Allogene Therapeutics (ALLO) Q3 2024 earnings summary

Executive summary

• Advanced pivotal Phase 2 ALPHA3 trial for cema-cel in large B-cell lymphoma, aiming to set a new standard in first-line treatment for high-risk patients, with enrollment expected to complete in H1 2026 and primary EFS data by year-end 2026.

• ALLO-316 in renal cell carcinoma showed a 33% confirmed and 50% best overall response rate in heavily pretreated patients, leading to RMAT designation from the FDA and implementation of new management algorithms for IEC-HS.

• Pipeline expanded with ALLO-329, a dual CD19/CD70 CAR targeting both B and T cells in autoimmune diseases, with IND filing expected in Q1 2025 and proof-of-concept data by year-end 2025.

• Focused on advancing cema-cel (ALLO-501A) in LBCL/CLL, ALLO-316 in RCC, and ALLO-329 for autoimmune diseases, while reducing workforce by 22% in 2024 to extend cash runway and prioritize core programs.

• Expanded CD19 license territory to EU and UK, increasing cema-cel's addressable market by over 50%.

Financial highlights

• Cash, cash equivalents, and investments totaled $403.4 million at Q3 2024 end, with runway into the second half of 2026.

• Q3 2024 R&D expenses were $44.7 million, including $5.6 million in non-cash stock-based compensation; G&A expenses were $16.3 million, with $7.8 million in non-cash stock-based compensation.

• Net loss for Q3 2024 was $66.3 million, or $0.32 per share, including $13.4 million in non-cash stock-based compensation and $10.7 million in non-cash impairment of long-lived assets.

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

• Q3 2024 revenue was $22,000, with accumulated deficit reaching $1.8 billion.

Outlook and guidance

• Cash and investments expected to fund operations into the second half of 2026.

• ALPHA3 trial expects primary event-free survival data by end of 2026 and potential BLA submission in 2027.

• ALLO-329 IND filing planned for Q1 2025, with proof-of-concept data anticipated by year-end 2025 and Phase 1 trial initiation mid-2025.

• ALLO-316 phase 1B expansion cohort update expected in 2025; durability data will inform pivotal trial design.

• Guidance excludes impact from potential business development activities.