Adicet Bio, Inc. filed a Current Report on Form 8-K dated September 8, 2026, disclosing an investor presentation posted to the company’s website. The filing includes Exhibit 99.1, which outlines the company’s business overview and forward-looking statements regarding its product candidates and financial outlook.
The presentation details the clinical development of prula-cel, a chimeric antigen receptor (CAR) T cell therapy targeting CD20 for autoimmune diseases. As of the cut-off date of August 31, 2025, clinical data included 7 patients (5 with lupus nephritis and 2 with systemic lupus erythematosus) with a follow-up ranging from 2 to 9 months. The data reportedly demonstrated clinical activity comparable to autologous CAR-T therapies, with improvements in kidney function and SLEDAI components. The company notes that patients discontinued immunosuppressants and tapered corticosteroids. The safety profile was described as well-tolerated, with no immune effector cell-associated neurotoxicity syndrome (ICANS), no cytokine release syndrome (CRS) greater than grade 2, and no hemophagocytic lymphohistiocytosis (IEC-HS).
The presentation highlights prula-cel as a potentially first-off-the-shelf, one-time therapy intended to address the logistical challenges and safety concerns associated with autologous CAR-T treatments. The company also discussed the preclinical and clinical development of ADI-212, an investigational new drug (IND) cleared for metastatic castrate-resistant prostate cancer (mCRPC). Adicet plans to initiate clinical enrollment for ADI-212 in the fourth quarter of 2026.
The document outlines a diversified pipeline of allogeneic gamma delta 1 CAR-T cell therapies targeting multiple myeloma, non-Hodgkin lymphoma, and solid tumors. It also includes anticipated near-term value-creating milestones across these programs for the years 2026 through 2029.
The filing includes a standard risk factor section, noting that forward-looking statements are subject to various uncertainties, including the impact of global economic conditions, the ability to execute on strategy, the success of clinical studies, and regulatory approval processes.
