Allogene Therapeutics Q1 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, recently provided an update on its corporate developments and financial results for the quarter ending March 31, 2024.

Dr. David Chang, President, CEO, and Co-Founder of Allogene, emphasized the company's progress, particularly the ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel), expected to yield results in 2026. He highlighted the strategic significance of securing rights in the EU and UK for the cema-cel program, which could potentially expand the market opportunity from $6 billion in the U.S. to over $9.5 billion when including the combined territories.

Allogene has expanded its development and commercialization rights for its CD19-directed allogeneic cell therapy products to all EU Member States and the UK, previously held by Servier. This extension not only broadens the market potential but also positions the company for further partnerships to enhance its commercial reach. Additionally, Allogene has future options to acquire rights in Japan and China, contingent on demonstrating adequate resources.

The pivotal Phase 2 ALPHA3 trial for cema-cel, targeting first-line (1L) consolidation treatment in Large B Cell Lymphoma (LBCL), is set to commence in mid-2024. This trial will involve about 240 patients, aiming to demonstrate significant improvement in event-free survival (EFS) compared to standard care. The trial leverages a novel minimal residual disease (MRD) test developed in collaboration with Foresight Diagnostics, which aims to predict relapse risk more accurately. Cema-cel will be administered as a one-time infusion immediately upon MRD detection following standard 1L chemoimmunotherapy. The study's key data readouts are scheduled for 2026, with a Biologics License Application (BLA) submission planned for 2027.

In chronic lymphocytic leukemia (CLL), the Phase 1 trial for relapsed/refractory (r/r) patients is ongoing, with initial data expected by the end of 2024. Given the challenges associated with autologous CAR T therapy in CLL, the trial explores the potential of allogeneic CAR T to enhance treatment efficacy.

For autoimmune diseases (AID), Allogene is developing ALLO-329, incorporating Dagger® technology to eliminate the need for lymphodepletion while targeting CD19+ B-cells and CD70+ activated T-cells. An Investigational New Drug (IND) application is planned for Q1 2025, with proof-of-concept data anticipated by year-end 2025.

In renal cell carcinoma (RCC), the ongoing TRAVERSE trial for ALLO-316 received a $15 million grant from the California Institute for Regenerative Medicine (CIRM). This trial employs a unique diagnostic and treatment algorithm to manage hyperinflammatory responses while maintaining CAR T function. Data updates from the trial are expected by the end of 2024.

Financially, Allogene reported a net loss of $65 million for Q1 2024, with research and development expenses amounting to $52.3 million. The company ended the quarter with $397.3 million in cash, cash equivalents, and investments, projecting a cash runway into 2026. The company expects to reduce its cash reserves by approximately $200 million in 2024, with anticipated GAAP operating expenses of around $300 million, inclusive of non-cash stock-based compensation expenses.

Allogene continues to advance its core programs, believing it is well-positioned to significantly impact the CAR T treatment landscape for the benefit of patients.