Madhav Vasanthavada
Analyst · Jefferies. Your line is live
Thanks, Vish, and hello, everyone. It has been about two weeks since ZEVASKYN's approval, and we are off to a very good start. The response from patients, caregivers, and the physician community since gaining ZEVASKYN's FDA approval has been incredible. Already in just the last two weeks, our patient hub, Abeona Assist, has received phone calls and email inquiries from about 30 patients and families across the country. We recognize that any new product approval comes with interest and excitement, but the volume and nature of these inbound inquiries are very encouraging. We are hearing from adult patients and parents of children who are all hopeful about the potential impact ZEVASKYN can have on them and their loved ones, and they want to know how soon they can access this treatment. These calls show the tremendously high unmet need and that patients are urgently seeking reliable and durable treatment options for their RDEB wounds. Many of the callers have told us that they are not satisfied with the currently available treatments, either because, in their opinion, these treatments are not reliably healing their wounds, or they are burdened by the continuous and potentially lifelong administration of the current options. ZEVASKYN is the only treatment proven to reliably close not just small wounds, but large wounded regions of the body with a single treatment application. With Lurie Children's activated as the first ZEVASKYN qualified treatment center, Dr. Amy Poller and her team at Lurie can now begin to schedule their identified patients for treatment with ZEVASKYN. Our teams will support Lurie as they identify eligible patients and secure the necessary payer authorizations, which we expect will take several weeks initially. We are currently anticipating the first patient to be biopsied in July 2025 and to receive this treatment in August 2025. In addition to Lurie, we are on track to activate other geographically dispersed QTCs by the end of 2025. Like Lurie's, the other hospitals we are in discussions with are well-recognized institutions with cell and gene therapy infrastructure and experienced in providing specialized care for ED patients. As we have previously mentioned, we expect to see a gradual ramp-up at QTCs, with centers getting accustomed to ZEVASKYN treatment process and the patient journey through treatment of their first one or two patients. With this initial treatment experience, we then expect a greater uptake of ZEVASKYN at each QTCs over time. With the already existing number of ZEVASKYN eligible patients at these large QTCs and the strong inbound interest we have begun to see through Abeona Assist, we remain optimistic about our ability to achieve our 2025 goal of treating 10 to 14 patients as we previously guided and look forward to a robust start to 2026. Beyond the positive response from patients, we are equally excited to see the enthusiasm from the ED physician community on the news of ZEVASKYN approval. Last week, we had very successful physician engagements at the Society for Investigative Dermatology annual meeting. Our two late-breaking scientific abstracts that Vish mentioned were very well received. Also, Dr. Jean Tang, one of the prominent ED experts and the lead investigator of our vital Phase 3 study, gave an oral presentation on ZEVASKYN's clinical data to a highly engaged audience and generated interest. We also held an Advisory Board Meeting at the SID meeting with an interdisciplinary group of ED physicians from our potential QTCs. The group was excited about ZEVASKYN's approval and was eager to discuss the immediate next steps to putting their identified patients on ZEVASKYN treatment, and we had a productive discussion. Over the past two weeks, we have also made significant strides in ensuring that the value of ZEVASKYN is recognized by payers and that patients have timely and broad access to this therapy. We are actively progressing discussions around outcomes-based agreements, reinforcing our confidence in ZEVASKYN's real-world impact, and supporting favorable access for patients. We are especially excited to announce that we have now executed outcomes-based agreements with two payer contracting organizations. The first with Anton Rx, a leading pharmacy solutions provider representing several regional commercial and managed Medicaid payers, and the second with one of the largest medical collectives, serving approximately 100 million commercially insured lives. These two agreements represent a significant milestone in our efforts to ensure ZEVASKYN reaches the patients who need it most. Additionally, we are continuing to actively engage with several well-recognized commercial payers and all state Medicaid programs to further expand ZEVASKYN access to eligible patients across the country, and we'll keep you updated on our progress. With that, I would like to hand the call over to our Chief Financial Officer, Joe Vazzano, to discuss our financial results. Joe?