IVERIC bio, Inc.

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, Mr. Chris Sims, Chief Commercial Officer, and we are pleased to welcome Mr. Tony Gibney as Chief Business and Strategy Officer. Tony joined the company in mid-December. It's a pleasure to have you with us, Tony. I would like to remind you that today we will be making statements relating to Iverick 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 quarterly report on Form 10-Q filed on November 9, 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, Cathy. Good morning, everybody, and thank you for joining our fourth quarter and year-end conference call. As we think about 2022, we continue to focus on execution, as evidenced by Gather 2, our second phase 3 clinical trial for Zamora for the treatment of geographic atrophy, or GA, which continues to exceed our expectation with an injection fidelity rate well above our stated goal of greater than 90% at month 12. We look forward to sharing top-line data in the second half of the year, This will be approximately one year after the enrollment of the last patient in, plus, as you know, the needed time to do the database lock and analysis, which Keith will speak to in a few moments. If the 12-month results are positive, we plan to file applications with the US FDA, as well as the European Medicines Agency, for marketing approval of Zmora in GA. As we get closer to reporting the GAT2 data, We continued our efforts internally to prepare for a potential filing of a new drug application for Zamora for the treatment of GA. We continue to gain momentum in building out our medical affairs team led by Double Desai, our chief development officer, and the commercial infrastructure led by Chris Sims, our chief commercial officer. These are two experienced and well-seasoned leaders with experience in working and launching retina drugs with blockbuster potential. We continue to execute on our IP strategy for Zamora. Earlier this month, the U.S. Patent and Trademark Office allowed claims for patent coverage covering methods of use of Zamora to treat GA. The patent, once issued, is expected to expire in 2034. We're also excited to have announced the results of a post-hoc analysis that evaluated various GA growth parameters to explore the rate of disease progression within the regions in the phobia in a subset analysis of patients from GATHER-1, which is our phase three clinical trial for the treatment of Zamora NGA. These data were recently presented at this year's angiogenesis, exudation, and degeneration conference, and Praveen will provide more details on the analysis in a few moments, and you will see why we are quite excited by this new data. As we think back over the past year, we successfully achieved a number of major milestones that we believe have laid the groundwork for 2022 to be a banner year for us. Let me briefly recap some of the significant highlights. First, we received a written agreement from the U.S. FDA under a special protocol assessment, or SPA, for the overall design of Gather 2. The agreement further solidifies our plans to file an NDA with the FDA for marketing approval of Zamora for GA if the ongoing Gather 2 clinical trial meets its primary endpoint at 12 months. As you know, Zamora met its primary efficacy endpoint at 12 months with statistical significance in a previously completed Gather 1 pivotal trial. In July, we announced the completion of patient enrollment in Gather 2. This was four months ahead of our original schedule. We also started the planning to initiate a phase three clinical trial studying Zamora in patients with intermediate AMD in the second half of this year. We continue to enroll patients in our STAR clinical trial. This is our phase two B screening trial of Zamora for treatment of autosomal recessive Stargardt disease. We also initiated a number of preclinical tolerability and pharmacokinetic studies for IC500 or HTRA1 inhibitor. However, we anticipate that the start of the IND-enabled tox studies will be later than originally planned. This is primarily due to the availability or lack of availability of study slots at contract research organizations in the wake of COVID-19 pandemic. We expect to submit an investigational new drug application or an IND to the FDA for IC500 during the mid-2023. We also strengthened our balance sheet by raising approximately $108 and $163 million in net proceeds from public offerings in July and October 2021, respectively. Dave will cover our cash and Cash One later in the call. We believe that these capital raises enable us to accelerate preparations for a potential commercial launch of Zamora and allow us to continue to invest in manufacturing capacity. In addition, we continue to invest money in additional lifecycle initiatives for Zamora in order to expand the patient population with additional indications, such as the initiation of an intermediate AMD trial and investing in multiple sustained release delivery technologies. On the corporate front, we're excited to welcome Christine Miller, who is the President and Chief Executive Officer of Malenta Therapeutics, to our Board of Directors. We're thrilled to have somebody of Christine's caliber join our board. Christine's extensive background in commercialization and supply chain management will be a valuable addition to our board of directors. We're also, as Kathy just mentioned, excited to welcome Tony Gibney to our company. He joined as Chief Business and Strategy Officer this past December. Tony's an experienced biotech executive and former investment banker, and as you know, is well-known throughout our industry. We look forward to Tony's leadership and extensive experience in contributing to our future success. I will ask Tony to say a few words about our business development strategy later on in this call. I'd like to now turn the call over to Keith.

Thanks, Glenn, and good morning, everyone. As Glenn mentioned, we completed patient enrollment in Gather 2 in July 2021 with 448 patients enrolled, four months ahead of our original schedule. Based on this timeline, we expect top line Gather2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient, plus the time needed for database lock and analysis. We are actively working internally and with our third party vendors to prepare for the Gather2 database lock. A major priority for us is to continue to aggressively drive patient retention and thereby further de-risk the Gather2 clinical trial. As Glenn mentioned, we are targeting patient retention for the GATHER-2 trial as measured by injection fidelity rate through month 12 of greater than 90%. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections. We consider injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of the drug or sham into the patient's eye. As of today, we continue to maintain an injection fidelity rate of well above our 12-month target of greater than 90%. As a comparison, the 12-month injection fidelity rate for our GATHER-1 trial, which showed a statistically significant reduction in GA progression at 12 months, was 87%. We continue to focus on injection fidelity, not only to protect the integrity of the data, but also to potentially observe the early and increasing treatment effect we previously observed in Gather 1. Patient retention is clearly an integral part of the Gather 2 outcome. To date, we are excited to have reached a trial completion rate of 84% for Year 1, the time point for the primary efficacy endpoint of the trial. Therefore, with only approximately 16% of Year 1 visits remaining in Gather 2, we are encouraged to see that our efforts to maximize patient retention in Gather 2 have resulted in even greater patient retention than was observed in GATHER1 through the same time period. To summarize, GATHER2 has exceeded our expectations for patient recruitment, patient retention, and injection fidelity. We continue to work with our investigators to provide a safe environment for patients, which we believe increases the patient's comfort and confidence to continue to participate in the GATHER2 clinical trial. As we discussed in the past, we implemented a number of initiatives to reduce the risk and exposure to COVID-19 for our patients and the staff treating them. We have found that many principal investigators are enthusiastic and committed to participating in GATHER2 clinical trial. We believe the positive GATHER1 12-month data further supported by the positive 18-month efficacy results and the safety profile that was maintained throughout the trial, along with the early and increasing treatment effect observed in GATHER1, are key motivators for retention in GATHER2. In addition, there are currently no therapies approved for GA in either the US or the European Union. Turning to Stargardt disease, patient enrollment in the STAR trial is ongoing with the goal of enrolling approximately 25 additional patients for a total of approximately 120 patients. The results of this trial are expected after the top line results of GATHER2. Thanks for your time, and I will now turn the call over to Praveen. Thank you, Keith.