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Fate Therapeutics, Inc. (NASDAQ: FATE) is a clinical-stage biopharmaceutical company based in the United States, specializing in the development of programmed cellular immunotherapies for cancer and autoimmune disorders. The company's innovative approach leverages induced pluripotent stem cell (iPSC) technology to create off-the-shelf, engineered NK- and T-cell product candidates designed to deliver multiple therapeutic mechanisms to patients.
Fate Therapeutics' proprietary iPSC product platform enables the mass production of multiplexed-engineered cell products that are uniform in composition and can be stored for off-the-shelf availability. This platform allows for the efficient manufacture of well-defined cell therapies that can be used in combination with other treatments, significantly overcoming the limitations of patient- or donor-sourced cells.
Recent highlights include the initiation of patient enrollment in the Phase 1 study of FT522, an ADR-armed, CD19-targeted CAR NK cell program for B-cell lymphoma. Additionally, the FDA has cleared the IND application for FT825/ONO-8250 in solid tumors, marking a key milestone in the company's collaboration with ONO Pharmaceutical. The expansion of the iPSC product platform into autoimmunity with FT819, targeting systemic lupus erythematosus, further underscores Fate Therapeutics' commitment to addressing complex diseases.
The company's financial health remains robust, bolstered by recent funding efforts, including the sale of shares and pre-funded warrants to institutional investors. Fate Therapeutics continues to lead in the field of cellular immunotherapies, with a strong pipeline of product candidates and an intellectual property portfolio comprising over 500 issued patents and 500 pending patent applications.
Headquartered in San Diego, CA, Fate Therapeutics is dedicated to advancing its clinical programs and providing innovative treatments to improve patient outcomes. For more information, please visit www.fatetherapeutics.com.
Fate Therapeutics reported Q3 2024 financial results and clinical updates. Key highlights include initial clinical data from three Phase 1 studies: FT819 in autoimmunity, FT522 in B-cell lymphoma, and FT825/ONO-8250 in solid tumors. The company reported $330.5 million in cash and investments, with Q3 revenue of $3.1 million and operating expenses of $55.5 million. FT819's Phase 1 study in lupus patients showed no significant safety concerns, and a new treatment arm without conditioning chemotherapy was opened. FT522 received FDA approval for a multi-indication IND in autoimmune diseases, while FT825 demonstrated favorable safety profiles in initial low-dose cohorts.
Fate Therapeutics (NASDAQ: FATE) presented initial clinical and preclinical data for FT825/ONO-8250, a CAR T-cell therapy targeting HER2 in advanced solid tumors. The Phase 1 study's first low-dose cohort of three heavily pre-treated patients showed favorable safety outcomes with no dose-limiting toxicities or adverse events. The therapy demonstrated CAR T-cell expansion and maintained activation state at Day 8 post-treatment.
The product incorporates a novel H2CasMab-2 binding domain designed to overcome on-target, off-tumor toxicity. Preclinical data showed selective targeting of cancer cells while limiting effects on normal HER2+ cells. The study continues enrollment at higher doses and in combination with EGFR-targeted antibody therapy.
Fate Therapeutics presented preclinical data for FT836, a novel CAR T-cell product candidate targeting MICA/B proteins expressed on cancer cells, at the 2024 SITC Annual Meeting. FT836 incorporates the company's Sword & Shield technology, designed to promote functional persistence without conditioning chemotherapy. The preclinical data demonstrated robust antigen-mediated expansion and durable anti-tumor activity across various solid tumors. The product uniquely targets the α3 domain of MICA/B, stabilizing expression and inducing cytolytic killing of tumor cells. Notably, treatment with chemotherapy or radiation therapy enhanced FT836's cytolytic activity, suggesting potential combination therapy opportunities.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies, has granted 20,000 restricted stock units (RSUs) to a new non-executive employee. The RSUs were approved by the Compensation Committee and granted under the Company's Amended and Restated Inducement Equity Plan, complying with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting annually, contingent on continuous employment.
Fate Therapeutics, a clinical-stage biopharmaceutical company focused on developing iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, has announced new employee inducement awards. On October 1, 2024, the company granted restricted stock units (RSUs) representing 16,400 shares of its common stock to two newly-hired non-executive employees.
The grants were approved by the Compensation Committee of Fate Therapeutics' Board of Directors under the company's Amended and Restated Inducement Equity Plan. These RSUs will vest over four years, with 25% of the shares vesting on each anniversary of the grant date, contingent on continuous employment. The awards comply with Nasdaq Listing Rule 5635(c)(4) as an inducement for new employees joining the company.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company, which focuses on developing iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, will present on Thursday, September 19, 2024, at 12:45 PM ET in New York.
Investors and interested parties can access a live webcast of the presentation through the 'Events & Presentations' section of Fate Therapeutics' website. The archived version will be available shortly after the event concludes. This conference appearance provides an opportunity for Fate Therapeutics to showcase its innovative pipeline and progress in the field of cellular immunotherapies to a global audience of healthcare professionals and investors.
Fate Therapeutics (NASDAQ: FATE) reported Q2 2024 financial results and business updates. Key highlights include:
1. Ongoing enrollment in FT819 Phase 1 autoimmunity study for SLE, now including single-agent cyclophosphamide as an alternative conditioning regimen.
2. First patient treated with FT522 CAR NK cell product in conditioning-free arm of Phase 1 B-cell lymphoma study.
3. FT522 multi-indication IND for autoimmune diseases to be submitted in Q3 2024.
4. Enrollment ongoing for FT825/ONO-8250 CAR T-cell product in Phase 1 solid tumor study.
5. $352 million in cash and investments, with projected runway through 2026.
6. Q2 2024 revenue of $6.8 million, including a $5 million milestone from Ono Pharmaceutical.
7. GAAP operating expenses of $51.9 million for Q2 2024.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on developing iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, has announced new employee inducement awards. On August 1, 2024, the company granted restricted stock units (RSUs) representing 34,200 shares of common stock to four newly-hired non-executive employees. These grants were approved by the Compensation Committee and issued under the company's Amended and Restated Inducement Equity Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting annually, contingent on continuous employment.
Fate Therapeutics (NASDAQ: FATE) has appointed Dr. Neely Mozaffarian to its Board of Directors. Dr. Mozaffarian brings over 20 years of experience in immunology and autoimmunity research and drug development. This appointment comes as Fate Therapeutics expands its clinical investigation of iPSC-derived cell products for autoimmune diseases.
The company recently treated its first systemic lupus erythematosus patient with FT819, an off-the-shelf, iPSC-derived CD8αβ+ T-cell product candidate. The patient, a 27-year-old woman with refractory disease, received a single dose of 360 million cells and was discharged after three days without notable adverse events.
Dr. Mozaffarian's expertise is expected to benefit Fate Therapeutics as it advances its pipeline of cell therapies for autoimmune conditions. Her background includes leadership roles at Atomwise, GentiBio, Janssen Pharmaceuticals, and other major pharmaceutical companies.
Fate Therapeutics, a clinical-stage biopharmaceutical company focused on induced pluripotent stem cell (iPSC)-derived cellular immunotherapies, announced employee inducement awards under Nasdaq Listing Rule 5635(c)(4). On July 1, 2024, the company granted restricted stock units (RSUs) totaling 28,200 shares of common stock to three newly-hired non-executive employees. These grants were approved by the Compensation Committee and will vest over four years, with 25% vesting annually, contingent on the employees' continuous employment.
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