Abeona Therapeutics Inc.

Good morning and welcome to the Abiona Therapeutics third quarter 2024 conference call. At this time all participants are in a listen only mode and we will open for questions following the presentation. If anyone should require operator assistance during this 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, Greg Ginn, VP of Investor Relations. Greg, the floor is yours.

Thank you, Jenny. Good morning, everyone, and thank you for joining us on our third quarter 2024 conference call. During this call, we'll refer to the press release issued this morning announcing the third quarter results, which is available on our corporate website at www.abionatherapeutics.com. 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, but are not limited to, those identified under the risk factor sections in our Form 10-K, and periodic reports filed with the SEC. These documents are available on our website at www.abionatherapeutics.com. On the call today with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, Dr. Mada 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. And with that, I will now turn the call over to Vish Sasadri to lead us off. Vish?

Thank you, Greg. We appreciate everybody joining this call this morning. We have continued to be productive since our last call and have made progress on multiple fronts toward bringing our lead product candidate, Pradamagene Zamycaracil, or PZ Cell, to patients with recessive dystrophic epidermolysis bullosa, or R-DEV. These patients continue to seek durable treatment options for their wounds. I'll start with the regulatory progress first. Since receiving the complete response letter, CRL, in April, we have worked closely with the FDA in preparing the resubmission of our PZ Cell biologics license application and getting it back in the review process. As a reminder, the CRL highlighted the need for additional CNC data pertaining to the validation of certain manufacturing and release testing methods. The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of PZ Cell. In August, we had a Type A meeting where we aligned with the FDA on the content of the resubmission, including additional information to address all the deficiencies noted in BCRL. I'm pleased to report that we completed the resubmission of our BLA for PZ Cell at the end of October. Just last week, the FDA accepted the resubmission for review and set a PDUFA date of April 29, 2025. Meeting this regulatory milestone in Q4, as per our guidance, was made possible by the tireless efforts and determination of our team, especially technical operations quality, regulatory and clinical, and I thank them for their dedication. The FDA's acceptance of our resubmission indicates that our package includes all the necessary data components, including those items identified in the CRO and observations from the pre-license inspection to support review of the updated dossier. The FDA has previously informed us that they do not intend to host an advisory committee or adcom meeting In addition, pre-licensed inspections for all clinical sites and our manufacturing facility were completed earlier this year. Therefore, we do not anticipate additional site inspections as part of the resubmission review process. We will continue to work with the FDA to facilitate their timely review. We remain confident in our prospects for approval given the unmet medical need in R-DEP to treat large chronic wounds. Our strong clinical data, our comprehensiveness in addressing every CRL item, and PLI observation and our collaborative interactions with and feedback to date from the FDA. So now the focus for the rest of this year and into 2025 is obviously to drive through the regulatory process as we continue to ramp up our commercial readiness activities for a potential launch next year, which Madhav will elaborate on in a moment. But before that, I'm excited to share that we have recently entered into a lease agreement for additional building space in Cleveland, Ohio, adjacent to our existing facility to enable capacity expansion beyond our current manufacturing footprint. I also want to briefly mention the recent issuance of a new U.S. patent for the PV cell. The patent is entitled Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa Using Genetically Corrected Autologous Keratinocytes. and includes claims that cover the use of PZ-cell for treatment of R-dead. The patent has an expiration date of Jan 3rd, 2037, subject to any applicable patent term extension. Another U.S. patent will issue on November 19th, 2024, relating to the packaging and transport system for PZ-cell sheets. Absent any patent term adjustment or extension, that patent would expire in July 2040. The issuance of these patents by the USPTO acknowledges the groundbreaking nature of the technology underlying PZ-Cell. If approved, PZ-Cell will be the first product to use gene-corrected keratinocyte sheets to treat RDEV. Based on PZ-Cell's clinical trial experience, we are optimistic that the underlying technology for making PZ-Cell and using it to treat a human patient that is claimed in this patent, which allows stable insertion of this functional collagen 7 gene into the genome of each patient's own skin cells could uniquely position PC cells to achieve wound healing and pain reduction RdEV wounds following a single administration. I'll now turn the call over to our Chief Commercial Officer, Dr. Madhav Vasanthavada, to highlight our commercial launch preparations. Madhav?