Adicet Bio (ACET) investor relations material

Key study results and clinical impact

• All seven patients with LN and SLE showed rapid, sustained reductions in SLEDAI-2K and PGA scores, with all experiencing clinical improvement.

• All five LN patients achieved improved renal function: three had complete renal responses and DORIS remissions, two had partial renal responses, with all responses ongoing.

• All patients discontinued immunosuppressants and tapered corticosteroids to zero or physiological levels after a single dose.

• The therapy is being evaluated as an off-the-shelf, one-time outpatient treatment for autoimmune diseases, with a favorable safety profile.

• The efficacy and safety profile supports broad adoption and commercial potential if approved.

Immune reset and biomarker evidence

• Deep and broad B cell depletion was observed in all patients, followed by reconstitution with naive and non-class switched B cells.

• Deep sequencing showed elimination of dominant, potentially pathogenic B cell clones and emergence of new, less antigen-experienced B cell repertoires.

• These findings confirm a robust immune reset at the B cell receptor level, supporting the mechanism of action for durable remission.

Safety and tolerability

• The therapy was well tolerated, with no serious adverse events, no ICANS, and only mild or Grade 1 CRS or infections.

• No cases of graft-versus-host disease, HLH-MAS, or prolonged neutropenia were reported.

• Safety profile supports potential for outpatient administration and compares favorably to autologous CAR-T therapies.