Adicet Bio (ACET) Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary

Key program highlights

• Gamma delta CAR T cell therapies are advancing for autoimmune diseases and solid tumors, with off-the-shelf availability and strong tissue penetration advantages.

• Recent data in lupus nephritis (LN) and systemic lupus erythematosus (SLE) showed excellent safety, no high-grade CRS or ICANS, and efficacy consistent with autologous CAR T therapies.

• All patients in the initial cohort discontinued immunosuppressants and reduced steroids, with ongoing responses and complete or partial renal responses in LN.

• Immune reset was confirmed by B cell depletion and BCR clone analysis, supporting durable responses.

• Enrollment is robust across seven indications, with 25 centers open and strong interest in systemic sclerosis (SSC) and other autoimmune diseases.

Clinical and regulatory milestones

• Multiple data readouts are expected in the first and second halves of next year for LN, SLE, and SSC.

• Plans to meet the FDA in Q1 next year and start a pivotal study in Q2, likely single-arm with 30–90 patients, focusing on complete renal response (CRR) or DORIS remission as endpoints.

• Safety database target is about 100 patients for regulatory filing, with current oncology data supporting this goal.

• SSC enrollment began recently, with first data expected in the first half of next year and further updates in the second half.

• RA studies are exploring low or no preconditioning regimens, with data expected next year.

Manufacturing and financials

• Manufacturing uses qualified Leukopak donations, a 14-day GMP process, and multiple CDMOs, ensuring global scalability.

• Cost of goods is projected to be less than 10% of pricing, providing flexibility and efficiency.

• Cash position is nearly $180 million as of September 30, supporting operations into the second half of 2027 and covering key clinical and regulatory milestones.