EYPT Q3 2026 earnings call transcript, November 12, 2026

My name is Deedee and I'll be your conference operator today. At this time, I would like to welcome everyone to the EYPT Third Quarter 2026 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, 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 iPoint.

Sir, please go ahead.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint's third quarter. 2026 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of iPoint. Jay will begin with a review of recent corporate updates and discuss our clinical program for DeReview and DME and the results from the WET AMD program. I will close with commentary on the third quarter 2026 financial results. We will then open the call for your questions where we will be joined by Dr. Ramiro Rivera. our chief medical officer, Mike Campbell, our chief commercial officer, and Dr. Tarek Hassan, our chief strategic science officer. 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.ipoint.bio. Before we begin our formal comments, I'll remind you that various remarks we 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 in 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 factor 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 I-Point.

Thank you, George.

Good morning, everyone, and thank you for joining us. This has been an eventful quarter for I-Point, and I want to begin with what is top of mind for all of us. This past August and October, we announced that our two Phase III wet AMD clinical trials did not meet the price. primary endpoint in the full analysis population. We are deeply disappointed with this result. At the same time, these two studies generated important clinical findings about DuraVue. Across both trials, DuraVue consistently demonstrated biological activity, as well as vision improvement, superior reduction in treatment burden, anatomic control as measured by OCT, and a face-to-face. ...safety profile with repeat dosing. In the pooled analysis of both trials, the greater than 50% of DuraVue-treated patients who went supplement-free up to week 56 manifested nominal non-inferiority in mean change in BCVA versus on-label 2 mg of liver subcontrol. These studies confirm that DuraVue is active and could... potentially play a role in exudative retinal disease. Following Lucia, we acted quickly to align the organization around the program where we believe additional resources are justified by both the evidence and the potential for improving patient care. As previously mentioned, and to pursue our cash runway, we are discontinuing the WETMD program, reducing our workforce by approximately 53%, and significantly reducing...

...our operating cost structure moving forward. Our main clinical priority now is diabetic macular edema, or DME. There are several reasons to believe DuraVue could perform differently in DME than it did in WETMD. Our confidence in Como and Capri rests on the following points. DME and WETMD are biologically distinct diseases. WETMD is primarily caused by macular neovascularization or the growth of... ...normal blood vessels from the choroid, with VEGF playing the central role in driving angiogenesis and vascular leakage. DME, in contrast, develops from diabetes-related injury to the retinal microvasculature and breakdown of the blood-retinal barrier due to inflammation, hyperglycemia, and other factors that result in the leakage. Intraocular biomarker data reflects this difference. Unlike in WETMD, patients with DME typically... show elevated IL-6 levels. IL-6 signaling acts not only as a biomarker, but as a link to inflammation, retinal vascular dysfunction, and the breakdown of the blood-retinal barrier. Previously presented clinical data suggests that blocking both IL-6 and VEGF can potentially give better results than blocking VEGF alone in DME patients. This is directly relevant to DuraVue. Because virulinib inhibits all VEGF isoforms, the PDGF receptor, and JAK1, a key mediator of IL-6 signaling. Our published preclinical work demonstrates a greater than 50% reduction in IL-6 activity through JAK1 inhibition.

Thus, DuraVue has the potential to address both VEGF-driven vascular permeability and IL-6-driven inflammation with one therapy. Further evidence comes from... ...from the fact that intraocular corticosteroids effectively treat DME, but with minimal benefit in wet MD. Studies in pseudophagic eyes demonstrate that corticosteroids exhibit similar activity to anti-VEGF biologics, despite corticosteroids acting primarily through anti-inflammatory mechanisms. Eye points Phase II Verona data showed equivalent vision improvement for DuraVue and Aflibrocept, but DuraVue eyes had superior reduction in... CST, as well as leakage, as measured by fluorescein angiography. In Verona, 73% of DuraVue patients remained supplement-free of anti-VEGF injections through week 24, versus 50% of the Aflibrocept controls. DuraVue also demonstrated rapid efficacy, with four to five letters of vision improvement and an approximately 50 micron improvement in CST, compared to Aflibrocept at week 4. DuraVue We believe this early improvement for patients, if confirmed in the Phase III trials, will be important. We now have substantial clinical experience with DuraVue in about 450 patients from the wet AMD Phase III trials demonstrating pharmacologic activity, durability, and safety with repeat dosing. The extensive safety experience is an important component in our confidence in DuraVue going forward. Sustained release may be particularly advantageous for DME as nearly 50% of patients discontinue treatment within six months. Patient age, comorbidities, treatment burden, and delayed perceived benefit contribute to undertreatment in the real world.

We believe DuraVue's potential to deliver earlier improvement with fewer injections could offer a compelling treatment profile. Taken together, the rationale for DuraVue and DME rests on these points. The distinct biology of DME, our compelling Verona data, and extensive DuraVue's clinical experience showing fluid control and safety with repeat dosing. With a unique multi-mechanism of action, robust clinical data package, proven delivery technology, the ability to be shipped and stored at ambient temperatures, and administration via a standard intravitreal injection, DuraVue represents a compelling and innovative product profile that has the potential to meaningfully change the treatment paradigm in DME, a $5 billion global market that includes $3 billion in the United States. We expect to announce top-line results from both Como and Capri, which enrolled over 550 patients, early in the fourth quarter of 2027. Our organization is focused on execution and delivering these results next year in order to maximize value for our shareholders and further our mission to improve the lives of patients with serious retinal diseases. Before passing it over to George to review our financials, I'd like to thank the entire iPoint team for their commitment and perseverance to our mission. We are grateful to the study participants.

Study coordinators and clinical investigators who enable our research. I will now turn the call over to George.

Thank you, Jay.

Thank you, George.

Thank you all for your attention this morning. I will now turn the call over to the operator for questions. Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced to withdraw your question.

Our next question comes from Mr. Kirchit of Jefferies. Your line is open.

Hi, this is Zeta on for Fazil.

Thank you for your comments.

I had a question regarding the DME study. Is there any futility analysis plan for this one?

Thank you for the question.

And again, Romero, why don't you take that question, please? Yeah, thanks for the question. So we're not planning futility analysis for the DME studies. The primary endpoint is the CTA from baseline to week 52-56. And as we disclose, we expect to have those Q4 of next year. Thank you. Thank you.

Our next question comes from Mr. Saneja of Guggenheim. Please go ahead.

Hi, guys.

Thank you for taking our question. It's Min, Dininger for Yoxin. So one quick question on the DME. So DME patients are generally younger with less GA and fewer age-related issues. Do you think this enrollment, like, reduces the risk of these non-Wet AMD vision loss that you guys saw in the Guggenheim? Thank you.

Our next question comes from Mr. Neshamovits of Citigroup. Please go ahead.

Yeah, hi. Thank you. Just a few here. Just on the runway, you know, it says that you have cash basically to the very end of 3Q and the readouts for DME are 4Q. So I just want to clarify. If you will, in fact, need to, you know, secure additional capital to actually make it to get to Como and Capri top line. That's the first question. And the second one is, you know, despite the wet AMD result, I presume you will still be using the data for the safety database from those studies to support a helpful DME filing. Is that correct? Thank you.

Thanks for the question, y'all. So I'll take the second question first. And the answer is yes. We are going to be using the safety database from wet AMD to help inform the safety for DME. So we should have greater than 300 patients with two years of data at the end of the DME trial, should they be positive, which should we expect. If positive, give us a label for reinjection indefinitely. So as for the runway, George, why don't you tackle that one?

Yeah, thanks, Yavala, and good question. I think as we said on the call, as part of the strategic adjustment of the organization, we have and continue to actively review forward obligations and for additional cost reductions and cash conservation as we focus on DME. And where we sit today, we just about get there. As we said on the call, there are multiple levers that we're evaluating and we'll continue to update the street on cash as we go into 2027. From a management perspective, our plan is to not run out of cash and to make sure that we get the organization and the company to and through DME data next year. Great. Thank you.

And our next question comes from Mr. Sivanovae of Mizuho. Please go ahead.

Thank you.

Good morning, and thanks for taking my questions. I just was wondering, in light of the Phase III data that you got in WETMD, you've been at various conferences this summer and fall, wondering what the feedback has been from the retinal specialist. And maybe as a related question, you talked about the potential to address the cash runway with potential BD opportunities. And I'm wondering what those conversations, if you can provide color, might be like and what kind of BD, you know, I guess, deal or would I point be interested at this point? Thanks. Yeah, Greg, thanks for the questions. I think the first question, I think we can universally say that the retina community was really disappointed. We know that our patients could benefit from sustained release in diseases like wet AMD and DME. And there was a lot of hope and expectation that Duraview would be able to supply that durability with stable vision. For wet AMD. The other thing that really strikes us when we talk to KOLs and frankly retina specialists in general. Is how well the drug performed with respect to the secondary endpoints. The primary endpoint of course is what gets us approval. The secondary endpoints is what would get us commercial success. The safety, the reduction in treatment. The excellent control of the fluid were all points that the retina community was really looking for. And many of the retina specialists told us in conversation that if this drug were approved with a profile they saw in Lugano and Lucia they would use it. So I think the overriding feeling frankly across the board with everybody involved was.

You know, really, really disappointment. Mike Campbell, perhaps you could expound a little bit on the commercial potential if we were able to get the drug approved in wet AMD based on the secondary endpoints? Sure, yes. You know, I said in the comments there's about a $5 billion global opportunity with a little more than $3 billion. In the US. And if you look at the patient population, it's about 50% of those DME patients are actually working age adults. So the treatment burden is actually exponentially higher in DME than it is in AMD. You know, these working adults taking off time from work and getting to appointments. And where it really shows up in the data is the discontinuation rate within DME patients. About 52% of these patients discontinued. With within one year of starting treatment. So there is a true burden of profile like DERVU where, you know, our Lugano and Lucia data showed that we could reduce treatment burden. And not only do it, but do it in a superior fashion compared to ILEA. I think if approved this, this, this profile fits actually ideally within DME.

Oh, thanks. Mike. In the second question about business development, I'm going to say two things, you know, really at the highest level. The first is we are going to proceed in a path that has the best opportunity to give our investors value. That's number one. Number two is we're leaving no stone unturned here. Obviously by our current market cap, the investment community is not really taking into account what we believe is a real opportunity in DME and our conversations with others suggest that DME is a real possibility along with potentially should we be able to identify a subgroup of patients or biomarker from the wet MD data that might suggest the ability to have a successful trial, the possibility of trying to get approval in wet MD again. So we are leaving no stone unturned here, Greg, and talking to any number of potential supporters.

Thank you. And our next question comes from Mr. Chen of Laidlaw. Please go ahead.

Good morning, and thanks for taking the questions. We have two here. The first one is that in terms of the COMO and the CAPRI, when you report the data in fourth quarter, would you report them at the same time or separately? Then I have... A quick follow-up.

Thanks for the question, Yeo.

Yeah, our plan is to report them simultaneously. The studies both ended within days of each other, and therefore the current plan would be to report them simultaneously, and that looks to be on track for early in the fourth quarter of 2027. Okay, and thanks. And the other one is you just... You mentioned in terms of the subgroup analysis of WebAMD study data. Any elaboration you can offer at this point? And thanks. Yeah, no elaboration at this point in the subgroup analysis. We want to, of course, be as sure as we can before we come out publicly with any findings as to specific biomarkers that would suggest success or failure. with Duraview or other demographics or other pieces of data that we're looking at. We have quite a bit of data to go through. And again, I mentioned this with respect to going forward, building value. We're leaving no stone unturned here. We believe that if approved, Duraview could help many patients with wet AMD. And so the question is, is there a pathway forward? in wet AMD. At the same time, we remain quite confident in DME. Okay. Great. Thanks. And best luck. Thank you. And our next question comes from Mr. Tatterjee of Jones. Please go ahead.

Thank you so much for taking my question. So if you identify a subgroup of patients that are... ...actually benefiting from DuraView more than the ApliVership arm, would you fall back on a similar trial design? Or if you think of a new trial in WET-AMD, would you consider a different design for that? So I think it's an excellent question. And we need to have the data first as to what might be new inclusion-exclusion criteria. Or a different design of a trial that may get us approval. So the first part of the answer is find what I've referred to as the smoking gun or smoking guns. Once we have that, if we can define it clearly, then I think the trial design follows. And obviously, we would want to run something that has a high probability of success. So we're, again, open to a variety of potential changes in the protocol, but not committing to anything right now until, in fact, we find enough scientific evidence that would make it a low-risk trial to run. Makes sense. A quick follow-up on the design. How do you think it might influence the outcome? If you measure the change from, instead of measuring the change from baseline in BCBA, like your baseline starts after the three loading doses versus before the three loading doses? Yes, so that's a good question, and that really gets back to the regulatory requirements for a wet AMD trial. First of all, the FDA is clear that they want to see randomization on...

day one. And while a run-in is possible, which might enrich the database of the population, one also needs to be cognizant that if you select for a very small subgroup of patients after a run-in, the risk you take is that the control... arm will not behave similarly to the control arms that gave us the non-inferiority margin. So, this is a regulatory question, and while I wouldn't say that a run-in would be not in the cards, I think we would obviously discuss it quite extensively with the agency before we went forward with something like that.

Thanks for the color.

Thank you. And our next question comes from Ms. Walter of RBC. Your line is open.

Oh, good morning, and thanks for taking our question. Just wondering, can you walk us through what inspired you to change the DME rescue criteria, and was this in response to the Lugano-Lucia studies? And as well, are you monitoring? Any blinded data in the Encomo and Capri, for instance, safety or rate of rescue injections? Any color here would be helpful.

Yeah, thanks, Lisa. So first of all, the decision we have, of course, with respect to rescue or supplemental injections has to do with the fact that we're supplementing with a different drug, not our drug. And therefore, it's quite clear that if in any trial, if the number of supplements is extensive, the statistical analysis may suggest that any good visual outcome would be attributed to the supplements as opposed to the study drug. On the other side, the fewer the supplements, the... the better the potential for commercial uptake. So it's a bit of threading a needle. And of course, when you think about only five letters of change, that's one line in an eye chart. That's not a lot of change. And especially in a group of patients where their vision can be variable from one visit to the next. So that's a little bit of background about supplements. But the decision to make this... change was to try to protect the non-inferiority margin. Thank you. And our next question comes from Mr. Seathouse from Cantor. Please go ahead.

Yeah, great.

Thanks so much.

Wanted to follow up on the DME trial protocol. But one of the features here, it looks like there's two additional ilead loading doses in the control arm of the Como and Capri studies that aren't in the Durabu arm. There's matching shams in the Durabu arm. And that's different from what AMD, obviously, where the number of loading doses was equal. So do you think that makes meeting non-inferiority here sort of even more of an uphill battle in the DME trials? Or what would be your response, I guess, to that? argument or concern? Thanks. Yes, Steve, that trial design came from two factors. The first factor is the FDA insists that if you're running a non-inferiority trial, and you can only run it against the control group of 2 milligram ilea or Lucentis, and you have to run it on label. On label, 2 milligram ilea for DME is five monthly injections, and then every other month. So that trial design for the control arm comes directly from requirements of the FDA. With respect to ilea in the study arm, remember in Verona, our phase 2 trial where we got excellent results as early as week 4, we only gave those active diabetic patients a single injection of ilea 30 minutes before they got to review. So we believe that two additional injections of ilea, when you look at the visual acuity improvements and the OCT improvements curves in DME, will be sufficient to give us non-inferiority as well as the important reduction in treatment burden, which we would expect to see and hope to see also.

Thanks, Jeff.

Thank you. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program and you may now disconnect. Everyone have a great day.