Allogene Therapeutics, Inc.

Hello, thank you for standing by and welcome to Allergy and Therapeutics first quarter 2025 conference call. After the speaker's presentation, there will be a question and answer session. As a reminder, to ask a question, you need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please be aware that today's conference 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.

Thank you, Operator, and thanks to all of you for joining this call. After the market closed, Allogene issued a press release that provided a business update and financial results for the first quarter of 2025. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that historically, questions have been multifaceted, but note that we will endeavor to keep this call to under an hour. I'm joined today by Dr. David Cheng, 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, 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 these potential risks can be found in our press release and latest FCC 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.

Thank you, Christine, and welcome, everyone. Today, we come together at a defining moment for Allogene. a moment that potentially validates the bold, forward-looking strategy we launched in January 2024. At the time, we committed to doing what Noel Carty had done before. That strategy wasn't about being autologous or allogeneic. It was about breaking boundaries. One year later, that decision looks not just bold, but prescient. I believe we have built something extraordinary, especially for a small biotechnology company in the current market environment. We have a trio of highly differentiated clinical assets, each with a potential to be transformative. Combined, they demonstrate that allergen is potentially changing the trajectory of cell therapy. At the center of that vision is Alpha-3, a pivotal first-line consolidation trial with Semicel, which we believe will transform care in large B-cell lymphoma and open the door for community cancer centers. The use of MRD paired with first-line treatment consolidation is a radical departure from traditional approaches, and it's gaining powerful traction. What once seemed ambitious is now being embraced across nearly 50 activated US sites. Investigators recognize that Alpha-3 is not just another CAR-T study. It seeks to redefine how to identify and when we treat high-risk patients. That recognition is reflected in the collaboration we are seeing across sites, many of which are proactively developing and sharing patient identification strategies. Launching this groundbreaking trial has come with important lessons. We've had to adapt quickly to unexpected hurdles from site level staffing shortages to educating patients who believe their treatment journey was complete when they received the news of a clean PET CT scan. These insights are now guiding smarter enrollment tactics, more effective communication with patients, and more precise forecasting. The result has been tangible. To date, over 250 patients have consented for MRD screening, with nearly half in the last three months. With improved site engagement and more patients introduced to the trial earlier, we are seeing the early returns of a system that is working. In light of these operational dynamics, we have shifted the lymphodepletion regimen selection and fertility analysis milestone into the first half of 2026. While that's two quarters later than planned, it reflects a strategic decision to prioritize precision, insight, and the stronger foundation for a future commercial launch. During this time, we are also actively evaluating what data will be most meaningful to share at the time of the lymphodepletion selection and fertility analysis in response to feedback from stakeholders. R0316 in the Traverse trial continues to break new ground. showing signs of efficacy in patients with heavily pretreated advanced renal cell carcinoma. These patients are highly refractory to treatment and often only have months to live. For these patients, L0316 may offer something they never thought possible, hope. With our CD70-targeted Dagger technology, Allo316 is providing a clear demonstration of potential that CAR-T holds in solid tumors, something the field long viewed as aspirational. Zach will comment further on Allo316 in our upcoming oral presentation at ASCO on June 1st. In the resolution trial launching mid-2025, Allo329 is poised to change how we treat autoimmune disease. This dual targeted alginate CAR T product offers the potential to eliminate lymphodepletion entirely, which is a major hurdle to broader CAR T adoption. This is not a variation of what others are doing. It's a completely new strategy designed to intercept disease at its root in conditions like lupus nephritis and systemic sclerosis. As we move our trials forward, we are keenly aware of the macroeconomic environment. Preserving our cash runway remains a top priority. With a refined operational strategy and efficiency-driven cost realignment, We have extended our cash runway into the second half of 2027. This gives us the ability to weather market headwinds as we drive ahead to our most promising clinical inflection points. The field of cell therapy is evolving. The autologous versus allogeneic debate is giving way to a bigger question. How broadly can CAR-T be applied? At Allogene, we are answering that question with action. Our strategy, set in motion in January 2024, was never about following existing models. It was about doing what had never been done before, and importantly, making CAR-T more accessible by harnessing the unique advantages only an allogeneic approach can deliver. With Alpha 3, Allo316, and Allo329. We believe we are proving that CAR-T is not just about cell type or delivery mechanism. It's about clinical ambition, real-world insights, and building a scalable future for patients who need more than incremental change. Finally, While it is unusual for me to use our quarterly call to address some of the macro issues impacting our industry, it is more important than ever to take a moment to do so. Like many in the industry, we are observing the evolving landscape at FDA and assessing potential implications, grounded in our continued confidence in the agency's mission scientific integrity, and dedication to patient-centered progress. The selection of Dr. Vinay Prasad, a well-known voice on drug development reform, has sparked a range of reactions. But in moments like this, it is important to take a breath and recognize the broader context. While Dr. Prasad has been a provocative voice at times, he has also long advocated for rigor transparency, and patient-centered outcomes, value we share. It is also worth remembering that the clinical review of oncology products, including those under CBER, continues to rest with the Oncology Center of Excellence. That structural continuity should offer some reassurance that therapeutic evaluation will remain grounded in science, precedence, and patient need. Rather than speculate, our approach will be to engage, educate, and collaborate. If this marks a new chapter in regulatory thinking, we intend to be a constructive part of that dialogue. Ultimately, we believe that strong science and meaningful clinical benefit will continue to carry the day, and we remain confident in the value of our programs to patients who needs better options. On all fronts, we believe allergen has a responsibility, not just to participate in the future of medicine, but to lead, to help shape and define it. I would like to now hand the call over to Zach.