Analyst Conference Summary

biotechnology

conference date: March 14, 2024
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $0, flat from year-earlier.

GAAP Net Income was negative $85.8 million, up from negative $97.3 million year-earlier.

GAAP EPS was negative $0.51, up from negative $0.67 year-earlier.

Guidance:

Expects to burn about $190 million in cash in 2024. Believe runway is until 2026.

Conference Highlights:

David Chang, CEO said "e are more enthusiastic than ever about the potential for allogeneic CAR T to transform the field. From our innovative ALPHA3 trial which is designed to embed cema-cel as part of a curative first-line regimen for patients with large B cell lymphoma, to specifically creating a CAR T that can meet the unique needs of patients with autoimmune disease and reduce reliance on lymphodepletion, our development approach focuses on the distinctive attributes of an off-the-shelf alternative and creates an advantage for our AlloCAR T programs... We are no longer developing CAR T using an outdated playbook. Now that we have established the viability of our allogeneic platform, our product can be developed using a fresh approach created for what we do, both in design of our trial and design of our constructs to meet the current and future needs of patients and dramatically expand opportunity."

Cema-Cel (ALLO-501A or cemacabtagene ansegedleucel) for large B cell lymphona (LBCL) is preparing for a pivotal Phase 2 study, Alpha3 for first line treatment for patients likely to relaspse following immunotherapy. Cema-Cel is an allogeneic cell therapy. 250 MRD positive patients to get Cema-Cel or current standard of care. EFS primary endpoint. Could begin mid-2024.

Cema-cel is also enrolling a Phase 1 trial in r/r CLL (chronic lymphocytic leukemia). An initial readout could occur by the end of 2024.

ALLO-329 for autoimmune disease could enter clinical trials in 2025. Plans to target both CD19 and CD70.

ALL-316 is in a trial for Renal Cell Carcinoma with an early data readout planned for Q2 2024 and then an update later in 2024.

Allogene believes the addressable Cema-Cel market could be upwards of $3 billion, which could easily be doubled if expanded to ex-US.

Total operating expenses (GAAP) were $85.1 million, consisting of: R&D $54.7 million; G&A $17.2 million; impairment $13.2 million. Loss from operations was $85.1 million. Other expense net $0.7 million.

Cash and equivalents ended at $449 million.

Q&A selective summary:

Why do you think you can do autoimmune therapy without the lymphodepletion step? Because ALLO-329 targets both CD19 and CD70, which play an active role in autoimmune disease. With Dagger 329 could work well independent of using a CD52 antibody. We have some clinical data supporting this. This should make ALLO-329 scalable and persistent, able to reset the immune system.

Partnership with Arbor? The CRISPR platform will give us more flexibility.

Enrollment for Cema-Cel LBCL study? Confident will quickly enroll. MRD clearance is big.

Autoimmune potential targets? Lupus, nephritis, multiple sclerosis. Will finalize the decision on the initial indication in a few months.

CLL competiton? We believe the T cells coming from a healthy donor will work better than from a sick patient's leukapheresis.

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