Analyst Conference Summary

biotechnology

conference date: November 7, 2024 @ 2:00 PM PT
for quarter ending: September 30, 2024 (third quarter, Q3)

Forward-looking statements

Overview: continues clinical trials.

Basic data (GAAP):

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

GAAP Net Income was negative $66 million, flat sequentially from negative $66 million, and down from negative $62 million year-earlier.

GAAP EPS was negative $0.32, up sequentially from negative $0.35, and up from negative $0.37 year-earlier. Increase due to increased share count.

Guidance:

Cash runway to H2 2026. 2024 cash burn about $200 million, GAAP op ex $300 million, of which $60 million is non-cash stock-based compensation.

Conference Highlights:

David Chang, CEO said "We are proud of the progress made in the third quarter of 2024 to advance our investigational allogeneic cell products in key firsts – our first-line consolidation trial in large B-cell lymphoma with cema-cel, ALLO-316 as the first allogeneic CAR T product candidate to demonstrate positive results in solid tumors, and the first CD19/CD70 dual CAR T candidate specifically designed for autoimmune disease. We believe these efforts have the potential to redefine treatment paradigms, tailoring therapies to meet the unique needs of large patient populations, and enabling broader real-world adoption. Allogene remains dedicated to driving innovation that improves outcomes for patients with both cancer and autoimmune diseases."

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.

Cema-cel is also enrolling a Phase 1 trial in r/r CLL (chronic lymphocytic leukemia). An initial readout could occur in early 2025.

ALLO-329 for autoimmune disease could enter clinical trials in 2025 after an IND in Q1. Plans to target both CD19 and CD70. Has Dagger technology to eliminate lymphodepletion. Preclinical data will be presented at ACR on November 18, 2024.

ALL-316 is enrolling a Phase 1 trial for advanced Renal Cell Carcinoma with 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 November 2024 is in Phase 1b. Continues to work on safety with diagnostics and improved protocol.

Total operating expenses (GAAP) were $72 million, consisting of: R&D $45 million; G&A $16 million; impairment $11 million. Loss from operations was $72 million. Other income net $5 million.

Cash and equivalents ended at $403 million, down sequentially from $445 million.

Q&A selective summary:

RCC expansion cohort timing? We are looking for 20 patients in the expansion cohort. We will have a program update next year?

Dagger in 316, implications for 329? We have demonstrated efficacy with substantially reduced lymphodepletion regimen. We believe that will work for 329 as well. We do see safety as more complex in advanced cancer patients from autoimmune patients. So we think the therapy intensity can be lower for 329.

Grade 5 event details? For this type of patient there is never a simple adverse event.

IEC-HS? We are getting better at managing this hyper-inflamatory event, pathological and biochemical hyperinflammatory syndrome, or IEC-HS (Immune Effector Cell-associated HLH-like Syndrome)

Cema-cel for CLL enrollment? Great response from sites. Onboarding sites quickly. Early sites are community sites, some without CAR T experience.

316 CD 52 differential? It is a small number, seeing responses in FC, which is interesting. Would not read too much into the difference.

316 durability goal? The bar is low. 2 patients in first group in ongoing partial remission. We have good access for communicating with the FDA. We will just have to wait for durability data, then discuss with FDA.

PRs v. CRs? We have collected a number of tumor biopsies, is in the poster, shows 316 ability to get into the tumor. We had one complete metabolic remission that deepened to a CR but then the patient caught covid and died. Other PRs are ongoing and deepening.

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