Abeona Therapeutics Inc.

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Abiona Q1 2022 earnings call. At this time, all participants are on a listen-only mode. After management's prepared remarks, there will be a question and answer session. I would now like to turn the call over to the host, Greg Chin, VP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Kelly. Good morning, everyone. I would like to welcome and thank everyone for joining us on our first quarter 2022 conference call. 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 vary differ- 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 section entitled Risk Factors in the company's annual report on Form 10-K and other periodic reports filed by the company with the Securities and Exchange Commission. These documents are available on our website at www.abionatherapeutics.com. With that, I will now turn the call over to our CEO, Vish Seshadri. Vish?

Thank you, Greg. Good morning, everybody, and thank you for joining us this morning. It's been only a few short weeks since we last spoke in late March when we announced a new strategic plan in which we reprioritize our portfolio investments to preserve capital and extend our projected cash runway into the second quarter of 2023. Since then, we have moved quickly to divest ABiona of the MPS programs. In a joint press release with Ultragenyx issued this morning, we reported an exclusive license agreement where Ultragenyx will assume all further development and commercialization responsibilities for ABO-102, and in return, Abiona will be eligible to receive tiered royalties up to 10% on net sales and commercial milestone payments up to $30 million, following regulatory approval. We believe that Ultragenyx, with its deep expertise in rare genetic diseases, including MPS, is an ideal partner to potentially bring ABO-102 to patients who have been waiting too long for a first treatment. We have discontinued development of ABO-101 for MPS-3B, as we had announced in the previous earnings call. Offloading the MPS programs in addition to seizing the build-out of additional AAV facilities should significantly reduce our cash burn and allow Aviona to fund operations over the next 12 months. We have now focused our finite resources more narrowly on EB101 Pivotal Phase III Vital Study Readout, which is our most significant near-term clinical milestone. Having completed the accrual of vital, we expect top-line results of the study in late third quarter of 2022, which could support filing a biologics license application. Our increased focus on EB101 is supported by the compelling long-term results from the Phase 1-2 study in recessive dystrophic EB. In that study, as previously reported, EB101 demonstrated instantaneous wound healing and pain reduction in the majority of treated wounds up to six years after treatment of large chronic wounds in RDEV patients. Later this week, additional long-term follow-up data for up to eight years from the Phase 1-2 study will be featured during an oral presentation at the Society of Investigative Dermatology, SID, annual meeting. We therefore anticipate similar results from our phase three vital study. Remember, in vital, as in the phase one and two study, we treated large chronic wounds that measured greater than 20 centimeters squared of body surface area at baseline. These are the most severe and problematic wounds inflicting intense pain and causing the greatest clinical burden on our patients. Unlike small recurring wounds that can close spontaneously, large chronic wounds rarely close themselves and remain open for more than six months, and in many cases, remain open for years. 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 EB-101. Regarding baseline wound characteristics, the mean body surface area of randomized wounds treated with EV101 per patient was 156 centimeters squared, the range being 80 to 200 centimeters squared. If you include the non-randomized wounds, the mean treated body surface area per patient in the study was 207 centimeters squared, the range being 120 to 240 centimeters squared. These baseline wound characteristics underscore the potentially unique value proposition of our investigational EB101 product in our debt. As we await results from Vital, we are aggressively exploring partnerships for commercialization of EB101. Also remember, EB101 has a rare pediatric designation, which means we have a potential opportunity for a priority review voucher at approval. Now, Turning briefly to our preclinical eye programs, at ARVO 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 macula area of the eye following administration directly into the vitreous of the eye by pararetinal administration which unlike subretinal administration does not create a retinal detachment. We're 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. We are investigating our novel AAV capsid in four undisclosed ophthalmic conditions with estimated US prevalence ranging from 5,000 to 15,000 patients. Looking ahead, we expect animal proof of concept data beginning in mid-2022 that could potentially support a pre-IND meeting with the FDA in the second half of 2022. I'll now turn the call over to Joe to review the financial results. Joe?