Fate Therapeutics Announces Q2 2024 Financials and Business Updates

Fate Therapeutics, a biopharmaceutical company in the clinical stage, focuses on advancing a pipeline of innovative immunotherapies derived from induced pluripotent stem cells (iPSCs) to treat cancer and autoimmune diseases. Recently, the company reported significant progress in its ongoing Phase 1 studies, highlighting key clinical advancements and financial outcomes for the second quarter ending June 30, 2024.

Scott Wolchko, President and CEO of Fate Therapeutics, expressed satisfaction with the early clinical and translational data from their three Phase 1 trials and announced plans to share detailed results later in the year. The company is concentrating on differentiating its treatments for autoimmune diseases using off-the-shelf products like FT819 CAR T-cell and FT522 CAR NK cell.

The FT819 iPSC-derived 1XX CAR T-cell product is currently being enrolled in a Phase 1 trial targeting systemic lupus erythematosus (SLE). This multi-center study aims to assess the safety, pharmacokinetics, and anti-B cell activity of FT819, which features a CD19-targeted CAR with a 1XX costimulatory domain. Initial treatment of a patient with refractory lupus nephritis showed promising safety results, with no severe adverse events reported. The study now includes single-agent cyclophosphamide as an alternative conditioning regimen, adding to the existing options of cyclophosphamide and fludarabine or bendamustine. Earlier data from another Phase 1 study in relapsed/refractory B cell malignancies indicated a favorable safety profile for FT819, showing minimal toxicity and significant B-cell depletion, supporting its potential in autoimmune disease treatment.

The FT825 / ONO-8250 CAR T-cell product candidate, developed in collaboration with Ono Pharmaceutical, is in a Phase 1 trial for advanced solid tumors. This study evaluates the safety and activity of FT825 / ONO-8250 both as a monotherapy and in combination with monoclonal antibody therapy. The product features seven synthetic controls of cell function, including a novel HER2-targeted CAR that has shown high specificity for cancer cells. Initial dosing at 100 million cells has been completed for three patients, with plans to escalate dosing and initiate combination therapy in the third quarter of 2024.

The FT522 CAR NK cell product has also seen substantial progress. FT522, designed to function without the need for conditioning chemotherapy, is in a Phase 1 trial targeting relapsed/refractory B-cell lymphoma. The first patient has been treated in a chemotherapy-free cohort, and another patient has been treated with conditioning chemotherapy. Early results indicate no dose-limiting toxicities, suggesting a well-tolerated safety profile. Fate Therapeutics plans to submit an Investigational New Drug (IND) application for FT522 in autoimmune diseases in the third quarter of 2024, following encouraging preclinical data showing significant B cell depletion and persistence in the immune system.

Financially, the company reported $352 million in cash, cash equivalents, and investments as of June 30, 2024, expected to sustain operations through the end of 2026. Total revenue for the second quarter was $6.8 million, primarily from milestone achievements and preclinical development under its collaboration with Ono. Operating expenses totaled $51.9 million, with research and development costs accounting for the majority. Despite a net loss of $38.4 million for the quarter, the company remains well-funded to continue its clinical and preclinical programs.

Fate Therapeutics leverages its proprietary iPSC product platform, which combines the self-renewal capability of iPSCs with multiplexed-engineering to create uniform, off-the-shelf cell products. This approach aims to overcome the limitations of traditional cell therapies, offering scalable and potentially more effective treatments for a broader patient population. The company holds a robust intellectual property portfolio, with over 500 issued patents and 500 pending applications, supporting its leadership in the field of iPSC-derived cellular immunotherapies.