Industry Overview - The global cancer treatment market is rapidly transforming due to increasing demand for more effective and less toxic therapies, with the U.S. expected to see 2,041,910 new cancer cases and 618,120 cancer-related deaths in 2025 [2] - Advances in early detection and treatment have led to a decline in mortality rates for certain cancers, but the overall rise in cancer incidence is driving higher spending on oncology care globally [2][4] - Innovative treatment approaches such as immunotherapy, targeted therapies, and personalized cancer vaccines are reshaping the oncology landscape [3] Market Dynamics - The rise in cancer prevalence is attributed to aging populations, lifestyle factors, and improved diagnostics, positioning the market for novel oncology drugs and diagnostics for robust growth [4] - Major pharmaceutical companies like Novartis, AstraZeneca, Pfizer, AbbVie, Bristol Myers, and Eli Lilly are actively developing next-generation cancer therapies, including antibody-drug conjugates and immuno-oncology agents [5] - Smaller biotech firms are also making significant advancements in cancer research, leading to increased interest from larger drugmakers in acquiring these companies for their innovative therapies [5] Company Highlights - Pfizer's oncology revenues grew 7% on an operational basis in Q1 2025, driven by drugs like Xtandi, Lorbrena, and Padcev, and it has advanced its oncology clinical pipeline with several candidates entering late-stage development [8][9] - Novartis reported a 24% increase in oncology sales to $3.9 billion in Q1 2025, with significant contributions from drugs like Kisqali and Pluvicto, and is investing in research for both common and rare cancers [11] - Fate Therapeutics is focused on developing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell platform, with ongoing clinical studies for its CAR T-cell product candidate [12][13][14]

Core Viewpoint - The article discusses the advancements in CAR-T cell therapy, particularly focusing on a new iPSC-derived CAR-T cell targeting HER2, which aims to overcome challenges in treating solid tumors [2][3]. Group 1: Research Development - Fate Therapeutics developed an iPSC-derived CAR-T cell that preferentially targets HER2-positive tumors, addressing multiple barriers to efficacy in solid tumors through gene editing and engineering modifications [2][3]. - The CAR-T cells are designed to distinguish between tumor cells and normal cells, detecting truncated and misfolded HER2, while also knocking out genes that cause immune rejection and T cell exhaustion [3][4]. Group 2: Mechanisms and Enhancements - The CAR-T cells have been engineered to express IL-7R fusion protein for enhanced persistence, TGF-β-IL-18R to resist immunosuppressive tumor microenvironments, and CXCR2 to promote specific migration to solid tumor tissues [4][5]. - The study highlights the CAR's ability to differentiate between tumor and normal cells, and the engineered cells exhibit improved persistence and migration capabilities, along with resistance to TGF-β mediated suppression [5]. Group 3: Results and Implications - The iPSC-derived HER2-targeting CAR-T cells demonstrated strong anti-tumor activity in both in vitro and in vivo environments, with limited cytolytic activity against HER2-positive normal cells [3][5]. - The combination of CAR and high-affinity, non-cleavable CD16a Fc receptor allows for comprehensive multi-antigen targeting, enhancing therapeutic potential [3][5].

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]