On May 13, 2026 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 March 31, 2026.

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"We are encouraged by the interim results from our ALPHA3 trial, which highlight cema-cel’s potential to deliver meaningful MRD clearance with a favorable safety profile in the outpatient setting," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "These findings support our belief that an allogeneic approach can expand access to CAR T earlier in treatment and into community-based practices, where most patients are treated. We are also encouraged by investigator enthusiasm and rapid enrollment and dose escalation in the ALLO-329 RESOLUTION trial as we evaluate the optimal cell dose and lymphodepletion regimen. With the capital raised in April, we believe we are well positioned to execute across our clinical programs and key milestones."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The Company’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the ALPHA3 trial, the first pivotal, randomized Phase 2 study in LBCL designed to assess whether MRD-guided intervention before relapse can potentially delay or prevent recurrence. The study identifies high-risk patients using Natera’s CLARITY MRD assay which is powered by its phased variant MRD technology.

In April, the Company reported data from the planned interim futility analysis of ALPHA3. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature suggests that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion.

Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and there were no treatment-related hospitalizations. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common.

At the time of the interim analysis, community cancer centers accounted for approximately one-third of screening activity and cema-cel infusions, including sites with limited or no prior CAR T experience. The Company believes participation from these centers, where most patients with LBCL are treated, supports the potential for cema-cel to be delivered beyond specialized academic institutions.

Approximately 80% of patients diagnosed with LBCL receive first-line treatment in the community setting, where autologous CAR T is not readily available. Despite strong clinical efficacy, access to autologous CAR T remains highly constrained, with only approximately 15% of eligible second-line patients receiving treatment.1 These well-documented barriers, including referral patterns, infrastructure requirements, management of adverse events, which requires hospitalization for a substantial portion of patients, and manufacturing constraints, underscore the need for a more accessible, scalable approach which ALPHA3 and cema-cel are designed to address.

MRD status post-treatment has emerged as a strong predictor of relapse in LBCL, creating a potential opportunity to intervene earlier in the course of disease, when disease burden is low, but the risk of progression remains high.2 3 Patients with LBCL who have completed curative-intent treatment in both front-line and later line settings, including autologous CAR T therapy, and achieve MRD-negative status have demonstrated improved progression-free survival (PFS) and EFS compared to those who do not.4 5

The study is currently enrolling across more than 60 sites in North America and is now expanding globally, with site activation and patient screening underway in South Korea and Australia, which will bring the trial to more than 80 sites worldwide. The study is expected to enroll approximately 220 patients, with enrollment anticipated to complete by the end of 2027. The study is powered to detect a 50% reduction in the risk of EFS events, which include the initiation of new anti-lymphoma therapy, disease progression, or death from any cause. The Company anticipates an interim EFS analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, these results could support a Biologics License Application (BLA) submission.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeted CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. Dagger is designed to provide built-in, targeted lymphodepletion by selectively eliminating activated CD70-positive T cells responsible for rejecting AlloCAR T products. This approach is intended to enable robust expansion of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion.

The ongoing Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating ALLO-329 following lymphodepletion with cyclophosphamide, with an option to add fludarabine, and a separate arm with no lymphodepletion.

Nine patients have been treated, including six patients across Dose Level 1 (20 million cells) and Dose Level 2 (40 million cells) following lymphodepletion with cyclophosphamide, and three patients across Dose Level 1 (20 million cells) with no lymphodepletion since enrollment began in November 2025. Initial observations at these early low dose levels show signs of clinical activity and favorable tolerability. For context, other CAR T programs in autoimmune trials are evaluating substantially higher dose levels ranging from approximately 100 million cells (autologous) to over 1 billion cells (allogeneic).

Enrollment continues to progress, supported by a strong pool of eligible patients and robust investigator interest in the program. The next update is expected in Q4 2026.

2026 First Quarter Financial Results

Research and development expenses were $32.0 million for the first quarter of 2026, which includes $2.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $14.1 million for the first quarter of 2026, which includes $5.6 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2026 was $42.6 million, or $0.18 per share, including non-cash stock-based compensation expense of $8.3 million.
The Company had $266.9 million in cash, cash equivalents, and investments as of March 31, 2026.

In April 2026, the Company completed a public offering which resulted in aggregate gross proceeds of $200.4 million, before deducting underwriting discounts and commissions and estimated offering expenses. As a result, the Company has extended its cash runway into the first quarter of 2029. Based upon our current forecast for the overall timing of the ALPHA3 program, we are modestly increasing our guidance for operating cash expense in 2026 from approximately $150 million to $165 million. GAAP Operating Expenses are also expected to modestly increase from approximately $210 million to $225 million, including estimated non-cash stock-based compensation expense of approximately $35 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, MAY 13, 2026, View Source [SID1234665621])