Capricor Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Capricorn Therapeutics third quarter 2025 conference call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Monday, November 10, 2025. I would now like to turn the conference over to our CFO, AJ Bergman, for the forward-looking statement. Please go ahead.

Thank you very much, and good afternoon, everyone. Before we start, I would like to state that we will be making certain forward-looking statements during today's presentation. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our product candidates, our future R&D plans, including our anticipated conduct and timing of preclinical and clinical studies, our enrollment of patients in our clinical studies, plans to present or report additional data, plans regarding regulatory filings, potential regulatory developments involving our product candidates, potential regulatory inspections, revenue and reimbursement estimates, projected terms of definitive agreements, manufacturing capabilities, potential milestone payments, our financial position, our possible uses of existing cash and investment resources. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve a number of risks and uncertainties that may cause our actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. Your caution not to place undue reliance on these forward-looking statements, and we disclaim any obligation to update such statements. With that, turn the call over to Linda Marband, CEO.

Good afternoon, and thank you for joining us on Capricor's third quarter 2025 conference call. This has been a very busy time for Capricor, as we are just weeks away from a major milestone, the top-line readout from our HOPE III, Phase III clinical study of Daromyosal, our investigational cell therapy for the treatment of Duchenne muscular dystrophy. This pivotal study represents the culmination of nearly a decade of scientific development, all aimed at helping boys and young men living with this devastating disease. Importantly, HOPE III focuses primarily on non-ambulant individuals, a patient population that has historically had limited clinical research dedicated to it. HOPE III was conducted across 20 leading academic and clinical centers in the United States. The trial enrolled 105 participants and is one of the largest double-blind placebo-controlled studies ever conducted in the Duchenne population. The study was designed with a one-to-one randomization and is statistically powered to detect changes in both upper limb function as measured by the performance of the upper limb, version 2.0, and cardiac function as measured by left ventricular ejection fraction measured by cardiac MRI. as well as several secondary and exploratory endpoints. These 105 patients enrolled in HOPE III represent two cohorts. Cohort A, which received Daromyosel manufactured from our Los Angeles clinical facility, and cohort B, which received product manufactured at our commercial GMP facility in San Diego. As a reminder, The FDA required the addition of cohort B to evaluate the efficacy of the commercial scale product. While we have demonstrated non-clinical comparability, cohort B provides the opportunity to generate direct evidence of efficacy for the commercial material. The San Diego facility was built to meet commercial manufacturing standards operating under elevated quality and compliance requirements to support commercial Daromyosal production. Because the San Diego manufactured product is intended for commercialization, the statistical analysis plan for HOPE III includes analyses designed to evaluate efficacy, both across the combined cohorts and independently within cohort B. We believe, in alignment with our biostatisticians and clinicians, who designed our statistical analysis plan with us that while the aggregated data are informative, demonstrating efficacy of the commercial scale product represents the most direct regulatory path to potential approval. From the standpoint of safety, which of course is the most important aspect of the clinical study, Safety data from the trial have been regularly reported to the FDA, and no new or emerging safety signals have been observed. Across our entire program, we have now administered more than 800 infusions for approximately 150 boys and young men with Duchenne, with DERM-ISL continuing to demonstrate a strong and consistent safety profile. At Capricorn, Our mission remains clear, to bring forward the first therapy that directly addresses Duchenne muscular dystrophy associated cardiomyopathy. Nearly every patient with Duchenne develops cardiomyopathy, which remains the leading cause of death in these boys and young men. Air Myofil has been shown to help preserve both cardiac and skeletal muscle function, and our goal will be to emphasize to the FDA the life-limiting cardiovascular impact of this disease. Should Daromyosal be approved, it would represent a first-in-class therapeutic option for this critical, unmet medical need. We are now in the final stages of data preparation. Our statistical analysis plan has been submitted to the FDA, and the comment period passed without additional feedback. We plan to unblind the study once all data management processes are finalized, which, as noted, will occur within the next several weeks. The process has required review of more than 300 MRIs by independent external readers who are fully blinded both to treatment allocation and sequence, a process that requires additional time to collect and analyze the data set. To remind you, after our pre-BLA meeting with the FDA in 2024, we submitted a BLA based on existing data from our HOPE II and the HOPE II open-label extension trials compared to an external control comparator from the cardiac consortium. At that time, the purpose of HOPE III was to support potential XUS expansion as well as label expansion. However, following receipt of the CRL in July, the role of HOPE III shifted. The CRL primarily cited the need for additional substantial evidence of effectiveness and certain CMC clarifications. Importantly, most of the CMC issues had already been addressed in prior information request responses. and the remainder were resolved shortly after the receipt of the CRL. While the CRL was unexpected, we were well positioned with HOPE III to provide the additional safety and efficacy data requested by the FDA. During our Type A meeting in August of this year, the FDA indicated that the HOPE III results could be submitted to address the issues raised in the CRL. A key element of that meeting was our request to keep the current BLA open and maintain the indication for DMD associated cardiomyopathy. To advance that path, we proposed designating left ventricular ejection fraction, LVEF, as the primary efficacy endpoint. While the FDA did not allow this formal change, they agreed to exercise regulatory flexibility in reviewing the HOPE III data. Accordingly, we plan to submit the HOPE III results as a formal complete response to the CRL with the goal of receiving a rapid review by the FDA and a new PDUFA date. As of now, FDA has classified the resubmission as Type 2, which means the review period can be up to six months. But there is precedent for faster review times. We will make every effort to advance DERM-ISL toward approval as efficiently as possible in 2026. To remind you, we are eligible to receive a priority review voucher if approved, if approval is attained prior to September 30th, 2026. and PRVs may become increasingly valuable as the program approaches its statutory sunset. While we cannot predict the exact timing of approval, we remain highly motivated to achieve approval as early as possible in 2026, well ahead of that deadline. This consistency demonstrated across multiple clinical studies underscores their potential to stabilize disease progression and preserve both muscle and heart function. We now look forward to seeing whether the data from hope three confirms these benefits and a larger rigorously controlled pivotal trial. As we approach our quiet period, I will remind you that we expect to report top-line data within the next few weeks, and we will do everything we can to keep both the market and the DMD community informed of our further plans with respect to this program and the release of the data. We also recently published a peer-reviewed paper in Biomedicine. detailing new mechanistic insights into Daromyosal's mechanism of action. The study described in the paper demonstrated that cardiosphere-derived cells, CDCs, the active component of Daromyosal, release exosomes and soluble factors that suppress byproduct gene expression, collagen 1 and collagen 3, and human fibroblasts. These findings were consistent across more than 100 manufacturing lots, validating DERMA-SL's anti-fibrotic and immunomodulatory properties and further supporting its mechanism of action. To complement this publication, we also released a scientific video illustrating DERMA-SL's mechanism of action, which is available on our website. reinforcing the biologic rationale and consistency that underline our entire development program for Daromyosal. Now, focusing for a moment on the CMC front, following acceptance by the FDA of all findings from our pre-license inspection, or PLI, our San Diego commercial facility is fully operational and preparing for GMP production activities. Our manufacturing and quality systems are fully implemented and all CMC related items cited in the CRL have been addressed. This achievement reflects the strength of our operations and represents a critical milestone in ensuring readiness for commercialization and long-term product consistency. In parallel, We continue to prepare for launch with advancing initiatives in physician education, patient services, market access, and reimbursement. We are engaging both neurology and cardiology specialists to ensure an integrated approach to patient care should DARE Myocella receive approval. While our immediate focus remains on U.S. approval, we are also laying the groundwork for potential global expansion and will share updates as appropriate. We are closely monitoring evolving U.S. and international pricing policies, including the current administration's stance on most favored nation frameworks, and will adapt our global strategy accordingly. So, I'd like to spend the next few minutes talking about our ExaZone platform. We continue to advance our StealthX program under Project NextGen, a U.S. government-funded initiative led by HHS and the National Institutes of Allergy and Infectious Disease to develop next-generation vaccines for COVID-19 and other potential infectious threats. The NIAID-sponsored Phase I clinical trial remains ongoing and is evaluating multiple dose levels of the monovalent vaccine targeting the spike or S antigen with an additional planned arm that will utilize a multivalent vaccine construct targeting spike, S, and the nucleocapsid N antigen pending separate FDA clearance. We expect initial data in the first quarter of 2026 subject to completion of the trial by NIAID. The goal is to validate stealth X as a versatile non M R a adjuvant free platform capable of delivering native proteins safely and efficiently a model that could potentially extend to infectious and rare diseases alike. Well, vaccines are not our core business. This program serves as a critical proof of concept for the stealth X platform. Positive results could open the door to strategic collaborations and highlight the platform's potential for target therapeutic delivery well beyond vaccinology. With that, I will now turn the call over to AJ to run through the financials. AJ?