Adicet Bio reports Q3 EPS , consensus (32c)

“We were pleased to announce positive preliminary data last month from seven SLE and LN patients treated in our Phase 1 trial of ADI-001, underscoring its broad potential as a transformative, off-the-shelf, one-time therapy for autoimmune diseases. We are now preparing to discuss the trial design for a potentially pivotal study of ADI-001 with the FDA in the first quarter of 2026, with initiation targeted for the second quarter of 2026,” said Chen Schor, President and Chief Executive Officer of Adicet Bio (ACET). “As part of our broader clinical strategy, we are also exploring the potential to reduce or eliminate the need for conditioning with a separate Phase 1 trial of ADI-001 in treatment-refractory RA patients. We are actively enrolling patients in our Phase 1 trial across LN, SLE, SSc, IIM, SPS and AAV patients, with a clinical update for LN, SLE and SSc expected in the first half of 2026. In addition, we are continuing to advance ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target prostate specific membrane antigen, and expect to submit a regulatory filing for the mCRPC program in the first quarter of 2026 and share initial clinical data in the second half of 2026, subject to regulatory clearance. ADI-212 is designed to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Supported by our recent capital raise in October, which extended our cash runway into the second half of 2027, we are well-positioned to continue clinical execution across our pipeline of differentiated gamma delta 1 CAR T therapies.”