Allogene Therapeutics, Inc. Q1 FY2025 earnings call

ALPHA3 Trial

• Pivotal first-line consolidation trial with cema-cel aiming to transform care in large B cell lymphoma. Over 250 patients consented for MRD screening, nearly half in the last three months. Shifted lymphodepletion regimen selection and futility analysis milestone to first half of 2026.

ALLO-316

• Shown efficacy in heavily pretreated advanced renal cell carcinoma, data to be presented at ASCO on June 1. Completed enrollment in Phase 1b expansion and evaluating strategic options.

ALLO-329

• RESOLUTION Trial launching mid-2025, dual-targeted allogeneic CART product with potential to eliminate lymphodepletion. Expected proof-of-concept data in first half of 2026.

Cash Runway

• Extended cash runway into second half of 2027 through targeted cost savings in manufacturing operations while maintaining core capabilities.

No specific product segment financial performance data on absolute revenue and contribution % provided in the transcript.

Cash Burn

• Expected cash burn of approximately $150 million in 2025.
• Full year 2025 GAAP operating expenses expected to be approximately $230 million, including non-cash stock based compensation of ~$45 million.

Trial Milestones

• Shifted lymphodepletion regimen selection and futility analysis milestone for ALPHA3 to first half of 2026.

Operational

• Site-level staffing shortages and administrative hurdles impacting trial enrollment and timing.

Regulatory

• Uncertainties around regulatory changes, including potential impacts from new FDA leadership, though confident in science-driven outcomes.

Q: Progress of enrollment in the first line study and logistical issues A: David and Zach discussed site-related delays (3-4 months from activation to screening) due to staffing, but recent months show increased patient consent for screening.

Q: ALPHA3 site differences and interim EFS readout A: No clear difference between community and academic sites in screening activity. Interim EFS readout timeline not specified beyond lymphodepletion selection in first half of 2026.

Q: INI strategy and ALLO-329 data timeline A: Open to partnering on INI program, with ALLO-329 data pushed to first half of 2026 to include more clinical responses.

Q: ALLO-329 data set and staffing challenges A: Data set to include dose escalation and testing two lymphodepletion regimens; site staffing issues are a concern but being addressed.

Q: ALLO-316 prioritization and autoimmune trial advantages A: ALLO-316 data to be presented at ASCO; off-the-shelf therapy like ALLO-329 has advantages in shorter tapering of immunosuppressants