On August 12, 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 June 30, 2026.
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"When we reset our strategy in 2024, we started with the patient and focused on where the distinct attributes of allogeneic CAR T could create a clinical advantage," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "ALPHA3 is the clearest expression of that strategy: identifying patients at high risk of relapse, treating before disease returns clinically, and enabling CAR T delivery where patients already receive care. We took the same patient-first approach with ALLO-329, recognizing early that chemotherapy-based lymphodepletion and treatment interruptions associated with leukapheresis in autologous therapy could create meaningful burdens for patients with autoimmune disease. Together, these programs demonstrate that the value of allogeneic CAR T extends well beyond off-the-shelf availability, offering the flexibility to address clinical and practical barriers other approaches cannot. We believe the scale of that opportunity will become increasingly apparent as our programs continue to advance."
Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
Cemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized Phase 2 trial in LBCL designed to assess whether MRD-guided treatment following first-line therapy can delay or prevent clinical relapse.
In July, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following review of the interim futility analysis. 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, with the majority clearing MRD by the first post-treatment assessment, 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 and cross-study benchmarks suggest 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), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common.
Most patients were treated and followed entirely in the outpatient setting. 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. These findings support ALPHA3’s potential to bring CAR T earlier in the course of disease and closer to where patients receive care.
The Company achieved its 2026 goal of activating more than 80 sites approximately six months ahead of schedule, driven by strong execution and increased investigator interest following the interim futility analysis. The Company now expects approximately 100 sites to be active by year-end, with the significant majority in the United States and additional sites in Canada, Australia and South Korea. This expansion is expected to support enrollment momentum, broaden access to the trial, and provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch.
ALPHA3 is expected to randomize approximately 220 MRD+ patients to either cema-cel consolidation or close observation, with enrollment anticipated to be completed by year-end 2027. The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027.
ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive host T cells, with the goal of supporting CAR T-cell expansion while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion.
The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating cell dose of ALLO-329 and the role played by Dagger with and without lymphodepletion across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis.
Enrollment continues at a brisk pace across cohorts, dose levels and lymphodepletion strategies. The Company remains on track to provide a clinical and translational update in the fourth quarter of 2026.
2026 Second Quarter Financial Results
•Research and development expenses were $30.7 million for the second quarter of 2026, which includes $2.1 million of non-cash stock-based compensation expense.
•General and administrative expenses were $20.8 million for the second quarter of 2026, which includes $10.3 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2026 was $42.7 million, or $0.13 per share, including non-cash stock-based compensation expense of $12.4 million.
•The Company had $423.6 million in cash, cash equivalents, and investments as of June 30, 2026.
Based on its cash, cash equivalents, and investments as of June 30, 2026, the Company currently projects its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $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, AUG 12, 2026, View Source [SID1234670014])