Adicet Bio (ACET) investor relations material

Strategic pipeline updates and upcoming disclosures

• Significant data disclosures are expected soon, including updates on in vivo CAR T pipeline and lead asset ADI-001 for autoimmune diseases and oncology.

• The upcoming data set in lupus nephritis (LN) and systemic lupus erythematosus (SLE) will be the largest reported for allogeneic off-the-shelf cell therapy in these indications.

• Additional clinical studies are underway for prostate cancer and systemic sclerosis, with data expected in the second half of the year.

• A study in rheumatoid arthritis is comparing two lymphodepletion regimens, which may influence future conditioning strategies.

• Regulatory feedback from recent FDA meetings will be shared with upcoming data, guiding pivotal study design.

Clinical data and differentiation

• ADI-001 targets CD20, achieving complete B cell depletion in blood and lymph nodes, with immune system reset observed post-treatment.

• The therapy is well-tolerated, does not require leukapheresis, and enables broader patient access across multiple countries.

• Data from 22 patients (13 with at least 12 months follow-up) will be disclosed, focusing on durability and remission rates comparable to autologous CAR T therapies.

• The product offers a simpler, faster, and better-tolerated alternative to autologous CAR T, with lower risk of severe side effects like ICANS.

• The pivotal study will likely start in LN, with potential expansion to SLE, mirroring strategies used by other industry leaders.

Market opportunity and study design considerations

• High unmet need exists among 35,000 LN patients in the US who have failed multiple immunosuppressants, with strong interest from both physicians and patients.

• The therapy could reduce chronic immunosuppressant use, hospitalizations, and associated costs, potentially appealing to payers.

• Traditional endpoints like SLEDAI and DORIS have limitations; additional endpoints such as drug-free remission, physician global assessment, and quality of life are being considered.

• The pivotal study is expected to be single-arm, enrolling 35–90 patients, with flexibility to adapt based on regulatory feedback and evolving data.

• Expansion to earlier lines of therapy and broader patient populations is anticipated as evidence and payer support grow.