Analyst Conference Summary

biotechnology

conference date: March 13, 2025 @ 2:00 PM PT
for quarter ending: December 31, 2025 (fourth quarter, Q4)

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 $60 million, up sequentially from negative $66 million, and up from negative $86 million year-earlier.

GAAP EPS was negative $0.28, up sequentially from negative $0.32, and up from negative $0.51 year-earlier.

Guidance:

Cash runway into 2H 2026. Expected cash burn for 2025 is $170 million.

Conference Highlights:

David Chang, CEO said "In 2024, we focused on delivering on our bold strategy to achieve what no CAR T has accomplished before. Our recent data, published in the Journal of Clinical Oncology, from the Phase 1 ALPHA/ALPHA2 trials in relapsed/refractory LBCL provided compelling evidence that cema-cel can induce durable remissions comparable to approved autologous CD19 CAR T therapies. With the ALPHA3 first line consolidation trial evaluating cema-cel in LBCL now underway, the ALLO-329 IND clearance to launch the RESOLUTION trial in autoimmune disease, and completion of the Phase 1b cohort with ALLO-316 in the TRAVERSE trial in RCC, we are demonstrating that Allogene’s vision for an off-the-shelf cell therapy may not just be a possibility, it could be a reality in hematology, autoimmune diseases, and solid tumors. We believe 2025 will be the year allogeneic CAR T broadly begins to demonstrate its potential to surpass autologous CAR T therapy by reaching more patients with greater accessibility." We stand on the brink of a transformative year.

Cema-Cel (ALLO-501A 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, followed by an interim analysis, then a full analysis by end of 2026. Patient enrollment rapid so far. Cema-Cel is an allogeneic cell therapy. 250 MRD positive patients to get Cema-Cel or current standard of care. EFS primary endpoint. Believes the market opportunity has expanded to more than $9.5 billion. Could make a BLA submission in 2027. Developing a test for MRD (minimal residual disease), which would predict patients likely to relapse after RCHOP treatment. But noted there is competition to get patients for this trial.

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 could enter clinical trials in mid-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.

ALL-316 is a Phase 1 trial for advanced Renal Cell Carcinoma, had a November early data readout showing an ORR of 50% in High CD70 tumors. Believes this is very meaningful, given the patient population. But there were two dose limiting toxicity events and three Grade 5 adverse events. As of March 2025 completed enrollment in Phase 1b expansion cohort. Continues to work on safety with diagnostics and improved protocol. Next data release mid-2025. 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 $60.5 million, consisting of: R&D $45 million; G&A $15.5 million; impairment $0 million. Loss from operations was $60.5 million. Other income net $1 million. Income tax $0.4 million.

Cash and equivalents ended at $373 million, down sequentially from $403 million.

Q&A selective summary:

Low disease burden vs. patients in Alpha3 trial? Strong correlation with disease burden for positive results and low adverse affects. Same for allogeneic CAR-T. MRD volume v. second line patients is about 200 fold less disease volume.

Mid 2025 futility in lymphodepletion, is it likely 647 will not be neeeded? We are agnostic on lymphodepletion outcome. Not needing it would be better. But requiring it would protect our status because it is our proprietary property.

DSMB interim bar? Not disclosing specifics. But there is is a formal efficacy test, so we will spend some alpha. We could end up with a statistically significant finding, which would accelerate our interaction with the FDA.

ALLO-329 data by year end, competition? We will start the clinical study in mid-2025, first data expected by year-end. Looking for biomarker based proof of concept. B-cell depletion, recovery, antibodies. Differentiation is allogeneic and ability to activate T-cells. Could lead to longer remissions.

Could you use a milder lymphodepletion agent? In the 329 Phase 1 we plan a milder lymphodepletion regimen. We will also have a cohort with no lymphodepletion.

Alpha3 powering, differences in depletion arms? EFS is primary endpoint. Will have about 110 patients, so well-powered. Our decisions will be data-driven.

Futility analysis will be very standard, really about the totality of the data. Mainly MRD conversion rate. If good, would look at the two lymphodepletion arms to see which is better.

Effects if no lymphoconditioning needed? There is a debate. Lymphodepletion is a barrier, eliminating it would be a game changer, allowing for wider use, for instance with less severe cases.

Plan is to have MRD test approved at the same time as Cema-Cel.

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