Announcement • Aug 15
Fate Therapeutics Initiates Potentially Registrational Reclaim-Ln Clinical Trial of Ft819 for the Treatment of Lupus Nephritis Fate Therapeutics highlighted the initiation of and treatment of the first patient in RECLAIM-LN (NCT07570862), its Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis. First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites. Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program. Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to complete enrollment in 15-18 months, by First Half 2028. Patients to receive a single 900 million-cell dose of off-the-shelf FT819 following less-intensive conditioning with bendamustine; complete renal response at Week 26 is the primary endpoint. RECLAIM-LN (FT819-201; NCT07570862) is a multicenter Phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of FT819 in patients with refractory moderate-to-severe SLE with Class III or IV lupus nephritis (with or without concomitant class V). One of the most serious manifestations of SLE, lupus nephritis, is a leading driver of kidney failure among patients with lupus, many of whom have exhausted available immunosuppressive treatment options. The study is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies. The primary endpoint is the proportion of participants achieving complete renal response (CRR) at Week 26. Secondary endpoints include evaluation of CRR at later timepoints, overall and partial renal response, lupus low disease activity state, remission, quality of life measures, and other disease-related and patient-reported outcomes. Preliminary data from the Phase 1 study demonstrated favorable safety and tolerability and clinically meaningful improvement with sustained improvements across several disease activity measures, including clinical Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K and urine protein-to-creatinine ratio (UPCr). Both measures showed further reductions with the use of less-intensive bendamustine conditioning. The RECLAIM-LN study was developed through interactions with the FDA under FT819 Regenerative Medicine Advanced Therapy (RMAT) designation. FT819 has also been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, which provides opportunities for early and enhanced communication with the FDA regarding CMC readiness for therapies with accelerated clinical development timelines. FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303). Reported Earnings • Aug 14
Second quarter 2026 earnings: EPS and revenues exceed analyst expectations Second quarter 2026 results: US$0.25 loss per share (improved from US$0.29 loss in 2Q 2025). Net loss: US$30.2m (loss narrowed 12% from 2Q 2025). Revenue exceeded analyst estimates by 63%. Earnings per share (EPS) also surpassed analyst estimates by 6.8%. Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. Recent Insider Transactions • Aug 06
President recently sold US$108k worth of stock On the 4th of August, Bahram Valamehr sold around 44k shares on-market at roughly US$2.46 per share. This transaction amounted to 23% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Bahram has been a net seller over the last 12 months, reducing personal holdings by US$168k. 
