Allogene Therapeutics Q2 2024 Financial Results and Business Update

Allogene Therapeutics, Inc., a biotechnology firm specializing in allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, has announced significant updates and financial results for the quarter ending June 30, 2024. The company is advancing its clinical trials and solidifying its financial stance, reflecting its commitment to revolutionizing CAR T therapies.

The company has commenced its pivotal Phase 2 ALPHA3 trial in June 2024, targeting large B-cell lymphoma (LBCL) patients. This groundbreaking study involves cemacabtagene ansegedleucel (cema-cel) in a first-line (1L) consolidation treatment for patients likely to relapse following standard 1L treatment. With ten community and academic sites already open, patient screening and enrollment are proceeding smoothly. The trial aims to enroll approximately 240 patients, utilizing the Foresight CLARITY™ Investigational Use Only (IUO) MRD test powered by PhasED-Seq™. The main objective is to demonstrate a substantial improvement in event-free survival (EFS) compared to the current standard of care, which is observation. Allogene expects to complete enrollment in the first half of 2026, with interim EFS analysis reviewed by an independent Data Safety Monitoring Board and a potential Biologics License Application (BLA) submission by 2027.

In addition to the ALPHA3 trial, ongoing enrollment continues for the Phase 1 ALPHA2 trial of cema-cel in chronic lymphocytic leukemia (CLL), focusing on patients with relapsed/refractory (r/r) CLL. Initial data from this cohort is anticipated by early 2025.

Allogene has also made strides with its ALLO-329 product, designed for autoimmune diseases (AID). ALLO-329 incorporates Dagger® technology aimed at eliminating or reducing the need for lymphodepletion while targeting CD19+ B-cells and CD70+ activated T-cells. An Investigational New Drug (IND) application is expected in Q1 2025, with proof-of-concept data projected by the end of 2025.

In renal cell carcinoma (RCC), the Phase 1 TRAVERSE trial involving ALLO-316 is progressing. A data update from around 20 patients with CD70 positive RCC is expected by the end of 2024. This update will include details on the diagnostic and treatment algorithm designed to mitigate the hyperinflammatory response observed in some patients. This effort is supported by a $15 million award from the California Institute for Regenerative Medicine (CIRM).

Financially, Allogene reported research and development expenses amounting to $50.4 million for Q2 2024, inclusive of $5.3 million in non-cash stock-based compensation. General and administrative expenses were $16.1 million, which includes $8.2 million of non-cash stock-based compensation. The net loss for this quarter was $66.4 million, or $0.35 per share, also factoring in non-cash stock-based compensation and impairment expenses. As of June 30, 2024, Allogene held $444.6 million in cash, cash equivalents, and investments, projecting this to support operations into the second half of 2026. The guidance for 2024 remains unchanged, with an anticipated reduction in cash and investments by about $200 million and GAAP operating expenses expected to be around $300 million, including approximately $60 million in non-cash stock-based compensation.

This quarter underscores Allogene's strategic advancements and steady financial health, reinforcing its mission to innovate CAR T therapies for both cancer and autoimmune diseases.