5/13/2026

speaker
Conference Operator
Operator

Hello, thank you for standing by and welcome to Allotine 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.

speaker
Christine Cassiano
Chief Corporate Affairs & 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&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.

speaker
Dr. David Chang
President & 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 Allergen, our lead program, Semicel, 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, Allo329 in Autoimmune Indications, is built on the same principle of product differentiation enabled by our understanding of CAR-T design and the biology of allergenic 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 semicell 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 therapy and by enabling semacell 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 Alpha-3 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 semicell 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 semicell in the first-line consolidation setting as we advance Alpha-3 towards the next key milestone, the interim EFS 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, 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 that forward-looking thesis, and these early data reaffirmed 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 Semisub can be used earlier, made readily available, delivered broadly, and potentially integrated into routine care beyond specialized centers. Turning to Allo329, the program is progressing through early clinical development in autoimmune indications with a resolution basket trial advancing efficiently through dose escalation. This progress embodies the same discipline and forward-looking development approach that underpins Alpha-3. Allo329 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 Allo316 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, beginning at a conservative dose level to establish clear understanding of tolerability before progressing to therapeutic dose levels. Patients treated today are within this initial dosing range as we evaluate both dose and lymphodepression strategy. Our focus is on characterizing how the therapy behaves in patients by establishing a probability 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. While 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 Allo329, but also the required lymphodepletion regimen. As the program progresses, we expect continued dose escalation and patient follow-up to further establish the activity, tolerability, and mechanistic profile of Allo329. 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.

Disclaimer

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