IVERIC bio, Inc.

Hello, and welcome to the Iverick Bios second quarter 2021 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchstone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. Now I'd like to turn the conference over to Kathy Galante, Senior Vice President, Investor Relations. Ms. Galante, please go ahead.

Thank you, Keith. Good morning and welcome to IvericBio's conference call. Representing IvericBio today are Mr. Glenn Splendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Mr. Keith Westby, Chief Operating Officer, Mr. Dave Carroll, Chief Financial Officer, Dr. Double Desai, Chief Development Officer, Dr. Abraham Scaria, Chief Scientific Officer, and Mr. Chris Sims, Chief Commercial Officer. I would like to remind you that today we will be making statements relating to Iberic Bio's future expectations regarding operational, financial, and research and development matters. These statements constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward-looking statement. I refer you to our SEC smilings and, in particular, to the risk factors included in our quarterly report on Form 10Q filed on May 5, 2021, for a detailed description of the risk factors affecting our business that could cause actual results or events to differ materially from the forward-looking statements that we make. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we disclaim any obligation to do so except as required by law. I would now like to turn the call over to Glenn.

Thanks, Kathy, and good morning, everyone, and thank you for joining us for our second quarter conference call. It's an exciting time for the company as we have delivered on several transformational milestones, particularly with regard to the execution of our Zamora Pivotal Program. We announced on July 6, 2021, that we received a written agreement from the FDA under a special protocol assessment, or SBA, for the overall design of GATHER2, our second pivotal clinical trial of Zamora in the development for the treatment of geographic atrophy, GA, secondary to age-related macular degeneration, or AMD. We believe this is the first and only SPA in GA This is quite an achievement, very happy and proud of the team that they were able to do this in collaboration with the FDA. The SPA solidifies our plans to file an application with the FDA for marketing approval of Zmora for GA secondary to AMD if the ongoing Gather 2 clinical trial meets its primary endpoint at 12 months. Zmora met its pre-specified primary endpoint at 12 months and reached statistical significance in the previously completed GATHER-1 trial, our first pivotal clinical trial of Zamora for the treatment of GA secondary to AMD. On July 26, 2021, we announced we completed the enrollment in GATHER-2, specifically four months ahead of our original schedule. We are on track for initial top-line data from GATHER-2 to be available during the second half of 2022. approximately one year after the enrollment of the last patient in GATHER2 clinical trial, plus obviously the time needed for database closure and analysis. GATHER2's patient retention, as measured by the injection fidelity rate, continues to exceed our expectation. We are targeting the 12-month injection fidelity rate to be greater than 90%, and we are entirely committed to maintaining patient retention in GATHER2 clinical trial. And importantly, the results of a post hoc analysis of Gather 1 in Druzen and Nation GA were presented at our Zamora symposium in June. These results suggest that Zamora may have a therapeutic benefit in earlier stages of GA. Following the Gather 2 SPA, we strengthened our balance sheet with a public offering, raising approximately $108 million in net proceeds. They will cover our cash and cash runway later in the call. We believe this capital allows us to advance a number of critical initiatives. First, it enables us to further support the efficient trial execution and maintain a high degree of integrity in our Zamora Gather 2 Phase 3 program. Second, it allows us to prepare and potentially file a new drug application or NDA and a marketing authorization application, or MAA, for Zamora. Third, allows us to begin preparations for a potential launch of Zamora in GA secondary to AMD. Next, to initiate a Jerusalem clinical trial program. And finally, invest in sustained release delivery technologies for Zamora. On the personnel front, we are thrilled, and he's on the call today, to welcome Chris Sims to Iverick Bio as Chief Commercial Officer. Chris is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Johnson & Johnson, Gentech, and Novartis, including focused expertise in retina, ophthalmology, and optometry. Chris joins us from Novartis, where he successfully managed commercial operations for the U.S. ophthalmic franchise launching B of U for WET-AMD. Before Novartis, he served as marketing lead for the Genentech ophthalmology business, which included creating a new brand, positioning, and launch campaign for Lucentis. At IvericBio, Chris's responsibility will include developing and implementing our commercial strategy and establishing our commercial infrastructure as we complete the Gather 2 clinical trial and prepare for a potential NDA and MA filings and begin to prepare for the potential launch of Zmora for the treatment of geographic atrophy secondary to AMD. On the gene therapy front, we welcome Dr. Hemet Khanna to iVergBio as Vice President, Preclinical Ocular Research. Hemet joins us from the University of Massachusetts Medical School, where he was the principal investigator for our Mini-Sept 290, Mini-ABCA4, and Mini-Sept USH 2A sponsored research programs. We are working to transition the research and preclinical development activities for these programs of University of Massachusetts Medical School to us. We are also preparing to establish laboratory space for Hemet and three other employees who joined us from University of Massachusetts to continue to work on these mini gene programs and other preclinical research activities that we have ongoing. We are excited to welcome well-accomplished and talented new members to the iveric bio team. The company over the past year has grown by a number of people, and we welcome them all. We couldn't get here without their help. I'll now turn the call over to Keith.