Fate Therapeutics Inc (FATE) News & EventsFATEFate Therapeutics Inc

Fate Therapeutics Reports Q2 Revenue of $2.08M, Beating Consensus

Reports Q2 revenue $2.08M, consensus $1.27M. "Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment," said Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics. "The use of a clonally engineered master cell bank provided us the unique advantage of producing a FT819 pivotal CAR T-cell drug product batch that is uniform in composition and consistent with previously manufactured batches, a level of manufacturing consistency that can be challenging to achieve with patient- and donor-sourced CAR T-cell therapies. The clinical development of the FT819 franchise is further strengthened through its FDA RMAT designation and CDRP program inclusion. With our first patient treated, multiple clinical sites activated, and pivotal drug product inventory in distribution depots ready to be shipped to clinical sites on demand, we are building momentum to accelerate the clinical development of RECLAIM-LN. In addition to FT819, our next generation CAR T-cell programs include FT839, a novel 13-point edited CAR T-cell product candidate co-targeting CD19 and CD38, which is advancing to first patient treatment in rheumatoid arthritis and other autoimmune diseases, as well as FT836, CAR T-cell product candidate targeting the stress ligands MICA/B for pan-tumor treatment which is showing early anti-tumor activity in colorectal cancer without conditioning chemotherapy. With these advancements and a strong cash position, we believe Fate is positioned for strong execution across our portfolio."

Fate Therapeutics FT839 Receives FDA IND Clearance

Fate Therapeutics announced that the FDA has cleared its investigational new drug, or IND, application for FT839, the company's next-generation, off-the-shelf CAR T-cell product candidate engineered to co-target CD19 and CD38. With IND clearance, the company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026.

Fate Therapeutics Q1 Revenue $1.3M, Below Consensus

Reports Q1 revenue $1.3M, consensus $1.55M. "We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, president and CEO of Fate Therapeutics. "Our acceptance into the FDA's highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics."