.0 million in the same quarter of the previous year [11][17] Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $272.7 million, which supports its ongoing operations and clinical development programs [11][19]

Core Viewpoint - Fate Therapeutics has received RMAT designation from the FDA for its investigational iPSC-derived CAR T-cell therapy, FT819, aimed at treating moderate to severe systemic lupus erythematosus (SLE) [1][2][3] Group 1: RMAT Designation and Its Implications - The RMAT designation acknowledges the potential of FT819 to meet the significant unmet needs of lupus patients and facilitates increased communication with the FDA during development [2][6] - The designation allows for early interactions with the FDA, including discussions on potential surrogate endpoints for accelerated approval [3][6] Group 2: Clinical Development of FT819 - FT819 is currently in Phase 1 clinical trials, focusing on safety and efficacy with a fludarabine-free conditioning regimen [2][6] - The ongoing study includes dose expansion to 10 patients at 360 million cells and safety assessments at 900 million cells [2] - Additional clinical data from the Phase 1 study is expected to be presented at scientific meetings later in 2025 [2][6] Group 3: Company Overview and iPSC Product Platform - Fate Therapeutics specializes in developing iPSC-derived cellular immunotherapies and has established a leadership position in creating multiplexed-engineered master iPSC lines [4][5] - The company's iPSC product platform is designed to produce uniform, off-the-shelf cell products that can be stored and administered in combination with other therapies [4][5] - Fate Therapeutics holds an extensive intellectual property portfolio with over 500 issued patents and 500 pending applications [4]