On November 6, 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 announced financial results for the quarter ended September 30, 2025. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings.

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"With our unique allogeneic approach to CAR T, the field has the ability to shift from highly personalized, patient-specific therapies to a new era of readily available, off-the-shelf treatments that can reach more patients earlier in their disease and wherever they receive care," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Having treated hundreds of patients, we’ve gained valuable insight into how ex vivo manufacturing enables more precise definition and control of our cell products before they reach patients, enhancing consistency, safety, and quality. This transformation is evident and goes far beyond incremental progress, it begins to establish a scalable allogeneic CAR T paradigm built to reach more patients, expand into broader care settings, and unlock the full potential of cell therapy."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026.

The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population.

With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated early signs of efficacy and tolerability.

2025 Third Quarter Financial Results

Research and development expenses were $31.2 million for the third quarter of 2025, which includes $2.8 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.7 million for the third quarter of 2025, which includes $5.9 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2025 was $41.4 million, or $0.19 per share, including non-cash stock-based compensation expense of $8.7 million.
The Company had $277.1 million in cash, cash equivalents, and investments as of September 30, 2025.
The Company continues to expect its cash runway to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 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.

(Press release, Allogene, NOV 6, 2025, View Source [SID1234659551])