Joe 00:11
Hello and welcome to Pathfinders, a podcast series from RBC Capital Markets, where we uncover the key trends and catalysts shaping the fast moving world of biopharma and healthcare. I'm your host. Joe Coletti. Today, we're streaming from RBC's Global Healthcare conference here in New York, and we're going to be exploring innovative therapeutics intended to improve the lives of patients with serious retinal disease.
Joe 00:36
Joining us is George Elston, Chief Financial Officer and Head of Corporate Development at Eyepoint Pharmaceuticals, which is developing groundbreaking programs such as DURAVYU and EYP 2301 designed to provide patients with better visual outcomes.
Joe 00:51
George is a seasoned financial executive with over 30 years of experience in the biopharma industry, including leadership roles at 2X Oncology and Enzyvant Therapeutics, culminating in his current position at Eyepoint Pharma, where he drives financial strategy and corporate development to help realize the company's ambitious goals. Today, we'll talk about Eyepoint's innovative approach to therapeutics combating retinal disease, their developing programs and trials and partnership network, and what investors should be looking out for in this exciting and evolving space.
George, it's great to have you with us today.
George 01:24
Thank you, Joe, happy to be here.
Joe 01:26
So in light of the macroeconomic environment, how's Eyepoint managing its capital allocation priorities right now? Particularly, I want to hear this from your lens as CFO and head of corporate development, which I think is a different angle that we always hear on our episodes.
George 01:40
That's an important question on every investor and company's mind. And I think, from my point's perspective, we are fortunate that we're in a very good capital position. We're in two global phase three trials with DURAVYU. Those trials are called Lugano and Lucia. They're two global trials. We're expected to have completion of enrollment this year with top line data readout in second half of 2026.
George 02:03
And importantly for us, we're funded not just through those trials, but into 2027 – we ended March with 318 million in cash, and that puts us in a very good place. To your point, it's been a very difficult market, and I think the entire space has been under a lot of pressure, including a lot of our investors. But we were fortunate to have raised capital on some DME data that we had in 2024 and put us in a really good position forward. I think, on the allocation perspective, we've been very focused on the execution. We are a wet AMD story. Our capital is allocated to completion of those wet AMD trials and preparing for an NDA filing. And that includes our commercial manufacturing facility, which is in Northbridge, Massachusetts. So we are not just focused on completing the Phase III and hopefully getting a positive readout, but also completing registration batches, preparing for a pre-approval inspection and ultimately commercial launch.
Joe 02:57
So with the market for retinal disease treatments expanding, how is Eyepoint positioning itself to lead the next wave of innovation that's coming?
George 03:06
Yeah, and thank you for that question. I think we are leading that. I think Eyepoint at its core, we are focused on delivery of drug to the back of the eye. We have a long history of developing innovative programs leveraging our Durasert™ technology, and now the newest version of that is Durasert E™, which stands for erodible, and that's the technology used in DURAVYU, which is in the phase III trials. What we love about the DURAVYU program, which is VERONA, it's a tyrosine kinase inhibitor. It's essentially the first new mechanism of action in retinal disease in the last 15 to 20 years. If you look at the treatment of wet AMD, in particular, it's been a series of anti-VEGF biologics, and they all work well, but they essentially have the same mechanism of action. And so as we think about DURAVYU as a sustained six-month option, it really represents a brand new MLA and new approach to treating that disease.
Joe 03:59
So you mentioned Durasert™ and Durasert E™ in particular. Can you talk a little bit about the kind of commercial and strategic differentiation around it in your view, and also, kind of how you're thinking about the long-term value that it's going to enable for the company?
George 04:14
Yeah, so the Durasert™ technology is core to Eyepoint. It is our sustained delivery technology. It's got four FDA-approved products using Durasert, and that's a non-erodible technology. And essentially what it is, it's a solid insert that's injected into the vitreous, which is the large space in the eye. And what this technology does, it allows us to deliver sustained release zero order kinetics, meaning same dose, 24/7 for six months or longer with DURAVYU. And it really represents a brand new approach in treating these diseases. You know, the current biologics work, and they work very well, and they're very safe, but they don't last long. You know, a biologic, in the eye, on average, they last about 28 days. And so what we have is this potential for constant dosing, constant drug on board, and a new mechanism of action, giving physicians and patients a new way to treat these diseases.
Joe 05:10
So you mentioned DURAVYU again. I wanted to give you a chance to just expand a little bit on DURAVYU. How are you thinking about its potential to sort of shift the broader competitive landscape? And you know, what do you see the implications for value creation are?
George 05:26
Yeah, so I think most importantly, DURAVYU is not another anti VEGF, right? What we do is bring a brand new mechanism of action to wet AMD. It's really differentiated in a sense that, you know, we if you look at every new product in wet AMD over the last 15, 20 years, their claim is we last a little bit longer than the prior drug use. And we bring a very different value proposition to doctors and patients. And our proposition is we will work in conjunction with the biologics, not instead of, you know, it's, it's not an either or, it's both. And we've always positioned and talked about DURAVYU as a maintenance therapy. And if you look at our phase III trial design, we're essentially loading patients Aflibercept, get your patients stable, put in DURAVYU. If our phase II data holds, we took two thirds of patients six months or longer with just our drug, and actually 50% of them went a full year. If physicians need to supplement with a biologic, that's fine, too. And so we are not looking to replace them. We're looking to work in conjunction with them, and again, bring that second mechanism of action to these diseases.
Joe 06:09
With potential FDA impacts on the horizon, how is Eyepoint positioning its DURAVYU program to sort of navigate any potential headwinds that you may encounter?
George 06:38
Yeah. So we've been very fortunate as a company. We did a robust phase II trial for DURAVYU and wet AMD. We also did one in DME, which is diabetic macular edema. And we've been engaged with the agency, you know, throughout that process. We held type C meeting; we've had an end of phase II meeting for wet AMD we had a we've just scheduled an end of phase II meeting for the DME indication for the summer. And what's been important in ophthalmology so far is we've seen no change in the FDA. We have the same program manager, the same attendees at our meetings. And in fact, in our recent interaction, the FDA has been on time/early. So you know, it appears, and we hope it continues, that at least within the ophthalmology division, it's unchanged.
Joe 07:22
Excellent. We want to talk a little bit about partnership models and collaboration. When you think about partnership models, what kinds are sort of most strategic for Eyepoint today, and how do you sort of determine and look for and evaluate the right fit?
George 07:37
Yeah, and that's a good question. We spend some time thinking about that. Retina is a unique space, certainly here in the United States. In the United States, there are about 2400 retinal doctors. The commercial footprint to reach them is not that heavy of a lift. You know, approximately 70 sales reps and a commercial organization can address that. And so we're gearing Eyepoint to launch this product in the United States.
George 09:03
Ex-U.S. is a very different story. The treatment dynamics are quite different. And so we've said publicly that we do plan on bringing in a global partner for Ex-U.S. And we're, you know, we're open to even some potential co-partner, co-promotion in the United States. But you know, clearly, Ex-U.S., we're certainly going to look to use a partner to launch.
Joe 08:23
In this role, are there any kind of major lessons that you have learned, or you would impart on people who maybe are looking to become a new CFO or may be growing into those kind of roles in the future? Anything that you've learned over the years that you think would surprise somebody maybe coming at the roller are your lessons of the trade, if you will.
George 08:42
I think starting at the beginning, and you know, finance and you know, and accounting people in general are risk averse, so one of the first conversations I have with people that want to go into biopharma is, don't do the math, because if you do the math, you will never go into biopharma. But the potential to be involved with a drug that can change patients' lives is really exciting, and is what drives me and my colleagues at Eyepoint every day.
George 09:06
You know, I've been in the industry a long time, and I think I have seen just about everything, the highs and the lows and the upturns and, you know, no CFO is worth their salt unless they've run out of cash, almost run out of cash at least once. And I've been there, and really don't want to do that again. And so I think for financial executives, as you think about entering into biopharma. I think an important message is to control your burn. Be bold about that. You see a lot of companies making mistakes. They raise money, and they spend a lot of money on furniture, fixtures, leases.
George 09:40
Investors want you to spend that money on drug development and clinical trials, and you're seeing a lot of that reversion today, a lot of companies that got funded several years ago that maybe shouldn't have. This is really the first time in my memory where you're actually seeing biotech companies go bankrupt and they're being forced to return cash to shareholders. And you don't ever want to be in that position. Hire wisely, manage your burn, ask tough questions, and, you know, be good stewards of your cash. Biopharma is one of those interesting spaces where every day I will have less cash tomorrow than I do today, and so use it well.
Joe 10:14
I think that's great advice. Final question is, sort of, for folks listening to this. If there's like, one, one or two things you want them to sort of take away about your company, you know, what do you want them to remember?
George 10:27
Yeah, I think, you know, Eyepoint is really a story on execution. Our team has just done a remarkable job over the last four years. If you look at DURAVYU, we dosed our first patient in 2021 in a Phase I trial. Here we are in 2025 in middle of two global Phase IIIs. Lugano trial is we is over 90% enrolled. Lucia is over 50% enrolled. And it's all about execution. It's about getting the right people around the table and really believing. And we're really proud of where we are. We are drug developers. We are focused not just on getting through the clinic, but getting the drug approved and, you know, more to follow.
Joe 11:08
George, it's been a pleasure. Thanks for being at the conference, but also thanks for joining us for the podcast today.
George 11:14
Yeah. Thanks very much for having us. Really appreciate it, and we'll see you soon.
Joe 11:21
Thanks for listening to Pathfinders in Biopharma, brought to you by RBC Capital Markets. Please remember to subscribe to get more great content and be alerted about future episodes. This episode was recorded on May 21, 2025. If you'd like to learn more or continue the conversation, please visit rbccm.com/biopharma. See you all next time.