IVERIC bio, Inc.

Good morning and welcome to the ivericbio third quarter 2021 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Kathy Galante, Senior Vice President, Investor Relations. Please go ahead.

Good morning and welcome to Ivericbio's conference call. Representing Ivericbio today are Mr. Glenn Splendoria, Chief Executive Officer, Dr. Praveen Dougal, President, Mr. Keith Westby, Chief Operating Officer, Mr. David Carroll, Chief Financial Officer, Dr. Double Desai, Chief Development Officer, and Mr. Chris Sims, Chief Commercial Officer. I would like to remind you that today we will be making statements relating to IVARIC-BIOS 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 filings and in particular to the risk factors included in our current report on Form 8K filed on October 21, 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 as required by law. I will now turn the call over to Glenn.

Thanks, Kathy, and good morning, everyone. Thank you for joining us for our third quarter conference call. 2021 has been a pivotal year for Iverick Bio as we set in motion our plans to accelerate the opportunity for Zamora to be first in class and best-in-class for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration, or AMD. In GATHER-2, our second pivotal clinical trial of Zamora and GA secondary to AMD, patient retention continues to exceed our expectations. We are targeting the 12-month injection fidelity rate to be greater than 90%. We are entirely committed to maintaining patient retention in the Gather 2 clinical trial, which Keith will discuss in a few moments. In parallel, preparations of a new drug application, or NDA, and building a commercial infrastructure are well underway for the potential launch of Zamora for the treatment of GA secondary to AMD, if approved. We're also in the process of assembling a seasoned commercial team with experience launching retina drugs with blockbuster potential. In August, we welcome Christopher Sims, a senior vice president and chief commercial officer, and the hiring of the commercial leadership team has already begun. Chris is an accomplished healthcare leader with more than 20 years of diverse commercial experience, leadership experience, and 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 Genentech's ophthalmic business, which included creating a new brand positioning and launching a new campaign for Lucentis. We are thrilled to have achieved several major milestones regarding the execution of our Zamora Pivotal program. First, in July, we completed patient enrollment in Gather 2, 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, plus time needed for database closure and analysis. Second, we received a written agreement from the FDA under a special protocol assessment, or SPA, for the overall design of GATHER-2. We believe that this is the first and only SPA in GA. For those who are not familiar, the SPA process is a procedure by which the FDA provides the 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. Praveen will provide additional details on the SPA in a moment. We did a post hoc analysis of the GATHER-1 trial, where we looked at Druzen and nascent GA, which showed that Zamora has the potential to impact earlier stages of AMD. Based on these analysis, we plan to accelerate development of Zamora in intermediate AMD by initiating a phase three clinical trial in 2022. Praveen will also provide more details on this trial in a few moments. We also strengthened our balance sheet by raising approximately $108 million and $163 million in net proceeds with public offerings in July and October 2021, respectively. Dave will cover our cash runway later in this call. We believe these fundraisers enable us to prepare Zamora for what could be first-to-market and best-in-class opportunities. Also, accelerate our preparations for potential commercial launch of Zamora and continue to invest in manufacturing capacity. In addition, we plan to invest in additional lifecycle initiatives for Zamora in order to expand the patient population with additional indications, such as accelerating our plans for intermediate AMD and investing in multiple sustained release delivery technologies for Zamora. The main priorities for us today are the retention of patients in Gather 2 and preparing for the potential commercialization of Zamora in the U.S. This is an exciting time for the company as we continue to execute on our Zamora Pivotal Program with the potential to create long-term shareholder value. I will now turn the call over to Keith.