Fate Therapeutics
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Fate Therapeutics (FATE) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2026-02-26 19:31
Core Viewpoint - Fate Therapeutics reported a quarterly loss of $0.27 per share, which aligns with the Zacks Consensus Estimate and shows an improvement from a loss of $0.31 per share a year ago, indicating a positive trend in financial performance [1] Financial Performance - The company posted revenues of $1.37 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 8.73% and down from $1.86 million in the same quarter last year [2] - Over the last four quarters, Fate Therapeutics has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Fate Therapeutics shares have increased by approximately 50.6% since the beginning of the year, significantly outperforming the S&P 500, which gained 1.5% [3] Future Outlook - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.30 for the coming quarter and -$1.16 for the current fiscal year, alongside expected revenues of $1.5 million and $6 million respectively [7] - The Zacks Rank for Fate Therapeutics is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fate Therapeutics belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable environment for stocks within this sector [8]
Fate Therapeutics(FATE) - 2025 Q4 - Annual Report
2026-02-26 14:07
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, 2025 ☐ 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 ...
Fate Therapeutics(FATE) - 2025 Q4 - Annual Results
2026-02-26 14:04
Exhibit 99.1 Fate Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates Outpatient treatment enabled under FT819-102 autoimmune basket protocol with patients now treated with FT819 off-the-shelf CAR T-cell therapy as same-day hospital discharge Four systemic sclerosis patients and the first idiopathic inflammatory myopathy patient treated with FT819; First systemic sclerosis patient reaching 3-month evaluation timepoint shows meaningful disease improvement using less- ...
Fate Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
Globenewswire· 2026-02-26 14:00
Outpatient treatment enabled under FT819-102 autoimmune basket protocol with patients now treated with FT819 off-the-shelf CAR T-cell therapy as same-day hospital discharge Four systemic sclerosis patients and the first idiopathic inflammatory myopathy patient treated with FT819; First systemic sclerosis patient reaching 3-month evaluation timepoint shows meaningful disease improvement using less-intensive conditioning chemotherapy FT819 Phase 1 enrollment expanded across 16 clinical sites in the U.S., U.K. ...
Fate Therapeutics (NasdaqGM:FATE) Earnings Call Presentation
2026-02-26 12:00
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 ...
Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus and Preclinical Advances in Next-Generation Off-the-Shelf CAR T-cell Programs
Globenewswire· 2025-12-08 13:00
Core Insights - Fate Therapeutics continues to show significant clinical progress with its FT819 CAR T-cell therapy for systemic lupus erythematosus (SLE), demonstrating meaningful and durable responses with a favorable safety profile [2][4] - The company is expanding its clinical trial capacity, including international sites, to enhance patient access to FT819 [2] - New preclinical data for next-generation CAR T-cell programs FT836 and FT839 indicate improved efficacy and safety for treating hematologic malignancies and autoimmune diseases [3][4] Clinical Trial Updates - FT819 is currently in a Phase 1 trial with 12 SLE patients treated, showing sustained clinical responses and durable B-cell depletion without intensive conditioning chemotherapy [2][5] - As of November 25, 2025, 12 SLE patients were treated across 14 clinical sites, with 10 patients having at least one month of follow-up [5] - Clinical SLEDAI-2K scores showed significant reductions, with mean scores dropping by 50% to 70% at three and six months post-treatment [8] Safety and Efficacy - The updated clinical data indicate no dose-limiting toxicities and no Grade >2 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) reported [6] - Five out of ten patients achieved a clinical SLEDAI-2K score of 0, with improvements in fatigue scores observed across all patients with multiple assessments [6][8] Next-Generation Programs - FT836 and FT839 are designed to target stress antigens and B-cell malignancies, showing enhanced potency and functional persistence compared to existing therapies [3][4] - These next-generation programs aim to provide a comprehensive treatment approach for multiple myeloma and other hematologic malignancies [3] Company Overview - Fate Therapeutics is focused on developing off-the-shelf, iPSC-derived cellular immunotherapies, leveraging its proprietary iPSC product platform to create engineered cell products that are uniform and scalable [9][10] - The company holds a robust intellectual property portfolio with over 500 issued patents and 500 pending applications, supporting its innovative approach in the biopharmaceutical industry [9]
Fate Therapeutics (NasdaqGM:FATE) FY Conference Transcript
2025-12-02 15:02
Summary of Fate Therapeutics FY Conference Call Company Overview - **Company**: Fate Therapeutics (NasdaqGM:FATE) - **Focus**: Development of induced pluripotent stem cells (iPSC)-derived cell therapies for immune diseases and oncology [1][2] Key Points and Arguments iPSC Technology - **Unique Properties**: iPSCs can grow indefinitely and differentiate into any of the 200 cell types in the body, allowing for the creation of a master cell bank [3][4] - **Off-the-Shelf Concept**: iPSCs enable the production of consistent and uniform drug products, reducing costs and improving accessibility [4][5] Transition to CAR iT Cells - **Shift from T Cells to CAR iT Cells**: The company transitioned from developing T cells to CAR iT cells due to the latter's superior response to stimulation and expansion, which is crucial for treating aggressive diseases [6][7][8] FT819 Development - **Target**: FT819 is a CD19 CAR iT cell therapy initially aimed at aggressive DLBCL, showing a 40% complete response (CR) rate in CAR-T naive patients [10][11] - **Lupus Indication**: The therapy has been adapted for lupus, demonstrating a favorable safety profile and significant efficacy improvements in various clinical metrics [12][13] Market Potential - **Patient Population**: The potential patient population for lupus is significantly larger than for DLBCL, with estimates of 200 million individuals affected [13][14] - **Manufacturing Capacity**: The company projects the ability to produce approximately 50,000 doses per year, with a cost of goods around $3,000 per dose [15][16] Clinical Development and Future Plans - **Next Steps**: The company aims to initiate pivotal registration studies for FT819 in lupus by 2026 and explore additional autoimmune diseases [20][21] - **Pipeline Expansion**: Future therapies include FT839 for more complex diseases and FT836 targeting MICA/MICB in oncology [21][27] Innovations in Treatment - **Reduced Conditioning**: The company is working towards outpatient treatment options with lighter conditioning regimens, enhancing patient experience and accessibility [24][26] - **Sophisticated Edits**: FT839 will include additional edits to target CD38, aiming for a broader approach in treating autoimmune diseases [22][23] Financial Position - **Cash Reserves**: Fate Therapeutics reported a cash position of approximately $226 million, extending its runway through the end of 2027, allowing for continued development of its therapies [35] Additional Important Information - **Partnerships**: The company is collaborating with Ono for the development of FT825, a HER2 CAR iT therapy, which has faced challenges in patient enrollment due to prior treatments affecting HER2 expression [33][34] - **Patient Enrollment**: The company is experiencing faster enrollment rates in lupus compared to competitors, with nearly 14 clinical sites activated [19][20] This summary encapsulates the critical insights and developments discussed during the Fate Therapeutics FY Conference Call, highlighting the company's innovative approaches and future directions in cell therapy.
Fate Therapeutics to Present at Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-25 13:00
Core Insights - Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases [1][3] Company Overview - The company utilizes a proprietary iPSC product platform to create multiplexed-engineered master iPSC lines and manufacture off-the-shelf, iPSC-derived cell products [3] - Fate Therapeutics has established a leadership position in the clinical development of iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to deliver multiple therapeutic mechanisms [3] - The company is headquartered in San Diego, California [3] Upcoming Events - Fate Therapeutics will present at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, in New York [1] - Company management will participate in a fireside chat at 9:00 AM ET and a cell therapy panel discussion at 12:00 PM ET [1]
Fate Therapeutics (FATE) Reports Q3 Loss, Beats Revenue Estimates
ZACKS· 2025-11-13 15:41
Core Insights - Fate Therapeutics reported a quarterly loss of $0.27 per share, which is better than the Zacks Consensus Estimate of a loss of $0.29, and an improvement from a loss of $0.40 per share a year ago [1][2] - The company achieved a revenue of $1.74 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 104.82%, although this is a decline from $3.07 million in the same quarter last year [3] Financial Performance - The earnings surprise for the quarter was +6.90%, and over the last four quarters, the company has consistently surpassed consensus EPS estimates [2] - Fate Therapeutics has also topped consensus revenue estimates four times in the last four quarters [3] Stock Performance - Since the beginning of the year, Fate Therapeutics shares have declined by approximately 37%, contrasting with a 16.5% gain in the S&P 500 [4] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [7] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $0.85 million, and for the current fiscal year, it is -$1.14 on revenues of $4.38 million [8] - The outlook for the Medical - Biomedical and Genetics industry is relatively strong, ranking in the top 35% of over 250 Zacks industries, which may positively influence stock performance [9]
Fate Therapeutics(FATE) - 2025 Q3 - Quarterly Report
2025-11-13 13:35
Financial Performance - The company has incurred net losses since inception, with significant expenses expected to continue due to ongoing research and development activities[111]. - Collaboration revenue for the three months ended September 30, 2025, was $1.7 million, down from $3.1 million in the same period in 2024, a decrease of 44%[142]. - For the nine months ended September 30, 2025, collaboration revenue was $5.3 million, down from $11.8 million in 2024, a decrease of 55%[146]. - The company incurred a net loss of $103.9 million for the nine months ended September 30, 2025, compared to a net loss of $134.1 million in 2024[153]. - As of September 30, 2025, the company had an accumulated deficit of $1.5 billion and cash and cash equivalents of $225.7 million[152][158]. Research and Development - The total estimated research and development fees under the Ono Agreement have increased to $44.5 million following multiple amendments[123]. - The company plans to continue significant investments in research and development activities over the next twelve months[127]. - The company has a pipeline of iPSC-derived CAR-targeted T-cell and NK cell product candidates currently under development[108]. - Research and development expenses decreased to $25.8 million for the three months ended September 30, 2025, from $34.7 million in 2024, a reduction of 25%[143]. - The company anticipates continued significant losses as it progresses with research and development of its product candidates, which have not yet achieved regulatory approval[162]. Collaboration and Funding - Collaboration revenue recognized during the three and nine months ended September 30, 2025, was $1.7 million and $5.3 million, respectively[125]. - The company received an upfront payment of $10.0 million from Ono Pharmaceutical Co., Ltd. as part of the collaboration agreement[115]. - The company has entered into research collaborations and license agreements with academic institutions to support the development of its iPSC product platform[108]. - The company was awarded $7.9 million from the California Institute for Regenerative Medicine (CIRM) for the Phase 1 study of FT819, with disbursements based on development milestones from April 1, 2024, to March 31, 2028[131]. - The company was awarded $4.0 million from CIRM for pre-clinical activities for FT836, with disbursements based on milestones from May 1, 2025, to October 31, 2025[135]. Expenses and Financial Obligations - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with regulatory requirements[129]. - General and administrative expenses decreased to $10.6 million for the three months ended September 30, 2025, from $20.8 million in 2024, a decrease of 49%[143]. - The company has a milestone payment obligation of up to $75.0 million to MSKCC, contingent on stock price increases, with an initial payment of $20.0 million already made[168]. - Additional capital will be required for ongoing research and development, with potential funding sources including public or private equity and debt securities[164]. Market and Economic Conditions - The company is closely monitoring inflation and global economic conditions, which may impact its financial condition and capital raising efforts[166]. - The forecast for cash adequacy to support operations involves significant risks and uncertainties, with actual results potentially varying materially from expectations[165]. - The company is subject to risks in the development of therapeutic products, including potential additional regulatory requirements that could increase costs and extend timelines[163]. Securities and Offerings - The company has a shelf registration statement allowing the issuance of up to $300.0 million in securities, with an additional at-the-market offering program of up to $100.0 million through Jefferies[159]. - In March 2024, the company sold 14,545,454 shares of common stock at $5.50 per share, raising approximately $80.0 million[160]. - Concurrently, the company sold pre-funded warrants for 3,636,364 shares at $5.499 each, totaling approximately $20.0 million in a private placement[161]. Contractual Obligations - The company has no material contractual obligations not fully recorded or disclosed in its financial statements[169].