Allogene Therapeutics (NASDAQ:ALLO) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below.
This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/.
The full earnings call is available at https://edge.media-server.com/mmc/p/nduedo4c/
Summary
Allogene Therapeutics reported a strong cash position of $266.9 million as of March 31, 2026, with an additional $200.4 million raised in April, extending their cash runway into Q1 2029.
The company’s lead program, Semacel, showed promising results in the Alpha 3 trial, achieving a 58.3% MRD clearance rate compared to 16.7% in the observation arm, with no treatment-related hospitalizations.
Allo 329 is advancing in early clinical development for autoimmune indications, demonstrating initial signs of clinical activity with favorable tolerability.
The company expects continued progress in its clinical programs and plans to provide further updates in Q4 2026.
Management expressed optimism about the future, focusing on execution and scalability, particularly with the potential for outpatient CAR T administration.
Full Transcript
OPERATOR
Hello. Thank you for standing by and welcome to Allogene Therapeutics first quarter 2026 conference call. After the speaker’s presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising. Your hand is raised to withdraw your question. Please press star 11 again. Please be aware that today’s conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Corporate affairs and brand strategy officer. Ms. Cassiano, please go ahead.
Christine Cassiano (Chief Corporate Affairs and Brand Strategy Officer)
Thank you, operator. And welcome everyone to Allogene’s conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the first quarter of 2026. This press release and today’s webcast are available on our website. Following our prepared remarks, we will host a Q and A session and will aim to keep the call to under an hour. I am joined today by Dr. David Chang, President and Chief Executive Officer, Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, and Jeff Parker, Chief Financial Officer. During today’s call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecasts, potential treatment settings and financial guidance, among other things. These forward looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward looking statements and Allogene disclaims any obligation to update these statements. I’ll now turn the call over to David.
David Chang (President and Chief Executive Officer)
Thank you, Christine. As we move through 2026, next generation cell therapy is shifting from promise to proof. The field is increasingly being defined by differentiated clinical evidence rather than platform ambition alone. At Allogene, our lead program, Semacel, is built around the clear objective to establish a differentiated development path. That strategy is now translating into data that provides support for our approach. Our second program, Alo 329 in Autoimmune Indications, is built on the same principle of product differentiation enabled by our understanding of CAR T design and the biology of allogenic rejection. While these two programs are at different stages of development, the evidence emerging to date is consistent and aligned with the design principles behind each. Starting with Alpha 3, we have taken an innovative approach of treating patients with Semacel in the first line consolidation setting for large B cell lymphoma with a primary goal of improving the cure rates. The key to achieving this goal is democratizing access by breaking the barriers that have historically limited the use of CAR T and by enabling Semacel to be delivered in the outpatient setting. We are very pleased with what we’ve seen in the recently announced interim fertility analysis from the Alpha3 trial. In this 24 patient analysis, Semacel achieved a 58.3% MRD clearance rate compared with 16.7% in the observation arm representing a 41.6% absolute difference. While preliminary, this differential exceeded threshold of MRD clearance reported in other trials that led to groundbreaking clinical outcomes. We also observed a rapid and substantial reduction in circulating tumor DNA or CTDNA in the Semacel arm while the opposite trend was seen in the observation arm where the CTDNA levels increased. Together, these early findings provide evidence consistent with the biological activity of Semacel in the first line consolidation setting as we advance Alpha 3 towards the next key milestone, the interim EFEFS analysis in mid-2027. Importantly, as we consider use in the outpatient community setting, this early biomarker efficacy signal was accompanied by a favorable safety profile. We observed no CRS or ICANS or treatment related hospitalization enabling the majority of patients to be managed in the outpatient setting. These results reflect the trial that was designed to lead, not follow. Under Zach’s leadership. Alpha 3 was built around MRD testing as a point of intervention rather than passive observation, an approach that moved beyond conventional trial design. We set out to test a forward looking thesis and these early data reaffirm my conviction that we are not only in the right path but ahead of the curve. Taken together, we believe these data provide compelling support for a different paradigm, one where SEMISA can be used earlier, made readily available, delivered broadly and potentially integrated into routine care beyond specialized Centers. Turning to Alo 329, the program is progressing through early clinical development in autoimmune indications with the Resolution Basket trial advancing efficiently through dose escalation. This progress embodies the same disciplined and forward looking development approach that underpins Alpha 3. ILO329 incorporates the Dagger technology which is designed to overcome premature rejection of allogeneic CAR T cells. This technology has previously been validated as part of our Allo 316 program in the metastatic solid tumor setting. However, autoimmune disease represents a fundamentally different clinical context with distinct biology and the different threshold for safety and tolerability. With that in mind, we designed a structured and stepwise clinical approach to beginning at a conservative dose level to establish clear understanding of tolerability before progressing to therapeutic dose levels. Patients treated to date are within this initial dosing range. As we evaluate both dose and lymphodepletion strategy, our focus is on characterizing how the therapy behaves in patients by establishing a tolerability profile that supports continued development while also assessing early signs of activity. Within this framework, we are very pleased with the pace of enrollment and are beginning to observe initial signs of clinical activity coupled with favorable tolerability whilst still early. These findings are highly encouraging and have important implications for the overall dosing paradigm which includes not only the dose of Dagger enabled Alo329 but also the required lymphoid depletion regimen. As the program progresses, we expect continued dose escalation and patient follow up to further establish the activity, tolerability and mechanistic profile of L329. We look forward to providing a further update in the fourth quarter. With that, I will turn it over to Zach to walk through the data in more detail.
Zachary Roberts (Executive Vice President of Research and Development and Chief Medical Officer)
Thanks David. I’ll start with Alpha 3 and then turn to Allo329. Alpha 3 was designed around a clear clinical hypothesis that intervening at the point of molecularly detectable disease before clinical relapse can meaningfully alter the course of disease. When we initiated the study, MRD was emerging as a prognostic tool in lbcl. Our objective was to move MRD beyond risk assessment and into a treatment decision point across oncology. We are now seeing the shift in approaching a potential breakout moment. A case in point is the Invigor 11 trial which evaluated Tecentriq in muscle invasive bladder cancer. In the trial, patients who were in remission but remained MRD positive after the standard first line procedure of complete surgical resection were randomized to Tecentriq or placebo with Tecentriq demonstrating improvement in both disease free and overall survival. The results of this trial could establish MRD as a clinically actionable endpoint following standard first line treatment. If approved for this indication, Tecentriq would become the first therapy for which treatment initiation is guided by an ultrasensitive CTDNA MRD assay rather than clinical progression, a defining moment for the field. Against this backdrop, Alpha 3 is positioned at the forefront of how this new paradigm could evolve in large B cell lymphoma. As the first pivotal trial designed to use MRD positivity as the trigger for CAR t therapy, the Alpha 3 study is enrolling patients who have responded to first line therapy but remain MRD positive and therefore at high risk of relapse. Patients are randomized to treatment with Semacel or observation. We partnered with Foresight, Now a wholly owned subsidiary of Natera, to utilize their Clarity MRD assay, enabling a highly sensitive and dynamic view of disease burden over time. This enhanced sensitivity, detecting disease at or even below one in a million or ten to the minus six is central to the design of Alpha 3 study and how we interpreted our interim futility data. At the interim analysis, we evaluated the first 24 patients enrolled in the ongoing two arms a single dose of semacell versus observation. We observed a 58.3% MRD clearance rate in the Semacell arm compared to a 16.7% in the observation arm representing a 41.6 percentage point absolute difference. We also saw a rapid and substantial reduction in circulating tumor DNA at the day 45 time point. The median CTDNA level decreased by nearly 98% in the semi cell arm while the median CTDNA level increased by more than 26% in the observation arm. The Alpha 3 Interim Futility Analysis rests on the assumption that MRD clearance fails foreshadows clinical benefit. This hypothesis is supported by a growing body of evidence in various clinical settings including NLBCL, linking MRD clearance in the range of 25 to 30% with meaningful reductions in EFS events. The magnitude of the difference we just announced exceeds that range. While these external data sets support the relationship between MRD clearance and clinical outcomes, the impact on EFS and durability will ultimately be determined through our planned interim and primary EFS analyses. From a safety and treatment administration perspective, we observed no CRS, ICANS or treatment related hospitalizations enabling the majority of patients to be managed entirely in the outpatient setting. We believe this encouraging tolerability profile is a function of treating patients earlier when disease burden is low, which is inherent to the Alpha 3 design. If the safety profile observed in the interim futility analysis bears out in the study overall, it could mark an important shift towards outpatient CAR T administration and enable semi cell treatment in community practices where most patients with LBCL receive care. As Alpha 3 progresses, interest in the study is growing. First and foremost, we are seeing robust engagement from existing clinical sites resulting in high rates of patient screening. At the same time, new sites are expressing significant interest in joining the study, further reinforcing its momentum. From an execution standpoint, the trial continues to scale. We are now enrolling across more than 60 sites with global expansion underway. We recently announced regulatory approval in Australia and South Korea, where site activations and patient screening have begun. We anticipate the Asia Pacific region to expand the study footprint to over 80 sites worldwide. These are not incremental additions. Australia and South Korea offer established clinical research infrastructure, experienced investigators and highly efficient healthcare systems. This expansion reflects both strong global investigator interest and the operational discipline required to execute at scale. We are also seeing meaningful participation from community cancer centers which contributed approximately one third of screening and semi treatments in our interim futility analysis. This is an important early proof point for the feasibility of broader administration as we look to move beyond specialized centers and into broader clinical practice. Let me now turn to Allo329 which as a first in human phase one trial has a different objective at this stage of development. The program is supported by robust pre clinical data recently published in Nature Communications supporting the design of Allo329. These data demonstrated an optimized CD70 car engineered to protect allogeneic CAR T cells from rejection by eliminating alloreactop host T cells. In those studies, co expression of CD 70 and CD 19 cars drove sustained car T cell persistence, elimination of pathogenic B cells and activated CD70 positive T cells in humanized SLE models, and corresponding reductions in autoantibody production. Importantly, the DAGGER technology which eliminates allureactive host T cells has been clinically validated by our third clinical program and first CD70 targeting program, ALLO316, with recently reported outcome data further supporting the approach and reinforcing our plans to advance the program in the near future. At this stage of development, our focus for Allo329 is to define a tolerability profile that supports continued dose escalation while generating early evidence that Allo329 can achieve meaningful biological activity in autoimmune disease consistent with its differentiated dual targeting mechanism. The Resolution Basket trial, which includes patients with systemic lupus erythematosus with and without …
This post was originally published here
