Clearside Biomedical, Inc.

Good afternoon, ladies and gentlemen. This is your operator. Your conference will begin momentarily. Please continue to stand by. Once again, this is your operator. Your conference will begin momentarily. Please continue to stand by. Good day and thank you for standing by. Welcome to the Clearside Biomedical Fourth Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 1 on your telephone. If you require any further assistance, please Press star zero. And now it is my pleasure to hand the conference over to your host today, Jenny Coben with the Clearside Biomedical Investor Relations. Thank you. Please go ahead.

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 than 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, 2020, and our other SEC filings available on our website. We expect that our 10-K for the year ended December 31st, 2021, will be filed tomorrow. 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 Luzeski, 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. 2021 was a year of validation for ClearSight and our super-choroidal injection platform. Last quarter, we achieved our first FDA approval with Zypyr, which solidified our position as the leader in delivering drugs into the suprachoroidal space. We have developed a truly innovative therapeutic approach in treating retinal diseases that allows unparalleled access to the back of the eye to directly target the site of disease. Zypyr is being commercialized in the U.S. by our partner Bausch & Lomb for the treatment of macular edema associated with uveitis. Zypyr is the first therapy approved for this indication, and we're honored to make a difference in the lives of these patients battling this potentially blinding condition. Bausch announced last month that they have launched Zypyr in the United States with focused physician training in the use of our proprietary SCS microinjector. Bausch is a well-respected leader in our industry, and we're confident in the strength and capabilities of their commercial team to advance this therapy to patients in need. During 2021, Arctic Vision, our China-based development and commercialization partner, also made great strides with Zypyr, which they refer to as ARBN001, and the brand name Arcadis. Last quarter, Arctic Vision initiated their confirmatory phase three trial in China in macular edema associated with uveitis. Their ultimate goal is to commercialize Arcadis, if approved, in their licensed regions of Greater China, South Korea, Australia, New Zealand, India, and 10 Southeast Asian countries. In addition, last week, Arctic Vision announced that they have dosed the first patient in China in a Phase I clinical trial of ARVN001 for the treatment of diabetic macular edema. The Zypher-related milestones also strengthened our balance sheet. In total, we generated $20 million of non-dilutive funding in the fourth quarter from Bausch and Arctic Vision that will be utilized to advance our internal pipeline programs. While Zypair is our first commercially available product, we also have a broad pipeline of internal programs and collaborations with our development partners targeting multiple indications, including macular degeneration, diabetic retinopathy, diabetic macular edema, and ocular cancer. The approval of Zypyr in the U.S. validates our strategic approach to focus on small molecule suspensions. Our lead internal pipeline product candidate, CLSAX, combines our proprietary small molecule suspension of the tyrosine kinase inhibitor, Exidinib, with delivery by our SES microinjector. In 2021, we reported positive data from cohorts 1 and 2 in our Phase I-IIa OASIS trial in patients with wet AMD. We achieved our primary safety endpoints in these first two cohorts as CLS-AX was well tolerated with no serious adverse events. And we are making progress in cohort three with the 0.5 milligram dose of CLS-AX, and we remain on track to report results from this cohort midyear. As a reminder, OASIS is a dose escalating study to explore a broad range of doses to take into a phase 2B clinical trial. Based on the positive safety profile to date and input from our scientific and clinical advisors, we are planning to add a fourth cohort in this trial. Prior to moving forward with a higher dose in cohort four, we will review the preliminary one-month safety data from cohort three. Unless we see dose-limiting toxicities, we plan to initiate Cohort 4 promptly after this safety data review at a higher dose than we used in Cohort 3. We expect both of these events to occur in the second quarter. Because we will be conducting Cohorts 3 and 4 in an overlapping schedule, we expect to complete the entire OASIS study and begin recruiting a larger Phase 2b clinical trial by the end of this year. I also want to highlight that our gene therapy and oncology partners have made tremendous strides in their superchoroidal clinical trials. Our gene therapy collaborator, Regenexx Bio, continues to advance their two Phase II clinical trials with their asset, RGX314, delivered superchoroidally with our SCS microinjector in patients with wet AMD and diabetic retinopathy. Last month, Regenexx Bio reported positive interim data in patients with diabetic retinopathy, reporting that RGX314 continues to be well-tolerated at six months, with nearly 50% of patients demonstrating a two- or more-step improvement from baseline compared to 0% of patients in the observational control. We look forward to additional data from both their wet AMD and diabetic retinopathy trials later this year. Our ophthalmology oncology partner, Aura Biosciences, is utilizing our SCS microinjector to deliver their viral-like drug conjugate, AU011, for the treatment of choroidal melanoma, the most common intraocular tumor in adults. We expect Aura to disclose more data from their current superchoroidal clinical trials later this year. To date, we have presented and published promising preclinical data on our gene therapy programs, and we are excited about the potential of our superchoroidal injection platform for both viral and non-viral vectors. Gene therapy remains an extremely promising approach to treating retinal disease, and the use of our proprietary SCS microinjector offers the potential to deliver a variety of gene therapy constructs superchoroidally through a non-invasive in-office procedure for the potential treatment of several ocular diseases. We believe that companies with specific gene therapy expertise will be able to advance these programs more rapidly. Therefore, in keeping with our strategic approach to focus on small molecule suspensions, we have decided to consider additional development and commercialization partners for gene therapy. Outside of the specific indications licensed to Regenexx Bio, we are in a position to partner with other companies working on gene therapy using non-viral vectors for any retinal disorder or viral vectors targeting inherited retinal disorders or retinal diseases that are not primarily treated with current anti-VEGF standard of care therapies, such as geographic atrophy. I will now turn over the call to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to discuss our clinical development programs and provide more detail around the data disclosed by our partners. Tom?