Arcellx (ACLX) investor relations material

Key clinical and pipeline updates

• Lead asset Anito-cel demonstrated a complete response rate in the 70% range and 18-month PFS of 66% in late-line multiple myeloma, with MRD negativity in the low 90% range.

• No cases of delayed neurotoxicity or immune-related enterocolitis observed, differentiating Anito-cel from other BCMA CAR-T therapies.

• Additional data with longer follow-up expected at ASH, with median follow-up anticipated to reach 17–18 months.

• Ongoing trials in AML and myasthenia gravis, with the latter aiming for durable, treatment-free periods for patients.

• ARC-SparX platform in phase 1 for AML, focusing on optimizing dosing and patient selection.

Regulatory and commercialization outlook

• Confident in regulatory path for Anito-cel, citing recent single-arm study approvals as precedent.

• BLA submission expected late 2024 or early 2025, targeting commercial launch in mid to late 2026.

• Market research indicates high physician confidence and anticipated strong adoption, especially in centers lacking CAR-T access.

• iMMagine-3 trial in earlier-line myeloma expands addressable population by removing lenalidomide-refractory requirement and including KDd as standard of care.

• Cash runway of $538 million extends into 2028, funding launch and post-launch milestones.

Industry trends and strategic perspectives

• AI leveraged for binder generation and D-domain optimization, enabling solutions to previously intractable problems.

• Open to business development opportunities globally, but cautious on R&D translation from China.

• Regulatory and tariff changes have not materially impacted operations; cell therapy seen as resilient to patent cliffs and IRA issues.