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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 (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, has announced its participation in four major upcoming investor conferences in February and March 2025:
• H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference - Fireside chat on February 25 at 1:30 PM ET
• TD Cowen 45th Annual Health Care Conference - Company presentation in Boston on March 3 at 11:50 AM ET
• Barclays 27th Annual Global Healthcare Conference - Fireside chat in Miami on March 11 at 8:30 AM ET
• Leerink Partners Global Healthcare Conference - Fireside chat in Miami on March 12 at 11:20 AM ET
Live webcasts of the presentations, when available, can be accessed through the Investors section of Fate Therapeutics' website under 'Events & Presentations,' with archived recordings available shortly after each event.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies, announced new employee inducement awards on February 4, 2025. The company granted stock options to one non-executive employee to purchase 35,000 shares at $1.27 per share, and restricted stock units (RSUs) for 20,400 shares to two non-executive employees.
The options will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following 36 months. The RSUs will vest over four years, with 25% vesting annually. These grants were approved by the Compensation Committee under the company's Amended and Restated Inducement Equity Plan, complying with Nasdaq Listing Rule 5635(c)(4).
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies, has announced new employee inducement awards. On January 2, 2025, the company granted stock options to two new non-executive employees to purchase 72,000 shares at $1.79 per share, which was the closing price on the grant date.
Additionally, one newly-hired non-executive employee received restricted stock units (RSUs) representing 3,200 shares. The options will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following 36 months. The RSUs will vest in four equal annual installments of 25% each, subject to continuous employment.
Fate Therapeutics (NASDAQ: FATE) presented new Phase 1 clinical data for FT819, its off-the-shelf CAR T-cell therapy for systemic lupus erythematosus (SLE). Three patients with active lupus nephritis received fludarabine-free conditioning followed by a single dose of FT819 at 360 million cells.
The treatment showed promising results with no dose-limiting toxicities, no cytokine release syndrome, and no immune effector-cell associated neurotoxicity. All patients demonstrated rapid B-cell depletion, with the first patient achieving DORIS clinical remission at 6 months and remaining free of immunosuppressive therapy.
Based on these positive results, the company plans to initiate dose expansion at the first dose level to include up to 10 patients and escalate dosing to 720 million cells. Additionally, the first patient has been treated with FT819 as an add-on to maintenance therapy without conditioning chemotherapy.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies, has granted 18,600 restricted stock units (RSUs) to a new non-executive employee. The grant, approved by the company's Compensation Committee, was made under the Amended and Restated Inducement Equity Plan in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting annually on each grant date anniversary, contingent on continuous employment.
Fate Therapeutics announced a leadership transition as Scott Wolchko will retire as President and CEO on December 31, 2024, after 10 years of leading the company's iPSC-derived cellular immunotherapies development. Bob Valamehr, current President of R&D, will become President and CEO on January 1, 2025. Under Wolchko's leadership, the company treated over 300 patients with engineered NK cell and T-cell product candidates. The company reported progress with FT819, their off-the-shelf CAR T-cell product, in treating systemic lupus erythematosus (SLE), with promising initial results in the first three patients with lupus nephritis, showing no dose-limiting toxicities.
Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, has announced its participation in two major healthcare conferences this December. The company will join Citi's 2024 Global Healthcare Conference in Miami on December 3, featuring a panel discussion at 2:30 PM ET, and Piper Sandler's 36th Annual Healthcare Conference in New York on December 4, participating in both a panel discussion at 3:00 PM ET and a fireside chat at 4:00 PM ET. Live webcasts will be available on the company's website under Events & Presentations.
Fate Therapeutics presented initial data from its Phase 1 Autoimmunity study of FT819, an off-the-shelf CAR T-cell therapy, in treating systemic lupus erythematosus (SLE). The first patient, a 27-year-old woman with active lupus nephritis, achieved DORIS clinical remission after receiving fludarabine-free conditioning and a single dose of FT819. The patient remains in remission and free of immunosuppressive therapies, with no significant adverse events reported. The treatment demonstrated favorable safety with no Grade ≥3 adverse events, CRS, ICANS, or GvHD. B-cell recovery showed promising immune reset indicators, with elimination of disease-associated B-cells. The company has opened a second treatment arm to evaluate FT819 as an add-on therapy without conditioning chemotherapy.
Fate Therapeutics presented initial clinical data for FT522, its off-the-shelf, ADR-armed CAR NK cell product for B-cell lymphoma and autoimmune diseases. In the Phase 1 lymphoma study, FT522 showed a favorable safety profile with complete responses and demonstrated ability to persist and target CD19+ B cells without conditioning chemotherapy. The company is initiating a Phase 1 basket study for B cell-mediated autoimmune diseases as an add-on to standard treatments. Initial data showed no dose-limiting toxicities, with complete responses observed in indolent lymphoma patients and partial responses in other lymphoma types. The study revealed dose-dependent activity and successful B-cell depletion, supporting FT522's potential in treating autoimmune conditions.
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.