Clearside Biomedical, Inc.

Greetings and welcome to the Clearside Biomedical fourth quarter 2024 financial results and corporate update call. At this time all participants are in a listen-only mode and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Jenny Coben of Investor Relations. Mom, the floor is yours.

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 31, 2024, 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 Ledeske, our Chief Executive Officer, Dr. Victor Chong, our Chief Medical Officer and Head of Research and Development, and Charlie Degnan, our Chief Financial Officer. We also have accompanying slides that are available on Clearside's website in the Events and Presentations section. 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, and good afternoon, everyone. ClearSight is the proven leader in the delivery of drugs and drug candidates to the supracoroidal space. Our SES microinjector provides safe and reliable delivery with over 15,000 supracoroidal injections performed to date. We continue to have increasing interest among retinal specialists and leading pharmaceutical companies in applying our innovative delivery platform to treating serious retinal diseases. We are pleased to announce that the positive results from our Odyssey Phase IIb WET-AMD clinical trial led to a successful end-of-Phase II meeting with the FDA regarding the planned Phase III activities for CLSAX. Based on our interactions with the FDA, we are aligned on a pivotal Phase III program that we believe is positioned for success and maximizes the commercial potential for CLSAX and WET-AMD. Victor will elaborate on these plans shortly. Our commercial and development partners have made excellent progress over the last several months as they continue to validate the broad applicability of superchoroidal delivery in several indications. Across our partners, superchoroidal treatments being developed for delivery by our SCS microinjector are now approved in two Asian territories under regulatory review in China and involved in two ongoing or planned Phase III trials. Our partner, Arctic Vision, achieved several regulatory milestones in the Asia-Pacific region with Arcadis, or Zypyr, for the treatment of uveitic macular edema. This year, they announced that a new drug application is currently under regulatory review in China and that the product was approved in Australia and Singapore. Importantly, Arctic Vision also entered into a commercial collaboration with Santan Pharmaceuticals for the marketing and distribution rights to Arcadis in China. In addition, Regenexx Bio, in collaboration with AbbVie, announced in January that a global Phase III clinical program in diabetic retinopathy for their gene therapy candidate, RGX314, now referred to as Cerevec, is planned to start later this year using our SCS microinjector. In addition, their Phase II altitude superchoroidal trial is currently enrolling a cohort of patients with center-involved diabetic macular edema, and their Phase III AVH superchoroidal trial is enrolling a cohort in wet AMD at dose level 4. Our oncology partner, Aura Biosciences, is enrolling its global superchoroidal phase 3 trial of BELSAR for the first-line treatment of patients with choroidal melanoma delivered using our SCS microinjector. Aura has also initiated a phase 2 trial in metastases to the choroid. And finally, our partner Biochrist recently highlighted plans to initiate clinical testing in 2025 of Orlistat, its plasmacalocrine inhibitor using supracoroidal administration for the potential treatment of DME. With that, I would now like to turn over the call to our chief medical officer and head of research and development, Dr. Victor Chong, to outline the phase three plans for CLSAX and other opportunities with our supracoroidal pipeline. Victor?