Latest news with #NuancePharma
Yahoo
16-05-2025
- Business
- Yahoo
Nuance seeks China approval for Ohtuvayre following Phase III trial success
Nuance Pharma's Ohtuvayre (ensifentrine) has met the primary endpoint in a Phase III chronic obstructive pulmonary disease (COPD) study in China. The medication was developed as part of a partnership with UK company Verona Pharma. In the ENHANCE-CHINA trial (NCT05743075), nebulised Ohtuvayre showed a statistically significant and clinically meaningful improvement in change in forced expiratory volume (FEV) of 110ml after 12 weeks. The trial also showed improvement in lung function, including a peak FEV of 174mL, a morning trough FEV increase of 36ml and an evening trough FEV increase of 65ml. Patients also receiving saw a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks, and there was a decrease in the risk of a moderate/severe exacerbation, measured by time to first exacerbation of 25%. There was also improvement in secondary endpoints, including dyspnea as measured by the Transition Dyspnea Index (TDI) of 0.8 compared to placebo over 24 weeks. Quality of Life (QoL), as measured by the St George's Respiratory Questionnaire (SGRQ) Total Score in the Ohtuvayre arm, also improved by -2.9, higher than the Minimal Clinically Important Difference (MCID) of -4. The therapy remained well-tolerated with adverse event (AE) incidence similar to placebo. Nuance Pharma CEO Mark Lotter said: "These promising results demonstrate Ohtuvayre's strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options.' Nuance Pharma plans to submit a new drug application to China's National Medical Products Administration (NMPA) in the second half of 2025. Shanghai-based Nuance gained rights to Ohtuvayre in June 2021 after signing a $219m strategic collaboration with Verona Pharma. The collaboration gave Nuance Pharma development and commercial rights in Greater China. Ohtuvayre is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects delivered through a standard jet nebuliser. The drug was approved by the US Food and Drug Administration (FDA) on 26 June 2024 for use in adult COPD patients. Approval for use in Europe has yet to be granted. Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences. According to GlobalData, Ohtuvayre could reach global sales of $1.63bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Nuance seeks China approval for Ohtuvayre following Phase III trial success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
16-05-2025
- Health
- Yahoo
Nuance Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-CHINA Trial for COPD
Statistically significant improvements in lung functionConsistent trends of quality of life and exacerbation rate reduction as ENHANCE-1/2Well tolerated safety profileNDA submission planned for 2H 2025 SHANGHAI, May 16, 2025 /PRNewswire/ -- Nuance Pharma ("Nuance") today announces its top-line Phase 3 ENHANCE-CHINA (NCT05743075) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD"). The ENHANCE-CHINA trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function. The investigational study drug, ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3; PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. Highlights - Study population (n = 526 randomized): Subject demographics and disease characteristics were well balanced between treatment groups Approximately 46% of subjects received background COPD therapy, either a long-acting muscarinic antagonist ("LAMA") or a long-acting beta-agonist ("LABA"). Additionally, approximately 38% of all subjects received inhaled corticosteroids ("ICS") with concomitant LABA. - Primary endpoint met (FEV1 AUC 0-12hr): Placebo corrected, change from baseline in average FEV1 area under the curve 0-12 hours post dose at week 12 was 110 mL (p<0.0001) for ensifentrine Statistically significant and clinically meaningful improvements with ensifentrine demonstrated across key subgroups including age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV1 reversibility - Secondary endpoints of lung function: Placebo corrected, increase in peak FEV1 of 174 mL (p<0.0001) at week 12 Placebo corrected, increase in morning trough FEV1 of 36 ml (p=0.0533) and evening trough FEV1 of 65 ml (p=0.0038) at week 12, confirming twice daily dosing regimen. Placebo corrected, increase in average FEV1 of 162 ml (p<0.0001) 0-4 hours post dose and 77 mL (p=0.0003) 6-12 hours post dose at week 12 - COPD symptoms and quality of life (QoL): Clinically meaningful improvements in dyspnea as measured by Transition Dyspnea Index (TDI) in the ensifentrine group were observed at all weeks (6, 12 and 24) with a statistically significant improvement of 0.8 unit compared to placebo at week 24. Quality of Life (QoL) as measured by St George's Respiratory Questionnaire (SGRQ) Total Score in the ensifentrine group improved from baseline to greater than the MCID of -4 units with a significant improvement of -2.9 units compared to placebo at week 24. Daily symptoms as measured by Evaluating Respiratory Symptoms (E-RS) Total Score in ensifentrine group showed improvement from baseline as early as 6 weeks and continued improvement at 12 and 24 weeks, numerically exceeding placebo at each measurement. - Exacerbation rate reduced Subjects receiving ensifentrine demonstrated a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks compared to those receiving placebo (RR = 0.72, 95% CI: (0.43, 1.22)) Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 25% (HR = 0.75, 95% CI: (0.44, 1.28)) - Favorable safety profile: Ensifentrine was well-tolerated with treatment related AE incidence similar to placebo Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said:"We are very pleased by the successful outcome of our Phase 3 ENHANCE-CHINA study, bringining us another step closer to providing a much needed novel therapy for COPD patients in China. These promising results demonstrate ensifentrine's strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options. We plan to submit a New Drug Application to the China NMPA in the second half of 2025. We would like to thank all the patients and investigators for their participation in the ENHANCE-CHINA program. " Charlie Chen, Chief Operating Officer of Nuance Pharma added:"The totality of ENHANCE data including improvements in lung function, symptoms, quality of life measure and reduction in exacerbations, coupled with favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. Following our ongoing early access programs in Hainan BoAo and Greater Bay Area, as well as regulatory approval in Macau, we look forward to bringing this medicine to patients in Greater China." David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, said:"we look forward to Nuance Pharma's continued progress and having Ohtuvayre® available for the millions of symptomatic patients needing additional treatment." Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences. In Feb 2025, the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients. In Nov 2024, Nuance Pharma launched Ohtuvayre™ in China's Hainan Boao Pilot Zone through early access program. In Sep 2024, Nuance Pharma completed recruitment for ENHANCE-CHINA, the phase 3 clinical trial of Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD. In June 2024, Nuance Pharma's global partner Verona Pharma plc (Nasdaq: VRNA), announced the US Food and Drug Administration ("FDA") approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients. In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre™ (ensifentrine) in Greater China (mainland China, Hong Kong, Macau and Taiwan). About Ohtuvayre™ (ensifentrine)Ohtuvayre™ is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre™ in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre™ met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. About the ENHANCE-CHINA programThe randomized, double-blind, placebo-controlled study evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and subjects may receive ICS. Patient Population: 526 moderate to severe, symptomatic, COPD patients at 46 sites in China. Dose/Duration: subjects were randomized to receive a 3mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV1 AUC 0-12 hours post dose at week 12. Secondary Endpoints: lung function endpoints including peak and morning trough FEV1, COPD symptoms and health related quality of life through 24 weeks via SGRQ and E-RS, and exacerbation at 24 weeks, and others Safety: Assessed over 24 weeks Further information about ENHANCE-CHINA program can be found at (NCT05743075) About Verona PharmaVerona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre™ (ensifentrine) is the Company's first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ohtuvayre™ (ensifentrine) has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit About Nuance PharmaNuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit Forward-looking StatementsThis news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. View original content: SOURCE Nuance Pharma Limited
Yahoo
02-05-2025
- Business
- Yahoo
Why Verona Pharma plc (VRNA) Soared on Tuesday
We recently published an article titled . In this article, we are going to take a look at where Verona Pharma plc (NASDAQ:VRNA) stands against the other stocks that soared on Tuesday. The stock market finished Tuesday's trading on a positive note with all major indices ending in the green, buoyed by the influx of corporate earnings results. The Dow Jones grew by 0.75 percent, the S&P 500 rose by 0.58 percent, and the Nasdaq was up by 0.55 percent. Ten companies mirrored the broader market optimism, leading the charge with strong gains, predominantly driven by impressive earnings results. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5-million trading volume. A patient in a clinic, taking a medication dose from a nebulizer to treat a respiratory disease. Verona Pharma plc (NASDAQ:VRNA) extended its rally for an eighth straight day on Tuesday, adding 6.37 percent to end at $73.21 apiece after the company posted an impressive earnings performance during the first three months of the year. In its earnings release, Verona Pharma plc (NASDAQ:VRNA) said that it narrowed its net loss by 36.8 percent to $16.3 million from $25.79 million in the same period a year earlier. Net revenues stood at $76.3 million, primarily driven by $71.3 million in net sales from Ohtuvayre, the company's maintenance treatment of COPD. In February this year, Verona Pharma plc (NASDAQ:VRNA), through its partner Nuance Pharma, secured the green light of the Macau government to sell Ohtuvayre in the special administrative region. Commenting on its strong performance, VRNA President and CEO David Zaccardelli said: 'We are extremely pleased to report that for the first time, Verona's quarterly revenue exceeded our operating expenses, excluding non-cash charges. We believe we are in a robust financial position to continue commercializing Ohtuvayre, advance our clinical pipeline, and implement our global strategy.' Overall VRNA ranks 6th on our list of the stocks that soared on Tuesday. While we acknowledge the potential of VRNA as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than VRNA but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: and . Disclosure: None. This article is originally published at . Sign in to access your portfolio
Associated Press
27-02-2025
- Business
- Associated Press
Verona Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Ohtuvayre TM (ensifentrine) recorded net product sales of $36.6 million in Q4 and $42.3 million in 2024 More prescriptions filled through February 2025 than in Q4 2024 Over 4,600 unique prescribers with ~55% of Tier 1 HCPs prescribing Ohtuvayre through February 2025 Phase 2 programs in bronchiectasis and fixed-dose combination in COPD advance Conference call today at 9:00 a.m. EST / 2:00 p.m. GMT LONDON and RALEIGH, N.C., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ('Verona Pharma' or the 'Company'), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2024, and provides a corporate update. '2024 was another transformational year for Verona Pharma with the US approval and launch of Ohtuvayre (ensifentrine), the first novel inhaled therapy available for the maintenance treatment of Chronic Obstructive Pulmonary Disease ('COPD') in over 20 years,' said David Zaccardelli, Pharm. D., President and Chief Executive Officer. 'We are very pleased to report the extremely strong start to the launch continues to build momentum with more prescriptions dispensed through February 2025 than in the entire fourth quarter of 2024. 'More than 4,600 unique healthcare professionals ('HCPs') including approximately 55% of our Tier 1 HCPs have prescribed Ohtuvayre. Additionally, to date, more than 275 HCPs have prescribed Ohtuvayre to over 20 patients in their practice. Ohtuvayre is being prescribed for maintenance therapy across a broad COPD population including those receiving background single, dual and approximately 50% on triple therapy. These data strengthen our belief that ensifentrine's novel bronchodilator and non-steroidal anti-inflammatory activity will redefine the treatment paradigm for COPD. 'Alongside our commercialization efforts, in the third quarter we initiated two Phase 2 clinical trials: a dose-ranging trial with glycopyrrolate, a long-acting muscarinic antagonist ('LAMA'), to support a nebulized fixed-dose combination of ensifentrine and glycopyrrolate for the maintenance treatment of COPD, and a study assessing the safety and efficacy of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis ('bronchiectasis'). We are pleased to report the glycopyrrolate dose-ranging trial was successfully completed and we plan to initiate a dose ranging Phase 2b trial with a fixed-dose combination of ensifentrine and glycopyrrolate in the second half of 2025. 'In addition to our successful Ohtuvayre launch, our development partner in Greater China, Nuance Pharma, announced in February 2025 that Ohtuvayre was approved in Macau, the first approval outside of the US, for the maintenance treatment of COPD. In addition, Nuance Pharma has completed enrollment in its own pivotal Phase 3 trial in China to evaluate ensifentrine for the maintenance treatment of COPD and expects to report results in mid-2025. 'In 2025, we will continue to build on the successful commercialization of Ohtuvayre in the US while progressing our Phase 2 programs. We are also initiating activities with regulatory authorities in the European Union and the UK for potential marketing authorization application submissions for Ohtuvayre.' Program Updates and Key Milestones The Company's near-term milestones include: In the second half of 2025, the Company plans to start a dose-ranging Phase 2b trial to assess the safety and efficacy of a fixed-dose nebulized combination of ensifentrine with glycopyrrolate. The Company has successfully completed a Phase 2 dose-ranging trial with glycopyrrolate to support this program. The Company continues to enroll subjects in a Phase 2 trial to assess the efficacy and safety of nebulized ensifentrine in patients with bronchiectasis. In 2025, the Company plans to progress the regulatory activities for potential marketing authorization application submissions for Ohtuvayre for the maintenance treatment of COPD in the European Union and in the UK. In mid-2025, the Company's development partner in Greater China, Nuance Pharma, is expected to report results from its pivotal Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China. Fourth Quarter and Recent Highlights In October 2024, the Company gave four oral presentations and presented two posters on analyses from the ENHANCE studies at CHEST Annual Meeting 2024. These included subgroup data supporting improvements in lung function, symptoms and quality of life, as well as reductions in the rate of exacerbations, regardless of COPD severity (moderate or severe), smoking status (current or former) and chronic bronchitis (with or without). An analysis of Ohtuvayre's impact on reducing exacerbation rates and COPD-related healthcare resource utilization was also presented. In November 2024, the 2025 GOLD report added Ohtuvayre to the COPD treatment algorithm. Also in November 2024, the Company completed enrollment in a Phase 2 dose-ranging trial with glycopyrrolate, a LAMA, supporting a fixed-dose combination program for the maintenance treatment of COPD via a nebulizer. On January 1, 2025, Ohtuvayre's product specific J-code became effective. In February 2025, the Company's development partner in Greater China, Nuance Pharma, announced Ohtuvayre has been approved in Macau for the maintenance treatment of COPD in adult patients. This is the first regulatory approval outside of the US. Fourth Quarter 2024 Financial Results Cash position: Cash and cash equivalents at December 31, 2024, were $399.8 million (December 31, 2023: $271.8 million). Product sales: Net sales of Ohtuvayre were $36.6 million for the fourth quarter ended December 31, 2024 (Q4 2023: $0 million). The Company received FDA approval on June 26, 2024 and the product was commercially available beginning in August 2024. Cost of sales: Cost of sales was $2.0 million for the fourth quarter ended December 31, 2024 (Q4 2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties. R&D Expenses: Research and development ('R&D') expenses were $7.9 million for the fourth quarter ended December 31, 2024 (Q4 2023: $4.1 million). This increase of $3.8 million was primarily due to an increase of $3.2 million in clinical trial and other development costs as we initiated two Phase 2 studies in the third quarter of 2024 related to the combination of nebulized ensifentrine and glycopyrrolate and for Ohtuvayre in patients with bronchiectasis, and an increase of $1.1 million in share-based compensation. SG&A Expenses: Selling general and administrative expenses ('SG&A') were $45.1 million for the fourth quarter ended December 31, 2024 (Q4 2023: $15.0 million). The increase of $30.1 million was driven primarily by an increase of $9.8 million in marketing and other commercial related activities, including travel, primarily related to the launch of Ohtuvayre, and an increase of $2.6 million in professional and consulting fees, information technology costs and other support costs due to the continued buildout of our commercial organization. Additionally, we had an increase of $8.8 million in people-related costs as we built out our commercial organization including much of the field sales team as well as an increase of $7.8 million related to share-based compensation. Net loss: Net loss was $33.8 million for the fourth quarter ended December 31, 2024 (Q4 2023: Net loss $14.1 million). Full Year 2024 Financial Results Product sales: Net sales were $42.3 million for the year ended December 31, 2024 (2023: $0 million) related to product sales of Ohtuvayre. Cost of sales: Cost of sales was $2.6 million for the year ended December 31, 2024 (2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties. R&D Expenses: R&D expenses were $44.6 million for the year ended December 31, 2024 (full year 2023: $17.2 million), an increase of $27.4 million. This increase was primarily due to an increase of $17.5 million in clinical trial and other development costs we incurred related to the two Phase 2 studies which were initiated in the third quarter of 2024 related to the combination of nebulized ensifentrine and glycopyrrolate and for Ohtuvayre in patients with bronchiectasis, the $6.3 million approval milestone, $3.1 million increase in share-based compensation, $2.0 million increase for people-related costs and $1.1 million related to pre-launch manufacturing costs for commercial supply. This was partially offset by a decrease of $1.3 million in consultant and professional fee costs which were higher in the prior year due to service costs associated with our New Drug Application and the related approval process. SG&A Expenses: SG&A expenses were $149.8 million for the year ended December 31, 2024 (full year 2023: $50.4 million), an increase of $99.4 million. This increase was driven primarily by an increase of $29.7 million in marketing and other commercial related activities, including travel, primarily related to the launch of Ohtuvayre, a charge of $15.0 million for the first sale milestone and an increase of $7.3 million in professional and consulting fees, information technology costs and other support costs due to the continued buildout of our commercial organization. Additionally, we had an increase of $26.8 million in people-related costs as we built out our commercial organization including much of the field sales team as well as an increase of $18.8 million related to share-based compensation. Net loss: Net loss was $173.4 million for the year ended December 31, 2024 (full year 2023: $54.4 million). Conference Call and Webcast Information Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on Thursday, February 27, 2025, to discuss the fourth quarter and full year 2024 financial results and the corporate update. To participate, please dial one of the following numbers and ask to join the Verona Pharma call: +1-800-836-8184 for callers in the United States +1-646-357-8785 for international callers A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, and the audio replay will be available for 90 days. An electronic copy of the fourth quarter and full year 2024 results press release will also be made available today on the Company's website. Important Safety Information Indication Ohtuvayre is a prescription medicine used to treat COPD in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both. What is the most important information I should know about Ohtuvayre? Ohtuvayre can cause serious side effects, including: Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Ohtuvayre and call your healthcare provider right away or go to the nearest hospital emergency room right away. Mental health problems including suicidal thoughts and behavior. You may experience mood or behavior changes when taking Ohtuvayre. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood. Do not use Ohtuvayre to treat sudden breathing problems. Always have a rescue inhaler with you. Who Should Not use Ohtuvayre? Do not use Ohtuvayre if you have had an allergic reaction to ensifentrine or any of the ingredients in Ohtuvayre. What should I tell my healthcare provider before using Ohtuvayre? Before you use Ohtuvayre, tell your healthcare professional if you have or have had a history of mental health problems including depression and suicidal behavior; have liver problems; are pregnant or plan to become pregnant; are breastfeeding. It is not known if Ohtuvayre may harm your unborn baby. It is not known if the medicine in Ohtuvayre passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the most common side effects of Ohtuvayre? The most common side effects of Ohtuvayre include back pain, high blood pressure, bladder infection and diarrhea. These are not all the possible side effects of Ohtuvayre. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This summary does not include all the information about Ohtuvayre and is not meant to take the place of a discussion with your healthcare provider about your treatment. For further information, please see the full Prescribing Information, including the Patient Information Leaflet. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For further information please contact: About Verona Pharma Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company's first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as 'anticipate,' 'believe,' 'plan,' 'expect,' 'intend,' 'may,' 'potential,' 'prepare,' 'possible' and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre to treat adult patients in the US with COPD, statements regarding our two recently initiated Phase 2 clinical trials, the Company's plans to initiate a Phase 2b clinical trial, potential regulatory approvals in the EU and UK, and Nuance Pharma's results from its pivotal Phase 3 trial, and the timing of any of the foregoing. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but 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, but not limited to, the following: risks related to our limited operating history; our need for additional funding to complete development and commercialization of Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; our commercial capabilities and infrastructure, including sales, marketing, operations, distribution, and reimbursement infrastructure, may not be adequate to successfully commercialize Ohtuvayre; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; the terms of our credit agreement and the revenue interest purchase and sale agreement ('RIPSA') place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RIPSA, our results of operations and financial condition may be harmed; our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics; and the other important factors discussed under the caption 'Risk Factors' in our Annual Report on Form 10-K for the period ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on February 27, 2025, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Verona Pharma plc Consolidated Financial Summary (unaudited) (in thousands, except share and per share amounts) Three months ended December 31, Years ended December 31, 2024 2023 2024 2023 Revenue Product sales, net $ 36,637 $ — $ 42,261 $ — Other revenue 18 — 18 — Total Revenue, net 36,655 — 42,279 — Operating expenses Cost of sales 2,039 — 2,582 — Research and development 7,870 4,122 44,574 17,216 Selling, general and administrative 45,085 14,972 149,750 50,353 Total operating expenses 54,994 19,094 196,906 67,569 Operating loss (18,339) (19,094) (154,627) (67,569) Other income/(expense) Research & development tax credit 556 1,034 3,600 1,104 Loss on extinguishment of debt — — (3,653) — Interest income 3,994 3,292 15,262 12,761 Interest expense (10,317) (623) (23,542) (2,057) Foreign exchange gain/(loss) (1,450) 1,206 (169) 1,866 Total other income/(expense), net (7,217) 4,909 (8,502) 13,674 Loss before income taxes (25,556) (14,185) (163,129) (53,895) Income tax benefit/(expense) (8,271) 53 (10,289) (474) Net loss $ (33,827) $ (14,132) $ (173,418) $ (54,369) Weighted average shares outstanding – basic and diluted 663,263,855 642,139,211 652,310,582 634,142,660 Loss per ordinary share - basic and diluted $ (0.05) $ (0.02) $ (0.27) $ (0.09) 2024 2023 Cash and cash equivalents $ 399,757 $ 271,772 Total assets 474,242 308,124 Shareholders' equity $ 204,559 $ 249,283
