Analyst Conference Summary

biotechnology

conference date: August 13, 2025 @ 2:00 PM PT
for quarter ending: June 3, 2025 (second quarter, Q2)

Forward-looking statements

Overview: Expects several important data readouts in 2025.

Basic data (GAAP):

Revenue was $0, flat sequentially and flat from year-earlier.

GAAP Net Income was negative $51 million, flat sequentially from negative $60 million, and up from negative $66 million year-earlier.

GAAP EPS was negative $0.23, flat sequentially from negative $0.28, and up from negative $0.35 year-earlier.

Guidance:

Cash runway into 2H 2027. Expected cash burn for 2025 is $150 million. Net loss higher mainly from non-cash compensation.

Conference Highlights:

David Chang, CEO said "This quarter marked a significant inflection point for Allogene as we advance the streamlined ALPHA3 trial toward its next key milestone, initiate clinical enrollment in our first autoimmune indications with ALLO-329, and aligned with the FDA on a pivotal path forward for ALLO-316 in solid tumors. Our progress reflects a focused and disciplined execution strategy, and a clear path to value creation as we advance the next wave of scalable and accessible cell therapies with potentially durable results." Now confident in the evidence and strategy.

Cema-Cel (ALLO-501 or cemacabtagene ansegedleucel) for large B cell lymphona (LBCL) began a pivotal Phase 2 study, Alpha3, in June 2024, for first line treatment for patients likely to relaspse following immunotherapy. Enrollment completion expected 1H 2026. In August 2025 announced would go forward with standard fludarabine and cyclophosphamide lymphodepletion regimen, in a two-arm trial compared to standard of care. Futility analysis has shifted to 1H 2026. Cema-Cel is an allogeneic cell therapy. PFS primary endpoint. Believes the market opportunity has expanded to more than $9.5 billion. Could make a BLA submission in 2027. Developed a test for MRD (minimal residual disease), which would predict patients likely to relapse after RCHOP treatment. Over 250 patients had been tested for MRD by May 2025. But noted despite interest from additional sites there is competition to get patients for this trial. In Q2 2025 began expansion of trial sites to outside the U.S.

Data from the Phase 1 trial was published in the Journal of Clinical Oncology in February 2025 in r/r CLL (chronic lymphocytic leukemia). Demonstrated durable responses compared to autologous CAR T therapies.

ALLO-329 for autoimmune disease started Phase 1 trial for rheumatology indications in Q2 2025 after an IND approved in January 2025. Targets both CD19 and CD70. Has Dagger technology to eliminate lymphodepletion. Preclinical data was be presented at ACR on November 18, 2024. Believes differentiated from competitors.

ALLO-316 is a Phase 1b trial for advanced Renal Cell Carcinoma and completed enrolling the cohort. Latest data released mid-2025 at ASCO is promising. Then met with FDA on pivotal trial design. Could pursue a strategic partnership for this potential therapy.

Allogene also has ALLO-213 and ALLO-182 for solid tumors in preclinical development.

Total operating expenses (GAAP) were $57 million, consisting of: R&D $40 million; G&A $14 million; impairment $2 million. Loss from operations was $57 million. Other income net $6 million. Income tax $0 million.

Cash and equivalents ended at $303 million, down sequentially from $336 million.

Q&A selective summary:

Futility analysis, what is success? Rough estimate is 30% difference between arms in MRD conversion. Other CARTs have shown 27% complete remissions, which were considered significant. The difference between standard of care and active arms was 33%. So 30% is a reasonable assumption for us. Fair to assume MRD conversion can be equated to CR.

Cash to PFS data? Depends on rate of patient enrollment. Will update at time of futility analysis. Data event could occur in second half of 2027.

Don't know how the discontinuation of the FCA arm will impact enrollment rate, but physicians seem to prefer FC. So possible positive impact.

There is no data in LBCL on MRD relapse or conversion rates. Ours is the first trial for this.

Durability of remission? Believe an MRD conversion correlates well with long-term disease control.

Cell expansion color, any changes? No change in thinking. Alpha3 is a low-volume disease setting. There degree of cell expanions needed [did not really say].

Adverse event (death) effect on enrollment? These patients have chemo refractory cancer, are likely to progress soon. Not in remission. But the event did make it seem appropriate to move forward only with the FC arm.

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