Hello, everyone, and thank you for joining the H.C. Wainwright Fourth Annual Ophthalmology Conference. My name is Vivian, and I'm an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts and over 650 companies covered across all sectors. If you would like more information, please visit hcwco.com. From a logistics standpoint, please make sure to reference your virtual conference online portal that provides your individual links to your meetings and all presentations. With that being said, we wish you a productive and enjoyable day. Now, I will hand it off to Kim Brazzell, the Head of R&D and Chief Medical Officer at KALA BIO. Thank you, Vivian, and I'd like to thank H.C. Wainwright for inviting us to provide an update on KALA BIO. KALA BIO is a leader in the emerging field of mesenchymal stem cell secretomes, with a focus on rare ophthalmic diseases. We have an ongoing phase II-B trial with KPI-012, our lead product from our proprietary secretome platform, for the treatment of persistent corneal epithelial defects, or PCED, with a top-line data readout targeted for Q1 of 2025. We believe PCED is potentially a billion-dollar market opportunity. We see KPI-012 as a pipeline and a product, and are evaluating other rare ocular indications, such as limbal stem cell deficiency, and also evaluating the utility of our secretome platform for treating rare retinal diseases. We've made significant progress in the last 18 months, with the U.S. IND being filed and accepted in late 2022. We initiated our ongoing phase II-B trial in 2023, and we're targeting a top-line data readout in Q1 of 2025. If positive, this should serve as the first of two pivotal trials needed for a BLA submission. In 2023, we were also awarded a $15 million grant from the California Institute for Regenerative Medicine to support our ongoing development program, which affirms the significant promise of the platform and of our KPI-012 program. We had cash and equivalents of $54.2 million as of the end of June, and a projected runway into Q4 of 2025. We have a very experienced management team, and Kala successfully developed and gained approval for two ophthalmic products, one for dry eye disease and the other for ocular inflammation, which we divested to Alcon to focus on our secretome platform. Our proprietary mesenchymal stem cell secretome platform is a cell-free regenerative approach to disease management. Secretomes are produced by collecting the biomolecules that cells secrete into their extracellular space to support their health and viability. In our case, we culture human bone marrow-derived mesenchymal stem cells from our master cell bank and allow the cells sufficient time to secrete the vast array of biomolecules they produce to support their growth and viability. We then remove the cells and process the supernatant, resulting in an aqueous solution of key proteins, growth factors, neurotrophic factors, and other biomolecules, which we then formulate into a non-preserved topical ocular formulation for self-administration by patients. As we're able to administer only the biofactors produced by the cells and not the cells themselves, we see the secretome approach offers many of the benefits of cell therapy while avoiding the safety and logistic concerns associated with many of the current cell therapy approaches. Preclinical studies have shown secretomes to have benefit in numerous ocular diseases owing to their broad mechanism of action. We have extensively characterized our secretome product by ELISA assays, antibody arrays, and cell-based potency assays, and are able to repeatedly produce a consistent product, not only in laboratory batches, but in full-scale engineering runs and GMP runs. We're now manufacturing our drug substance at commercial scale. We believe the secretome platform has numerous applications in rare ocular diseases of both front and back of the eye and have chosen PCED as our first indication. Our lead product, KPI-012, is composed of the biomolecules produced by the human bone marrow-derived mesenchymal stem cells and then formulated into a topical ocular single-dose unit formulation. We're currently in a phase II-B clinical trial for PCED. The product contains key classes of molecules associated with corneal wound healing, such as growth factors, neurotrophic factors, protease inhibitors, and matrix proteins, which together provide a multifactorial approach to addressing impaired corneal healing, such as that seen in PCED. Because of the broad-spectrum corneal wound healing mechanism of action of KPI-012, we believe it has significant potential beyond PCED as well. We're evaluating other front-of-the-eye disease indications, such as limbal stem cell deficiency, which we can pursue utilizing our current preclinical data package and our existing formulation. We also have a preclinical program evaluating secretomes as potential therapies for rare inherited retinal diseases. PCED, the first indication we're pursuing, is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments. PCED can be caused by a number of underlying etiologies, such as trauma, diabetic keratopathy, viral keratitis, neurotrophic keratitis, severe ocular surface disease, and complications from various surgical procedures. Patients often have more than one etiology, which further complicates the treatment. PCED can be associated with significant symptomatology, such as pain, photophobia, and visual impairment. If left untreated, a PCED can become infected, can continue to worsen, leading to thinning and scarring of the cornea, and can lead to corneal perforation and vision loss. There are approximately 100,000 patients in the U.S. with PCED, and 238,000 in U.S., E.U., and Japan combined. In our initial phase I-B clinical trial with PCED, patients of varying etiologies, which we will discuss in a moment, KPI-012 produced significant clinical improvement in all 8 treated patients, with complete healing of the PCED in six of 8. PCED is a clinically burdensome disease with a high level of unmet need. There's only one approved pharmaceutical therapy in this space, Oxervate, which is approved for only neurotrophic keratitis, which represents only about a third of all PCED patients. There are no approved therapies for the other two-thirds of patients. The Oxervate sales trend has been quite robust since launching 5 years ago. Sources indicate that Oxervate is approaching $1 billion in U.S. sales, making it one of the most successful orphan disease product launches in the last 5 years. We feel that a single therapy that can treat PCEDs of all etiologies is a significant unmet need, and we believe that the multifactorial mechanism of action of KPI-012 has the potential to address all underlying etiologies of PCED, and we are pursuing a broad PCED indication in our development program. The mechanism of action of KPI-012 for addressing impaired corneal healing in conditions such as PCED is illustrated here. KPI-012 contains key biomolecules known to facilitate corneal wound healing, growth factors such as hepatocyte growth factor, neurotrophic factors such as PEDF, protease inhibitors such as TIMP-1, and matrix proteins such as fibronectin and collagen. Administering these key components provide the cornea with the essential biomolecule to stimulate healing at multiple points in the healing pathway. We were highly encouraged by the results of a phase I-B clinical trial that we have completed. The trial started with a 3-patient safety cohort, which showed no safety or tolerability issues, and was followed with an 8-patient efficacy cohort in which PCED patients were administered KPI-012 from 1 to 8 weeks, and then followed for up to 19 weeks. All 8 of the patients in the efficacy cohort showed improvement of their PCED, and in 6 of 8 patients, the PCED completely healed, as measured by resolution of corneal fluorescein staining. 4 of the patients healed after only 1 week of dosing, 2 within 2 weeks, and 1 within 4 weeks. This result is particularly important, as complete healing of the PCED, as measured by fluorescein staining, is the primary efficacy endpoint that FDA wants to see for the demonstration of efficacy in our pivotal trials. It's also very important because ophthalmologists and eye care professionals that are treating PCED, their primary goal is to heal the PCED, as that will lead to a stopping of several of the potential problems. KPI-012 was well-tolerated, with no safety issues observed in the efficacy portion of the trial. The individual patient results are shown in this table. As you see in the second and third columns, the study involved patients with a variety of different etiology, lesion sizes, and PCED durations. Four of the patients had complete healing of PCED at one week, one at two weeks, and one at four weeks. All healed PCED patients remained healed through the end of follow-up. The rapid and sustained healing across various etiologies suggests potential for broad efficacy of KPI-012 in PCED. Many of the patients with PCED report significant pain, and the same was true in our study. Six of eight treated patients reported significant pain prior to treatment. All of the six reported improvement in pain after one week of dosing, and all the patients had complete resolution of pain by week three. This further supports the efficacy of our approach. We're making significant progress in our development program. We filed our U.S. IND in November 2022, which was accepted within 30 days of FDA's review. Our phase II-B trial was initiated in Q1 of this year. We recently had a very productive meeting with FDA, where they agreed that our ongoing CMC and potency assay programs are aligned with expectations of FDA for a BLA submission. The study design for our ongoing trial is shown in this slide. The trial is a 90-patient, randomized, double-masked study of 1 and 3 units of KPI-012, dosed 4 times a day in an 8-week treatment period, plus 2-week and 6-month follow-up. The 1-unit dose is the same as that was studied in our phase I-B trial. FDA did request a safety cohort at the high dose of the trial, as we'd only studied the low dose in our phase I-B trial. We completed that portion of the trial with no safety or tolerability issues, and now are recruiting patients for the efficacy portion of the trial. We are utilizing approximately 40 investigator sites, with a mix of academic and independent sites. The primary endpoint for the trial is the proportion of patients that are completely staining-free at week 8 and week 10 in the KPI-012 treatment group versus the vehicle group. This assessment is based on central reading assessment of photographs of corneal fluorescein staining that are done in a masked fashion. This is consistent with the endpoint that we measured in our successful phase I-B trial. Top-line data, again, is targeted for Q1 of 2025. One of the follow-up indications we are considering is limbal stem cell deficiency, or LSCD. It is an ocular surface disease characterized by the loss or deficiency of stem cells in the junction of the cornea and limbus. These stem cells play an essential role in the generation and repopulation of corneal epithelial cells. When the limbal stem cell population is reduced or depleted, the ability of the corneal epithelium to repair and renew itself is compromised, which can result in recurrent epithelial breakdown, neovascularization of the cornea, conjunctival overgrowth, and sequelae that can lead to the loss of corneal clarity and visual impairment, as well as significant pain and diminished quality of life. There are currently no approved products for the treatment of LSCD today. In addition to KPI-012's effects on corneal healing, observed in both animal models and our PCED patients, there is data in the literature that suggests that MSC secretomes can restore the limbal stem cell niche, which would be of significant benefit to these patients. We also believe our secretome platform could have utility for retinal degenerative diseases, such as retinitis pigmentosa and Stargardt's disease, and we're currently conducting preclinical studies evaluating the effects of various iterations of the secretome on the retinal cell types, and we'll be moving into animal models and retinal degenerations in coming months. In summary, we are very pleased with our progress toward implementing our new corporate strategy and becoming a leading ophthalmology rare disease company. We continue to make significant progress with our lead product candidate, KPI-012, and as I said before, are targeting a key clinical readout in Q1 of 2025. We're evaluating additional indications for KPI-012, for which we will be able to leverage our existing CMC program and other IND-enabling activities to allow us to proceed rapidly into initial evaluation. We are also generating encouraging data for our retina program, which we believe has significant promise for treating rare and severe retinal diseases. We look forward to continuing to update you on our progress going forward, and are excited about our prospects for the future. Thank you. Great. Thank you, Kim, and thank you to KALA BIO for your presentation. It was very informative. The H.C. Wainwright team is grateful for your presence at the Annual Ophthalmology Conference and for your efforts in preparing for your session.