EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) Q1 2025 Earnings Call Transcript

EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) Q1 2025 Earnings Call Transcript May 7, 2025

EyePoint Pharmaceuticals, Inc. reports earnings inline with expectations. Reported EPS is $-0.65 EPS, expectations were $-0.65.

Operator: Good morning. My name is Towanda and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint First Quarter 2025 Financial Results and Recent Corporate Developments Conference Call. There will be a question-and-answer session to follow at the completion of the prepared remarks. 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. Sir, you may begin.

George Elston: Thank you. And thank you all for joining us on today’s conference call to discuss EyePoint’s first quarter 2025 financial results and 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 the ongoing clinical trials for DURAVYU. I will close with commentary on the first quarter of 2025 financial results and we will then open the call for your questions. Earlier this morning we issued a press release detailing our financial results and recent corporate developments. A copy of the 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.

Jay Duker: Thank you, George. Good morning, everyone, and thank you for joining us. We are proud to report yet another quarter of exceptional execution as we advance our lead program, DURAVYU, through late-stage clinical development. Notably, we continue to receive strong positive feedback from both physicians and patients for our ongoing global Phase 3 trials, LUGANO and LUCIA for DURAVYU in wet age-related macular degeneration or wet AMD, underscoring the impressive enrollment rate we are seeing. In fact, as we reported in this morning’s press release, we have randomized over 90% of patients into the, LUGANO trial and over 50% into the LUCIA trial. This gives us great confidence that we will meet our time line to complete enrollment in the second half of 2025 and deepens our conviction that DURAVYU is on track to be the first to market of the current investigational sustained release treatments for wet AMD.

We believe this clinical momentum highlights the significant opportunity for DURAVYU as a differentiated treatment option in treating retinal disease. Our team is committed to our goal of delivering life-changing treatments to patients with severe retinal diseases, beginning with wet AMD. I want to take a moment to review why we believe DURAVYU is a best-in-class program and represents a compelling and strategically derisked opportunity in wet AMD. First, DURAVYU is not another anti-VEGF program. DURAVYU is a clinically validated, differentiated and potentially best-in-class sustained release TKI. DURAVYU’s receptor level inhibition of VEGF blocking all isoforms of VEGF offers a broader and possibly more durable disease control compared to current ligand blocking therapeutics.

By also blocking PDGF receptors, DURAVYU may help reduce fibrosis, a key driver of long-term visual loss, which could further differentiate this potential wet AMD therapy. Next, DURAVYU’s efficacy is supported by our Phase I and Phase II data sets, which are the most robust investigational data sets in wet AMD amongst all sustained delivery programs. In our Phase II DAVIO 2 trial in wet AMD in a tough-to-treat population, approximately 2/3 of patients remained rescue-free for six months and nearly half remained rescue-free for one year with stable vision and anatomy from a single DURAVYU treatment. DURAVYU has established a very favorable safety profile with no DURAVYU -related ocular or systemic SAEs observed in over 190 patients evaluated across clinical trials for multiple indications.

Additionally, there are also four FDA-approved products using our Durasert technology administered to tens of thousands of patients in real-world settings with a strong safety record. Our Phase III non-inferiority program was developed in direct alignment with the FDA follows recognized industry best practices and is strategically designed to enhance the probability of both regulatory and commercial success. And finally, DURAVYU has the potential to address a large unmet need in an established and growing multibillion-dollar market where patients are actively seeking safe, durable, longer-acting treatments. I want to also highlight our excitement around the potential for DURAVYU in diabetic macular edema or DME. While our company is currently focused on the execution of our wet AMD Phase III program, our recently reported positive 24-week Phase II results in DME further validates both the mechanism of action of vorolanib and the commercial potential of our Durasert E technology across multiple large retinal disease markets.

Turning to wet AMD. Our goal in the Phase III trials is to demonstrate that DURAVYU can maintain stable vision and retinal anatomy for the majority of wet AMD patients with an every six-month dosing schedule. This would represent a significant improvement compared to the current anti-VEGF treatments in the US that are dosed on average every two months. From a clinical perspective, this would provide patients and practitioners with the flexibility to reduce the number of visits without sacrificing visual outcomes and would ensure compliance over that six-month interval. Since initiating our Phase III trials, we’ve seen remarkable patient and physician interest. Supporting the life-altering potential of DURAVYU, I’m pleased that both the LUGANO and LUCIA trials continue to meaningfully surpass our enrollment expectations with patient randomization in excess of 90% for the LUGANO trial and over 50% for the LUCIA trial.

These enrollment rates significantly exceed those observed in comparable historic and other ongoing wet AMD trials, which we believe is driven by DURAVYU’s robust clinical data package, including an outstanding safety profile and established efficacy demonstrated in the robust DAVIO 2 Phase 2 trial. This also highlights the significant need for more durable treatment options. The continued support and enthusiasm for DURAVYU from the retinal community not only reinforces our expected enrollment completion in both pivotal trials in the second half of this year, but also reaffirms our confidence in our de-risked trial design. Our global double-masked identical trials reflect a tried and true non-inferiority design used in the last four wet AMD drug approvals.

There are several key reasons why we believe our well-powered rigorously controlled program is structured to produce data that support approval and are meaningful for retinal specialists and patients. First, the Lugano and Lucia trials were specifically designed for regulatory and commercial success. Our trial design was informed by a robust Phase 2 trial and multiple FDA interactions with written agreement from the agency on our path to approval. Second, our trials incorporate a fixed prespecified every six-month dosing for DURAVYU, a clean, predictable design that mirrors intended real-world use and that provides a clear regulatory pathway. Learning from our Phase 2, supplemental injections are only permitted if a patient meets strict predefined criteria and are adjudicated in a masked manner to minimize variability and bias.

Our disciplined protocol is aimed at eliminating physician discretion in unnecessary supplemental treatments. Finally, the inclusion of both treatment-naive and previously treated patients enhances the broad applicability of our data and can support not just approval but increased physician adoption and a potentially broader label. As we continue to execute in the clinic, we are also laying the foundation for a potential commercial launch with our state-of-the-art GMP-compliant manufacturing facility in Northbridge, Massachusetts. Our facility is operational and will be capable of producing more than 1 million DURAVYU treatments annually to support expected global demand. Importantly, we are well-positioned with regard to potential tariff impacts as we also source our API from a U.S.-based manufacturer.

Turning to our DME program. DURAVYU met the trial’s primary and secondary endpoints for our Phase 2 VERONA trial, demonstrating compelling efficacy and durability results. DURAVYU is the only sustained-release TKI program with demonstrated activity and safety in DME. DME is the second largest retinal disease indication, representing a $3 billion market opportunity by 2030. We believe DURAVYU is uniquely positioned to potentially extend the therapeutic dosing interval compared to currently available treatment options. To recap the VERONA results, both DURAVYU doses met the primary endpoint of longer time to first supplement versus the aflibercept control. DURAVYU 2.7 milligrams demonstrated an early, sustained and clinically meaningful improvement in best corrected visual acuity, or BCVA, with a gain of 7.1 letters compared to the baseline and a central subfield thickness, or CST, improvement of 76 microns on OCT measurement.

This represented a 75% more drying effect versus the aflibercept control. Immediate bioavailability of the drug was demonstrated from the visual and anatomic gains observed as early as week four and were much more robust than those achieved in the aflibercept control eyes at this time point. A subset of unsupplemented patients further supported the robust results for the DURAVYU arms. These highly positive Phase 2 data will be critical in our planned engagement with the FDA this summer to solidify plans for a pivotal program. In summary, our identical pivotal Phase 3 LUGANO and LUCIA trials in wet AMD are exceeding expectations and remain on track to complete enrollment in the second half of this year with top-line data for both trials in the second half of 2026.

The positive safety and efficacy data from the Phase 2 VERONA trial in DME further strengthens DURAVYU’s profile as a potentially paradigm-shifting treatment option and positions DURAVYU to become a potential multibillion-dollar blockbuster franchise in the two largest retinal diseases. Finally, thank you to the entire EyePoint team for another strong quarter and for your unwavering commitment to our collective goal of improving patients’ lives through better vision. Outside of our organization, it’s been humbling to see such high levels of engagement from the patients and clinical investigators eager to participate in our ongoing trials. We deeply appreciate your confidence in us, and we’re proud to advance our therapeutics for the benefit of the entire retina community.

With our best-in-class sustained ocular delivery technology and promising clinical pipeline across multiple blockbuster indications, we look forward to continued progress towards our upcoming milestones as the leader in sustained ocular drug delivery. I will now turn the call over to George to review the financials. George?

George Elston: Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our resources, ending the first quarter with $318.2 million in cash and investments. We affirm previous guidance and expect this cash will support our operations into 2027 beyond key data readouts from our Phase 3 LUGANO and LUCIA pivotal trials next year. As the financial results for the three months ended March 31, 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 March 31, 2025, total net revenue was $24.5 million compared to $11.7 million for the quarter ended March 31, 2024. Net product revenue for the quarter ended March 31, 2025, was $0.7 million, consistent with the quarter ended March 31, 2024.

We expect net product revenue to continue at immaterial levels as we will no longer be supplying YUTIQ to ANI Pharmaceuticals, our U.S. partner, after May 31, 2025. Consistent with our strategy, our manufacturing focus forward is on our DURAVYU program to support clinical trials, a potential NDA filing and future commercial launch. Net revenue from royalties and collaborations for the quarter ended March 31, 2025, totaled $23.7 million compared to $11 million in the corresponding period in 2024. The increase was primarily driven by recognition of remaining deferred revenue from the out-license of YUTIQ US rights in 2023. Operating expenses for the quarter ended March 31, 2025, totaled $73.3 million compared to $45 million in the prior year period.

This increase was primarily driven by the ongoing LUGANO and LUCIA Phase 3 trials for DURAVYU in wet AMD as enrollment is tracking ahead of expectations. Net non-operating income totaled $3.6 million and net loss was $45.2 million or $0.65 per share, compared to a net loss of $29.3 million or $0.55 per share for the prior year period. As I noted earlier, cash, cash equivalents and investments in marketable securities on March 31, 2025, totaled $318.2 million, compared to $371 million as of December 31, 2024. In conclusion, we are incredibly pleased with EyePoint’s progress so far in 2025 and remain well-capitalized to deliver DURAVYU Phase 3 data in 2026. I will now turn the call back over to Jay for closing remarks.

Jay Duker: Thank you, George. As outlined this morning, we ended the first quarter in an excellent position and remain committed to advancing DURAVYU, a best-in-class program across multiple indications in retinal disease. We believe EyePoint represents a significant investment opportunity that is meaningfully derisked both clinically and financially. Our strong balance sheet will enable us to execute on our upcoming clinical milestones, which include enrollment completion in the Phase 3 LUGANO and LUCIA trials in wet AMD expected in the second half of 2025, top line data for these trials anticipated in 2026, and an end of Phase 2 meeting with the FDA around a pivotal trial in DME this summer. To close, 2025 is off to a great start for EyePoint.

The progress we’ve achieved to date underscores our dedication to advancing our pipeline and delivering innovative treatments to improve the lives of patients suffering from serious retinal diseases. We’re very excited to continue our momentum and look forward to providing additional updates in the coming quarters. Thank you all very much for your attention this morning. I will now turn the call back over to the operator for your questions.

Operator: Thank you. [Operator Instructions]

Jay Duker: And before we start with the Q&A, I would like to reiterate a few points that we just made. At EyePoint, we’re completely focused on the execution of our pivotal Phase 3 wet AMD trials, LUGANO and LUCIA and the preparation for our NDA filing, which includes manufacturing of registration batches in our Northbridge, Massachusetts commercial facility. Based on our terrific Phase 2 DURAVYU 2 data, the rapid enrollment in our Phase 3 trials and the continued clean safety profile for DURAVYU, we are confident in the value creation that successful LUGANO and LUCIA results will produce. With respect to strategy, we are focused on value creation for our current shareholders, while advancing DURAVYU through Phase 3 trials. This means good stewardship of our cash, while maximizing the value of DURAVU. We’re now happy to take some questions.

Q&A Session

Operator: Thank you. Our first question comes from the line of Jennifer Kim with Cantor. Your line is open.

Jennifer Kim: Hi, good morning. Congrats on the progress, and thanks for taking our question. Maybe to start off, I understand that you’ve reiterated guidance to complete Phase 3 enrollment in the second half of this year. But just looking at the pace of enrollment here, it seems like you guys are well on track to complete enrollment maybe earlier than investors appreciate. Am I thinking about this the right way? Or can you help us walk us through the math here?

Jay Duker: Hey, good morning, Jennifer and thanks for the question. We are still guiding to full enrollment in both trials in the second half of this year. But yes, if you look at the public statements we’ve made around enrollment and kind of draw a line through the data points, we could certainly potentially have completion of enrollment in the first trial, LUGANO in the second quarter of this year. That remains to be seen. You may know that the start of the LUCIA trial was approximately two months or so after LUGANO, and we would expect that the LUCIA results will come in approximately two months after LUGANO as well.

Q – Jennifer Kim: Okay. That’s helpful. And if I could sneak in one more question, just because DME underappreciated opportunity. Can you just remind us what you’re looking for in your upcoming meeting with the FDA and just some comments on, I guess, timing and potential outcomes? Thanks.

Jay Duker: Sure. We have our Chief Medical Officer, Ramiro Ribeiro, on the line also. Ramiro, do you want to talk a little bit about the upcoming end of Phase 2 meeting with the FDA over DME?

Ramiro Ribeiro: Sure. Hey, Jennifer. So we are going to be proposing a clinical plan, meaning a Phase 3 study that brings efficiency to our program. So we are going to propose one single study comparing our drug to standard of care. And the primary endpoint is going to be as expected for DME trial, BCVA. We’re planning to have the meeting with the FDA soon, as Jay mentioned, and we have that by the summer.

Q – Jennifer Kim: Thanks again, guys.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Tessa Romero with JPMorgan. Your line is open.

Q – Tessa Romero: Hey, Jay and team. Thanks so much for taking our question this morning. Big picture, so what do you attribute the rapid pace of enrollment here in your Phase 3 wet AMD trials? Anything anecdotally you can tell us on what you are hearing from your clinical sites? And secondly, where are you most focused in terms of clinical trial execution in terms of mitigating any risks? Thanks so much.

Jay Duker: Terrific questions, Tess. Thank you very much for them. And again, I’m going to attribute most of our success in the rapid enrollment to Ramiro and his team. And I’m going to let him again answer that question on why it is that we’re rapidly enrolling as well as what he and his team are focusing on to make sure our results are sound.

Ramiro Ribeiro: Yes, Tess, thanks for the question. So I think the number one feedback we get from investigators is that our study is patient-centric, is easy to follow. And the robust data that we have from Phase 2 study as well as our Phase 1 program give them confidence when they are discussing to a patient and potentially offering participation in the study. Of course, we do a lot of things to make the study easy foresights and patients. But the most important part is the robust data that we have that give confidence to investigators and patients. I think we are doing an excellent job identifying any potential risk in our Phase 3 program on the conduct of the study. So we look at all areas to ensure the integrity of the data is pristine, so that it can be efficient on our NDA submission.

Q – Tessa Romero: Thank you.

Operator: Thank you. Please, stand-by for our next question. Our next question comes from the line of Tyler Van Buren with TD Cowen. Your line is open.

Tyler Van Buren: Hey, guys. Good morning. The enrollment progress is very, very impressive. So with the increased time lines to enrollment completion in the LUGANO and LUCIA trials, does it make sense to potentially run a small Phase 2 study in RVO, considering that it is a significant additional opportunity in part of the market beyond wet AMD and DME. Is there any way that you could do this in a cost-efficient manner as we wait for the Phase 3 data?

Jay Duker: Yes. Hi, Tyler, thanks for the question. And it is really something that we’ve thought about really more in the long-term of how we can create more value around DURAVYU and what are the other potential add-on indications. RVO is certainly one of them. But as I stated in my comments, we are really focused on wet AMD right now and on our cash runway after data. And so the value that we would get at this point from an RVO trial probably is not something that would suggest to us that it’s a pathway we would take right now. With the anticipation of — and the hope of good data, great data from our Phase 3 program, I’m sure you’ll see expansion into other areas for which DURAVYU might be beneficial, such as RVO. And I think there are some areas which you could certainly think about other expansion of the market, too.

For example, we think with the growing number of high myopes in the world that myopic corneal vascularization would be another area that DURAVYU would do very well in. So yes, this is part of the longer-term program, but I don’t think we’re going to see it in the short-term.

Operator: Thank you. Please, stand-by for our next question. Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja: Hey, guys. Thank you for taking my question. Maybe just a quick one for me. Are you able to comment on the screen failure rate for both studies? Also the type of patient or the mix of patient naive versus VEGF exposed patients that you are able to enroll? And anything you are able to comment on the safety side, at least on the blinded basis, given that one study is almost complete from an enrollment perspective? Thank you.

Jay Duker: Thanks, Yatin. Nice to hear from you again. With respect to screen failure rates, what I can say is historically, screen failure rates in wet AMD are approximately 50%, and we’re doing a little bit better than that in both trials. And there’s always some learning. The screen failure rates at the beginning of the trial tend to be a little higher. And as the doctors understand exactly what type of patient meets the criteria, the screen failure rates do go down, and we’re seeing that in both trials. With respect to the mix of naive versus previously treated, we’re going for approximately 75% naive, 25% previously treated. And given the reality that previously treated patients are already in the doctor’s practices and can be identified ahead of time, we anticipated at the beginning of both trials, most of the enrolled patients would be previously treated.

And that’s, in fact, what we saw. And early on in both trials, we capped the number of patients who were previously treated, we capped the enrollments, so that from now in both trials, we’re just recruiting naive patients. And this is again to be expected. What we’ve been very surprised about is, we expected that the rapid enrollment seen early on with the allowance of previously treated patients would slow down once we cap them, and we didn’t see that. What’s been remarkable is that in both trials, the enrollment rates have been very high and very steady. As for release of masked data, we really aren’t thinking about doing that right now. I think we might do that in the future. Certainly, things like mask data around demographics of the patients would not be something that would compromise the registrational trials by introducing any operational bias or the ability to have a well-controlled trial.

But we’re certainly not going to disclose things piecemeal, and we’re certainly not going to disclose any masked Phase III results just because of the risk of compromising the data and introducing operational bias. So with respect to safety, what I can say in general is that based on our public statements prior, the safety of DURAVYU has been very, very good.

Yatin Suneja: Excellent. Thank you.

Operator: Thank you. Our next question comes from the line of Kambiz Yazdi with Jefferies. Your line is open.

Kambiz Yazdi: Thank you so much for the questions. A couple for me. How should we model R&D going forward? And then separately, I was curious if you’d be so kind as to provide your perspective on how biosimilars are shaping the wet AMD market. Would you consider a biosimilar aflibercept loading in a post-marketing study for DURAVYU? It’s obviously not at all a focus for you right now, but I’m curious on your perspective if there could be any value in exploring that. Thank you.

Ramiro Ribeiro: Thanks, Kambiz. Appreciate the questions. Let me take the second one first, and then I’ll ask George to comment on R&D costs going forward. First of all, we’re agnostic to the biosimilar market, whether a doctor — if and when we get approval with an every 6-month dosing interval, what the doctor chooses to load with before the use of DURAVYU, we’re really agnostic to that. We have no reason to believe that a biosimilar aflibercept would behave any differently than any — than on label aflibercept. The rest of it, with respect to any other loading of an anti-VEGF, whether it’s off-label Avastin, Lucentis, Vabysmo, the 3 monthly doses, you wouldn’t expect a patient to respond any differently to any of them over those first three months.

So if you look at all of the curves of all the approved drugs and look at the first 3 months, they’re really quite similar in their visual acuity improvement in the OCT improvement. So as a general rule, we wouldn’t think the choice of a ligand blocker for the load would make any difference. George, do you want to go ahead and talk about anticipated R&D costs?

George Elston: Sure. And Kambiz, thanks for the question. As I noted on the call, our R&D burn is up year-over-year, but that’s really driven by the exceptional recruitment we’ve seen. And part two of that is our cash guidance is unchanged. So if you think about R&D in 2025, your prior year — or your current model is probably correct for the full year, but we just spent more in Q1 because the trials are going so well. So I think full year is probably the same, just move some of that burn you may have in Q2 and Q3 up a little bit.

Kambiz Yazdi: Great. Thank you so much.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open.

Unidentified Analyst: Hi, all. This is Sam on for Greg. Thank you for taking our question. Maybe a couple for me. Has the recent shortages at co-pay assistance programs that we’ve been hearing from retinal disease companies impacting the enrollment in your studies in any way? And also as it relates to enrollment, can you point to anything specific in terms of either trial design or differentiating factors that one would choose enrolling in your studies versus that of your competitors? Thank you.

Jay Duker: Thanks for the question, Sam. And they are good timing of the questions and really topical. So that co-pay assistance program that Sam mentioned is called the — good Days program. And it was funded to allow for co-pays for patients who were not totally covered for their branded either wet AMD drug or GA drug. for reasons that I’m not sure have been totally made public, but the companies that have funded good days in the past chose not to fund it so far in 2025. What this means is that patients who have the onset of wet AMD and do not have secondary coverage or coverage for the co-pays and want to be treated with a branded drug could have significant out-of-pocket costs. We expect that this is helping our enrollment because, obviously, we would offer no charge, the drugs in our study.

So that the lack of the good days program, I’m sure, is lifting all boats here, and I would expect that all of the wet AMD trials would benefit from that. As for specifics around why doctors are choosing our trial, we believe, first to a large degree. Again, I’d like to defer to Romero about anything specific that his interactions with our investigators and the investigational sites are telling them about this.

Ramiro Ribeiro: Yes. Thanks for the question, Sam. As I mentioned, the number one feedback we get from site is the fact that we have run a robust large Phase 2 study. And that provides them confidence on the data, on the efficacy data, but most important, on the safety data that gives them comfort on offering this study to a patient, knowing that we have dosed over 190 patients with DURAVYU. And then after that, things like being a study that is very patient-centric. So every patient is treated in this study, either with aflibercept or with our investigational drug. How easy it is to conduct the study. It’s not too burdensome to patients and physicians. And great support that EyePoint is providing to sites via our Clinical Operations team as well as our Medical Affairs team.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Nick Quartapella with Baird. Your line is open.

Nick Quartapella: Hi everyone. This is Nick on for Colleen. Thanks for taking my question and congrats on the progress again. I just want to get a little more color on, how the FDA views the impact of rescues on the primary endpoint for wet AMD. I was wondering if there’s a number on how many rescues are allowed. And is there a certain window where rescues are not allowed, for example, within a number of weeks before — within the primary endpoint? Thanks.

George Elston: Thanks for the questions, Nick. First of all, our interactions with the FDA around rescues have been consistent. They have not, at any of the interactions, either at our Type C meeting in 2022 or the End-of-Phase 2 meeting in 2024, suggested that there was a number of rescues by which a patient would be eliminated from the trial per se. What does that mean? Well, this is an intent-to-treat study; the top-line data will be from all patients. And then sensitivity analysis will be applied to the patients who got supplemented or rescued. And remember, in our trial, the control aflibercept arm can also be rescued. So there will also be a calculation of the rescues compared in each arm. With respect to timing of rescues, that was not something that was ever brought up at either of our meetings.

And there’s nothing in writing that we’ve received from the FDA about weighting the timing of a rescue or that a patient who got rescued at a certain point in the study would be eliminated from the study. That’s not something that the FDA has brought up with us.

Nick Quartapella: Thank you, teams.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Deb Chatterjee with Jones. Your line is open.

Deb Chatterjee: Hi. Thanks for taking my question. So I have another follow-up on the biosimilars. So based on your KOL interactions, especially, let’s say, at ARVO to what extent do you see Amgen’s “Paglu” impacting the wet AMD commercial landscape? And maybe could you comment on the potential for price erosion and any implications for DURAVYU?

George Elston: Well, thanks for the question. And there’s something, obviously, that we’ve been thinking about and projecting. It’s hard for me to answer the question about how the biosimilars will impact the market in general. Once again, with respect to DURAVYU, we don’t believe they’ll have any impact on DURAVYU’s acceptance because we’re a different MOA, different target, and we last six months or longer with a single injection — something that none of the biosimilars can do. Right now, the last data I saw was that the biosimilar market was still quite small in the United States. I think it’s running about 5% of the usage. And much of it, again, is driven by economics — economics either to the payer or to the physician practice.

So I think, in order to try to project out how biosimilars are going to be adopted, I think you have to take a look at the economics of them, and that’s just a general statement that really, again, has nothing in particular to do with our drug. Pricing is something that we’re thinking about and that we’re working through. And again, George, if you want to make a comment at a high level how we’re viewing pricing and whether we think biosimilars will impact that at all, happy to have you comment.

George Elston : Yes. And thank you for those questions. I think going back to what Jay said during the call is DURAVYU is not another anti-VEGF. And as you — as our team thinks about approaching it in the marketplace, we’re bringing something very different. We’re not another ligand blocker. We’re bringing sustained delivery, new MOA, and that’s going to be a very important part of our negotiation, not just with FDA, but ultimately with payers. And so just broadly speaking, as we — and if you look at the trial design for DURAVYU, DURAVYU replaces 3 anti-VEGFs. And so as you think about your pricing models, that’s a good place to start.

Deb Chatterjee: Okay. Great. That’s very helpful. Thank you.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Greg Harrison with Scotiabank. Your line is open.

Unidentified Analyst : Hi, everyone. Thank you for taking our questions. This is Joe on for Greg. Just thinking to the future a little bit here, assuming LUGANO and LUCIA will read out at different rates, is there a potential for a rolling NDA submission? And how might that impact your top line data release strategy in the second half of ’26? Thank you.

Jay Duker : Thanks for the questions, Joe. The NDA submission is really the rate-limiting step is last visit, last patient in of the second trial, in our case, the LUCIA trial. From a rolling perspective, there’s an internal rolling that we’re doing already, which is preparing the various documents in the various sections that we already have. And we will fully expect to just as the data comes in from the two trials, drop the data into the documents so that we can shorten the time between last patient in top line results and actual NDA submission. Romero, again, is really deep into this, and I’ll ask him to make any other comments about steps that we’re taking to minimize that time between last patient, last visit and submission.

Ramiro Ribeiro : Thanks, Jay. So as Jay mentioned, the limitation factor for the full submission is going to be the last patient on the second study. However, since LUGANO is enrolling quite faster, we might have a good opportunity to accelerate things, especially interpretation of the results on the first study. And because the two studies are so similar, that would certainly bring efficiency when we are doing things for the second study, meaning that there’s a lot of analysis, interpretation, writing that needs to happen. If we do that for the first study, again, because the second study is identical, we’ll certainly bring efficiency when we do that again for the second.

Unidentified Analyst : Perfect. Thank you so much.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Yale Jen with Laidlaw & Company.

Yale Jen : Thanks for taking the question. Just actually a follow-up on the previous one to get some color, which is when you do the data release next year, would that twodata — would that be sort of roughly two months apart for each of those or you have other plans?

Jay Duker: Good morning, Yale. Thanks for the question. Well, approximately two months, I think, is likely. We’ll know, obviously, when that last patient is enrolled in the first trial and then the last patient is enrolled in the second trial, the mathematics will be pretty easy at that point. Our plan, because we do expect them to be separated by several months, we will release the data as the data becomes available in each trial. But again, we anticipate it will be approximately two months apart based on the study start and based on the similar enrollment patterns that we’re seeing in both trials.

Yale Jen : Okay. Great. Thanks and congrats on the rapid enrollment.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Yi Chen with H.C. Wainwright. Your line is open.

Unidentified Analyst: Good morning. This is Eduardo [ph] on for you. Thanks for taking the question. I had a question regarding the baseline patient characteristics in the LUGANO and LUCIA trials. It seems like prior trials, you had BCVA letters between 35 and 85, and now it’s between 35 and 78. I’m just curious if you see what’s the rationale behind using that cutoff at 78 instead of 85 letters.

Amir Panush: Sure, Eduardo. Good question. And the answer to that is in the pivotal trials, I think the FDA has made it clear both historically and in the draft guidelines that you must enroll patients who have active wet AMD into your trials. And what does that mean? Well, they have to have imaging that shows that they have AMD and that they have an active choral neovascular membrane, and they have to have decreased vision and they have to have some fluid on OCT that is indicative of wet AMD fluid. So in order to have decreased vision, there’s a cutoff. And historically, I think if you go back to the other wet AMD trials, 78 letters is very typical for the best vision that is typically allowed into the study. So the quick answer to the question is you have to enroll patients with active wet AMD.

Unidentified Analyst: Got it. That’s really helpful. And maybe you mentioned this, but you reported a subgroup within the DME trial had the 10.3 letter improvement. I’m curious what are the attributes of that patient population and what fraction of the DME population share those attributes?

Amir Panush: Well, so that’s a really good question about what attributes show it. First of all, it was a subgroup of patients in the DME trial and the high dose, the 2.7 milligram dose, which is the dose we’re using in wet AMD and the presumed go-to-market dose. In that dose of the eyes that did not get rescued, they improved 10 letters. So, the implication being is when our drug works in DME and it seemed to work in the vast majority of those patients out of the 11, it seemed to work quite well in the majority, it works really, really well. Those patients who were not rescued had an immediate improvement in vision seen at four weeks. They had immediate reduction in their OCT seen at four weeks, and it was sustained in those eyes throughout the study.

In other words, at the tail end, near 24 weeks, the visual acuities weren’t dropping and the eyes weren’t getting more wet. And in fact, in that subgroup, they had about 120 microns improvement in their OCTs. So for that subgroup, it worked really well. Even though if you look at the patients who did get rescued, there was perhaps only one patient out of that group that you would say that really had active disease during the trial despite the use of our drug. So, the other eyes that got rescued got rescued because they didn’t have over 10% improvement in their OCTs, but they were still doing pretty well even at the time of rescue. So, be that as it may, it would be great to be able to identify those patients, which I think is what your question was getting at.

And because the end of the trial was relatively low, I don’t think we have enough data right now to state which of the patients who can go six months with great improvement and will not need a rescue. Hopefully, we hope, obviously, in the pivotal trials, we’ll be able to elucidate that so that the retina community can identify the patients who are going to do best with the drug.

Unidentified Analyst: Got it. That’s really helpful. Thanks so much.

Operator: Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open.

Yigal Nochomovitz: Yes, hi. Thank you. Can you just walk through the thinking as far as your views on potentially being first to file an NDA for the long-acting TKIs, given the strength of the enrollment curves that you’re seeing across your Phase 2 programs? Thank you.

Ramiro Ribeiro: Thanks for the question, Yigal. I think the first two file, we’ve talked a little bit about this. What is it dependent on? It’s dependent on last patient in, in your second pivotal trial. And we have great confidence given the enrollment rates that we’re seeing in our trials and the timing of the various trials of the other long-acting agents that are out there. We are quite confident that we will get last patient in our second trial before any of the competitors do. Given the length of the trial, 56 weeks, which is similar to what our competitors are doing and the fact that our eyes get randomized on day one, there’s no run-in before randomization. All of this gives us great confidence at this point that we will be first to file. And if approved, therefore, we will have the first-to-market advantage.

Yigal Nochomovitz: Okay. Thank you. And could you just review your positioning with respect to supply chain and IT? You may have talked about it at the beginning, but I may have missed it.

Jay Duker: So vis-à-vis supply chain and for the commercial product, once again, as we did talk about in the opening remarks, our API is manufactured in the United States, and our inserts are manufactured by us here in Massachusetts. The Phase 3 wet AMD inserts were manufactured in our facility in Watertown. We have built a state-of-the-art manufacturing facility in Northbridge, Massachusetts, which is about an hour west of Watertown. And in that facility, we are in the midst of making registration batches and preparing for FDA pre-market visits. And we’re confident that, that facility will be able to supply the entire global need for DURAVYU should we get approval. So from a supply chain perspective, we’re really in control of the supply to a very large degree.

And remember also, the vorolanib is a small molecule. It’s not a biologic. It’s not gene therapy. And as such, the manufacturing is relatively less expensive. And because our inserts only contain each 1.34 milligram of vorolanib, a batch or run of vorolanib can take us a very long way. So we are quite confident that our supply chain will be intact and that the tariff issues that some companies are facing, we think we are in good shape there.

Yigal Nochomovitz: Thank you very much.

Operator: Thank you. Ladies and gentlemen, I’m showing no further questions in the queue at this time. This does conclude your program. Thank you for participating in today’s conference. You may now disconnect. Everyone, have a great day.