Verona Pharma plc

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 III Enhance II trial evaluating nebulized MC-sen trends for the maintenance treatment of COPD. The company also issued a press release announcing its financial results. The three months ended June 30, 2022. Copies of both press releases can be found on 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 involves 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 abuse or 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.

Thank you, and welcome everyone to today's call to discuss the positive top line results from our phase three enhanced two trial, as well as Verona Pharma's second quarter 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 Rowe, 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 Healthcare System, is joining us today to provide his thoughts on this exciting study results 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 III Enhanced II trial, evaluating nebulized ncfentrin for the maintenance treatment of COPD. As a reminder, the Enhanced I and Enhanced II 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, NC-Fentron has successfully met the primary endpoint and secondary endpoints evaluating lung function in the ENHANCE-II trial. In addition, encephentrin treatment resulted in a significant reduction in rate of exacerbations. Encephentrin was well-tolerated with safety results similar to placebo. So 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 ncfentrin 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, ALAMA, 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 to 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 less than 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 to 4 hours post-dose with a p-value of 0.0001 and morning trough FEV1 of 49 milliliters with a p-value equal to 0.0017 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 to 12 hours at week 12 with ncfentrin. We are incredibly pleased to show on the next slide that subjects receiving treatment with ncfentrin 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 And the Ncfentrin treatment group continued to demonstrate reduced rate of exacerbation events over 24 weeks. Treatment with Ncfentrin significantly decreased the risk of 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 NC-Fenton'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 ERS, total score, in the ncfentrin group exceeded the MCID of minus two 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 ncfentrin group exceeded the MCID of minus four 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 ncfentrin treatment group were seen as early as six weeks and showed continued improvement at 12 and 24 weeks, exceeding placebo at each measurement. We are continuing to evaluate the observed results of ERS and SGRQ to determine if conducting the trial during the COVID 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, Ncfentrin 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 encephalogen 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 first half of 2023 for inhaled Ncfentrin for the maintenance treatment of COPD. I will now turn the call over to Mark to review our financial results for the second quarter of 2022.