Abeona Therapeutics Inc.

Greetings. Welcome to Abiona Therapeutics' full year 2020 for results and business update conference call. At this time, all participants are in a listen-only mode. 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, Greg Chin, VP of Investor Relations and Communications at Abiona. Greg, you may begin.

Thank you, Paul. Good morning and thank you for joining us on our full year 2024 results and business update conference call. During this call, we will refer to the press release issued this morning announcing the financial results. It's available on our corporate website at www.abionatherapeutics.com. Remarks made during today's call may contain projections and forward-looking statements, which 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. 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 factors 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.avionatherapeutics.com. On the call today with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, Dr. Madhav Vasantavada, Chief Commercial Officer and Head of Business Development, Dr. Brian Keveny, Chief Technical Officer, and Joe Vizzano, Chief Financial Officer. And with that, I will now turn the call over to Vish Seshadri to leave us off. Vish?

Thank you, Greg. We appreciate everybody joining the call this morning. We're less than six weeks away from our PDUFA date of April 29th, for Pradimogene zamykyracel, or PZ cell, for recessive dystrophic epidermolysis bullosa, or RDEP. Since resubmitting our PZ cell biologics license application in late October and receiving FDA acceptance in early November, we have been working with the FDA on the review process. As a reminder, the FDA has not indicated the need for additional site inspections or an adcom as part of this review. On March 14th, 2025, we received from the FDA a marked up version of the draft USPI to initiate label discussions. We have also received some post-marketing commitments and requirements from the FDA. The potential approval of PzCell would be a significant moment for the RDEB community, a major milestone for our company, and would be the main driver of growth and profitability for Abiona for years to come. In anticipation of the PDUFA date, Our launch preparations for PZ-cells for our DEB are well underway. While five renowned EB treatment centers in the US are undergoing onboarding and activation activities to become PZ-cell qualified treatment centers, or QTCs, we anticipate that sites will be activated and ready to biopsy patients starting in the third quarter of this year, approximately three months after the PDUFA date, similar to past autologous cell therapy launches. In other words, We anticipate launching PZ Cell in the third quarter of this year, pending FDA approval. The RDEP community continues to highlight the unmet medical need for new therapies. These patients continue to seek reliable and durable treatment options for their wounds. The strength of our clinical data, manufacturing capabilities, commercial readiness efforts, and significant cell and gene therapy launch experience of our commercial team, Abiona is poised to serve the U.S. RDEB community following an approval. We are confident that if approved, BD Cell and its differentiating clinical profile will transform the treatment paradigm for RDEB patients. I'll end my remarks with a brief mention of our partnered program with Ultragenyx for Sanfilippo Syndrome Type A, or MPS3A, In December, Ultragenyx submitted a BLA to the FDA seeking accelerated approval for UX111 for patients with MPS3A. Last month, Ultragenyx announced that the FDA granted the BLA a priority review with a PDUFA action date of August 18, 2025. So 2025 is shaping up to be a very exciting and momentous year in our company's history with the potential for two FDA approvals of our internal and partnered products. I'll now hand the call to our Chief Commercial Officer, Madhav Vasanthavara, to highlight our commercial launch preparations for PZ-Cell. Madhav?