Abeona Therapeutics Inc.

Ladies and gentlemen, and welcome to the Abiona Q2 2022 earnings call. At this time, all participants are on a listen-only mode. The floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Greg Ginn, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Holly. Good morning, everyone. I would like to welcome and thank everyone for joining us on our second quarter 2022 conference call. The press release announcing the results is available on our website at www.abionatherapeutics.com. On the call today with prepared remarks are Vish Seshadri, Chief Executive Officer of Abiona, and Joe Vizzano, Chief Financial Officer. After the prepared remarks, we will host the Q&A session. And we are also joined by Dr. Brian Keveny, Chief Technical Officer and Head of Research. Before we start, I will review our Safe Harbor Statement. Remarks made during today's call may contain projections and forward-looking statements regarding future events. 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 are identified under the section entitled Risk Factors in the Company's Annual Report on Form 10-K and other periodic reports filed by the company with the SEC. These documents are available on our website at www.abionatherapeutics.com. And with that, I will now turn the call over to our CEO, Vish Seshadri. Vish?

Thank you, Greg. Good morning, everybody, and thank you all for joining us this morning. We are focused on developing transformational therapies for serious diseases with the highest unmet need. During the second quarter, we took decisive action to direct our resources toward our lead asset, EB101. In May, we announced an exclusive agreement whereby Ultragenyx assumed all financial responsibility for the continued development of ABO102 for San Filippo Syndrome Type A, or MPS3A, including certain prior development costs and other transition costs. In return, EBIONA is eligible to receive tiered royalties on net sales and certain commercial milestone payments following regulatory approval. We have also discontinued development of ABO 101 for MPS 3B. With the disposition of the MPS programs, we were able to extend our cash runway well beyond the vital readout into the second quarter of 2023. The additional runway puts us in a strong position to forge the optimal commercial partnership that fully appreciates the value of EB101 post-data readout. For recessive dystrophic epidemolysis bullosa, or RDEB, we are investigating EB101's potential in treating the most debilitating aspects of the disease, that is, large chronic wounds that typically do not heal spontaneously and inflict the greatest pain and clinical burden. It is very exciting to be reading our top-line results from the EB101 Pivotal Phase III Vital Study in RDEB in the coming months. And following a potential positive outcome, we plan to submit a biologics license application with the FDA. This study reached an important milestone earlier this year when we achieved target enrollment in March. With our final patient visit for the vital study planned in mid-September, we anticipate reporting top-line results around end of third quarter or early fourth quarter. The top-line report will include data on wound characterization, the co-primary endpoints for efficacy, as well as safety. In the meanwhile, we have continued our active engagement with potential partners to commercialize EB101 with the goal of finalizing an agreement after release of top-line data. Our steadfast belief in the promise of EB101 for RDEV patients is supported by compelling long-term results from a completed Phase I-II study. In May, additional long-term follow-up data and quality-of-life data from the Phase I-II study were featured during an oral presentation at the Society of Investigative Dermatology, or SID, annual meeting. The data showed EB101 treatment of large chronic R-DEP wounds resulted in considerable wound healing at a mean of 5.9 years of follow-up and a maximum of 8 years of follow-up. In addition, reduced wound burden was associated with long-term symptomatic relief, including reduction in pain. Remember, in vital, as in the Phase I-II study, we treated large chronic wounds. Unlike the small recurring wounds that can close spontaneously, large chronic wounds cannot close themselves, and remain open for more than six months. In fact, many wounds treated in vital had been chronically open for years. For that reason, we anticipate very little spontaneous healing in the untreated control arm of the study. In vital, we treated a total of 43 randomized large chronic wounds in 11 patients, and each of the 43 wounds was paired with an untreated control wound within the same patient. An additional 14 non-randomized wounds were also treated with EB101. Baseline wound characteristics underscore the large size and severe pain associated with the wounds included in the vital study and include the following. Mean body surface area of randomized wounds treated with EB101 per patient was 156 centimeters squared. And if you included the non-randomized wounds, mean treated body surface area per patient was 207 centimeters squared. Remember, pain reduction is the second co-primary endpoint in vital. Pain for each wound is assessed during dressing change, the time at which pain is most intense, using the Wong-Baker FACES pain rating scale of 0 to 10. At baseline, many patients noted severe pain, with 8 of the 11 patients reporting a minimum pain score of 6 in at least one randomized wound, and four of the 11 patients reporting a maximum baseline pain score of 10 for certain randomized wounds. Clearly, the wounds that we have treated in vital are representative of the most problematic painful wounds that can lead patients to opioid use for pain management. EB101 is the only investigational product that has a co-primary endpoint of pain reduction in the pivotal study. Returning briefly to our preclinical iPrograms. At the rVOTE 2022 Annual Meeting in early May, we reported non-human primate data for AAV204, a novel AAV capsid from our AIM capsid library. The results showed AAV204's ability to produce more robust transduction in the macular area of the eye following administration directly into the vitreous of the eye by pararetinal administration which, unlike subretinal administration, has not been associated with retinal detachment. We are excited by AAV204's ability to achieve high macular and optic nerve transduction levels in non-human primates with a potentially less invasive and safer administration route than subretinal injection. Looking ahead, we are excited to share that ongoing proof-of-concept studies in our undisclosed ophthalmic indications have begun to demonstrate proof of gene expression in target tissues. Functional readouts from these studies will begin to be reported this quarter, which we hope will support pre-IND meetings with the FDA in the second half of 2022 to early 2023. I'll now turn the call over to Joe to review the financial results.