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spk06: Welcome to the I-Point third quarter 2022 financial results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star 1-1 on your touchstone telephone. As a reminder, today's conference call is being recorded. I will now turn the conference over to your host, Mr. George Elston, Chief Financial Officer of I-Point Pharmaceuticals. Please go ahead, sir.
spk11: Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' third quarter 2022 financial results and recent corporate developments. With me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss Phase II clinical trials for EYP1901 and Scott will comment on our third quarter 2022 commercial performance. I will close with commentary on the third quarter 2022 financial results, and we will then open up the call for your questions. Earlier this morning, we issued a press release detailing our financial results, as well as commercial and operational developments. A copy of this release can be found in the investor relations tab on the corporate website, www.ipointpharma.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. This includes statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and other 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 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 Nancy Lurker, President and Chief Executive Officer of iPoint Pharmaceuticals.
spk01: Thank you, George. Good morning, everyone, and thank you for joining us to discuss the continued progress that iPoint made in the third quarter of 2022. Despite the challenging macroeconomic conditions, we are well-funded to reach our critical readouts, and we remain optimistic about the direction we're headed in as we work to bring innovative ocular therapies to patients with serious eye disorders. Prior to turn the call over to my colleagues, I'd like to highlight a few of our achievements last quarter. We continue to consistently and successfully execute important milestones across our pipeline, with the first patient dose in our Phase II PAVIA clinical trial, evaluating EYP1901 for non-proliferative diabetic retinopathy, or NPDR, in September. Notably, this was our second Phase II clinical trial for EYP1901 initiated in the third quarter. As a reminder, in July, we dosed the first patient in our Phase II Davio II clinical trial for wet age-related macular degeneration, also known as wet AMD. In the 18 months since initiating our Phase I Davio trial, we've completed the trial and reported positive 6- and 12-month data. held a type C meeting with the FDA for our phase two and three clinical trial plans, and initiated our phase two W02 clinical trial for wet AMD and phase two PAVIA trial for NPDR, respectively. I'm very proud of these achievements and will continue to execute consistently and effectively. EYP1901 combines the VEGF receptor binding tyrosine kinase inhibitor virolinib and a bioerodible formulation. of our proprietary DuraCert technology. EYP-1901 has the potential to provide patients a duration between treatments of six months or longer while maintaining stable visual acuity and macular anatomy. It's important to highlight that we view 1901 not as a replacement for current standard of care large molecule anti-VEGF treatments, but as a maintenance therapy with a different mechanism of action. Under this treat to maintain strategy, patients can potentially be extended six months or longer with EYP1901 after becoming stabilized with anti-VEGF standard of care treatment. We are extremely excited to have successfully dosed the first patients in both EYP1901 phase two clinical trials as planned and look forward to providing updates on these trials in the quarters to come. Dr. Jay Duker will review EYP1901's unique value proposition for patients in more detail later on the call. Turning to our commercial business, data from the UTIC-CALM registry study will be presented at a poster presentation at the Retina Society 55th Annual Scientific Meeting, which is taking place right now in Pasadena, California. The CALM study is a phase four multicenter registry study and a joint collaboration between iPoint and the Cleveland Clinic. that will become a valuable resource in furthering the understanding of posterior segment uveitis. Importantly, our commercial team delivered another strong quarter for UTEEQ, with $7.3 million in net product revenue, an increase of 85% from the third quarter of last year, along with continued strong customer demand for UTEEQ. Scott will provide additional detail for this topic later on. Finally, we wanted to share an update on our DexyQ franchise. In October, the company and Impromis Rx mutually terminated an agreement for the commercialization of Dex-Q effective December 31, 2022. This was a result of CMS's proposed hospital outpatient rule published in July, which did not contain an extension of the past year payment period for Dex-Q beyond December 31 of this year. The final 2023 CMS HOPPS rule, which was published yesterday, November 1st, did not modify the proposed rule. This loss of pass-through status at the end of this year will significantly reduce the amount of Medicare reimbursement provided to the companies to execute customers and will result in a significant reduction in the companies to execute product revenues. We are actively looking at all the strategic options for the asset and will provide additional updates in subsequent quarters. I'd like to thank the talented I-Point team for our company's success to date. As we advance the future of sustained ocular drug delivery, we look forward to continued execution on multiple near-term clinical catalysts so that we can become the leader in sustained ocular delivery and ultimately create a better future for patients living with these serious eye disorders. I'll now turn the call over to Dr. Jay Duker, our Chief Operating Officer, to provide an update on our lead program, EYP1901, as well as other initiatives. Jay?
spk12: Thank you, Nancy, and good morning, everyone. Before I begin, I want to reiterate what a productive quarter this has been for the iPoint clinical team as we executed on multiple milestones, further advancing our innovative pipeline. Turning to our product pipeline, EYP1901 is an investigational sustained release therapy using a bioerodible formulation of our Duracert technology with Virolinib, a tyrosine kinase inhibitor that binds the receptor, therefore blocking all isoforms of VEGF. Varolinib's differentiated mechanism of action from the standard of care ligand blockers may provide additional benefits such as neuroprotection. Compared to other TKIs, Varolinib features reduced off-target binding, leading to a potentially improved safety profile with no reported ocular toxicity. Duracert as a proven and safe sustained release delivery platform differentiates EYP1901 from other agents targeting VEGF-mediated retinal disease. as this bioerodible insert allows for true sustained release of the drug with zero-order kinetics with up to nine months duration of activity. In wet AMD, EYP1901 is being studied as a maintenance therapy following induction therapy with a standard of care anti-VEGF therapeutic, a new treatment paradigm which we call Treat to Maintain. Our goal is to sustain the majority of wet AMD patients' treatment interval up to six months or longer with a single injection of EYP1901. By providing this sustained delivery therapy, patients and practitioners can potentially have the flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained intravitreal delivery of a differentiated anti-VEGF drug. Turning to non-proliferative diabetic retinopathy, or NPDR, it is a very common disease, affecting almost one-third of diabetic adults over the age of 40. and it's projected to impact over 14 million Americans by 2050. In NPDR, blood vessels are weakened, and this may lead to both swelling of the macula and abnormal blood vessel growth. If left unchecked, NPDR can be the harbinger of severe visual loss as well as other ocular complications. Because the currently approved therapies for NPDR require a significant visit and treatment burden, 97% of NPDR patients are currently observed. This provides a significant market opportunity for EYP1901, which may be able to be effectively delivered at a nine-month interval or longer in NPDR. Revisiting the Phase I DAWIO clinical trial for EYP1901, we recently reported positive 12-month safety and efficacy results at the American Academy of Ophthalmology meeting in Chicago. The DAWIO trial enrolled 17 patients, and each received a single intravitreal injection of EYP-1901 at one of four different dose levels. All enrolled patients were previously treated with standard of care anti-VEGF therapy. No reinjection, but the study drug was performed during the trial and typical criteria for supplementation with a standard of care anti-VEGF was employed. We were pleased that the 12-month data featured no reports of ocular SAEs or drug-related systemic SAEs no reported events of vitreous floaters, endophthalmitis, retinal detachment, insert migration to the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events. Further, the 12-month follow-up confirmed stable best corrected visual acuity of minus 4.12 ETDRS letters and stable central subfield thickness on OCT of minus 2.76 microns. Interestingly, one-third of eyes were supplemental anti-VEGF-free up to 12 months after a single injection of EYP-1901. Up to six months, 53% of eyes were supplement-free. Additionally, there continued to be positive treatment burden reduction of 73% at 12 months compared to 75% at the six-month visit. On the heels of these positive data, we enrolled our first patients in two separate Phase II clinical trials of EYP-1901, one for the treatment of wet age-related macular degeneration called W02, and one studying the drug of non-proliferative diabetic retinopathy called the PAVIA study. The W02 trial is expected to enroll approximately 150 wet AMD patients previously treated with a standard of care anti-VEGF therapy and randomly assigned to one of two doses of EYP1901, approximately two milligrams or approximately three milligrams versus an on-label of Flibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA-approved anti-VEGF treatments. The primary efficacy endpoint of the W02 trial is non-inferiority to the efflubricate control as measured by change in best corrected visual acuity six months after the 1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplement the anti-VEGF, reduction in treatment burden, and safety. We look forward to progressing the W2 trial and anticipate top-line results in the fourth quarter of 2023. The first patient was dosed in the Phase II PAVIA clinical trial of EYP1901 for the treatment of NPGR in September of 2022. The trial is expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP1901, approximately 2 milligrams or approximately 3 milligrams, or to the control group, which will receive a sham injection. In this trial as well, UIP-1901 is delivered with a single intravitreal injection in the physician's office. The primary efficacy endpoint of the trial is improvement of at least two diabetic retinopathy severity scale levels at week 36. Secondary endpoints include onset of vision-threatening complications, occurrence of diabetic macular edema and or proliferative disease, retinal ischemia non-perfusion, and safety. In summary, we are very proud of the clinically validating results we've seen from the Phase 1 trial of EYP-1901, and we are excited to provide updates on the W02 and PEVIA trial in the quarters to come. I will now turn the call over to Scott Jones, Chief Commercial Officer, for the commercial update. Scott?
spk10: Thank you, Jay. We're excited to report a strong quarter for our commercial business with $9.7 million of net product revenue, an increase of 13% from the third quarter of last year. Our Q3 net product revenue for UTIC and DEXA-Q was $7.3 million and $2.4 million, respectively. Customer demand for the third quarter was approximately 890 units of UTIC, 14,100 units of DEXA-Q. Customer demand for UTIC continues to grow as we see positive traction from our focus on retinal specialists for posterior segment inflammation and continued use by uveitis specialists. We hope to see increased demand continue in the quarters to come with further support from the ongoing phase four studies that are currently underway. As Nancy previously discussed, in October of 2022, the company mutually terminated an agreement with Impromise Rx for the commercialization of Dexa-Q effective December 31st, 2022, as a result of the Medicare hospital outpatient prospective payment system and ASC payment system proposed rule. which was published in the Federal Register by the Center for Medicare and Medicaid Services on July 26, 2022. The final rule, published yesterday, did not contain an extension of the pass-through payment period for Dexa-Q beyond December 31, 2022. We will work with the ImpromiseRx team supporting the Dexa-Q franchise through Q4, while also actively looking at all strategic options available to us for the asset. We're very pleased by the progress that we've made with our commercial businesses and remain on track for breakeven for the franchise in 2022. I'd like to thank our commercial teams for their dedication in bringing our ophthalmic therapies to physicians and patients in need. I would now like to turn the call over to George to review the financials. George?
spk11: Thank you, Scott. As the financial results for the three months ended September 30th, 2022 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 third quarter ended September 30, 2022, total net revenue was $10 million compared to $9.1 million for the quarter ended September 30, 2021. This includes net product revenue for the third quarter of $9.7 million compared to net product revenue of $8.6 million for the prior year period, an increase of 13%. Net revenue from royalties and collaborations for the third quarter ended September 30, 2022, totaled $0.3 million compared to $0.5 million in the corresponding period in 2021. Operating expenses for the third quarter ended September 30, 2022, totaled $28.4 million versus $24.4 million in the prior year period, primarily driven by an investment in personnel across the organization, including non-cash stock compensation, and ongoing clinical trial and development costs for EYP 1901. Non-operating expense net totaled 0.02 million and net loss was 18.4 million or 49 cents per share compared to a net loss of 16.7 million or 58 cents per share for the prior year period. Cash and investments at September 30th, 2022 totaled $157.3 million compared to $171.2 million at June 30, 2022. We expect cash, cash equivalents, and investments on hand at September 30, 2022, and expected net cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024. In conclusion, we are pleased with iPoint's progress in the third quarter of 2022 and are well capitalized to advance our product pipeline to key value inflection points. Thank you all very much for listening this morning, and I'll now turn the call over to the operator for questions.
spk06: Thank you. Again, ladies and gentlemen, if you'd like to ask a question, please press star 1-1 on your touchtone telephone. Again, to ask a question, please press star 1-1. Our first question comes from Jennifer Kim of Cantor. Your line is open.
spk08: Hey, good morning, and thanks for taking my question. I have a few here. Maybe to start off, How do you think about the positioning of sustained release therapies on the back of the detailed high-dose ilea data?
spk01: Yeah. So, first of all, I want to stress a couple things, and then I'm going to have Dr. Duker elaborate. It's very important that people realize this is meant as maintenance therapy, EYP1901. So, we've never viewed ourselves as a competitor to the large molecule anti-VEGF. And as we also have shown in our phase one data, we are able to get a majority of patients out beyond six months. The other thing to consider is that as we further develop the product, we're continuing to work on the mechanism of action. And it is a different mechanism of action. And generally speaking, that can be a positive when you look at approaching a disease from multiple angles. And we've got some interesting data preclinical animal data that Jay can elaborate on, which we believe further highlights there could be some additional benefit to using a different mechanism of action while you occasionally may need to supplement with a large molecule antibody, excuse me, antibody, anti-VEG. Jay?
spk12: Well, thanks for the question, Jennifer. To elaborate a little bit more on what Nancy said and just to go over the data, Regeneron announced that about 77% of their wet AMD patients within the study could be dosed at an extended timeframe up to four months. In our Davio trial, we had 76% of eyes go out that long. And in addition, of course, we had 53% go up to six months without a rescue or supplement. And we had a third of eyes go one year. And those are findings that really the ligand blockers are unable to achieve. So to differentiate on just the basis of longevity, I think that we have the possibility of going significantly longer with a single injection. We don't have to do that in everybody to have a very successful product. If you, again, look at our Davio data, even the patients who required a supplement before six months in general those patients received much less treatment than they had been getting prior so that reduction in treatment burden from every month or two will still be a benefit to patients even if they require treatment every three to four months with eyp 1901 uh and and finally uh the differentiated mix of action i think a nancy touched on this but we do have some pre-clinical data in a retinal detachment model that suggested that verolinib, which is our tarsocutis inhibitor, showed neuroprotection, both measuring vision in affected animals as well as looking at the OCT findings of the outer retina in this retinal detachment model. So we're certainly encouraged by that, and we're looking at other preclinical evidence of other a mechanism of action that may differentiate berolinib from the standard of care. And, of course, the clinical data, we hope, will bear that out as well.
spk08: Okay, that's really helpful. Thanks. My second question is, I know it's a little early, but any color around the rate of enrollment in DAVO2, and I know it's even earlier, but in PAVIA? Yeah, go ahead, Jay.
spk12: Yeah, so I would say the onset, you know, the first patient dosed, in the W2 trial was exactly where we had planned. In saying that, I think the initial enrollment has been a bit slower than what we hoped for. That had a lot to do with the rolling out of the sites. Now we have a lot of sites up and running, and we are now enrolling at a respectable clip. And we still, at this point, I believe we'll have top line data to share in approximately a year in the fourth quarter of next year. Pavia, again, right on target at this point. I think because of, as Nancy used the term macroeconomic, because of macroeconomic factors at both the CROs and the sites, it's been a little slower getting the sites up and running. But once the sites are up and running, then the enrollment is going just fine.
spk08: Okay, very helpful. And then my last question is, you mentioned actively looking for alternative paths around execute. Could you give a bit more color on that and when we might get an update?
spk01: So, let me just comment on that, which is that we're going to look at potential partnerships because I just want to remind everyone. CMS has indicated they will provide reimbursement. should you have a pain indication. And given that we have an FDA-approved drug, it still retains significant value with a patent life out until at least 2035. So we are going to be looking at various options to potentially complete those pain studies, but nothing definitive yet, and we'll be back to the investors as soon as we nail down exactly what we're doing.
spk08: Okay, great. Thanks again, guys.
spk06: Thank you. One moment, please. Our next question comes from the line of Georgie Yordanovan of Calwin.
spk09: Your line is open. Hi, Georgie.
spk04: How are you? Regarding some of the interesting data that you presented, the subset analysis from W in patients with no residual fluid, So maybe we were just wondering if you can kind of like dive deeper into those results. They seem very impressive. Do they in any way kind of like inform future designs of the pivotal trials or in kind of like any way clarify the opportunity there? And then we have a couple of follow-ups.
spk01: Yeah, Jay.
spk12: Yeah, I'd be happy to answer that. So first of all, what Yorgi's referring to is we went back in the Davio data, the phase one data, and looked at the patients who entered the study dry with no excess fluid. Remember, we didn't have any fluid cutoffs in the Davio trial for enrollment. We enrolled patients who were under good control, bad control. We really took all comers. Nine of the patients of the 17 were dry going in, and those patients did exceptionally well. with about 67%, I think, up to six months without a supplement. Within the first six months, the three that did need supplement only needed one. The change in visual acuity in the first six months was about a letter minus. And the OCTs looked good. And so that subset of patients did very well. So parenthetically, I got asked a question by Jennifer earlier about hydrosylea. Well, high-dose ilea, if you look at the data, about 50% of regular-dose ilea patients at 16 weeks are dry. High-dose ilea at 60%. So if this data holds for EYP1901 that drier eyes do better, in some ways, high-dose ilea may actually be a better drug to lead into 1901 than regular ilea is because more eyes will be dry. How does this inform us? Well, again, we are really trying to enroll patients who are basically doing well on anti-VEGF therapy in W2. And we're not excluding a little bit of fluid because there is certainly evidence that a little bit of subretinal fluid is maybe protective to visual acuity in the long term. But you also may recall, and I'll remind everybody on the call, that every patient in W2 is getting a loading dose of ilea. And so even though these are patients who were previously treated, we're loading up everybody with three monthly injections. And that should also increase the number of patients who, at the time they get EYP1901, are dry. And so that should, we hope, result in more robust findings in TAVIO2 than what we saw in TAVIO1.
spk04: Great. Thank you so much. This is super helpful. And another follow-up. I guess just broadly on the technology, you've really shown that the DuraCert technology is a powerful platform. So maybe can you speak to your opportunities to bring any other molecules to DuraCert? One area we've been following where DuraCert could be particularly beneficial would be GA. So can you maybe just talk through the strategic considerations of potentially exploring that area?
spk01: Well, I'll comment on that and thank you for the question. We're actively engaged in that. However, these things take time. And beyond that, we're not going to go into specifics because obviously we want to keep things confidential in terms of some of the specifics that we look at. But we do believe that this could be a significant opportunity. And I'll let Jay comment on the opportunity with GA and a longer treatment duration.
spk12: Well, I think we all hope that we will have an approved drug for geographic atrophy in the near future. And if we do, it looks as if the approved drugs, the ones that are being looked at, what we hope shortly approved drugs, will have to be delivered quite frequently, probably every month to be effective. So clearly, if there's a delivery system that can deliver an anti-complement that's safe and effective that can go out longer than that, that would be a tremendous advantage. I think that's obvious. So in order for us to be a differentiator, we have to be able to take a molecule and put it into DuraCert and be able to deliver it for that period of time. And so there's a lot that goes into the evaluation of such a molecule, size, solubility, the dose you actually need to achieve the clinical endpoint. And so, as Nancy indicated, this is an area that we are actively looking at. And when we have some positive news, we will certainly announce it. I will add, though, neuroprotection, which I touched on briefly, is another area that is a bit of a holy grail for poster segment disease. And while neuroprotection as a mechanism of action is a little less defined, I would say, than complemented inhibition and geographic atrophy, Neuroprotection opens up a lot of other markets, and so that's another area in general where we're looking at molecules that can provide neuroprotection to the retina or to the ganglion cells in a sustained release delivery system. Great.
spk04: Thank you so much for all the details, and congratulations on all the progress. Thank you.
spk07: Thank you. One moment, please. Our next question comes from the line of Yi Chen of HC Wainwright.
spk06: Your line is open.
spk02: Thank you for taking my question. So for the patients enrolled into the Phase II Pavier trial for MPDR, are these newly diagnosed patients or existing patients who are receiving active treatment or existing patients who are not receiving active treatment?
spk08: Jay, go ahead.
spk12: Well, so active treatment would be an exclusion. So NPDR patients in general see well and have minimal symptoms. NPDR is, you know, diagnosed in the doctor's office based on examination of the fundus. We do know that, you know, NPDR is a progressive disease and left unchecked, it will eventually progress and in many cases go on to diabetic macular edema or proliferative diabetic retinopathy. So these patients could be newly diagnosed. If they're newly diagnosed, it doesn't mean they just had diabetes for a short period of time. In order to get moderate to severe NPDR, you really have to have diabetes for a while, but they may have just come into a doctor's office for the first time. So in a sense, they could be newly diagnosed. But if they're being actively treated for the complications of DME or PDR, then they won't be eligible for the study.
spk02: Okay. So these are moderately severe to severe in PDR patients and they usually reject treatment even after diagnosis by the ophthalmologist, correct?
spk12: Yeah, I think to say, I'm not sure they reject it more than most retina specialists still are reluctant to offer it. So there are two approved drugs for the treatment of non-proliferative diabetic retinopathy. And our research to the market suggests that no more than 2% to 3% of patients are actually getting the drugs because they require at the beginning monthly treatment. And after a while, you can cut back a little. But if you go too far, the cutback of treatment, then you're going to lose the effect. So it really has to be something like a sustained release that would enable these patients to go on with their lives normally and not be tied into the doctor's office. Because remember, these NPDR patients are not patients who are typically visiting the doctor every month or two. They may be on a six-month to one-year schedule. So if they're asymptomatic with good vision, asking them to undergo an injection monthly for an asymptomatic condition is a big lift. And so I don't think it's just patient reluctance. I think there's some physician reluctance there, too. Got it.
spk02: Got it.
spk12: Thank you.
spk02: And I don't know if you can provide any color on the potential growth trajectory of UT in 2023 at this point.
spk01: Yeah, sorry about that. I was on mute. So I'll let Scott comment on it, but we don't give forward guidance. However, we continue to have some very good quarters. And Scott, you want to just comment a little bit on our approach with UTiQ?
spk10: Sure. Thank you, Nancy. Yeah, as Nancy mentioned, we will not provide guidance for the fourth quarter or for future quarters. However, I would say that a month into the fourth quarter, we're very pleased with the performance of the product. And what we have seen coming out of the third quarter is that physicians kind of fully back in the office and We're starting to see a lot more patients flowing through, and as you can imagine, that provides a lot of more opportunities for treatment. I would say that, as I mentioned previously in the discussion, we have been really pleased with the uptake of Butique overall in the marketplace, especially within the retinal segment. We're seeing a lot of retina physicians, a lot of new retina physicians, come on board in terms of utilizing UT. And so we see that as a nice harbinger for the future.
spk02: Got it. Thank you.
spk07: Thank you. One moment, please.
spk06: Our next question comes from the line of Yale Jen of Laidlaw and Company. Your line is open.
spk05: Good morning, and thanks for taking the question. My first question is that for the W-2 study, how many sites currently being enrolled and what will be the targeted number of sites to be enrolled in the study?
spk01: Hi, Yale. Yeah, we're not going to disclose that. But suffice it to say, it's typical. So we don't go into that level of detail in our clinical studies.
spk05: Okay, no problem. Thanks for that. Just two more quick ones. The first one for the PAVIO study and the readout is the two TRSS level changes. Does this endpoint also could be used for the future pivotal study or you're thinking about something else?
spk01: Okay, go ahead.
spk12: Oh, no, that would be, as of now, the endpoint for the future pivotal studies. That is a, you know, approvable endpoint. Both Lucentis and ILEA were approved for NPDR based on that endpoint, and so the plan right now would be to use that as the endpoint in the pivotals.
spk05: Okay, great. And maybe the last question here is that the assumption for the runway, would that include a very minimum execute revenue as the base case?
spk11: Yeah, I can answer that, Yale. Thank you for that. Yeah, we guided about DEXA Q and Q2. We kind of knew that the pass-through extension was unlikely. And so that's always been, you know, the reduction in DEXA Q revenues has always been part of our cash projection. Recall that we brought in Inframis as a commercial alliance partner. back in 2020, so it's been a non-core program for us, and while, yes, it's been break-even, it wasn't a significant component of our cash generation.
spk05: Okay, great. Thanks a lot, and I look forward to see the progress.
spk09: Thank you. Thank you. Operator?
spk06: Please make sure your phone is on mute. Our next question comes from the line of Danielle Godlin of Chardon.
spk13: Hey, good morning, guys. Thanks for taking the question. Just a quick one on, I guess, on a bigger big trend long term. Can you comment on the plans with regard to other anti-VGF indications, such as plans for RVO?
spk01: Yeah, go ahead, Jay.
spk12: Yeah, so the next indication which we plan on pursuing is diabetic macular edema, and the current plans, we expect to initiate that study in the second half of next year. We will probably do RVO at some point. We don't have it built into our models yet. Again, RVO is a much smaller market than the others, and while we think there probably will be benefit, that's not in our current plan, but we expect as uh we unfold with the pivotal trials uh for wet amd and pdr that will come more into focus i'll also add you know there's other smaller indications which we will probably layer on eventually as well like myopic coronal neovascularization we expect that 1901 would do very well in that indication and we're also looking at the possibility of using eyp 1901 in a high-risk eye, in other words, an eye that has dry macular degeneration but has not yet converted to wet macular degeneration, using UIP-1901 as a preventative kind of maintenance therapy to prevent the conversion to wet. There's considerable evidence from the oral studies of erolative and wet AMD that there was a protective effect to the fellow eye, so that's another potential indication that we will be modeling and looking at in the future. Got it.
spk13: Thank you.
spk12: That was very helpful.
spk06: Thank you. Our next question. One moment, please. Our next question comes from the line of Juan G. of B Raleigh. Your line is open.
spk03: Good morning. Thank you for taking our question. Can you remind us the market opportunity of MPDR patients? And when you look at the treatment landscape, what do you think could be the standard of care two years later when you are planning or initiating your potential phase three trials in MPDR? Thank you.
spk01: Yeah, Scott, you can answer the market opportunity and then Jay on the clinical side.
spk10: Thank you for the question. Yes, as you're certainly well aware, the population with diabetes is continuing to grow and is a substantial number of patients at this point. It could be numbering as many as 15 million patients who are flowing through some form of ophthalmology practice or optometrist practice. We believe that certainly the opportunity, as we said, is extremely large. Jay, I think, did a really good job of laying out kind of the current conundrum as it relates to the treatment paradigm, which we believe we certainly offer a really unique opportunity moving forward.
spk09: Okay.
spk12: Yes, so it's hard to, you know, project anything in this day and age, but looking realistically at the two FDA-approved drugs for NPDR, it's hard to believe that the market is going to open up substantially in the next two years. I think inroads will be made. I think more of the young doctors might be more interested in pursuing an aggressive treatment of NPDR. By aggressive, I mean frequent injections. But again, in this patient population who are generally younger and working, It's hard to think in an asymptomatic disease they're going to want to come in that frequently and subject themselves to the small but finite risk of multiple injections. Other sustained release products are going to, I'm sure, look at the NPD market. But, you know, this, again, is a risk-benefit kind of thing. You know, the refillable port technology, I would expect if Lucentis is effective, it would be as well. But that may not meet the standard of risk versus benefit. And again, I think some of the other products out there, you know, gene therapy is potentially a pathway to have sustained release of any drug too, but that remains to be tested. So we think that there's still going to be in two years substantial opportunity for an every nine months or perhaps even once a year intravitreal in-office bioerodible injection that that could substantially alter the course for the positive in many patients with NPDR.
spk09: Thank you. That's very helpful.
spk06: Thank you. I'm sure no further questions at this time. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating. You may now disconnect. Have a great day.
spk01: Thank you.
spk06: You're welcome. Thank you.
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