Cema-cel & ALPHA3 Trial - The ALPHA3 trial is designed to predict and intervene BEFORE relapse in LBCL patients, using cema-cel as a 1L consolidation treatment for MRD+ patients[16] - Phase 1 data showed cema-cel achieved a 100% CR rate in patients with low disease burden, paving the way for ALPHA3[19] - The ALPHA3 trial aims to enroll ~240 LBCL patients in CR/PR at the end of 1L therapy with MRD across ~50 US cancer centers and additional international sites[41] - The ALPHA3 addressable population creates a ~$5 billion potential market opportunity in the US and EU5[44, 92] ALLO-329 - Phase 1 Rheumatology Basket Trial for ALLO-329 was IND cleared in Jan 2025, with trial initiation expected in mid-2025 and potential clinical and biomarker PoC data in 1H 2026[52] - ALLO-329 is a dual CD19/CD70 allogeneic CAR T with Dagger® technology, designed to maximize CAR T expansion and potentially eliminate the need for lymphodepletion[54] - The RESOLUTION basket study will address four large diseases: Lupus (SLE) with an estimated US diagnosed prevalence of 330,000, Lupus Nephritis with 90,000, Systemic Sclerosis with 100,000 and Myositis with 70,000[63] ALLO-316 - The TRAVERSE Ph1 trial supports the potential of ALLO-316 in CD70+ RCC, with encouraging activity in solid tumors and FDA RMAT designation[64] - ASCO 2025 will feature the next Ph1b data update for ALLO-316[65] - The TRAVERSE addressable population creates a >$3.5 billion global market opportunity[65, 97] Financial Position - Allogene has a strong financial position with $335.5 million in cash, cash equivalents, and investments at the end of Q1 2025, projecting runway into 2H 2027[78]
Allogene Therapeutics (ALLO) Earnings Call Presentation