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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock | FATE | Nasdaq Global ...

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]

Financial Performance - Fate Therapeutics reported a loss of 31 cents per share in Q4 2024, which is narrower than the Zacks Consensus Estimate of a loss of 44 cents, and an improvement from a loss of 45 cents per share in the same period last year [1] - The total loss per share, including an impairment loss of $14.7 million, was 44 cents [1] - For the full year 2024, the loss per share was $1.64, slightly wider than the Zacks Consensus Estimate of $1.63, remaining flat year-over-year [18] Revenue Generation - The company earned collaboration revenues of $1.9 million in Q4 2024, exceeding the Zacks Consensus Estimate of $1 million and up from $1.7 million in the year-ago quarter [2] - Total collaboration revenues for 2024 were $13.6 million, surpassing the Zacks Consensus Estimate of $12.53 million, but down from $63.5 million in 2023 [18] Expenses - Research and Development (R&D) expenses increased by 5.6% to $33.6 million [2] - General and Administrative (G&A) expenses decreased by 14.9% to $15.3 million [2] Cash Position - As of December 31, 2024, cash, cash equivalents, and investments totaled $306.7 million, which is expected to sustain operations through 2026 [3] Stock Performance - Fate Therapeutics' shares have declined by 88.7% year-to-date, compared to a 7.6% decline in the industry [3] Pipeline Developments - The company is focused on developing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) platform, including 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 for up to 10 patients [6][7] - FT819 has shown no dose-limiting toxicities or events of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome, or graft-versus-host disease as of the latest data cutoff [8] - The FDA has allowed the clinical investigation of additional B cell-mediated autoimmune diseases under the current phase I clinical trial of FT819, with plans to initiate dose-expansion cohorts in 2025 [10][11] Collaboration and Co-Development - Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical, currently in a phase I study for advanced solid tumors [12] - Initial clinical data from FT825/ONO-8250 indicated a favorable safety profile with no dose-limiting toxicities [15] Future Plans - Fate intends to assess further clinical development of FT522 in relapsed/refractory B-cell lymphoma upon completion of dose escalation [16] - The FDA has permitted the assessment of FT522 across a basket of B cell-mediated autoimmune diseases, with plans for multiple doses without conditioning chemotherapy [17]

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 [474]. - The company has not generated any revenues from therapeutic product sales or royalties to date, relying on collaboration agreements and government grants for funding [478]. - The company expects to incur significant commercialization expenses if regulatory approval is obtained for any product candidates [476]. - The company reported a net cash used in operating activities of $122.9 million in 2024, compared to $132.3 million in 2023 [524]. - As of December 31, 2024, the company had an accumulated deficit of $1.4 billion and anticipates continued net losses [524]. - The company expects to continue incurring significant losses as it develops its product candidates and seeks regulatory approvals [535]. Collaboration Agreements - Collaboration revenue recognized under the Ono Agreement was $13.6 million for the year ended December 31, 2024, and $11.2 million for the year ended December 31, 2023 [487]. - The company received a total of $100.0 million from the Janssen Agreement, including a $50.0 million upfront cash payment and a $50.0 million equity investment [488]. - The company recognized $52.3 million of collaboration revenue under the Janssen Agreement for the year ended December 31, 2023 [491]. - Collaboration revenue decreased to $13.6 million in 2024 from $63.5 million in 2023, primarily due to the termination of the collaboration with Janssen in April 2023 [522]. Research and Development - The company plans to continue significant investments in research and development activities, focusing on clinical and preclinical development of product candidates [493]. - The company has a pipeline of iPSC-derived, chimeric antigen receptor (CAR)-targeted T-cell and NK cell product candidates currently under development [471]. - Research and development expenses were $135.0 million in 2024, down from $172.6 million in 2023, reflecting a decrease of $37.6 million [523]. - The aggregate estimated research and preclinical development fees under the Ono Agreement have increased to approximately $38.0 million following recent amendments [485]. - The company anticipates ongoing costs related to clinical trials, including expenses for research and development activities and third-party service providers [91]. General and Administrative Expenses - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with SEC requirements [496]. - General and administrative expenses decreased to $74.2 million in 2024 from $81.4 million in 2023, a reduction of $7.2 million [523]. Funding and Cash Position - The company received $7.9 million from the California Institute for Regenerative Medicine (CIRM) to support the Phase 1 study of FT819, with disbursements based on development milestones from April 2024 to March 2028 [498]. - Financing activities provided cash of $99.9 million in 2024, primarily from the issuance of 14,545,454 shares of common stock at $5.50 per share [529]. - The company had aggregate cash, cash equivalents, and investments of $306.7 million as of December 31, 2024 [531]. Impairment and Other Income - An impairment charge of $13.4 million against property and equipment and $1.3 million against the right-of-use asset was recorded in 2024 due to a sustained decline in the company's stock price [514]. - The company recorded $5.1 million of other income from the Employee Retention Credit during the year ended December 31, 2023, but no such amount was recognized in 2024 [503]. - The FT516 CIRM Award of $4.0 million was treated as a grant in Q1 2023, reversing the associated liability and recording it as other income [502]. Future Obligations and Milestones - The company has obligations under various license agreements to make future payments totaling up to $75.0 million to MSKCC based on the achievement of specified clinical milestones [543]. - The maximum aggregate milestone payments per product under the license agreement with the Whitehead Institute for Biomedical Research are $2.3 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with The Scripps Research Institute are $1.8 million, with royalties on net sales in the low- to mid-single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with the Regents of the University of Minnesota are $4.6 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with MSKCC are $12.5 million, with royalties on net sales up to the high-single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with Dana Farber Cancer Institute are $25 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with Baylor College of Medicine are $7.0 million, with royalties on net sales in the low single digits [550]. - The maximum aggregate milestone payments per product under the license agreement with Max Delbruck Center for Molecular Medicine are $11.0 million, with royalties on net sales in the low single digits [550]. Market and Economic Factors - Inflationary factors may adversely affect the company's operating results, although no material impact has been observed to date [548]. - The company may require additional debt or equity capital to make milestone payments that are contingent upon the achievement of certain development, regulatory, and commercial milestones [545].