Good afternoon, everyone. Thank you for joining us for another session in H.C. Wainwright 's 27th Annual Global Investment Conference. My name is Eduardo Martinez. I'm a Biotechnology Equity Research Associate at H.C. Wainwright, and it's my pleasure to introduce Dr. Kim Brazzell, Head of R&D at KALA BIO. Thank you, and I'd like to thank the H.C. Wainwright team for inviting us to give an update on KALA. Okay. There we go. Just a reminder that this presentation will contain some forward-looking statements, and that should be considered in light of what we filed with SEC and what's on our website. KALA BIO is focused on leveraging our proprietary mesenchymal stem cell secretome platform for the treatment of rare ophthalmic diseases with significant unmet need. Our lead program, KPI-012, is currently in a phase IIb clinical trial for the treatment of persistent corneal epithelial defects, a rare disease with an unmet need that needs to be addressed, and we think this would serve as a pivotal trial for a BLA submission. We're making good progress with the clinical trial. We completed enrollment in June of 2025, and are targeting a top-line data readout the end of September, so just right around the corner. We have an experienced management team who are with us today, and together we developed and obtained NDA approval for two ophthalmic products, one for dry disease and the other for postsurgical inflammation. We divested those products to Alcon, who are marketing them now to allow us to focus on our secretome platform, so a little bit of background on secretomes. Secretomes are defined as those biomolecules that are secreted by cells into their extracellular space, really to support their health and viability, and with our platform, we start with human bone marrow-derived mesenchymal stem cells, for which we have a master cell bank that will last the duration of the development program and the duration of the product life. We have a well-defined GMP manufacturing method that allows us to move quickly forward once we get the results of this trial. A little bit about how we manufacture the product that helped share some light on really what the secretome is. We start with these human mesenchymal stem cells. We culture them for a specific amount of time, allow them to secrete all the biomolecules they would normally secrete to support their health and viability. We then remove the cells, are left with an aqueous supernatant, which then we process into a very simple, patient-friendly topical eye drop formulation. We think one of the benefits of the secretome is it offers a number of the characteristics of cell therapy without having to administer the cells. And there's been a good deal of work published on the benefits of secretome preclinically in corneal injury and a variety of other corneal diseases and retinal diseases. And the primary mechanisms of action are wound healing, tissue repair. They have anti-inflammatory, immunomodulatory effects, as well as neuroprotective and neurotrophic effect as well. We think that the platform itself and our lead program has the potential to treat multiple rare ophthalmic diseases. The first that we're focused on, as I said, are persistent corneal epithelial defects that we call PCEDs. But we're also looking to expand that into other areas. And the next program we're looking at is a condition called limbal stem cell deficiency, which itself is a blinding condition. But we'll focus primarily on KPI-012, our lead molecule. It is, as I said, composed of biomolecules that are generated from the mesenchymal stem cells and formulated into a simple, patient-friendly, topical, ocular, non-preserved single-dose unit formulation. The product contains key classes of biomolecules, and we'll touch on those in a minute, that are associated with corneal wound healing: growth factors, protease inhibitors, matrix proteins, and neurotrophic agents, among others, and this provides a multifactorial mechanism for addressing conditions characterized by impaired corneal healing. As I said, we're currently in development for persistent epithelial defects with a goal of providing complete healing, and we'll talk about the importance of that going forward, and we think we would be able to address all underlying etiologies of the PCED, as opposed to the one product that's on the market today that only addresses about a third of patients with this potentially blinding condition. We have Orphan Drug and Fast Track designation for KPI-012. As I said, our first indication is persistent corneal epithelial defects. And they are basically, as they sound, they are non-healing corneal wounds or defects on the surface of the eye that are refractory to conventional treatments. As you might expect, when you have an area of denuded epithelium on the cornea, with the cornea being the most highly innervated organ in the body, you have significant symptomatology. Patients typically have a good deal of pain unless they're neurotrophic. They have significant sensitivity to light. And these defects or wounds are often in the visual axis, so they can have significant visual impairment. This condition can be caused by a number of underlying etiologies. Trauma is a common one, neurotrophic keratitis that we'll touch on a bit, diabetic keratopathy, severe dry eye disease, Sjögren's disease, infectious keratitis, particularly herpes keratitis, is a significant etiology. And often patients have more than one underlying etiology, so you often have to address more than one etiology. And that's why we think the multifactorial nature of our product is very important. The estimated incidence in the U.S. is about 100,000 per year, and you can scale that up, of course, for the rest of the world. We'll talk in a bit about the results from a phase IIb trial that we conducted recently, where we saw significant improvement in complete healing in PCED patients in six of eight patients. There are currently no FDA-approved products for broad treatment of PCED. There is one product, OXERVATE. It's marketed by a private Italian company. It's recombinant nerve growth factor, and it's indicated only for neurotrophic keratitis, which is about a third of all PCED cases, and we'll talk a bit. It's complex and burdensome for patients to administer, but as you'll see, it sold over $1 billion last year in 2024, so this is a clinically burdensome disease with significant unmet need. And as we said, as there's only one product that only addresses about a third of patients, one of the key unmet needs is a single therapy that can address all etiologies, and as I said, many of these patients have more than one etiology that needs to be addressed. Of course, rapid and sustained wound healing. Clinicians' goal when they see this condition is to heal it as quickly as possible because these patients are at significant risk of infection, which can cause them to lose an eye and lose vision in that eye. They're also at significant risk of the lesion further degrading into deeper areas of the cornea. That can cause scarring of the cornea. It can cause corneal perforation. Again, it can result in loss of vision and loss of the eye. So when a clinician sees this, and it's primarily treated by corneal specialists, when they see a patient with this, their first thought is, "I have to heal this as quickly as possible to prevent these other sequelae and the vision-threatening implications they have." As I said, the one therapy on the market, OXERVATE, is only indicated for PCED secondary to neurotrophic keratitis, and that represents about a third of all patients. It requires six times a day dosing. It is a quite burdensome 19-step process that the patient has to do for their daily dose. And it's usually recommended to be dosed every two hours for 12 hours of the day. It also has a significant adverse event of corneal pain. This appears to be a neuropathic pain. It's listed in their package insert at 16% of patients. But when we talk to clinicians that treat this, they say they see it to some degree in almost every patient. So we think there is certainly a need for improved products with regards to tolerability and that are simpler to administer. When we look at the overall market for PCED, we think it could be in excess of $3 billion. As I said, OXERVATE reported U.S. sales in 2024 of over $1.1 billion. So this is a significant marketplace, and they're only addressing a third of patients. And we feel with our unique mechanism, we can address that third of patients as well as the other two-thirds of etiologies. So we think that KPI- 012 could be the first approved product with a broad PCED indication for treating all patients with this potentially sight-threatening condition. A little bit about the mechanism that will help you understand why we are studying it across all etiologies. There's a lot known in the literature. It's been studied for over 50 years of the mechanisms involved in corneal wound healing. And if you think simply, there's a corneal wound as an area of denuded epithelium, often with an impaired or damaged basement membrane. For healing to occur, the epithelial cells have to be able to migrate into the wound site. You also have to have then epithelial cells to back them up because corneal epithelium turns over every five to six days. So these have to migrate into the wound bed, and there has to be an intact basement membrane because they have to adhere first before they can start the proliferation that helps in terms of providing the healing that's needed. We know that in many of these conditions, particularly with a lot of inflammation, you get an upregulation of proteases, and this proteolysis is what's generally the cause of the damage to the basement membrane. So that has to be addressed. And then we also know there's a very interesting cross-talk between the surface of the eye, the corneal epithelium, the corneal nerves, and the healing process. That's evolutionary. When you have a wound, if you've ever had a scratch in your eye, you get significant pain, and that signals the healing process to start. So when you have impaired innervation of the cornea, such as those in neurotrophic keratitis, that can lead again to an impaired wound healing process. So our product has multiple biofactors that address these impairments, growth factors such as hepatocyte growth factor, pigment epithelium-derived factor that promote epithelial cell function. So they promote the migration of epithelial cells and attachment to the matrix. Protease inhibitors that inhibit the protease that can degrade the basement membrane. We are providing back protease inhibitors, TIMP-1 and serpins, a variety of serpins to address that. We also are providing back matrix proteins, fibronectin and collagen to provide the factors that are needed to rebuild the damaged matrix membrane and neurotrophic factors as well. In our case, PEDF, BDNF, and CNTF. So we feel that addressing all these etiologies is possible with this product. We have promising results from a phase IIb trial in patients with persistent epithelial defects. This was first-in-man, so it started out with a safety cohort of three patients without corneal disease. They were dosed for a week. There was no safety, no tolerability issues in that. And so we moved into patients with persistent epithelial defects. We studied eight patients overall. As first-in-man, it was dosed twice a day from one to eight weeks, and was followed up for 19 weeks. The key efficacy endpoint for this trial and for our current trial is healing of the PCED based on corneal staining photographs. Corneal fluorescein staining is a very common technique that's used by virtually all eye care providers. You basically put fluorescein on the surface of the eye. It adheres to areas of denuded cornea. When you look at it through a slit lamp with a special filter, you can see, as you see on the photograph, a green area, and that denotes the area where there is no epithelium. You can take photographs of this area, and so you can read that based on the photographs. In our ongoing trial, we're using a central reading center to grade that. So it's a very objective endpoint. So we saw in this that all eight of these patients showed significant healing. Six of eight patients had complete healing of the PCED. That's 75%. That compares well to what OXERVATE showed in their pivotal trials, 65%-70%. And that's very important because, again, as I said, that's what clinicians are looking for when they treat this condition, complete healing of the condition. It's also the endpoint that FDA wants to see to demonstrate efficacy. So in these patients, as shown in this slide, four of eight of these patients healed in a week. The green dots represent when it was healed. The green line represents the duration of therapy. The gray line is how long we followed these patients up. Six of eight completely healed, four of those within a week, two of those within two weeks, and six of one within four weeks. We followed these patients for up to 19 weeks and saw no recurrence of the lesion. They healed and they remained healed. We also saw significant pain relief. Six of eight of the patients had significant pain at baseline, and those all had gone down to zero pain by the end of therapy. We had a productive pre-IND meeting in 2020 where FDA indicated they were open to a broad PCED indication if we enrolled a trial like we're currently doing of all etiologies. As I said, we have orphan drug and fast track. We filed the IND in November of 2022, and it got accepted within the 30-day window. FDA did ask us to do a small safety cohort at the high dose, and we'll touch on that. We also had a very productive type C meeting with FDA a year ago in April where we presented our CMC and our potency assay program, and FDA was totally on board with what we were doing. So we feel that we have a very good manufacturing process, but more importantly, or as importantly, a very good potency assay program that they completely agreed with. So the ongoing trial, which, as I said, we have completed enrollment. We had an initial two-patient open label evaluation safety and tolerability at the high dose, the three-unit per ml dose, and saw no safety or tolerability concerns in that portion. Then we moved into the multi-dose randomized portion of the trial where we're looking at two different doses versus placebo or vehicle as we use one unit QID. The phase IIb trial was one unit BID. So we stepped that up to QID, a three-unit dose QID, and the vehicle in a one-to-one-to-one randomization. So an eight-week treatment period plus a two-week or a 10-week follow-up two weeks later and a six-month follow-up for safety. And the primary endpoint is the proportion of patients that were completely healed as measured by being completely staining free, that fluorescein staining in the area of the lesion at week eight and remain healed at week 10. And that, as I said, we've completed enrollment. We had a total of 79 evaluable patients. To give some information on that, we based our powering on the OXERVATE second phase III trial or second pivotal. It was actually a phase II trial as well. So with 79 patients, if we assume 26 per treatment arm, and if we assume the same treatment effect that they saw, 65% healed in the treated arm versus 17% in the placebo arm, we would have a 96+% power to achieve statistical significance at the 0.05 level. One unique design element of this trial is after patients are screened and determined to be eligible, they go into a one-week run-in where they're only given non-preserved artificial tears to help manage their pain and non-preserved antibiotic because, again, they are at significant risk of developing a severe infection. If patients improved, if their lesion size decreased by more than 10%, they weren't randomized into the trial. That allowed us to weed out anybody that was in the healing process. We lost about 40% of patients during that run-in phase, but we feel it will allow us to have a significantly lower placebo effect than others have seen in the past. We know that there have been a couple of failures in the neurotrophic keratitis space, and we know one of those announced because it had a greater than expected placebo effect. So we feel that this run-in phase will help us to minimize the placebo effect and further improve our statistical power. So again, we're looking for top-line data in a couple of weeks, the end of September, and we're very excited about that and look forward to further updates in the future. Thank you.