Analyst Conference Summary

biotechnology

conference date: May 13, 2025 @ 2:00 PM PT
for quarter ending: March 31, 2025 (first quarter, Q1)

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, flat sequentially from negative $60 million, and up from negative $65 million year-earlier.

GAAP EPS was negative $0.28, flat sequentially from negative $0.28, and up from negative $0.38 year-earlier.

Guidance:

Cash runway into 2H 2027. Expected cash burn for 2025 is $170 million.

Conference Highlights:

David Chang, CEO said "In January 2024 we committed to doing what no CAR T had done before . . . One year later that decision looks prescient. We have a treo of highly differentiated clinical assets, each with the potential to be transformative." Taking steps to extend the financial runway, including reductions in manufacturing. Remains confident in FDA competence.

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, but lymphodepletion selection and futility analysis has shifted to 1H 2026. 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. 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 there is competition to get patients for this trial. In Q2 2025 will begin 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 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.

ALLO-316 is a Phase 1b trial for advanced Renal Cell Carcinoma and completed enrolling the cohort. Had a November 2024 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 at ASCO. 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 $65 million, consisting of: R&D $50 million; G&A $15 million; impairment $0 million. Loss from operations was $65 million. Other income net $5 million. Income tax $0 million.

Cash and equivalents ended at $336 million, down sequentially from $373 million. Cash burn was substantially less than GAAP net loss.

Q&A selective summary:

Enrollment in Cema-Cel color? Alpha3 investigators have been enthusiastic. But seeing a persistent 3 to 4 month delay in enrollments after site activations due to site-related issues. But now improving rate of patient consents. 250 is not patients ready to be randomized, it is tested population, positives will translate into enrollments.

Criticisms of MRD do not apply to our study, as it is a risk stratification strategy, not an endpoint. The clinical endpoint is event-free survival. This is a randomized control study, the gold standard.

Sites are now adequately staffed, generally. It took some doing. New sites may still have the issue, but we are better at dealing with it.

We don't expect going to international sites will change the patient population, since RCHOP is used everywhere.

We would consider a reasonable partnership deal in the autoimmune program. That would extend our cash runway.

Site staffing is likely to be an issue in the autoimmune studies as well.

We are starting with the assumption that about 1 in 5 screened patients will be MRD positive.

Has ALLO-316 been de-prioritized? We will make the presentation at ASCO, then can talk about priorities.

Shelf life of cells? Frozen stability appears to be several years. We test over time, so updates later. We believe our inventory will last for all planned clinical studies.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: