IVERIC bio, Inc.

Good day and welcome to the Ibericbio third 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 touchtone phone. To withdraw your question, please press star then two. Please note, today's 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 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 Iverett Biles' 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 or implied by any forward-looking statement. I refer you to our SEC filings, and in particular to the risk factors included in our quarterly report on Form 10Q, filed on July 26, 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 as except required by law. I would now like to turn the call over to Glenn.

Well, thank you, Kathy, and good morning, everyone, and thank you for joining us for our third quarter conference call. During the third quarter, we were thrilled to announce positive efficacy and favorable safety results from GATHER-2, our second phase three clinical trial of Avacyncaptad Pegol, or ACP, also known as Amora, for the treatment of geographic atrophy. We're proud to have achieved something that has never been done before in GA, deliver two phase three studies that met their pre-specified primary endpoint at 12 months of slowing GA progression. Our key focus now is to make ACP commercially available to physicians and their patients with GA as expeditiously as possible, subject to regulatory review and approval. The positive results from GATHER-1, our Phase III clinical trial of ACP for the treatment of GA, and GATHER-2, as well as our Special Protocol Assessment, or SPA, with the FDA provide the basis for our new drug application. As a reminder, we received written agreement from the FDA under an SPA for the overall design of Gather 2 in July of 2021. 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. The earlier completed Gather 1 clinical trial allowed us to get a head start on assembling the NDA prior to receiving the Gather 2 results. Importantly, we are ahead of schedule in preparing our NDA for ACP for the treatment of GA and therefore are moving up our submission timeline to the end of this year. We look forward to continuing to engage with the FDA throughout the review process We're also planning to submit a marketing authorization application, or an MAA, to the European Medicines Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe. We're also delighted that Gather 2 efficacy and safety results for ACP were presented in two oral presentations as part of the Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting on September 30, 2022, in Chicago. We appreciated the opportunity to share the results of GATHER2 with eye care specialists from around the world at this highly respected medical meeting. Additionally, this week, GATHER1 and GATHER2 data will be presented at the Retina Society in Pasadena, California, and we will highlight the observed efficacy data from both studies. Praveen's going to talk about this in more detail in just a moment. Looking ahead, we're excited about the possibility to expand ACP into earlier stages of AMD. We received favorable feedback from the FDA on our development plans for intermediate AMD. We are more determined than ever to evaluate ACP for this important patient population. We look forward to continuing our productive and collaborative discussions with the FDA and updating you further as we clarify our strategy. We continue to invest in additional lifecycle initiatives for ACP to expand the patient population and to continue to evaluate multiple technologies for ACP. During the third quarter, we secured a term loan credit facility, providing us with access to $250 million in debt financing with Hercules and Silicon Valley Bank. This financing further strengthens our balance sheet and provides financial flexibility as we continue to build our U.S. launch readiness plan and prepare for the potential commercialization of ACP. In July, we borrowed $50 million at closing. With the positive Gather 2 results, we believe we have satisfied the first performance milestone under the facility, which allows us access to an additional $50 million tranche from the facility, which we plan to borrow before the end of the year. Well, again, thank you for your support, and I will now turn the call over to Praveen.