Q1 2025 EyePoint Pharmaceuticals Inc Earnings Call
Thank you for watching!
Thanks for watching. Subscribe for more video. Please like and share. Have a great day. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye.
Tawanda: Good morning, my name is Suwanda, and I'll 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 development conference call.
Tawanda: 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.
Speaker Change: I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of Apprent. Sir, you may begin.
Speaker Change: 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.
Speaker Change: Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for Derivue. I will close with commentary on the first quarter 2025 financial results, and we will then open the call for your questions.
Speaker Change: Earlier this morning, we issued a press release detailing our financial results and recent corporate developments.
Speaker Change: 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.
Speaker Change: The potential success of our products and product candidates, financial projections in our plans and prospects.
Speaker Change: Actual results made different materially from those indicated by these forward looking statements.
Speaker Change: As a result of various important factors, including those discussed in the risk factor section of our most recent annual report on Form 10K, which is on file with the SEC, and in other filings that we have made or may make with the SEC in the future.
Speaker Change: 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.
Speaker Change: I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.
Speaker Change: Thank you George. Good morning everyone and thank you for joining us.
Speaker Change: We are proud to report yet another quarter of exceptional execution as we advance our lead program to review through late-stage clinical development.
Speaker Change: Notably, we continue to receive strong positive feedback from both physicians and patients.
Speaker Change: for our ongoing global phase three trials, Lugano and Luchia, for dervue and wet age-related macular degeneration or wet AMD, underscoring the impressive enrollment rate we are seeing.
Speaker Change: In fact, as we reported in this morning's press release, we have randomized over 90 percent of patients into the Lugano trial and over 50 percent into the Luchia trial.
Speaker Change: This gives us great confidence that we will meet our timeline to complete enrollments in the second half of 2025, and deepens our conviction that the review is on track to be the first to market of the current investigational, sustained release treatments for wet AMD.
Speaker Change: We believe this clinical momentum highlights the significant opportunity for due review as a differentiated treatment option in treating retinal disease.
Speaker Change: Our team is committed to our goal of delivering life-changing treatments to patients with severe retinal diseases, beginning with WEDAMD.
Speaker Change: I want to take a moment to review why we believe to review as a Best in Class program and represent the compelling and strategically de-risked opportunity in Web AMD.
Speaker Change: First, Dureview is not another anti-vigette program. Dureview is a clinically validated, differentiated and potentially best in class, sustained release TKI.
Speaker Change: DuraVue's receptor-level inhibition of edge-f, blocking all isoforms of edge-f, offers a broader and possibly more durable disease control compared to current ligand blocking therapeutics.
By also blocking PDGF receptors, your review may help reduce fibrosis.
Speaker Change: A key driver of long-term visual loss which could further differentiate this potential wet AMD therapy.
Speaker Change: In our Phase 2WO2 trial in Wed AMD, in a tough-to-treat population, approximately two-thirds of patients remained rescue-free for six months.
Speaker Change: and nearly half remained rescue-free for one year with stable vision and anatomy from a single
Speaker Change: Derivue has established a very favorable safety profile with no derivue related ocula or systemic SAEs observed in over 190 patients evaluated across clinical trials for multiple indications.
Speaker Change: Additionally, there are also four FDA-proof products using our Derrister technology administered to tens of thousands of patients in real-world settings with a strong safety record.
Speaker Change: Our Phase 3 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. [inaudible]
Speaker Change: And finally, Dureview has the potential to address a large unmet need in an established and growing multi-billion dollar market where patients are actively seeking safe, durable, longer-acting treatments.
Speaker Change: I want to also highlight our excitement around the potential for guru view in diabetic macular edema, or DME.
Speaker Change: While our company is currently focused on the execution of our Wedding MD Phase 3 program,
Speaker Change: Our recently reported positive 24-week Phase II results in DME further validates both the mechanism of action of a rollinib and the commercial potential of our duristered E-technology across multiple
Speaker Change: Turning to WETAMD, our goal in the Phase III trials is to demonstrate that Duraview can maintain stable vision and retinal anatomy for the majority of WETAMD patients within every six month dosing schedule.
Speaker Change: This would represent a significant improvement compared to the current anti-vitchef treatments in the US that are dosed on average every two months.
Speaker Change: 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
Speaker Change: Since initiating our phase three trials, we've seen remarkable patient and physician interest.
Supporting the life-altering potential of derivview.
Speaker Change: I'm pleased that both the Lugano and Luchia trials continue to meaningfully surpass our enrollment expectations, with patient randomization and excess of 90% for the Lugano trial and over 50% for the Luchia trial.
Speaker Change: Decent Roman rates significantly exceed those observed in comparable historic and other ongoing wet AMD trials.
Speaker Change: which we believe is driven by derives robust clinical data package, including an outstanding safety profile and established efficacy demonstrated in the robust W2 phase 2 trial.
Speaker Change: This also highlights the significant need for more durable treatment options.
Speaker Change: The continued support and enthusiasm for due review 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-risk trial design.
Speaker Change: Our global, double mass, identical trials reflect a tried and true, non-inferiority design, used in the last four wet AMD drug approvals.
Speaker Change: 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 specialist
First, the Lugano and Luchia trials were specifically designed for regulatory and commercial success.
Speaker Change: Our trial design was informed by a robust phase 2 trial and multiple FDA interactions.
Speaker Change: with written agreement from the agency on our path to approval.
Speaker Change: Second, our trials incorporate a fixed, pre-specified, every six-month dosing for DuraView, a clean, predictable design that mirrors intended real-world use, and that provides a clear regulatory pathway.
Speaker Change: Learning from our phase two, supplemental injections are only permitted if a patient needs strict predefined criteria and are adjudicated in a masked manner to minimize variability and bias.
Speaker Change: Our discipline protocol is aimed at eliminating physician discretion in unnecessary supplemental
Speaker Change: 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
Speaker Change: 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.
Speaker Change: Our facility is operational and will be capable of producing more than one million to review treatments annually to support expected global demand.
Speaker Change: Importantly, we are well positioned with regard to potential tariff impacts as we also source our API from a U.S.-based manufacturer.
Speaker Change: Turning to our DME program, Derivy met the trials primary and secondary endpoints for our phase 2 Verona trial, demonstrating compelling efficacy and durability results.
Speaker Change: Derivy was the only sustained release TKI program with demonstrated activity and safety in DME.
Speaker Change: DME is the second largest retinal disease indication, representing a $3 billion market opportunity by 2030. We believe the review is uniquely positioned to potentially extend the therapeutic dosing interval compared to currently available treatment options.
Speaker Change: To recap the Verona results, both to review doses met the primary endpoint of longer time to
versus the Flipper-Sept control. [inaudible]
Speaker Change: Deriview 2.7 milligrams demonstrated in early, sustained, and clinically meaningful improvement in best corrected visual acuity, or BCVA, with a gain of 7.1 letters compared to the baseline.
Speaker Change: and a central subfield thickness or CST improvement of 76 microns on OCT measurement.
Speaker Change: This represented a 75% more drying effect versus the off-liber set control.
Speaker Change: Immediate bioavailability, 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 flip or step control
Speaker Change: A subset of unsupplemented patients further supported the robust results for the de-review arms. These highly positive face to data will be critical in our planned engagement with the FDA this summer to solidify plans for a pivotal program.
Speaker Change: In summary, our identical pivotal Phase III Lugano and Luchiya Trials in WebMD 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.
Speaker Change: The positive safety and efficacy data from the Phase 2 Verona trial and DMV further strengthens to review profile as a potentially paradigm shifting treatment option.
Speaker Change: and Positions to review to become a potential multi-billion dollar blockbuster franchise in the two largest retinal diseases.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: We deeply appreciate your confidence in us, and we're proud to advance our therapeutics for the benefit of the entire retina community.
Speaker Change: 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.
Speaker Change: I will now turn the call over to George to review the financials. George?
George Elston: Thank you, Jay. To begin, we continue discipline, financial management and good stewardship of our resources, ending the first quarter with 318.2 million in cash and investments.
George Elston: We affirm previous guidance and expect this cash will support our operations into 2027 beyond key data in our readouts from our Phase III Lugano and Luchia Pivotal Files next year.
George Elston: As the financial results for the three months ended March 31st, 2025, were included in the press release issued this morning, my comments today will be focused on a high level review for the quarter.
George Elston: For the quarter ended March 31st, 2025, total net revenue was 24.5 million compared to 11.7 million for the quarter ended March 31st, 2024.
George Elston: Net Product Revenue for the quarter-ended March 31st, 2025 was 0.7 million consistent with the quarter-ended March 31st, 2024.
George Elston: We expect net product revenue to continue in material levels as we will no longer be supplying you to ANI Pharmaceuticals, our US partner after May 31st, 2025.
George Elston: Consistent with our strategy, our manufacturing focused forward is on our Derivue program to support clinical trials, a potential NDA filing and future commercial launch.
George Elston: 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.
George Elston: The increase was primarily driven by recognition of remaining deferred revenue from the outlicence of UTQS rights in 2023.
George Elston: Operating expenses for the quarter ended March 31st, 2025, totaled 73.3 million compared to 45 million in the prior year period.
George Elston: This increase was primarily driven by the ongoing Luke Gano and Lucia Face3 trials for DuraVue and Wed AMD, as enrollment is tracking ahead of expectations.
George Elston: Net non-operating income total 3.6 million and net loss was 45.2 million or 65 cents per share compared to a net loss of 29.3 million or 55 cents per share for the prior year period.
George Elston: As I noted earlier, cash equivalents and investments in marketable securities on March 31st, 2025 total 318.2 million compared to 371 million as of December 31st, 2024.
George Elston: In conclusion, we are incredibly pleased with EyePoint's progress so far in 2025 and remain well-capitalized to deliver dervue phase 3 data in 2026. I will now turn the call back over to Jay for closing remarks.
Thank you, George.
Speaker Change: As outlined this morning, we ended the first quarter in an excellent position or remain committed to advancing Duraview, a best-in-class program across multiple indications in retinal disease.
Speaker Change: We believe EyePoint represents a significant investment opportunity that is meaningfully to keep the risk both clinically and financially.
Speaker Change: 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 and Wed AMD expected in the second half of 2025.
Top-Line Data for these trials anticipated in 2026.
Speaker Change: and an end-of-face to meeting with the FDA around a pivotal trial in DME this summer.
Speaker Change: To close, 2025 is off to a great start for EyePoint.
Speaker Change: 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.
Speaker Change: We're very excited to continue our momentum and look forward to providing additional updates in the coming quarters.
Speaker Change: Thank you all very much for your attention this morning. I will now turn the call back over to the operator for your questions.
Thank you.
Speaker Change: Ladies and gentlemen, to ask the question, please first start one more on your telephone, then wait for your name to be announced.
Speaker Change: As usual, we'll try to get to as many questions as we can through the course of the call. But if you limit the number of questions you ask to one, it will give others a fair chance to participate.
Please stand by while we compile the K&A roster.
Speaker Change: At EyePoint, we're completely focused on the execution of our pivotal phase three wet AMD trials, Lugano and Luchia, and the preparation for our NDA filing, which includes manufacturing of registration batches in our Northbridge, Massachusetts commercial facility.
Speaker Change: Based on our terrific Phase 2W2 data, the rapid enrollment in our Phase 3 trials in the continued clean safety profile for DuraVue. We are confident in the value creation that successful Lugano and Luchia results will produce.
Speaker Change: With respect to strategy, we are focused on value creation for our current shareholders while advancing their review through phase three trials. This means good stewardship of our cash while maximizing the value of their review.
We're now happy to take some questions.
Thank you.
Speaker Change: Our first question comes from the line of Jennifer Kim, with Cantor. Your line is open.
Jennifer Kim: Good morning. Congrats on the progress. Thanks for taking our question. Maybe to start off, I understand that you've reiterated guidance to complete face-to-rollment in the second half of this year, but
Speaker Change: This is 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?
Speaker Change: Good morning Jennifer, thanks for the question. We are still guiding to full enrollment in both trials in the second half of this year.
Speaker Change: But yes, if you look at the public statements we've made around enrollment and kind of draw a line through the data points.
Speaker Change: We could certainly potentially have completion of enrollment in the first tri-Lugano in the second quarter of this year. That remains to be seen.
Speaker Change: You may know that the start of the luchiya trial was approximately two months or so after Lugano, and we would expect that the luchiya results will come in approximately two months after Lugano as well.
Speaker Change: Okay, that's helpful. And if I could sneak in one more question, just because DME underpriced your 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. Thank you very much.
Speaker Change: We have our Chief Medical Officer, Romero Ribeiro on the line also. Romero, do you want to talk a little bit about the upcoming end of phase two meeting with the FDA over DME?
Romero Rivera: Sure, Jennifer, so we are going to be proposing a clinical plan mini-a-phase three study that brings efficiency to our program. So we are going to propose one single study.
Romero Rivera: Comparing our drug to standard care, and the primary endpoint is going to be as expected for the entire BCVA. We're planning to have the meeting with the FDA soon as Jay mentioned and we have that by this summer.
Thank you again, guys.
R. Thank you. Please stand by for our next question.
Speaker Change: Our next question comes from the line of tests, Romero with JP Morgan, Eliana's open.
Tess Romero: Hey, JNP, thanks so much for taking our questions this morning. A big picture to what do you attribute the rapid pace of enrollment here in your Phase III, WETAMD trials? Anything anecdotally you can tell us on what you are hearing from your clinical sites.
Tess Romero: 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 Romero and his team,
Jay Duker: 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.
Romero Rivera: Yes, 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.
Romero Rivera: and the robust data that we have from phase two study, as well as our phase one program, give them confidence when they are discussing cooperation and potentially offering participation in this study.
Romero Rivera: Of course, we do a lot of things to make this study easy for sides and patience.
Romero Rivera: But the most important part is the robust data that we have that gives confidence to investigators and patients.
Romero Rivera: I think we are doing an excellent job identifying any potential risk in our phase 3 program on the conduct of this study.
Romero Rivera: So we look at our areas to ensure the integrity of the data is perceived so that can be efficient on our NDA submission.
Thank you.
Thank you.
please stand by for our next question.
Speaker Change: Our next question comes from the line of Tyler Van Buren with T.D. Cohen. Your line is open.
Speaker Change: Hey guys, good morning. The enrollment progress is very, very impressive. So, with the increased timelines to enrollment completion in the Lugano and Luchia Trials.
Speaker Change: Does it make sense to potentially run a small phase two study in RVO, considering that it is a significant additional opportunity a part of the market beyond wet AMB and DME? Is there any way that you could do this in a cost efficient manner as we wait for the phase three data?
Speaker Change: Yeah, 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 the review and what are the other potential add-on indications.
Speaker Change: RVO is certainly one of them. But as I stated in my comments, we are really focused on WEDMD right now and on our cash runway after data. And so the value that we would get...
Speaker Change: 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.
Speaker Change: Oscarization would be another area that the review would do very well and 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.
Thank you.
Please stand by for our next question.
Speaker Change: And next question comes from the line of Yatin Suneja with Guggenheim, Yalana Sultin.
from both studies,
Speaker Change: Also, the type of patient or the mix of patient, naive versus vegetable exposed patient that you are able to enroll and anything you are able to comment on the safety strategies on the blinded basis given that one study is almost complete with from an enrollment perspective. Thank you.
Speaker Change: 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 percent?
Speaker Change: and we're doing a little bit better than that in both trials.
Speaker Change: And there's always some learning, you know, the screen failure rates hit 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.
Speaker Change: With respect to the mix of naïve versus previously treated, we're going for approximately 75% naïve, 25% previously treated.
Speaker Change: and given the reality that previously-created patients are already in the doctors' practices and can be identified ahead of time,
Speaker Change: 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.
Speaker Change: The number of patients who were previously treated, we capped the enrollments so that from now and both trials were just recruiting naive patients, and this is again to be expected.
Speaker Change: 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 kept them and we didn't see that.
Speaker Change: What's been remarkable is that in both trials, the enrollment rates have been very high and very steady.
Speaker Change: As for release of masks, masks data, we really aren't thinking about doing that right now. I think we might do that in the future certainly things like mass data around demographics.
of the patients,
Speaker Change: just because of the risk of compromising the data and introducing operational bias. So with respect to safety, what I can say general is that based on our public statements prior, the safety of the review has been very, very good.
Excellent, thank you.
Thank you.
Please stand by for our next question.
Speaker Change: Our next question comes from the line of Kambiz Yasi with Jeffries. Eliana is open.
Speaker Change: Thank you. Thank you so much for the questions. A couple for me. How should we model our indeed on forward?
Speaker Change: and then separately, I was curious if it would be so kind as the provider's perspective on biosimilars are shaping the WDMD market.
Speaker Change: Would you consider biosimilar upfliperset loading in a post-marketing study for DuraView? 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.
Thanks, Kabiz. Appreciate the questions.
Speaker Change: Let me take the second one first, and then I'll ask George to comment on R&D costs going forward.
George Elston: First of all, we're agnostic to the biosimilar market whether a doctor, if and when we get approval with an every six-month dosing interval,
George Elston: What the doctor chooses to load with, before the use of the review, we're really agnostic to that. We have no reason to believe that a biosimilar effliversept would behave any differently than on label effliversept.
George Elston: The rest of it, you know, with respect to any other loading of an anti-BHF, whether it's off label-a-vast, and Lucentis Fabaismo, the three-monthly doses, you wouldn't expect a patient to respond any differently to any of them over those first three months.
George Elston: So, if you look at all of the curves of all the approved drugs and look at the first three months, they're really quite similar in their visual acuity improvement and the OCT improvements. So, as a general rule, we wouldn't think that choice of a ligand blocker for the load would make any difference.
George Elston: George, do you want to go ahead and talk about anticipated R&D class? Sure, and Kambiz, thanks for the question, as I noted on the call, our R&D burn is up.
George Elston: Yiro Ribeiro, but that's really driven by the exceptional recruitment we've seen.
and, you know, our-
George Elston: Part two of that is our cash guidance is unchanged. So if you think about R&D in 2025, your current model is probably correct for the full year, but we just spent more on Q1 because the trials are going so well. So I think full year is probably the same, just move some of that.
George Elston: Buren, you may have in Q2 and Q3, up a little bit.
Great, thank you so much.
Thank you.
please stand by for our next question.
George Elston: Our next question comes from the line of Greg Suvannavejh with Mizuhu, Yalana's Open.
Speaker Change: Hi, all. This is Sam on Fograg. Thank you for taking our questions. Maybe a couple from me. Has the recent shortages that co-pay assistance programs that we've been hearing from retinal disease companies impacting the enrollment in your studies in any way?
Speaker Change: 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 rolling in your studies versus that of your competitors? Thank you.
Thanks for the questions, Sam. They are good.
Speaker Change: 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.
Speaker Change: For reasons that I'm not sure have been totally made public but the companies that have funded good days in the past shows not to fund it so far in 2025.
What this means is that patience.
who have the onset of what AMD.
Speaker Change: and do not have secondary coverage or coverage for the copays and want to be treated with a brand to drug could have significant out-of-pocket costs.
Speaker Change: We expect that this is helping our enrollment because obviously we would offer, you know, 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 AMG trials would benefit from that.
Speaker Change: 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 in the investigational sites are telling them about this.
Speaker Change: Yeah, thanks for the questions, Sam. As I mentioned, the number one feedback we get from site is the fact that we have run a robust large phase two study.
Romero Rivera: And that provides them confidence on the data, the efficacy data, but most important on the safety data, that gives them comfort on offering these studies to a patient knowing that
We have those over 190 patients with the review.
Romero Rivera: And then after that, things like, you know, being a study that is very patient-centric, so every patient is treated in this study, either with respect or with our investigational drug.
Romero Rivera: how easy it is to conduct the study. It's not too burdened to patients and physicians and great support that iPoint is providing to sites via our clinical operations team as well as our medical affairs team.
Thank you.
Thank you.
Please stand by for our next question.
Speaker Change: Our next question comes from the line of Nick Quantapella, with Bear, Eliana Sopin.
Nick Quantepella: Hi everyone, this is Nick on for Colleen. Thanks for tuning our 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 and point for what MD says. I was wondering if-
Nick Quantepella: There's a number on how many rescues are allowed and is there a certain window, but rescues are not allowed, for example within
for
with within the primary endpoint, thanks.
Nick Quantepella: 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. Thank you very much.
Nick Quantepella: What does that mean? Well, this is an intensive treat study that the top line data will be from all patients.
Nick Quantepella: and then sensitivity analysis will be applied to the patients who got supplemented or rescued. And remember, in our trial, the control of flibersept arm can also be rescued.
Nick Quantepella: So there will be also a calculation of the rescues compared in each arm.
Nick Quantepella: With respect to timing of rescues, that was not something that was ever brought up.
at
Nick Quantepella: Either of our meetings, and there's nothing in writing that we've received from the FDA, about waiting the timing of a rescue, or that a patient who got rescued at a certain point of the study would be eliminated from the study. That's not something that the FDA has brought up with us.
Thank you.
Thank you.
Please stand by for our next question.
Speaker Change: Our next question comes from the line of debt, Chatterjee with Joneses, Yaline is open.
Hi, thanks for taking my question.
Deb Chatterjee: So, you know, 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 Amjance Baglu impacting the wedding decommasional landscape? And maybe could you comment on the potential for price erosion and any implications for due review?
Deb Chatterjee: It's hard for me to answer the question about how the biosimilars will impact the market in general.
Speaker Change: Once again, with respect to DuraVue, we don't believe they'll have any impact on DuraVue'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.
Speaker Change: Right now, the last data I saw was 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.
Speaker Change: 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 are you in pricing and whether we think by similar will impact that at all? Happy to have you comment.
Speaker Change: Yeah, and thank you for those questions. I think going back to what Jay said during the call is Dervis not another anti-ved Jeff and as our team thinks about approaching it in the marketplace.
Speaker Change: You know, 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 very important part of our negotiation, not just with FDA, but ultimately with payers. And so, you know, just broadly speaking, as we, you know, if you look at the trial design. [inaudible]
Speaker Change: for DuraVue, you know, one DuraVue replaces three anti-vegetics, and so as you think about your pricing models, that's a good place to start.
Okay, great. That's very helpful. Thank you
Thank you.
Please stand by for our next question.
Speaker Change: Our next question comes from the line of Greg Harrison with Scotia Bank. Your line is open.
Joe: Morning, everyone. Thank you for taking our question. This is Joe on for Greg.
Speaker Change: Just thinking to the future a little bit here, assuming Nugano and Lucia will read out at different rates, is there potential for a rolling NDA submission? And how might that impact your top line data release strategy in the second half of 26th? Thank you.
Speaker Change: Thanks for the questions, Joe. The NDA submission is really the rate-lippening step is last visit, last patient in of the second trial, in our case the Luchiya trial.
Speaker Change: Romero again is really deep into this and asked him to make any other comments about steps that we're taking to minimize that time between last patient, last visit and submission.
Thanks Jay. So, as Jay mentioned,
Speaker Change: The Libertation Factor for the full summation is going to be...
Speaker Change: The Last Patient on the Second Study. However, since Dukana is enrolling quite fast and we might have a good opportunity to accelerate things, especially interpretation of the results.
Speaker Change: 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.
Speaker Change: 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 study. [inaudible]
Great, thank you so much.
Thank you.
Speaker Change: Please stand by for our next question. Our next question comes from the line of Yale Jones, it's late law and company. Your line is open.
Speaker Change: Thanks for taking the questions. Just a quick follow up on the previous one.
Speaker Change: Get Some Colors, which is the one you do the data release next year, with that two data, would that be sort of roughly two months apart for each of those, or you have other plans? And thanks.
Speaker Change: 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.
Speaker Change: 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.
Okay, great thanks and congrats on the rapid enrollment.
Thank you.
Please stand by for our next question.
Alana Yixin: Our next question comes from the line of Yishin with H.C. Wainwright, Yalanda Salkin.
Alana Yixin: Good morning, this is Eduardo on for you. Thanks for taking the question. I had a question regarding the bass line, patient character ispis in the Lugano and the Sea of Trials. It seems like prior trials you had BCVA letters.
Alana Yixin: 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 75 letters, 85 letters.
Alana Yixin: and what does that mean? Well, they have to have imaging that shows that they have...
Alana Yixin: A.M.D., and that they have an active coronavascular membrane, and they have to have decreased vision, and they have to have some fluid on OCT that is indicative of wet A.M.D. fluid.
Alana Yixin: So, in order to have decreased vision, there's a cutoff, and historically, I think if you go back to the other wet MP trials, 78 letters is very typical for the best vision.
Alana Yixin: that is typically allowed into the study. So the quick answer to the question is you have to enroll patients with active WEDAMD.
Speaker Change: Got it. That's really helpful. And, um, maybe you mentioned this, but you reported a subgroup within the DME trial, um, at the 10.3 letter improvement. I'm curious what are the attributes of that patient population and what fraction of the DME population showed those attributes.
Speaker Change: Well, so that's a really good question about what attributes show it. First of all, it was the subgroup of patients in the DME trial and the high dose, the 2.7 milligram dose, which is the dose we're using in Wed AMD and the presumed go to market dose in that dose of the eyes that did not get rescued. So that's a really good question about what attributes do you have in the DME trial and the low dose?
They improved 10 letters. [inaudible]
Speaker Change: 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.
Speaker Change: Those patients who were not rescued had an immediate improvement in vision, seen it for weeks, they had immediate reduction in their OCTs, seen it for weeks, and it was sustained in those eyes throughout the study. In other words, at the tail end near 24 weeks, the visual acuties 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.
Speaker Change: Even though if you look at the patients who did get rescued.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: So be that as it may, it would be great to be all 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 are the patients
Speaker Change: who can go six months with great improvement and will not need a rescue. Hopefully, we hope that 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.
Got it. That's really helpful. Thanks so much. Thank you.
Speaker Change: Our next question comes from the line of Yigal Nochomovitz with City Group. Eliana is open.
EGLE Nochemovitz: Yeah, hi, thank you. Can you just walk through the thinking as far as your views on potentially being forced to file an NDA for the long-acting TKI's given the strength of the enrollment curves that you're seeing across your phase three programs? Thank you.
EGLE Nochemovitz: 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 your second pivotal trial.
EGLE Nochemovitz: and we have great confidence given the enrollment rates that we're seeing in our trials.
EGLE Nochemovitz: In 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.
EGLE Nochemovitz: 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.
Speaker Change: Okay, thank you. And could you just review your positioning with respect to supply chain and IP? You may have talked about it at the beginning but I may have missed it.
Speaker Change: So vis-a-vis supply chain for the commercial product, once again as we did talk about in the opening remarks, RAPI is manufactured in the United States.
and our inserts are manufactured by us here in Massachusetts.
Speaker Change: The phase three wet AMD inserts were manufactured in our facility in Watertown.
Speaker Change: We have built the state of the art manufacturing facility in Northbridge, Massachusetts, which is about an hour west.
Speaker Change: of Watertown, and in that facility we are in the midst of making registration batches and preparing for FDA pre-market visits.
Speaker Change: And we're confident that that facility will be able to supply the entire global need for to review should we get approval.
Speaker Change: So, from a supply chain perspective, we're really in control of the supply to a very large degree.
Speaker Change: And remember also, the virulment was 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...
Speaker Change: Each 1.34 milligram of a rollinib, a batch or a run of a rollinib can take us a very long way. So we are quite confident that our supply chain will be intact in that the tariff issues that some companies are facing, we think we are in good shape there.
All right, thank you very much.
Speaker Change: 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.