Clearside Biomedical, Inc.

Ladies and gentlemen your conference call will begin momentarily. Thank you for your patience and please stand by. Thank you. Thank you. Ladies and gentlemen, thank you for standing by, and welcome to the Clearside Biomedical Third Quarter 2020 Financial Results Conference Call. At this time, all participants are in 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 keypad. If you require any further assistance during the conference, please press stars and zero, and your operator will be happy to assist you. I would now like to hand the conference over to Jenny Cobin, Clearside Investor Relations. Thank you, and please go ahead, Madam.

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 factor section of our annual report on Form 10-K for the year ended December 31, 2019, our quarterly report on Form 10-Q for the quarter ended September 30, 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 Levesque, 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. The third quarter of 2020 was very productive for ClearSight both operationally and clinically as we had numerous positive advances to our pipeline. As we announced on our last quarterly call, we secured acceptance of our investigational new drug application for our lead development asset, CLS-AX, our proprietary suspension of exudinib for suprachoroidal injections. With this IND, we plan to initiate our first clinical trial with CLS-AX in wet AMD patients. I'm extremely proud of the cross-functional team that's worked so diligently to take Excedinib from just a concept a little over one year ago to our expected initiation of a phase one, two-way clinical trial by the end of this year. As Tom will discuss in his remarks, we are eager to advance Excedinib into the clinic as we believe its intrinsic Tyrosine kinase inhibitor characteristics can be further leveraged through our SCS microinjector. In preclinical studies, CLSAX delivered supracoroidally was observed to be well-tolerated and showed significant tissue concentrations over time. These characteristics, if demonstrated clinically, may support supracoroidal excedinib's potential to reduce the profound treatment burden for patients suffering from wet AMD. Our Phase 1-2A clinical trial for CLS-AX is expected to begin by the end of this year, and we anticipate reporting initial data from the first cohort in mid-2021. In addition, we continue to progress our internal preclinical work to expand our pipeline. One of our focus areas is on a non-viral vector gene therapy program that we refer to as our therapeutic biofactory. We are also working on a development program utilizing superchoroidal administration of an integrin inhibitor small molecule suspension, initially focused on diabetic macular edema. Tom will elaborate on these early stage programs shortly. For Zypyr, our new contract manufacturer is completing the technology transfer and working diligently to prepare to manufacture the Zypyr drug product GMP batches. Once these batches are made, we expect that we will be able to generate the required stability data for our new drug application resubmission to the FDA. The cooperation and productivity of our new CMO working together with the ClearSide team has been exceptional, and I'm very pleased to report that we remain on track with our expectation to resubmit our NDA in the first half of 2021. Excuse me. and we expect the FDA will review the NDA within six months of the resubmission date. We are excited by the progress made this past quarter by our development partners using our SCS microinjector to deliver their drug candidates into the superchoroidal space. Regenexx Bio has enrolled and dosed multiple patients in its Phase II clinical trial to evaluate the superchoroidal delivery of RGX314, and adeno-associated virus gene therapy using our SCS microinjector for the treatment of wet AMD. Based on our licensing agreement with Regenexx Bio, this progress triggered a milestone payment to us in the third quarter. Regenexx Bio also announced that they received IND clearance by the FDA to evaluate the superchoroidal delivery of RGX314 in patients with diabetic retinopathy. This trial is now active. and Regenexx Bio expects to begin enrolling patients with diabetic retinopathy by the end of this year. Our oncology licensing partner, Aura Biosciences, announced they have dosed the first patient in their Phase II clinical trial evaluating the safety and efficacy of supracoroidal administration of AU011 as a potential first-line treatment for patients with primary choroidal melanoma. The initiations of these clinical trials represent major milestones for us as they are the first partnered programs to utilize our SCS microinjector as the mode of administration for the partner's therapeutic products. We believe we are the partner of choice for accessing the superchoroidal space as our SCS microinjector has been used in multiple clinical trials with consistent safety and reliability. As such, we continue to expand our intellectual property portfolio in the U.S. and in Europe. We now have 21 granted U.S. patents and 20 European patents providing extensive coverage of our SCS microinjector and its use, administration of any drug into the superchoroidal space by injection, as well as coverage for specific superchoroidal product candidates. We are committed to extending our global patent estate as we continue to expand our internal product pipeline, and increase patient access to innovative therapies through our superchoroidal injection platform. With that, I will now ask Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to elaborate on our research and clinical development programs. Tom?