Clearside Biomedical, Inc.

Good morning, ladies and gentlemen, and welcome to the ClearSight Biomedical Incorporated third quarter 2022 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Jenny Coburn, with Investor Relations. Ma'am, the floor is yours.

Good morning, and thank you for joining us on the call this morning. On today's call, we will have a brief discussion around Clearside's third quarter financials, followed by the results from the OASIS Phase 1-2A clinical trial. 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 may make during this call about the company's future expectations, plans, and prospects constitute statements 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, 2021, and our other FDC 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 Levesque, our Chief Executive Officer, Dr. Thomas Shula, our Chief Medical Officer and Chief Development Officer, Charlie Dugnan, our Chief Financial Officer, and Dr. Arshad Kanani, who is a Managing Partner at Sierra Eye Associates and a Clinical Associate Professor at the University of Nevada, Reno. The remarks on today's call will be accompanied by a slide presentation, which is available in the Events section of Clearside's Investor Relations website at clearsidebio.com. I would now like to turn the call over to George.

Thank you, Jenny, and thank you all for joining us this morning. For today's call, I'll make some opening remarks, and then I will turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, who will walk through our CLSAX Phase 1-2A clinical trial entitled OASIS. We are also joined this morning by Dr. Arshad Kanani, a retinal specialist with extensive experience treating multiple back of the eye diseases. After our formal remarks, we will take your questions. This morning, we issued our press release on the OASIS data, as well as our quarterly earnings announcement, where we reported that our current cash and cash equivalents as of September 30, 2022, totaled $53.4 million. As of now, this gives us a financial runway into 2024. and we will be able to further refine our financial runway once we finalize our plans for a randomized controlled CLS-AX Phase II trial. Today we are going to focus on our CLS-AX data, but our CFO, Charlie Begman, is on the call with us to take any questions as needed. Our OASIS update includes the final data from all four dosing cohorts for the three-month endpoint for the trial. as well as interim data from the extension study with a data cut as of October 27, 2022. The extension study follows patients in cohorts two, three, and four who agreed to be monitored for an additional three months, making it a total of six months after a single dose of CLSAX. Moving now to slide three in the presentation. We are very pleased to report the data today from the OASIS trial, a single-dose escalating trial in anti-VEGF treatment experience sub-responders. The primary endpoint for OASIS was safety and tolerability, and we saw a very favorable safety profile for CLSAX at all doses and time points throughout the study. In addition, we are very encouraged by the durability data that has emerged from the trial to date at higher doses in cohorts three and four. As Tom will elaborate, CLSAX provided at least 73% reduction in treatment burden to the three-month time point in OASIS. From the ongoing extension study, current data shows at least a 90% reduction in treatment burden from the average monthly injections in the six months before CLSAX administration. Further, the OASIS study demonstrated both a stable mean best corrected visual acuity and a stable mean central subfield thickness at both the three-month time point and to date in the extension study. In the extension study, anatomical signs of CLSAX biological effect were also observed on OCT in the subresponder population. While we will continue to follow the remaining eight patients in our extension study, this data gives us very high confidence to move ahead with future CLS-AX clinical trials. We expect to report the final extension study data in the first quarter of 2023. I will now turn the call over to Tom to review our OASIS results. Tom?