Welcome to Verona Pharma's conference call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing top-line results from its phase three ENHANCE-2 trial evaluating nebulized ensifentrine for the maintenance treatment of COPD. The company also issued a press release announcing its financial results for the three months ended June 30, 2022. Copies of both press releases can be found on the Investor Relations tab on the corporate website, veronapharma.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 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, including, without limitation, the impact of the COVID-19 pandemic and the Russia/Ukraine conflict on such progress and on status, recruitment, timing, results, and cost of our clinical trials. Any such forward-looking statements represent management's estimates as of the day 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 ninety days. I'd now like to turn the call over to Dr. David Zaccardelli, Chief Executive Officer. Please go ahead. Thank you, and welcome everyone to today's call to discuss the positive top-line results from our Phase 3 ENHANCE two trial, as well as Verona Pharma's Q2 financial results and operating highlights. With me today are Mark Hahn, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, Chris Martin, our Senior Vice President of Commercial, and Dr. Tara Rheault, our Senior Vice President of Research and Development. In addition, we are very pleased that Dr. Antonio Anzueto, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Health Care System, is joining us today to provide his thoughts on this exciting study result and will be available during the Q&A portion of the call. Note the slides we are showing today will be available on our website after the call. As we endeavor to address the significant unmet need faced by patients with COPD, we are very pleased to announce positive top-line data from our Phase three ENHANCE-2 trial evaluating nebulized ensifentrine for the maintenance treatment of COPD. As a reminder, the ENHANCE-1 and ENHANCE-2 trials replicate measurements of efficacy and safety over 24 weeks, and ENHANCE-1 also evaluates longer-term safety over 48 weeks. The trials were designed to enroll approximately 800 moderate to severe symptomatic COPD subjects for a total of approximately 1,600 subjects across sites primarily in the United States and Europe. In summary, ensifentrine has successfully met the primary endpoint and secondary endpoints evaluating lung function in the ENHANCE-2 trial. In addition, ensifentrine treatment resulted in a significant reduction in rate of exacerbations. Ensifentrine was well-tolerated with safety results similar to placebo. Now let's walk through the study results. First, let's review the types of subjects enrolled in the study. Overall, the demographic and disease characteristics were very well balanced between the ensifentrine and placebo groups. The study enrolled moderate to severe symptomatic COPD patients with compromised lung function with a predicted post-bronchodilator FEV1 of approximately 50% in both groups. The study population included approximately 52% of patients on background therapy, including either a long-acting muscarinic antagonist, a LAMA, or a long-acting beta agonist, a LABA, and 15% of all subjects received inhaled corticosteroids, or ICS, in addition to their bronchodilator medication. On the next slide, let's review in detail each of the lung function study endpoints by looking at the serial FEV1 curve over 12 hours at week 12. The primary endpoint of average FEV1 AUC 0-12 hours post-dose at week 12 demonstrated a placebo-corrected, highly statistically significant and clinically meaningful improvement at week 12 of 94 milliliters with a P-value of <0.0001. We are also pleased the secondary endpoints evaluating lung function were met. Statistically significant and clinically meaningful increases in placebo-corrected peak FEV1 of 146 milliliters 0-4 hours post-dose with a P-value of 0.0001 and morning trough FEV1 of 49 milliliters with a P-value = 0.017 were observed at week 12, supporting a twice daily dosing regimen. As noted on the next slide, all subgroups including gender, age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis diagnosis, FEV1 reversibility, and geographic region demonstrated statistically significant improvements in the change from baseline in average FEV1 AUC 0-12 hours at week 12 with ensifentrine. We are incredibly pleased to show on the next slide that subjects receiving treatment with ensifentrine had a significant 42% reduction in the rate of moderate or severe COPD exacerbation compared with placebo over 24 weeks with a P value of 0.0109. As a reminder, an exacerbation was defined in the protocol as a worsening of symptoms requiring either a minimum of three days of treatment with oral or systemic steroids and/or antibiotics or a hospitalization. On the next slide is the Kaplan-Meier graph, which displays the exacerbation events in each group over the study period. Specifically, the occurrence of exacerbations separated early in the ensifentrine treatment group continued to demonstrate reduced rate of exacerbation events over 24 weeks. Treatment with ensifentrine significantly decreased the risk of an exacerbation as measured by time to first exacerbation when compared with placebo by 42% with a P value of 0.0088. We believe this outstanding result is due to ensifentrine's anti-inflammatory activity in addition to its improvement in lung function. On the next slide, let's review the secondary endpoint measurements of symptoms and health-related quality of life measures. The improvement in daily symptoms observed via the Evaluating Respiratory Symptoms or E-RS total score in the ensifentrine group exceeded the MCID of -2 units at week 24. However, this result was not statistically significant as the placebo arm continued to improve over time. Furthermore, the improvement in health-related quality of life observed by the St. George's Respiratory Questionnaire or SGRQ total score in the ensifentrine group exceeded the MCID of -4 units at week 24. However, again, this effect was not statistically significant as the placebo arm continued to improve over time. Numerical improvements in these measures in the ensifentrine treatment group were seen as early as 6 weeks and showed continued improvement at 12 and 24 weeks, exceeding placebo at each measurement. We are continuing to evaluate the observed results of E-RS and SGRQ to determine if conducting the trial during the COVID-19 pandemic may have affected the results of these subjective measurements of COPD symptoms and quality of life. Turning to safety results on the next slide, ensifentrine was well-tolerated with safety results similar to placebo, including occurrence of pneumonia, gastrointestinal, and cardiovascular adverse events. Treatment emergent adverse events exceeding 1% and greater than placebo events were relatively few and comparable to placebo. Finally, the next slide summarizes the top-line data from the ENHANCE-2 trial. We are delighted with the ENHANCE-2 trial results, which we believe highlight the important potential of ensifentrine to treat symptomatic COPD patients. We plan to release additional information from ENHANCE-2 at upcoming scientific conferences. Looking ahead, we are on track to report top-line data from ENHANCE-1 around the end of the year. If the ENHANCE-1 data are also positive, we plan to submit a new drug application to the FDA in the H1 of 2023 for inhaled ensifentrine for the maintenance treatment of COPD. I will now turn the call over to Mark to review our financial results for the Q2 of 2022. Thank you, Dave. We ended the Q2 of 2022 with $111.5 million in cash and equivalents. We believe our cash and equivalents at June 30, 2022, expected cash receipts from the UK tax credit program and funding expected to become available under the $30 million SVB debt facility will enable us to fund our planned operating expenses and capital expenditure requirements through at least the end of 2023. For the three months ended June 30, 2022, the loss after tax was $17.8 million compared to a loss after tax of $22.1 million for the same period in 2021. This represents a loss of $0.04 per ordinary share for the three months ended June 30, 2022, compared to a loss of $0.05 per ordinary share in the same period of 2021. Research and development costs were $15 million for the three months ended June 30, 2022, compared to the $20.6 million reported for the same period in 2021. The decrease of $5.6 million was primarily due to a $4.2 million decrease in clinical trial and other development costs. As we progress to the later stages of our phase 3 ENHANCE program, and a $1.9 million decrease in share-based compensation charges. Selling, general and administrative expenses were $5.5 million for the three months ended June 30, 2022, compared to $8 million reported for the same period in 2021. This decrease of $2.5 million was primarily due to a decrease in share-based compensation charges. The UK R&D tax credit remains an important element in our financing strategy. As you will recall from previous calls, we are eligible to receive a cash payment from the UK government based on our prior year's qualified R&D spend under the UK's SME R&D tax credit program. In 2022, the program was modified to create caps, could limit the amount of a credit available to a company. In the Q1, we accounted for this credit, assuming Verona Pharma would be subject to the cap. However, we recently received guidance from the HMRC that we qualify for certain exemptions from the cap. Therefore, we recorded the full credit for Q2, and also in Q2, we recognized an incremental $2.3 million relating to catching Q1 up to the full credit amount. As a result, the R&D tax credit for the three months ended June 30, 2022 was $5.4 million, or $1.6 million higher than the $3.8 million credit for the three months ended June 30, 2021. In the next few months, we intend to submit a claim for approximately $14 million related to our 2021 R&D spend. We expect to receive the reimbursement payment later in 2022, further strengthening our balance sheet as we prepare to receive ENHANCE one data. I'll now turn the call back to the operator for the Q&A. We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. If you are 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. The first question today comes from Suji Jeong with Jefferies. Please go ahead. Hi, Suji. Suji, your line is open. You may now ask a question. Oh, sorry. I was muted. My apologies. Congrats on the really good data, and thanks for taking my question. I have a couple questions. The first one is, when you looked at the exacerbation data, was there any subgroup that had more benefit or greater benefit than other groups? The second question is about the commercialization plan. With the exacerbation data that you showed today, have you considered any changes to your plan to commercialize ensifentrine? Previously, you guys said that about 100 sales force could be able or might be able to target those prescribers. I'm just wondering with this data today, if there has been any changes to the plan. Thank you. Thanks, Suji, for the questions. With regard to exacerbation data and subgroup analysis, as this is the top-line data, we haven't had a chance to look at that data specifically. Of course, we will over time. Stay tuned for that. With regard to commercialization, I'll turn it over to Chris Martin for his comments. Thanks, Dave, and thanks, Suji, for the question. When we look at the commercialization plans, we still anticipate that a sales force of about 100 reps would be able to reach the opportunity. As you look at the market, one of the things that's very interesting is the concentration of prescribers across all these drugs that are used in COPD is very small. If you look at some of the products that are on the market, it ranges from about 1,200 physicians doing 70% of the scripts to a little over 15,000 physicians doing 70% of the volume of prescriptions as well. We believe that 100 sales rep number is a very good estimation for what we will need to go and commercialize ensifentrine. Thank you. Hi, this is Dr. Anzueto. I just would like to add a comment of your observation. Certainly, it will be interesting to see if there is any specifics of groups. If you look at the Kaplan-Meier curves of the risk to the first exacerbation, this is something that is very consistent and actually separates over time. Having a patient population with moderate to severe COPD, I would anticipate that we're gonna see the effect pretty much across the board. Thank you. Thank you. Operator, next question. The next question comes from Andreas Argyrides with Wedbush Securities. Please go ahead. All right. Thanks for taking our questions. Good morning, and definitely congrats on these very exciting results. For Dr. Anzueto, how are you thinking about exacerbations versus symptoms, quality of life measures in terms of prioritizing one over the other? I have one follow-up. Sure. Yeah. I think there's a couple of important issues here. I think it's important to emphasize that this is a medication who has both, anti-inflammatory bronchodilator effects. We see the bronchodilator effect, the phosphodiesterase, that we cannot see it even with the oral medication. It is a bronchodilator and works very well. I mean, the data is very strong. I think what makes more interesting is the significant reduction in exacerbation. The impact on exacerbation having 42% decrease, the rate of exacerbation and a similar 42% decrease of the time to the first exacerbation, I think this is really striking. Certainly. How we translate that into a quality of life. I mean, the quality of life is, you look at the slide number 10. For example, at six weeks, there is a very striking difference between the intervention group versus the placebo. This effect kind of gets lost over time. I think there is several issues. Some of the issues are we're losing some individuals, the people who they are more fitted, and it was mentioned before, we have to understand the impact of the pandemic, and this is at 24 weeks. Having the second phase three trial that's going to be longer, the ENHANCE-1 study, we're gonna be able to better understand the impact in quality of life. The fact that we're seeing the significant decrease in exacerbation at 24 weeks, I think is very remarkable. Okay. Just a quick follow-up. Greg, do you have a follow-up? Oh. Yeah. Was there any difference in the E-RS and SGRQ scores in patients that were on background versus those that were not on background? Yeah. As we mentioned before. And then analysis- Oh, sorry. Just say that the analysis hasn't been done yet, so, but you know, we'll of course, with a dataset of this size, there's an enormous amount that we can look at in subset analyses, which we will do over time, with the proper care. I think we're just reviewing the top line today. Okay. Fantastic. Just I had that one follow-up for Dr. Anzueto. Now with this exacerbation data in hand, where do you see ensifentrin sitting in the treatment paradigm? How would you know, look to prescribe it? Thanks. Sure. This is on top of patients being already in long-acting bronchodilators. One is this is a nebulized medication, and today we have three other classes of medication given nebulization. Nebulization is pretty much becoming a standard of care to many patients. I can see this given to patients that either having persistent exacerbation despite being on maximal therapy, or also be used in patients who are on bronchodilators adding this medication to prevent future exacerbations. This will be a medication that with this data will improvement in lung function and in reduction in exacerbation, will be medication we'll give the patients who are at risk for these events. Great. Thank you, and congrats again on the day. Thanks very much. Operator? The next question comes from Joon Lee with Truist Securities. Please go ahead. Hey, guys. Congrats on the impressive data. It's really nice to see this dual mechanism of action theory actually playing out in the clinic. My question is the reduction in exacerbation not captured by E-RS and SGRQ assessments you're tracking, or is it somehow captured in the quality of life assessments, but the placebo response sort of derailed the statistical significance? I have a follow-up. Yeah. Yeah. I'll turn it over to Tara and have her give you her thoughts on it. Sure. The E-RS captures daily symptoms, including bronchodilation, cough and sputum and chest symptoms. Quality of life, it captures symptoms, activity and impact. You don't specifically capture exacerbation events within those tools. Okay. For the upcoming second phase three, you mentioned in the press release that you're watching the ongoing Russia-Ukraine conflict closely. Could you remind us- Mm-hmm. The proportion of ENHANCE-1 patients who are in the U.S. versus EU in that study? And of the EU patients, how many are in the Eastern European sites? Sure. We've got in that study about a third of the patients coming from the U.S. and about two-thirds of the patients coming outside of the U.S. Of those patients coming outside of the U.S., the majority of those are in Eastern Europe with a small proportion in other countries such as Russia, South Korea and U.K. All right. Thank you. The next question comes from Ram Selvaraju with H.C. Wainwright & Co. Please go ahead. Hi, this is Mitchell on for Ram. Thanks for taking our questions. Wanted to ask if you could talk about anything unexpectedly positive that may have come out of the data, that you'd like to highlight. You know, if you could talk about when you expect to publish these results. Yeah. I'm not sure I think it's unexpectedly positive. I think we're very pleased with seeing ensifentrine's effects over a 24-week period, in the results of the study, not only on improvement in lung function but also improvement in exacerbation, which I think gives us a real window in viewing how it's been talked about already, the dual activity of PDE3, PDE4 inhibition as a bronchodilator and anti-inflammatory compound, impacting positively in the treatment of COPD. I think it was a reinforcement of what we've seen earlier, understand from its basic pharmacology, insights that came from phase 2. I think it was an extension confirmation and really good to see these effects and not necessarily unexpected. We are pleased with the strength of the data, not only on lung function, but on exacerbation. I think, you know, it's always interesting to keep in mind that the exacerbations, because it requires worsening of symptoms, inherently captures the concept of symptoms in that. I think that's something we're gonna look at in even more detail. With regard to publication of the data, I think, you know, we will move it along as quickly as we can. I think the strength of the data lends itself to a publication in a premier journal, and so we'll be working towards that as quickly as we can. Well, let me make the comment about the safety. The Achilles heel of the phosphodiesterase inhibitors were Formoterol and then other medications being developed over the years, uncertain, have been side effects and GI side effects and all kind of side effects. Here, these phase three data confirm what it was seen in the phase one and phase two, that given the medication nebulized is very, very safe. You have minimal GI side effects and basically you get the tolerability and you get the efficacy. Okay. Thank you. Yeah. Thank you, doctor. I just wanted to ask if you expect to see anything different come out of the second trial, and if so, could you just describe what those might be? I don't think we're thinking of anything differently. I think as to remind everyone that the studies are essentially identical in design over the first 24 weeks from an efficacy and safety standpoint all the way to primary and secondary endpoints in the intended patient population that is enrolling in the study. We think the read-through should be quite strong. Of course, the noted difference between the second study coming on ENHANCE-1 later this year is that we have a additional subgroup for safety up to 48 weeks. Based on where we are as Dr. Anzueto just reviewed on the safety, you know, we're expecting that to be maintained over the 48 week period. We're encouraged by the ENHANCE-2 trial results, and because of the design and the structure of the study, we think the read-through should be quite strong. Thank you very much. The next question comes from Tom Shrader with BTIG. Please go ahead. Good morning. Congratulations. It's really nice data. I had a question on exacerbations, I guess like everyone else. Is your 42% pretty comparable to the 20% and 30% that Daliresp saw? Are they similar measurements? I'm just. It looks to me like your exacerbation rate is pretty high. You get such a robust result in kind of a small trial. How comparable are these numbers? Sure. I think from an endpoint perspective, the analysis is essentially the same. The treatment effect that we're seeing with ensifentrine is obviously much greater, given that and just noting that the populations are also quite different, as this study did not restrict to patients with chronic bronchitis only. Okay. I had two more questions. I think it's important to emphasize, from the Formoterol study, especially the phase three trial excluded patients were not allowed to be on ICS. This was a cohort where long-acting bronchodilator without inhaled corticosteroids, and here there are 10% of the population who is on ICS. As you said before, this is probably different patient population. Got it. Similarly, you didn't give the exact numbers, but it looks like the primary, depending on background therapy, is something like 75 mL and 115 mL. Were the patients on background therapy meaningfully sicker? Was their starting FEV1 worse? No. I think, our look at it so far is there was a lot of comparability between the two based on the entry criteria, between background therapy and not. Your point estimates in fact are about right as well. It's really a drug effect. All right. Congratulations. Thank you very much. Thanks, Tom. As a reminder, if you would like to ask a question, please press star then one to enter the question queue. The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead. Good morning, team, and my big congrats to you to a very stellar data set. Maybe the first question is to you, team Verona. Is there an opportunity of being able to look at the subcomponent of the SGRQ total score and system in being able to see whether one component was driven more on the placebo and maybe, you know, statistical differences can be detected in the sub scores? That's one question. Then a question for Dr. Anzueto. It's pretty remarkable to see not only the exacerbation data, but also its fast response, being able to capture a difference within four weeks. Could you maybe enlighten us how meaningful this is and how it compares to other therapies that you have accessible to you, being able to see a fast-acting response? Thank you again for taking my questions. Go ahead, Dr. Anzueto. Why don't you answer the second question first? Sure. Sometimes we see the separation, it's very early in the course, and if you will see that in the Kaplan-Meier curve. I think this is very remarkable, especially taking into consideration that the patient's baseline therapy as well as the patient's FEV1. I think it's hard to say too is comparable, but we have seen curve separations like this with recent publications on the triple therapy. The same data separation starts occurring between four-six weeks after the start of the medications. I can talk a little bit about the domain analysis and the subgroup analysis. We definitely do intend to take a close look at that, once we have a fuller set of data in our hands. I think just one thing I'd like to point out is that this placebo response that we saw in this study was extremely large. I think larger than you would historically have seen in other programs. Thank you. Team, I apologize, maybe one other last-minute question that popped into my head. Given this data is now hot off the press, I'm certain that you can go and take this data and probably share it with the investigators that are involved in the ENHANCE-1 study. Could you maybe give us a perspective on sort of the operational homework that's ahead of you to share this exciting data with the investigators? Do you think that's gonna drive, you know, enrollment and expedite it? Just give us a little bit of perspective of the aftermath of these outstanding data when it comes to interaction with the investigators to ensure top-line data for end of 2022. Thank you again for letting me ask one more question. Sure. Our enrollment in the second study, ENHANCE-1, has completed. We don't expect any impacts there. We are in that space where we're completing the patients that had already enrolled. The top-line data obviously is public, and they will have access to that. All of the ENHANCE-1 data is still blinded at this time, so we don't expect that to, you know, obviously have any impact whatsoever on our ongoing trial. Okay, great. Thank you. Thanks, yes. The next question is a follow-up from Joon Lee with Truist Securities. Please go ahead. Hey, thanks for taking our questions. A follow-up question. It's actually a follow-up from the prior question. In fact, I think my question would be: What are you gonna do to make sure that this doesn't get disseminated too much to the point where it might drive up the placebo response in the patients who are still in the trial? Thank you. Sure. I think one comment I could say there is that the patient population is probably not the group that is the fastest uptake on, you know, new phase three results. Again, it's a single trial that we've released so far, so we're really not expecting any impacts there. That certainly has not been the case in other programs. This is Dr. Anzueto. As an investigator in clinical trials, you know, if I will be part of the long-term trial, and I see that these positive results, it really is gonna encourage me to try to collect all the data, to get all the protocols, everything, try to wrap up, because I can see as an investigator the importance to complete the other trial as soon as possible. Okay. You know, actually quick follow-up. You know, I'm looking at the data FEV1 mean change based on demographics like, you know, gender, age. Like male patients tend to extract greater benefits than female patients. Are the patients in you know, the ongoing phase three, sort of the demographic distribution, not the geographic distribution which you mentioned already. Are the demographic distributions similar between the two trials? Yes. They are fairly similar. You know, one thing I can mention is that you typically have a higher starting baseline lung function in males than you do have in females. That's expected. All right. Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. David Zaccardelli for any closing remarks. Thank you, operator. We'd like to thank everyone for your questions today. To thank the patients and healthcare professionals participating in the ENHANCE program. Finally, I'd like to thank our shareholders for their continued support and the dedicated and talented team at Verona for their commitment. We look forward to discussing these highly positive results with many of you in the coming weeks and months. I also wanna thank Dr. Anzueto for joining us today on the call and providing his insights. With that, we can conclude today's call.