Clearside Biomedical, Inc.

Greetings and welcome to the Clearsight Biomedical First Quarter Financial Results and Corporate Update Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Ms. Jenny Cobin, Clearsight Investor Relations. Ma'am, please go ahead.

Good afternoon, everyone, and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our annual report on Form 10-K for the year ended December 31, 2020, and our other SEC filings available on our website. In addition, any forward-looking statements represent our views 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 in the future, we specifically disclaim any obligation to do so even if our views change. On today's call, we have George Lozeski, our Chief Executive Officer, Dr. Thomas Chula, our Chief Medical Officer and Chief Development Officer, and Charlie Degnan, our Chief Financial Officer. After our formal remarks, we will open the call for your questions. I would now like to turn the call over to George.

Thank you, Jenny. Good afternoon, and thank you for joining us on the call today. We have made meaningful progress since we hosted our last earnings call in March. We resubmitted our Zypier new drug application to the U.S. Food and Drug Administration. Zypyr is our proprietary suspension of the corticosteroid triamcinolone. It's formulated for superchoroidal administration for the treatment of macular edema associated with uveitis, which is delivered by our patented SCS microinjector. This is an important milestone for our company and our shareholders for two reasons. First, Zypyr approval would represent ClearSight's first commercial product approval. Second, it would be the first drug approved for delivery into the supracoroidal space, which is behind the patient's visual field. This innovative approach to ophthalmic drug delivery could be a major breakthrough for the treatment of retinal diseases, as it demonstrates the potential for a reliable, non-surgical, office-based method to deliver a variety of therapeutic products for a broad range of back-of-the-eye diseases. Our team has worked tirelessly throughout this Zypher NDA resubmission process, and I'd like to publicly recognize their efforts. They successfully accomplished the technology transfer to our new manufacturing partner in an incredibly short period of time. The efficiency of this transfer process is a testament to the hard work, cooperation, and professionalism of both the ClearSight team and the team at our new contract manufacturer. The Zyper NDA resubmission is a full and complete response to all of the items identified in the complete response letter we received from the FDA in October 2019. We anticipate FDA acceptance of the resubmission of the NDA within approximately 30 days of its submission date, and we believe this application will be considered a Class 2 resubmission with a targeted six-month review timeline under the Prescription Drug User Fee Act. We will provide an update when we receive our assigned PDUFA date. The potential approval of Zypyr will further validate our superchoroidal injection platform and its utility in delivering small molecule suspensions into the superchoroidal space. For the commercialization of Zypyr, we have two outstanding global partners, Bausch & Lomb and Arctic Vision. Bausch Health and Bausch & Lomb, its leading global eye health business, has the exclusive license for commercialization and development of Zypyr in the United States and Canada, as well as exclusive options for the European Union, United Kingdom, and other territories. We have maintained an ongoing dialogue with Bausch Health and Bausch & Lomb as we prepared the Zypyr NDA resubmission, and they provided input and support in connection with the filings. Our medical affairs, supply chain, and clinical teams have also worked closely with Bausch Health and Bausch & Lomb as they prepare for the commercial launch of Zypyr in the U.S., once approved. In Asia, Arctic Vision has the exclusive license for the commercialization and development of Zypyr in Greater China and South Korea. They announced in December that they obtained approval from the Chinese Regulatory Authority for their investigational new drug application in uveitic macular edema. They currently expect to begin Phase III clinical trials in that indication later this year. The second small molecule suspension for supercoroid of delivery in our internal pipeline is CLS-AX, our proprietary suspension of the tyrosine kinase inhibitor Excedinib. We're excited about this program because we believe that CLS-AX may improve the treatment of neovascular age-related macular degeneration, commonly known as wet AMD. through potentially improved safety and efficacy, and by reducing the frequency of patient injections with its prolonged durability. CLSA-X is currently being evaluated in a U.S.-based Phase 1-2A clinical trial entitled OASIS. It is a multicenter, open-label study to evaluate safety and tolerability of escalating single doses of CLSA-X in wet AMD patients. We have completed patient dosing in Cohort 1, and we expect to announce Cohort 1 results by the end of June after the last patient visit and data analysis. I'll now turn over the call to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to elaborate on CLS-AX, our partnered programs, and recent data presentations. Tom?