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IVERIC bio, Inc.
5/5/2021
Good morning and welcome to the Iverik BIO first quarter 2021 earnings 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. Please note this call 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 Ibericbio's conference call. Representing Ibericbio today are Glenn Slandorio, Chief Executive Officer, Praveen Dougal, President, David Carroll, Chief Financial Officer, Davil Desai, Chief Development Officer, Abraham Skaria, Chief Scientific Officer, and Keith Westby, Chief Operating Officer. I would like to remind you that today we will be making statements relating to IbericBio's future expectations regarding operational, financial, and research and development matters, including statements regarding our expectations for patient enrollment and patient retention in GATHER-2, our second Phase III clinical trial evaluating Zamora for the treatment of geographic atrophy secondary to age-related macular degeneration, our expectations to use GATHER-1, our previously announced clinical trial of Zamora, for the treatment of GA secondary to AMD as a Phase III clinical trial, our development and regulatory strategy for Zamora, and our other product candidates, including our expectations for additional indications for which we may pursue the development of Zamora and IC500, our hypothesis regarding complement inhibition and H-1 inhibition as mechanism of actions for the treatment of GA and potentially other stages of AMD. Our projected use of cash and cash balances, the timing, progress, and results of clinical trials and other research and development activities and regulatory submissions. The potential utility and development potential of our product candidates and the potential for our business development strategy and our personnel, advisory committee members, and human capital resources. 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, including risks related to the future progression of the COVID-19 pandemic, responsive measures to the pandemic, and their impact on our research and development programs. operations and financial position, initiation of the progress of research and development programs and clinical trials, including enrollment and retention in clinical trials, availability of data from these programs, reliance on contract development and manufacturing organizations, universities, collaborators, and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, developments from our competitors and the marketplace for our products, need for additional financing and negotiation and consummation of business development transactions and other risks. 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 March 4, 2021, for a detailed description of the risk factors affecting our business. 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, everybody. I thank you for joining us for our first quarter conference call. The first quarter of 2021 has been very productive for us at IVARIC-BIO. I am pleased to share that we are excited to be executing and moving towards completing enrollment in the GATHER2 clinical trial, our second phase three clinical trial for Zamora, a novel complement C5 inhibitor for the treatment of geographic atrophy or GA, secondary to age-related macular degeneration. We expect to complete this trial in the third quarter of this year. To date, both recruitment and retention of patients in GATHER2 are exceeding our expectations. we are on track for initial top-line data from Gather 2 to be available approximately one year after the enrollment of the last patient in the Gather 2 clinical trial. Of course, we have to add some time for database closure and analysis of the initial top-line data. If the 12-month results from Gather 2 are positive, We've planned to file applications with the US FDA and the European Medicines Agency for marketing approval of Zamora for GA. I also wanted to mention some organizational changes that further strengthen our management team. I am thrilled to announce that Dr. Praveen Dougal has been promoted to president effective May 1. Praveen has played a critical role in our execution of strategy. He's been a key part of the executive management team leading the company's strategy, and I want to also congratulate Kathy Galante on her well-deserved promotion to Senior Vice President, Investor Relations. I look forward to continuing to work with both of them at this exciting time in our company. Finally, I want to acknowledge David Geyer, my friend, who will be stepping down from our board after 14 years for his leadership as co-founder and executive chairman. I sincerely thank David for his hard work and significant contributions to the company. We wish David well as he rejoins SB Health Investors as a venture partner. I would now like to turn the call over to Keith, who will review enrollment and retention for Gather 2 and update you on our gene therapy pipeline in orphan inherited retinal diseases. Following Keith, Praveen will discuss our strategy in AMD and the formation of our Gene Therapy Inherited Retinal Disease Scientific Advisory Committee. Keith?
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