Fate Therapeutics(FATE)

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Fate Therapeutics (FATE) Reports Q2 Loss, Beats Revenue Estimates
ZACKS· 2025-08-12 22:16
Fate Therapeutics (FATE) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.35. This compares to a loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +17.14%. A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.39 per share when it actually produced a loss of $0.32, delivering a surprise ...
Fate Therapeutics(FATE) - 2025 Q2 - Quarterly Report
2025-08-12 20:09
For the quarterly period ended June 30, 2025 OR 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 (IRS Employer Identification No.) 12278 Scripps Summit Drive, San Diego, CA 92131 (Address of principal executive offices) (Zip Code) (858) 875-1800 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: ☐ TRANSITION REPORT ...
Fate Therapeutics(FATE) - 2025 Q2 - Quarterly Results
2025-08-12 20:07
[Q2 2025 Business Highlights and CEO Commentary](index=1&type=section&id=Fate%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Business%20Updates) The company reported significant clinical progress for FT819 in lupus, received FDA allowance for FT836, and extended its cash runway through 2027 [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) The company reported significant clinical progress for its lead candidate FT819 in lupus, including positive 12-month durability data and initial FDA discussions for a registrational pathway. The FDA also allowed an Investigational New Drug (IND) application for FT836 in solid tumors. Operationally, the company extended its cash runway through year-end 2027, supported by $249 million in cash and investments - Demonstrated durability of response in a severe lupus nephritis patient at 12-month follow-up with FT819[1](index=1&type=chunk) - Held initial discussions with the FDA under FT819's RMAT designation to plan a registrational pathway in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN)[1](index=1&type=chunk) - FDA allowed the IND application for FT836, a MICA/B-targeted CAR T-cell therapy for solid tumors, featuring Sword and Shield™ technology for conditioning-free treatment[1](index=1&type=chunk) - Extended projected operating cash runway through the end of 2027, with **$249 million** in cash, cash equivalents, and investments[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Bob Valamehr highlighted the company's focus on patient enrollment for FT819 in autoimmune diseases, citing encouraging data with less-intensive conditioning. The company aims to start a registrational study for FT819 in 2026 under its RMAT designation. He also noted that proactive resource allocation has extended the company's cash runway, enabling execution across the pipeline - The company's priority is to drive patient enrollment for FT819 in autoimmune diseases to demonstrate its therapeutic differentiation and on-demand availability[2](index=2&type=chunk) - The goal is to commence a registrational study for FT819 in SLE and LN in 2026, following discussions with the FDA under the RMAT designation[2](index=2&type=chunk) - Proactive steps were taken to optimize resource allocation and extend the cash runway, positioning the company to execute on its pipeline goals[2](index=2&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) This section details the progress of FT819 in autoimmune diseases, FT825/ONO-8250 in solid tumors, and next-generation CAR T-cell programs [FT819 Program in Autoimmune Disease](index=2&type=section&id=FT819%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20program%20in%20autoimmune%20disease) The FT819 program is advancing rapidly with ongoing FDA discussions for a registrational study in SLE and LN under its RMAT designation. Interim Phase 1 data showed promising responses, including a 12-month durable remission in one patient using a fludarabine-free regimen. The study is also exploring FT819 as an add-on therapy without conditioning and has been expanded to include other B cell-mediated autoimmune diseases like AAV, IIM, and SSc [FDA Discussions and RMAT Designation](index=2&type=section&id=FDA%20Discussions%20and%20RMAT%20Designation) The company is in discussions with the FDA regarding a potential registrational study design for FT819 in moderate-to-severe SLE and refractory LN. This follows the FDA granting Regenerative Medicine Advanced Therapy (RMAT) designation for this indication in April 2025, which is intended to expedite development and review - Met with the FDA in August under its RMAT designation to get preliminary feedback on a proposed registrational study design for FT819 in SLE and LN[3](index=3&type=chunk) - The RMAT designation, granted in April 2025, was created to expedite the development and review of regenerative medicine therapies for serious conditions[3](index=3&type=chunk) [Phase 1 SLE Interim Data](index=2&type=section&id=Phase%201%20SLE%20Interim%20Data) Interim Phase 1 data presented at EULAR 2025 showed positive results in patients with moderate-to-severe SLE. All three LN patients treated with a single 360 million cell dose and a fludarabine-free regimen achieved an objective renal response. Notably, the first LN patient demonstrated a durable remission (DORIS) at the 12-month follow-up - All three refractory active LN patients treated with a single **360 million cell dose** of FT819 following a flu-free conditioning regimen achieved an objective renal response[3](index=3&type=chunk) - The first LN patient achieved DORIS (drug-free definition of remission) and complete renal response at 6 months, which was sustained at the 12-month follow-up[3](index=3&type=chunk) [Add-on Therapy Trial](index=2&type=section&id=Add-on%20Therapy%20Trial) The Phase 1 study is also assessing FT819 as an add-on to standard-of-care maintenance therapy without any conditioning chemotherapy. The first patient treated in this cohort achieved Low Lupus Disease Activity State (LLDAS) at 3 and 6 months, along with a reduction in disease scores and steroid dosage - The first patient treated with FT819 as an add-on to maintenance therapy (without conditioning) achieved LLDAS at 3- and 6-months[3](index=3&type=chunk) - The patient also experienced a reduction in SLEDAI-2K score from 8 to 2 and was able to taper their steroid dose[3](index=3&type=chunk) [Study Expansion](index=3&type=section&id=Study%20Expansion) The Phase 1 trial of FT819 has been expanded to investigate its potential in other B cell-mediated autoimmune diseases. The company plans to initiate dose-expansion cohorts in the second half of 2025 for anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc) - The Phase 1 clinical trial of FT819 has been expanded to include other B cell-mediated autoimmune diseases[4](index=4&type=chunk) - The company plans to initiate dose-expansion cohorts in H2 2025 for AAV, IIM, and SSc[4](index=4&type=chunk) [FT825 / ONO-8250 Program in Solid Tumors](index=3&type=section&id=FT825%20%2F%20ONO-8250%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20Program%20in%20Solid%20Tumors) The Phase 1 study of FT825 / ONO-8250, a HER2-targeting CAR T-cell therapy developed with Ono Pharmaceutical, is ongoing in patients with advanced solid tumors. Dose escalation is proceeding to the third level (900 million cells), and the therapy has shown a favorable safety profile with no dose-limiting toxicities reported to date - A Phase 1 study is ongoing for FT825 / ONO-8250, a HER2-targeting CAR T-cell candidate, in patients with advanced solid tumors[5](index=5&type=chunk) - Dose escalation is currently ongoing at the third dose level of **900 million cells**[5](index=5&type=chunk) - FT825 / ONO-8250 has demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs) to date[5](index=5&type=chunk) [Next-Generation CAR T-cell Programs (Sword & Shield™ Technology)](index=3&type=section&id=Next-generation%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20Programs) The company is advancing its next-generation programs designed to reduce or eliminate the need for conditioning chemotherapy. The FDA has allowed the IND for FT836, a MICA/B-targeted CAR T-cell for solid tumors. Additionally, a master iPSC bank has been created for FT839, a dual CD19/CD38 CAR T-cell candidate, with clinical investigation planned to begin in 2026 - The FDA allowed the IND application for FT836, a MICA/B-targeted CAR T-cell product candidate, for Phase 1 testing in advanced solid tumors without conditioning chemotherapy[6](index=6&type=chunk) - A master iPSC bank has been generated for FT839, a CD19/CD38 dual-CAR T-cell product candidate[6](index=6&type=chunk) - The company is evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmunity, with plans to start in 2026[6](index=6&type=chunk) [Corporate and Financial Updates](index=4&type=section&id=Corporate%20and%20Financial%20Updates) This section covers the extension of the collaboration with Ono Pharmaceutical, strategic operational adjustments, and the company's second quarter 2025 financial performance [Corporate Developments](index=4&type=section&id=Corporate%20Developments) Fate Therapeutics extended its collaboration with Ono Pharmaceutical for a second solid tumor CAR T-cell candidate, securing co-funding through at least June 2026. The company also implemented a tactical operations plan, including a 12% headcount reduction and other cost-saving measures, to extend its cash runway through the end of 2027 - Extended the research term of its collaboration with Ono for a second iPSC-derived CAR T-cell candidate, with co-funding expected to continue through at least June 2026[9](index=9&type=chunk) - Implemented a tactical operations plan, including a **12% reduction in employee headcount**, to extend its cash runway through the end of 2027[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, Fate Therapeutics reported revenues of $1.9 million, derived from its collaboration with Ono Pharmaceutical. Total operating expenses were $38.9 million. The company ended the quarter with a strong cash, cash equivalents, and investments position of $248.9 million Q2 2025 Financial Highlights | Metric | Value | | :--- | :--- | | **Cash, Cash Equivalents & Investments** | $248.9 million | | **Total Revenue** | $1.9 million | | **Total Operating Expenses** | $38.9 million | | **Research & Development Expenses** | $27.4 million | | **General & Administrative Expenses** | $11.4 million | | **Non-cash Stock-based Compensation** | $7.2 million | [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents the condensed consolidated statements of operations and balance sheets for the second quarter of 2025 and comparative periods [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $34.1 million, or $0.29 per share, for the three months ended June 30, 2025. This represents an improvement from a net loss of $38.4 million, or $0.33 per share, for the same period in 2024. The reduced loss was primarily driven by lower operating expenses, which decreased from $51.9 million in Q2 2024 to $38.9 million in Q2 2025 Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--- | :--- | :--- | | **Collaboration Revenue** | $1,907 | $6,772 | | **Total Operating Expenses** | $38,875 | $51,855 | | **Loss from Operations** | $(36,968) | $(45,083) | | **Net Loss** | $(34,070) | $(38,427) | | **Net Loss per Share** | $(0.29) | $(0.33) | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Fate Therapeutics had total assets of $371.6 million and total stockholders' equity of $261.4 million. Cash, cash equivalents, and investments totaled $248.9 million, compared to $306.7 million at the end of 2024 Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash, Cash Equivalents & Investments** | $248,927 | $306,725 | | **Total Assets** | $371,632 | $440,694 | | **Total Liabilities** | $110,268 | $121,968 | | **Total Stockholders' Equity** | $261,364 | $318,726 | [Company Overview](index=5&type=section&id=Company%20Overview) This section provides an overview of Fate Therapeutics' proprietary iPSC product platform and its focus on developing iPSC-derived cellular immunotherapies [iPSC Product Platform](index=5&type=section&id=About%20Fate%20Therapeutics'%20iPSC%20Product%20Platform) The company's proprietary iPSC product platform utilizes multiplexed-engineered human induced pluripotent stem cells to create clonal master iPSC lines. This innovative approach allows for the mass production of well-defined, uniform, off-the-shelf cell therapy products, aiming to overcome the limitations associated with patient- or donor-sourced therapies. The platform is protected by a robust intellectual property portfolio of over 500 issued patents - The platform uses clonal master iPSC lines as a starting source to manufacture engineered cell products, analogous to master cell lines for biopharmaceuticals[10](index=10&type=chunk) - This method is designed to produce well-defined, uniform products that can be stored for off-the-shelf availability and administered to a broad patient population[10](index=10&type=chunk) - The platform is supported by an intellectual property portfolio of over **500 issued patents** and **500 pending patent applications**[10](index=10&type=chunk) [About Fate Therapeutics, Inc.](index=5&type=section&id=About%20Fate%20Therapeutics%2C%20Inc.) Fate Therapeutics is a clinical-stage biopharmaceutical company based in San Diego, CA, dedicated to developing iPSC-derived cellular immunotherapies. The company's pipeline includes engineered T-cell and natural killer (NK) cell product candidates designed to deliver multiple therapeutic mechanisms to patients - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies[11](index=11&type=chunk) - The company's pipeline includes iPSC-derived T-cell and NK cell product candidates with novel synthetic controls[11](index=11&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard legal disclaimers regarding forward-looking statements, which involve risks and uncertainties. It cautions that actual results may differ materially from expectations due to various factors, including clinical trial outcomes, regulatory hurdles, manufacturing challenges, and other risks detailed in the company's SEC filings - The release contains forward-looking statements based on management's current expectations, which are subject to a number of risks and uncertainties[13](index=13&type=chunk) - Key risks include product candidates not demonstrating requisite safety or efficacy, delays in clinical trials or manufacturing, and potential failure to maintain collaboration agreements[13](index=13&type=chunk) - Readers are advised to review the company's periodic filings with the Securities and Exchange Commission for a more detailed discussion of risks[13](index=13&type=chunk)
Fate Therapeutics (FATE) Earnings Call Presentation
2025-07-02 15:10
iPSC Product Platform - Fate Therapeutics' iPSC product platform is supported by an IP portfolio with over 500 issued patents and over 500 pending patent applications[17] - One iPSC MCB vial has the potential to yield trillions of uniformly-engineered cells[18] - The company has a 40,000 ft2 cGMP manufacturing facility co-located with corporate headquarters[21] FT819 Program (CD19-targeted CAR T-cell) - In a Phase 1 study (n=25), FT819 showed no dose-limiting toxicities (DLTs), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD)[35] - In relapsed/refractory aggressive BCL patients (n=17), FT819 achieved a 47% Overall Response Rate (ORR) and a 24% Complete Response (CR), with 60% ORR and 40% CR in patients naïve to auto CD19-targeted CAR T[35] - In FT819-102, three Lupus Nephritis patients were dosed at DL1 (single dose, 360 million cells) with no dose limiting toxicities (DLTs) observed[45] FT825 Program (HER2-targeted CAR T-cell) - FT825/ONO-8250 is engineered for enhanced solid tumor efficacy, overcoming tumor heterogeneity and improving cell trafficking[62] - Preclinical data shows potent CAR-mediated activity of FT825 that can be further enhanced in combination with mAb[70] FT522 Program (CD19-targeted CAR NK Cell) - Preclinical data shows dose-dependent trafficking, infiltration, & residency in primary, secondary & tertiary tissues without cytokine support at human dose equivalency levels of 250 million & 1 billion cells per dose[112] - FT522 has the unique ability to eliminate both B cells and Plasma Cells Without the Need for Conditioning Chemotherapy[119]
Why Is Fate Therapeutics (FATE) Up 61.5% Since Last Earnings Report?
ZACKS· 2025-06-12 16:30
Core Viewpoint - Fate Therapeutics has seen a significant increase in share price, gaining approximately 61.5% over the past month, outperforming the S&P 500, raising questions about the sustainability of this trend leading up to the next earnings report [1] Group 1: Earnings and Estimates - The consensus estimate for Fate Therapeutics has shifted upward by 12.68% in the past month, indicating positive revisions [2] - The stock has a Zacks Rank of 2 (Buy), suggesting expectations for above-average returns in the coming months [4] Group 2: VGM Scores - Fate Therapeutics has a subpar Growth Score of D, a Momentum Score of D, and a Value Score of D, placing it in the bottom 40% for investment strategies, resulting in an overall VGM Score of F [3] Group 3: Industry Performance - Fate Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where Novavax has reported a revenue of $666.66 million, reflecting a year-over-year increase of 610.3% [5] - Novavax is expected to report a loss of $0.12 per share for the current quarter, with a year-over-year change of -112.1%, and has a Zacks Rank of 3 (Hold) [6]
Fate Therapeutics Announces Updated Clinical Data for FT819 Off-the-shelf CAR T-cell Product Candidate Demonstrating Durability of Drug-free Remission for Severe Lupus Nephritis at EULAR 2025 Congress
Globenewswire· 2025-06-11 13:00
Core Insights - Fate Therapeutics announced promising clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), showing all five patients treated achieved significant disease improvement [2][3] - The first patient reached a 12-month follow-up and continues in drug-free remission, indicating the potential for durable treatment effects [2][4] - The company is expanding its clinical trials to include multiple B cell-mediated autoimmune diseases, with plans for independent dose-expansion cohorts in various conditions [8] Clinical Data Summary - A multi-center, Phase 1 clinical trial is evaluating FT819's safety and efficacy in patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus [3] - As of May 15, 2025, five patients have been treated, with all showing significant improvements in disease activity scores [3][4] - Three patients with active lupus nephritis achieved primary efficacy renal response, with reductions in SLEDAI-2K scores of 10 points or more [4][5] Treatment Regimens - FT819 was administered under two regimens: a fludarabine-free conditioning regimen and a conditioning-free regimen [3][6] - In the fludarabine-free regimen, three patients with active lupus nephritis showed significant reductions in SLEDAI-2K scores, with one patient achieving a score reduction from 20 to 4 at 12 months [4] - One patient with extrarenal lupus on maintenance therapy achieved low lupus disease activity state (LLDAS) at 3 months, maintained at 6 months, with a reduction in SLEDAI-2K from 8 to 2 [6] B-cell Remodeling - Patients treated with FT819 exhibited rapid B-cell depletion and a shift towards a non-switched, naïve B-cell repertoire within the first 60 days [7] - This remodeling was observed in both treatment regimens, indicating a potential mechanism of action for FT819 [7] Safety Profile - The treatment demonstrated a favorable safety profile, with low incidence of cytokine release syndrome and no events of neurotoxicity or graft-versus-host disease [8][10] - All patients were discharged after a short hospitalization, supporting the potential for outpatient administration [10] Regulatory and Development Plans - Fate Therapeutics has reached an agreement with the FDA to investigate multiple autoimmune diseases under its Phase 1 trial for FT819 [8] - The company plans to discuss registrational strategies with the FDA for FT819 in SLE under its RMAT designation [8]
Top Cancer Stocks to Supercharge Your 2025 Portfolio
ZACKS· 2025-06-10 15:26
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]
Cell子刊:Fate公司的iPSC-CAR-T细胞疗法,克服实体瘤治疗难题
生物世界· 2025-06-05 03:43
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].
Fate Therapeutics Appoints Matthew Abernethy, M.B.A., to its Board of Directors
Globenewswire· 2025-05-30 20:30
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]
Fate Therapeutics Announces Phase 1 Data Presentation of FT819 Off-the-Shelf CAR T-cell Product Candidate for SLE at EULAR 2025 Congress
Globenewswire· 2025-05-28 21:54
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]