FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a c ...

Summary of Fate Therapeutics FY Conference Call Company Overview - **Company**: Fate Therapeutics (NasdaqGM:FATE) - **Focus**: Development of induced pluripotent stem cells (iPSC)-derived cell therapies for immune diseases and oncology [1][2] Key Points and Arguments iPSC Technology - **Unique Properties**: iPSCs can grow indefinitely and differentiate into any of the 200 cell types in the body, allowing for the creation of a master cell bank [3][4] - **Off-the-Shelf Concept**: iPSCs enable the production of consistent and uniform drug products, reducing costs and improving accessibility [4][5] Transition to CAR iT Cells - **Shift from T Cells to CAR iT Cells**: The company transitioned from developing T cells to CAR iT cells due to the latter's superior response to stimulation and expansion, which is crucial for treating aggressive diseases [6][7][8] FT819 Development - **Target**: FT819 is a CD19 CAR iT cell therapy initially aimed at aggressive DLBCL, showing a 40% complete response (CR) rate in CAR-T naive patients [10][11] - **Lupus Indication**: The therapy has been adapted for lupus, demonstrating a favorable safety profile and significant efficacy improvements in various clinical metrics [12][13] Market Potential - **Patient Population**: The potential patient population for lupus is significantly larger than for DLBCL, with estimates of 200 million individuals affected [13][14] - **Manufacturing Capacity**: The company projects the ability to produce approximately 50,000 doses per year, with a cost of goods around $3,000 per dose [15][16] Clinical Development and Future Plans - **Next Steps**: The company aims to initiate pivotal registration studies for FT819 in lupus by 2026 and explore additional autoimmune diseases [20][21] - **Pipeline Expansion**: Future therapies include FT839 for more complex diseases and FT836 targeting MICA/MICB in oncology [21][27] Innovations in Treatment - **Reduced Conditioning**: The company is working towards outpatient treatment options with lighter conditioning regimens, enhancing patient experience and accessibility [24][26] - **Sophisticated Edits**: FT839 will include additional edits to target CD38, aiming for a broader approach in treating autoimmune diseases [22][23] Financial Position - **Cash Reserves**: Fate Therapeutics reported a cash position of approximately $226 million, extending its runway through the end of 2027, allowing for continued development of its therapies [35] Additional Important Information - **Partnerships**: The company is collaborating with Ono for the development of FT825, a HER2 CAR iT therapy, which has faced challenges in patient enrollment due to prior treatments affecting HER2 expression [33][34] - **Patient Enrollment**: The company is experiencing faster enrollment rates in lupus compared to competitors, with nearly 14 clinical sites activated [19][20] This summary encapsulates the critical insights and developments discussed during the Fate Therapeutics FY Conference Call, highlighting the company's innovative approaches and future directions in cell therapy.

Core Insights - Fate Therapeutics has received authorization from UK and EU authorities to activate clinical trial sites for FT819, an off-the-shelf CD19-targeted CAR T-cell product candidate, aimed at improving patient accessibility with less-intensive or no conditioning [1][3] - The company reported promising preliminary clinical data for FT819, showing significant reductions in disease activity in patients with systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) [5][6] - Fate Therapeutics has a strong financial position with $226 million in cash and equivalents projected to fund operations through the end of 2027 [1][12] R&D Highlights and Updates - FT819 is designed to be a cost-effective, off-the-shelf CAR T-cell therapy that can be stored for on-demand availability, overcoming limitations of traditional patient-sourced therapies [3][11] - The first patient with systemic sclerosis has been treated in a Phase 1 study, demonstrating the potential of FT819 to address significant unmet medical needs in autoimmune diseases [5][6] - FT836, another CAR T-cell candidate targeting solid tumors, has also begun patient treatment without conditioning chemotherapy, showcasing the versatility of the company's technology [7][8] Financial Results - For Q3 2025, the company reported total revenue of $1.7 million, primarily from preclinical development activities [12][17] - Total operating expenses for the same period were $36.5 million, with research and development expenses accounting for $25.8 million [12][17] - The net loss for Q3 2025 was $32.3 million, reflecting ongoing investments in R&D and operational activities [12][17] Corporate Updates - Kamal Adawi has been appointed as Chief Financial Officer, bringing over 20 years of financial leadership experience in the life sciences sector [9] - The company continues to strengthen its iPSC platform and next-generation CAR T-cell programs, focusing on expanding access to innovative therapies for patients [2][3]

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]

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]