Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, will report its second quarter 2026 financial results and provide a business update on August 12, 2026, after the close of the market. This announcement sets the stage for investors to review the company’s progress in developing off-the-shelf CAR T cell product candidates aimed at delivering readily available cell therapy on-demand, more reliably, and at greater scale.

The financial update will be followed by a live audio webcast and conference call scheduled for 2:00 p.m. PT/5:00 p.m. ET on August 12, 2026. Management intends to use this platform to discuss the quarter’s performance and outline future strategic directions for its pipeline of AlloCAR T therapies.

Conference Call and Webcast Details

Investors seeking to participate in the conference call must register in advance to receive a personal PIN for access. The registration process ensures that participants can ask questions during the live session. For those unable to join the live call, a listen-only webcast will be available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. A replay of the webcast will remain accessible on the website for approximately 30 days.

About Allogene Therapeutics

Headquartered in South San Francisco, Allogene Therapeutics is led by cell therapy veterans applying proven CAR T experience to develop a pipeline of off-the-shelf CAR T cell product candidates. The company’s goal is to address unmet medical needs by making cell therapy more accessible to patients with cancer and autoimmune diseases.

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include projections regarding Allogene’s ability to develop and deliver allogeneic CAR T products. Various factors may cause material differences between expectations and actual results, including risks related to novel technologies, development timelines, safety, efficacy, and regulatory approval. These risks are discussed in greater detail in Allogene’s filings with the SEC, including under the "Risk Factors" heading in its Form 10-Q filed for the quarter ended March 31, 2026. Any forward-looking statements speak only as of the date of this press release, and Allogene assumes no obligation to update them based on new information or future events.

Allogene Therapeutics, Inc. (Nasdaq: ALLO) has secured Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for cemacabtagene ansegedleucel (cema-cel). The designations target adult patients with large B-cell lymphoma (LBCL) who are minimal residual disease (MRD)-positive after first-line therapy. This regulatory progress is driven by strong interim data from the pivotal ALPHA3 trial, which demonstrated a 58.3% MRD clearance rate in the cema-cel arm compared to 16.7% in the observation arm, signaling potential to transform first-line consolidation care.

The FDA granted the RMAT designation following a full review of the interim futility analysis from the ongoing ALPHA3 trial. The Fast Track designation further supports expedited development and review, including potential eligibility for rolling review and priority review. These mechanisms enable more frequent engagement with the FDA, reducing uncertainty and time-to-market for this allogeneic CAR T (AlloCAR T) product. The designations underscore the continued need for new treatment options for high-risk LBCL patients who are at risk of relapse despite achieving complete or partial response to initial chemoimmunotherapy.

Clinical Data Driving Regulatory Milestones

The regulatory approvals were based on protocol-defined data cutoff results from the ALPHA3 trial, triggered when the 24th patient completed the Day 45 MRD assessment. The trial uses Natera’s CLARITY™ MRD assay to identify patients in remission but likely to experience disease recurrence. Key findings include:

Published literature suggests that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion. The observed 41.6% absolute difference exceeds this benchmark, supporting the therapy’s potential efficacy. Additionally, cema-cel induced rapid and substantial MRD clearance, with a 97.7% median decrease in plasma ctDNA at Day 45 compared to a 26.6% median increase in the observation arm.

Safety Profile and Outpatient Potential

Cema-cel was well-tolerated as of the data cutoff, with no treatment-related serious adverse events reported. 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. Most patients were managed in the outpatient setting.

This safety profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common. Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene Therapeutics, noted that these findings support cema-cel’s potential as an off-the-shelf therapy that can be delivered at scale in community settings, where approximately 80% of first-line patients receive their care.

What the Numbers Show

The combination of high MRD clearance rates and a robust safety profile positions cema-cel to address significant unmet needs in LBCL treatment. The 41.6% absolute difference in MRD clearance between the cema-cel and observation arms is a key differentiator, suggesting superior efficacy over the current standard of care (close observation). Furthermore, the ability to administer the therapy in an outpatient setting without hospitalizations could reduce healthcare costs and improve patient access. Investors should monitor upcoming clinical trial data readouts, as the success of the RMAT and Fast Track pathways will ultimately depend on robust clinical evidence supporting the therapy’s safety and efficacy in this precise patient cohort.