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spk11: Pharma's first quarter 2023 financial results and operating highlights conference call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended March 31, 2023. A copy can be found in the Investor Relations tab on the corporate website, www. Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans, and prospects are forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees. and involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. Any such forward-looking statements represent management's estimates as of the date of this conference call. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. As a reminder, this call is being recorded and will remain available for 90 days. I'd now like to turn the call over to Dr. David Zacardelli, Chief Executive Officer. Please go ahead.
spk09: Thank you, and welcome everyone to today's call. With me today are Mark Hahn, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, and Chris Martin, our Senior Vice President of Commercial. During the first quarter, we continued to make substantial progress toward the planned submission of our NDA for nebulized Ncfentrin for the maintenance treatment of COPD in the United States. We recently had a pre-NDA meeting with the FDA and believe that we are aligned on the content of the regulatory package. The NDA will comprise data from the successful phase three enhanced program and other NC-Fentron clinical studies, including safety data from approximately 3,000 subjects. We remain on schedule to submit the NDA in the second quarter and look forward to providing an update later this quarter. In parallel, our pre-commercialization efforts and U.S. launch activities are proceeding as planned. After reporting our positive Enhance-2 data in August 2022, we began adding key leadership positions across commercial, HR, IT, and finance functions. And after announcing the Enhance-1 data in December 2022, We expanded these efforts, adding leadership positions across medical affairs and compliance, and deepened our commercial teams in marketing, market access, and commercial operations. Our pre-commercialization efforts continue to accelerate as we prepare the market for the potential launch of NC Venturin in the second half of 2024. These efforts are critical in setting the stage for NC Venturin, which has the potential to be the first novel MOA launched for the maintenance treatment of COPD in over 10 years. Turning to our global partnering strategy, last month, Nuance Pharma, our development partner in Greater China, announced they enrolled the first subject in their Phase III trial evaluating Ncfentrin for the maintenance treatment of COPD in China. As a reminder, Nuance Pharma has exclusive right to develop and commercialize Ncfentrin in Greater China and as such, will play a key role in addressing the global need for a novel treatment for COPD. Nuance Pharma previously received clearance from China's Center for Drug Evaluation to begin phase one and phase three studies with Ncfentrin for COPD in China, and we look forward to providing further updates as these studies progress. We believe Ncfentrin, if approved, has the potential to change the treatment paradigm for COPD. The data from our Phase III enhanced program was highly positive, and NC-Fentron successfully met the primary endpoints in both Enhance I and Enhance II, demonstrating statistically significant and clinically meaningful improvements in lung function, as well as remarkable reductions in the rate and risk of exacerbation. The success of these trials and our work towards submitting the NDA for NC-Fentron brings us closer to providing ncfentrin to a patient population in urgent need of a new effective treatment option. As announced earlier this month, we are looking forward to presenting additional analyses from the enhanced studies at the American Thoracic Society International Conference later this month. We will present 12 abstracts and a clinical trial symposium on subgroup data and pooled analysis from Enhance I and Enhance II covering exacerbation, symptoms, quality of life, use of rescue medication, healthcare utilization, and safety. An overview of the enhanced trial results will be presented as part of the clinical trial symposium reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the May issue of the American Journal of Respiratory and Critical Care Medicine. We will also be hosting a webcast and conference call on Tuesday, May 23rd, to discuss these data. Currently, more than 380 million patients suffer from COPD worldwide, and it is the third leading cause of death. Despite the availability of existing COPD treatments, Approximately 50% of patients experience symptoms for more than 24 days per month, and physicians require new and effective COPD therapies to provide relief to their patients. With its novel mechanism of action as a selective PDE3 and PDE4 inhibitor, we believe ncfentrin, if approved, will be a transformational advance in the treatment for COPD patients. In conclusion, we expect 2023 to be another pivotal year for Verona as we advance towards our mission of delivering NC-Fenton to patients with COPD. I will now turn the call over to Mark to review our financial results for the first quarter.
spk07: Thank you, Dave, and good morning, everyone. We ended the first quarter of 2023 with $291.4 million in cash and equivalents. We believe our balance sheet remains strong, and with the cash currently on hand, expected receipts from the UK tax credit program, and funding expected to be available under the Oxford Loan Facility, we expect to have sufficient runway at least through the end of 2025, including the planned commercial launch of NC Fenton in the United States, pending regulatory approval. For the quarter ended March 31, 2023, the net loss after tax was $16.7 million compared to a net loss after tax of $24.8 million for the same period in 2022. This represents a loss of 3 cents per ordinary share or 22 cents per ADS for the quarter compared to a loss of 5 cents per ordinary share or 41 cents per ADS for the first quarter of 2022. Research and development costs were $12.6 million for the quarter ended March 31, 2023, compared to the $17.6 million reported for the first quarter of 2022. The decrease was primarily due to a $5.1 million decrease in clinical trial and other development costs as Q1 2022 was a period of heavy trial enrollment and Q1 2023 was focused on finalizing data analysis and related activities of the Phase III enhanced program. Selling, general, and administrative expenses were $9.6 million for the quarter ended March 31, 2023, compared to $7.4 million reported for the same period in 2022. This increase was primarily due to a $2.7 million increase in people-related costs, including share-based compensation, as well as an increase of $.8 million in costs related to the build-out of our commercial infrastructure as we prepare for a potential commercial launch. The increase in SG&A expenses was partially offset by a non-recurring $2 million charge related to the modification of our LIGAN agreement, which was incurred during the first quarter of 2022. I'll now turn the call back over to the operator for the Q&A.
spk11: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question is from Yasmine Rahimi with Piper Sandler. Please go ahead.
spk10: Hi, guys. This is Lauren on for Yaz. Just a few questions for us. First, could you comment on what type of feedback you received in your pre-NDA meeting? And then how important is completion of the pre-NDA meeting in strategic discussion?
spk09: Hello, Lauren. Good morning. Yeah, so the pre-NDA meeting, as really expected, was structured around, you know, I would say highly administrative in nature regarding content, how we were handling certain data, what the agency wanted to see in certain areas and so there was nothing that was you know difficult problematic or anything like that but rather just confirmatory and making sure that we were aligned as we mentioned in the press release, with regard to the content and the format of the NDA. So I think, you know, we covered many topics, as you should typically in these meetings. And, you know, as I said, I think we're in a good position to, again, meet our timeline projection of submitting in the second quarter. With regard to the pre-NDA meeting as an item for partnering, I think, you know, all activities have some impact depending on the partner. So, you know, it's difficult to assess that exactly. But, you know, progress is continual with us, and I think all of these activities are helpful in our partnerings.
spk10: Great. Thank you. And just one more. Why is ATS such a critically important conference for you guys with the 12 posters? Just maybe a little bit color there. Thanks.
spk09: Yeah, sure. Well, I think, you know, timing is important. Of course, it was really the first major conference that we had after really getting all the data. from the enhanced program. So I think timing worked out very nice. We also have a very strong history of transparency, making sure that we provide all the data that we can in the right forum. I think we're very excited about all the data that we're sharing at ATS. with regard to subset analyses and, as I mentioned, a lot of different pooled analyses as well between the Enhanced 1 and Enhanced 2 studies. So, I do encourage everyone to be there. I think it's going to be an exciting time and really a moment where NC-Fentra is going to be highlighted for all the data that we've generated over the years and specifically an enhanced program. Big moment for Antifendrin, for sure, and we look forward to it.
spk10: Great. Thanks so much, guys.
spk09: Sure.
spk11: The next question is from Andreas Argarides with Wedbush Securities. Please go ahead.
spk00: Hey, good morning, and thanks for taking our questions here. Yeah, follow up to the question that was just asked on ATS. You have a lot of posters there, and you have some subgroup analyses. How are you framing or how are they framing how you're thinking about the commercial opportunity, where insufficiency fits in, and the ideal patient population for this therapy? And then what are the gating factors to submitting the NDA? Thanks.
spk09: Sure, Hunter. Good morning. Let me sort of take the second one first, and I'll turn it over to Chris for him to comment on our commercialization. I think, you know, the gating items for the NDA is just what an NDA is, and it is a massive document, sub-documents, interrelated documents, and the totality of the program, which is substantial, and putting that together. And so the team has been working diligently to do that. And we've made incredible progress. And at the same time, some of the items can't be done concurrently. They must be done consecutively as they feed off each other as far as the content. Um, and when you put together an MDA, and so all of that is lining up and, and really is what, you know, if you want to call that gating, it's more of just, um, the work streams that are involved in putting together an MDA and anyone who's done it understands the magnitude of that, um, event. So, and that, um, that workload. So, um, that's where we're at and we're, we're quite pleased with the progress. Um, so with that, I'll turn it over to Chris.
spk03: Thanks, Dave. And Andreas, appreciate the question that you posed about ATS and where NC-Pentron fits in. I think one of the great things about the ATS conference coming up is the data that will be highlighted there continues to show the consistency of how NC-Pentron performs in a COPD patient population. I think when you look at the data that we've produced out of the enhanced trials and will be shown at ATS is But we also see in our market research, which is physicians being attracted to this early and sustained response of ncfentrin that's seen in the lung function data, where you have acute bronchodilation, but also seen in symptoms and quality of life improvements, but then also seen in the exacerbation risk reduction, which separates from placebo between four and six weeks. So when you take that totality of a profile, what you see is physicians from a market research standpoint really seeing ncventrin as a extremely complementary product to the current mechanisms that are out there. So they're using ncventrin as an add-on in our market research to those patients that remain symptomatic on all current therapies. I think one of the things that we know about the COPD patient population today is that they're still struggling with daily burdens of symptoms. and they're still struggling with the risk of exacerbations. And up until the potential approval of ncfentrin, the doctors have been limited in MOAs that they've been using for 20 plus years. So the physicians are extraordinarily excited when they see in a profile of ncfentrin, and they see patients that come in on a very regular basis that are symptomatic and in need of additional help, that ncfentrin could provide a much needed alternative and new kind of weapon in their treatment paradigm for the patient. So, we see very broad usage of N-C-Pentrin across symptomatic COPD patients that are on the current therapies.
spk02: Okay, great. Thanks for the color, and we're looking forward to ATS. Thanks.
spk11: The next question is from David Reisinger with SVB Securities. Please go ahead.
spk05: Thanks very much. Good morning, David and team. So I have two questions. First, could you provide some more color on your vision for commercial adoption of ncfentrin, including the expected mix of prescribing between pulmonologists versus other prescribers? And then second, could you provide an update on your phase two development programs and go forward R&D spending relative to the $12.6 million in the first quarter. Thank you.
spk09: David, good morning. Maybe I'll just comment briefly on the Phase II programs. Mark can comment on spend, and then Chris can comment on the commercialization question. You know, our phase two programs, I guess specifically referring to, you know, asthma, for example, cystic fibrosis, are tremendous opportunities for NC Fentron as we move forward. They're based on the pharmacology. As you know, NC Fentron makes great sense in asthma for sure. And we look forward to progressing that. We've been very careful to stay focused really since joining in the beginning of 2020 to progress the COPD indication, which we have, and I think we'll continue to do that through 2023, being laser-focused on making sure that we bring NC-FEN for COPD forward. We do look to our partners to help us with other indications, specifically around devices, for example, MDIs, DPIs, And besides offering expertise, possibly a proprietary devices and intellectual property around the space, all would be advantageous as we continue the development in these other indications. So I would not expect great, you know, differences in our strategy in 23. But as we get through 23 and into 24, and as our partnering continues to progress, I think you'll see more clarity around that. I do want to comment that we are progressing a N-Centrin and a LAMA combination nebulized product for COPD. We find that fits very nicely with the pharmacology, fits very well with how physicians treat patients, allows us to really look at a dual bronchodilator with different pharmacology and anti-inflammatory activity in a nebulized product which doesn't exist. And we think that's a great step forward for NCF Entrant as well. And so, you'll hear more about that as we progress through 2023 as well. So, with that, I don't know if, Mark, you wanted to talk about anything with regard to spend?
spk07: Yeah, yeah, thanks. So, just a couple thoughts. One is that, you know, there are some lingering cost related to the phase three program as we're continuing to work with IQVIA and other suppliers. on the wrap up of the study. There's also, as Dave mentioned, some early cost related to that combination product. We're doing some formulation work, so there'll be some, I'd call it small dollar spend on that. And then, of course, there's the NDA filing fee that will be incurred this quarter as well. And then there's some CMC work going on as we do the validation batches. I think as you look at it from a spend perspective, the $12.6 million will probably be tapering down over the balance of the year, but it could still be fairly significant in Q2 and then much lower as we get through Q3 and Q4.
spk03: And then I can answer the comment on the color and adoption and what we think of the mix here, David, for you. So as we think about NC Fenton at launch, We believe that about 100 reps is the appropriate size sales force to reach the opportunity for the Ncfentrin patient and the prescribers that are most likely to use Ncfentrin. From our market research, what we see is that pulmonologists, we believe, are the driver of utilization and adoption early on with Ncfentrin. So our primary focus from a call point will be pulmonology. But there are also nurse practitioners and PAs, nurse physician assistants that we believe are very important and are one of the largest growing prescriber segments within COPD that will be influential in the treatment of the COPD patient, but also the adoption of ncPentrin. And then there are certain areas in the country where patients do not have access to a pulmonologist And we believe that in those type of areas, we would be calling on what, you know, potentially some, not a large number, but some primary care doctors that are acting like pulmonology within the community. In all, we believe that there's about 12,000, 12 to 13,000 physicians that will be critical for adoption at the initial stages of launch with NC Venturin. And again, about 100 reps are able to handle that quite easily. And we believe is the right way to size the organization accordingly.
spk02: as we prepare for launch. Great. Thank you.
spk11: The next question is from Tom Schrader with BTIG. Please go ahead.
spk01: Good morning. Thanks for taking the questions. You're sitting on a pile of data. I'm wondering what your publication schedule looks like, and is it as soon as possible in your mind, or does it make sense to wait for closer to the launch? And then with a related question, I think probably for Chris, we've done a lot of KOL work, and we get wildly disparate answers. We get people who want to use the drug and a third of their patients on day one and people who say serious patients only. And I'm curious if you're getting the same sort of feedback and what data is most compelling in talking to people and changing their minds. Thank you.
spk09: Great. Good morning, Tom. So, just a brief comment on publication strategy, and I'll ask Kathy to opine as well, is that, you know, we do have a mountain of data, as you mentioned. Much of that, you know, is going to come out as well at ATS. We have submitted the enhanced publication, and so we would expect that to come out, you know, as we, you know, we don't control the timing very much, but of course, we expect that to come out in the relatively near future, hopefully. And then we would continue to progress. And I don't know if, Kathy, you want to comment on publications overall and ATS specifically.
spk12: All right. Well, as Dave says, the enhanced Data is submitted, and we're waiting for the go-ahead with that. We have a couple other publications that were submitted recently, and again, as Dave says, we don't encode the timing of those, but we anticipate those will come out recently. Also, all the data presented at ATS, and many of those will be now worked into various forms of formal publications to different scientific journals to further enhance the background and the profile of ncfentrin i think it's very important to understand that ats is probably the leading scientific meeting of all respiratory experts around the world particularly also in the us and so we anticipate that all of that data being presented there will be very well received and will continue to proceed with publications for those data thanks kathy and chris do you want to talk about our market research
spk03: Yeah. Yeah. Thanks, Dave. And thanks, Tom, for the question. You know, one thing, you know, we, as you mentioned, we have mountains of data on NC Fentron from the enhanced studies. We now have a significant amount of market research on NC Fentron, too. I think we're close to almost between 800 and 1,000 HCPs over the course of the last few years talking about NC Fentron in market research. And the thing that we've seen within that is very similar to what we saw in the clinical data, which is there's consistency in how they answer how they'll use ncfentrin and what they see the potential of ncfentrin being. You know, I think what they see ncfentrin as is the potential to be a novel mechanism that can be added to many symptomatic patients that are in their practice. As you mentioned, you know, the serious patient, as we talk to KOLs, you know, one of the places that's the first place that they think about using ncfentrin is maybe on top of those patients on dual or triple therapy that are symptomatic we know there's a significant number of those patients on them out there in the market and those physicians have no other choices to use or they have very limited choices to use in that patient population but as the enhanced data has come out and we went from enhanced two to enhance one and you saw the consistency of the data on lung function symptoms and exacerbations physicians started moving the drug earlier into the treatment paradigm. So they're looking at these patients maybe on a single bronchodilator or a LABA ICS, which is almost five to six million patients in the United States. And they say the next logical choice really is Ncfentrin given the data that's come out of the clinical trials. So you see that second and then sometimes the first patient being that much broader patient population in the physician's minds as well. I think the other thing that's really important, and you asked about the compelling data points that physicians point to, it's a balance between efficacy profile, which shows the early and sustained response on all key measures that they're worried about, lung function, symptoms, risk of exacerbations, but that balance with a safety profile that's comparable or similar to placebo. So the physicians can get this profile of a novel mechanism without taking much risk. So that allows them to make very quick decisions and choices in adding N-C-Fentron to these patients. And in most cases, they're going to be able to find out in a short period of time how the product's going to work within the patient population as well.
spk02: Great. Thank you.
spk11: The next question is from Bubulan Pakyapan with H.C. Wainwright. Please go ahead.
spk06: Hi. Good morning, Tim. Congrats on the progress. A few questions from us. Firstly, can you speak to us whether the FDA has provided any comments or clarifications regarding the applicability of AMEN's data for NDA filing, particularly about ISS, ISE, and CMC sections, and did they communicate any outstanding issue in their radar?
spk09: Good morning. You know, of course, we would cover general concepts with regard to ISE, ISS, For example, CMC topics as well. And as I've mentioned, there is nothing that we see is prohibiting us from proceeding with the submission in the second quarter. Much of the, you know, meeting was, again, as I mentioned, related to alignment, clarification, confirmation. and making sure we understood and they also had the information from us about how we were going to approach different topics in those sections. So, again, very pleased with our progress. And I think for a pre-NDA meeting, it accomplished exactly what it's supposed to do.
spk06: Okay, thanks for the color. Can you share any preliminary discussions you had with the agency with respect to NC-Fentrin label and also what label expansion or improvement opportunities are you more excited about in the future?
spk09: Yeah, I mean, I think it's incredibly premature to talk about a label. I think that, you know, everything is a review issue, as you'd expect. And so, we will submit what we view as the label, and then the review will commence. So, I think, again, we'll wait on that. As far as expansion. in the label. You know, I think there are many opportunities for us. I think we first need to see where we end up, of course, at the end of this process, as well as looking for other indications, as I mentioned, as well as expansion of other products with ncfentrin as a combination with a llama, for example, I think are great opportunities to continue to allow ncfentrin to be utilized in COPD and to extract the maximum benefit for patients from ncfentrin. So I think there's a lot of opportunity as we progress with it.
spk06: Okay, maybe one last one, maybe for Kathy. Oh, Kathy, sorry. I'm curious to hear your thoughts on off-label use of biologics in COPD treatment, maybe staying in that lane. How does DUPICS and COPD exacerbation data take up against your NC-10 performance, and then how this could impact NC-10 adoption?
spk09: Kathy, you want to talk about that?
spk12: Sure. I think you need to understand that there are very different populations of patients that are being studied here. So Dupixen really looks at the patients who are very severe, having multiple exacerbations, and only those patients. And so they have an effect in patients who have, you know, really on the end of the spectrum for that. So it's a very small, limited population of the COPD patients that we all treat as pulmonologists. The very difference of MC Fentorin is we're looking at the general COPD population, so the population that's treated every day by pulmonologists in the U.S. and, as Chris mentioned, PAs, NPs, and primary care physicians, patients who have COPD that may or may not have an exacerbation one or two a year but have a lot of symptoms, have a lot of problems. And the significance of that is that we're able to show a significant decrease in exacerbations in this very general population, which we didn't have to enhance for patients who are having exacerbations. And the reason why many products do that is because they can't show a difference unless they enhance for patients who are having many exacerbations. So I think the the relevance of anti-frenziness is applicable to all COPD patients out there, whereas many products, including Zipixin, are only applicable to a certain small portion of the COPD population. I hope that helps. Yeah.
spk11: Thanks.
spk02: Thanks very much.
spk11: Again, if you have a question, please press star, then 1. The next Question comes from June Lee with Truist. Please go ahead.
spk08: Hey, thanks for taking our questions. As Tom just alluded to, you have a mountain of data, and one in particular was interesting, the abstract showing that subjects with, even subjects with eosinophil count greater than 150 cells per microliter benefited from encephentrin. Is there any reason why some COPD patients with allergic component wouldn't use encephentrin? And I have a follow-up.
spk09: Kathy, you want to comment on that?
spk12: Right. There is no reason why you wouldn't use it. And I'd hesitate to call it an allergic component. That certainly could be driving it in some COPD patients, but not necessarily in most COPD patients. It's just an interesting pattern that some patients have higher eosinophils in COPD, which is, again, a smaller number, generally about 25%, maybe 30%. And oftentimes, you see that around an acute exacerbation. So, we're not quite sure why the eosinophils go at that time. So, I don't think there's any reason to suspect why there would be a different effect. In fact, there's no reason. We've actually shown that we work in both subjects who have high eosinophils and low eosinophils. So, it doesn't affect the ability of ncfenthrin to work in those types of patients.
spk08: And then, you know, as you look at the COPD patients, like what are the percentage of COPD patients who are contraindicated for being on Lama-Lama duotherapy?
spk12: Are you asking what percent are contraindicated for Lama-Lama duotherapy? Is that the question?
spk08: Yeah. What percentage of COPD patients are not qualified or not or have preexisting medical condition or tolerability issues that would preclude them from being on LAMA and LABA?
spk12: All right. Well, that's kind of a broad question. And quite frankly, it really depends on the individual patient and the physician needs to assess their background use of other medications in the past, whether they've done these in the past, their underlying status of cardiovascular disease and so forth. So I don't know that I can specifically tell you that there's a certain percentage that are contraindicated, but certainly you need to take the whole gestalt of what has been done with the patient before, what the reaction's for, and all of their underlying medical conditions. As you know, from a COPD perspective, many of these patients have many other comorbidities that we have to take in hand when we're looking at how to treat them.
spk08: Yeah. And last question, you know, you have a lot of presentations at ATS. What additional data could possibly expect at CHESS in October?
spk12: Hey, Kathy. Dave, I'll tell you. Yeah.
spk08: Yeah.
spk12: So, we are going to be expanding on the data we're showing at ATS to further analysis, further subgroup analysis, further data on safety from that perspective. So just bringing out more of the nuances of the amount of data, which as Dave and all have said, we have extensive data. And so we're trying to bring all the different facets of that. And that's what some of the abstracts we'll be presenting at CHESS also. All right.
spk08: Looking forward. Thank you.
spk11: Next, we have a follow-up question from Yasmine Rahimi with Piper Sandler. Please go ahead.
spk10: Hi, guys. Thanks so much. Sorry, just one last one for me, for Chris. Could you just talk to us about your game plan post-NDA filing and acceptance? Thanks.
spk03: Yeah, Lauren, thanks. I think, you know, as we get past the NDA filing, we will continue to accelerate our commercialization efforts. So I'll talk in a couple of buckets. One is on distribution and market access. Our team has been working very diligently in setting up our distribution pathway for NC Fentron to get product to the patient. And we've been actively having discussions on the market access side. So we'll continue to ramp up those discussions and finalize that distribution pathway and continue to work with the payers as far as how NC Fentron will be covered outside of Medicare Part B, because we know Medicare Part B is the primary reimbursement channel. So that'll be one work stream that continues to accelerate. I think another important work stream that not only my team from a marketing perspective, but also medical affairs is working through, which is disease shaping or market shaping. As Dave mentioned, NC Fentron has the potential to be the first new product launch new mechanism in over 10 years. So the idea of making sure the market is ready and providing the right information to the market from a disease state education will be critical. That work is being done today through medical affairs, but you could expect some sort of marketing efforts regarding that as well, which is very critical and something that I think you know, will really differentiate us as we get closer and closer to launch so that we're setting the market right before NC Venture is launched in 2024. I think the other work stream is really on the operations and system side. We are actively setting up all our commercial operations and the systems needed to support the commercial infrastructure. So that work is started, but that work will be finalized post the enhanced data so that we're ready to actively and be promoting the product as quickly as possible after a PDUFA date.
spk10: Great. Thank you so much for the color. Thanks.
spk02: Yep.
spk11: This concludes our question and answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks.
spk09: Great, just I want to thank everyone for your questions and thank you to the patients and healthcare professionals that participated in the HANSS program. We are extremely excited about the potential of NC Centron and look forward to providing you further updates. And of course, finally, I'd like to thank our shareholders for their continued support and absolutely the dedicated and talented team at Verona for their commitment. Operator, that concludes today's call.
spk11: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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