Clearside Biomedical, Inc.

ladies and gentlemen thank you for your patience this conference will begin shortly once again thank you for your patience and this conference will begin shortly Thank you. Greetings and welcome to the ClearBioMedical second quarter 2023 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 Corbin of Investor Relations. 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 31st, 2022, our quarterly report on Form 10-Q for the quarter ended June 30th, 2023, 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 Lazewski, our Chief Executive 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.

Thanks, Jenny. The last six months have demonstrated that ClearSight is the clear leader in delivering agents to the supercoroidal space. We have a proprietary supercoroidal space injection technology that utilizes our patented SCS microinjector. We're able to deliver small molecules and gene therapy behind the visual field targeting multiple retinal diseases. We have the first and only FDA approved SCS product with Zypyr. And we have four external validating SCS delivery collaborations as well as an early stage internal research and development pipeline. Importantly, as we expand our development opportunities both internally and with our partners, our versatile therapeutic platform continues to grow together With our licensing partners, there are now six ongoing SCS trials in five different indications utilizing four potential therapies. ClearSight's lead internal clinical development program is CLS-AX, our proprietary suspension of Vixidinib delivered into the suprachoroidal space. CLS-AX is targeting the multi-billion dollar market for wet AMD, so let me take a moment to talk about the market opportunity and why we believe we can truly make a difference in the lives of the millions of patients suffering from this disorder. What AMD is a crowded arena for the development of new products mainly due to the large and growing market as a result of the aging population, particularly in the US. With the higher demand, there's room for new treatments that provide significant improvement over current therapies, including reducing the treatment burden for patients and their caregivers. Based on the label for existing marketed products for wet AMD, Lucentis is recommended to be dosed 12 times a year, ILEA 2 milligrams 6 times a year, and recently approved Vivizmo up to 6 times per year. In contrast, we believe that CLSAX may be up to a twice-a-year treatment for wet AMD. This matters because it has been well documented that patient compliance is a challenge. and therefore a treatment option where patients maintain their vision with less frequent dosing may achieve improved patient outcomes. CLSA-X could reduce the onerous treatment burden for patients who currently require frequent dosing and numerous office visits with existing approved drugs. CLSA-X has the potential to be a better maintenance treatment option based on three main differentiating factors. First, CLSA-X utilizes Excedinib, which is the most highly potent tyrosine kinase inhibitor. delivering 10 times more potency than other TKIs in preclinical studies. Second, CLSA-X is administered superchoroidally using our proprietary SCS microinjector. This delivery mechanism does not require surgery and does not require an implant inserted into the eye. It's delivered by physicians in their office and has proven to be safe and reliable both commercially and in multiple clinical trials. And thirdly, in our OASIS Phase I-IIa clinical trial, we showed that a single administration of CLSAX demonstrated a favorable safety profile with no signs of inflammation. In terms of duration, in the extension study of OASIS in higher-dose cohorts with a single dose of CLSAX, two-thirds of the participants did not need supplemental treatment for six months or more. Also, these participants experienced a 77% to 85% reduction in treatment burden as measured by the number of anti-VEGF treatments they received during the six months compared to the six-month period prior to entering the OASIS trial. Importantly, we also observed signs of biological effect with stable mean best corrective visual acuity, or BCBA, and stable mean central subfield thickness, or CST. Encouraged by the promising OASIS results and following the FDA draft guidance for drug development of treatments for wet AMD, last quarter we initiated ODYSSEY, a randomized double-masked, multi-center, Phase IIb clinical trial in participants with wet AMD. The overall objective for the trial is to evaluate the safety, efficacy, and duration of CLSAX treatment in participants with wet AMD. The other arm in the trial is a current standard of care, ILEA or a Flibber set. Our goals for the ODYSSEY trial are to demonstrate similar visual acuity outcomes with a lower treatment burden for the CLSA exon and to obtain the necessary clinical data to determine a desired CLSA-X fixed dosing regimen for a Phase III WET-AMD clinical development program. We are pleased that the trial is off to a solid start and is progressing as planned. Multiple participants have been randomized to receive either CLSA-X or a FlibroSense. Clinical trial sites have been eager to be part of the trial, and we have nearly all of our planned 30 sites currently open to enroll participants in the trial. As a reminder, Odyssey is expected to enroll a total of 60 participants, randomized to either CLSAX 1 milligram or Aflibirseb 2 milligrams, with a 2-to-1 randomization schedule. This means that there is expected to be 40 participants in the CLSAX arm and 20 participants in the Aflibirseb arm. The treatment period is a total of 36 weeks. In the trial, CLSA-X will be administered by supracoital injection using clear sides at CS microinjectants, and Aflibrisib will be administered by intravitreal injection. The primary outcome measures for the trial are the mean change in BCVA over the 36-week period, as well as the assessment of safety and tolerability of CLSA-X. The secondary outcome measurements are treatment burden, as measured by total injections, including the need for supplemental therapy over the trial duration, and other changes in visual function and ocular anatomy, such as CST. One important component of ODYSSEY is the eligibility criteria. Our inclusion criteria is designed to ensure that participants in our trial have active disease at screening. Eligible participants will be treatment experienced and will undergo diagnostic imaging after screening visit, followed by mass reading center confirmation of persistent active disease. This level of specificity is to ensure that participants are in need of treatment, will likely respond to and benefit from treatment with anti-VEGF therapy. We believe this will allow the proper assessment of the potential advantages of CLS-AX in patients with wet AMD. We further believe CLSA-X will demonstrate the ability to maintain visual acuity with a longer duration of action in order to reduce the treatment burden for patients with wet AMD. We are confident in our overall trial design and the potential success in ODYSSEY, and we look forward to reporting top line data in the third quarter of 2024. Moving on to Zypyr, we continue to receive positive feedback from clinicians regarding the use of Zypyr with patients. our North American commercial partner for Zypyr Bausch & Lomb continues to conduct product education and training sessions for healthcare providers with more than 1200 retinal specialists trained to date. These sessions have been well attended and well received. Physicians report that the suprachoroidal injection procedure utilizing the SCS microinjector is easy to learn and that Zypyr is highly effective in treating their patients with macular edema associated with uveitis. Looking forward, Baoshan Lam is focused on increasing engagement with uveitis specialists across the country and working on reimbursement parameters that will make it simpler for physicians to use Zypure for their patients. Our Asia-Pacific partner, Arctic Vision, continues to move forward in two indications with their development of Zypure, which they refer to as Arcadis. For the first indication of uveitic macular edema, Arctic Vision is currently enrolling a confirmatory Phase III trial in China. If positive, the data will allow Arctic to apply for marketing approval in China. In addition, Arctic recently announced that the Therapeutic Goods Administration of Australia has formally accepted its new drug application for suprachoroidal use of Arcadis for the treatment of ureotic macular edema. The acceptance of the NDA in Australia is an additional validation of the suprachoroidal administration being an innovative, recognized form of ophthalmic drug delivery and another step towards the global commercialization of Zyphus. The second indication of Arctic is diabetic macular edema. Arctic has completed a phase one clinical trial, and we expect them to report the data from the trial later this year. This data could provide helpful insight into potential for broadening the use of Zypyr and other indications. We're excited about the progress Arctic Vision has made to expand the use of Zypyr, and we look forward to further updates from them. We also continue to work closely with our partners developing breakthrough technologies to deliver gene therapy and ocular oncology treatment utilizing suprachoroidal delivery with our SCS microinjector. Earlier this month, Regenexx Bio announced updates on its ABBB-RGX314 program for the treatment of wet AMD and diabetic retinopathy being developed in collaboration with AbbVie. In July, Regenexx Bio presented interim data from the Phase II, AV8, and Altitude trials demonstrating suprachoroidal delivery of 314 administered to patients with prophylactic steroid eyedrops resulted in zero cases of intraocular inflammation. Additional data from Regenexx Bio on both trials is expected over the next six months. Interim efficacy data from the Altitude trial and diabetic retinopathy is planned for the American Academy of Ophthalmology meeting in November of 2023, and the interim efficacy data from the ABA trial in wet AMD is expected to be presented at the Hawaiian Eye and Retina meeting in January 2024. Our oncology partner, Ora Biosciences, announced their progress last week with their drug candidate, Belsar, for the treatment of choroidal melanoma. Their global Phase III clinical trial is expected to dose the first patient in the second half of 2023 and is designed as a superiority trial comparing BELSAR versus sham with the primary endpoint as time to tumor progression. ORA has qualified trial sites globally with multiple sites ready to enroll patients in the U.S. In addition, ORA expects to present updated efficacy data in the second half of 2023 The Phase 2 data will include 12 months' median follow-up of patients treated with the therapeutic regimen intended to be used in the global Phase 3 trial. With that summary of our programs, I'll now turn the call over to our CFO, Charlie Degnan, for a financial update.