Video Transcription
Michael Webb 00:02
So Epion Therapeutics is an ophthalmology company developing a drug-device combination for the treatment of keratoconus. Keratoconus is a debilitating vision-losing disease that affects millions of people around the world. You can see a keratoconic eye there in the center of the slide. Your cornea is bulging, you can't focus, and eventually, you become blind. There are about 3 million patients in the US, and many more millions outside the US, particularly in Africa and the Middle East. We have a world-class group of people involved in the company. Myself, I've done six biotech ventures. Michael Belen is the Chief Medical Officer, and he's the world leader in keratoconus diagnosis. We also have additional corneal luminaries, including John Talal, our Chairman, who's a previous Chief Medical Officer of J&J Vision. Recently, we've made quite a few milestones. We're almost two-thirds of the way done with our 800-patient Phase 3 trial; we anticipate data late next year or early the following year. We raised a $32 million round with lead investment from AXA Global Health, and we have about 60 leading cornea specialists who have funded the company through Phase 2. Right now, we have a Series A extension open for up to $15 million to complete the Phase 3 and prepare for commercial prep. We envision monetization of the company through IPO or sale in the next 24 months. Keratoconus is a bilateral disease; it affects both your eyes, typically diagnosed in children from 10 to really up to about 21 years old. But many people have it diagnosed later in life, between 45 and 60. I actually have two first cousins in a nine-person group with the disease that I discovered after I took on this project. Cross-linking, which is what we do, stabilizes the cornea and freezes it in structural shape so that it doesn't
Michael Webb 01:55
distend any longer. It's a very large market in the US right now; the
Michael Webb 02:01
current treatments are highly invasive. They either rely on mechanical disruption or chemical disruption of the surface of the eye. Hence, only about 20,000 patients a year are treated. We envision that when we have the first true minimally invasive technology to treat this disease, it will open the market to treating 100,000 to 200,000 patients per year, and at $4,000 per eye, which is what the drug costs—the price that's being paid in the marketplace today—that's over a $20 billion market opportunity. The secret to our formulation for riboflavin is the addition of a catalytic amount of sodium iodide. Sodium iodide blocks the undesirable type one reaction that consumes riboflavin and drives the green reaction, which is what you want. So we have stable riboflavin that permeates the corneal surface really easily, loading the stroma. We get lots of cross-linking, and we don't have to disturb the surface of the eye whatsoever. In our 800-patient Phase 2 trial, we had really amazing results. Over 80% of the patients had stable vision after 12 months. And really, what was amazing was this result, which is that 25% of the patients under 21 years old had a three-line gain in vision because we could regularize the cornea and then correct it with contacts or glasses. Our procedure is quite easy to do. You can treat both eyes simultaneously in 50 minutes. We apply the riboflavin eye drops through a sponge that's on the surface of the eye, and then we expose the eye for about 20 minutes to UVA light, and we can treat them both in 50 minutes without any chemical or mechanical disruption of the surface of the eye. Hence, our patients go back to school or work in one to two days and have very minimal side effects. Our FDA-agreed plan is to move this disease treatment from very late diagnosis, where the current techniques are approved, all the way to the front end and all along the continuum. So that opens up a huge market opportunity. The FDA agreed with us that we should be treating this disease upon initial diagnosis when possible. But anyone with a diagnosis of keratoconus, no matter what stage, can be treated. We can, amazingly, in an ophthalmology trial, treat both eyes at the same time, which is rarely allowed by the FDA because if you mess up one eye, you want to have a spare, right? Well, we're treating both. And in fact, in the Phase 2, over 70% of the patients were treated simultaneously in both eyes. In fact, in the Phase 3, it's running about 72%, and we have approval to use devices that diagnose keratoconus worldwide, which is really important in low and middle-income countries. So we believe we will be the first true epithelium-on treatment for keratoconus. Our competitor has offered epithelium-off for a number of years and is developing a comparable procedure to ours. We believe we will be significantly superior, and I'll show you why. They don't treat—they treat one eye at a time. They treat only an indication of progressive late-stage keratoconus, and their treatments require significant post-op follow-up and potential infection. Riboflavin, which is one of the active ingredients in cross-linking, glows green under UV light. That's the green riboflavin glowing in a rabbit eye with our treatment. And this is the green, or partial green, in our competitor's product for the same application. So you can see they don't have a lot of loading; it's very spotty, it's not very homogeneous. And we achieve really superior loading. The more riboflavin you have during the eye, the more cross-linking you get, so the more stabilization you get, so that it actually works. Voice to the customer has been quite strong. We have about 24 sites enrolling in the US in Phase 3, and we recently surveyed them and a few other KOLs. It was very strong that they would convert the procedures they're doing today with epithelium-off cross-linking, the current procedure. They would move that to our procedure almost overnight. And that's 20,000 procedures. So at $4,000 a dose, 20,000 procedures, we think out of the gate commercially, we will do quite well. We have a very large intellectual property estate. We have 11 granted US patents covering the device, the drug, and the combination, and a whole suite of these patents making their way through the European system. So we believe the future is our product, which collectively we call EpiSmart. We give patients a lifetime of preserved vision. We can treat keratoconus upon initial diagnosis or anywhere along the continuum. We can use advanced imaging to find it really early before the patient loses any vision at all, and we can get them back to school or work in one to two days. And that's a 3 million patient market in the US, plus Europe and plus LMICs. So this is our timeline today. We're in Q3 2024; we've enrolled over 500 patients in the 800-patient trial. It started about nine months ago, so it's gone extremely rapidly, and we think we'll be done with enrollment at the end of this year or very early next. We have 12 months of follow-up on the patients to measure their vision at the end of 12 months, so we should have data at the end of Q4 next year, early Q1, and then we hope in 2026 to monetize the company, either through IPO or sale of the company. So thank you very much. Applause.
