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spk07: Welcome to Verona Pharma's third quarter 2023 financial results and operating highlights conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal the conference by pressing star and zero. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended September 30, 2023. A copy can be found in the investor relations tab on the corporate website, www.veronafarma.com. 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 risk uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectation 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 Zaccardelli, Chief Executive Officer. Please go ahead.
spk12: Thank you and welcome everyone to today's call. With me today are Mark Khan, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, and Chris Martin, our Senior Vice President of Commercial. The third quarter continued our constant progress toward our goal of providing N-C-Pentrin as a novel treatment for COPD patients. In August, the FDA accepted for review our new drug application seeking approval of N-C-Pentrin for the maintenance treatment of patients with COPD. The agency assigned a PDUFA target action date of June 26, 2024, and is not currently planning to hold an advisory committee meeting to discuss the application. We look forward to continuing our work with the FDA during the review. If approved, Ncfentrin is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years. We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD. Recently, we hosted an in-person investor meeting in New York to provide an overview of our commercial preparations for the potential U.S. launch of NC Veterans with the company's senior management team and key opinion leader, Dr. Jamie Rutland. During the meeting, we shared detailed overview of preparations for the planned launch of NC-Fentron, including a review of the current COPD market, unmet treatment needs, launch access, distribution, reimbursement strategies, and plans for field deployment. For those who may have missed it, a replay of the meeting is available on our website. Overall, we believe we are very well positioned to launch NCFentron, with many key hires already in place across our commercial team and strong relationships being built on both the physician and payer fronts. With this, we are confident we will be able to quickly capitalize on the U.S. launch of NCFentron, pending approval next June. In September, we presented additional analyses of the Enhance One 24-week exacerbation data at ERS, which demonstrated treatment with ncfentrin resulted in a substantial decrease in the rate and risk of moderate and severe COPD exacerbations. In addition, it highlighted the impact of ncfentrin treatment on healthcare resource utilization related to COPD, including fewer physician's office visits, emergency department visits, and hospitalizations compared with placebo treatment. In October, we presented additional analyses from the ENHANCE-1 and ENHANCE-2 studies at the CHESS annual meeting. The data from pooled analyses demonstrated that treatment with encipentrin resulted in substantial reductions in the rate and risk of COPD exacerbations regardless of recent exacerbation history. And the medication was well tolerated across patient groups. Additionally, subgroup data analyses demonstrated treatment with NC-Phengrin resulted in improvements in lung function, symptoms, quality of life endpoints, and reductions in the rate and risk of exacerbations, regardless of background therapy, as well as reductions in daily rescue medication use. Also at CHESS, we launched the disease awareness campaign titled Unspoken COPD, The campaign highlights the severe impact COPD has on patients' daily life and encourages HCPs to engage in deeper conversations to fully understand COPD's impact on each patient in their practice. Turning to our global partnering strategy, Nuance Pharma, our development partner in Greater China, has continued their phase three trial evaluating NC-Pentron for the maintenance treatment of COPD in China. As a reminder, Nuance Pharma has exclusive rights to develop and commercialize MC-Fenton in Greater China, and as such, will play a key role in addressing the global need for novel treatment for COPD. We look forward to providing updates as the trial progresses. Looking ahead, we are expanding our pipeline, starting with a plan to initiate two clinical programs. We are developing a fixed-dose combination formulation with N-C-Pentrin and glycopyrrolate, ALAMA, for the maintenance treatment of COPD delivered via a nebulizer. Fixed-dose combination therapies are commonly used in the treatment of COPD, historically in DPI and PMDI therapies only. Based on market research, there is an unmet need for a nebulized fixed-dose combination therapy. We believe the combination of ncfentrin with ALAMA will provide COPD patients with the first nebulized six-dose combination that has bronchodilation through a dual mechanism and also non-steroidal anti-inflammatory effects via PDE inhibition. If a feasible formulation is developed, we plan to submit an investigational drug application to the FDA, and, if cleared, start a Phase II clinical trial assessing the safety and efficacy of a fixed-dose formulation of n-C-fentrin and glycopyrrolate in the second half of 2024. Additionally, based on the clinical profile of n-C-fentrin in COPD patients, including data that supports reduction in exacerbation burden, improvement in lung function, and the PDE3 and PDE4 mechanism of action supporting enhanced mucociliary clearance, we believe N-chefentrin could be an effective treatment for non-cystic fibrosis bronchiectasis. This is a severe chronic condition where the airways of the lung become abnormally widened, leading to a cycle of infection, inflammation, and exacerbation that cause lung tissue damage. The condition affects approximately 370,000 patients in the U.S. And there are currently no therapies approved specifically for non-CF bronchiectasis. Physicians use bronchodilators, antibiotics, steroids, and surgery to treat patients. If our NDA is approved, we plan to commence a phase two clinical trial to assess the efficacy and safety of nebulized end-definition in patients with non-CF bronchiectasis in the second half of 2024, subject to clearance by the FDA. We are pleased with our constant progress in all areas, including regulatory, commercial preparation, and new program development. I will now turn the call over to Mark to review our financial results for the third quarter.
spk11: Thank you, Dave, and good morning, everyone. We ended the third quarter of 2023 with $257.4 million in cash and equivalents. We believe our balance sheet remains strong with the cash currently on hand expected cash receipts from the UK tax credit program, and funding anticipated 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-Fentron in the US pending regulatory approval. For the quarter ended September 30, 2023, net loss after tax was $14.7 million compared to a net loss after tax of $15.6 million for the same period in 2022. This represents a loss of 2 cents per ordinary share or 18 cents per ADS for the quarter, compared to a loss of 3 cents per ordinary share or 24 cents per ADS for the third quarter of 2022. Research and development costs were $3 million for the quarter ended September 30, 2023, compared to costs of $9.8 million for the third quarter of 2022. The decrease was primarily due to a $7.9 million decrease in clinical trial costs as all study conduct and analyses under the phase three enhanced program were complete, whereas in the same period in 2022, significant costs were incurred associated with the then ongoing study conduct. The 2023 third quarter clinical trial and other development costs also include the impact of $2.2 million of credits received related to the final financial reconciliation of a Phase 3 enhanced program supplier. This decrease was partially offset by an increase of $.7 million in people-related costs. Selling, general, and administrative expenses were $13.4 million for the quarter ended September 30, 2023, compared to $5.3 million reported for the same period in 2022. This increase was primarily due to a $4.7 million increase in people-related costs, as well as an increase of $2.9 million for costs primarily related to the build-out of the distribution network and work related to payer and disease education, as well as advancing the commercial and information technology infrastructure in preparation for potential commercial launch.
spk10: I'll now turn the call back over to the operator for the Q&A.
spk06: Thank you. Thank you.
spk07: We will now begin the question and answer session. To ask a question, please press star and one to be joined into the queue. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.
spk06: Our first question comes from Andrew with Jeffrey.
spk07: Please go ahead.
spk08: Hi, good morning. Thanks so much for taking our questions. Appreciate all the updates as well. So first question is only to the extent you can share. How are FDA discussions going about the NDA? What kinds of questions has the agency asked you since accepting the filing? And as it relates to you know, the PDUFA, what exactly keeps you guys up at night? What would be the risks here, really, in your view? And then secondly, you know, let's just say antifension is approved. As we think about your initial launch cadence, could it be realistic to think that an initial low-hanging fruit could be patients who are taking an additional therapy after triples, specifically Dolarest? So can we expect n-subvention to immediately displace DLRF specifically? You know, could that be the low-hanging fruit immediately upon launch? Thanks.
spk12: Great. Thanks, Andrew, for the questions. And maybe I'll start on the first one and then turn it over to Chris for his thoughts on the launch. With regard to the FDA questions, You know, what I would say is typical during the review process, as you'd expect, the FDA asks for, you know, data, different questions, clarifications. And I would say it's very typical and normal in my experience, especially at this stage, of course. relatively early in the review, even prior to mid-cycle. So I think it's going well from our view. With regard to what keeps us up at night and to do for risks, again, I think we feel we have an extremely strong package that we submitted across CMC, non-clinical, clinical, and the total benefit to risk of NC-Fentrin we believe is very compelling. So, at this time, you know, I think we're comfortable where we're at in the FDA review process. So, with that, I'll turn it over to Chris and talk about the launch.
spk00: Thanks, Dave, and Andrew, appreciate the question. As we think about kind of that launch cadence and who's the first patient that a physician may prescribe Ncfentrin to, I think it's important to kind of just ground everybody in what's happening with these patients today. We know today there's 8.6 million patients treated with COPD maintenance medications. We also know today that at least half of them, either if they're on a single, a dual, a triple agent, are remaining symptomatic. And when a patient has persistent symptoms, physicians are very likely to add new therapies or try to help these patients start to feel better and hopefully prevent the risk of exacerbations in the future. So if we think about that 8.6 million, really what we hear in our market research is there are two groups of patients that the physicians see as low-hanging fruit or patients that they would try N-C-Fentron very quickly on. The first is the group of patients that are on single LAMA or LABA or a LABA ICS product. And when they look at our data and they look at what the data Dave described, they think of N-C-Fentron as being the potential drug to add to these patients if it's approved. And they think about doing that at a very high rate. The second group of patients, which is the patients that potentially could even be on value rest today, are these patients on dual and triple therapy that are looking for additional symptom relief and help. And the physicians at NC Fentron, and about 20% to 45% of the time in these patients' treatment armament area, I think the important thing to keep in mind here is in that patient group that I'm talking about there, there's about 75 to 85,000 patients on DALY-REST today that could potentially be an option for physicians to add a PDE3-4 mechanism to. So we believe very strongly that there are two distinct patient populations, either those patients on single, bronchodilator, or lab ICS, and those patients that are on dual and triple, that NC-Fentrin could be added to very easily. And I think it's all driven by the fact that these patients remain symptomatic, they remain having issues in their daily lives, and the physicians are actively looking for new mechanisms to be able to layer on top of the patient's treatment path so they can get them going back to doing some of the normal things that they want to do in their daily lives.
spk08: Thanks.
spk10: Very clear. Thank you again. Thanks, Sandra.
spk06: Our next question comes from Yasmin Rahimi with Piper Sandler.
spk05: Please go ahead. Good morning, team. Thank you so much for all the updates. Would love to dig a little bit more into these two new studies that you spoke about. I guess, where are you in the formulation process at this junction? Like, if you could just give us some color beyond what you've said, like, and how soon could you have it completed? And then what would a design, what would like the study design look like for a fixed combo? Like, what would the duration be and the size, et cetera? And then same goes for the second phase two study and the that you're also planning to kick off. So I think a lot of clients would love to hear maybe beyond the initial indication around size, cost associated with them, and what sort of the cadence of the next steps, just a little bit more granular. That would be really helpful for us.
spk12: Great. Good morning, guys. So let me just talk briefly about the formulation, and then I'll turn it over to Kathy. to talk about both the trial design concepts for fixed combo as well as for bronchiectasis. Within fixed combo product formulation development, you know, we are advancing with the typical formulation development where we're co-formulating both glycopyrrolate and antipentrin and the nebulized formulation. Of course, there's acute chemistry that we can look at. There's also longer-term stability data that gets generated at three and six months, typically under normal and accelerated conditions, to convince us that we have a commercially acceptable formulation. So that work is ongoing as we speak. Certain aspects can't be sped up, especially when you're looking at six-month stability time points. We expect to be more fully informed on the co-formulation somewhere in the first quarter of 2024. And that's why we provided the guidance that we'd be looking to initiate the studies actually for both fixed dose combo and bronchiectasis in the second half of 24. So with that, I'll give it, turn it over to Kathy for her thoughts on the design.
spk03: Sure. So let's talk about first the fixed dose combination. So certainly we're in early stages of development of what a protocol will look like. We know what in general we would like to do or need to do in a phase two type program, so the initial studies for that. So our goals would be to first establish efficacy and some initial safety in probably designs that are similar to our phase two studies that we did for NC Fincher to begin with, more likely be a shorter design, maybe up to anywhere up to about 12 weeks or so. But also we need to establish dose ranging. So that would be the goals of the studies that we would do for phase two is to look at initial efficacy and safety and dose ranging. If you look at the second study, study for non-CF bronchiectasis. It's a slightly different disease, slightly different type of design. We certainly would need to establish in a phase two, again, efficacy and safety. These studies may need to be a little longer because some of the primary endpoints for non-CF bronchiectasis relate to exacerbations. So they may be up to a six-month type of design. But again, keep in mind that we are in the early phase of developing these designs and we're starting to make more definite ideas about the designs as we get further along into our development program.
spk10: Thank you, Kathy. Thanks, Yes.
spk07: Our next question comes from Andreas Argaritas with Dead Bush Securities. Please go ahead.
spk09: Good morning, guys, and thanks for taking my questions. couple here. So in expectations of approval for NC Central, can you remind us what the label is likely to look like from an efficacy and safety standpoint? And then while you don't expect an adcom, the FDA has a curious history of changing its mind on a whim. Is there a threshold at which point an adcom would definitely not be held? And if there is an adcom, would it necessarily be a bad thing? Thanks.
spk12: Great. Good morning, Andreas. Thanks for the questions. With regard to the label, uh, for NC pension, again, just to remind everybody that, uh, We expect and have provided data to support an indication of the maintenance treatment of COPD, which is a fairly broad indication and consistent with recent approvals, and we believe the data provided supports that indication. We'd of course expect the rest of the clinical data results to be in the clinical section in the label as appropriate. Clearly, the FDA needs to continue their review and we're quite some time away from specific labeling conversations. And so, I think we'll see how that comes out, you know, I'm sure in 2024. So, but otherwise, we think the indication is fairly broad. With regard to an adcom, yes, they've guided that they do not plan to have an adcom. And yes, you're correct. I think the FDA can decide on how they want to address that during the review. We don't expect one. You know, as time passes by, especially, you know, after mid-cycle review, for example, and even as we get into 2024, that timing gets shorter and shorter. So there's certain practicalities about it. But nonetheless, I wouldn't comment any further on the adcom. And of course, it's in the FDA's hands.
spk09: All right. And just one last follow-up from us. With regard to the two new potential indications, maybe just some thoughts on how this potentially unlocks strategic value for the company and its attention. Thanks.
spk12: Yeah, well, sure. I mean, I think it speaks loudly to what we believe N-C-Fentrin can do broadly in the treatment of COPD, either by itself or as a combination therapy. We have clean and excellent data from the enhanced trials that combining N-C-Fentrin with Alama provides. is quite advantageous as well. And so I think it speaks loudly to the power of ncfentrin, the PD3, PD4 mechanism and its application. And then of course, broader than that, and as we've reviewed today in non-CF bronchiectasis, Because of the underlying pharmacology, which has been demonstrated so clearly in COPD, we think it's highly applicable in other diseases like bronchiectasis. I think ultimately any partner can see that ncfentrin's underlying pharmacology can be applied quite widely to various respiratory diseases, which we've really stated from the beginning as the full potential of ncfentrin.
spk09: Thanks, guys, and congrats on all the progress.
spk10: Thanks, Andrea.
spk06: The next question comes from June Lee with True Securities.
spk07: Please go ahead.
spk04: Good morning. This is Asimwan for June. Thanks for taking the questions. My first question is, what are you looking for in a European partner and can you guide to any updates on that front? And then also just wondering if you could talk about the ramp in SG&A in preparation for launch and when we could expect hiring for the around 100-person sales force. Thank you.
spk12: Great. Good morning. Thanks for the question. I'll speak to the partnering and then turn it over to Mark to talk about SG&A and Chris for the reps. But I think that with regard to European partner or in general, our partnering strategy, it continues to be the same. That is, we look to partner outside the U.S., much as we've done in greater China with Nuance Pharma. So the strategy has not changed. I think that ideally in a partner, European or otherwise, besides, of course, you know, elements around expertise in regulatory, clinical, and commercial in the respiratory space, as you'd expect, we also are looking for opportunities in partners that have expertise in device PMDI or DPI device development manufacturing and or IP, which I think could be quite advantageous as we look for the full lifecycle management and other indications for NC-Fentrin, as well as ability to manufacture specifically drug product, but also potentially drug substance or API. And I think that this would serve us well, having, of course, a second source, potentially a source with a lower cost point. Keep in mind that we're looking to supply the world with NC Fentron in different markets. And so, looking for somebody with that manufacturing capability is another feature of our partnering strategy. So, with that, I'll turn it over to Mark for RAMP on SG&A.
spk11: Sure. Sure. Thanks. Thanks for the question. So if you look at SG&A over the last couple of years, you'll see that it has been ramping. A year ago, it was $5-ish million in Q3, and this year it's $13-ish million. And I think what you should expect is that that ramp will continue for the next several quarters. Through Q2, I think that our total expense through Q2 of next year, I think that our total expense should be in the $20 to $25 million range on a quarterly basis. That includes both SG&A and R&D. And then once we get to Q3, assuming approval at the end of June, you would see that the SG&A ramps again as we bring on the sales reps that Chris will talk about.
spk00: Thanks, Mark. Yeah, thanks, Mark, on that. As we think about, you know, June, the reps and how we would potentially hire these people. We first have to think about how a structure looks like for that type of an organization. And, you know, typically when we have a field force of about 100, you're going to look at two area executive directors or executive sales directors that cover the east and the west. We brought those two individuals on And then we are actively looking at the next level under that, which is the RSDs, our regional sales directors, which are directly rep managers. And you would expect those people to be hired maybe three to four months before PDUFA. And then our plan for reps is to hire them around at PDUFA or contingent on PDUFA. We've done this in the past as a team where we – create a pool of candidates that we're able to hire and kind of hold until the drug is approved around the PDUFA date and quickly convert those offers into active employees with an organization. So our plan would be to have those reps come on right after PDUFA and then have them trained and ready to go sell NC Fenton if it's approved. I think the other important aspect here is we believe that a proper field force covering NC-Fentra not only includes field-based reps, but also ways that we can interact with doctors virtually and also support the reimbursement pathway with field reimbursement managers. So I think as you think about the totality of the commercial organization, We want to make sure that we cover the physicians and the patients in a way that they see how the utility of the product, but then can also get the product to the patients that are most in need. And, again, all that large number of representatives and people to support that would be coming around PDUFA right after PDUFA.
spk10: Thank you.
spk07: Next question comes from Tom Schrader with BDIG. Please go ahead.
spk02: Good morning. Thanks for holding the call. I have all combination questions. So the specific LAMA you used, how de-risking is that for the class? The molecules ever not play together, or is it really the mechanisms you're working out? And then there's some old data for encephentrin. It was really quite striking that it made llamas work faster. Maybe for Kathy, does that data hold up in your mind, and is that something that you would be very eager to try to see if you can repeat? I'm going to have a follow-up on bronchiectasis.
spk12: Great. Thanks, Tom. Yeah, I'll turn it over to Cassie to talk about her thoughts on glycopyrrolate in general and then, you know, potentially how NC-Fentron and glycopyrrolate work together.
spk03: Yes. Thanks, Tom, for the question. So glycopyrrolate is like other llamas, works very similar. They've been in use for a long time. So we know a lot about them from that perspective. And they all work fairly similar. So I don't expect to have any surprises from their efficacy or whatever that we look at in studies from that perspective. As far as acting faster, we do have some older data that shows that it's not just llamas, but also for beta agonists, that when you combine the two together, you do get a shortening of the response time to peak efficacy. Again, those were done in shorter studies. but I wouldn't expect that that would go away. I would expect to still see that in the combination type of when we use them together from that perspective. I don't, was there another question I'm forgetting?
spk02: I haven't asked it yet. Okay.
spk03: Okay.
spk02: Go ahead, Tom. Just historically on bronchiectasis, have bronchodilators been tried and failed? Are you mostly betting or focused on the anti-inflammatory properties to show this is an effective drug?
spk03: So bronchiectasis have not failed per se. As was mentioned, there are no approved drugs for non-CF bronchiectasis. Bronchiectasis has some similar things that we see that are similar to COPD, for example, infections, They have widening of the airways, and they have destruction in the airways and increased mucus. So many of the things that we see in bronchiectasis, we see effects from encephentrin and COPD. So, for example, bronchodilation may help clear out the mucus better. It doesn't necessarily work like you would see in somebody with asthma, where you're actually looking to actually bronchodilate the airways, but you're looking for it increasing, getting rid of the mucus and all that are sitting in the airways because that's what's causing all the underlying infections. When you have stuff sitting there, it gets infected and then it leads to an exacerbation. So do we use them? Yes, we use them. We use everything we have because we don't have anything else to use. So we're going to use bronchodilators, we're going to use steroids, we're going to use whatever we have available. because that's what we have to use to treat bronchiectasis. I think we also think from NC-Fenton's perspective, both the non-steroidal anti-inflammatory effect and its ability to increase mucociliary clearance will help clear mucus out of the airways and help prevent and decrease exacerbations that we may see with patients with bronchiectasis.
spk10: Great. Thank you. Thanks, Don.
spk06: As a reminder, if you have a question, please press star, then 1 to be joined into the queue.
spk07: Our next question comes from Dipesh Patel with H.C. Wainwright. Please go ahead.
spk01: Hi, guys. This is Dipesh covering for Bubbal and H.C. Wainwright. In one of the HCP-focused market research slides that you presented last month, we see that Ncfentrin's twice-a-day dosing schedule was the least preferred attribute among seven others. so the score was not that bad. Thinking long-term, how do you expect the twice-a-day regimen to potentially impact NCPentrin's market adoption?
spk12: Great. Chris, do you want to speak to it?
spk00: Yeah, thanks, Dave, and appreciate the question, Dipesh. I think, you know, I think you're referring to the slide on the attributes of drugs, attributes of NCPentrin and how physicians rated that. I think it's really important to just ground ourselves in how impressive the response was from physicians on the profile of ncfentrin. You know, as you mentioned, that was the lowest score, but it's still well above the median. But, you know, for every attribute that's listed from least important to most important, ncfentrin scores extraordinarily high within a physician's mindset. And I think that plays, based on what we've heard in qualitative and KOL interactions, too, the unmet need that still exists in the marketplace. As we discussed earlier, 50% of these patients are having persistent symptoms. So the physicians are looking for drugs that have the potential to have an effect on their patient lives that potentially NC-Fentrin could have. You know, when we talk specifically to doctors about BID dosing, one of the things that's interesting is what we hear from them is that many patients struggle, and Kathy can talk about this, but many patients struggle when they wake up in the mornings. because single or once-a-day drugs tend to lose their effect over time. So in their mind, sometimes the BID dosing is very beneficial for the patient because they get that evening dose that allows them to wake up in a better place than maybe they would have with a single once-a-day type product. So when we look at overall adoption and how physicians look at the profile, we don't believe that a BID dose is a hindrance at all. And you can see that on the second part of that slide, which basically says that 90% of the HCPs believe that you know, they'll be adopting NC-Fentron within the first year of launch. And, you know, that's a remarkably high adoption rate. And it, again, speaks to the unmet need and the overall differentiated profile that NC-Fentron has.
spk01: Great. Thank you for the details. I have a couple more questions. You may have touched on this in some of the prior questions, but can you discuss the challenges you anticipate solving as you work on testing the combinability of enzapentin plus LAMA in a single nebulizer formulation? And I think you had noted earlier on, just to confirm, that you're going to be expecting the clinical trial to begin second half of 24 on that?
spk12: Yes, thanks for the question. Yeah, our general cadence for that development would be You know, getting through the formulation development activities, which takes some time because you want to see the durability of the formulation. That's nothing new in drug development. And that work is ongoing. With regard to challenges, I think it's Nothing that we know of other than getting the work done and having the data to support the plan forward. We believe the formulation can work, but we need the data to support that. We need to make sure that the dose delivered for both ncfentrin and glycopyrrolate when co-formulated is where we want it to be. So there's a lot of technical aspects in a formulation, the chemistry, the dose delivered, the particle size generation, all of that work, which of course we've done previously with ncfentrin we need to do with the combination. So that work will be ongoing. And that's why it puts us in looking at a clinical trial in the second half of 2024. Got it.
spk01: Thank you. And final question. How should we think about R&D expenses moving forward? Specifically, what will the remaining R&D expense relate to? Go ahead, Mark.
spk11: Yep. Yep. Thanks for the question. So, I think in the very near term, you should expect R&D expenses to be fairly limited because we're not running any clinical trials. As we get into the back half of next year, they should go up marginally. These phase two programs that we're talking about are not of the same scope that you're seeing at NC Venture during our phase three program. They're much, much smaller. So the expense levels will be back more like Verona had in the 2019 timeframe. I think single digit, low to mid single digit quarterly R&D expense for the foreseeable future until we get to a phase three program.
spk01: Great. Thank you so much for the update, guys.
spk10: Thank you.
spk06: This concludes our question and answer session.
spk07: I would like to turn the conference back over to Dr. David Zaccardelli for any closing remarks.
spk12: Great. Thank you everybody for attending today's call. We appreciate your support and we look forward to updating you in the future at conferences.
spk10: Have a great day. The conference has now concluded. Thank you for attending today's presentation. You may all now disconnect.
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