Clearside Biomedical, Inc.

good afternoon everyone this is your operator your conference will begin momentarily please continue to stand by once again this is your operator your conference will begin momentarily please continue to stand by so Good day and thank you for standing by. Welcome to the Clearside Biomedical First Quarter 2022 Financial Results and Corporate Update Conference Call. This time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. And now, it is my pleasure to hand the conference over to your first speaker today, Johnny Cobin, Clearside Investor Relations. Thank you. 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 31st, 2021, 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 Lazewski, 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. We continue to make steady progress in 2022. In March, we were pleased that Bausch & Lomb announced their U.S. launch of Xypher in the United States as the first therapy approved for macular edema associated with uveitis, a potentially blinding condition. Ahead of the official launch, Bausch worked closely with hundreds of retinal specialists throughout the country to train them on the use of our SCS microinjector, and to build interest in using Zypure to treat their uveitic macular edema patients. Bausch is very active at medical meetings with both a commercial and medical presence at the events, including five presentations at ARVO last week. Bausch continues to be a thoughtful and progressive partner, and we are confident in the strength and capabilities of their commercial team to advance this suprachoroidal therapy to patients in need. Our China-based development and commercialization partner, Arctic Vision, also continues to progress in its development of Zypyr, which they refer to as ARVN001 and the brand name Arcadis. They are currently enrolling two trials in China, a confirmatory phase three trial in macular edema associated with uveitis and a phase one clinical trial for the treatment of diabetic macular edema. We look forward to their continued progress in these two programs. The approval of Zypher in the U.S. validates delivery into the superchoroidal space by our proprietary SCS microinjector and supports our strategy to focus on small molecule suspensions. Our lead internal superchoroidal pipeline product candidate, CLSAX, combines our proprietary small molecule suspension of the tyrosine kinase inhibitor, Exidinib, with delivery by our STS microinjector. As Tom will discuss in more detail, we continue to make progress on our Phase I-IIa OASIS clinical trial targeting patients with wet A&D. OASIS is a single-dose escalating study to explore the safety and tolerability from 30 micrograms to 1 milligram, which is an over 30-fold range of doses. Our safety monitoring committee reviewed one-month initial safety data from Cohort 3, and we are pleased to report that there were no dose-limiting toxicities observed at the 0.5 milligram dose. As a result, we are now enrolling patients in Cohort 4 at a higher dose of 1 milligram, while simultaneously continuing our Cohort 3 enrollment. We are targeting up to 25 patients in total from all four OASIS cohorts. This expanded enrollment of Cohort 3 and the addition of Cohort 4 will allow us to collect more CLSAx patient data in order to help guide our selection of the most appropriate dosing protocol for our planned Phase 2b clinical trial. We now expect to report safety and tolerability data from both Cohorts 3 and 4 in the fourth quarter of this year. This will allow us to report a more comprehensive set of patient data as we will be able to include the complete analysis from all four dosing cohorts of the OASIS trial, in addition to the detailed individual patient data from the final two cohorts. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to discuss our research and development update. Tom will provide more details on the OASIS study and address the progress made by our partners. Tom?