Clearside Biomedical, Inc.

Good day and thank you for standing by. Welcome to the ClearSight Biomedical Q2 2022 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Janet Colbin, Clearsight Investor Relations.

Please go ahead. Good morning, 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, 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 Lizeski, our Chief Executive Officer Dr. Thomas Chula, our Chief Medical Officer and Chief Development Officer, and Charlie Degman, 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. Over the last three months, we've made significant progress on multiple fronts. With the approval of Zypier, the advancement of CLSAX, and broader use of our SCS microinjector with select partners, we've created a new paradigm in retinal drug delivery. On the clinical operation side, we achieved a significant milestone by successfully completing dosing in OASIS, our CLSAX Phase I-IIA clinical trial. CLSAX combines the pan-VEGF inhibition from the highly potent TKI excedinib with targeted delivery to the affected choreoretinal tissues utilizing our proprietary SCS microinjector. OASIS is a single-dose escalation trial. In May, we announced that we were able to accelerate initiation of Cohort 4 as a result of the positive safety data reviewed by the Safety Monitoring Committee. And we recently announced we have now completed enrollment in both Cohorts 3 and 4 with a total enrollment of 27 patients for all four cohorts. We expect to report our final three-month OASIS safety and tolerability data from all four cohorts in November of this year. We believe that this comprehensive data set will provide more insight into the potential benefits of CLSAX-injected superchoroid length. To further assist our planned clinical activities for CLSAx, we announced in June the appointment of Susan Coltis as our Chief Clinical Officer. Susan joins us with extensive operational experience and responsibility for advancing ophthalmic trials from early clinical stages through approval. Tom, as Chief Medical Officer and Chief Development Officer, continues to have overall management responsibility for the ClearSight product pipeline and clinical development strategy, including all clinical trial design. We are excited to now have Susan on board to assume responsibility for clinical operational planning and to provide management oversight of the execution of our future clinical trials. Yesterday, we announced that we entered into a royalty interest purchase and sale agreement with healthcare royalty partners, primarily to support the funding of our planned CLS-AX Phase II clinical trial. This transaction was achievable because of the successful U.S. FDA approval of our first commercial product, Zypyr, and the subsequent commercial launch of the product by our partner, Bausch & Lomb. The opportunity to obtain meaningful non-diluted capital by leveraging future royalties from Zypyr and certain SCS microinjector license agreements provides us financial flexibility during this volatile market environment. We completed this financing now because the funds will assist us in advancing CLSAX should the final data readout from OASIS be supported. If it is, this will position us to initiate activities by the end of this year for our phase two trial and enable us to begin enrolling patients soon thereafter. Charlie will discuss the details of the financing transaction shortly. I will now turn the call over to Dr. Tom Chula to elaborate on our OASIS study and recent progress made by our partners. Tom?