Arcellx (ACLX) Status Update summary

Market opportunity and launch strategy

• Myeloma CAR T market projected to reach $12B by 2028, expanding to $20B as therapies move frontline.

• Anito-cel expected to launch in the US in mid to late 2026, initially targeting the $3.5B fourth-line-plus segment.

• Market research with 300+ physicians shows anito-cel could achieve up to 83% market share in its class.

• Launch plans include rapid expansion to 160 US ATCs in year one, supported by robust manufacturing and logistics via Kite.

• Preapproval information exchange aims for 80% payer coverage within 30 days and 90% within 90 days of launch.

Clinical data and product differentiation

• Phase 1 data: 100% overall response, 79% complete response, median PFS 30.2 months, no delayed neurotoxicity.

• Phase 2 (IMAGINE-1): 97% overall response, 68% complete response, 93% MRD negativity, median follow-up 12.6 months.

• Safety profile: 85% had grade 1 or less CRS, 92% had no ICANS, no delayed or non-ICANS neurotoxicity, no secondary T-cell malignancies.

• Manufacturing success rate at 99%, with less than 17-day turnaround and high in-spec rates via Kite.

Physician and patient perspectives

• Physicians value anito-cel's efficacy, safety, and predictable logistics, especially compared to current CAR Ts.

• Safety concerns with existing CAR Ts (delayed neurotoxicity, enterocolitis) limit their use in earlier lines and frail patients.

• Anito-cel's profile may enable broader use, including in older and frailer populations.

• Predictable manufacturing and logistics (Kite Connect) are seen as major operational advantages.