On March 13, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and reported financial results for the quarter and full year ended December 31, 2024 (Press release, Allogene, MAR 13, 2025, View Source [SID1234651122]).
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"In 2024, we focused on delivering on our bold strategy to achieve what no CAR T has accomplished before," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. "Our recent data, published in the Journal of Clinical Oncology, from the Phase 1 ALPHA/ALPHA2 trials in relapsed/refractory LBCL provided compelling evidence that cema-cel can induce durable remissions comparable to approved autologous CD19 CAR T therapies. With the ALPHA3 first line consolidation trial evaluating cema-cel in LBCL now underway, the ALLO-329 IND clearance to launch the RESOLUTION trial in autoimmune disease, and completion of the Phase 1b cohort with ALLO-316 in the TRAVERSE trial in RCC, we are demonstrating that Allogene’s vision for an "off-the-shelf" cell therapy may not just be a possibility, it could be a reality in hematology, autoimmune diseases, and solid tumors. We believe 2025 will be the year allogeneic CAR T broadly begins to demonstrate its potential to surpass autologous CAR T therapy by reaching more patients with greater accessibility."
Program Updates
Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial remains a central program for the Company. The trial, which initiated in June 2024, now has 40 sites activated and continues to generate strong enthusiasm from both community cancer centers and academic institutions.
This groundbreaking study is evaluating consolidation treatment with cema-cel as part of the 1L treatment regimen for patients with LBCL with minimal residual disease (MRD) after standard 1L treatment with R-CHOP or other chemoimmunotherapy. ALPHA3 is the first pivotal trial to offer CAR T to potentially eradicate MRD to improve cure rates in LBCL.
This innovative ALPHA3 trial will identify patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). The lymphodepletion selection and futility analysis are anticipated around mid-2025. Efficacy analyses from the ALPHA3 trial are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis around YE 2026. A potential biologics license application (BLA) submission is targeted for 2027.
In February 2025, the Journal of Clinical Oncology published data from the Company’s Phase 1 ALPHA/ALPHA2 trials of cema-cel in relapsed/refractory LBCL, demonstrating durable responses comparable to approved autologous CD19 CAR T therapies. In addition, the Company announced that it had expanded its strategic partnership with Foresight Diagnostics to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel.
ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
ALLO-329 offers a novel approach to treating autoimmune diseases as the first allogeneic CD19/CD70 dual CAR T product specifically designed to target CD19+ B-cells and CD70+ activated T-cells, both of which are key players in autoimmune diseases. The investigational product utilizes CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion, believed to be a potentially significant obstacle to the wider adoption of CAR T therapies in autoimmune indications.
In January 2025, the FDA cleared the IND application to initiate clinical trials of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. The innovative design of the RESOLUTION basket trial includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone and another that eliminates lymphodepletion entirely. The trial is scheduled to begin in mid-2025, aiming to provide proof-of-concept around year-end 2025.
During the fourth quarter, the Company presented pre-clinical data for ALLO-329, at the American College of Rheumatology’s annual meeting, showcasing its potential to address both B-cell and T-cell dysfunction in autoimmune diseases.
ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. In Q4 2024, the Company announced positive Phase 1 data from the TRAVERSE trial highlighting a manageable safety profile and significant anti-tumor activity of ALLO-316 in heavily pretreated patients with advanced or metastatic RCC.
Enrollment has completed in the Phase 1b expansion cohort, which is evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T cells). As the product that brought clinical validation of the Dagger effect, clinical activity of ALLO-316 at this dose level is achieved without ALLO-647-enhanced lymphodepletion and follows a standard lymphodepletion regimen with fludarabine and cyclophosphamide. Data from this cohort is planned for mid-2025.
Also during the quarter, the Company announced that it had received Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 for adult patients with advanced or metastatic RCC based on the Phase 1 clinical data from the TRAVERSE trial.
2024 Fourth Quarter and Year-End Financial Results
Research and development expenses were $45.0 million for the fourth quarter of 2024, which includes $5.6 million of non-cash stock-based compensation expense. For the full year of 2024, research and development expenses were $192.3 million, which includes $20.4 million of non-cash stock-based compensation expense.
General and administrative expenses were $15.5 million for the fourth quarter of 2024, which includes $7.3 million of non-cash stock-based compensation expense. For the full year of 2024, general and administrative expenses were $65.2 million, which includes $31.3 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2024 was $59.9 million, or $0.28 per share, including non-cash stock-based compensation expense of $12.9 million. For the full year of 2024, net loss was $257.6 million, or $1.32 per share, including non-cash stock-based compensation expense of $51.7 million and $15.7 million in non-cash impairment of long-lived asset expense.
The Company had $373.1 million in cash, cash equivalents, and investments as of December 31, 2024.
Based on its cash, cash equivalents and investments as of December 31, 2024, the Company continues to expect its cash runway to fund operations into the second half of 2026. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $170 million. GAAP Operating Expenses are expected to be approximately $250 million, including estimated non-cash stock-based compensation expense of approximately $50 million. These estimates exclude any impact from potential business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.