Allogene Therapeutics, Inc. Q4 FY2024 earnings call

• All three key programs (large B cell lymphoma, autoimmune disease, renal cell carcinoma) are approaching critical milestones. • ALLO-501A's pivotal phase two alpha three trial in first-line consolidation large B cell lymphoma has 40 sites activated and anticipates a mid-2025 lymphodepletion selection and futility analysis. • ALLO-329 marked expansion into autoimmune disease with FDA clearance for a Phase one resolution basket trial, designed to potentially reduce or eliminate lymphodepletion using DAGR technology. • ALLO-316 shows promise in renal cell carcinoma, with phase one b cohort data expected mid-2025. • JCO publication of ALLO-501A Phase one ALPHA trial results showed efficacy comparable to autologous CAR Ts, high complete response rates, excellent durability, and a best-in-class safety profile.

No specific product segment financial performance breakdown provided in the transcript.

• Expect cash burn of approximately $170 million in 2025. • Full-year 2025 GAAP operating expenses expected to be approximately $250 million, including an estimated non-cash stock-based compensation expense of approximately $50 million. • Guidance excludes impact from potential business development activities.

• Forward-looking statements are subject to change based on current information, assumptions, and expectations. • Potential risks include uncertainties regarding the success and timing of clinical trials, regulatory filings, safety and efficacy of product candidates, and commercial market forecast, as detailed in press releases and SEC documents.

Q: How do patients with low disease burden in the JCO publication compare to those being enrolled in ALPHA3?

A: David Chang noted a strong correlation between low disease volume and higher response likelihood with lower serious adverse events, and ALPHA3 is a randomized trial evaluating CAR T as first-line consolidation therapy for MRD-positive patients.

Q: What is the criteria for the interim DSMB efficacy analysis in ALPHA3?

A: Zachary Roberts stated it is a formal efficacy test with primary endpoint of event-free survival, and they are looking forward to the analysis as a significant milestone.

Q: What data are you looking to show by year-end for ALLO-329's proof of concept?

A: David Chang mentioned biomarker-based proof of concept data including B cell depletion, cell expansion, and early safety results, with potential to address T cells as well.

Q: How much follow-up is needed for the lymphodepletion-free strategy in ALLO-329?

A: David Chang said the phase one study is built to address key questions about whether milder or no lymphodepletion can be achieved, with biomarker data and early safety results expected.

Q: What is the futility analysis looking at for ALPHA3?

A: David Chang said it looks at safety and signs of efficacy, primarily relying on MRD conversion rate.