Earnings Call Transcript - EYPT Q1 2022

Operator, Operator

Good morning. My name is Josh and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals First Quarter 2022 Financial Results and Recent Corporate Developments Conference Call. There will be a question-and-answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Chief Financial Officer of EyePoint Pharmaceuticals.

George Elston, CFO

Thank you, Josh, and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals' first quarter 2022 financial results and recent corporate developments. With me today is 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 pipeline developments for EYP-1901, and Scott will comment on our Q1 2022 commercial activities. I will close by covering the first quarter financial results and then we'll 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 corporate website, www.eyepointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations; clinical developments and regulatory matters and timelines; the potential success of our products and product candidates; financial projections; and 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 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 EyePoint Pharmaceuticals.

Nancy Lurker, CEO

Thank you, George, and apologies for my hoarse voice; I'm still getting over a cold. So, good morning, and I do want to thank you for joining us to discuss the very solid progress EyePoint made in the first quarter of 2022. Our team has maintained the positive momentum we had in 2021 and now into 2022, and the company continues to be well-positioned to create long-term value for our shareholders, particularly should subsequent clinical trials for EYP-1901 report out positively. We are keenly focused on our goal of becoming the leader in ocular drug delivery. In the first quarter, EyePoint presented additional validating clinical results of our ongoing Phase 1 trial for our lead pipeline program, EYP-1901, while simultaneously advancing two strategic corporate initiatives: refinancing our debt, and our just announced enhanced agreement with Betta Pharmaceuticals. We also made important leadership hires that position the company for long-term successful growth that encompasses our overarching mission of improving the lives of patients with serious eye disorders and bringing our innovative products to patients in the United States and around the world. Prior to turning the call over to my colleagues, I'd like to highlight a few of our achievements in 2022 so far. I'm incredibly pleased with the team's consistent execution of our Phase 1 DAVIO clinical trial for our lead pipeline asset, EYP-1901 in wet AMD. As many of you know, wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD-related blindness. But despite the safe and effective FDA-approved medications on the market, treatment adherence remains an ongoing challenge for patients and physicians. Currently, most patients with wet AMD are treated every month or every other month with eye injection. EYP-1901, which is a combination of a small molecule TKI vorolanib and our proprietary BioErodible drug delivery technology, Durasert, has the potential to transform the currently burdensome treatment paradigm for many wet AMD patients. EYP-1901 may provide the substantial benefit of a longer duration between physician office visits and eye injections of up to six months, while maintaining stable visual acuity and macular anatomy. We believe, based on our interim Phase 1 DAVIO clinical trial results, that a majority of patients can potentially be maintained with EYP-1901 for up to six months, with no supplemental therapy after an initial induction period with traditional anti-VEGF drug. Under this treat-to-maintain treatment paradigm, EYP-1901 provides a number of potential benefits, including a new mechanism of action using vorolanib, an anti-VEGF tyrosine kinase inhibitor; zero-order kinetics delivery that provides consistent stable release of vorolanib; and the potential ability to sustain a majority of patients up to six months, while potentially significantly reducing the treatment burden for patients with wet AMD. As Jay will discuss in more detail later in the call, we continue to be pleased with the ongoing Phase 1 DAVIO trial results, which showed positive safety data with no significant inflammation, as well as promising efficacy data at the six and now eight months follow-up so far. We look forward to announcing our 12-month Phase 1 DAVIO data at ASRS in July of this year. Looking ahead, we expect to initiate our Phase 2 clinical trial for EYP-1901 in wet AMD in the third quarter of 2022, and we anticipate the interim six months results in the second half of 2023. I'd like to thank the entire EyePoint team for their tireless work focused on bringing this innovative technology to as many patients as quickly as possible, and we look forward to sharing additional updates this year on EYP-1901's exciting progress. In addition to advancing the Phase 3 clinical trial of EYP-1901 for wet AMD, we are preparing to expand this innovative treatment to additional indications with a Phase 2 study of EYP-1901 for non-proliferative diabetic retinopathy, or NPDR beginning in the second half of this year. Along with our focus on the development of EYP-1901 in the U.S., we continue to consider our options for partnering outside of North America. This quarter, we entered into an agreement to develop and commercialize EYP-1901 in China and other selected Asian territories with Betta Pharmaceuticals. This extension of our current partnership was already contemplated as part of our 2020 agreement with Betta. We secured vorolanib, a critical component of EYP-1901. In addition, we expanded our rights to local delivery of vorolanib for all of ophthalmology, including DME. We look forward to continuing our work with Betta, and we also look to additional partnering opportunities outside of North America at the appropriate time. Regarding our commercial products, we had a strong first quarter with $9 million in net product revenues, an increase of 32% from the first quarter of last year, along with strong customer demand for both YUTIQ and DEXYCU. This strong start to 2022 supports our strategy as a commercial business franchise to achieve breakeven status this year. Additionally, we wanted to share an update on our Phase 3 trial of YUTIQ of potential six months sustained delivery for the posterior segment of the eye. The FDA has recently updated the regulatory requirements for ophthalmic drug and device combination products, such as YUTIQ. These regulatory changes now require EyePoint to complete an additional clinical trial YUTIQ 50, beyond what was originally communicated for the planned post-approval supplement, resulting in a significant increase in the program's anticipated cost. As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward. I would like to emphasize that this decision is driven by financial considerations only. We still believe in the safety of YUTIQ 50 and its potential clinical utility given the proven track record of YUTIQ 180. Despite this, as an organization, we recognize that we must take a disciplined approach to our pipeline investments and continue to focus our resources on the EYP-1901 clinical development. I'd also like to add that we remain committed to serving the posterior segment uveitis patient community with YUTIQ 180, and learn more about this serious eye disorder to improve patient outcomes through our ongoing YUTIQ CALM Registry Study, which is the first and only registry trial for posterior uveitis, and our YUTIQ Phase 4 Synchronicity Study, which is a prospective, open-label, uncontrolled, two-year follow-up study designed to evaluate the safety and efficacy of the YUTIQ 180 endometrial implant for posterior segment uveitis. We plan to update the scientific and patient communities on these important studies in the months to come. As you'll hear from George later on, we remain well-capitalized to execute on our pipeline, and we remain focused on EyePoint's financial health and cash runway. This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2.8 million of annual interest savings. Finally, we made important leadership appointments in the first quarter, building out our growing team with two new industry veterans. Earlier this year, we were very pleased to announce the appointment of Michael C. Pine as Chief Corporate Development and Strategy Officer. He brings more than 20 years of business development and strategy experience to EyePoint Pharmaceuticals, and we are thrilled to have him on board during this exciting time in the company's evolution. Recently, EyePoint also appointed Isabella Lefebvre as Chief Regulatory Officer. Ms. Lefebvre brings over 30 years of global regulatory affairs experience across all phases of drug development, especially in ophthalmic conditions, and we look forward to receiving her guidance on FDA-related matters and global regulatory strategies. I'd like to thank the talented EyePoint team for the company's clinical, operational, and financial success to date. As we advance the future of sustained ocular drug delivery, we look forward to executing on multiple near-term clinical catalysts so that we can deliver improved ocular treatment and ultimately, create a better future for patients living with 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, EYP-1901, as well as other pipeline initiatives. Jay?

Jay Duker, COO

Thank you, Nancy, and good morning, everyone. Before I begin, I want to reiterate what an exciting time this is as our team is poised to execute on multiple clinical catalysts this year as we advance our pipeline. As Nancy stated earlier, we are quite pleased with the results of our Phase 1 DAVIO clinical trial for our lead pipeline program EYP-1901, an investigational sustained-release delivery treatment for wet age-related macular degeneration, being studied as a maintenance therapy following induction therapy with an anti-VEGF, a therapeutic approach, which we refer to as treat-to-maintain. The largest unmet need in the wet AMD landscape is the longevity of action of anti-VEGFs. Our goal is to sustain the majority of wet AMD patients' treatment interval up to six months or longer after a single injection of EYP-1901, allowing patients and practitioners the flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained intravitreal delivery of an anti-VEGF drug. The recent positive eight-month safety data and efficacy results give us increased confidence that EYP-1901 may have a differentiated profile for safety, efficacy, and tolerability in wet AMD. Before we review the data, I'd like to touch on EYP-1901's use of the Durasert delivery technology and its differentiation from alternatives in the retinal drug delivery landscape. BioErodible Durasert allows for true sustained release of drug with zero-order kinetics after an initial beneficial burst of medication. In its non-erodible formulation, Durasert has a best-in-class track record of proven safety, tolerability, and consistent medication delivery. Durasert has been safely administered to thousands of patients across four U.S. FDA-approved products, and the safety and efficacy results we have seen so far with the BioErodible formulation used in the DAVIO trial bolster our confidence in this differentiated drug delivery system. EYP-1901 combines a BioErodible formulation of the Durasert sustained-release technology I just described with vorolanib, a small molecule tyrosine kinase inhibitor. Vorolanib binds to the VEGF receptors, blocking all isoforms of VEGF as well as PDGF. This is different from the antibody fragmented trap molecules that are the current anti-VEGFs on the market today. These molecules bind VEGF. This differentiated anti-VEGF mechanism of action, coupled with our BioErodible Durasert zero-order kinetics technology, could potentially change the treatment paradigm to a much less burdensome approach with EYP-1901, which we have coined treat-to-maintain. Turning now to our DAVIO study. DAVIO is a Phase 1 open-label dose escalation trial that enrolled 17 patients across four dose cohorts. All enrolled patients were previously treated with standard-of-care anti-VEGF therapy; no reinjection with the study drug was performed during the study, and typical criteria for supplementation with a standard-of-care anti-VEGF was employed. Following a positive six-month data readout in October of last year, we reported positive interim eight-month safety and efficacy data from the DAVIO trial in February at the Angiogenesis 2022 Virtual Meeting. We're quite pleased with the interim results we have observed so far. Importantly, we've seen impressive efficacy and durability, with over 50% of patients supplemental anti-VEGF-free up to six months and 41% up to nine months, as well as significant reduction in treatment burden for patients, with 79% at six months and 75% at eight months. Additionally, we observed stable visual acuity and central subfield thickness as measured by optical coherence tomography, with the updated eight-month data showing a change in best-corrected visual acuity of minus three ETDRS letters and a central subfield thickness change of plus 13 microns. Furthermore, the eight-month data highlighted positive safety, with no ocular serious adverse events and no drug-related systemic SAEs. Additionally, no dose-limiting toxicities, no retinal detachment, no cases of endophthalmitis, no occurrences of implant migration into the anterior chamber, or any posterior segment ocular inflammation were reported. As Nancy mentioned, we planned to initiate a randomized controlled Phase 2 study of EYP-1901 for previously treated wet AMD in Q3 2022. The wet AMD Phase 2 trial is expected to enroll 144 patients, randomly assigned to one of two doses of EYP-1901, approximately two milligrams or three milligrams, or an aflibercept control. The efficacy endpoints are change in best-corrected visual acuity, change in central subfield thickness as measured by OCT, time to supplementation, and safety. Looking ahead, we anticipate sharing interim six-month data for this Phase 2 trial in the second half of 2023. We are also working to explore the paradigm change in treatment potential of EYP-1901 in several other severe eye disorders, including diabetic retinopathy, diabetic macular edema, and retinal vein occlusion. In the second half of this year, we plan to initiate a Phase 2 trial of EYP-1901 in non-proliferative diabetic retinopathy. In addition, we now expect our third Phase 2 trial employing EYP-1901 in serious ocular disease will be for the indication of DME. Diabetic macular edema is the most common sight-threatening complication of diabetic retinopathy. We expect to initiate this Phase 2 trial in Q1 of 2023. We will continue to provide clinical updates on these additional indications throughout the year as our rapidly growing pipeline advances. I will now turn the call over to Scott Jones, Chief Commercial Officer, for the commercial update. Scott?

Scott Jones, CCO

Thank you, Jay. We're excited to record a strong quarter for our commercial business with $9 million of net product revenue, an increase of 32% from the first quarter of last year. Our Q1 net product revenue for YUTIQ and DEXYCU was $4.6 million and $4.4 million respectively. Customer demand was approximately 14,800 units of DEXYCU and 650 units of YUTIQ compared to approximately 13,000 units and 650 units, respectively, in Q4 2021. Customer demand for DEXYCU saw approximately 7% growth from Q4 2021. Customer demand for DEXYCU came from our strong commercial presence and our collaboration with our commercial alliance partner, ImprimisRx, which assumed full responsibility for U.S. sales and marketing activity for DEXYCU as of January 1, 2022. EyePoint retains the DEXYCU NDA, revenue recognition, manufacturing, and distribution responsibilities for all markets. ImprimisRx has been a strong partner and we look forward to continued growth for that franchise. Customer demand for YUTIQ remains strong due to ongoing expansion of YUTIQ sales efforts into the retina community for the treatment of posterior segment uveitis and from an approved siliconized needle that provides preferred procedural experience for physicians and patients. Although demand for YUTIQ was consistent with Q4 2021, it's important to note that historically, first quarter demand numbers usually turn down due to insurance deductible resets for these patients. We are incredibly pleased by the progress we've made of our commercial businesses and with the performance of our commercial teams. Our mission is to continue to provide a unique, sustained delivery system across all platforms that provides fewer visits to the doctor's office, a key attribute for each product's value proposition for both patients and doctors. We look forward to updating you on revenues and demand in the quarters to come. I'd now like to turn the call over to George to review the financials. George?

George Elston, CFO

Thank you, Scott. As the financial results for the three months ended March 31, 2022, were included in the press release issued this morning, my comments today will focus on a high-level review for the quarter. To begin, in the first quarter, we continued our balance sheet focus and entered into a new loan agreement with Silicon Valley Bank to replace our existing CRG credit facility with improved economic terms. The new loan agreement with Silicon Valley Bank provides for senior secured credit facilities in the aggregate amount of $45 million and reduces the loan interest rate from 12.5% to a blended rate of approximately 5%, resulting in an estimated $2.8 million in annualized interest savings. For the first quarter ended March 31, 2022, total net revenue was $9.3 million, compared to $7.3 million in the quarter ended March 31, 2021. This includes net product revenue for the first quarter of $9 million compared to net product revenue for the first quarter ended March 31, 2021, of $6.8 million, an increase of 32%. Net revenue from royalties and collaborations for the first quarter ended March 31, 2022, totaled $0.3 million compared to $0.5 million in the corresponding period in 2021. Operating expenses for the first quarter ended March 31, 2022, totaled $27.6 million versus $18.3 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, including non-cash stock-based compensation. Non-operating expenses totaled $2.7 million, and the net loss was $21 million, or $0.56 per share, compared to a net loss of $12.3 million, or $0.50 per share, for the prior year period. Cash and investments at March 31, 2022, totaled $190.8 million compared to $211.6 million at December 31, 2021. We expect the cash and investments on hand at March 31, 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 EyePoint's progress in the first 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 will now turn the call over to the operator for questions.

Operator, Operator

Thank you. Our first question comes from Georgi Yordanov with Cowen. You may proceed with your question.

Georgi Yordanov, Analyst

Hi, team, thank you so much for taking our questions and congratulations on all the progress. So, maybe just a few on our end, now that you have the full DAVIO data, appreciating the fact that is to allude to the number of patients, but has this data helped you better refine the commercial opportunity for 1901? Who do you think would be the most optimal patient for a maintenance product like that and what percentage of the patient population do these patients represent? And then secondly, given the efficacy we've seen from 1901 in DAVIO, what do you see as the main risks to a successful registrational trial? And I guess related to that, what would be the most optimal trial design that could maximize your chances of success while still ensuring you get the durability you've demonstrated so far on the label?

Nancy Lurker, CEO

Wow, that's quite a list. Good morning, Georgi. Let me see if I can answer an overview, and then I'm going to triage it out to the team here. So, if we missed some of your questions, just reiterate them. I would say definitely as the data continues to come in, of course, it refines our approach, because it informs exactly how long this is working. And we remain really pleased with what we're seeing. I mean, we're out nine months on, which we've reported on, rescue eight months on overall safety and efficacy, and we continue just to see really good sustainability of treatments. Now, we're going to continue to keep this designed as a six-month treatment just because we want to be able to capture a majority of patients. And we still believe, obviously depending on Phase 2 results, that a majority of patients can be treated with EYP-1901. I want to just elaborate a bit on this treat-to-maintain approach that we're taking. It's important to understand that we're not here to replace current anti-VEGF; they are very effective and safe. The problem, as we all know, is they're not as durable and long-acting as patients really need, particularly given the fact patients have to keep coming in all the time to doctors' offices to get their eyes injected, which is a real burden. So, the goal is to be able to first go ahead and induce your patients with an anti-VEGF, get the eye as cleared up as possible, and then you can put in EYP-1901 to maintain that patient. So, treat-to-maintain for we hope, a majority of patients up to six months. And then for some patients, who may be particularly resistant to anti-VEGF therapy, or they just can't get rid of all the fluids, you can supplement as needed with existing therapies. So, that is—and again, because we have two different mechanisms of action on board, there is often a benefit, though I want to put caveats that we don't know everything yet—could be I want to put caveats, we don't know everything yet to having two different mechanisms of action at work on the eye. So, we think there's a lot of benefits for patients. We continue to have a group headed up by Scott; I'm going to let him comment just a bit. We just launched a new group for early commercial development. Scott and his team's task is to begin to more fully understand the commercial opportunity and what we need to do to more appropriately develop that commercial opportunity because it is a new treatment paradigm.

Jay Duker, COO

Yes, thanks, Nancy. And I think you've covered things well. I probably just add a few more thoughts based on the DAVIO results. Georgi, you asked what percentage of wet AMD patients would benefit from this treatment? The way I would answer that is based strictly on the 17 patients from DAVIO, one would extrapolate that the market would be at least 85% of wet AMD. What I mean by that is there was a clear-cut benefit to about 85% of the patients who enrolled in the trial, either they didn't require any supplemental anti-VEGF, or if they did require supplemental anti-VEGF, it was at a very reduced rate compared to prior to enrollment. Now, I think we can speculate in more of a broad spectrum of what AMD patients, not the spectrum we enrolled in DAVIO that the benefit might be greater than that. But again, that's speculation. That's why we're doing a Phase 2 trial to see in a broader population of wet AMD patients than what we enrolled in DAVIO, how—what percentage is going to benefit and we're optimistic that that benefit will be a majority of patients. The major risks—major risks of any trial are safety and efficacy at a very high level. The good news, as with N equals 17, we really had no safety issues. Of course, that's a small number. We're confident though that safety will probably not bubble up to be a problem. And the confidence stems from the experience with Durasert in tens of thousands of patients, number one. And the safety of vorolanib, both preclinical and so far in patients. I have to say that in our preclinical studies, we haven't been able to find a maximally tolerated dose in animals for EYP-1901. And I think that would be a safe thing to say N equals 17 from the Phase 1 that we didn't find an MTD in humans either. So far, it looks safe. Again, anything can happen as you expand these trials. From an efficacy perspective, from the risks—the number one thing we're trying to hit here is non-inferior visual acuity compared to EYLEA. That's the primary endpoint. Looking at the DAVIO trial, and again, trying to extrapolate over six months, we're optimistic that that's a value that we will be able to statistically meet. But obviously, that's the big risk as well that in this population or with whom you enroll, that you won't be able to achieve that. But certainly, extrapolation would suggest that we have a very good chance. Last question was around trial design and once again, the trial design is an iterative process. When we get more data, and the data suggests that a trial should be designed in a specific way, that's the way we go now. Our wet AMD Phase 2 DAVIO 2 trial is really on target to start in the third quarter of this year; the protocol is set, and that protocol inclusion/exclusion criteria was largely influenced by the patients that we saw who did well in DAVIO 1 and those who didn't. I think those inclusion/exclusion criteria will reflect that. So, I hope we covered everything. I think if there's any commercial comments, perhaps Scott can weigh in.

Scott Jones, CCO

Sure. Thank you for the question. As Jay said, I think there we're still examining the exact percent of patients, but certainly a large percent of the currently treated patients we believe will be correct for our potential therapy. But just to take a step back to think about why there is such a need for this in the marketplace. As you know, that it's currently AMD, it's a very large market. But if you think about what's going to occur in the next several years, we have an aging population. We have an expansion of the number of patients with diabetes. We currently have a very undertreated diabetic retinopathy market. And the number of retina specialists isn't expanding appreciably to be able to meet those needs. So, the demand for more durable therapy, we think it's—we're just meeting a need that is growing every day. So, we certainly think there is just an enormous opportunity for us to bring a durable therapy to the marketplace. But again, as Jay said, we're currently evaluating which patients we believe will be the most appropriate as we move forward. I'm certain that we'll have more information to come in the coming years.

Nancy Lurker, CEO

Hopefully, we captured all your questions, Georgi?

Georgi Yordanov, Analyst

Incredibly comprehensive. Thank you so much, really appreciate it and congratulations again on the results.

Operator, Operator

Thank you. Our next question comes from Yatin Suneja with Guggenheim. You may proceed with your question.

Yatin Suneja, Analyst

Hey guys, congrats on the result. Just a couple for me. First is on the 1901 Phase 2 study. Just I think one of the confusion out there is that I think we and the investor community are used to thinking about EYLEA or other injections as a comparison. So, just help us understand what the right come to us it seems like poor delivery study that was run with the center's might be the right to think about how you are conducting the Phase 2 study. Can you maybe comment on that; is that the right way to look at it? And then obviously, the study is going to start in Q3. Can you talk about how long it might take for you to report the interim data? Any ballpark you could give on the enrollment and data readout timeframe that'd be helpful? Thanks.

Nancy Lurker, CEO

Sure. No problem. Jay, why don't you take those questions?

Jay Duker, COO

Sure. So, Yatin, thanks for the questions and as usual, very insightful. The first is a comparison of our trial, and I would say at a high level, the primary endpoint of non-inferior visual acuity is what has been used in all the recent wet AMD trials. Once you have a standard of care—the standard of care was LUCENTIS initially, and that's how the comparisons needed to be set. Non-inferiority margins were determined by the prior studies, by the size of your study and the statistics involved. So at a very high level, one could look at any of the recent studies that were non-inferior visual acuity. However, as you point out, we're looking at a different patient population. The only previous trial that looked at a non-naive patient population for maintenance therapy was the poor delivery system. So in some ways, the poor delivery system trials would be in some ways comparable to the patient population that we're enrolling. However, their control group was monthly; it was LUCENTIS. Our control group is monthly EYLEA times three, and then EYLEA every other month after that. So, we have a bit of a different control group as well, with a different treatment interval. And I'd also like to point out that given that EYLEA will be dosed after the first three months as every other month, there's the potential for anti-VEGF supplementation in our control group, which I believe is a bit unique for any of these studies. So while there are comparisons to many of the previous wet AMD trials, I'd say, given the patient population, the longevity of action of our drug, and the rescue criteria, there are also going to be some differentiation. But at a very high level, what we're trying to do is inherently different than what some of our previous anti-VEGF molecules have been trying to do, which is again, as Nancy pointed out at the beginning, we're not necessarily replacing EYLEA or Faricimab; we are working to maintain the gains that those drugs give patients initially over the long-term, because we're sustained release, which helps to account for patients who can't make it back for visits or extended intervals that have been extended beyond perhaps what might be safe. Because we know in the real world, patients with these branded drugs still over the year or two into their disease lose much of the visual gain that they had. So, there's a definite unmet need out there for continuous treatment. And that's what we aim to provide.

Nancy Lurker, CEO

Yes. Let me just also add on to your last question, Yatin, which was, we expect that we will report out the Phase 2 wet AMD results in the second half of 2023. So, we're on track with this; of course, timing of all the patients to being enrolled is still a variable, but we're pulling out all the stops to enroll as quickly as possible. As we stated earlier, we're on track for the third quarter of this year to enroll our first patient.

Yatin Suneja, Analyst

Got it. Just one more question, if I may, with regard to the update on the YUTIQ 50 that you're pausing the study. Can you just provide a little bit more detail on what exactly the FDA asked us to do that may be driving the cost of this program?

Nancy Lurker, CEO

Yes, good question. As again, some people may know, but others may not. The FDA recently issued new guidance related to drug-device combinations. This new guidance was a result of a lawsuit that was filed by another company against the FDA on their particular product, and it's called the genius decision that was handed down by an appellate court. As a result, the FDA issued new guidance. And as a result of that, for some products, they want more studies to be done. And that's the case with YUTIQ 50. So instead of one study, they're requiring now two studies. We don't see any impact right now on EYP-1901, because we already are anticipating that we will be doing multiple Phase 3 pivotal studies. So we don't see any impact on YUTIQ—excuse me, EYP-1901; unfortunately, we had planned for one study on YUTIQ 50, and the guidance is now that we have to do two studies. So as you can imagine, YUTIQ is a nice, steady consistent product, growing very nicely in revenues, but it's never going to be a huge drug, as I've often said. It is going to deliver some nice profits to the bottom line over an extended period of time, because we don't have to put a lot of money into it. However, these are not large drugs. And so as a result, the cost of doing another Phase 3 study for YUTIQ 50 may become problematic for us to see the ROI on YUTIQ 50.

Yatin Suneja, Analyst

Got it. So basically more of an ROI or NPV decision. It seems like two studies, but given that for 1901, you will be required to do multiple studies until it gets approved should not have retrieved, right?

Nancy Lurker, CEO

Yes, exactly.

Yi Chen, Analyst

Thank you for taking my questions. The first question, just to clarify, with respect to the new FDA regulations for companies and drug-device, does it apply to the non-erodible Durasert technology as well as the relative to some technology?

Nancy Lurker, CEO

Yes. Let me just reiterate a couple of things. Yes. And by the way, let me just reiterate, it applies to a number of ophthalmology and even non-ophthalmology products. This is not specific to just ophthalmology or even our product; it's a drug-device combination, so regulation. So anytime that you have a drug combined with a device, and the definition of a device is quite broad, I might add, the FDA now has to require more data. But I want to reiterate the way that the regulations based on the ruling came out is that it doesn't add anything more to 1901, because 1901 is delivered in an injector. Obviously, it's also in an implant. It qualifies under these regulations. But we always anticipated doing all the work that is being promulgated. The difference was in this particular case, YUTIQ 50, they need more than just one study, because the YUTIQ 50 was not previously on the market, and we did not have a clinical study around it. So they need two clinical studies, which, as I said, we always anticipated with the multiple indications on 1901, regardless.

Yi Chen, Analyst

Thank you. And just to confirm, there's no upfront payment for the Betta Pharmaceuticals licensing agreement, right?

Nancy Lurker, CEO

That is correct.

Yi Chen, Analyst

Okay. Last question: for the upcoming NPDR Phase 2 trial in the second half of the year, what will be the drug used in the control group?

Jay Duker, COO

Yes, at this point, the control group will consist of a sham EYP-1901 injection, so there will be no active control.

Yi Chen, Analyst

Okay. Do you think it will be necessary at a certain point in the future to evaluate the drug against an active control?

Jay Duker, COO

We really can't speculate on that. At the current time, we believe from a regulatory perspective. As of now, that's not necessary. But that could change in the future. But our current belief in discussing this with regulatory advisors is that sham non-active control is still permissible. And that's because while there are two FDA-approved products in this space for DR, the usage of them is so minimal.

Operator, Operator

Thank you. 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 concludes your program, and you may now disconnect. Everyone have a great day.

Nancy Lurker, CEO

Thank you, everyone.