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 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 Insights - Fate Therapeutics is advancing its iPSC-derived CAR T-cell therapy products aimed at providing conditioning chemotherapy-free treatments for autoimmune diseases and cancer [1][2][7] - The company will present five sets of clinical and preclinical data at the ASGCT Annual Meeting, highlighting the potential of its innovative therapies [1][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 for cancer and autoimmune diseases [7] - The company utilizes a proprietary iPSC product platform that combines multiplexed-engineering and single-cell selection to create clonal master iPSC lines, which are essential for manufacturing engineered cell products [5][6] Product Development - The company will deliver an oral presentation on its Phase 1 clinical trial of FT522, a CD19-targeted CAR NK cell product candidate, which aims to eliminate the need for conditioning chemotherapy [2][3] - Preclinical data will also be presented on various iPSC-derived CAR T-cell products targeting autoimmune diseases, hematological malignancies, and solid tumors [2][4] Presentation Details - The oral presentation on FT522 is scheduled for May 17, 2025, at the ASGCT Annual Meeting [3] - Multiple poster presentations will occur on May 13 and May 14, 2025, showcasing various aspects of the company's iPSC-derived therapies [4][3]