Updated clinical and preclinical data showcase iPSC-derived off-the-shelf CAR T-cell therapy products for conditioning chemotherapy-free treatment across autoimmune and cancer indicationsSAN DIEGO, April 29, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients, today announced that five presentations of clinical and precli ...

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]

SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical- stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)- derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the t ...

Fate Therapeutics (FATE) reported a loss of 31 cents per share (excluding impairment loss) in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 44 cents. The company reported a loss of 45 cents per share in the year-ago period.Including the impairment loss of $14.7 million, loss per share was 44 cents.The company earned collaboration revenues of $1.9 million, surpassing the Zacks Consensus Estimate of $1 million. The figure also increased from $1.7 million reported in the y ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

Financial Position - Fate Therapeutics reported $307 million in cash, cash equivalents, and investments, providing an operating runway projected through the end of 2026[1]. - Cash and cash equivalents decreased to $36,056,000 in 2024 from $41,870,000 in 2023, a decline of 14%[17]. - Total assets decreased to $440,694,000 in 2024 from $506,217,000 in 2023, a reduction of 13%[17]. - Stockholders' equity decreased to $318,726,000 in 2024 from $368,417,000 in 2023, a decline of 13%[17]. Revenue and Expenses - Total revenue for Q4 2024 was $1.9 million, derived from preclinical development activities for a collaboration candidate targeting an undisclosed solid tumor antigen[10]. - Collaboration revenue for Q4 2024 was $1,860,000, an increase of 11% from $1,676,000 in Q4 2023[15]. - Total operating expenses for Q4 2024 were $63.6 million, including $33.6 million in research and development expenses and $15.3 million in general and administrative expenses[10]. - Total operating expenses for Q4 2024 were $63,608,000, up 28% from $49,751,000 in Q4 2023[15]. - Research and development expenses for the year ended 2024 were $135,001,000, down 22% from $172,596,000 in 2023[15]. - General and administrative expenses for the year ended 2024 were $74,169,000, a decrease of 9% from $81,448,000 in 2023[15]. - Net loss for Q4 2024 was $52,153,000, compared to a net loss of $44,122,000 in Q4 2023, representing an increase of 18%[15]. - Net loss per common share for the year ended 2024 was $1.64, unchanged from the previous year[15]. - The company reported an impairment loss of $14,737,000 in Q4 2024, with no impairment loss reported in Q4 2023[15]. Clinical Development - The Phase 1 dose expansion for FT819 in systemic lupus erythematosus (SLE) has been initiated, targeting up to 10 patients at a dose of 360 million cells[3]. - No dose-limiting toxicities or cytokine release syndrome were reported in the first three patients treated with FT819 for SLE[6]. - The FDA has approved the inclusion of additional B cell-mediated autoimmune diseases in the FT819 Phase 1 study, with plans to initiate dose-expansion cohorts in 2025[6]. - FT825, in collaboration with Ono Pharmaceutical, is advancing into higher-dose cohorts for advanced solid tumors, with ongoing enrollment at the third dose level of 900 million cells[2]. - Initial clinical data for FT825 showed a favorable safety profile with no dose-limiting toxicities in heavily pre-treated patients[7]. - The company is evaluating unique clinical development opportunities for FT522 in autoimmunity, with the FDA allowing an IND application for multiple B cell-mediated autoimmune diseases[10]. Shareholder Information - As of December 31, 2024, common shares outstanding were 113.9 million, with pre-funded warrants and preferred shares totaling 3.9 million and 2.8 million, respectively[10].

Phase 1 Dose Expansion Initiated for FT819 Off-the-Shelf CAR T-cell Product Candidate with Fludarabine-free Conditioning in Moderate-to-Severe SLE Completed Type D Meeting with FDA to Enable FT819 Off-the-Shelf CAR T-cell Dose Expansion in Additional B Cell-mediated Autoimmune Diseases First FT819 Off-the-Shelf CAR T-cell Patient Treated without Conditioning Chemotherapy as Add-on to Maintenance Therapy in SLE $307 Million in Cash, Cash Equivalents and Investments with Projected Operating Runway through YE ...

Company Overview - Fate Therapeutics (FATE) is expected to report a quarterly loss of $0.44 per share, reflecting a year-over-year change of +2.2% [3] - Revenues are anticipated to be $1.27 million, down 24.4% from the same quarter last year [3] Earnings Expectations - The consensus EPS estimate has been revised 0.22% higher in the last 30 days, indicating a slight bullish sentiment among analysts [4] - The Most Accurate Estimate for Fate Therapeutics is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +3.82% [10][11] Historical Performance - In the last reported quarter, Fate Therapeutics was expected to post a loss of $0.42 per share but actually reported a loss of $0.40, achieving a surprise of +4.76% [12] - Over the last four quarters, the company has beaten consensus EPS estimates three times [13] Comparative Industry Analysis - In the Zacks Medical - Biomedical and Genetics industry, Guardant Health (GH) is expected to post a loss of $0.50 per share, with a year-over-year change of +68.4% [17] - Guardant Health's revenue is projected to be $199.86 million, up 28.9% from the previous year [17] - The consensus EPS estimate for Guardant Health has been revised 7.1% higher in the last 30 days, and it has an Earnings ESP of 1.75% combined with a Zacks Rank of 2 (Buy), indicating a likely earnings beat [18]

Core Viewpoint - Fate Therapeutics, Inc. is focused on developing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases [2] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company headquartered in San Diego, CA, specializing in iPSC-derived cellular immunotherapies [2] - The company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products [2] - The pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates designed with novel synthetic controls to deliver multiple therapeutic mechanisms [2] Upcoming Events - The company will participate in several investor conferences, including: - H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference on February 25, 2025, with a fireside chat at 1:30 PM ET [3] - TD Cowen 45th Annual Health Care Conference on March 3, 2025, with a presentation at 11:50 AM ET in Boston, Massachusetts [3] - Barclays 27th Annual Global Healthcare Conference on March 11, 2025, with a fireside chat at 8:30 AM ET in Miami, Florida [3] - Leerink Partners Global Healthcare Conference on March 12, 2025, with a fireside chat at 11:20 AM ET in Miami, Florida [3]

Core Insights - Fate Therapeutics is a microcap biopharma company focusing on cellular therapies, initially targeting oncology but has shifted towards immunology to enter a less crowded market [1] Company Overview - The company utilizes induced pluripotent stem cells (iPSCs) in its therapeutic approaches [1] Market Position - Fate Therapeutics is adapting its strategy to capitalize on opportunities in the immunology sector, which may offer less competition compared to its previous focus on oncology [1]