Allogene Therapeutics, Inc. Q2 FY2025 earnings call

• David Chang highlighted progress across the portfolio, including the ALPHA3 study for cema-cel being streamlined into a 2-arm randomized trial, progress with ALLO-316 CD70 targeted CAR T with Phase I data presented at ASCO, and enrollment in the RESOLUTION study for autoimmune disease. • Zachary Roberts discussed the ALPHA3 trial design, noting the early biomarker and safety data from the standard FC arm, alignment with FDA on ALLO-316 pivotal trial strategy, and details on the RESOLUTION study in autoimmune disease. • Geoff Parker provided financial updates, including cash position as of June 30, 2025, R&D and G&A expenses for the second quarter, and guidance on 2025 cash burn and full-year GAAP operating expenses.

No specific product segment financial performance breakdown provided as the transcript does not detail revenue contribution by product segments in the traditional sense.

• Expected 2025 cash burn of approximately $150 million. • Full year GAAP operating expenses of approximately $230 million, including an estimated noncash stock-based compensation expense of approximately $45 million. • Guidance excludes impact from potential business development activities.

• Potential risks in clinical development, including uncertainties in trial outcomes and safety events. • Discussion of a Grade 5 event related to ALLO-647 and its implications on enrollment, but consensus that it wouldn't materially slow enrollment. • Uncertainties in translating MRD conversion rates and efficacy across different disease settings.

Q: Tyler Van Buren with TD Cowen asked about the bar for success with MRD conversion rates in the ALPHA3 study.

A: David Chang referenced comparison to complete remission rates in approved CAR T studies like YESCARTA and BREYANZI.

Q: Biren Amin with Piper Sandler asked about translating MRD conversion delta and cash runway for ALPHA3 EFS data.

A: Zachary Roberts said MRD conversion can be equated to complete remission, and Geoff Parker discussed cash runway depending on enrollment pace.

Q: Mark on for Salveen Richter with Goldman Sachs asked about ALPHA3 enrollment progress.

A: Zachary Roberts said momentum continues, positive feedback from investigators on the simplified regimen.

Q: Dingding Shi with Jefferies asked about MRD timing impact and efficacy bar setting.

A: David Chang and Zachary Roberts discussed MRD timing and alignment with prior study data.

Q: Jack Allen with Baird asked about MRD conversion correlation with durability and ALLO-329 data.

A: Zachary Roberts said MRD conversion correlates with long-term disease control, and details on ALLO-329 data to come.

Q: Samantha Corwin with William Blair asked about MRD data sharing impact and ALLO-329 data.

A: David Chang discussed sensitivity of data sharing and focus on biomarker and early clinical data for ALLO-329.

Q: Matthew Biegler with Oppenheimer asked about cell expansion thinking in lower tumor burden setting.

A: David Chang said thinking hasn't changed drastically and more to come.

Q: Samantha Semenkow with Citi asked about protocol amendment status and enrollment eligibility.

A: Zachary Roberts discussed protocol amendment approval and enrollment eligibility.

Q: Shelby Hill on for Luca Issi with RBC Capital Markets asked about death event impact on enrollment.

A: Zachary Roberts said consensus was enrollment wouldn't be materially slowed.

Q: Asthika Goonewardene with Truist asked about MRD conversion patient distribution.

A: David Chang said patient distribution info may be shared.

Q: William Pickering with Bernstein asked about interim analysis quantitative criteria.

A: Zachary Roberts discussed MRD assessment and data sharing.

Q: Reni Benjamin with Citizens asked about ALLO-329 cyclophosphamide regimen choice and proof-of-concept.

A: David Chang discussed cyclophosphamide choice and what to look for in proof-of-concept data.

Q: Lut Ming Cheng with JPMorgan asked about 30% delta bar translation to consolidation line.

A: Zachary Roberts said the 30% reference is a good point despite being from later line trials.