Allogene Therapeutics (ALLO) Q3 2025 earnings summary

Executive summary

• Focused on advancing scalable, off-the-shelf cell therapies with the Allogene XL platform, targeting oncology and autoimmune diseases, with three core clinical programs: ALPHA3 (cema-cel for LBCL), RESOLUTION (ALLO-329 for autoimmune diseases), and TRAVERSE (ALLO-316 for RCC).

• ALPHA3 pivotal Phase 2 trial ongoing for cema-cel; FCA arm closed due to a Grade 5 SAE, now proceeding with FC lymphodepletion only.

• ALLO-329 initiated Phase 1 basket study in autoimmune diseases, exploring reduced or no lymphodepletion regimens, and received three Fast Track Designations.

• ALLO-316 in renal cell carcinoma showed durable responses, with 31% ORR in high CD70 expression patients and informs dual CD19/CD70 construct design.

• May 2025 workforce reduction of 28% to focus resources on clinical programs and reduce manufacturing operations.

Financial highlights

• Cash, cash equivalents, and investments totaled $277.1 million as of September 30, 2025.

• Q3 2025 R&D expenses were $31.2 million (including $2.8 million non-cash stock-based compensation); G&A expenses were $13.7 million (including $5.9 million non-cash stock-based compensation).

• Net loss for Q3 2025 was $41.4 million, or $0.19 per share; net loss for the nine months ended September 30, 2025 was $152.1 million.

• 2025 cash burn expected to be $150 million; full-year GAAP operating expenses projected at $230 million, including $45 million in non-cash stock-based compensation.

• Weighted-average shares outstanding: 222.0 million for Q3 2025; accumulated deficit reached $2.0 billion as of September 30, 2025.

Outlook and guidance

• Cash runway extends into the second half of 2027, expected to fund operations for at least the next 12 months.

• Interim futility analysis for ALPHA3 (cema-cel) and proof-of-concept data for ALLO-329 expected in the first half of 2026.

• Full-year operating expense guidance excludes potential business development impacts.