IVERIC bio, Inc.

Good morning and welcome to the ivericbio second 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 start key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Kathy Galante. Please go ahead.

Good morning and welcome to ivericbio's conference call. Representing Ivericbio today are Mr. Glenn Slendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Devil 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 Ivericbio'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 in 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 10-Q, filed on May 4, 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 required by law. I would now like to turn the call over to Glenn.

Thanks, Kathy, and good morning, everyone. Thank you for joining us for our second quarter conference call. We're excited to share that today marks the one-year point since we completed patient enrollment of GATHER2, our second Phase III clinical trial for Zamora, a novel C5 complement inhibitor. for the treatment of geographic atrophy, or GA. We look forward to reporting the top line data gathered to in September of this year, approximately one year after enrolling of the last patient, plus the time needed for database lock and analysis. Our team executed well all year as we continue to exceed our expectations for patient retention and injection fidelity, which we believe further de-risk gathers to and is an integral part of the clinical trial outcome. Keith will discuss this important data in a moment. Now let's discuss our expectations for reporting the upcoming GATHER2 top-line data. Once available, we will report the preliminary, the pre-specified primary efficacy endpoint analyzed by the mean rate of GA growth or the slope estimated based on GA area measured by fundus, in at least three time points, baseline, six months, and 12 months, calculated by using the square root transformation of the GA area. This is consistent with our written agreement with the US Food and Drug Administration, or the FDA, under a special protocol announcement, or SBA. In addition, we will present the same data with a point analysis. We will also report a summary of the safety profile including potential cases of choroidal neovascularization, CNV, as reported in the traditional manner, commonly defined in the retinal community as choroidal neovascular membrane, or CNVM. While the FDA did not request potential CNV cases to be reported using the non-traditional, recently defined terms such as exudative versus non-exudative CNV, we plan to also provide these data. For detailed definition of exudated and non-exudated CMV, as defined by the Center for Ocular Research and Evaluation, also known as CORE, at the Cole Eye Institute of the Cleveland Clinic, please see our Form 8K on April 4, 2022. In addition to CMV, we plan to also provide rates of potential inflammation and endophthalmitis, if any. As a reminder, we received a written agreement from FDA under an 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 a new drug application or NDA. If the results from Gather 2 are positive, our key objective and plan is to make Zmora commercially available to physicians and their patients with GA as quickly as possible, obviously assuming regulatory approval. Therefore, we have already began to assemble an NDA. Following a potential positive outcome of Gather 2, we plan to submit applications with the FDA and the European Medicines Agency for marketing approval of Zamora for GA. We're also very excited to have entered into a license agreement with Delta Tech, providing us a worldwide exclusive license to develop and commercialize the sustained release formulation of Zamora using Delta Tech's silica-based sustained release technology. Praveen will discuss this in more details in a moment. On the corporate front, earlier today, we announced that we have an agreement for up to $250 million in non-dilutive debt financing with Hercules and Silicon Valley Bank under a term loan debt financing facility. This non-dilutive financing further strengthens our balance sheet and provides flexibility as we look to finance the potential launch of Zamora. Dave will provide more details in a few moments. We continue to focus on the execution and bringing Zamora to patients suffering from this horrible disease geographic atrophy as our top priority. I will now turn the call over to Keith.