IVERIC bio, Inc.

Hello, and welcome to the Iverick Bio, Inc. First Quarter 2022 Earnings 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. I'd now like to turn the conference over to Kathy Galante. Ms. Galante, please go ahead.

Good morning and welcome to Ivericbio's conference call. Representing Ivericbio today are Mr. Glenn Splendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Double Desai, Chief Development Officer, Chris Sims, Chief Commercial Officer, and Tony Gibney, Chief Business and Strategy 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 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 or implied by any forward-looking statement. I refer you to our SEC filings and in particular to the risk factors included in our annual report on Form 10-K filed on February 24, 2022 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, Cathy, and good morning, everyone, and thanks for joining our first quarter conference call. This is an exciting time for ivericbio as we prepare for top line data readout from Gather 2, our second phase three clinical trial for Zamora for the treatment of geographic atrophy, or GA, in the third quarter of this year. This is approximately one year after the enrollment of the last patient, plus some time needed for database lock analysis, which Keith will discuss in more detail in a moment. Our key objective and plan is to make Zimora commercially available to physicians and their patients with GA as quickly as possible, assuming a positive data outcome from Gather 2 and regulatory approval. As we prepare for Gather 2 results, we are working diligently to assemble a thorough and complete new drug application, or NDA. Following a potential positive outcome of Gather 2, we plan to submit applications with the FDA and the European Medicines Agency for marking approval of Zomora for GA. As a reminder, we received a written agreement from the FDA under a special protocol assessment, or SPA, for the overall design of Gather 2 in July of 2021. For those who may not be familiar, the SPA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for an NDA. As we get closer to reporting the Gather 2 top line, we made a number of new hires to lay the groundwork for a successful launch. IFSAMURA is approved. We are well positioned and with an established medical affairs team already in place and continue to build out our commercial infrastructure with a team that has extensive experience in launching drugs for retinal diseases with large market potentials. As we announced in our press release this morning, we continue to provide additional exploratory analysis from GATHER-1, which we believe further supports the consistency of the positive data that we previously reported for GATHER-1 and inform future potential development opportunities for Zamora and other indications. Both Dr. Dougal and Dr. Desai will review the details of the analysis in a few moments. We also continue to execute our IP strategy for Zamora. In March of this year, the US Patent and Trademark Office granted us a patent with claims covering methods of use to treat GA. This issue patent is expected to expire in 2034, which we which will extend our market exclusivity in the U.S. by several years. We also plan to initiate a clinical trial studying Zamora in patients with intermediate AMD in the fourth quarter of 2022. Our development strategy in this indication is subject to global regulatory feedback from the FDA and other regulatory authorities, which we plan to obtain before initiating this trial. Looking ahead at the potential of Zamora, we continue to invest in additional lifecycle initiatives for Zamora in order to expand the patient population with additional indications, and we are also evaluating multiple sustained release delivery technologies. We look forward to the exciting opportunities that lie ahead of us in 2022, including receiving top-line data for GATHER2, and being closer to reaching our goal of providing patients and physicians with a treatment for GA for which there are currently no treatment options available. I'd like to now turn the call over to Keith.