Abeona Therapeutics Inc.

Greetings and welcome to the Arbiona Therapeutics third quarter 2023 conference call. At this time, all participants are on a listen-only mode and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Greg Ginn. Sir, you may begin.

Thank you, Ali. Good morning, everyone. I would like to welcome and thank everyone for joining us on our third quarter 2023 update conference call. The press release announcing the third quarter 23 results is available on our website at www.abionatherapeutics.com. Before we start, I would like to note that remarks made during today's call may contain projections and forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on current expectations and are subject to change, and actual results may differ materially from those expressed or implied in the forward-looking statements. Various factors that could cause actual results to differ include, that are not limited to, those identified under the risk factor section in our Form 10-K and periodic reports filed with the Securities and Exchange Commission. These documents are available on our website at www.abionatherapeutics.com. On today's call, with prepared remarks, are Dr. Vish Sassadri, Chief Executive Officer, Dr. Mata Vizantavada, Chief Commercial Officer and Head of Business Development, and Joe Vizano, Chief Financial Officer. Also joining us for the Q&A session will be Dr. Brian Keveny, Chief Technical Officer. With that, I will now turn the call over to Vish Seshadri. Go ahead, Vish.

Thank you, Greg. Hello, everybody. Thank you for joining us this morning. I'm pleased to update you on our continued progress, evolving from a clinical stage company to one with a significant commercial opportunity. Let me start with the highlight that everyone at Aviona is thrilled about. We achieved That's the most meaningful milestone yet in Aviona's history at the end of September with submission to the FDA of our biologics license application, or VLA, for Pradamagene zamycaracil, or PzCel, which was formerly known as EB101. PzCel is our investigational autologous Col7a1 gene corrected epidermal sheet for recessive dystrophic epidermolysis bullosa, or RDET. As a reminder, In clinical trials, a one-time application of PV cell had demonstrated wound healing and pain reduction for the toughest-to-treat large chronic wounds. Some wounds that were treated in our Phase I-IIa clinical trial remained healed after eight years. The sustained treatment effect we have seen is due to the integration of col7a1 transgene into the host genome during the transduction of patient keratinocytes ex vivo. Our BLA submission represents a critical step toward the potential approval of PZ Cell as the first therapy to provide instantaneous wound coverage and multi-year healing in RdEV wounds with a one-time application. I want to take a moment to thank many stakeholders who contributed to this milestone achievement, not just for Aviona, but for the whole RdEV community. From the patients, caregivers, and physicians, who participated in the vital clinical trial, the patient advocacy community, and the FDA for their level of engagement and constructive guidance in the months leading up to the pre-BLA meeting that occurred in late August. I also would like to acknowledge our entire submission team for their tremendous determination over many months to prepare the BLA. We recently completed our application orientation meeting with the FDA. where we overviewed our BLA and walked them through our clinical data. Our understanding is that this meeting is one of the last steps before the FDA decides on acceptance of the application for formal review. Regarding what we can expect next, the FDA's decision on whether the BLA review process can start is typically made during the 60-day window following submission, which in our case goes out to late November. With the BLA submission, We requested the FDA grant a six-month priority review. Under a priority review scenario, PZ Cell could be approved in the second quarter of 2024. I'll remind you that PZ Cell has been granted rare pediatric disease designation by the FDA, so upon its potential approval, we continue to believe that we're eligible to receive a priority review voucher, or PRV. It's permissible to sell PRVs And other PRVs have been worth approximately $100 million based on recent PRV transactions. Planning for the potential success of our VLA, our manufacturing team is focusing on supporting the VLA review process, preparing for pre-approval site inspection, and scaling up our internal capabilities and staffing for commercial launch. In the first full year of launch, we currently plan to supply PC Cell for up to 120 patient treatments or manufacturing cycles per year. Following launch, we will assess our longer term plan to further build up that capacity. We are excited about the prospect of transitioning to a commercial stage organization with Aviona's first product launch. However, it is important to note that PZ Cell will not be the first psychologist therapy launch for this leadership team, as Madhav and I will draw upon our previous launch experiences with Brianzi and Abekma. As Chief Commercial Officer, Madhav will oversee all aspects of commercial strategy, planning, and operations. His extensive and diverse leadership experience across sales, marketing, and market access Coupled with a strong track record launching autologous cell therapies with a heavy focus on customer experience makes Madhav the ideal candidate to lead the stage build-out of our highly focused, nimble commercial organization to maximize the potential commercial opportunity for PZ Cell. I'll now ask Madhav to talk about our near-term commercialization focus and launch preparations. Madhav? Thanks, Vaish. We are, of course, excited for the potential commercial launch of PgCell pending FDA approval. In terms of our commercialization approach, our near-term focus is simply on two main areas. One is to onboard and prepare five to seven high-volume EV treatment centers so that they can treat with PgCell upon approval. These centers already have the expertise in caring for EB patients and are geographically dispersed across the U.S., which would help make PZ cell treatment accessible for these patients. And two, working with commercial and government health insurance systems to ensure broad access for all eligible patients at a price point that captures the value that a transformative therapy like PZ cell might bring. We are happy with our progress so far on both these fronts. To elaborate further, in terms of site onboarding, shortly after our BLA submission, we conducted an advisory board meeting that was attended by eight well-respected physicians, PD physicians from across the U.S. We discussed not only the clinical data and the care coordination needed for surgical application of PD cells, but also For the first time, we shared some of the before and after images from several large wounds across multiple anatomical areas treated with PZ-Cell, as well as patient and caregiver testimonials about their experience with PZ-Cell in clinical trials. They're very encouraged by the physician's feedback, which included their suggestions on ways to operationalize PZ-Cell at treatment centers. We have received interest from these physicians to initiate easy-sell site onboarding discussions at their institutions, and we are very excited by it. With respect to the second focus area of payer engagement, we will continue to engage payers over the coming months to educate them about easy-sell and further assess the price potential. Early feedback from payers and hospital administrators supports positive coverage for PT cell and pricing in line with the value of a cell and gene therapy that provides instantaneous coverage for large wound areas and that demonstrates years of wound healing and pain reduction, even in the toughest to treat RdEV wounds following a one-time application. Furthermore, we hope that the sustained effect we see in our clinical trials on wound areas with a one-time application of PT cell could minimize the treatment burden incurred by patients and caregivers in continuously caring for their wounds day after day and week after week with current standards of care. Additionally, in speaking with our clinical trial patients and the advocacy community, we continue to hear enthusiasm for PZ-Cell. In fact, in our ongoing phase 3B trials, all three patients are repeat patients. who fully appreciate the involved nature of the procedure and have elected to receive PZ-Cell again for their previously untreated wound areas. We will continue to work with patient groups and make sure that the voices of the patients, the families, and the caregivers are well represented as we engage with the FDA and payers. Lastly, since our BLA submission, we have leveraged our network and have moved quickly to fill crucial commercial roles, including key account management, market access, and marketing, with proven biopharma veterans who bring additional launch and commercialization expertise with autologous cell therapies. Their contributions will be an important piece of our launch planning. We intend to further build out our commercial organization and infrastructure in a stage-gated manner aligned to BLA acceptance. Now I'll hand the call over to Joe to discuss our third quarter financial results. Joe?