Clearside Biomedical, Inc.

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, 2020, 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 Lizeski, our Chief Executive Officer, Dr. Thomas Chula, our Chief Medical Officer and Chief Development Officer, and Charlie Dedman, 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. It's our pleasure to join you on the call today to discuss ClearSide's accomplishments in the last two months. Simply put, we've achieved an impressive number of firsts. With the FDA's recent approval, Zypyr is the first commercial product developed by ClearSide and the first product approved for injection into the suprachoroidal space. In addition to being an exciting accomplishment for ClearSide, we believe this approval represents a potential game-changer for as we have developed a truly innovative therapeutic approach in the field of retinal diseases. Our supracoroidal injection platform is a novel, patented approach providing unparalleled access to the back of the eye that precisely administers drug at the site of disease. With our proprietary SES microinjector, we have developed a clinically tested, non-surgical, repeatable microinjection platform designed to unlock the potential clinical benefits of supracoroidal administration. Further, Zypyr is now the first therapy approved for patients suffering from macular edema associated with uveitis, and I am proud of the fact that we are able to make a difference in the lives of these patients battling this potentially blinding condition. With this approval, we are redefining the treatment of macular edema associated with uveitis. Zypyr will be commercialized in the U.S. by our partner, Bausch & Lomb. Bausch is a well-respected leader in our industry and has been a tremendous partner throughout this process. We now expect to receive $15 million in approval and pre-launch milestones from Bausch. We continue to work closely and cooperatively with the Bausch team as they prepare to launch Zypyr and educate retinal specialists on the use of our SCS microinjector. Bausch expects to launch Zypyr in the first quarter of 2022. Also during the quarter, we expanded our Zypyr licensing agreement with Arctic Vision, a Chinese Chinese-based biotechnology company focused on ophthalmic therapies. Based on Arctic's commitment and belief in the product, we agreed to expand their licensed territory from greater China and South Korea to also include Australia, New Zealand, India, and 10 Southeast Asian countries. We received $3 million in upfront payments as consideration for the expanded territory, and we also expect to receive $4 million based on our recent U.S. approval of Zyperin. Arctic Vision is planning to initiate a confirmatory Phase III clinical trial in macular edema associated with uveitis in China by the end of this year with the ultimate goal of commercializing Zypyr, if approved, in their licensed regions. In addition, in the past two months, our clinical development partners reported promising results utilizing our SCS microinjector to deliver their therapeutics into the supercoital space. Regenexx Bio reported initial data from two Phase II clinical trials, which represents the first data ever presented utilizing gene therapy delivered into the supracoroidal space. We look forward to Regenexx Bio reporting additional Phase II data at the upcoming American Academy of Ophthalmology meeting later this week. And our partner, Aura Biosciences, reported the first data ever presented in ocular oncology, with their viral-like drug conjugate administered by suprachoroidal injection to treat choroidal melanoma. We're very excited about the progress to date from our partners, and we look forward to future results from these trials. Finally, our lead clinical development candidate, CLSA-X, continues to progress in our Phase I-IIa OASIS trial in patients with wet AMD. CLS-AX combines our proprietary suspension of the tyrosine kinase inhibitor, Exidinib, for supracoroidal use with our SCS microinjector. We have completed enrollment in Cohort 2 and expect to report safety and tolerability data from this cohort by the end of this year. With the PanVEGF attributes of Exidinib delivered into the supracoroidal space, we have the opportunity to improve the treatment of patients with wet AMD, as we believe CLSA-X may offer improved safety and efficacy, as well as prolonged durability by reducing the frequency of patient injections. With an approved product and four ongoing clinical trials utilizing three distinctly different therapeutic assets, we are revolutionizing the delivery of therapeutics to the back of the eye through the supracoroidal space. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to discuss our clinical development programs and more detail around the data disclosed by our partners. Tom?

Thank you, George, and good afternoon, everyone. Before I discuss our clinical development programs, I would just like to take a moment to recognize the excitement and momentum created by the approval of Zypher. This is a tremendous achievement for our dedicated employees, as they have worked diligently to bring the first drug approval to fruition. As a retina physician, I'm truly thrilled that my physician colleagues and their patients now have a new, innovative treatment option for those suffering from uveitic macular edema, a serious, potentially blinding disease. Retina physicians love adopting new technologies and embracing new therapies to add to their treatment arsenal. And as many of our meeting presentations and publications have shown, there is strong interest in our supracordial delivery platform within the retina community. In fact, our published study Evaluating use of our STS microinjector highlighted that supracordial injection was well accepted by physician investigators with potential for rapid adoption into clinical practice. Importantly, our microinjector has been clinically tested in multiple disorders with over 1,200 supracordial injections and a favorable safety profile in clinical trials. As background on the treatment need for Zypyr, UVI is a set of ocular inflammatory conditions. Approximately one-third of uveitis patients will develop uveitic macular edema, the buildup of fluid in the macula, which causes rapid swelling and distorted vision. Macular edema is a leading cause of vision loss and blindness in uveitis patients, and can occur from uveitis affecting any anatomic location, anterior, intermediate, posterior, or pan uveitis. We are pleased with the FDA-approved label for Zypyr, which includes all of these anatomic locations, to potentially treat a broad patient population, with macular edema associated with uveitis. Approval of ZodCare supports our supracordial delivery platform, as our preclinical work has now translated to proven clinical results. The core advantages of treating via the supracordial space include targeted delivery to affected core retinal tissues for potential efficacy benefits, compartmentalization away from unaffected tissues for potential safety benefits, and bioavailability as the core retinal tissues are essentially bathed with therapy. Furthermore, for small molecule suspensions, there are prolonged pharmacokinetics which facilitate durable therapies. This targeted delivery and compartmentalization was associated with our successful phase three pH-free clinical trial, supporting the efficacy and safety of Xypher. Durability was demonstrated in our Magnolia extension study, and is driven by the relative insolubility in particle size of the formulation in the supracordial space. We have seen similar preclinical durability with other small-molecule suspensions, including a complement inhibitor, a plasmacalocrine inhibitor, and the tyrosine kinase inhibitor, Exitinib, which is the active ingredient in our CLSA-X proprietary formulation. I will next discuss our CLSA-X program in more detail. I'm very excited about combining the potential benefits of panVEGF inhibition with the targeting, compartmentalization, and durability potential benefits of supracordial delivery. Of note, current AMD therapies bind VEGF-A. However, inhibition of VEGF-A has been shown to upregulate other forms of VEGF, which may contribute to limited outcomes. Excentinib, a highly potent tyrosine kinase inhibitor, may improve these outcomes with its broad VEGF blockade. and has already been shown to effectively inhibit corneal, retinal, and choroidal angiogenesis in numerous animal models. In addition, suprachoroidal administration may further leverage these potential benefits of Exitinib by more directly targeting the affected retinal and choroidal tissues. We recently published a preclinical study demonstrating this targeted delivery with suprachoroidal administration, along with favorable ocular distribution and durability compared to intravitreal delivery. These preclinical studies help provide the rationale for our first-in-man supracoroidal CLSAX clinical program and support our belief that supracoroidal CLSAX could represent a very competitive therapy in the future. As we reported last quarter, we are pleased with the promising safety and tolerability results from Cohort 1 of OASIS, our ongoing Phase 1-2A clinical trial with CLSAX. OHS is a multicenter, open-label study to establish the safety and tolerability of escalating doses of CLSAX administered by supracordial injection in patients suffering from wet AMD. The study involves three cohorts of approximately five patients each. The primary endpoint for the trial will assess the safety and tolerability for three months following supracordial administration of CLSAX. To recap our supracordial safety and tolerability data from cohort one, No study suspension of stopping rules were met, and there were no serious adverse events. Importantly, there were no signs of inflammation, vitreous haze, intraocular pressure safety signals, vasculitis, or intravitreal dispersion of CLSAX. There were two treatment emergent adverse events that were assessed as unrelated to CLSAX. Durability is an important component of our treatment plan, and we are encouraged by the preliminary signs of potential durability that we saw in cohort one. especially given the very low initial dose of 0.03 milligrams of CLSAX in these highly anti-VEGF treatment-experienced patients that were enrolled. With these results from Cohort 1, we've advanced to Cohort 2 at a dose of 0.1 milligram. While this is still a low dose of CLSAX, it's a 3.3-fold increase compared to the Cohort 1 dose. In September, we reported that we completed enrollment in Cohort 2 whereby all patients have received a Flibberstep at their first visit and a single dose of CLSAX at their second visit one month later. Patients are monitored monthly by their physicians for the next three months of their treatment, and we expect to report safety and tolerability results from Cohort 2 by the end of this year. For Cohort 2, we're also adding a three-month extension study to follow patients over a longer period of time. We believe that by combining the pan-VEGF attributes of excitinib with our proprietary CLSAX formulation and delivery via our SDS microinjector, we may facilitate an effective treatment option for patients suffering from wet AMD. Furthermore, a well-characterized small molecule like excitinib may have less potential for immune response compared to a biologic agent. With the recent well-documented safety challenges associated with other approved and investigational wet AMD therapies, We cannot emphasize enough the importance and prime focus of the safety component in our OASIS trial. If our Cohort 2 data readout continues to demonstrate supportive safety results, we will both escalate in Cohort 3 and have potential to escalate even further if we believe it's appropriate. With respect to our partner programs, the last few weeks have been a very exciting time for ClearSight in our supercoital delivery platform as our development partners have reported promising results from several trials using our SCS microinjector to deliver their product candidates into the suprachoroidal space. I will start with Regenexx Bio as they are running two multicenter, open-label, randomized control dose escalating studies evaluating the efficacy, safety, and tolerability of suprachoroidal delivery of RGX314. Excitingly, data presented by Regenexx Bio is the first data ever presented utilizing gene therapy delivered in the supracortical space. The first trial, entitled Aviate, is targeting the treatment of patients with severe wet AMD who are responsive to anti-VEGF treatment. Importantly, patients in this trial do not receive prophylactic immune-suppressive corticosteroid therapy. In September, Regenexx Bio reported the following. In cohorts 1, 2, and 3, supracoital delivery of RGX314 was well-tolerated in 50 patients with no drug-related serious adverse events. In cohort 1, positive initial efficacy data at six months after one-time treatment of RGX314 showed a treatment effect observed with stable visual acuity and retinal thickness, and RGX314 demonstrated meaningful reduction in anti-VEGF treatment burdens. For cohort two, Regenexx Bio plans to report interim results at six months of follow-up at the upcoming AAO meeting later this week. Cohort three has completed dosing in patients positive for neutralizing antibodies. And Regenexx Bio is expanding the trial to enroll cohorts four and five at a higher dose. The second RGX314 clinical trial is a phase two trial for the treatment of diabetic retinopathy entitled altitude. Similar to AV8, patients in this trial do not receive prophylactic immune-suppressive corticosteroid therapy before or after administration of RGX314. In October, Regenexx Bio reported the following. Cohort 1 had positive initial data that demonstrated supracoital delivery of RGX314 was well-tolerated in 15 patients with no drug-related serious adverse events. No interocular inflammation was observed. And 33% of patients demonstrated a two or more step improvement from baseline on a standardized diabetic retinopathy severity scale, compared to 0% of patients in the observational control. Cohort two is currently enrolling. And cohort three is currently enrolling patients positive for neutralizing antibodies. In addition, our partner, Oro Bioscience, has presented the first set of data utilizing supracoital delivery to treat coital melanoma. the most common primary ocular cancer in adults. Ora reported that suprachoral administration VRISCS microinjector may improve the therapeutic index and optimize treatment parameters for AU011. Ora is currently running a phase two trial comprised of an open label dose escalating phase and a randomized mass dose expansion phase that is assessing the safety and efficacy of ascending single and repeat doses of AU011 via SCS microinjector administration. In October, ORRA reported the following. Interim safety data showed no treatments related serious adverse events, dose-limiting toxicities, or grade 3 adverse events. Cohorts 1 through 5 are fully enrolled with a total of 13 patients. And cohort 6 is enrolling. The randomized phase of the trial is planned to begin the second half of 2022 in patients with documented growth, to establish the safety and efficacy of AU011 and serve as the first pivotal trial for the treatment of indeterminate lesions and chordal melanoma. The continued progress by Regenexx Bio and Ora Biosciences is very encouraging, and we look forward to their ongoing clinical trial results. Before I conclude my discussion, I would like to touch on our integrin and gene therapy programs. We're working on integrin formulation studies that will continue into 2022, as our research team is currently running preclinical studies, including pharmacokinetic work assessing ocular distribution. In our gene therapy program, this year we presented and published data including preclinical studies and supercoitally delivered non-viral DNA nanoparticles containing the MYO7 gene, which causes Usher syndrome and is too large to fit in AAV vectors. Outside of our existing gene therapy licensing relationship with the genic spinal, we have the opportunity to partner with other companies working on gene therapy using non-viral vectors or viral vectors targeting diseases that are not primarily treated with current standard of care anti-VEGF therapies, such as geographic atrophy and inherited retinal diseases, including Usher syndrome or Starbuck disease. In closing, we continue to remain active within the retina physician community with 10 presentations recently given at the Retina Society and American Society of Retina Specialists medical meetings. We will also have three Zypair presentations at the American Academy of Ophthalmology meeting this weekend. These presentations and other ongoing interactions with leaders in the field continue to generate interest in the suprachordal space and the potential to adopt this procedure in their practices. I will now turn the call over to our CFO, Charlie Degnan, to review our financial results. Charlie?