Fate Therapeutics Q1 2024 Financial Results and Business Updates

Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, announced significant milestones and financial results for the first quarter ending March 31, 2024.

The company's CEO, Scott Wolchko, highlighted major developments in their clinical programs, including the treatment of the first patient with FT819 CAR T-cell therapy for autoimmunity, the initiation of patient enrollment for FT522 CAR NK cell therapy without conditioning chemotherapy, and the treatment of the first patient with FT825 CAR T-cell therapy for solid tumors.

The FT819 CAR T-cell program made notable strides in its application for autoimmune diseases. The first patient, a 27-year-old woman with systemic lupus erythematosus (SLE), was treated in a Phase 1 study designed to evaluate the safety and efficacy of FT819. The results were promising, showing rapid and potent depletion of the patient’s CD19+ B cells without notable adverse events. Preclinical and translational data presented at the American Society of Gene and Cell Therapy (ASGCT) revealed that a single dose of FT819 could reset the immune system in patients with B cell-mediated autoimmune diseases. These findings support further clinical development of FT819 exclusively for autoimmune indications.

The FT825 CAR T-cell program, in collaboration with Ono Pharmaceutical Co., Ltd., treated its first patient with HER2-positive gastroesophageal junction adenocarcinoma in a Phase 1 study. This study aims to assess the safety and efficacy of FT825, which incorporates synthetic controls for cell function and a cancer-specific CAR for HER2. The initial results are encouraging, showing potential for this therapy in treating advanced solid tumors.

FT522, an iPSC-derived CAR NK cell product, began patient enrollment in a Phase 1 study for relapsed/refractory B-cell lymphoma without the need for conditioning chemotherapy. FT522 employs Alloimmune Defense Receptor (ADR) technology to eliminate the requirement for conditioning treatments. Initial clinical observations indicated rapid and sustained B-cell depletion and enhanced persistence of FT522 in the periphery. Fate Therapeutics plans to submit an Investigational New Drug (IND) application to the FDA for using FT522 in various autoimmune diseases.

Lastly, the FT576 CAR NK cell program completed its dose escalation phase in a Phase 1 study for relapsed/refractory multiple myeloma. In this trial, patients received treatment with standard conditioning chemotherapy, showing no dose-limiting toxicities or severe adverse events. Most patients achieved a clinical response, with some showing very good partial responses. However, the company does not plan to advance FT576 into further Phase 1 dose expansion for multiple myeloma, focusing instead on preclinical evaluation of next-generation BCMA-targeted cell products.

Financially, Fate Therapeutics reported $391.1 million in cash, cash equivalents, and investments as of March 31, 2024. The company generated $1.9 million in revenue from preclinical development activities in collaboration with Ono. Operating expenses for the quarter totaled $53.0 million, with research and development costs accounting for $32.1 million. The net loss for the quarter was $48.0 million, attributed to ongoing research and development efforts and operational costs.

Fate Therapeutics continues to advance its clinical programs and leverage its iPSC product platform to address significant unmet needs in cancer and autoimmune diseases. The company's focus on off-the-shelf cellular immunotherapies aims to provide innovative treatments that can potentially improve patient outcomes and accessibility.