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spk02: to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Chief Financial Officer of IvePoint Pharmaceuticals.
spk13: Thank you, and thank you all for joining us on today's conference call to discuss IvePoint Pharmaceuticals' second 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 clinical plans for EYP 1901, and Scott will comment on our 2Q 2022 commercial performance. I will close with commentary on the second quarter 2022 financial results. 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 the release can be found on the Investor Relations tab on the company 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. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC. and in other filings 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 I-Point Pharmaceuticals.
spk06: Thank you, George. Good morning, everyone, and thank you for joining us. It's been an exciting quarter for Eye Point Pharmaceuticals, and we are very proud of the work we have done to bring ocular therapies to patients with serious eye disorders, and at the same time, create long-term value for our shareholders. It's been a busy quarter, and I'll now review our recent accomplishments. We continue to execute on our pipeline with the first patient dose, and we're very excited about this, last week, in our Phase II W02 clinical trial, evaluating EYP1901 for wet age-related macular degeneration, or wet AMD. As a reminder, EYP1901 is a combination of the small molecule tyrosine kinase inhibitor, Virolinib, and a bioerodible formulation of our proprietary DuraCert technology. We look forward to providing an update on our Phase II PAVIA trial for EYP1901 in a second indication, non-proliferative diabetic retinopathy, also known as NPDR, later this quarter. In July, we presented positive 12-month safety and efficacy data from the Phase 1 Davio clinical trial at the American Society of Retinal Specialists annual meeting. Wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD-related blindness. Although there are safe and effective FDA approved medications on the market, the treatment paradigm remains a challenging one for patients and physicians. As most patients with wet AMD are treated every month or every other month, requiring frequent trips to the doctor's office and countless injections over their lifetime. EYP 1901 has the potential to provide the substantial benefit of allowing patients a longer duration between doctor's offices and visits of up to six months while maintaining stable visual acuity and macular anatomy. It's important to highlight that we view EYP-1901 not as replacement therapy for existing large molecule anti-VEGF therapy, such as ILEA, Aflibircept, or Lucentis, Renabizumab, but as a treat-to-maintain therapy with a different mechanism of action, a receptor versus ligand binding. that can potentially act as maintenance therapy and use current treatments as supplemental support as needed. Dr. Jay Duker will review in more detail the results of our 12-month Davio2 data later in the call. As I've mentioned in quarters past, I'm very proud of our team's execution of our Phase 1 Davio clinical trial. Just 18 months after we began our trial, we have disclosed positive 12-month data have aligned with the FDA for our phase two trial, and now dosed the first patient in our phase two DAVIO2 clinical trial for wet AMD. Additionally, we were pleased to have hosted our first Investor Day event where we featured commentary from iPoint's management team, as well as guest speakers, Dr. Carl Ruggillo, Professor of Ophthalmology, Thomas Jefferson University, and Dr. Charlie Wyckoff, Director of Research, Retina Consultants of Texas. We discussed the incredible science behind EyePoint's DuraCert drug delivery platform, clinical results, and Phase II plans for EYP1901, and gave a commercial update on UTIC, flucinolone acetonide intravitreal implant, for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. Turning to our commercial products, we announced the approval of UTIC in China with OccuMention Therapeutics. Utique is the first drug for commercial use in OccuMention's innovative pipeline. We're very pleased to partner with OccuMention to expand Utique's global reach in the emerging Chinese market. And they will now be marking an important milestone in furthering our mission of improving the lives of patients with serious eye disorders around the world. Finally, we saw record net product revenues in Q2 2022, primarily driven by a strong second quarter for Utique. which you'll hear more about from Scott and George later on. On the corporate front, we announced two new board appointments in June and July, and we continue to strategically build out our board and leadership team as our company grows and evolves. First, in June, we elected Dr. Tony Ademus to the board of directors, who is a pioneer in the discovery and early development of anti-VEGF drugs for the treatment of ophthalmic diseases. Tony is best known for his co-discovery of the role of vascular endothelial growth factor, VEGF, in ocular disease, including wet AMD and diabetic retinopathy. Second, in July, we welcomed Karen Siderish, who currently serves as Axogen's president and CEO, to our board of directors. Karen is a pharmaceutical industry veteran who brings more than 35 years of biopharmaceutical and medical device leadership and commercial experience to the role. We also thank the contribution that Ron Eastman, EW Healthcare Partners, made to the board during his four-year tenure. I am indebted to and grateful for the talented iPoint team, which continues to execute quarter over quarter on all clinical, operational, and financial aspects of our business. We are steadfast in our mission to become the leader in sustained ocular delivery in order to deliver improved retinal treatment and bring much-needed therapies to patients around the world. 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 an incredible quarter this has been for the I-Point clinical team, as we executed on multiple milestones, and we expect to continue to do so as we advance our pipeline. To provide a brief overview of our product candidates and pipeline, as we discussed at our recent investor day, EYP1901 is an investigational sustained release anti-VEGF treatment. We deliver Virolinib, a small molecule tyrosine kinase inhibitor, which is the active ingredient in EYP1901. using iPoint's proprietary drug delivery technology, DuraCert. DuraCert differentiates UIP-1901 from other currently approved anti-VEGF drugs, as this bioerodible insert allows for true sustained release of the drug with zero-order kinetics after initial beneficial burst of medication. Virolative binds to all VEGF receptors, utilizing a differentiated mechanism of action, Compared to other TKIs, virolinib features reduced off-target binding, leading to a potentially improved safety profile with so far no reported ocular toxicity. In our first indication, wet AMD, EYP1901 is being studied as a maintenance therapy following induction therapy with an anti-VEGF therapeutic approach, which we refer to as treat-to-maintain. With regards to wet AMD, our goal is to sustain a majority of wet AMD patients' treatment interval up to six months or longer after a single injection of EYP1901, as the largest unmet need in wet AMD landscape is the longevity of anti-VEGF therapy. By providing this sustained delivery treatment, patients and practitioners could potentially have the flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained intravitreal delivery of an anti-VEGF drug. Turning to our most recent data update, we reported positive 12-month results of the EYP1901 Davio Phase I clinical trial for the treatment of wet AMD at the American Society of Retinal Specialists in mid-July. The Davio trial enrolled 17 patients and each received a single intravitreal injection of EYP1901 at one of four different dose levels. All enrolled patients were previously treated with standard of care anti-VEGF therapy. No reinjection with the study drug was performed during the trial, and typical criteria for supplementation with a standard of care anti-VEGF was employed. We are pleased that the 12-month data demonstrated no reports of ocular SAEs or drug-related systemic SAEs, No reported events of vitreous floaters, endophthalmitis, retinal detachment, insert migration into 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 optical coherence tomography of minus 2.76 microns. As expected, there was an observed increase in supplemental anti-VEGF therapy after nine months, given the insert's expected drug depletion. However, 35% of eyes were supplemental anti-VEGF free up to 12 months after injection with EYP1901. Up to six months, 53% of eyes were supplement free. Additionally, there continued to be a positive treatment burden reduction of 74% at 12 months versus 79% at six months. We're very pleased with our Davio Phase I results, which demonstrate that EYP1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy. On the heels of this positive data, we have enrolled our first patient in the Phase II clinical trial of EYP1901 for wet age-related macular degeneration, called Davio-2. The trial is expected to enroll approximately 150 wet AMD patients previously treated with standard of care anti-VEGF therapy and randomly assigned to one of two doses of EYP-1901, approximately two milligrams or approximately three milligrams. This is 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 Aflib-Ricep control as measured by change in best-corrected visual acuity six months after the EYP1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. We look forward to progressing our Phase 2 trial and anticipate top-line results in the second half of 2023. We are also looking forward to our potentially paradigm-changing exploration of EYP1901 and other severe eye disorders, including our Phase 2 PAVIA trial of EYP1901 and non-proliferative diabetic retinopathy, also known as NPDR. NPDR affects almost one-third of adults over the age of 40 with diabetes and is projected to impact over 14 million Americans by 2050. In NPDR, blood vessels are weakened and may leak fluid into the retina, causing swelling of the macula and lead to vision changes. If left uncontrolled, it can lead to severe visual loss and other ocular complications. The current standard of care includes intravitreal injections or laser photocoagulation and which can be burdensome for patients. The PAVIA trial is a 12-month randomized controlled phase two trial of EYP1901 for NPDR, which is expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP1901, approximately two milligrams or approximately three milligrams, or to the control group receiving a sham injection. EYP1901 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 DRSS or diabetic retinopathy severity score severity levels as of week 36 after the EYP1901 injection. Secondary endpoints include vision-threatening complications, occurrence of diabetic macular edema and or proliferative disease, retinal ischemia, non-perfusion, and safety. We look forward to providing updates on the clinical trial in subsequent quarters. In conclusion, we are very proud of the clinically validating results we've seen from the Phase 1 trial of EYP1901, and we are excited to have initiated DAVIO2 for EYP1901 last week with the Phase 2 PAVIA trial plan for NPDR later this quarter. We will continue working to provide potentially life-altering therapies to patients with serious eye disorders as we further explore the potential of EYP 1901. I will now return the call over to Scott Jones, Chief Commercial Officer, for the commercial update.
spk11: Scott? Thank you, Jay. We're excited to report a strong quarter for our commercial business with $11.3 million of net product revenue, an increase of 30% from the second quarter of last year. Our Q2 net product revenue for UTiQ and DexaQ was $7.4 million and $3.9 million respectively. Customer demand was approximately 900 units for UTiQ, an approximate 40% increase from Q1 of 2022, and 14,700 units of DexaQ consistent with the first quarter. Customer demand for UTiQ continues to grow as we see positive traction from our focus on retina specialists for posterior segment inflammation, and continued use by UVitis specialists. We hope to see increased demand continue in the quarters to come with further support from our ongoing Phase 4 studies that are underway. Customer demand for Dexa-Q was strong and consistent with Q1 of 2022, as our commercial alliance partner, InframusRx, continues to drive strong demand. In July of 2022, I point out that the CMS draft hospital outpatient prospective payment rule did not extend pass-through status for expiring drugs, thus impacting DexAQ. If the draft rule is finalized, DexAQ's pass-through status will expire on December 31st of 2022. CMS did clarify that they intend to offer ongoing pass-through to non-opioid pain alternatives and that they will require a pain indication in order for a product to be eligible for continued reimbursement. In light of this recent news, we're evaluating next steps for potential execute pain indication. We're very pleased by the progress we've made with our commercial businesses and remain on track for break even for the franchise in 2022. I'd like to thank our commercial teams for their dedication to bring our ophthalmic therapies to physicians and patients in need. We look forward to updating you on revenues and demand in the quarters to come. I would now like to turn the call over to George to review the financials. George?
spk13: Thank you, Scott. As the financial results for the three months ended June 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 second quarter ended June 30, 2022, total net revenue was $11.6 million compared to $9 million for the quarter ended June 30, 2021. This includes net product revenue for the second quarter of $11.3 million compared to net product revenue of $8.7 million for the prior year period, an increase of 30%. Net revenue from royalties and collaborations for the second quarter ended June 30, 2022, totaled $0.3 million, consistent with the corresponding period in 2021. Operating expenses for the second quarter ended June 30, 2022, totaled $30.8 million versus $20 million in the prior year period, primarily driven by an increase in R&D spending, including clinical trial costs for EYP 1901 and investment in personnel across the organization and non-cash stock-based compensation. Non-operating expense net totaled 0.2 million and net loss was 19.4 million or 52 cents per share compared to a net loss of 10 million or 35 cents per share for the prior year period. Cash and investments at June 30th, 2022 totaled 171.2 million compared to 211.6 million at December 31st, 2021. We expect the cash, cash equivalents and investments on hand at June 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 second quarter of 2022 and are well capitalized to advance our pipeline to key value inflection points. Thank you all very much for listening this morning, and I now turn the call over to the operator for questions.
spk02: As a reminder, if you'd like to ask a question, please press star 1-1. Our first question comes from Stacy Koo with Cohen. Your line is open.
spk01: Thanks so much for taking our questions, and congratulations on the progress. The first question is, do you plan to provide quarterly enrollment updates for your Phase II, W-2 trial? I believe you've got it to six months. just some color around the gating of enrollment and maybe you could speak to the level of physician awareness and engagement so far as you initiate the sites. Thanks.
spk06: Yeah. Hi. Thank you for that, Stacey. No, we have not ever done that for W01. We don't plan to for W02. As you know, these clinical trial enrollments can be like sine waves. And so you can get a big bolus come in and then a valley, and it just doesn't give much insights, I think, to investors. So we obviously will issue a press release when we have complete enrollment, but that's always been our target. And I'm gonna actually have Dr. Jay Duker comment on Just sort of how the trial is going so far.
spk12: Yes, so the physician engagement is very high We had well over a hundred sites interested in being participating in the study I think at this point the TKI and the delivery system that we feature is resonating with physicians and And I think our phase one clinical trial data has been very well received. So I think there's a lot of excitement out there in the retina community about the potential for EYP-1901.
spk01: Okay, perfect. And so two more questions on the DAWVIA-2. First, what are the powering assumptions versus the ILEA arm? So 1901 versus ILEA to achieve non-inferiority. And the second question on DAWVIA-2, how close do you expect the design will be with the pivotal trials I know at the Investor Day we talked about potential six-month retreatment for phase three, so any additional details would be appreciated. Thank you so much.
spk12: So we haven't publicly announced the statistics around W02. At this point, they're descriptive only. Given the end of the study, the study, you know, is not necessarily powered to a high enough level to be confident to that 95% level. the results. The statistics, again, are descriptive. The reinjection issue, again, at this point, there is no planned injection in the W02 trial. We do expect to study that in patients prior to the pivotal trial, and we still anticipate that in our wet AMD pivotal trials, the pace of reinjection will be every six months. That's the anticipated testing. We had a very productive Type C meeting with the FDA several months ago, and at that meeting, we asked some very specific questions around the structure of the pivotal trials. So, we have a pretty good idea of what the pivotal trials might look like, but in saying that, one of the reasons you do a Phase II trial is to inform your pivotals around dosing and other things. And so, we do expect to learn things from W02 that certainly may alter the structure of the pivotal trials as we see them now. But we're comfortable, and the FDA is comfortable with the outline of what the pivotal trials might look like.
spk06: Yeah, let me just add to that. I want to make sure that we're very clear on this. We have not designed this to be a pivotal trial nor even have the chance of hitting a statistical endpoint. Our goal is to understand better the dosing, what dose we take into Phase III, as well as entry criteria, et cetera, and what types of patients perform best. Our goal is to make sure that we get this study done ASAP and not have a large number of patients so that we can potentially hit pivotal. We really do need to learn just a few things to make sure we have optimal success in phase three. So we have no intentions of releasing statistics around this because it would be meaningless.
spk01: Okay, that's super helpful. Thank you so much.
spk02: Our next question comes from Eddie Hickman with Guggenheim Partners. Your line is open.
spk07: Good morning, and thanks for taking the question. This is Eddie on this morning. Question on 1901. For the diabetic retinopathy study, what dosing work have you done to make you choose those two and three milligram doses for the study? And then for that study, since the endpoints are a bit different, how are you going to handle the rescue criteria as compared to the Davio studies? And then just quickly on DEX, when will you know about that CMS pass or decision and how long would that extension be if it does get approved? Thanks.
spk12: Jay, let me start with the first two questions and thank you very much for discussing the PAVIA trial. First of all, we haven't found a maximally tolerated dose for EYP1901 in either any animal studies or humans. And since we don't know what doses will be effective, we elected to go with the two highest doses that we used in Davio for the NPDR trial. It's certainly possible that a lower dose will be just as effective, but we do hope to learn something about dosing from the Pavia trial. There is no rescue criteria in a diabetic retinopathy study. The control group is observation. In the real world, although there are labels for two anti-VEGFs for treatment of moderate to severe NPDR, we believe that only 2% to 3% of patients in the real world are actually getting treated with anti-VEGFs. And therefore, using an inactive control, a sham injection, we believe is appropriate for this indication. And therefore, rescue criteria would only really be applied to any patient who progressed to a center involving maxillary edema or proliferative diabetic retinopathy.
spk06: Yeah, I'll make one comment, and then I'll have Scott on the pass-through with Dexi-Q. But remember, the final rules come out in November. So that's when we would expect to know, but Scott, you want to add anything further on some color around?
spk11: Sure. So, um, when we talk about pastor, we're actually talking about 2 separate, uh, opportunities for pastor extension. 1 is related to. Extending the public health emergency, which as we saw in 2022 allowed for extension to our tolling period, which is the period of which data is collected on the utilization of outside of the bundle. So that would be potentially in the final rule, which would be in November. The second part of the pass related to the non-opioid pain indication or pain sparing products, excuse me, non-opioid sparing products related to pain. There's certainly, we saw draft rules in the 22 rule and in the 23 proposed rule. We do believe there will be a finalization of those rules in the final rule, which comes out again in early November.
spk03: Thank you.
spk02: Our next question comes from Jennifer Kim with Cantor. Your line is open.
spk05: Hey, good morning. Thanks for taking my question. I have two here. The first is just a clarification on how we should think about reinjection data in the pivotal for wet AMD. I think at the investor day you said you would expect a readout nine months after the last injection, and then you anticipate reinjection would happen at six months. Does that mean data on the reinjected dose would only go out to three months? And then my second question is just on the pain indication with execute. If you go forward with exploring that, what would the anticipated cost and, I guess, timing around that be? Thanks.
spk12: So, Jennifer, it's Jay again. Thanks for the questions, and I'll take the first part. Yeah, I think your summary of the pivotal structure is correct. The initial efficacy readout would be approximately nine months after the initial dose of UIP-1901. At about six months after that initial dose, however, we would anticipate giving a second dose. That works. Most wet AMV studies at this point are approximately one-year efficacy trial and two-year safety trial. We do anticipate taking the pivot out for a full two years for safety, which also means that we would plan on reinjecting a total of four times within that study.
spk06: But the readout would be before two years? Yes.
spk12: The efficacy readout would be at approximately one year after the initiation of the study as it's currently structured or planned.
spk06: Jennifer, on... So number one, not made any decision. I want to be clear on that. Number two, the cost of the studies would be in the mid-teens. But there are various options if we decide to go forward with it that we would look at for some potential non-dilutive ways to access that capital. We want to be careful that we do not expect in any way that if we go forward we would impact our cash runway. And then finally, obviously you can imagine, it's been very clear that they want to make sure that they have non-opioid pain products available. And in fact, they gave extended, if you want to call it almost permanent pass-through for some of these drugs that have a pain indication. So they've been very, you get a pain indication, you're going to get extended pass-through, permanently through. So the IRR, as you can imagine, is quite robust, and the risk of doing a pain indication for dexamethasone is relatively low because dexamethasone is a known pain reliever. So we feel confident that if we decide to go forward, our odds of achieving a successful outcome are quite high. Nevertheless, no decisions have been made. We're going to be very thoughtful about how we approach this. This is not our core asset, and we recognize that, and our goal is to make sure that we have the capital and the runway to execute on our EYP1901 program.
spk05: Okay, great. Thanks. Actually, if I could sneak one more question. You've also talked about exploring other molecules with Derser, like complement inhibitors. Are there other molecules that you're also exploring? And also, what are you looking for in a partner to take this forward.
spk06: Thanks. So, yes, there are other molecules that we are looking at. And the beauty about DuraCert is that you can, as we've said before, put many small molecules in and possibly up to some small peptides. So, there's a number of opportunities. We like to go after assets that have proof of concept. Because remember, we're not a research-driven company. We are a drug delivery and development stage company. We don't really want to take brand new mechanism of action risk on APIs. I'm going to actually have Jay comment further on any other specifics that we find interesting. Please note as well, we have in-licensed in the TIE2 activators. And we have two molecules associated with that, a small molecule and a bispecific. So clearly that is one pathway that we are potentially exploring.
spk12: Just to add a little more color, we have a very active BD outreach right now. And we are looking to partner with companies who have a release problem, let's call it, that they have a molecule that has a differentiated or proven MOA, but they have a short life in the eye, or they are giving it systemically and have systemic side effects. That's kind of the perfect partner for us in DuraCert. There are certain areas of unmet need that we're really interested in. You mentioned complement, and I would just even extend that to dry macular degeneration in general. Neuroprotection is another area that we're actively interested in. And there are several other smaller niche areas of the poster segment of the eye diseases that we're ongoing, have ongoing talks with other potential partners to develop other molecules that have been de-risked through other programs.
spk05: All right, great. Thanks so much, guys.
spk02: Our next question comes from Yeo Jin with Laidlaw. Your line is open.
spk10: Good morning and thanks for taking the questions. My first question is that for the W2 study that I remember you guys talking about earlier that you might enrich some patients that has been better managed by the current VEGF therapies. Are there colors you can share on this regard?
spk12: Sure. That's an excellent question. And I think perhaps I'm not sure enriching is quite the right word. We looked very carefully at the patients who were enrolled in the Phase 1 Davio trial who did well with EYP1901 versus those in whom the benefit of EYP1901 was not as apparent. And what was clear from that evaluation is that patients who were failing standard of care, in other words, were getting an ileo or lucentis injection every four or five or six weeks, but still had a lot of fluid or increasing fluid or decreasing vision despite that frequency of standard of care injections, it didn't appear that EYP1901 offered a lot of benefit to those patients. And therefore, the inclusion-exclusion criteria for DAVIO2 tried to eliminate, best we could, the patients who are not doing well on standard of care. So by doing that, we hope that the benefit of EYP1901 is more apparent in W02 than it was in W01.
spk10: Okay, great. That's very helpful. And in terms of W02 and Pavio, are there many clinical sites you anticipate to be overlapping or there will be a or that's not the case?
spk12: You know, that's a really good question, and off the top of my head, I don't know the answer. I mean, I've seen both lists, and so you'd think I could probably put it together, but suffice it to say that they are different diseases, both treated by retinal specialists, but there's a geographic diversity, I would say, with respect to these diseases. There are certain patient populations in areas of the country where macular degeneration is more common and other areas where the population isn't as elderly and may have more incidents of diabetes. So I fully expect that there's going to be some overlap, but not necessarily 100%. Okay, great.
spk10: That's helpful. And maybe the last question here is that the Given the unique sales and the usage appears to be pretty good this quarter, what types of outlook you guys may anticipate just for the remaining of the year? And thanks.
spk11: Yeah, thanks for the question and thanks for your comments relative to UT. Obviously, we're not providing any additional guidance towards the sales the remainder of the year. We are happy that the customer demand remains strong. We continue to have really good out customers and really good feedback. So, you know, we are happy with the performance of the product and with the sales force.
spk10: Okay, great. That's very helpful. And again, thanks a lot. Thank you, Yael.
spk02: Our next question comes from Yi Chen with HC Wainwright. Your line is open.
spk09: Hi, thank you for taking my question. So in the W trial, within those 53% of eyes that do not require the supplemental anti-VEGF up to six months and 35% up to 12 months, do they share any similar characteristics within those patients that could help you better enroll the patients for that W2 trial?
spk12: So I would say there was some disparity in the patient's length of time that they had disease and their OCT appearance at enrollment. But one of the characteristics that they all had was a positive response to standard of care anti-VEGF. And by positive, I don't mean just a little reduction in fluid, that these people were generally under good control with the standard of care anti-VEGF. Now retina specialists have a hard time defining good control. Some of us would say those that are getting monthly injections and are completely dry with good vision or under good control despite the frequency of injection. And so I would include patients in that category. Patients who did not have a lot of fluid and had good vision but required frequent injections. And I think that that's a niche that we really hope EYP1901 will fill. Patients that are well treated but require frequent injections.
spk09: And what would be the minimum of prior injections or minimum length of treatment before getting enrolled into the DAPL-2 trial?
spk12: So one of the inclusion criteria is the diagnosis of what AMD has been made less than nine months prior to screening. And the patients have had to have a minimum of two standard of guarantee VEGFs. And according to the enrolling investigator, they've had to show a positive response to those injections.
spk09: Got it. Thank you.
spk02: Our next question comes from Daniel Gotland with Chardon. Your line is open.
spk08: Hi. Good morning. Thank you for taking the question. I have one on the injection device. I believe that the analysts say you mentioned that you were fine-tuning or finalizing the specs for the injection device so that it can reliably deliver the implant. I just wanted to ask what the status of that is and what the remaining regulatory requirements are.
spk12: So, the status is the project is moving along very nicely. We believe we've developed a state-of-the-art injection system that will have the inserts preloaded. The device is designed to handle both UTEC and EYP1901, and we're on track to have that, we hope, tested in humans in the very near future. The regulatory part is, as you may know, the FDA has made things a little more complicated in that we're now considered a drug-device combination. However, with respect to EYP-1901, we anticipated that to be the case from the start. And therefore, we have developed from the initial start of EYP-1901 as a drug-device combination along with the new injector, we're doing all the regulatory things that will need to get done to make sure that that's met. I believe that regulatory issues also exist within the EMA, and therefore we are attuned to making sure that these regulatory requirements are met. With respect to UTiQ, because UTiQ is a prior approved product, when we do change the injection system, we will have to supply the FDA with background in that, including details around what the injection system development program consists of. Once again, I think we're, as a company, we're right on top of that, and we don't anticipate that that aspect will slow down the program at all.
spk06: We are filing robust patents around this device. It will be proprietary.
spk08: Got it. Thank you. Very helpful. And I have one big picture question to you. To Jay, in terms of your confidence for UIP1901 in DME and how does the confidence from the mechanistic sampling compares in contrast to NPDR?
spk12: So, every other product that's an anti-VEGF that's worked in one indication has worked in all indications. I think that that, you know, suggests that Virolanib, as it's released, Dura-Surg should be the same. We think that the real advantages in a disease like NPDR, in which Clearly, anti-VEGFs have a positive role in the disease course, but patients are really not getting them because of the frequency of injection. And I'd expand that to DME. While there is certainly evidence that VEGF is not the only mediator in diabetic macular edema, early on in the disease, it's primarily felt to be a VEGF-mediated disease. We also think that it's possible that virulence may have some alternative benefits. patients other than just its anti-VEGF benefits. Because it blocks VEGF receptor 1, there's probably some anti-inflammatory benefits. And as we disclosed at Investor Day, we just recently some pretty strong preclinical evidence in a retinal detachment model that virolinib actually has neuroprotection receptors. So those other potential methods of action may also be beneficial in diabetes, both diabetic macular edema and diabetic retinopathy. And again, the zero-order kinetics release combined with the ability to lengthen the cycle of injection should have a benefit.
spk03: All right. Thank you very much.
spk02: Our next question comes from Yuan Ji with B Reilly. Your line is open.
spk14: Thank you for taking our question. Just one question from us. Can you clarify for W2 12-month trial, is there a follow-up period beyond the 12 months to look into safety and viral function? Thank you.
spk12: Excellent question. Thanks for bringing that up. At present, there's not a plan to extend the study beyond 12 months. I think potentially that's something we may consider. But again, we don't plan on doing anything that's going to negatively impact the start of the pivotal trial.
spk14: Yeah, got it. Thank you.
spk02: And I'm showing no further questions in the queue at this time. 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.
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