Adicet Bio's Lupus Trial Delivers 100% Response, Setting Stage For Phase 2

Core Viewpoint - Adicet Bio Inc. has experienced a decline in share price following the announcement of an $80 million direct offering, despite positive early safety and efficacy data from its Phase 1 trial of ADI-001 for autoimmune diseases [1][7]. Financial Offering - The company has priced a registered direct offering of 70 million shares and pre-funded warrants for 10 million shares at $1.00 per share and $0.9999 per warrant, aiming for gross proceeds of approximately $80 million [1]. Clinical Trial Results - Initial safety and efficacy data from the first seven patients treated with ADI-001 showed promising results, with 100% of patients in the lupus nephritis cohort achieving a renal response, including three complete responses [3][4]. - All patients experienced rapid and sustained reductions in SLEDAI-2K and PGA scores, indicating the potential for a durable effect on a wide range of lupus symptoms [4]. Safety Profile - ADI-001 was generally well-tolerated, with no serious adverse events reported among the seven patients, suggesting a favorable safety profile that may allow for outpatient dosing [5]. Future Development Plans - The company plans to request a meeting with the FDA in Q1 2026 to discuss the design of a potentially pivotal Phase 2 trial, which is expected to start in Q2 2026 [6].