Allogene Therapeutics (ALLO) Q2 2024 earnings summary

Executive summary

• Advanced pivotal Phase 2 ALPHA3 trial for cema-cel in LBCL, with rapid enrollment and site activation, and expanded clinical programs in CLL, RCC, and autoimmune diseases, including next-gen ALLO-329 for autoimmune indications.

• Expanded CD19 product license territory to the EU and UK, increasing market opportunity by over 50%.

• All clinical manufacturing now conducted in-house at Cell Forge 1, reducing reliance on contract manufacturers and supporting operational momentum.

• Completed a 22% workforce reduction in June 2024 to prioritize core programs and extend cash resources.

• Raised $105.2 million in a May 2024 registered offering, extending the cash runway into the second half of 2026.

Financial highlights

• Q2 2024 cash, cash equivalents, and investments totaled $444.6 million, with a cash runway projected into the second half of 2026.

• Q2 2024 R&D expenses were $50.4 million (including $5.3 million non-cash stock-based compensation); G&A expenses were $16.1 million (including $8.2 million non-cash stock-based compensation).

• Net loss for Q2 2024 was $66.4 million, or $0.35 per share, including $13.6 million non-cash stock-based compensation and $5 million non-cash impairment of long-lived assets.

• Operating cash outflow was $119.5 million for the first half of 2024, compared to $128.5 million in the prior year period.

• 2024 cash burn expected to be approximately $200 million; full-year GAAP operating expenses projected at $300 million, with $60 million in non-cash stock-based compensation.

Outlook and guidance

• ALPHA3 trial expects lymphodepletion regimen selection by mid-2025, enrollment completion in H1 2026, interim efficacy analysis in H1 2026, and primary data readout by year-end 2026; BLA submission anticipated in 2027 if pivotal trial is successful.

• ALLO-329 IND filing planned for Q1 2025, with trial opening mid-2025 and proof-of-concept data by end of 2025.

• Initial data from the ALPHA2 CLL cohort expected in early 2025; Phase 1 update for ALLO-316 in RCC planned by year-end 2024.

• Cash, cash equivalents, and investments expected to decrease by ~$200 million in 2024; full-year 2024 GAAP operating expenses projected at ~$300 million.

• Guidance excludes potential business development activities.