Analyst Conference Summary

biotechnology

conference date: November 6, 2025 @ 2:00 PM PT
for quarter ending: September 30, 2025 (third quarter, Q3)

Forward-looking statements

Overview:

Basic data (GAAP):

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

GAAP Net Income was negative $41.4 million, up sequentially from negative $51 million, and up from negative $66.3 million year-earlier.

GAAP EPS was negative $0.19, up sequentially from negative $0.23, and up from negative $0.32 year-earlier.

Guidance:

Cash runway into 2H 2027. 2025 full year cash burn $150 million.

Conference Highlights:

David Chang, CEO said "With our unique allogeneic approach to CAR T, the field has the ability to shift from highly personalized, patient-specific therapies to a new era of readily available, off-the-shelf treatments that can reach more patients earlier in their disease and wherever they receive care. Having treated hundreds of patients, we've gained valuable insight into how ex vivo manufacturing enables more precise definition and control of our cell products before they reach patients, enhancing consistency, safety, and quality. This transformation is evident and goes far beyond incremental progress, it begins to establish a scalable allogeneic CAR T paradigm built to reach more patients, expand into broader care settings, and unlock the full potential of cell therapy." We are aware of the shifting conversation in the field. We believe our platform could change the current paradigm.

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. Futility analysis (comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation) expected in 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.

ALLO-329 for autoimmune disease started Phase 1 trial for rheumatology indications in Q2 2025. Resolution is a basket trial across several autoimmune conditions including lupus, systemic sclerosis, and idiopathic inflammatory myopathies. Targets both CD19 and CD70. Has Dagger technology to eliminate lymphodepletion. Believes differentiated from competitors.

ALLO-316 is a Phase 1b trial (Traverse) 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 $45 million, consisting of: R&D $31 million; G&A $14 million; impairment $0 million. Loss from operations was $45 million. Other income net $3.5 million. Income tax $0 million.

Cash and equivalents ended at $277 million, down sequentially from $303 million.

Q&A selective summary:

Futility analysis, data in it? Focus is on MRD conversion. Not allocating alpha, not looking at primary efficacy endpoints. MRD would be a significant win. 30% would be a pretty strong showing for MRD clearance. On track for first half of 2026.

Active sights, how many are actually enrolling patients? Of the over 50 active sites, close to all of them should be open to enrollment.

329 data set? Phase 1 initial data will be just a handful of patients. We believe that can be meaningful in this setting.

So far MRD positive rates for patients are holding to our assumption.

Lymphodepletion v. efficacy? We have higher confidence that 329 in autoimmune setting will work well without lymphodepletion. But we need to show that in the trial. Second cohort of the trial will be without depletion.

Data on T cell depletion? We will be looking at both CD70 positive and negative T cells.

329 B cell reset, choice of indications? Biomarket data will be very meaningful, we hope to show some proof of concept including some clinical responses.

Confidence in prognostic value of MRD endpoint? Pretty confident. The test seems to be pretty good at correlating with long-term outcomes. It is a dynamic test, we can test relatively soon after dosing.

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