Fate Therapeutic Stock Price, News & Analysis

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.

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.