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spk04: Good day and thank you for standing by. Welcome to the I-Point third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, George Elston, Chief Financial Officer. Please go ahead.
spk08: Thank you all for joining us on today's conference call to discuss iPoint Pharmaceutical's third quarter 2021 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 recent progress made on our commercial activities. I will close with commentary on the third quarter 2021 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 the release can be found in 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 in regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of the various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is filed and on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represents 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.
spk02: Thank you, George. Good morning, everyone, and thank you for joining us. We are pleased with our progress during the third quarter, as I point pharmaceuticals continue to make progress across our ocular pipeline to treat serious ocular diseases, as well as maintaining customer demand across our commercial business. We remain laser focused on executing on our overarching mission of bringing innovation to patients with serious ophthalmic diseases. Prior to turning the call over to my colleagues, I'd like to discuss a few of our recent achievements from this past quarter. Importantly, our team continues to advance our Phase 1 DOBO trial for our lead pipeline asset, EYP-1901, a potential twice-yearly treatment for wet age-related macular degeneration, or wet AMD. And we're very much on track to report interim data in the coming weeks. To reiterate our progress throughout 2021, we initiated our Phase 1 trial, dosed the first patient, and completed trial enrollment. Notably, last month, we were pleased to report preliminary three-month safety data for all doses from the Davio trial at the American Society of Retinal Specialists, citing no serious adverse events, ocular or systemic, no adverse events related to significant ocular inflammation or best-corrected visual acuity reduction, nor an elevation of interocular pressure in all 17 patients enrolled. Additionally, no events of endophthalmitis, retinal detachment, or migration into the interior chamber were reported. We're incredibly excited about our progress and we're looking forward to reporting interim safety and efficacy results later this month. Should the results of our Davio interim data prove to be positive, we anticipate starting phase two trials next year. In addition to our focus on EYP 1901, we remain committed to the initiation of a phase three trial for UTIC 5.0 in the fourth quarter of this year. UTIC 5.0 is a potential six-month sustained delivery treatment for uveitis affecting the posterior segment of the eye. UTIC 5.0 will be filed as an SMDA upon completion of this single phase three clinical trial. UTIC 5.0 represents an important part of our expanding pipeline, and we look forward to updating you on our progress in the upcoming quarters. Also included at ASRS was an e-poster presentation highlighting our UTIC CALM real-world registry study, collecting data on patients who have received the UT-CAM plant. This study included patients 18 years of age and older with a diagnosis of noninfectious uveitis affecting the posterior segment. The importance of the UT-CALM real-world registry study cannot be understated. The study is the first of its kind. As I point, we'll be diligently tracking patients suffering from posterior uveitis for up to five years and possibly beyond. The longitudinal data from the CALM study provides scientists and physicians with a unique opportunity to, for the first time, understand the etiology and disease progression of this devastating eye disease. Most importantly, the study should show how UTIC is positively impacting patients' disease compared to standard of care, therefore serving as the foundation for continued innovation in the treatment of posterior segment uveitis. At ASRS, we were very pleased to report that most patients had relatively controlled intraocular inflammation, the hallmark of uveitis, and the registry study continues to progress as we enroll and follow more patients. Turning to our commercial business, we're pleased to report continued growth in underlying customer demand for both products and net product revenues from our shipments to distributors up 49% from Q3 2020. This continued recovery from the pandemic represents an important shift in our patient's comfort level of returning to the doctor's office, and we look forward to bringing our products to more patients in need of transformative ophthalmic therapies. Finally, on Monday, I was very pleased to announce the appointment of Dr. Jay Duker as Chief Operating Officer at iPoint, taking on a full-time expanded role as we continue to develop and advance our innovative pipeline programs. Jay's extensive entrepreneurial experience coupled with his decades of service as chair of the ophthalmology department at Tufts University and his many publications on retinal eye diseases proves him invaluable to iPoint, and we're thrilled to have him on board in this new role. I'd like to thank our fantastic team at iPoint Pharmaceuticals for our company's clinical, operational, and financial success to date. We're very proud of our work thus far across all fronts and look forward to continuing our momentum into the fourth quarter of 2021 and throughout 2022. We're excited about the future of iPoint Pharmaceuticals as we execute on multiple clinical catalysts and strengthen our commercial business while maintaining a strong balance sheet. 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?
spk10: Thank you, Nancy, and good morning, everyone. Before I begin, I would like to sincerely thank Nancy and the entire I-Point Pharmaceuticals organization for their continued trust in me and overarching support as I begin my new role as Chief Operating Officer. I look forward to building I-Point into an even more successful clinical and commercial company as we continuously build out our pipeline and grow our business. As Nancy stated earlier, we are excited with the progress thus far on our phase one Davio trial for our lead asset EYP1901, a potential twice yearly treatment for wet age related macular degeneration. We continue to underscore the pride we feel for our clinical and regulatory teams who have so far flawlessly executed our phase one trial. Our team managed to initiate then complete enrollment of all 17 patients in under four months. We are pleased with the recent, very encouraging, positive three-month safety data report, and we are looking forward to reporting further safety and initial efficacy data later this month on Saturday, November 13th at the American Academy of Ophthalmology in New Orleans. Wet AMD is a chronic, progressive, and potentially devastating eye disorder. Its hallmark is the development of abnormal blood vessels under the macula, which is the center of the retina, that leak fluid and blood. It typically presents with blurred and distorted vision and can result in a permitted blind spot in the central vision. It is the leading cause of vision in people over 65 years of age in the United States and other developed countries. Despite safe and effective FDA-approved medications on the market to treat wet AMD, there is a significant opportunity for longer-lasting therapies than those currently available. I-Point seeks to provide a reliable, safe, long-term, sustained release treatment option that would allow fewer visits to the doctor's office than the current standard of care. Our lead asset, EYP1901, is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of iPoint's proprietary Duracert sustained release technology, which has been utilized in four FDA-approved products, combined with Virolinib, a tyrosine kinase inhibitor. The Phase 1 Davio trial is an open-label dose escalation trial that enrolled 17 patients across four dose groups. All enrolled patients were previously treated with standard-of-care anti-VEGF therapy. The positive three-month safety data we reported in October at the American Society of Retina Specialists for the Phase 1 Daviau trial with EYP1901 highlighted some critical safety observation. Most importantly, there were no serious adverse events, ocular or systemic, amongst any of the patients thus far in the trial. In addition, there were no reported adverse events related to severe intraocular inflammation, best corrected visual acuity reduction, or any elevation of intraocular pressure in any of the 17 patients. The post-dosing follow-up also showed no events of endophthalmitis, migration of the EYP1901 insert into the anterior chamber, retinal vasculitis, or vitritis. With this very clean safety data in hand, we remain excited about EYP1901's potential to alter the paradigm for patients with wet AMD, as well as the potential application of EYP1901 to other severe eye disorders, including diabetic retinopathy and retinal vein occlusion. As we've discussed in prior quarters, we're on track to initiate a Phase III 60-person, six-month clinical trial for UTIC50, a potential six-month sustained delivery treatment for uveitis affecting the posterior segment of the eye in the fourth quarter of this year. UTIK50 will use the same non-erodible duracert and corticosteroid as is used in UTIK, which has a proven track record as a clinically and commercially viable product used in thousands of eyes across the country. UTIK50's design offers an intravitreal insert with a shorter duration of action, that provides physicians with the flexibility to dose over shorter intervals compared to the three-year interval that UT currently provides. We plan to file an SNDA with the FDA and we expect to initiate our phase three trial in the fourth quarter of this year. We look forward to providing an update on EYP-1901 as well as our other pipeline initiatives over the upcoming quarters. As Nancy mentioned, at the American Society of Retina Specialists meeting, we reported preliminary data from our UTIC-COM, a real-world registry study of the flucinolone implant in chronic noninfectious posterior uveitis. This real-world registry study is collecting data on patients who have received the flucinolone implant. This study includes patients 18 years of age and older with a diagnosis of noninfectious uveitis affecting the posterior segment and who have no contraindications to the implant. We're excited to see that most patients had relatively good control of their intraocular inflammation as measured by interchamber cell and vitreous haze. The registry is ongoing and we look forward to reporting additional data at upcoming meetings. I will now turn the call over to Scott Jones Chief Commercial Officer for the commercial update. Scott.
spk07: Thank you, Jay. We're pleased the third quarter customer demand sustained its rise from pre-COVID levels, and we reported a 49% increase in net product revenues for commercial products, DEXA-Q and UT, compared to Q3 2020. Like many commercial companies, our net product sales and underlying customer demand were negatively impacted by the COVID-19 pandemic in 2020 and into 2021. And we're pleased to see patients return to doctor's offices and schedule their previously delayed surgeries and procedures. Our Q3 net product revenues of 8.6 million increased from 5.8 million in Q3 2020. This includes net product revenues of $4.7 million and $3.9 million for Dexa-Q and UT respectively. Customer demand was approximately 13,100 units of Dexa-Q and 560 units for UT, increases of 175% and 22% respectively from Q2 2021. Customer demand for Dexa-Q continues to stem from both our strong sales and marketing team and our collaboration with our commercial alliance partner, InframusRx. Customer demand for UTiQ remains strong, in part a result of the improved siliconized needle our commercial team rolled out this year, providing a more optimal procedural experience for physicians and patients. We are incredibly pleased by the progress we've made during the third quarter to return DexaQ and UTiQ to pre-pandemic levels. iPoint's mission is to provide a unique, sustained delivery system across all of our products that require fewer visits to the doctor's office, a key attribute for each product's value proposition that both patients and doctors rely on. We'd also like to thank all of our patients and doctors for their continued support and use of our products. 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?
spk08: Thank you, Scott. As the financial results for the three months ended September 30th, 2021 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 three months ended September 30th, 2021, total net revenue was $9.1 million compared to $15.7 million for the three months ended September 30th, 2020. This includes net product revenue for the third quarter of $8.6 million compared to net product revenues for the third quarter ended September 30th, 2020 of $5.8 million. Net revenue from royalties and collaborations for the third quarter ended September 30th, 2021 totaled $0.5 million compared to $9.9 million in the corresponding period in 2020. This decrease was driven by one-time milestone payments received in Q3 2020 that did not recur in 2021. Operating expenses for the quarter ended September 30, 2021, totaled $24.4 million versus $17.7 million in the prior year period. This increase was primarily due to a $4.4 million increase in R&D expense, a $2.1 million increase in sales and marketing expense, and a $0.3 million increase in G&A expense, offset by a $0.1 decrease in cost of sales. Non-operating expense net totaled $1.4 million and net loss was $16.7 million, or $0.58 per share, compared to a net loss of $3.8 million, or $0.30 per share, for the prior year period. Cash and cash equivalents at September 30, 2021, totaled $119.7 million, compared to $44.9 million at December 31, 2020. We expect the cash on hand at September 30, 2021, and expected net cash inflows from our product sales will enable us to fund our current and planned operations through the end of 2022. In conclusion, we are thrilled with iPoint's progress in the third quarter and first nine months of 2021 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 now turn the call over to the operator for questions.
spk04: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Ken Catattori from Cowan & Company. Your line is now open.
spk09: Hi, everyone. This is for Ken. Thank you so much for taking our questions, and congratulations on all the progress. So maybe we can start with Dr. Duker. Given the highly anticipated readout next week for Davio, could you maybe frame what are the most important aspects of the results investors should focus on, given that it will be the first time we'll be seeing data from 1901? And then I have a few more follow-ups.
spk10: Sure. Thank you very much for the question. And given that this is a Phase I trial whose primary endpoint is safety and that is the most important thing to focus on, is does the product appear to be safe in these 17 patients? Remember also, we hope to enter a market that has several FDA-approved products that are very safe, and therefore safety really is paramount. Beyond safety, I think we'd all hope to see some sign that, the EYP1901 insert is controlling wet macular degeneration. So given that this is a previously treated population of patients, we would anticipate that if there is some sign of efficacy, it would mean stable visual acuity and stable fluid on OCT. Beyond that, We do hope to show a significant number of patients who are able to go at least four months without having a standard of care rescue. And we also hope that there is some reduction in what we would refer to as treatment burden. Treatment burden means a calculation of the ratio of how many injections did the patients get prior to enrolling in our study against how many did they get for the six months following enrollment. So I think those five issues with safety being by far the most important are what we all should look closely at.
spk09: Thank you. This is very helpful. And then maybe could you also remind us of the number of patients and doses for the four cohorts we'll be seeing data from? And how long of a follow-up should we expect for the higher dose groups? Sure.
spk10: So we have 17 patients enrolled. Three patients were enrolled in the lowest dose, which was 400 micrograms. One patient was enrolled in a low-medium dose, which was approximately 1 milligram. Eight patients received approximately 2 milligrams. And five patients were in the high dose, which is approximately three milligrams. We should have virtually all the six-month visits occur prior to data. Again, we have them scheduled for prior to the AAO, but given that the patients don't necessarily all come in for their visits when they're scheduled, we certainly can't guarantee that. But the vast majority, well over 90% of the visits should have occurred by the time we released the data.
spk02: This is a great thing. Let me get back to you. Let me add a comment as well, which is that we're going to be looking at how far we can get patients out, obviously, at four months, five months, six months, and beyond. So I just want to add that it's not just four months.
spk09: Yeah, got it. Thank you so much, and we're looking forward to seeing the data. Thank you.
spk04: Thank you. Our next question comes from the line of Jennifer Kim from Cantor Fitzgerald. Your line is now open.
spk01: Hey, good morning. Congrats, everyone, and thanks for taking my questions. I have a couple of here. The first one is just on the quarterly numbers. The implied ASPs look to be a bit lower for UDIC and DEXA-Q, just looking at the number of units sold compared to the revenue performance. And in particular, the DEXA-Q units, I think, were up around 20% quarter-over-quarter, but sales were up around 2%. So I'm just wondering if you have any color here on how we should think about, I guess, the sales price per product going forward. And then my second question is SG&A and R&D both ticked up a bit this quarter, and do you have any color on what drove that and how we should think about modeling those going forward? I have one more, but I'll wait until after.
spk02: George, why don't you take those?
spk08: Sure. Yes, Jennifer, a couple of things. First, with revenue, keep in mind that the units that we report in the earnings release is underlying customer demand. We recognize revenue based upon revenue purchases by distributors from us, and then we report the demand to show the underlying business. And so there's always going to be a disconnect between what we show in customer demand and what actually gets purchased by distributors. And so that straight, you know, it's not perfect. There's always inventory swings in between. So doing a straight calculation on ASP isn't really that easy based on those numbers. I will say that, you know, product mix does come into play a little bit. You know, UT has a much higher price than Dexacute. And so I think from a general perspective, our UT pricing has stayed pretty consistent. That product is not discounted. Dexacute does go through some level of rebates and discounting for that customer base. And so we're going to see a swing in ASP. on a total calculation simply because of the way that unfolds. And I would say that Dex-EQ will certainly weight any swings in that more than UTIC will. On the P&L side, R&D is really driven based upon the ongoing Phase I study as we continue to focus on building our pipeline. And so certainly clinical costs associated with EYP-19-1 are a big component of that. There's also some underlying non-cash spending related to stock compensation, and that's affected both R&D and G&A as we've continued to build out the R&D organization. That's the quick answer there.
spk01: Okay, great. And then one more question. Jay, first of all, congrats again on your new role. For you, I'm just wondering, what are you most excited to do Under your new role, where are your priorities? And I guess what would you highlight in terms of where your focus is?
spk10: Well, thanks for the congratulations. It's my third day on the job, so I'm still trying to find out where the coffee maker is. But, you know, my priorities at a high level are kind of doing what I've been doing for 30, 31 years, which is helping people to see better. This is just a different way of doing it. we are focusing on a large population, not an individual sitting in front of me in my office. So I think with success, this type of position, we're able to really help people in a very, very large fashion as opposed to one at a time. The skill set that I bring, I think I've honed for the last 30 years running a large department and starting companies and and having responsibilities of moving programs forward. I think they're still going to have a lot to learn because there's a lot about the corporate side of things that, despite having been a part of the company for almost a year and a half, I've still got to really get a handle on. But essentially, at a very high level, what I'm trying to do is save people's sight.
spk01: Great. And are you more excited, I guess, in terms of where your excitement is, Is it on 1901 or is it really on driving, I guess, the technology and, you know, given your previous experience with Hemera, are you more excited about the early pipeline?
spk10: Yeah, it's even beyond that. Yeah, I mean, those are all things that are exciting. The Duracell technology is really terrific. In taking a step back and looking at it from the outside and having seen it for, you know, in use for almost 30 years, I think it's a highly underutilized asset. I think there's a lot more that we can do with it. But it goes beyond DuraSearch because we are committed to being the leader in drug delivery in the eye, and so we are evaluating other potential drug delivery systems. But in the end, those are all tools to achieve better vision, better life, better easier, you know, times for patients, families, and frankly, for insurers as well. I mean, we have a whole constituency that we're trying to help here. So the delivery system or tools, EYP1901 is the first step. If we can show that a small molecule like Rolanib can be safely and successfully delivered to the eye, I think there's a wealth of other similar type of molecules with other mechanisms of action that we can potentially deliver. But At a high level and a personal level, I like challenges, and I like to take on things and be successful with them. So I don't think that taking just a single program or a single molecule or a single delivery system is what excites me. It's moving the company forward with a common goal.
spk01: Awesome. Great. Congrats again, and thanks, everyone.
spk03: Thank you. Our next question comes from Yasin Saneja from Guggenheim. Your line is open.
spk11: Hi, guys. Thank you for taking my questions, and congrats from my side as well. Just a couple from me. So at AAO, we're going to get the five-month data for the high dose. Will you release six-month data for all doses once it is available, let's say in December, or do we have to wait for a scientific content for a full six-month data release?
spk02: Yeah, I'll take that question. So we're always just a bit cautious in what we wanted to commit to in terms of what we would show at AAO because you never know if patients will make their visits in a timely way. The good news is they have. And so what we expect to show at AAO is all cohorts. Well, let me back up. We're going to show the low dose, the low-mid dose, and the mid dose all the way through six months for safety and efficacy. And then in the high dose, we will show all patients. There's one patient who has not yet come in for their visit. If we can get that patient in before AAO, we'll show that patient. Otherwise, we'll be shy, one patient. And we'll show... the four out of five patients through six months in that high-dose cohort with one patient at five months. So basically we're going to be able to show almost all the data through six months, or excuse me, up to six months. Let me be clear, up to six months. And then perhaps one patient will be still at five months in the high-dose cohort.
spk11: Got it. Very good. Very helpful. Then a couple more. So obviously, you know, the drug seems to be very, very safe. And one of the questions that I have gotten from investors is that what is your view on the dose level? Are these, the fact that we are seeing such a good safety profile, could that be a function of that you are an underdosing patient or defective? Do you think these doses are relatively active and you should be able to reach the therapeutic window that you are hoping with one of these three dosing schedules that you have?
spk02: Yeah, let me comment real quickly and then I'm going to turn it over to Jay. So first of all, we're not going to give any forward guidance and we'll be expected to see. So I want to be very clear about that. And, of course, there's always, in any therapeutic area, you always have that tradeoff between safety and efficacy. But with that being said, as you know, we have a very remarkably good safety profile. And, frankly, I think you'll just have to wait and see what the data shows when we roll it out at AAO. Jay, I'm going to let you expand on that if you have anything else you'd like to add.
spk10: Not a lot, except to state that in our preclinical models, in our IND-enabling studies, there was a very good safety profile for both virolinib and EYP19-01, virolinib and Duracert. And we never found a maximally tolerated dose in animals. And so that I will agree with Nancy that we will have some efficacy data to share in another week and a half or so, and we'll leave it at that.
spk11: Got it. Just one final question, if I may. So with regard to the – I think, Jay, you spoke about it today, but I joined a little bit later. So with regard to the changes in BCA and OCT – I think you mentioned about five letter plus minus would be okay and 50 microns would be okay. Just trying to get a sense of how likely a letter or an OCD loss would be. I'm not sure if a five letter positive would be fine, but a drop, I don't know how we should be thinking about that.
spk10: So I think you need to think about it in a couple of ways. there's really three kind of views of this. And the first view is, what does the FDA think? Because ultimately, we need to get the product FDA approved. So if the FDA says that, and again, you pick a number, it doesn't matter, two, three, four, seven, ten letters is an approvable endpoint, even for a loss, then the FDA has spoken. The second thing is, What do the retina specialists feel? What is an acceptable safety profile and efficacy profile to use the product? Now, remember, we report data across a large population, or certainly in a phase one, I wouldn't call it a large population. It's N equals 17. It's a small population. But that doesn't mean that you can't pick out, even if in a large population, the efficacy doesn't look strong, right? But in individual subgroups it does, and you can identify those subgroups, then you can have a very successful product by choosing the patients you use it on well. And that's no different than any other drug product. What's different in this area is we didn't have an option before. It was an injectable anti-VEGF. Lucentis, Ilea, Avastin, and if you inject them monthly, they all work about the same and they're all about the same safety. So this is a paradigm shift now because what we hope to accomplish is true sustained release for many months and not just a month or two. And it doesn't need to work perfectly in every patient as long as it's safe and one can identify the groups of patients that it does work well in. And so the last group that needs to be satisfied, of course, is the patients. They need to see the value in having a visit perhaps every four, five, or six months instead of every one or two months. I think that would be obvious. But if there's a change in their vision, plus or minus, it really needs to be something that they can live with. So back to the question specifically about visual acuity, If you follow the space, you know that for newly diagnosed wet AMD, all the visual acuity is gained in the first three months. And if you look at the curves after that, they're basically flat in wet AMD. And in fact, in the real world, they go down. And a couple of real-world studies show that after three months, in the real world, where on average patients get six injections a year, by the first year out, as a group, they've given back all the visual acuity gains. So that if you had a control group, which we do not in a phase one, that was standard of care, you would expect that there might be over six months some loss of letters. How much is significant? Again, I have to go back to those three groups. What's significant for the FDA? What's significant for the retina specialist to use? And what's significant for the patients? Yet to be seen. OCT is the same. And in fact, OCT gains are almost always in the first month or two. So if you've got a group of patients who have been diagnosed for three or four months and they're stable, presumably. They may or may not have fluid. They've gotten all their visual. And so that a successful product should be able to keep that group relatively stable. So that was a long-winded answer, but I hope I answered your question.
spk11: No, that's very good. Thank you so much.
spk04: Thank you. Our next question comes from the line of Yale Chen from Laidlaw and Company. Your line is now open.
spk12: Good morning and thanks for taking the questions and congrats on the progress. In terms, my first question in terms of the 1901, you have three milligrams and two milligrams groups and also you highlighted some of the efficacy information sort of categories that need to be paid attention to. Do you anticipate most of the efficacy or sign of efficacy will likely be in those high-dose groups, or you may even think that even at one milligram, you could start to see some sort of directional changes?
spk10: We can't speculate. There really is no kind of guidance we can give here about efficacy for any of the groups.
spk12: Okay, that's fine. I appreciate that. And maybe just one more question. In terms of UT.com, I think that was very useful information. Is there any follow-up in terms of reporting or what should we anticipate maybe sometime in 2022, additional sort of update from that?
spk02: Yeah, we expect to give continuous updates on that data set. That's going to go out. for a minimum of five years and possibly even beyond. So as I said in the press release, it's really an incredible amount of data that we're going to be able to capture on the longitudinal etiology of the progression of the disease, which no one has right now. So we feel like we're contributing not only to the overall understanding of posterior segment uveitis, but then also how UT helps to manage that disease. So we expect that we'll be giving regular, consistent updates on that longitudinal study as it progresses.
spk12: Okay, great. And maybe one final question here is in terms of UT, six months per trial to start in this quarter, what should we anticipate be the primary endpoint for that study? And thanks.
spk02: It's going to be run identical to our Phase III programs for the UTEEQ three-year program, so it will be reduction in uveitic flares. Obviously, you always are going to be looking at other secondary endpoints, obviously safety, of course, and obviously some vision maintenance or how you control the vision as these patients progress with their disease. But the primary endpoint will be reduction in uveitic flares.
spk12: Okay, great. Thanks a lot, and congrats, and we look forward to read the data.
spk04: Thank you. Thank you. Our next question comes from the line of Yi Chen from HC Wainwright. Your line is now open.
spk05: Thank you for taking my questions. Could you comment on the volume of questions? ocular surgery in the current quarter, whether it has returned to the normal volume compared to pre-COVID times?
spk02: Do you want to answer that? Can you repeat that question? It was a little hard to understand.
spk05: I wonder if you can comment on whether the volume of ocular surgeries have returned to the normal levels.
spk10: I think the answer is probably not, but I'm not sure that there's any central place one could look for that data, you know, this soon. You know, you can look at claims data, but that usually takes a while to find. So I'm just off the cuffing it here, talking to my colleagues and knowing what's going on. at least in the New England area and outside, I think the volumes are close to pre-COVID in the 90%, but not quite there. But again, that is non-scientific.
spk02: Scott, do you want to comment on that as our head of sales and what the field is seeing out in the real world as well?
spk06: Absolutely. Thanks, Nancy. Specifically to cataract surgery, rather than focusing on all ophthalmic surgeries, but what we're seeing in the cataract market, it is slowly returning back to normal. We are seeing certain areas that will pop up, specifically related to COVID having an outbreak in particular areas where we see a slowdown. So while I can't give you a specific number of cataracts that occurred during the second or third quarter, we are seeing most areas of the country slowly return back to normal levels.
spk05: Thank you. My next question is FDA recently approved SUSVMO or the port delivery system with Ranivizumab for the treatment of wet AMD for up to six months. So what does 1901 need to demonstrate to out-compete Susfimo on the market in the future?
spk10: So a couple of things. First of all, from a safety issue, we all need to be aware that to place this implant, there's surgery involved and there's always some risk to this surgical operation. The second thing is starting even in the phase one where one out of 20 patients in their phase one trial got endophthalmitis, which is a serious infection of the inside of the eye. 1.5% of the patients approximately in the phase three trials got endophthalmitis. And so that is something where we hope that an in-office injectable could do better from a safety perspective. And certainly back to the surgical part of it, you know, we think that from a convenience perspective, not having to go to the operating room and, you know, relatively elderly patients is going to be an advantage as well. Remember also our drug is different. The mechanism of action is different. And so that there may be some efficacy around receptor blockage and being able to block all isoforms of VEGF. that we may see as further studies are performed. So that, you know, congratulations to the company. That was a tough slog to get that through. It's a really game changer and potential paradigm shift. But we believe that if our product can show safety and similar efficacy, that because we're non-surgical and because we're likely to have failure fewer cases of endophthalmitis that we will be able to carve out market share.
spk05: Got it. Thank you.
spk04: Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to Nancy Lurker, CEO, for closing remarks.
spk02: Thank you, everyone, for joining today, and we very much look forward to giving you an update at post-RAO data release.
spk04: Thank you again. This concludes today's conference call. Thank you for participating. You may now disconnect.
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