Capricor Therapeutics, Inc.

financial results and corporate update call. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. As a reminder, this conference call is being recorded. I would now like to turn the conference over to our host, Mr. A.J. Bergman, Capricor's Chief Financial Officer.

Thank you. And thank you for joining today's call. 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 research and development plans, including our anticipated conduct and timing of preclinical and clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory developments involving our product candidates, manufacturing capabilities, potential milestone payments, and 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 actual results to defer 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 Marban, CEO.

Thank you, AJ. Good afternoon, and thank you for joining our first quarter 2023 conference call. Today, I will provide important updates on our Phase 3 DMG program, as well as our ExaZone platforms. We are pleased with the progress that we have made in the first few months of 2023 and believe we are well positioned to execute on our key priorities and reach multiple milestones throughout this year, which include continuing discussions with FDA regarding pathway towards the biologics license application for CAP 1002 in DMD, presenting 24-month follow-up data from our HOPE II open-label extension study in the second quarter of 2023, reporting the outcome of the interim analysis of HOPE III in the fourth quarter of 2023, as well as exploring opportunities for additional strategic partnerships outside of the United States and Japan to support the potential commercialization of CAP 1002 and DMD. We also are looking forward to the expansion of our ExaZone pipeline, focusing on securing partnerships as well as other opportunities for non-dilutive funding. Now, let me begin my remark today by providing an update on our recent FDA interactions. Earlier this year, under our RMAT designation, we held a Type B CMC, or Chemistry, Manufacturing, and Controls meeting with the FDA where we outlined our plans for production of commercial scale GMP Cap 1002. We were also able to outline plans for our potency assay and other release criteria in order to support the filing of the BLA, which is a great accomplishment. Although this meeting was focused on CMC aspects of our development program, there was a discussion about the possible need for some patients to be treated with product manufactured from our GMP San Diego site. That discussion has not yet been finalized and is still ongoing. I would like to reiterate that our goal is to work with FDA on the shortest path to filing a BLA. And to that end, we are currently working closely with them on this important issue and will provide updates on our clinical development plan as it becomes available. This now leads me to an update on our San Diego manufacturing facility for CAP 1002. As you know, we designed this facility within our R&D headquarters to be able to produce commercial-scale GMP CAP 1002 doses. We see this facility as a versatile and cost-effective way to potentially bring CAP 1002 to the market. I am pleased to inform you that we are on track to release GMP Cap 1002 doses in the third quarter of this year. Should Cap 1002 obtain market approval, we firmly believe that our ability to manufacture in-house will greatly increase our margins and support the early launch of this product. As this facility becomes fully operational, we will be able to provide more color on potential capabilities and production capacity for this site. Next, I would like to provide a clinical update on HOPE III. Our Phase III clinical trial continues to enroll well. As of today, we have 13 active sites and remain on track to enroll 68 patients by the second half of this year, which is the currently designed sample size. We're continuing to activate sites and plan to have additional targeted sites activated by the second quarter, which we believe is both a testament to the high level of engagement by our clinical trial sites, as well as our team's strategic execution. Our plans to conduct an interim analysis for sample size re-estimation and analysis of conditional power remains unchanged and we are on track to have these results available in the fourth quarter of this year. As I mentioned previously, we are working closely with the FDA to optimize the HOPE III clinical trial design and will provide updates on any feedback, once available, should any changes be necessary. In parallel, we continue to treat patients in the Open Label Extension, or OLE, portion of the HOPE II Phase II study. These patients are going to their fifth year of follow-up and going into a third year of OLE treatment. Further, while we continue to see efficacy in these patients, as previously presented, the safety profile of CAP-1002 in the OLE study continues to be consistent with our Phase II results and is now supported by well over 100 IV infusions. we continue to see a statistically significant as well as clinically relevant slowing down of disease progression for patients treated with CAP10 and 2, including for these patients who are initially on placebo compared with the natural progression of the disease. The data presented at both the 12 and 18 months showed an average of 65% slowing of disease progressions. And we plan to report the 24-month performance of the upper limb and cardiac function data at a medical conference in the second quarter of this year. We are thankful to the patients and their families for their continuous commitment to working with us on exploring the potential benefits of CAP-1002. We look forward to building on our body of positive data that further positions CAP-1002 as potential anchor therapy for DMD. Furthermore, we believe that combination therapies may be necessary for the long term to delay disease progression in DMD. Most likely, patients requiring a dystrophin replacement therapy will also need additional therapies that can attenuate inflammation, promote healthy muscle growth, and preserve cardiac function. We believe that CAP-10 or 2 can potentially be paired with any of the approved therapies and will likely be necessary to get the greatest benefit from the gene or exon skipping therapy. We stand with all of the patients with DMD whose only wish is that their disease does not get worse. Now turning to our commercial partnership strategy, as announced in February, we entered into a second agreement with Nippon Shinnyaku for the distribution rights to CAP 1002 for DMD in Japan, where we received a $12 million upfront payment and will potentially receive additional milestone payments of up to approximately $89 million and a meaningful double-digit share of net product revenue. We continue to work with Nippon Shinnyaku and look forward to continuing to leverage their expertise and infrastructure already established for Viltepso, their exon skipping drug, that is already approved in the U.S. and Japan. We are now focused on securing additional partners in other markets around the world with Europe being a key priority. Overall, we are delighted with the progress of our GMD program, and we look forward to further sharing updates from our interaction with FDA, our progress with HOPE III, and the development of potential additional partnerships in new territories. Now, briefly turning to our exosome platform technology, which leverages the natural cell signaling communication of the body, we are harnessing exosomes to serve as a novel drug delivery system with broad therapeutic applications. Our strong scientific foundation is supportive of further downstream efforts for innovative therapeutic payload loading methods and tissue-specific targeting. Our proprietary StealthX expression platform is at the core of our Exosome program and is focused on the development of two broad modalities, vaccinology and precision therapeutics. We recently published in Microbiology Spectrum a peer-reviewed journal of the American Society of Microbiology on StealthX, which in preclinical studies generated two potential vaccine candidates that independently and in combination induced a strong immune response against two SARS-CoV-2 proteins, spike and nucleocapsid. Using the StealthX platform, we have successfully developed a targeting strategy which will allow us to potentially expand our exosome program into precision-based therapeutics. While we are exploring many different therapeutic applications, we are currently working on targets in neuromuscular disease, which is an area of core strength for Capricorn. With our small team of experts working on exosomes, our current plans are to explore business development and partnering strategies as well as non-dilutive grant funding. We look forward to leveraging our Exosome platform to support the advancement of next-generation vaccines and innovative targeted therapeutics, and we'll provide updates on this program as they become available. In closing, we are pleased with the advancements across our DMD program and the growing body of data within our Exosome platform technology. We look forward to executing on our upcoming milestones. With that, I will turn the call over to Chief Financial Officer A.J. Bergman to run through our financial results. A.J.?