Fate Therapeutics Conference Call Summary Company Overview - **Company**: Fate Therapeutics (NasdaqGM:FATE) - **Event**: 2026 Conference on March 09, 2026 - **Key Speaker**: Bob Valamehr, CEO Core Points and Arguments FT819 Overview - FT819 is an allogeneic CAR T-cell therapy, differing from traditional CAR T therapies by utilizing a master cell bank, allowing for consistent and uniform production of the therapy [4][8] - The master cell bank can produce approximately **10 million doses**, with each dose containing around **1 billion cells** [4][7] - The therapy is designed to ensure safety and controlled expansion of CAR T-cells, addressing concerns of adverse events associated with uncontrolled cell expansion [9][10] Clinical Focus and Efficacy - FT819 targets **CD19** and is being advanced for use in **autoimmune diseases** such as lupus nephritis, myositis, systemic sclerosis, and vasculitis [12] - The therapy has shown promising results in treating nearly **70 patients**, with a focus on balancing activity and safety [10][11] - In aggressive DLBCL, the complete response rate was about **40%**, but durability was an issue due to the design of the CAR [10][11] Manufacturing and Accessibility - The current facility can produce **50,000 doses** at full scale, with a cost of goods at **$3,000 per dose**, providing a competitive advantage [22] - FT819 is designed for outpatient therapy, allowing patients to receive treatment without extended hospital stays, enhancing accessibility for those with chronic conditions [23][24] Regulatory Path and Future Trials - The company is preparing for a pivotal Phase 2 trial focusing on lupus nephritis, with complete renal response as the primary endpoint [25] - Initial results show that the first two patients treated achieved a complete renal response within **6 months** [30] - The company aims to complete the single-arm study quickly, with expectations to enroll around **25 lupus patients** by summer [33] Next Generation Products - Fate Therapeutics is developing next-generation products, FT839 and FT836, which utilize multiplex editing to eliminate the need for conditioning and target a broader range of autoimmune diseases [62][66] - FT839 includes a dual-targeting approach (CD19 and CD38) to address multiple complex autoimmune diseases and potentially create immune tolerance [65][66] Market Position and Competitive Landscape - The company believes FT819 is superior to existing therapies like obinutuzumab and voclosporin, emphasizing its safety, accessibility, and efficacy [42] - The unique single-administration approach of FT819 positions it favorably against traditional therapies that require ongoing treatment [49] Additional Important Content - The discussion highlighted the importance of safety in CAR T therapies, with FT819 showing no instances of ICANS or GVHD, and low-grade CRS [24] - The CEO emphasized the need to demonstrate the safety and efficacy of FT819 to regulatory agencies to ensure it is held to the same standards as other approved products [42] - The company is exploring the potential for extra-renal lupus treatments and is in discussions with the FDA regarding endpoints for these studies [39] This summary encapsulates the key points discussed during the Fate Therapeutics conference call, focusing on the company's innovative CAR T-cell therapy, its clinical applications, manufacturing capabilities, and future directions in research and development.

Core Insights - Fate Therapeutics has made significant progress in 2025, particularly with the outpatient treatment of FT819 off-the-shelf CAR T cells, which enhances accessibility for autoimmune patients and improves health system economics [2][5] - The company is advancing towards its first Phase 2 clinical trial in lupus nephritis and is actively recruiting patients for the Phase 1 basket study of FT819 across multiple regions [2][3] - FT819 has shown promising clinical results, including a 78% reduction in disease activity in systemic lupus erythematosus patients and improvements in systemic sclerosis patients [5][7] Clinical Development & Program Updates - FT819 is an off-the-shelf CD19-targeting CAR T-cell product designed for improved safety and efficacy, produced from a clonal master induced pluripotent stem cell (iPSC) bank [3][12] - The Phase 1 clinical trial of FT819 is currently enrolling patients at 16 sites in the U.S., U.K., and EU, focusing on various autoimmune diseases [3][4] - The outpatient treatment model for FT819 eliminates the need for extended hospitalization and conditioning chemotherapy, facilitating broader patient access [5][6] Financial Overview - As of December 31, 2025, the company reported cash, cash equivalents, and investments totaling $205 million, providing a runway through the end of 2027 [9][11] - Total revenue for the fourth quarter of 2025 was $1.4 million, with total operating expenses of $36.1 million, resulting in a net loss of $32.4 million for the quarter [16][19] - The company has reduced operating expenses by 30% in 2025 compared to 2024, which supports the achievement of key clinical and collaboration milestones [9][11] Next-Generation CAR T-cell Programs - FT836, a next-generation CAR T-cell product, has demonstrated early clinical activity in colorectal cancer without the use of conditioning chemotherapy, showing over a 50% reduction in carcinoembryonic antigen (CEA) levels [6][11] - The company has secured a $4 million award from the California Institute of Regenerative Medicine to support IND-enabling activities for FT836 [8] - FT839, another product candidate, is designed to target multiple antigens and is expected to enter clinical investigation for autoimmune diseases and hematologic malignancies in 2026 [11][12]

TRANSFORMING THE LIVES OF PATIENTS WITH AUTOIMMUNE DISEASES AND CANCER Making Cell Therapies Accessible to AllTM Corporate Presentation February 2026 © 2026 Fate Therapeutics. All rights reserved. - 1 - Q1 2026 Business Updates & Near-Term Objectives Competitively positioned to accelerate clinical stage development | | Milestones Achieved | Near Term Next Steps | | --- | --- | --- | | | ✓ 15 lupus patients enrolled with 7 initial sites, with 16 | Complete Phase 1 SLE cohort enrollment by mid-2026 | | Autoim ...

Core Insights - Fate Therapeutics continues to show significant clinical progress with its FT819 CAR T-cell therapy for systemic lupus erythematosus (SLE), demonstrating meaningful and durable responses with a favorable safety profile [2][4] - The company is expanding its clinical trial capacity, including international sites, to enhance patient access to FT819 [2] - New preclinical data for next-generation CAR T-cell programs FT836 and FT839 indicate improved efficacy and safety for treating hematologic malignancies and autoimmune diseases [3][4] Clinical Trial Updates - FT819 is currently in a Phase 1 trial with 12 SLE patients treated, showing sustained clinical responses and durable B-cell depletion without intensive conditioning chemotherapy [2][5] - As of November 25, 2025, 12 SLE patients were treated across 14 clinical sites, with 10 patients having at least one month of follow-up [5] - Clinical SLEDAI-2K scores showed significant reductions, with mean scores dropping by 50% to 70% at three and six months post-treatment [8] Safety and Efficacy - The updated clinical data indicate no dose-limiting toxicities and no Grade >2 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) reported [6] - Five out of ten patients achieved a clinical SLEDAI-2K score of 0, with improvements in fatigue scores observed across all patients with multiple assessments [6][8] Next-Generation Programs - FT836 and FT839 are designed to target stress antigens and B-cell malignancies, showing enhanced potency and functional persistence compared to existing therapies [3][4] - These next-generation programs aim to provide a comprehensive treatment approach for multiple myeloma and other hematologic malignancies [3] Company Overview - Fate Therapeutics is focused on developing off-the-shelf, iPSC-derived cellular immunotherapies, leveraging its proprietary iPSC product platform to create engineered cell products that are uniform and scalable [9][10] - The company holds a robust intellectual property portfolio with over 500 issued patents and 500 pending applications, supporting its innovative approach in the biopharmaceutical industry [9]

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 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 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]