EyePoint Pharmaceuticals Inc (EYPT) 2025 Q3 法說會逐字稿

Good morning. My name is Antoine, and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint third quarter, 2025 financial results and recent corporate developments conference call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint. Please go ahead.

Thank you and thank you all for joining us on today's conference call to discuss EyePoint's third quarter 2025 financial results in recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss our clinical programs for door review in wet AMD and DME.

I will close with commentary on the third quarter 2025 financial results. We will then open the call for your questions where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of this release can be found in the Investor Relations tab on the company website www.eyepointpharma.com.

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, financial projections and our plans and prospects. 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 most recent annual report on Form 10-/k, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future.

Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.

Thank you, George. Good morning, everyone, and thank you for joining us. I'm pleased to discuss with you today the tremendous progress we've made during the past quarter, continuing our strong track record of execution.

As you will hear, our momentum underscores our confidence in the differentiated clinical profile of DURAVYU, our lead program, and its potential to transform the treatment paradigm in the two largest retinal disease markets wet age-flated macular degeneration, or wet AMD, and diabetic macular edema, or DME.

I'd like to start with a brief overview of our recent highlights.

DURAVYU is on track to be the first to file and first to market among all current investigational sustained delivery Wet AMD and DME programs, positioning DURAVYU at the forefront of the treatment landscape with potential first mover advantage.

We completed enrollment of the LUCIA trial, the second phase 3 trial for DURAVYU and wet AMD, in July. Both trials, LUGANO and LUCIA, were enrolled in seven months and together recruited over 900 patients, making them among the fastest enrolling Wet AMD pivotal programs to date.

Top-line data for DURAVYU and wet AMD is expected in mid 2026. Following the positive end of phase 2 meeting in July for DME, we were pleased to align with the FDA on a non-inferiority trial design that we believe is clinically rigorous, efficient, and de-risked.

As a reminder, DURAVYU is the only tyrosine kinase inhibitor, or TKI in development for DME. We are rapidly moving forward with a pivotal phase 3 DME program, with first patient dosing expected in Q1 2026.

The phase 3 DME trials, COMO and CAPRI, will leverage our existing wet AMD clinical trial infrastructure and our enthusiastic network of investigators.

We announced new pre-clinical data showing that Vorolanib, the active drug in DURAVYU, is unique among TKIs being tested in retinal diseases, as it [inhibits] both VEGF-mediated vascular permeability and Interleukin 6 or IL-6 mediated inflammation. This multi-mechanism of action has the potential to be particularly effective in the treatment of multifactorial diseases such as wet AMD and DME.

These new data underscore the impressive phase 2 results of the VERONA trial in DME and strengthened our confidence in our clinical programs.

Finally, our path to potential success in phase 3 is supported by our strong balance sheet. We ended September 2025 with over $200 million in cash and equivalents and closed a $172 million follow on offering in October.

Our cash is now expected to fund operations into Q4 2027, well beyond phase 3 wet AMD data anticipated in 2026. With this continued exceptional track record, EyePoint will enter an eventful 2026 from a position of strength.

Now I'd like to take a closer look at the current market landscape for wet AMD and DME. With a combined current global market of $10 billion and growing, these indications make up the vast majority of the global branded retinal disease market.

Despite the size and scale of these diseases, they are dominated by a single treatment modality, monotherapy anti-VEGF biologics. Due to the high burden of frequent injections, many patients remain undertreated, even with the addition of recently approved extended duration options.

Additionally, these current standard of care anti-VEGF demonstrate subpar real-world efficacy in DME with growing literature supporting the role of not only VEGF activation, but also IL-6 signaling and inflammation driving disease severity.

We believe our lead product candidate DURAVYU is well positioned to deliver much needed innovation in both wet AMD and DME. As a differentiated sustained release TKI, DURAVYU is designed to improve the current standard of care by providing durable disease control while reducing the treatment burden.

Further, DURAVYU potential multi-MOA blocking VEGF, PDGF, and IL-6 signaling may be uniquely suited to effectively address multifactorial retinal diseases such as DME and wet AMD.

Beyond its unique MOA, DURAVYU offers a compelling product profile that supports strong competitive positioning in both wet AMD and DME. Unlike other sustained release options in development, DURAVYU is formulated in our Durasert Etechnology, a bio-erodable sustained release insert specifically designed to prevent free floating drug particles.

Additionally, DURAVYU is shipped and stored at ambient temperature and administered via a standard intravitreal injection. DURAVYU features the most robust clinical data package among all investigational sustained release programs.

This includes phase 2 wet AMD and DME data demonstrating meaningful visual and anatomic improvements from a single DURAVYU dose. And a consistent and favorable safety and tolerability profile with no safety signals observed in over 190 patients across four completed clinical trials.

Given its advantageous clinical profile, multi-target MOA, and unique storage and administration conveniences, we are confident that the DURAVYU offers a differentiated value proposition that is meaningful to physicians and patients and if approved, would present a compelling option within the current and future landscape for retinal disease treatment.

Let me now walk through recent updates for our phase 3 programs beginning with wet AMD.

Our fully enrolled phase 3 pivotal program remains on track to deliver topline data starting in mid-2026. As a reminder, in July, we completed enrollment of the phase 3 program with over 900 patients randomized across the two trials. To ensure we are positioned for commercialization, we are highly focused on our manufacturing capability and CMC submission for an NDA.

We have already produced the review registration batches at our state-of-the-art GMP compliant manufacturing facility in Northbridge, Massachusetts. The 41,000 square foot facility was built to both US FDA and EMA standards and will have capacity to support the commercial launch.

Moving on to the recently initiated phase 3 program in DME, our program consists of two non-inferiority trials, COMO and CAPRI, evaluating DURAVYU 2.7 mg versus on-label of aflibercept control.

Each trial will enroll approximately 240 patients. Additionally, given the established non-inferiority pathway, as well as our ability to leverage our existing phase 3 clinical trial infrastructure, we believe the program is significantly de-risked.

We look forward to dosing our first patient in Q1 2026.

As I mentioned earlier, there's growing clinical evidence supporting the multifactorial nature of retinal vascular diseases, with both VEGF-mediated vascular leakage and inflammation contributing to disease pathogenesis.

IL-6, a pro-inflammatory Cytokine, is a key driver of this inflammation and is found at significantly higher levels in DME and wet AMD patients versus healthy individuals.

Recent preclinical findings which we presented at the American Academy of Ophthalmology meeting in October demonstrate that [Vorolanib], the active ingredient in DURAVYU, inhibits IL-6 signaling through JAK-1 receptor blockage.

In addition to its known inhibition of PDGF and all VEGF receptors.

In vitro data shows a meaningful reduction in IL-6 activity of more than 50% with Vorolanib, suggesting a multi-MOA capability. This data may explain the rapid fluid reduction and vision improvements observed as early as week four in the DURAVYU arms in the phase 2 VERONA trial.

In summary, we are well positioned to extend our clinical leadership and sustained release therapy for the two largest retinal disease markets. We remain focused on reporting top-line phase 3 data for both LUGANO and LUCIA starting mid next year, positioning DURAVYU to be the first to file and potentially first to market among all investigational sustained release programs in wet AMD.

Our phase 3 DME program is now underway, and we expect first patient dosed during the first quarter of 2026. We are moving swiftly and confidently to bring DURAVYU to patients in need while continuing to ensure our progress follows a de-risked, clinically rigorous, and patient-centric approach.

Before passing it over to George to review our financials, I want to thank the entire EyePoint team for your dedication to improving patients' lives through better vision, as well as the patients, study coordinators, and clinical investigators outside of our organization who enable our clinical research.

We are grateful for your confidence, and we are proud to advance our therapeutics for the benefit of the entire Retina community.

We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery.

I will now turn the call over to George. George.

Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our resources, ending the third quarter with $204 million in cash and investments.

As Jay mentioned, in October, we completed a $150 million follow-on financing plus the exercise of the underwriter's green shoe option on October 29, for a total of approximately $172 million in gross proceeds, adding to our cash position and enabling the execution of the phase 3 DME program.

We expect that cash and investments as of September 30, along with net proceeds of the financing will support our operations into the fourth quarter of 2027, well beyond key data readouts from the Phase 3 LUGANO and LUCIA pivotal trials anticipated in mid-2026.

As the results for the three months ended September 30, 2025, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter.

For the quarter ended September 30, 2025, total net revenue was $1 million compared to $10.5 million for the quarter ended September 30, 2024. This decrease was primarily driven by the recognition of deferred revenue related to the company's 2023 agreement for the license of unique product rights in the prior year period.

Operating expenses for the quarter ended September 30th, 2025, totaled $63 million compared to $43.3 million in the prior year period. This increase was primarily driven by clinical trial costs related to the ongoing phase 3 LUGANO and LUCIA clinical trials of DURAVYU for wet AMD.

Net non-operating income totaled $2.3 million and net loss was $59.7 million, or $0.85 per share, compared to a total net loss of $29.4 million or $0.54 per share in the prior year period.

As I noted earlier, cash and investments on September 30, 2025 totaled $204 million compared to $371 million as of December 31, 2024, which, along with net proceeds from the October financing, we expect will enable operations into Q4 2027.

In conclusion, we are very pleased with our progress and continued execution in 2025 and are well capitalized to deliver the review phase 3 wet AMD data in 2026 while advancing our Phase 3 DME program with the COMO and CAPRI clinical trials. I will now turn the call back over to Jay for closing remarks.

Thank you, George. As you've heard this morning, EyePoint is on the [cusp] of a milestone year in 2026.

Our decades of drug development experience, clinical track record, next generation technology, and blockbuster potential of our DURAVYU franchise underscore our exciting growth story.

With our strong balance sheet and disciplined cash management along with our thoughtful de-risk development strategy, we are prepared to execute through our key upcoming milestones, including.

Top-line data for the phase 3 LUGANO trial anticipated in mid 2026 with LUCIA data to closely follow positioning us for a potential NDA submission for the review in wet AMD.

And the first patient dosing on our pivotal phase 3 DME program anticipated in Q1 2026 with full enrollment expected in the second half of 2026.

Thank you all for your attention this morning. I will now turn the call over to the operator for your questions.

(Operator Instructions)

Tessa Romero, JPMorgan.

Go ahead.

Thank you. Good morning, Jay and team.

I wanted to ask a marketing, market sizing question today. Can you just refresh us for the wet AMD population overall here in the US? What percent of patients are treated every four weeks, every six weeks, every eight weeks, or longer?

And what is your latest view on how the doctors will use DURAVYU if available in that context?

Good morning, Tessa. Thanks for the question. It is insightful and as you may surmise, the data is not strong to give exact numbers for each of those intervals. What we do know is approximately 20% of wet AMD patients have to be treated monthly regardless of the drug that they're using.

If you look at the clinical trial data, even with the newer extended duration agents, 50% of the eyes can't go longer than every eight weeks. Depending on a doctor's toleration for fluid, some patients can certainly go three and four months, in between injections.

But again, it's individualized to the patient and oftentimes individualized to the doctor's tolerance of fluid. And [adherence] to the label. So, I don't off the top of my head have exact numbers to give you for those other percentages, and I'll pause and see if, Ramiro has any other insight.

Yeah, no thanks for the question. I think when we think about the DURAVYU.

In our phase 2 data, we showed that after dosing due review, about 65% of patients do not require any supplement injection with anti-VEGF. And even when we look at 0 or 1 injection over that six-month period, then the number is about 90%.

So we believe that review is really well positioned. If we see the results in the phase 3 study being replicated to be in the market for [vitamD] patients.

And to answer the second part of your question, Tessa, I don't think you can look at it as an either or, meaning if the review is approved, doctors will be limited to just using one agent. We're a different MOA and clearly the more recent data with IL-6 inhibition suggests that we may offer an MOA that the ligand blockers cannot.

That would open up the market tremendously to us. And as Ramiro just explained, physicians, I'm sure, would be willing to take advantage of two MOAs. We do that in chronic diseases all the time. And therefore, the market share for DURAVYU, when you, speak to some of the KOLs on the podium even recently have said up to 80% of their patients would be eligible.

So we're really optimistic that, the acceptance of a multi-MOA TKI with sustained release in both wet AMD and DME is going to be hIgh.

Great. Thanks so much.

Yigal Nochomovitz, Citi.

Hey, this is Jhon Kim on for you to go. Thanks for taking our question. Regarding DME, can you provide any additional color on how you're structuring your enrollment criteria to provide the broadest reach in the DME marketplace relative autistic competitors in the long-acting [TTI] space?

Sure, I'll let Romero answer that question. Thank you very much for it. And again, I can quickly answer the second part of the question. We're the only TKI sustained release, that has a DME program, so that part's easy, but Ramiro, why don't you talk a little bit about how we've designed the trial.

Yeah, so first you give an overview on our phase 3 DME program, common copy. So we are going to be enrolling patients with active DME both treatment naive and previously treated.

As a control arm, we're going to use a fibersap own label, and then do review is going to be being dosed every six months.

We are very fortunate to have a strong infrastructure here at EyePoint as we conducted our wet AMD study. We have also a very strong relationship with investigators. So for our DME program, we're going to be able to leverage those strengths into a, hopefully rapid enrollment for the DME program.

I think it's our understanding that we might be the only phase 3 program enrolling patients next year for this indication. So again, I think we expect to see a rapid enrollment, similar strength as we did for the web enrollment program.

And regarding enrollment, just for clarification, I believe I heard you say second half '26. Is that for both COMA and CAPRI?

So I think what we're guiding now is that both studies are going to be starting Q1 of next year, 2026.

Tyler Van Bure, TD Cowan.

Hi, this is Sam, on for Tyler. Thanks for taking our question. I wanted to ask about the use of the blended endpoint which you guys have remained consistent on with the pivotal wet AMD and DME trials. We've seen the FDA green light a single endpoint more recently, so curious, if you thought about using a single endpoint at all for the DME studies and why you believe the blended endpoint is the best approach. Thanks.

Thanks, Sam. I appreciate the question, and I'll let Ramiro go into the details, but, to answer quite simply, did you, think about a single endpoint? Quick answer is no.

Ramiro, why don't you, talk a little bit about our interactions with the FDA over endpoint and why the blended endpoint is actually de-risking.

Yeah, and thanks, Sam, for the question. So for both our wet AMD program and our DME program, we are using blended endpoint. Meaning that for the primary endpoint, we're counting two visits.

The benefit of that is that we prevent missing data. So in this type of study, it's not uncommon to see patients missing the visit because they have medical appointments or they're in the hospital for some systemic disease. So by having two visits, we reduce the amount of missing data.

And also very important, if a patient has for any reason, a loss in vision in one of the visits, it has the ability to capture the recovery of that vision in the next visit.

The use of blended endpoint has been common in clinical trials for retinal disease for the past few years, with the main goal of decreasing the variability and increasing the power of the study.

And that's why we feel confident on using the blended endpoints for both wet AMD and DME. And of course, we have the green light from the FDA to do so.

Clara Dong, Jeffries.

Hi, good morning. Thanks for taking our questions. This is Jenna for Clara. Could you talk about the, differentiation in IL-6 inhibition? And could you help us kind of elaborate on how that could translate into clinical benefit in DME, versus an, anti-VEGF only approach?

Thanks for the question, Jenna, and this is really timely, because you may be aware, there's some recent data from Genentech, who used an IL-6 blocker in a DME trial combined with an anti-VEGF.

Both were delivered monthly, and the armed with the IL-6 blocker, along with the anti-VEGF had better vision. It's early as week four and sustained through the trial, we were able to show a very similar vision improvement and course of improvement in our VERONA trial, using just two injections over six months as opposed to 12 injections over six months. And when we looked into it, more closely, we discovered that in fact Vorolanib is. A potent inhibitor of IL-6 pathway by blocking the JAK-1 receptor.

There's substantial evidence in both wet AMD and DME that IL-6 plays a pathogenic role, especially in eyes that are not responding, and therefore the ability to block both VEGF pathway and inflammatory IL-6 pathway could be it could be a significant improvement over what we have now, especially, coupled with sustained release so that you're not having to give two biologics on a monthly basis.

Yatin Suneja, Guggenheim.

Hey guys, thank you for taking my question. Maybe two questions for me. One is on the mechanism regarding the IL-6. Jay, if you can comment on, the relevance of it, in one disease versus the other, do you think there is more relevance in DME versus, AMD? So that's one.

And then the second question is, now more around the expectation now that the studies, wet AMD expectations right now the studies are enrolled. I think our investors are sort of, beginning to think about what we should be expecting from the data, and I think that is focused on three things. One is the, [BCVA] and non-inferiority, what sort of injection burden you can, produce, and how should we think about rescue rate. So if you can comment on that, that'd be very helpful.

Thank you.

Thanks, and two great questions. Let me start with, the IL-6 question. IL-6 has been implicated in inflammatory macular edema for well over a decade, and additional data suggests that IL-6 levels in the vitreous are much higher in DME patients than in diabetics with no, diabetic retinopathy.

In addition, there's data that suggests high IL-6 levels in aqueous humor portend a worse outcome in both DME and wet AMD.

So overall, the evidence for an role of IL-6 as an inflammatory pathway in DME is very strong, and while it's there in wet AMD as well, it appears to be a prognostic factor in the percentage of eyes that aren't doing well with VEGF blockage alone.

We believe that, if the pre-clinical data, we have shown, and the rapid and early and sustained response in our VERONA DME trial can be shown in phase 3, this would be an exceptional result, which would put us at the forefront of both wet AMD and DMB therapies.

As for the clinical trial results, which we expect again, the first trial LUGANO mid next year, second trial LUCIA soon to follow, based on our strong phase two data, we would expect non-inferiority to the on-label aflibercept control with continued safety.

Safety and again safety is of paramount importance here as, I'm sure you all know, but based on the ongoing mask safety that we've seen in these two phase 3 trials as well as the extensive safety database we have for both DURAVYU and Vorolanib, we're confident that the safety will be, is, will be quite good.

As for reduction in treatment burden again, that's important. There's no specific cutoff that says it has to be above or below a certain level and based on our discussions with KOLs and the design of the trials, we think a 50% reduction in treatment burden will, again put us into the forefront of, therapies for wet AMD.

Debanjana Chatterjee, Jones.

Hi, thanks for taking my question and congrats on all the progress. So assuming LUGANO and LUCIA meets its, -- their non-inferiority endpoint, does your statistical analysis plan allow for testing superiority? And if so, how do you expect clinicians to interpret those data related to on-label aflibercept compared to potential competitors pursuing superiority claims, based on, like, less frequent dosing?

So Ramiro, why don't you answer that? Thanks, Debanjana. I appreciate the question.

Yeah, thanks for the great question. So our, as you mentioned -- our analysis plan this allow for testing superiority again, the aflibercept, if our non-inferiority is met. So it's a hierarchical test. So we have the ability to test for that.

Of course, if we see that the DURAVYU produce superior visual outcomes compared to on-label aflibercept, then, of course, I think it would be an outstanding result for the retina community and wet AMD patients and it would allow us to position to review as a premium medication.

Of course, having a superiority claim against on-label aflibercept, I think from a retina special perspective, is much more relevant than having superiority versus a single dose of aflibercept.

So we are, we continue to be optimistic with our LUGANA LUCIA study. We were very fortunate to have the [W-2 or phase] to study to support, the design of the phase 3 programs. A lot of the learnings coming from there and we're looking forward to see the results mid next year.

Thank you.

This concludes the question-and-answer session. I will now turn it over to Jay Duker for closing remarks.

Thanks very much. Before we close, I do want to mention a tremendous honor that EyePoint received this week. We were voted a 2026 Best Places to Work by Biospace. In fact, we were in the Top Five best biotech companies nationally. This is a testament to the incredible team and culture we built here at EyePoint.

Exceptional execution does not come in a vacuum. I want to thank all of our amazing team for this honor, but especially our Human Resources Group led by our Chief People Officer Jennifer Leonard.

Thank you all for your time and attention this morning.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.