Abeona Therapeutics Inc.

Good morning everyone and welcome to the Abiona Therapeutics full year 2025 results conference call. At this time all participants are in a listen only mode and the floor will be open for questions following the presentation. If anyone should require operator assistance during this conference please press star zero on your phone keypad. Please note this conference is being recorded. During this call, we will refer to the press release issued this morning announcing the financial results, which is available on our corporate website at www.abionatherapeutics.com. We anticipate making projections and forward-looking statements during today's call, which are made pursuant to the safe harbor provisions of the federal securities law. These forward-looking statements are based on current expectations and are subject to change. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including but not limited to those outlined in our Form 10-K and periodic reports filed with the Security and Exchange Commission. These documents are available on our website at www.abionatherapeutics.com. Joining us on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, and Dr. Madhav Vasanthavada, Chief Commercial Officer, Joe Vazano, Chief Financial Officer, and Brian Keveny, Chief Technical Officer. After the prepared remarks, we will conduct a question and answer session. So with that, I will now turn the call over to Vish Seshadri to lead us off.

Vish, over to you. Thank you, Jenny, and good morning, everyone. We continue to see growing patient demand for ZivaSkin, the first and only autologous cell-based gene therapy for the treatment of adults and pediatric patients with recessive dystrophic epidemolysis bullosa, or RDEV. As a reminder, ZivaSkin was approved in April 2025, but our launch was delayed to quarter four 2025 as we optimized a sterility test that was required for product release. Treating our first commercial patient this past December was a significant milestone for Aviona, but 2026 is where the launch execution ramps up. We aren't just looking at one-off successes anymore. We're focused on building a consistent cadence of biopsies, product delivery, and treatments. Since resuming manufacturing in late January after our annual shutdown, We've treated one patient this quarter, biopsied three additional patients with treatment schedule over the coming weeks, and expect to perform additional biopsies this month. All patient treatments and biopsies performed to date have come from the first two of our four qualified treatment centers, Lurie Children's Hospital in Chicago and Lucille Packard Children's Hospital at Stanford. As our third and fourth QTCs, which are Children's Hospital of Colorado and UTMB at Galveston, Texas, also begin to schedule their patients into upcoming biopsy slots, we anticipate a healthy cadence of patient biopsies in the coming months. This momentum provides Abiona the opportunity to demonstrate that the operational machine behind ZivaSkin works at scale from initial biopsy through final delivery. At the same time, we are hyper-focused on ensuring a seamless experience for every patient in the ZivaSkin treatment journey. and we are building a foundation of operational excellence that resonates with this close-knit RDEB community. We recognize that in this patient-driven market, providing a smooth journey is the most effective way to catalyze the organic demand needed to scale ZivaSkin in 2026 and beyond. To further elaborate on how our launch is gathering momentum, I'll now hand the call to our Chief Commercial Officer, Dr. Madhav Vasanthavada, to review the commercial update. Madhav?

Thank you, Vish, and hello, everyone. Demand for ZivaSkin continues to grow. We previously had reported that nearly 50 potentially eligible patients were identified across our initial qualified treatment centers and community-based physicians. Starting this year, we have deployed a field team that has been engaging with community physicians and the number of identified eligible ZivaSkin patients has now grown to more than 100. While demand continues to grow, the speed at which identified patients receive ZivaSkin treatment has significantly varied during these initial months of launch, but the momentum is picking up. Since our launch in Q4 2025, two patients have been treated with ZivaSkin, Three additional patients have been biopsied for treatment over the coming weeks, and we expect to biopsy additional patients this month. Currently, we also know of at least 10 more patients who are advancing through the administrative process and targeting the second quarter 2026 biopsy. As Vish mentioned, The patient treatments and biopsies until now have all come from the first two QTCs that were activated in the middle of last year. While it has taken a long time to move the very first patients through the funnel to treatment, we have not seen patient attrition during this process, and no payers so far have denied insurance coverage for ZivaSkin, reflecting the strong value ZivaSkin offers to this patient community. As QTCs and payers treat more patients and gain experience with the overall process, we expect the speed of patient treatment to go faster. Additionally, as the remaining two QTCs treat patients, we anticipate that the number of ZivaSkin treatments will grow in the coming quarters. Now, regarding activating additional QTCs for ZivaSkin, Becoming a QTC is a multi-step process that starts with a dermatologist who is an EB specialist championing Zivakin at their institution and requires a buy-in and sign-off from various functions and committees all the way to the level of CEO or CFO of that institution. Once the decision is made to become a QTC, several moving parts, including a master service agreement, trade policy, clinical training for biopsy and treatment, and registry protocols with IRB approvals must be put into place. That makes Q2C onboarding a several-month process. Once a site is activated, it may then begin patient consultations for ZivaSkin, work with insurers, to secure clinical authorizations and financial commitment for that individual patient, and then schedule patients for biopsy. As mentioned earlier, we have four QOTCs activated. Two have started treating patients, and the other two have patients that are moving through the administrative process to schedule a biopsy. In addition to the four current QOTCs, we are actively working toward onboarding five additional centers, and are in various stages of the site onboarding process. To ensure a geographically expansive footprint, our goal is to have at least seven QTCs active by the end of 2026. Lastly, on the market access front, I would like to reiterate All major commercial payers, including UnitedHealthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans have published coverage policies for ZivaSkin, representing roughly 80% of commercially covered lives. ZivaSkin also has baseline coverage across all Medicaid programs for all 50 states. In addition, CMS has established a permanent HCPCS J-code for ZivaSkin effective January 1, 2026. We expect a J-code to be an important enabler for streamlined billing and reimbursement for QTCs. Ultimately, every step forward, every biopsy, every treatment, every positive patient story strengthens our confidence in the impact ZivaSkin can have. We are energized by the early momentum and remain committed to delivering a seamless ZivaSkin experience. With that, I'll now pass the call to our Chief Financial Officer, Joe Vizzano, to discuss our financial results. Joe?