Announcement • Oct 18
Verona Pharma plc Files Form 15 Verona Pharma plc has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Ordinary Shares, nominal value £0.05 per share and American Depositary Shares, each representing eight ordinary shares under the Securities Exchange Act of 1934, as amended. Announcement • Jul 10
Merck Reportedly Nears $10 Billion Deal to Buy Verona Pharma Merck & Co., Inc. (NYSE:MRK) is nearing a $10 billion deal to buy lung diseases focused Verona Pharma plc (NasdaqGM:VRNA), as the U.S. drugmaker is eyeing deals to offset the upcoming patent expiry of its blockbuster cancer drug, the Financial Times reported on July 09, 2025. The deal values London-based Verona at about $107 per American depository share, the report said, citing three people familiar with the matter. The reported purchase price represents a premium of about 23% to Verona ADS' last close on the NASDAQ. The deal would be Merck's largest since its $10.8 billion buyout of Prometheus Biosciences in 2023. News of the upcoming deal sent Verona's U.S.-listed shares soaring about 18% to $102.8 in premarket trading. Merck and London-based Verona didn't immediately respond to Reuters requests for comment. Reuters couldn't immediately verify the report. Announcement • Jul 09
Merck Sharp & Dohme LLC entered into a definitive agreement to acquire Verona Pharma plc (NasdaqGM:VRNA) for $9.7 billion. Merck Sharp & Dohme LLC entered into a definitive agreement to acquire Verona Pharma plc (NasdaqGM:VRNA) for $9.7billion on July 8, 2025. As part of consideration, Merck Sharp & Dohme LLC will acquire Verona Pharma for $107 per American Depository Share (ADS), each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion. Through this acquisition Merck will add Ohtuvayre® (ensifentrine), a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio. The transaction is expected to negatively impact non-GAAP EPS by ~$0.16 in the first 12 months, representing costs associated with financing the transaction partially offset by Ohtuvayre® performance, and will turn accretive to non-GAAP EPS in 2027 and be accretive for the full year 2028. The acquisition has the flexibility to finance the transaction through a combination of cash, commercial paper and new debt issuance. The Company may be required to pay Merck Sharp & Dohme LLC a termination fee of $100 million, that the Board no longer supports the consummation of the Transaction or no longer wishes the Court to sanction the Scheme of Arrangement.
The transaction was unanimously approved by both the Merck and Verona Pharma Boards of Directors and is intended to be effected by way of a scheme of arrangement under UK law. Closing of the proposed acquisition is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act, approval of Verona Pharma shareholders, sanction by the High Court of Justice of England and Wales and other customary conditions. The transaction is expected to close in the fourth quarter of 2025.
Citigroup Inc. acted as financial advisor for Merck Sharp & Dohme LLC. Morgan Stanley & Co. LLC acted as financial advisor for Merck Sharp & Dohme LLC. Jenny Hochenberg of Freshfields LLP acted as legal advisor for Merck Sharp & Dohme LLC. Centerview Partners LLC acted as financial advisor for Verona Pharma plc. Peter Handrinos, Scott Shean, Sam Newhouse and Douglas Abernethy of Latham & Watkins LLP acted as legal advisor for Verona Pharma plc. Announcement • May 06
Verona Pharma plc to Present Seven Analyses of the Phase 3 ENHANCE Studies in COPD at ATS 2025 Verona Pharma plc announced ten posters including seven additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD"), two from nonclinical studies, and one from a real-world data analysis, will be presented at the American Thoracic Society Conference ("ATS") 2025. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3 and PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre are the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The ENHANCE posters highlight subgroup analyses of patients when used as monotherapy, in patients with COPD and comorbid cardiac disorders and, separately, in patients with COPD & comorbid type 2 diabetes. An analysis of Ohtuvayre's effect on COPD exacerbations relative to lung function results will also be presented. Nonclinical posters describe a tissue distribution study in rat demonstrating lack of brain exposure, and a bleomycin model in rat demonstrating antifibrotic effects following inhaled ensifentrine dosing. In addition, the Company will have an exhibition booth, 2237, which will host presentations led by clinical experts. Details of Verona's posters are listed below and linked to the ATS website. Announcement • Apr 15
Verona Pharma plc to Report Q1, 2025 Results on Apr 29, 2025 Verona Pharma plc announced that they will report Q1, 2025 results on Apr 29, 2025 Announcement • Feb 13
Verona Pharma plc to Report Q4, 2024 Results on Feb 27, 2025 Verona Pharma plc announced that they will report Q4, 2024 results at 9:30 AM, US Eastern Standard Time on Feb 27, 2025 Recent Insider Transactions • Nov 08
President recently sold €568k worth of stock On the 4th of November, David Zaccardelli sold around 18k shares on-market at roughly €32.23 per share. This transaction amounted to 1.1% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €1.2m. David has been a net seller over the last 12 months, reducing personal holdings by €1.2m. Breakeven Date Change • Nov 04
No longer forecast to breakeven The 6 analysts covering Verona Pharma no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$115.4m in 2026. New consensus forecast suggests the company will make a loss of US$36.5m in 2026. Recent Insider Transactions • Oct 28
President recently sold €586k worth of stock On the 25th of October, David Zaccardelli sold around 18k shares on-market at roughly €32.36 per share. This transaction amounted to 1.2% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €1.2m. This was David's only on-market trade for the last 12 months. Announcement • Oct 21
Verona Pharma plc to Report Q3, 2024 Results on Nov 04, 2024 Verona Pharma plc announced that they will report Q3, 2024 results on Nov 04, 2024 Announcement • Oct 01
Verona Pharma plc to Present Six Analyses of the Phase 3 ENHANCE Studies in COPD at CHEST 2024 Verona Pharma plc announced presentations of analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at CHEST Annual Meeting (“CHEST”) 2024. The analyses are published in the CHEST Annual Meeting on-line supplement. Ohtuvayre (ensifentrine) is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase three and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The analyses will summarize the efficacy and safety of Ohtuvayre in subgroups of COPD patients including 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). Furthermore, an analysis of ensifentrine’s impact on reducing exacerbation rates and COPD-related healthcare resource utilization over 48 weeks will also be presented. 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. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Announcement • Sep 18
Ritedose Corporation, Inc. Partners with Verona Pharma plc for Development and Manufacturing of Ohtuvayre for Copd Treatment The Ritedose Corporation Inc. partner with Verona Pharma plc as the development and manufacturing partner of Ohtuvayre, a new novel product for Chronic Obstructive Pulmonary Disease (COPD). The U.S. Food and Drug Administration (FDA) approved Ohtuvayre on June 26 for the maintenance treatment of COPD in adult patients. It is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPd in more than 20 years. Ohtuvayre is delivered through a standard jet nebulizer and is expected to redefine the treatment paradigm for COPD. Despite maintenance therapy in multiple combinations, most COPD patients grapple with daily symptoms including breathlessness and persistent coughing. Ohtuvayre, an innovative first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique, important advancement in the treatment of COPD. COPD affects more than 480 million people across the globe and more than 14 million people in the United States. Approximately half of COPD patients experience almost daily symptoms, including increased shortness of breath, frequent coughing, wheezing and unusual tiredness. There is no cure for COPD. Treatments, including Ohtuvayre, are known as "main maintenance" treatments. Despite available treatment options, COPD is the third leading cause of death globally. Ritedose is proud to work alongside Verona Pharma on the development and manufacturing of national launch quantities of Ohtuvayre so this novel product can be available to all the COPD patients who need it. Announcement • Sep 05
Verona Pharma plc to Present Additional Analyses of Phase 3 ENHANCE Studies in COPD at ERS International Congress 2024 Verona Pharma plc announced one oral presentation and 3 posters on additional analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (COPD) will be presented at the European Respiratory Society (ERS) International Congress 2024. The abstracts are available to conference participants on the ERS website and will be published in an upcoming issue of the peer reviewed publication, European Respiratory Journal. Ohtuvayre (ensifentrine) is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The therapy is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The analyses will summarize the efficacy and safety of Ohtuvayre in the subgroup of patients, including reduction in the rate of exacerbation, with or without chronic bronchitis and in European patients. Additionally, a pooled analysis of patient reported outcomes and the effect of Ohtuvayre on reducing cough and sputum will also be presented. Oral presentation 2780: Ensifentrine improved lung function and reduced moderate/severe exacerbation rate and risk in patients with COPD regardless of chronic bronchitis history Participant:Jadwiga Wedzicha, MD, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK Session 265: Airway diseases therapeutics: novel research studies Poster 2991: Ensifentrine treatment improves COPD symptoms and quality of life in a pooled analysis of the ENHANCE trials Participant:Alexander Mathioudakis, MD, NIHR Clinical Lecturer in Respiratory Medicine, University of Manchester, UK Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management Poster 2995: Efficacy and safety of ensifentrine in European patients with moderate to severe COPD: pooled results from the ENHANCE trials Participant:Frits M.E. Franssen, MD, Head of the Department of Respiratory Medicine, Maastricht University Medical Center, The Netherlands Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management Poster 2997: Ensifentrine improved symptoms and reduced moderate/severe exacerbation rate and risk in patients with COPD and significant cough and sputum Participant:Victor Kim, MD, Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, US Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management. New Risk • Jul 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Revenue is less than US$1m. Announcement • Jul 25
Verona Pharma plc to Report Q2, 2024 Results on Aug 08, 2024 Verona Pharma plc announced that they will report Q2, 2024 results on Aug 08, 2024 Announcement • Jun 27
Verona Pharma Announces US FDA Approval of Ohtuvayre (Ensifentrine) Verona Pharma plc announced the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD. Announcement • May 03
Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024 Verona Pharma plc announced eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at the American Thoracic Society International Conference (“ATS”) 2024. Pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the US FDA, and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 demonstrating statistically significant improvements in lung function across both primary and secondary endpoints. In a pre-specified endpoint, ensifentrine substantially reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The posters will summarize the efficacy and safety endpoints of ensifentrine when added to a long-acting muscarinic antagonist or a long-acting beta-agonist/inhaled corticosteroids (“LABA/ICS”), reductions in the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations, and the impact of ensifentrine on improving dyspnea. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts. Announcement • Apr 26
Verona Pharma plc to Report Q1, 2024 Results on May 09, 2024 Verona Pharma plc announced that they will report Q1, 2024 results on May 09, 2024 Announcement • Mar 21
Verona Pharma plc, Annual General Meeting, Apr 26, 2024 Verona Pharma plc, Annual General Meeting, Apr 26, 2024, at 10:00 Coordinated Universal Time. Location: Latham & Watkins at 99 Bishopsgate London United Kingdom Agenda: To consider re-election of Directors; to receive and adopt the U.K. statutory annual accounts and Directors' report for the year ended December 31, 2023 and the report of the auditors thereon; to receive and approve, as a non-binding advisory resolution, the U.K. statutory Directors' Remuneration Report for the year ended December 31, 2023; to receive and approve the U.K. Directors' Remuneration Policy; to approve an increase in the maximum aggregate level of Non-Executive Director annual remuneration; to appoint Ernst & Young LLP as the Company's auditors, to hold office until the conclusion of the next annual general meeting of shareholders; to authorize the Audit and Risk Committee to determine the auditors' remuneration for the year ending December 31, 2024; to approve, on an advisory (non-binding) basis, the compensation of the Company's named executive officers; and to consider any other matters. New Risk • Mar 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (2.3% increase in shares outstanding). Announcement • Mar 05
Verona Pharma plc Announces Management Changes Verona Pharma plc announces Mr. Andrew Fisher has joined the Company as General Counsel, and member of the Executive Management Team. Mr. Fisher is an accomplished lawyer with more than 25 years of experience in the life sciences industry. He brings a wealth of legal and strategic expertise supporting global, pre-clinical and clinical development, manufacturing and commercialization including launching four pulmonary therapies. Most recently, he founded and led a consulting practice focused on providing strategic advice to start-up companies. Previously, from 2001 until 2018, he was an early team member at United Therapeutics Corporation where he served for 17 years holding roles of increasing responsibility including Executive Vice President, Chief Strategy Officer and Deputy General Counsel while leading successful patent defense strategy. During this period, the company grew from an early-stage business to a company with 850 employees, a market capitalization of $4.7 billion and five marketed products. He has a JD from George Washington University and a BA from University of Michigan. Verona Pharma also announces that Ms. Claire Poll is retiring as General Counsel, effective March 4, 2024. Breakeven Date Change • Mar 01
Forecast breakeven date moved forward to 2025 The 4 analysts covering Verona Pharma previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 69% per year to 2024. The company is expected to make a profit of US$7.83m in 2025. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Announcement • Feb 15
Verona Pharma plc to Report Q4, 2023 Results on Feb 29, 2024 Verona Pharma plc announced that they will report Q4, 2023 results on Feb 29, 2024 Announcement • Feb 03
Verona Pharma plc Announces Board Changes On January 31, 2024, Mr. Rishi Gupta resigned as a non-executive director of the Board of Directors (the “Board”) of Verona Pharma plc (the “Company”), effective as of January 31, 2024. Mr. Gupta’s resignation was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies and practices. On January 31, 2024, the Board appointed Michael Austwick as a non-executive director, effective as of February 1, 2024 (the “Appointment Date”). As a non-executive director, Mr. Austwick will receive a £40,000 annual retainer for his service on the Board. On the Appointment Date, Mr. Austwick received an award of an option to purchase 144,000 Ordinary Shares of the Company (represented by 18,000 American Depositary Shares, each of which represents eight (8) Ordinary Shares of the Company) (the “Initial Award”). The Initial Award has an exercise price equal to $18.35 per American Depositary Share (equivalent to $2.29 per Ordinary Share), the fair market value of an American Depositary Share on January 31, 2024, and will vest and become exercisable as to one-third of the options on February 1, 2025 and the remaining options vesting in equal quarterly installments over the two years thereafter, subject to Mr. Austwick’s continued service on the Board through each such vesting date. In connection with his appointment, Mr. Austwick entered into the Company’s standard letter of appointment for non-executive directors and also entered into the Company’s standard director deed of indemnity. Announcement • Feb 01
Verona Pharma plc Announces Board Changes Verona Pharma plc announced Mr. Michael Austwick has on February 1, 2024 joined the board as a Non-Executive Director. Mr. Austwick brings a wealth of strategic and operational experience in the biopharmaceutical industry including more than 15 years of respiratory expertise in leadership roles across the US, China, Europe and Japan. Most recently, he served as CEO at Vectura, and previously as Nordic General Manager and Head of the Global Respiratory Franchise at Novartis and as Head of US Respiratory and Vice President Global Inhaled Respiratory at AstraZeneca. Mr. Austwick has led the development and commercialization of more than 10 brands, covering inhaled and biologic assets at a country and global level. He has an MSc in Information Management from the University of Hull and a BSc in Management and Systems from City University, London. Verona Pharma also announced that Mr. Rishi Gupta, Partner at OrbiMed, has stepped down from the board as a Non-Executive Director effective January 31, 2024. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 7 analysts covering Verona Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$121.9m in 2026. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Breakeven Date Change • Nov 03
Forecast to breakeven in 2025 The 7 analysts covering Verona Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$2.55m in 2025. Average annual earnings growth of 74% is required to achieve expected profit on schedule. Announcement • Oct 19
Verona Pharma plc to Report Q3, 2023 Results on Nov 02, 2023 Verona Pharma plc announced that they will report Q3, 2023 results on Nov 02, 2023 Announcement • Aug 31
Verona Pharma plc Appoints Christina Ackermann as Non-Executive Director, Effective September 1, 2023 Verona Pharma plc announced effective September 1, 2023, Ms. Christina Ackermann will join the board as a Non-Executive Director. Ms. Ackermann brings over 25 years of legal and management experience across the pharmaceutical, device and consumer products industries. Most recently, she served as Executive Vice President, General Counsel and Global President Ophthalmic Pharmaceuticals at Bausch + Lomb Corporation where she was responsible for strategic planning and worldwide commercialization of pharmaceutical prescription assets across the portfolio as well as global legal affairs. Previously, Ms. Ackermann was part of the Novartis group of companies for 14 years where she served in multiple leadership roles of increasing responsibility including Global Head, Legal and General Counsel of Alcon and Sandoz. Earlier in her career, Ms. Ackermann held Associate General Counsel roles at both Bristol-Myers Squibb and DuPont Pharmaceuticals. Ms. Ackermann currently serves as a Non-Executive Director on the board of Oculis Holding AG. She holds a Post Graduate Diploma in EC Competition Law from King’s College at the University of London, UK, and a LLB from Queen’s University, Kingston, Canada. Breakeven Date Change • Aug 06 The 7 analysts covering Verona Pharma previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$11.5m in 2025. Average annual earnings growth of 0.6% is required to achieve expected profit on schedule.
New Risk • Aug 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.6% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$458k revenue). Minor Risks Share price has been volatile over the past 3 months (6.6% average weekly change). Shareholders have been diluted in the past year (32% increase in shares outstanding). Announcement • Jul 22
Verona Pharma plc to Report Q2, 2023 Results on Aug 03, 2023 Verona Pharma plc announced that they will report Q2, 2023 results on Aug 03, 2023 Announcement • Jun 30
Verona Pharma plc Announces Publication of Phase 3 Enhance Data in the American Journal of Respiratory and Critical Care Medicine Verona Pharma plc announced the American Journal of Respiratory and Critical Care Medicine ("AJRCCM") has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease ("COPD"). The publication reports results from Verona Pharma's successful ENHANCE trials demonstrating improvements with ensifentrine in lung function, symptoms and quality of life measures, as well as a substantial reduction in the rate and risk of COPD exacerbations and a favourable safety profile. The manuscript, entitled 'Ensifentrine, a Novel PDE3 and PDE4 Inhibitor for the Treatment of COPD: Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Trials (The ENHANCE Trials)', is available online here and will be published in an upcoming issue of AJRCCM. It follows announcements of top-line data from the ENHANCE-1 and ENHANCE-2 trials in December and August 2022, respectively. Data from the ENHANCE program formed the basis of Verona Pharma's New Drug Application ("NDA"), which was submitted in June 2023 to the US Food and Drug Administration ("FDA") for the approval of ensifentrine for the maintenance treatment of patients with COPD. Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years. The American Journal of Respiratory & Critical Care Medicine, also known as the "Blue Journal", is a leading peer reviewed journal published by the American Thoracic Society. The publication focuses on human biology and disease, as well as animal and in vitro studies that contribute to the understanding of pathophysiology and treatment of diseases that affect the respiratory system and critically ill patients. About Ensifentrine Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years. Breakeven Date Change • Mar 10
Forecast to breakeven in 2025 The 7 analysts covering Verona Pharma expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 0.5% per year to 2024. The company is expected to make a profit of US$18.2m in 2025. Average annual earnings growth of 63% is required to achieve expected profit on schedule. Announcement • Dec 20
Verona Pharma plc Announces Ensifentrine Meets Primary and Key Secondary Endpoints in Phase 3 ENHANCE-1 Trial for COPD Verona Pharma plc announced positive results of its Phase 3 ENHANCE-1 trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease. The ENHANCE-1 trial successfully met its primary and key secondary endpoints demonstrating significant improvements in lung function, symptoms and quality of life measures. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated over 24 and 48 weeks. Ensifentrine is a first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one compound. Highlights: Study population (n=763): Subject demographics and disease characteristics were well balanced between treatment groups; Approximately 66% of subjects received background COPD therapy, either a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist (“LABA”). Additionally, approximately 21% of all subjects received inhaled corticosteroids (“ICS”) with concomitant LAMA or LABA. Primary endpoint met (FEV1* AUC 0-12 hr): Placebo corrected, change from baseline in FEV1 area under the curve 0-12 hours post dose at week 12 was 87 mL (p<0.0001) for ensifentrine; Demonstrated consistent improvements in all subgroups including gender, age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV1 reversibility and geographic region. Key secondary endpoints of lung function, symptoms and quality of life measures met: Placebo corrected, increase in peak FEV1 of 147 mL (p<0.0001) 0-4 hours post dose at week 12; Daily symptoms as measured by E-RS Total Score in the ensifentrine group improved from baseline to greater than the minimal clinically important difference of -2 units with a statistically significant improvement compared to placebo at week 24. Improvements in symptoms were early and sustained with statistical significance versus placebo at weeks 6, 12 and 24; Quality of Life (“QOL”) as measured by SGRQ Total Score in the ensifentrine group improved from baseline to greater than the MCID of -4 units with a statistically significant improvement compared to placebo at week 24. Improvements in QOL were early and sustained with statistical significance versus placebo at weeks 6, 12 and 24; Placebo corrected, increase in morning trough FEV1 of 35 mL (p=0.0421) at week 12, supporting twice daily dosing regimen. Exacerbation rate and risk reduced: Subjects receiving ensifentrine demonstrated a 36% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks (p=0.0505) compared to those receiving placebo; Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 38% (p=0.0378); Pooled exacerbation data from ENHANCE-1 and ENHANCE-2, ensifentrine demonstrated a 40% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks (p=0.0012) compared to those receiving placebo. Additionally, ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 41% (p=0.0008). Favorable safety profile: Ensifentrine was well-tolerated with very few events occurring in more than 1% of subjects and greater than placebo over 24 and 48 weeks. Announcement • Oct 26
Verona Pharma plc to Report Q3, 2022 Results on Nov 09, 2022 Verona Pharma plc announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 09, 2022 Announcement • Aug 24
Verona Pharma plc Announces Executive Changes Verona Pharma plc Announced appointments of Matthew Casbon, Vice President of Sales, Marketing and Training, and Matthew Rysavy, Vice President of Market Access and Trade. They each bring approximately 25 years of commercialization expertise spanning marketing, sales, training, market access, trade and business development across a variety of therapeutic areas. Mr. Casbon brings over 25 years of commercial healthcare experience to Verona Pharma. Previously, he served as Chief Business Officer of Target RWE, a real-world evidence solutions provider, where he was instrumental in building the business development function and completing a Series C financing. Prior to this, Mr. Casbon was at Circassia Pharmaceuticals, a global respiratory pharmaceutical and device company, serving as the Senior Vice President, Global Strategic Marketing, Training and Global Research Sales. Mr. Casbon was Associate Vice President of Marketing at Salix Pharmaceuticals until its acquisition by Valeant Pharmaceuticals and Business Director for the Cystic Fibrosis Franchise at Solvay Pharmaceuticals, where he spent over 13 years until Abbott Laboratories purchased the company. He received a Bachelor of Arts in Speech Communication from West Chester University. Mr. Rysavy has over 24 years of pharmaceutical experience with 13 years in Market Access & Trade roles covering a broad range of products, channel management, and distribution strategies. Prior to Verona Pharma, Mr. Rysavy served as Head of Market Access and Trade at BioDelivery Sciences International, where he was responsible for building the Market Access team to support existing and launch products. He was instrumental in developing key contracting and distribution strategies for the company. Previously, Mr. Rysavy was Director of Market Access at US World Meds/HEMA Biologics where he was responsible for securing formulary access to the company’s new and existing products. Throughout his career, he has launched multiple products in Market Access roles working closely with major Pharmacy Benefit Management’s and Payers across the US. Mr. Rysavy spent 13 years in roles of increasing responsibility at Salix Pharmaceuticals after starting his career at Johnson and Johnson. He received a Bachelor of Liberal Studies degree from Iowa State University. Announcement • Aug 19
Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China Nuance Pharma announced the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal clinical trial of Ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") in mainland China. Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and anti-inflammatory activities in one compound. This activity has the potential to alleviate respiratory symptoms such as breathlessness and cough, as well as providing anti-inflammatory benefits for those with COPD. On August 9th, 2022, Verona Pharma announced its ENHANCE-2 Phase III trial evaluating nebulized Ensifentrine for the maintenance treatment of COPD met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations. Verona Pharma expects to report top-line results from its ongoing ENHANCE-1 Phase III trial around the end of the 2022 and, if similarly positive, plans to submit a New Drug Application to the US Food and Drug Administration for Ensifentrine in first half 2023. In 2021, Nuance Pharma entered into an agreement with Verona Pharma with a potential value of up to $219 million, granting Nuance Pharma exclusive rights to develop and commercialize Ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). In return, Verona Pharma received an upfront payment of USD 25 million in cash and an equity interest valued at USD 15 million. Meanwhile, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater China. Announcement • Aug 12
Verona Pharma plc has completed a Follow-on Equity Offering in the amount of $130.2 million. Verona Pharma plc has completed a Follow-on Equity Offering in the amount of $130.2 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 12,400,000
Price\Range: $10.5
Discount Per Security: $0.63 Announcement • Jul 29
Verona Pharma plc to Report Q2, 2022 Results on Aug 15, 2022 Verona Pharma plc announced that they will report Q2, 2022 results on Aug 15, 2022 Announcement • Jun 09
Verona Pharma Completes Enrollment in Phase 3 ENHANCE-1 Trial Evaluating Ensifentrine for Maintenance Treatment of COPD Verona Pharma plc announced it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-1 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This concludes enrollment in the Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program. Top-line data are expected from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 subjects to date. The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) 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. The two study designs replicate measurements of efficacy and safety data over 24 weeks and ENHANCE-1 also evaluates longer-term safety over 48 weeks. Patient Population: Moderate to severe, symptomatic, COPD patients at sites primarily in the U.S. and Europe. Dose/Duration: Patients are randomized to receive a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks in ENHANCE-2 and 24 or 48 weeks in ENHANCE-1. Primary Endpoint: Improvement in lung function as measured by forced expiratory volume in one second (FEV1) over 12 hours with ensifentrine after 12 weeks of treatment. Key Secondary Endpoints: COPD symptoms and health-related quality of life through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS, and additional lung function endpoints including peak and morning trough FEV1. Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1. Announcement • Apr 19
Verona Pharma plc to Report Q1, 2022 Results on May 03, 2022 Verona Pharma plc announced that they will report Q1, 2022 results on May 03, 2022 Announcement • Mar 05
Verona Pharma plc Announces Phase 3 ENHANCE Program on Track to Report Top-Line COPD Data in 2022 Verona Pharma plc are close to completing enrollment in the ENHANCE program and excited about reporting top-line data. The company expects to complete enrollment in the 24-week subset of ENHANCE-1 around the end of the second quarter of 2022, which is the final step in completing enrollment in the program. Top-line data is expected from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of the year. Announcement • Feb 17
Verona Pharma plc to Report Q4, 2021 Results on Mar 03, 2022 Verona Pharma plc announced that they will report Q4, 2021 results on Mar 03, 2022 Announcement • Jan 24
Verona Pharma plc Completes Enrollment in Phase 3 ENHANCE-2 Trial Evaluating Ensifentrine for Maintenance Treatment of COPD Verona Pharma plc announced that it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-2 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Top-line data are expected in the third quarter of 2022. The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program consists of two double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluating nebulized ensifentrine for the maintenance treatment of COPD. The 48-week subset of the ENHANCE-1 trial completed enrollment of approximately 400 subjects in December 2021, which was first reported on January 5, 2022. Enrollment in the 24-week subset of ENHANCE-1 is expected to complete in the second quarter of 2022. Data for both subsets of ENHANCE-1 are expected around the end of 2022. Conditional upon positive results, the Company intends to file a New Drug Application (“NDA”) with the U.S. Food & Drug Administration (“FDA”) in the first half of 2023 Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 subjects to date. Announcement • Jan 06
Verona Pharma plc Completes Enrollment in ENHANCE-1 48-Week Subset Verona Pharma plc announced enrollment completed in the 48-week subset of the ENHANCE-1 trial in December 2021. The ENHANCE-2 trial has completed screening with 788 subjects randomized as of January 4, 2022, and full enrollment is expected by the end of January 2022. The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program is evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Although it has not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2021, the Company expects to report it had approximately $148.4 million in cash and cash equivalents as of December 31, 2021 (December 31, 2020: $188.0 million). Verona believes its cash and cash equivalents at December 31, 2021, expected cash receipts from the U.K. tax credit program and funding expected to be available under the $30.0 million financing facility secured in November 2020, will enable the Company to fund its planned operating expenses and capital expenditure requirements through at least the end of 2023. Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in patients with COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date. Announcement • Dec 16
Verona Pharma Reports TQT Study Successfully Demonstrated No Clinically Relevant Effect on Cardiac Conduction Verona Pharma plc announced ensifentrine met all safety objectives in a thorough QT (“TQT”) study designed to evaluate effects, if any, of ensifentrine on cardiac conduction in healthy individuals. No clinically relevant changes in measures of cardiac conduction including QTcF, PR and QRS intervals were observed with either 3 mg or 9 mg inhaled ensifentrine dose at any time point over 24 hours. The U.S. Food and Drug Administration (“FDA”) requires a TQT study to support most New Drug Applications for potential new medications. The protocol was reviewed by the FDA prior to commencing the study, and these results will support the planned submission for ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Announcement • Sep 21
Verona Pharam Common Shares to Be Deleted from Other OTC Verona Pharam plc, Adderbury Common Shares will be deleted from Other OTC effective from September 21, 2021, due to Inactive Security. Announcement • Apr 28
Verona Pharma plc Announces Publication of Phase 2B Dose-Ranging COPD Data in the International Journal of Chronic Obstructive Pulmonary Disease Verona Pharma plc announced publication of efficacy and safety results from a previously reported Phase 2b clinical trial with nebulized ensifentrine added on to maintenance bronchodilator therapy in symptomatic chronic obstructive pulmonary disease ('COPD') patients. The study results were published in the leading peer reviewed journal, International Journal of Chronic Obstructive Pulmonary Disease. The publication reports on results from the 4-week 416-patient study, first reported by Verona Pharma on January 13, 2020, where nebulized ensifentrine added on to maintenance tiotropium (Spiriva® Respimat®), a long-acting muscarinic antagonist (“LAMA”) bronchodilator, met the primary endpoint demonstrating clinically and statistically significant dose-dependent improvements in lung function at all doses. In addition, clinically relevant secondary endpoints were met including statistically significant and clinically meaningful improvements in quality of life compared to placebo added on to tiotropium over 4 weeks of treatment. Ensifentrine demonstrated a safety profile similar to placebo. Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase (“PDE”) 3 and 4 that has been shown to act both as a bronchodilator and anti-inflammatory agent in a single compound. Announcement • Mar 20
Verona Pharma plc, Annual General Meeting, Apr 27, 2021 Verona Pharma plc, Annual General Meeting, Apr 27, 2021, at 08:00 US Eastern Standard Time. Agenda: To consider re-election of director of the company, Dr. David Ebsworth; Dr. Martin Edwards; Dr. Sven Anders Ullman who retires in accordance with article 26.2 of the company’s articles of association and offers himself for re-election; to receive and adopt the U.K. statutory annual accounts and directors’ report for the year ended December 31, 2020 and the report of the auditors thereon; to receive and approve, as a non-binding advisory resolution, the U.K. statutory directors’ remuneration report for the year ended December 31, 2020; to re-appoint PricewaterhouseCoopers LLP as the Company’s auditors, to hold office until the conclusion of the next annual general meeting of shareholders; to authorize the Audit and Risk Committee to determine the auditors’ remuneration for the year ending December 31, 2021; and to consider other matter. Announcement • Mar 03
Lisa Deschamps Joins Verona Pharma as Non-Executive Director Verona Pharma plc announces, effective March 1, 2021, Ms. Lisa Deschamps has joined the board as a Non-Executive Director. Ms. Deschamps is Senior Vice President, Chief Business Officer, of Novartis Gene Therapies (GTx) where she is responsible for strategic planning and worldwide commercialization of pipeline and in-market assets across the gene therapy portfolio. This includes managing significant revenue growth targets and profitability margins worldwide. Prior to this role, Ms. Deschamps was the Head of the Global Neuroscience Franchise. During her 25-year career at Novartis, she has successfully brought small molecules, biologics and gene therapies from the clinic to commercialization. Throughout her tenure, Ms. Deschamps has gained significant global and US experience in bringing respiratory and other specialized therapeutic area products to the marketplace. In addition, she has extensive experience in the exploration of potential acquisition and partnering opportunities. Announcement • Feb 26
Verona Pharma plc Provides Update on Clinical Trials Verona Pharma plc earlier reported positive Phase 2 results with pMDI ensifentrine in COPD. Enrollment ongoing in ENHANCE Phase 3 program. Announcement • Feb 18
Verona Pharma plc to Report Q4, 2020 Results on Feb 25, 2021 Verona Pharma plc announced that they will report Q4, 2020 results on Feb 25, 2021 Announcement • Feb 02
Verona Pharma Reports Positive Phase 2 Results with pMDI Formulation of Ensifentrine in COPD Verona Pharma plc announced positive Phase 2 data with a pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). Ensifentrine delivered by pMDI met all of the primary and secondary lung function endpoints in the 7 day, Phase 2 clinical trial. The magnitude of improvement in lung function was dose-ordered and highly statistically significant at peak and over the 12-hour dosing interval compared with placebo, and supports twice-daily dosing of ensifentrine via pMDI for the treatment of COPD. Highlights: Primary endpoint met at all doses: highly statistically significant and clinically meaningful increase in lung function as measured by peak forced expiratory volume in one second (“FEV1”)1 measured over 4 hours post-dose, compared to placebo after 7 days of treatment. Improvements in peak FEV1 corrected for placebo were 205 mL (p<0.0001) for the 300 mg dose, 277 mL (p<0.0001) for the 1000 mg dose, and 326 mL (p<0.0001) for the 3000 mg dose. Secondary lung function endpoints met: results support twice-daily dosing. Statistically significant improvements in average FEV1 over 12 hours corrected for placebo (average FEV1 AUC (0-12hr)2) were 120 mL (p=0.0018) for the 300 mg dose, 187 mL (p<0.0001) for the 1000 mg dose, and 197 mL (p<0.0001) for the 3000 mg dose. Statistically significant improvements in morning trough FEV1 corrected for placebo were 46 mL (not significant) for the 300 mg dose, 80 mL (p=0.0115) for the 1000 mg dose, and 110 mL (p=0.0066) for the 3000 mg dose. Statistically significant improvements in average FEV1 over 4 hours corrected for placebo (average FEV1 AUC (0-4hr)2) were 178 mL (p<0.0001) for the 300 mg dose, 256 mL (p<0.0001) for the 1000 mg dose, and 301 mL (p<0.0001) for the 3000 mg dose. Ensifentrine pMDI formulation was well tolerated at each dose with an adverse event profile similar to placebo. Study Design: The randomized, double-blind, two-part Phase 2 trial evaluated the pharmacokinetics, efficacy and safety of pMDI ensifentrine for the treatment of moderate to severe COPD after a single dose and repeat doses over 7 days. Part A of the study evaluated the pharmacokinetic profile, safety and efficacy following a single dose of ensifentrine over 5 dose levels in a parallel group design. In Part B, patients who completed Part A were randomized to receive 3 doses of ensifentrine (300 mg, 1000 mg, or 3000 mg) or placebo twice-daily over 7 days in a complete block crossover design. Announcement • Jan 14
Verona Pharma Completes Enrollment in Pilot Study of pMDI Ensifentrine in U.S. Patients Hospitalized with COVID-19 Verona Pharma plc announced it has completed enrollment (n=45) in its pilot clinical study evaluating the efficacy and safety of ensifentrine delivered via pressurized metered-dose inhaler (pMDI) formulation in U.S. patients hospitalized with COVID-19. Ensifentrine is a first-in-class product candidate with both bronchodilator and anti-inflammatory activities in one compound. Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown ensifentrine improved lung function, reduced inflammation in the lungs and reduced symptoms of cough and sputum production. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people. Announcement • Oct 30
Verona Pharma plc Provides Update on AIM Delisting Verona Pharma plc provided a further update with regards to its intended delisting and cancellation of its Ordinary Shares from trading on AIM, as announced on September 21, 2020. As previously announced, the last day of trading of the Company’s Ordinary Shares on AIM will be October 29, 2020 and the proposed AIM Delisting will be effective from 7.00 am London time on October 30, 2020. Verona Pharma will retain the listing of its ADSs on the Nasdaq Global Market under ticker symbol VRNA. Following the AIM Delisting, shares will only be tradable on Nasdaq. Announcement • Oct 13
Verona Pharma to Present Phase 2b COPD Symptom and Quality of Life Data with Ensifentrine at CHEST 2020 Verona Pharma plc announced that it will present new analyses from a Phase 2b clinical trial with nebulized ensifentrine in chronic obstructive pulmonary disease (“COPD”) at CHEST Annual Meeting (“CHEST”) 2020 taking place on October 18-21. The data are published in the CHEST Annual Meeting online supplement. The posters present further analysis of Phase 2b data, first reported by Verona Pharma on January 13, 2020, demonstrating that nebulized ensifentrine added to tiotropium (Spiriva® Respimat®), a long acting anti-muscarinic (“LAMA”) bronchodilator, provides meaningful additional improvement in quality of life as measured by St. George’s Respiratory Questionnaire: COPD (SGRQ-C). This was shown in symptomatic COPD patients over 4 weeks, including statistically significant improvement in both activity and impacts subscales compared to placebo added on to tiotropium. Importantly, a responder analysis of the proportion of patients achieving a clinically important difference in quality of life on the SGRQ-C showed responses in favor of ensifentrine, which were particularly notable in COPD patients who were not reversible to albuterol. An evaluation of inspiratory capacity over 4 weeks demonstrated a clinically meaningful and statistically significant improvement in inspiratory capacity (“IC”). Improvements in IC have been shown to correlate with improvements in dyspnea, suggesting that ensifentrine improves symptoms and quality of life via a physiological mechanism. In addition to the Phase 2b data with nebulized ensifentrine, Verona Pharma will highlight Phase 2 data with a pressurized metered dose inhaler (“pMDI”) formulation of ensifentrine. This data showed a rapid and meaningful bronchodilatory response in COPD patients following a single dose of ensifentrine pMDI. This effect was sustained for 12 hours. Data from this study were first reported on March 31, 2020. Notably, the Company will also present pre-clinical data demonstrating the anti-inflammatory effects of ensifentrine, which further support its dual mechanism of action as an inhibitor of phosphodiesterases (“PDE”) 3 and 4. Announcement • Sep 24
Verona Pharma plc Initiates Phase 3 Clinical Trials with Nebulized Ensifentrine for the Maintenance Treatment of COPD Verona Pharma plc announced the initiation of its ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) Phase 3 trials to evaluate the efficacy and safety of nebulized ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date. The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) will evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA (“long acting muscarinic antagonist”) or a LABA (“long acting beta-agonist”), compared to placebo. The two study designs will replicate measurements of efficacy and safety data over 24 weeks and ENHANCE-1 will also evaluate longer-term safety over 48 weeks. Patient Population: Each study will enroll approximately 800 moderate to severe, symptomatic, COPD patients at sites primarily in the U.S. and Europe. Dose/Duration: Patients will be randomized to receive a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks in ENHANCE-2 or 48 weeks in ENHANCE-1. Primary Endpoint: Improvement in lung function as measured by forced expiratory volume* in one second (“FEV1”) over 12 hours with ensifentrine after 12 weeks of treatment. Key Secondary Endpoints: COPD symptoms and health-related quality of life through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS: COPD. Additional lung function endpoints including peak and morning trough FEV1 will also be assessed. Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1. Announcement • Sep 22
Verona Pharma Announces Its Intention to Cancel the Admission to Trading of the Company’s Ordinary Shares on AIM Verona Pharma plc announced its intention to cancel the admission to trading of the Company’s ordinary shares (“Ordinary Shares”) on AIM (the “AIM Delisting”). Verona Pharma hereby provides the requisite 20 business days' notice of the intended AIM Delisting. The Company intends that the last day of trading of the Company’s Ordinary Shares on AIM will be October 29, 2020 and the proposed AIM Delisting will be effective from 7.00 am London time on October 30, 2020. Verona Pharma will retain the listing of its American Depositary Shares (“ADSs”) on the Nasdaq Global Market (“Nasdaq”) under ticker symbol VRNA. Existing holders of ADSs do not need to take any action as a result of this announcement. Following the AIM Delisting, shares will only be tradeable on Nasdaq. Announcement • Sep 17
Verona Pharma Provides Phase 2B COPD Symptom Data Update Verona Pharma plc announced publication of detailed analysis of symptom data from a previously reported Phase 2b clinical trial with nebulized ensifentrine as maintenance treatment for chronic obstructive pulmonary disease in leading peer reviewed journal for specialists and healthcare professionals, International Journal of Chronic Obstructive Pulmonary Disease. The analyses demonstrate that ensifentrine meaningfully improved COPD symptoms in only 4 weeks, with the largest effect on breathlessness, across two different assessment tools, the E-RS™: COPD breathlessness subscale and the Transitional Dyspnea Index. Statistically significant and meaningful improvements in cough/sputum and chest symptoms were also observed, as well as improvements in health-related quality of life measured by SGRQ-C. The paper is entitled Symptom improvement following treatment with the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in patients with moderate to severe COPD – a detailed analysis. Results from the 4-week 405-patient study, first reported in March 2018, demonstrated that ensifentrine met the primary endpoint producing clinically and statistically significant improvements in lung function at all doses. In addition, clinically relevant secondary endpoints were met including significant progressive improvements in COPD symptoms. Further information about this study can be found at www.clinicaltrials.gov, NCT03443414. Ensifentrine is an inhaled, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In January 2020, Verona Pharma reported positive top-line results from a second 4-week 416-patient Phase 2b study, in which nebulized ensifentrine was added on to inhaled tiotropium therapy, a long acting anti-muscarinic bronchodilator, in symptomatic COPD patients. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people to date. Announcement • Jul 31
Verona Pharma plc to Report Q2, 2020 Results on Aug 14, 2020 Verona Pharma plc announced that they will report Q2, 2020 results at 6:00 AM, GMT Standard Time on Aug 14, 2020 Announcement • Jul 18
Verona Pharma plc has completed a Follow-on Equity Offering in the amount of $200.155042 million. Verona Pharma plc has completed a Follow-on Equity Offering in the amount of $200.155042 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 39,090,009
Price\Range: $4.5
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 43,111,112
Price\Range: $0.5625
Transaction Features: Subsequent Direct Listing