This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
8/7/2024
Hello, and thank you for standing by. Welcome to Allergy and Therapeutics' second quarter 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automatic message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the call over to Christine Cassiana. You may begin.
Thank you, operator, and welcome to all who have joined this call. After the market closed today, Allergy issued a press release that provides a business update and financial results for the second quarter of 2024. 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. Joining me today are 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, and 2024 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 the 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.
Thank you, Christine, and welcome to those on the call today. We hope you've all enjoyed a pleasant summer so far. As I think about the first half of 2024 for Allergen, the word that continually comes to mind is momentum. Early in 2024, we reset the clinical development plan by advancing Semacel, our lead CD19 Allocard T product, into an LBCL first-line consolidation study and announced our decision to develop and advance our next-generation Allocard T product, Allo329, into autoimmune indications, thereby placing Allogen in an enviable position of having clinical programs in heme malignancies, solid tumors, and autoimmune indications. Hard work creates opportunities, but external factors must line up to create and build momentum. As we think about the two programs, we get asked about most often, alpha-3 with semicell and allo-329 in autoimmune. Momentum is on our side. To be clear, This does not mean that it has been easy. Our team is working harder than ever. But that same hard work and dedication, along with the bold choices we've made over the last year, set off a chain reaction that we see daily as we work with investigators and external stakeholders on our programs. Simply put, the reset that was based on our longstanding conviction on our Alucard T programs have put us in a position to potentially change the CAR-T landscape. Momentum for us is merely a starting point. Now that we have shifted strategy into a clear and honorable leadership position, our programs continue to build speed, and it has been remarkable for our lead program, Alpha 3. I will spotlight three measures that may not be as visible to investors as they are to us internally at Allergen. First, while the market is not kind to biotech right now, we strengthened our base of investors in this last round with some of the highest caliber investors any company could hope for. We don't take that for granted. The number of sites who want to participate in our Alpha 3 trial and the energy with which they are engaged can be likened to what we saw in the early days of OTALIS-CAR-T. There seems to be undercurrent of understanding that this trial has the potential to forever change their practices. Third, the collaborative engagement from the FDA on this trial has been illuminating. We believe we have achieved support for Alpha-3 based on three key benefits that stem from the innovative study design. One, advancing CAR-T into earlier line setting maximizes the curative potential of the virality. Two, treating minimum residual disease, or MRD, the lowest disease volume one can measure, has the potential to make CAR-T safer and more effective. Using MRD to select and treat only the patient who will likely experience recurrence makes Alpha-3 design very efficient, concentrating treatment in only the patient population who needs it and leaving everybody else alone. We believe these key points are well aligned with the views of FDA and other key stakeholders. We aim to validate the support for this trial. We have also continued to strengthen allergens, even if not in the spotlight or something that garners headlines, to ensure that we can deliver on our promises, such as the work done in our South Forge One facility in the East Bay, where we now manufacture all of our CAR-T investigational products. This significantly minimizes our reliance on contract manufacturers for the products and provides allergens with a critical strategic asset, the manufacturing capacity to serve the market that we are addressing in our trials. As the months continue, I am confident that this exceptional momentum we feel internally will become increasingly evident to the outside world. I will now turn the call over to Zach to discuss the programs of most significant interest to investors.
You're reading a preview of the ALLO Q2 2024 earnings call.
Free account.
