Fate Therapeutic Stock Price, News & Analysis

Fate Therapeutics, a clinical-stage biopharmaceutical company (NASDAQ: FATE), announced a conference call on February 28, 2023, at 5:00 PM ET to discuss its fourth quarter and full year 2022 financial results. The company is focused on developing first-in-class induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune disorders. Its pipeline includes off-the-shelf iPSC-derived natural killer (NK) cells and T-cell product candidates that aim to work alongside existing cancer treatments. Archived webcasts will be available post-event on the company's website.

Fate Therapeutics has ended 2022 with approximately $475 million in cash and cash equivalents, ensuring a funding runway through 2025. The company terminated its collaboration with Janssen Biotech and will wind down associated activities, focusing instead on developing its innovative NK and CAR T-cell programs. Key advancements include the second-generation CD19-targeted CAR NK cell program and ongoing Phase 1 studies for FT576 and FT819. The strategic shift aims to enhance clinical applications while reducing operational costs, including workforce reductions.

Fate Therapeutics showcased innovative preclinical data at the 64th ASH Annual Meeting, focusing on strategies to enhance the effectiveness of iPSC-derived cancer immunotherapies without conditioning chemotherapy. These strategies include the introduction of an alloimmune defense receptor, genetic ablation of CD38, and dual knockouts of CD54 and CD58, aimed at improving the persistence and anti-tumor activity of engineered NK cells. The findings suggest a significant leap toward safer, off-the-shelf cell therapies for hematologic malignancies and solid tumors.

Fate Therapeutics presented promising interim Phase 1 data for its BCMA-targeted product candidate, FT576, at the 64th American Society of Hematology Annual Meeting. The trial showed encouraging clinical activity in patients with relapsed/refractory multiple myeloma, with no instances of cytokine release syndrome. Initial results indicated that patients treated with FT576 in combination with daratumumab experienced substantial reductions in soluble BCMA levels. Additionally, the company highlighted preclinical data for FT555, its GPRC5D-targeted candidate, which demonstrated effective tumor regression in aggressive myeloma models.

Fate Therapeutics presented interim clinical data for FT819, its novel CAR T-cell therapy, at the American Society of Hematology meeting. This Phase 1 trial targets relapsed/refractory large B-cell lymphoma with promising results. As of September 8, 2022, of 10 treated patients, 3 achieved complete responses (CR) after a single dose. Notably, FT819 exhibited a favorable safety profile with no serious adverse events. Its unique iPSC-derived platform enhances production consistency and accessibility for patients. The ongoing trial seeks to establish optimum dosing and further evaluate efficacy.

Fate Therapeutics announced a collaboration with ONO Pharmaceutical to develop the FT825/ONO-8250 CAR T-cell product candidate targeting HER2-expressing solid tumors. ONO has exercised its option to FT825/ONO-8250, enabling joint commercialization in the U.S. and Europe, while ONO holds exclusive rights in the rest of the world. Fate will receive milestone payments and is set to initiate IND-enabling activities aiming for an FDA IND application in 2023. Preclinical data suggest FT825/ONO-8250 has a unique therapeutic profile, overcoming challenges in solid tumor treatments.

Fate Therapeutics (NASDAQ: FATE) announced its participation in several upcoming investor conferences. The key events include Cowen’s 6th Annual IO Next Summit on November 11, 2022, Jefferies London Healthcare Conference on November 16, 2022, and Piper Sandler 34th Annual Healthcare Conference on November 29, 2022. Presentations will be available via live webcasts on the Company’s website, with archived recordings shortly after the events. Fate Therapeutics focuses on developing innovative cellular immunotherapies for cancer patients using its proprietary iPSC platform.

Fate Therapeutics reported on November 3, 2022, positive FDA feedback for its FT516 program under RMAT designation, supporting its iPSC product platform for aggressive lymphomas. The company is conducting multiple Phase 1 studies, including FT596 for r/r B-cell lymphoma and FT576 for multiple myeloma. The third quarter of 2022 saw total revenue of $15 million against R&D expenses of $79.8 million, reflecting significant investment in product development. Cash and investments totaled $519.1 million, providing a solid financial foundation for ongoing clinical trials.

Fate Therapeutics announced that fourteen presentations have been accepted for the 64th American Society of Hematology Annual Meeting from December 10-13, 2022. Key highlights include initial Phase 1 clinical data for the FT576 CAR NK cell targeting BCMA and FT819 CAR T-cell targeting CD19. The company will also present preclinical data for FT555 and discuss innovative methods to enhance the efficacy of off-the-shelf iPSC-derived cell therapies, such as eliminating patient conditioning. The ASH presentations aim to showcase advancements in Fate's iPSC product platform.