Clearside Biomedical, Inc.

Good day, everyone, and thank you for standing by. Welcome to the ClearSight Biomedical Second Quarter of 2021 Financial Results and Corporate Update Call. At 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 the session, you will need to press star 1 on your telephone. And please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Ms. Janie Coben, ClearSight Investor Relations. 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 will 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 Lizeski, 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 up for your questions. During our call today, Dr. Chula will discuss the key results from cohort one of our phase 1-2A clinical trial for CLSAX that we announced last month. Slides related to this data are available on our website as supporting materials for this earnings call webcast. Now, I'd like to turn the call over to George. Thank you, Jenny.

Thank you, Jenny. Good afternoon, everyone, and thank you for joining us on the call today. We continue to demonstrate our position as the leader in the superchoroidal space with multiple clinical trials in several different ophthalmic indications, a new drug application for Zypyr currently under FDA review, and a recent positive results from our CLS-AX wet AMD clinical trial. We are the first company to develop a clinically tested, non-surgical, repeatable microinjection technology designed to unlock the potential clinical benefits of administering drugs into the superchoroidal space. We have over 85 global patents to protect our platform technology, which includes patents covering our proprietary SES microinjector, as well as the delivery of therapeutic agents into the superchoroidal space. Internally, our research team has proven our capabilities to transform existing small-molecule drugs into proprietary suspensions for delivery into the supracoroidal space to target back-of-the-eye diseases. Our first product candidate, Zypyr, is a proprietary suspension of trimicinolodacinidine for the potential treatment of patients with macular edema associated with uveitis. If approved, Excuse me. Zypyr is now under review by the U.S. FDA with a PDUFA action date of October 30, 2021. If approved, Zypyr will be our first commercial product, the first therapy approved for macular edema associated with uveitis, and the first product ever approved for suprachoroidal administration. Zypyr will be sold in the U.S. and Canada by our partner Bausch Health and Bausch & Lomb, its leading global eye health business. In addition, Arctic Vision, our partner in Greater China and South Korea, is planning a confirmatory Phase III clinical trial in macular edema associated with uveitis to begin in China later this year with the ultimate goal of commercializing Zypyr in that region. The lead clinical development candidate in our pipeline is CLSAX, which combines our proprietary suspension of the tyrosine kinase inhibitor Exidinib for suprachoroidal delivery with our SCS microinjector. As Tom will discuss in detail, we achieved our safety and tolerability objectives in cohort one of our phase 1-2a OASIS trial in patients with wet AMD. We are now enrolling cohort two and expect to complete recruitment this month with data by the end of this year. With the PanVEGF attributes of Excedinib delivered to the suprachoroidal space, we have the opportunity to improve the treatment of patients with wet AMD as we believe CLS-AX may offer improved safety and efficacy, as well as prolonged durability by reducing the frequency of patient injections. The clinical experience with our SCS microinjector is unparalleled. At Clearside, we have tested it in over 1,200 suprachoroidal injections in multiple global clinical trials in a variety of retinal disorders. The safety profile of our suprachoroidal injections is comparable to intravitreal injections with no procedure-related serious adverse events to date. In addition, we have published data that indicates the superchoroidal injection procedure utilizing our SCS microinjector is well accepted by physician investigators and could readily be adopted in clinical practice by retinal specialists. Further, our technology is currently being used in three separate clinical trials being conducted by our two clinical development partners, Regenexx Bio and Oro Biosciences. Regenexx Bio is delivering its AAV-based gene therapy with our SCS microinjector in two ongoing Phase II clinical trials in wet AMD and diabetic retinopathy, potentially transforming gene therapy delivery into an office-based, non-surgical treatment option. As Tom will discuss shortly, Regenexx Bio continues to make meaningful progress on both of these programs, and Ora Biosciences is delivering their viral-like drug conjugates into the superchoroidal space to treat choroidal melanoma, again, using our SCS microinjector. We are excited about the progress to date with our partners and look forward to future results from these trials. As such, we believe we are the leader in developing small molecule superchoroidal products and the partner of choice for the delivery of a variety of other therapeutic agents into the superchoroidal space. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to delve into our CLSAx data and review our partners' programs. Tom?