Clearside Biomedical, Inc.

Greetings and welcome to the Clearsight Biomedical Q4 2023 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. 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 Clearsight Investor Relations. Jenny, you may begin.

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, 2023, that will be filed today, 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 Lozesky, our Chief Executive Officer, and Charlie Dugnan, 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, and good afternoon, everyone. The tremendous progress that we accomplished in 2023 has propelled us into 2024 and positioned us for an important year. Last year, we advanced our CLSAX Clinical Development Program and WET-AMD, meeting our targeted timeline and budgets. In February 2023, we reported positive results from our OASIS extension study that supported initiation of our Phase IIb clinical trial, Odyssey. Later that year, we initiated and completed enrollment in Odyssey, again, on our targeted timeline and budget. This rapid enrollment was primarily a result of significant enthusiasm from physicians because of the compelling aspects and potential clinical impact of the program. During 2023, each of our licensing partners reported excellent progress in their clinical development programs. Collectively, there are now four assets in clinical development with superchoroidal delivery for five different indications. In addition, we were pleased to announce a new collaboration with Biochrist Pharmaceuticals to utilize our SES microinjector to deliver their proprietary compound, alborlistat, to treat diabetic macular edema. This adds both another asset and another indication to our collaboration pipeline. As we look ahead, 2024 will be a critical year for ClearSight as we execute on two key areas of focus. First, the primary data readout for our Odyssey Phase 2b trial will occur in third quarter this year. Second, we and our partners expect to continue demonstrating the benefits of drug delivery into the supracoroidal space with our SCS microinjector device technology. I'll start with ODYSSEY, our randomized double-masked active control clinical trial in participants with wet AMD. We are utilizing our patented suprachoroidal injection technology to deliver CLSAX, a small molecule suspension of the tyrosine kinase inhibitor, Exidinib. Our proven delivery method, combined with the differentiated mechanism of action and high potency of Exidinib, offers the potential for CLSAX to be a long-term maintenance therapy for wet AMD patients. In Odyssey, we are looking to replicate the excellent safety profile, stable vision, and reduced frequency of injections over six months that we observed in our OASIS extension study. The efficacy and safety results from Odyssey will support the design of our Pivotal Phase III Development Program, or CLSAX. With our focus on extending treatment duration utilizing supercoital delivery of small molecules, I think it's relevant to highlight recent positive real-world outcomes from Zypure usage. This analysis was presented by Dr. Michael Singer at the Macula Society meeting last month. In his presentation, Dr. Singer evaluated nearly 800 eyes utilizing the American Academy of Ophthalmology IRIS registry and open-source claims data. This real-world data showed excellent durability where over 75% of eyes did not require re-treatment for six months after just one dose of Zypyr. This durability is consistent with the Zypyr preclinical pharmacokinetic data and the data from our Phase III, PH3 clinical trial. Importantly, we believe this analysis validates Clearsight's approach to extended small molecule drug release and reduce treatment burden for patients by delivering drug directly to the suprachoroidal space with our SCS microinjector. As we look back over the last several years, I'm thrilled with the progress we have seen leading to the adoption and acceptance of suprachoroidal delivery. As the original pioneers in the space, we are proud that ClearSight's technology has led the way for this important and innovative approach for delivering of drugs behind the visual field directly to the retina. The supracoroidal injection procedure now has a permanent Category 1 CPT code available to help facilitate better access, adoption, and insurance coverage. This CPT code is a major milestone for the procedure itself. Our proprietary SCS microinjector continues to enable reliable, simple, in-office, non-surgical drug delivery, as shown with its use in multiple ongoing clinical trials and with our commercially approved product, Zypera. Most importantly, our SCS microinjector has demonstrated a positive safety profile with over 2,000 injections performed to date. We believe this strong safety profile is due in part to the fact that drug delivery by SCS injection is compartmentalized in the supracoroidal space, keeping it away from non-diseased tissues and entirely behind the visual field. We do not put drug into the vitreous, and we do not place physical inserts or gels in the vitreous that rely on complete bioerosion over time. Since the suprachoroidal injection allows for drug to flow behind the retina to the back of the eye, this limits the risk of vitreous floaters, vitreal or anterior chamber toxicity, or possibly impairing or interfering with the patient's vision. To date, we've established multiple partnerships with leading biopharma companies who have elected to utilize our SCS microinjector over other delivery methods. We believe that superchoroidal delivery may become the delivery method of choice for gene therapy and ophthalmology. Utilizing our SCS microinjector, our partner RegenixBio has demonstrated in their wet AMD clinical trial that there were zero cases of inflammation observed in patients who received just seven weeks of prophylactic topical steroids. In contrast, recently reported data from other gene therapies in development using intravitreal delivery have shown inflammation despite prophylactic steroid treatments of over 20 weeks. These steroid regimens involved injections, oral medications, and in some cases, extended release steroid inserts. So we're excited about the progress Regenexx Bio has made in their two programs utilizing our SCS microinjector. In diabetic retinopathy, Regenexx Bio presented data last November from their altitude trial showing that RGX314 prevented disease progression in non-proliferative DR patients at one year. In wet AMD, they presented data in January 2024 from their ABA trial showing that patients treated with RGX314 continued to demonstrate stable vision and retinal anatomy with a meaningful reduction in treatment burden at six months. Regenexx Bio expects to share new program and data updates for their altitude trial in Q2 of this year and for the ABA trial in mid-2024. Ora Biosciences chose to exclusively use superchoroidal delivery over intravitreal injection for their Phase III COMPASS trial, which is evaluating the safety and efficacy of BELSAR for first-line treatment in adults of early-stage choroidal melanoma.