Core Insights - Fate Therapeutics, Inc. has appointed Matthew Abernethy to its Board of Directors, effective May 29, 2025, while Timothy P. Coughlin has stepped down from the Board [1][2] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on developing induced pluripotent stem cell (iPSC)-derived cellular immunotherapies [4] - The company aims to create a pipeline of off-the-shelf cell therapy products targeting autoimmunity and oncology [4] Leadership Changes - Matthew Abernethy brings over 15 years of experience in corporate finance and investor relations within the biotech and medical device sectors [1][2] - Abernethy has served as Chief Financial Officer at Neurocrine Biosciences since November 2017 and has held various finance roles at Zimmer Biomet Holdings [2][3] Strategic Focus - Abernethy emphasizes the potential of cell therapy to aid patients with cancer and immunological disorders, particularly highlighting the product FT819 for autoimmune diseases like lupus [2]

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]

Financial Performance - The company has incurred net losses since inception, with significant expenses expected to continue for ongoing and planned clinical trials and research activities [103]. - The company reported a net loss of $37.6 million for Q1 2025, compared to a net loss of $48.0 million in Q1 2024 [137][138]. - As of March 31, 2025, the accumulated deficit stood at $1.4 billion [136]. - Cash used in operating activities was $33.8 million in Q1 2025, slightly higher than $33.4 million in Q1 2024 [137][138]. - Investing activities generated cash of $42.7 million in Q1 2025, compared to $17.3 million in Q1 2024 [139]. - The company anticipates continued significant losses as it progresses with research and development activities [146]. Revenue and Collaboration - Collaboration revenue recognized during Q1 2025 was $1.6 million, compared to $1.9 million in Q1 2024 [115]. - Collaboration revenue for Q1 2025 was $1.6 million, a decrease of 15.4% from $1.9 million in Q1 2024 [131]. - The company received a $10.0 million upfront payment and is entitled to an estimated $30.7 million in aggregate research and development fees under the Ono Agreement [107][113]. - The initial transaction price under the Ono Agreement was determined to be $48.0 million, which includes the upfront payment and estimated research fees [114]. - The company has not generated any revenues from therapeutic product sales or royalties, relying instead on collaboration agreements and government grants [106]. - The company has entered into collaborations with pharmaceutical companies for the development of iPSC-derived CAR T-cell and CAR NK cell product candidates for cancer treatment [101]. Research and Development - Research and development expenses include costs for clinical trials, employee-related costs, and third-party services, with a focus on advancing the iPSC product platform [116][118]. - Research and development expenses decreased to $29.1 million in Q1 2025 from $32.1 million in Q1 2024, a reduction of 9.3% [132]. - The company plans to maintain significant investment in research and development activities, including collaborations with Ono and other institutions [117]. - The company is focused on the costs and outcomes of clinical trials and preclinical studies for its product candidates, including GMP production capabilities [155]. - The company is assessing the costs associated with regulatory approvals and milestone payments under existing in-license agreements, including those owed to MSKCC [155]. - The company is evaluating the costs of research and development activities, including hiring additional employees and procuring equipment [155]. Grants and Funding - The company was awarded $7.9 million from the California Institute for Regenerative Medicine to support a Phase 1 study of FT819, with disbursements tied to development milestones from April 2024 to March 2028 [122]. - A $4.0 million grant was approved in January 2025 to support pre-clinical activities for FT836 [127]. Strategic Initiatives - The company is establishing collaborations and strategic alliances to enhance its market position [155]. - The company is considering future in-licensing and out-licensing transactions to expand its product offerings [155]. - The company is focused on the costs of establishing sales, marketing, manufacturing, and distribution capabilities for products that may receive regulatory approval [155]. - The company entered into a license agreement with MSKCC, obtaining rights for iPSC-derived cellular immunotherapy, with potential milestone payments totaling up to $75.0 million based on stock price increases [153]. - The company achieved a specified clinical milestone in July 2021, resulting in a milestone payment of $20.0 million to MSKCC due to the stock price exceeding the first threshold [153]. Administrative Expenses - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with regulatory requirements [120]. - General and administrative expenses fell to $13.8 million in Q1 2025, down 33.9% from $20.9 million in Q1 2024 [132]. - The company has no material contractual obligations not fully recorded on its unaudited condensed consolidated balance sheets [154].

Exhibit 99.1 Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates Additional Phase 1 Data for FT819 Off-the-Shelf CAR T-cell Product Candidate in Moderate-to- Severe Systemic Lupus Erythematosus to be Featured in Oral Presentation at EULAR 2025 Congress in June Regenerative Medicine Advanced Therapy Designation Granted by the FDA for FT819 in Moderate- to-Severe Systemic Lupus Erythematosus Expanding FT819 Phase 1 Study to Include Treatment of Multiple Additional B Cell-mediat ...

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]

Group 1 - The article discusses the author's mixed feelings about Fate Therapeutics, highlighting skepticism towards certain stock rallies that lack substantial backing [1] - The author emphasizes the importance of understanding the science behind biotech investments and aims to educate investors to avoid pitfalls in this sector [1] Group 2 - No relevant content available for this section [2][3]

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]

Core Insights - Fate Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational candidate FT819, aimed at treating active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis [1][3] Company Developments - FT819 is an off-the-shelf, iPSC-derived CAR T-cell product candidate featuring CD8αβ+ T cells with a memory phenotype and high CXCR4 expression, which enhances tissue trafficking [3] - The RMAT designation allows for increased interactions with FDA officials and facilitates accelerated approval processes for FT819 [2] - The company is currently in early-stage development for FT819, having initiated dose expansion in up to 10 patients at 360 million cells based on initial clinical data [5] - The ongoing phase I study is evaluating the safety and efficacy of a fludarabine-free conditioning regimen, using either bendamustine or cyclophosphamide, followed by a single dose of FT819 [6] - As of December 4, 2024, no dose-limiting toxicities or severe adverse events have been observed in the initial patient cohort [9] Market Performance - Year to date, Fate Therapeutics shares have declined by 44%, contrasting with a 9% decline in the broader industry [4]

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]