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, Inc. is a clinical-stage biopharmaceutical company focused on developing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases [3] Company Overview - The company utilizes a proprietary iPSC product platform to create multiplexed-engineered master iPSC lines and manufacture off-the-shelf, iPSC-derived cell products [3] - Fate Therapeutics has established a leadership position in the clinical development of iPSC-derived T-cell and natural killer (NK) cell product candidates, which are designed to deliver multiple therapeutic mechanisms [3] - The company is headquartered in San Diego, California [3] Upcoming Events - Management will participate in a fireside chat at the Leerink Partners 2026 Global Healthcare Conference on March 9, 2026, at 9:20 AM ET [2] - A live webcast of the fireside chat will be available on the company's website, with an archived replay accessible for 90 days post-event [2]

Core Viewpoint - Fate Therapeutics reported a quarterly loss of $0.27 per share, which aligns with the Zacks Consensus Estimate and shows an improvement from a loss of $0.31 per share a year ago, indicating a positive trend in financial performance [1] Financial Performance - The company posted revenues of $1.37 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 8.73% and down from $1.86 million in the same quarter last year [2] - Over the last four quarters, Fate Therapeutics has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Fate Therapeutics shares have increased by approximately 50.6% since the beginning of the year, significantly outperforming the S&P 500, which gained 1.5% [3] Future Outlook - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.30 for the coming quarter and -$1.16 for the current fiscal year, alongside expected revenues of $1.5 million and $6 million respectively [7] - The Zacks Rank for Fate Therapeutics is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fate Therapeutics belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable environment for stocks within this sector [8]

Financial Performance - The company has incurred net losses since its inception in 2007, with significant expenses related to research and development and general administrative costs [522]. - The company anticipates ongoing operating losses for the foreseeable future, with expenses expected to remain high due to clinical trials and manufacturing activities [522][523]. - The company had an accumulated deficit of $1.5 billion as of December 31, 2025, and anticipates continued net losses in the foreseeable future [570]. - Net cash used in operating activities was $106.1 million in 2025, compared to $122.9 million in 2024, indicating an improvement in cash flow management [572][573]. - Other income fell to $11.4 million in 2025 from $24.0 million in 2024, primarily due to a decrease in interest income [569]. Revenue Sources - Collaboration revenue has not been generated from therapeutic product sales, with revenues derived from collaboration agreements and government grants [525]. - The company received a non-refundable upfront payment of $10.0 million from Ono Pharmaceutical Co., Ltd. as part of a collaboration agreement, with an estimated total of $29.3 million in research and preclinical development fees [526][528]. - In 2022, the company recognized $12.5 million from an option exercise fee related to the development of Candidate 2 [531]. - For the years ended December 31, 2025 and 2024, the company recognized $6.6 million and $13.6 million of collaboration revenue, respectively [537]. - Collaboration revenue decreased to $6.6 million in 2025 from $13.6 million in 2024, primarily due to a $5.0 million milestone recognition in 2024 [567]. Research and Development - Research and development expenses include costs for clinical trials, salaries, and third-party service providers, with plans to continue significant investment in these activities [538][539]. - Research and development expenses were $107.8 million in 2025, down from $135.0 million in 2024, reflecting a decrease of $27.2 million [568]. - The company has a pipeline of iPSC-derived CAR T-cell and NK cell product candidates currently under development, with collaborations to enhance its product platform [519][520]. - The company estimates accrued research and development expenses based on open contracts and service provider communications, with adjustments made as necessary [560][561]. Administrative Expenses - General and administrative expenses are expected to remain significant, focusing on innovation, compliance, and intellectual property protection [541]. - General and administrative expenses decreased to $46.5 million in 2025 from $74.2 million in 2024, a reduction of $27.6 million [568]. Funding and Financial Obligations - The company has sufficient funding to operate for at least twelve months from the date of the financial statements [523]. - The company expects to finance future capital requirements through public or private equity sales, debt securities, or collaborations [583]. - Future operating lease obligations total $119.3 million as of December 31, 2025 [588]. - The company may require additional debt or equity capital to make milestone payments due to the timing of revenue from product sales [592]. - The company has future payment obligations under various license agreements, with maximum aggregate milestone payments per product ranging from $1.8 million to $25 million [592][596]. Awards and Grants - The company was awarded $7.9 million from the California Institute for Regenerative Medicine (CIRM) to support the Phase 1 study of FT819, with disbursements expected from April 1, 2024, to March 31, 2028 [543][545]. - As of December 31, 2025, the company received three disbursements totaling $6.6 million under the FT819 CIRM Award, classified as a liability with $5.3 million as current and $1.3 million as non-current [547]. - The company was awarded $4.0 million from CIRM for FT836 to support preclinical and IND-enabling activities, with disbursements based on development milestones from May 1, 2025, to October 31, 2025 [548][550]. - As of December 31, 2025, the company received four disbursements totaling $4.0 million under the FT836 CIRM Award, with $3.2 million classified as current and $0.8 million as non-current [550]. Impairments and Charges - The company recorded a $13.4 million impairment charge against property and equipment and a $1.3 million impairment charge against the right-of-use asset during the year ended December 31, 2024, due to a decline in market capitalization [559]. - Stock price appreciation milestones under the Amended MSKCC License resulted in a payment of $20.0 million during the year ended December 31, 2021, with ongoing fair value assessments impacting earnings [558]. Risks and Market Conditions - The company is subject to risks related to regulatory approvals and may require additional capital for ongoing research and development activities [581][586]. - Inflation has increased during the reporting period, which may adversely affect operating results, although it has not materially impacted financial position to date [594]. Licensing and Royalties - The company is required to pay royalties on net sales of products covered by the in-licensed intellectual property, typically in the low single digits, with potential reductions for third-party payments [592][596]. - The license agreement with MSKCC includes additional milestone payments contingent upon increases in the company's stock price following the achievement of specified clinical milestones [592]. - The company has obligations to make annual maintenance payments under all license agreements, which are not specified in the maximum milestone payments [592][596]. Contracts and Agreements - Contracts with clinical sites and service providers are generally cancelable and not included in the table of contractual obligations [593]. - The company has entered into contracts for clinical trials and product manufacturing, which are standard in the industry and typically allow for termination on notice [593].

Clinical Trials and Therapies - FT819 off-the-shelf CAR T-cell therapy has been successfully administered as outpatient treatment, allowing for same-day hospital discharge and improving patient access in underserved regions [1]. - The Phase 1 clinical trial of FT819 is now enrolling patients across 16 clinical sites in the U.S., U.K., and EU, with 15 systemic lupus erythematosus patients treated to date [5]. - FT836, a MICA/B-targeted CAR T-cell therapy, demonstrated over 50% reduction in carcinoembryonic antigen (CEA) levels in a colorectal cancer patient, highlighting early clinical activity without conditioning chemotherapy [8]. - FT819's first systemic sclerosis patient showed meaningful disease improvement at the 3-month evaluation point using less-intensive conditioning chemotherapy [1]. - The company plans to advance FT819 to commercialization in various autoimmune diseases and is actively recruiting patients for its Phase 1 basket study [2]. - FT836 is designed to eliminate the need for conditioning chemotherapy and has received a $4 million award from the California Institute of Regenerative Medicine to support its development [8]. - FT839, a dual-CAR T-cell product candidate, is in preclinical development and aims to treat autoimmune diseases and hematologic malignancies without conditioning chemotherapy [9]. Financial Performance - The company reported total revenue of $1.4 million for Q4 2025, primarily from preclinical development activities [12]. - Total operating expenses for Q4 2025 were $36.1 million, including $25.4 million in research and development expenses [12]. - Collaboration revenue for the year ended December 31, 2025, was $6,646,000, a decrease from $13,631,000 in 2024 [17]. - Total operating expenses for the year ended December 31, 2025, were $154,350,000, down from $223,907,000 in 2024 [17]. - Net loss for the year ended December 31, 2025, was $136,315,000, compared to a net loss of $186,262,000 in 2024 [17]. - Cash and cash equivalents increased to $46,628,000 as of December 31, 2025, from $36,056,000 in 2024 [19]. - Total assets decreased to $318,937,000 as of December 31, 2025, from $440,694,000 in 2024 [19]. - Stockholders' equity decreased to $207,184,000 as of December 31, 2025, from $318,726,000 in 2024 [19]. - Research and development expenses for the year ended December 31, 2025, were $107,829,000, down from $135,001,000 in 2024 [17]. - General and administrative expenses for the year ended December 31, 2025, were $46,521,000, compared to $74,169,000 in 2024 [17]. - Interest income for the year ended December 31, 2025, was $11,052,000, down from $17,288,000 in 2024 [17]. - The company reported a basic and diluted net loss per share of $1.15 for the year ended December 31, 2025, compared to $1.64 in 2024 [17]. Cash Position and Future Outlook - The company has a cash position of $205 million as of December 31, 2025, providing a projected operating runway through year-end 2027 [12].

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 - The report highlights the growing momentum in the clinical trial pipeline for iPSC-derived NK cells, with over 12 companies actively developing more than 15 pipeline drugs [1][5] - It provides a comprehensive analysis of the competitive landscape, emerging therapies, and clinical strategies, enabling stakeholders to make informed decisions [1][5] Company and Drug Pipeline Overview - Key companies involved in the development of iPSC-derived NK cells include Centuary Therapeutics, Fate Therapeutics, and Cartherics Pty Ltd, among others [5][6] - Prominent drugs in the pipeline include CNTY-101, FT522, NCR300, and CTH-401, which are at various stages of clinical trials [5][6] Clinical Development and Regulatory Insights - The report includes insights into clinical trial benchmarking, partnering and licensing activities, and regulatory pathways involving the FDA and EMA [1] - Recent developments include Century Therapeutics continuing the CNTY-101 trial and ViGenCell's agreement with Therabest for TB-420, an iPSC-derived NK cell therapy [9] Advantages of iPSC-derived NK Cells - iPSC-derived NK cells offer significant advantages over traditional donor-derived NK cells, including a renewable source, consistent phenotype, and the ability to be genetically engineered for enhanced efficacy [4][5] - Their potential to overcome limitations of primary NK cells positions them as a cornerstone of next-generation immunotherapy [5][6] Market Dynamics and Future Perspectives - The report indicates strong market momentum driven by the unique properties of iPSC-derived NK cells, including clonal uniformity and off-the-shelf manufacturability [5][6] - With advancing clinical validation and regulatory frameworks, iPSC-derived NK cells are expected to become a foundational modality in cancer immunotherapy [5][6]

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.