Clearside Biomedical, Inc.

Ladies and gentlemen, thank you for your patience. This conference will begin momentarily. Once again, thank you for your patience, and this conference will begin momentarily. Greetings. And welcome to the Clearside Biomedical Third Quarter 2023 Financial Results and Corporate Update call. At this time, all participants are on 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 Colbin of Clearsight Investor Relations. Ma, 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, 2022, our quarterly report on Form 10-Q for the quarter ended September 30, 2023 to 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 Levesque, 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.

Thanks, Jenny, and good afternoon, everyone. Today, I'm excited to discuss several recent value-creating achievements related to our SuperCoroidal platform. We've had two weeks of really good news. We completed enrollment in Odyssey, our Phase 2b wet AMD clinical trial, with top-line data expected in the third quarter of 2024. We announced a new partnership with BioCrisp Pharmaceuticals to expand our external development pipeline with a plasma calocrine inhibitor for the treatment of diabetic macular edema. Both of our other superchoroidal collaboration partners, Regenexx Bio and Aura Biosciences, recently presented positive safety and efficacy data through Phase II with their respective compounds using our SES microinjector. As for our Zypyr partners, Bausch & Lomb announced that Zypyr has been granted a permanent Category 1 CPT code in the U.S. to help facilitate better access and adoption of the product. Arctic Vision completed enrollment in their phase three clinical trials, Arcadis, also known as Zypyr, in uveitic macular edema in China. So let me discuss, let me start with discussing our lead program, CLSA-X. Last month, we completed recruitment in our Odyssey Phase 2B clinical trial, evaluating the safety and efficacy of CLSA-X, our highly potent tyrosine kinase inhibitor delivered by our patented SCS microinjector. As a reminder, Odyssey is a randomized, double-masked, active-controlled, multi-center study in participants with wet AMD. One of the most encouraging aspects of our CLS-AX program is the feedback that we receive from the medical community. Multiple leading retinal physicians have presented data from our OASIS Phase 1-2A clinical trial of CLS-AX in wet AMD at top ophthalmic meetings, including the recent AAO, ASRS, and Retina Society meetings. These presentations highlighted the excellent safety profile, stable vision, and reduced frequency of injections observed for up to six months. These presentations also created significant interest in our program from clinical trial participants, investigators, and sites that helped drive strong recruitment for our Odyssey Phase 2b trial. The completion of recruitment is a critical accomplishment for us as the final participants in the study advanced to randomization, either to the CLSAx treatment arm or the on-label of Flibbercept comparator arm. We expect randomization to be completed by the middle of December 2023, and we remain on track to report top-line data from Odyssey in the third quarter of 2024. Our goals for the Odyssey trial are to demonstrate an excellent safety profile, stable visual acuity, and a lower treatment burden in the CLSAx arm. The efficacy and safety results from Odyssey will then guide our pivotal Phase III development program or CLSAX. We believe the differentiated mechanism of action and high potency of excitinib, combined with safe and reliable delivery into the suprachoroidal space, has the potential to be a best-in-class approach for long-term maintenance therapy for individuals with wet AMD. We were thrilled to start this month by announcing our new global licensing partnership with Biocrist Pharmaceuticals. This collaboration expands the reach and demonstrates the versatility of our superchoroidal injection platform by adding another compound to be delivered with our proprietary SCS microinjector. The agreement includes $5 million in an upfront license fee, plus the potential for future milestone payments and sales royalties. The partnership with Biochrist is focused on the development of their proprietary small molecule, a vorlistat, to be administered via the superchoroidal injection for the treatment of diabetic macular edema. DME is the most common cause of vision loss in individuals with diabetes, and we believe there's a significant market opportunity in this indication. Avorlistat has high potency and low solubility, which are characteristics that are well-suited for suprachoroidal administration and important to achieving potential efficacy with reduced dosing frequency. Delivering Avorlistat into the suprachoroidal space and behind the visual field could allow orlistat to inhibit plasma calocrine directly at the location where the edema forms with a desirable durability of effect. Biocrist expects to continue conducting formulation and nonclinical work into 2024 and begin clinical trials in 2025. The versatility of our supercoital injection platform was on display at this month's American Academy of Ophthalmology medical meeting, where two of our other partners, Regenexx Bio and Oral Biosciences, presented very promising data with their respective compounds utilizing our SCS microinjector. Regenexx Bio reported the results of their Phase II altitude trial evaluating their gene therapy ABBB-RGX314 in diabetic retinopathy. the leading cause of vision loss in adults between 24 and 75 years of age worldwide. 314 continues to be well tolerated in 50 patients from dose levels 1 and 2 with no drug-related serious adverse events. At the second dose level, 314 prevented disease progression and reduced vision-threatening events in nonproliferative diabetic retinopathy at one year. Regenexx Bio has indicated they believe that a one-time in-office suprachoroidal injection of 314 gene therapy has the potential to stabilize and improve diabetic retinopathy severity score and reduce the long-term risk of vision-threatening events. Ora Biosciences reported positive clinical efficacy updates from its ongoing Phase II clinical trial with suprachoroidal administration of BELSAR for the first-line treatment of early-stage choroidal melanoma. Their Phase II trial is assessing the safety and preliminary efficacy of single and multiple ascending doses of BELSAR for up to three cycles of treatment. The Phase II data, with 90% of their patients at 12 months of follow-up, demonstrated 80% tumor control and 90% visual acuity preservation for patients that have been treated with three cycles of BELSAR and that meet the Phase III enrollment criteria. Safety profile continues to be favorable, no significant or treatment-related serious adverse events. This is very encouraging as most of these patients had tumors close to the fovea or optic disc and would likely have experienced severe and irreversible vision loss with the current standard of care. ORAS also announced agreement with the FDA under a special protocol assessment for the design and planned analysis of their Phase III COMPASS trial. They plan to dose the first patient in this trial this quarter. In addition to the R&D progress over the last few months, our commercial partnership with Zypyr have also announced important achievements. Bausch & Lomb announced that the American Medical Association has granted a new current procedural terminology or CPT code for Zypyr with support from the American Academy of Ophthalmology and the American Society of Retina Specialists. Category 1 code for the suprachoroidal injection procedure will help facilitate better access and adoption of Zypyr in the United States. The new CPT Category 1 code will be effective on January 1, 2024, replacing the current miscellaneous Category 3 code. At AAO, Baushamam also presented survey data on positive physician experience using Zypyr in the treatment of uveitic macular edema, indicating that physicians found Zypyr superchoroidal injection easy to learn with patient outcomes consistent with clinical trial data. Our Asia Pacific partner, Arctic Vision, also accomplished a major milestone with completion of enrollment in China of its phase three randomized double-blind placebo-controlled clinical trial with Zypyr in uveitic macular edema. As a reminder, Zypyr is referred to as Arcadis in China. If positive, the data from the phase three trial will allow Arctic Vision to apply for marketing approval in China. In addition, Earlier this year, Arctic Vision applied for marketing approval of Arcadis in Australia. We appreciate the commitment of both Bausch & Lomb and Arctic Vision to expand the use of Zypere and look forward to further updates. I'll now turn over the call to our CFO, Charlie Degnan, to provide a financial update. Charlie?