Allogene Therapeutics (ALLO) investor relations material

Strategic vision and platform overview

• Focus on advancing allogeneic CAR T therapies across hematologic malignancies, autoimmune diseases, and solid tumors, leveraging proprietary TALEN® gene-editing and Dagger® technology for enhanced efficacy and scalability.

• Three lead programs: cema-cel (CD19) for LBCL, ALLO-329 (CD19/CD70) for autoimmune diseases, and ALLO-316 (CD70) for renal cell carcinoma, each targeting multi-billion-dollar market opportunities.

• Manufacturing capacity supports 30,000–60,000 doses/year at a cost of $10,000–$20,000 per dose, with a financial runway into Q1 2029.

Clinical development highlights

• ALPHA3 pivotal trial for cema-cel in 1L consolidation LBCL is designed to improve cure rates, with interim futility analysis in April 2026 and primary EFS data expected mid-2028.

• Interim data show cema-cel achieved a 26.6% higher MRD clearance rate and rapid ctDNA reduction compared to observation, with well-tolerated safety supporting outpatient use.

• ALLO-329 in the RESOLUTION trial for autoimmune diseases shows early clinical activity and favorable tolerability, with a program update expected in Q4 2026.

• ALLO-316 demonstrates durable responses in heavily pre-treated RCC patients, with robust CAR T expansion and FDA RMAT designation.

Market opportunity and access

• Projected $5B annual market for 1L consolidation CAR T in LBCL, with cema-cel targeting 7,000–10,000 patients/year and 50–70% market share among MRD+ patients.

• ALLO-329 addresses >$15B market in rheumatology indications, while ALLO-316 targets >$3.5B in RCC, with potential expansion to other solid tumors.

• ALPHA3 trial expands CAR T access to community settings, with ~33% of infusions at community centers and plans for ~100 active sites by end of 2026.