Allogene Therapeutics (NASDAQ:ALLO) said its first quarter of 2026 was marked by early clinical progress for its lead allogeneic CAR-T programs and a strengthened cash position following an April financing.
On the company’s quarterly conference call, President and Chief Executive Officer Dr. David Chang said Allogene’s lead program, cema-cel, is being developed with the goal of moving CAR-T treatment earlier in large B-cell lymphoma and making it more accessible outside specialized centers.
Cema-cel interim analysis shows MRD clearance signal
Allogene highlighted the recently announced interim futility analysis from its ALPHA3 trial, which is evaluating cema-cel in the first-line consolidation setting for large B-cell lymphoma patients who have responded to first-line therapy but remain minimal residual disease, or MRD, positive.
In the 24-patient analysis, cema-cel achieved a 58.3% MRD clearance rate compared with 16.7% in the observation arm, representing a 41.6 percentage point absolute difference. Chang said the result exceeded thresholds of MRD clearance reported in other trials that were associated with significant clinical outcomes.
Dr. Zachary Roberts, executive vice president of research and development and chief medical officer, said ALPHA3 was designed to test whether intervening when disease is detectable at a molecular level, before clinical relapse, can change the course of disease. The trial uses the CLARITY MRD assay from Foresight, now a wholly owned subsidiary of Natera, which Roberts said can detect disease at or below 1 in 1 million.
Allogene also reported that circulating tumor DNA levels fell sharply in patients treated with cema-cel. At day 45, the median ctDNA level decreased by nearly 98% in the cema-cel arm, while the median ctDNA level increased by more than 26% in the observation arm.
Roberts cautioned that the relationship between MRD clearance and event-free survival will ultimately be determined through the company’s planned EFS analyses. Allogene expects an interim EFS analysis in mid-2027 and a primary analysis in mid-2028, according to Chief Financial Officer Geoffrey Parker.
Safety profile supports outpatient focus
Management emphasized that the interim ALPHA3 analysis showed no cytokine release syndrome, no ICANS and no treatment-related hospitalizations, enabling most patients to be managed in an outpatient setting. Roberts said the company believes the tolerability profile may be related to treating patients earlier, when disease burden is lower.
Chang said the safety findings are important to the company’s goal of expanding CAR-T administration into community practices. In response to analyst questions, Roberts said feedback from community and academic sites following the interim data has been “overwhelmingly and uniformly positive,” with some community networks seeking to add additional sites to the study.
Allogene said ALPHA3 is enrolling across more than 60 sites, with expansion underway in Australia and South Korea following regulatory approvals. Roberts said the Asia-Pacific expansion is expected to bring the trial footprint to more than 80 sites worldwide. Community cancer centers contributed about one-third of screening and cema-cel treatments in the interim futility analysis, he added.
ALLO-329 autoimmune study advances through dose escalation
Allogene also discussed ALLO-329, its allogeneic CAR-T candidate for autoimmune diseases, which is being evaluated in the Phase 1 RESOLUTION basket trial. The study includes patients with systemic lupus erythematosus with and without nephritis, scleroderma and inflammatory myositis.
Roberts said nine patients have been treated since enrollment began in November 2025. Three patients received 20 million cells with cyclophosphamide lymphodepletion, three received 40 million cells with cyclophosphamide, and three received 20 million cells without lymphodepletion.
The company said investigators have reported early signs of clinical activity at the doses tested so far, both with and without cyclophosphamide, while tolerability has been favorable. Management declined to provide detailed activity or B-cell reduction data, saying a more comprehensive update is expected in the fourth quarter.
Chang said Allogene is targeting a safety profile that would allow ALLO-329 to be administered and managed in the outpatient setting. Roberts said the company does not currently see a need to change the dose-escalation plan and is continuing to increase doses, with the next cohort at 80 million cells.
In the Q&A session, management said the fourth-quarter update could include data beyond the 20 million and 40 million cell doses, depending on enrollment pace. Roberts also said the company plans to analyze both B-cell and T-cell repertoires as part of the study, reflecting ALLO-329’s design to target CD19 and CD70.
Cash runway extended into 2029
Parker said Allogene ended the first quarter with $266.9 million in cash, cash equivalents and investments. In April, the company completed a public offering that generated approximately $200.4 million in gross proceeds, extending its cash runway into the first quarter of 2029.
First-quarter research and development expenses were $32 million, including $2.7 million of non-cash stock-based compensation. General and administrative expenses were $14.1 million, including $5.6 million of non-cash stock-based compensation.
Allogene reported a first-quarter net loss of $42.6 million, or $0.18 per share, including $8.3 million of non-cash stock-based compensation expense.
The company modestly increased its 2026 operating cash expense guidance to approximately $165 million, up from $150 million. GAAP operating expenses are now expected to be approximately $225 million, up from $210 million, including estimated non-cash stock-based compensation expense of about $35 million. The guidance excludes any potential business development activity.
Parker said the runway is intended to support completion of the ALPHA3 study and the Phase 1 RESOLUTION study for ALLO-329. Chang closed the call by saying Allogene’s focus is on completing ALPHA3 enrollment, advancing ALLO-329 through dose escalation and generating data to define the role of allogeneic CAR-T in oncology and autoimmune disease.
About Allogene Therapeutics (NASDAQ:ALLO)
Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic, or “off-the-shelf,” chimeric antigen receptor T-cell (CAR T) therapies to treat a range of hematologic malignancies and solid tumors. The company leverages gene-editing technologies to generate universally compatible engineered T cells, aiming to overcome the limitations of patient-specific CAR T approaches such as manufacturing delays, variable product quality and treatment resistance.
The company’s pipeline includes multiple allogeneic CAR T candidates targeting key antigens in blood cancers.
