Category: Company News

Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre® (ensifentrine), a First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade

Acquisition aligns with Merck’s science-led business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases
Merck to hold investor call at 8 a.m. ET today

RAHWAY, N.J. & RALEIGH, N.C.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, 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 U.S. Food and Drug Administration approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first novel inhaled mechanism for the treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of non-cystic fibrosis bronchiectasis.

“This acquisition of Verona Pharma reflects the commitment we have to delivering innovative treatments to patients and our ability to execute on our science-led and value-driven business development strategy,” said Robert M. Davis, chairman and chief executive officer, Merck. “Ohtuvayre complements and expands our pipeline and portfolio of treatments for cardio-pulmonary diseases while delivering near- and long-term growth as well as value for shareholders. This novel, first-in-class treatment addresses an important unmet need for COPD patients persistently symptomatic based on its unique combination of bronchodilatory and non-steroidal anti-inflammatory effects. We look forward to welcoming the talented Verona Pharma team to Merck.”

“Today’s announced agreement with Merck is the culmination of years of focus and determination by the Verona Pharma team advancing Ohtuvayre, the first novel inhaled mechanism for the maintenance treatment of COPD in two decades,” said David Zaccardelli, president and chief executive officer, Verona Pharma. “Since launching Ohtuvayre in August 2024 we have seen rapid and accelerating uptake in the U.S. We believe Merck’s commercial footprint and industry-leading clinical capabilities will help accelerate the potential of Ohtuvayre to reach more patients living with COPD. This agreement will enable the strong launch trajectory of this important medicine and provides value to Verona Pharma shareholders.”

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 and will result in the capitalization of most of the purchase price as an intangible asset for Ohtuvayre (which will be amortized as a GAAP-only charge over the life of the product).

Investor Call

Merck will hold an investor call today, July 9, 2025 at 8 a.m. ET to discuss the proposed transaction. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 2398172.

Advisors

Citi and Morgan Stanley & Co. LLC acted as financial advisors to Merck in this transaction and Freshfields LLP acted as Merck’s legal advisor. Centerview Partners LLC acted as exclusive financial advisor to Verona Pharma and Latham & Watkins LLP as Verona Pharma’s legal advisor.

Ohtuvayre Indication and Important Safety Information

INDICATION

Ohtuvayre is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

IMPORTANT SAFETY INFORMATION

Contraindication: Ohtuvayre is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

Warnings and Precautions:

Acute Episodes of Bronchospasm Ohtuvayre should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

Paradoxical Bronchospasm As with other inhaled medicines, Ohtuvayre may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Ohtuvayre, it should be treated immediately with an inhaled, short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative therapy should be instituted.

Psychiatric Events Including Suicidality Before initiating treatment with Ohtuvayre, healthcare providers should carefully weigh the risk and benefits of treatment with Ohtuvayre in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with Ohtuvayre if such events occur.

Treatment with Ohtuvayre is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received Ohtuvayre (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] Ohtuvayre 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] Ohtuvayre 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients [0.4%] receiving Ohtuvayre and no patients receiving placebo.

Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.

These are not all of the possible risks associated with Ohtuvayre.

Please see Prescribing Information for Ohtuvayre (ensifentrine) at: https://ohtuvayrehcp.com/wp-content/uploads/sites/2/2024/11/Ohtuvayre-US-Prescribing-Information.pdf, Patient Information for Ohtuvayre at: https://ohtuvayre.com/wp-content/uploads/2024/11/Ohtuvayre-US-Prescribing-Information.pdf.

About Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition that causes restricted airflow and breathing problems. Emphysema and chronic bronchitis are the two most common types of COPD. Common symptoms of COPD include shortness of breath an ongoing cough or a cough that produces a lot of mucus, wheezing, chest tightness or heaviness and fatigue. Smoking and air pollution are the most common causes of COPD. An estimated 390 million people suffer from COPD worldwide as of 2019 and COPD is the fourth leading cause of death worldwide. There is no cure for COPD.

About Ohtuvayre® (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of adults with 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.

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. 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. Ensifentrine has potential in other respiratory diseases such as non-cystic fibrosis bronchiectasis. For more information, please visit www.veronapharma.com.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

UK Takeover Code does not apply

Verona Pharma is not a company subject to regulation under the City Code on Takeovers and Mergers (the “UK Takeover Code”), therefore no dealing disclosures are required to be made under Rule 8 of the UK Takeover Code by shareholders of Verona Pharma or Merck.

Additional Information and Where to Find it

In connection with the proposed transaction between Verona Pharma and Merck, Verona Pharma will file with the Securities and Exchange Commission (“SEC”) a proxy statement on Schedule 14A. Additionally, Verona Pharma may file other relevant materials with the SEC in connection with the proposed transaction. Investors and securityholders of Verona Pharma are urged to read the proxy statement (which will include an explanatory statement in respect of the Scheme of Arrangement of Verona Pharma, in accordance with the requirements of the U.K. Companies Act 2006) and any other relevant materials filed or that will be filed with the SEC, as well as any amendments or supplements to these materials and documents incorporated by reference therein, carefully and in their entirety when they become available because they contain or will contain important information about the proposed transaction and related matters. The definitive version of the proxy statement will be mailed or otherwise made available to Verona Pharma’s securityholders. Investors and securityholders will be able to obtain a copy of the proxy statement (when it is available) as well as other filings containing information about the proposed transaction that are filed by Verona Pharma or Merck with the SEC, free of charge on EDGAR at www.sec.gov, on the investor relations page of Verona Pharma’s website at https://www.veronapharma.com/investors/, by contacting Verona Pharma’s investor relations department at IR@veronapharma.com, or on Merck’s website at www.merck.com.

Participants in the Solicitation

Verona Pharma, Merck and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Verona Pharma in connection with the proposed transaction. Information about Verona Pharma’s directors and executive officers, including a description of their direct interests, by security holdings or otherwise, will be included in the proxy statement (when available). You may also find additional information about Verona Pharma’s directors and executive officers in Verona Pharma’s proxy statement for its 2025 Annual General Meeting filed on March 18, 2025 and Verona Pharma’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov), including any statements of beneficial ownership on Form 3 or Form 4 filed with the SEC after such proxy statement. Information about Merck and its directors and executive officers can be found in Merck’s proxy statement filed on April 9, 2025 and Merck’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov), including any statements of beneficial ownership on Form 3 or Form 4 filed with the SEC after such proxy statement. Verona Pharma shareholders may obtain additional information regarding the direct and indirect interests of the participants in the solicitation of proxies in connection with the proposed transaction, including the interests of Verona Pharma directors and executive officers in the proposed transaction, which may be different than those of Verona Pharma shareholders generally, by reading the proxy statement and any other relevant documents that are filed or will be filed with the SEC relating to the proposed transaction. You may obtain free copies of these document using the sources indicated above.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including with respect to the company’s proposed acquisition of Verona Pharma, and readers are cautioned not to place undue reliance on such statements. Such forward-looking statements include, but are not limited to, the ability of the company and Verona Pharma to complete the transactions contemplated by the transaction agreement, including the parties’ ability to satisfy the conditions to the consummation of the transaction contemplated thereby, statements about the expected timetable for completing the transaction, the company’s and Verona Pharma’s beliefs and expectations and statements about the benefits sought to be achieved in the company’s proposed acquisition of Verona Pharma, the potential effects of the acquisition on both the company and Verona Pharma, the possibility of any termination of the transaction agreement, as well as the expected benefits and success of Verona Pharma’s products and product candidates. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable or at all, or that any pipeline candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the proposed transaction; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the proposed transaction contained in the transaction agreement may not be satisfied or waived (including, but not limited to, the failure to obtain the approval of the proposed transaction by Verona Pharma shareholders and the failure to obtain the sanction of the High Court of Justice of England and Wales); the effects of disruption from the transactions contemplated by the transaction agreement and the impact of the announcement and pendency of the transactions on Verona Pharma’s business; the risk that shareholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Forward-Looking Statements of Verona Pharma

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including with respect to the proposed acquisition of Verona Pharma, and readers are cautioned not to place undue reliance on such statements. Such forward-looking statements include, but are not limited to, the ability of Merck and Verona Pharma to complete the transactions contemplated by the transaction agreement, including statements about the transaction contemplated thereby, statements about the expected timetable for completing the transaction, Verona Pharma’s beliefs and expectations and statements about the benefits sought to be achieved in the proposed acquisition, the potential effects of the acquisition on Verona Pharma, as well as the expected benefits and success of Verona Pharma’s products and product candidates. These statements are based upon the current beliefs and expectations of Verona Pharma’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable or at all, or that any pipeline candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the proposed transaction; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the proposed transaction contained in the transaction agreement may not be satisfied or waived (including, but not limited to, the failure to obtain the approval of the proposed transaction by Verona Pharma shareholders and the failure to obtain the sanction of the High Court of Justice of England and Wales); the effects of disruption from the transactions contemplated by the transaction agreement and the impact of the announcement and pendency of the transactions on Verona Pharma’s business; the risk that shareholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; Verona Pharma’s dependence on the successful commercialization of Ohtuvayre and the uncertain market acceptance of Ohtuvayre as a treatment for COPD; and risks related to pharmaceutical product development, including Verona Pharma’s ongoing development of ensifentrine and any other product candidates and combinations, and the uncertainty of clinical success.

Verona Pharma undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Verona Pharma’s Annual Report on Form 10-K for the year ended December 31, 2024 and Verona Pharma’s other filings with the SEC.

 

Contacts

Merck Investor Contact: 
Peter Dannenbaum
(732) 594-1579

Merck Media Contacts: 
Robert Josephson
(203) 914- 2372

Justine Moore
(347) 281-3754

Verona Pharma plc: 
Victoria Stewart
+1 (844) 341-9901
IR@veronapharma.com

Argot Partners: 
Verona Pharma – US Investor Enquiries 
+1 (212) 600-1902
verona@argotpartners.com

Ten Bridge Communications: 
Verona Pharma – International / US Media Enquiries 
Wendy Ryan
+1 (781) 316-4424
tbcverona@tenbridgecommunications.com

 

Verona Pharma to Present Seven Analyses of the Phase 3 ENHANCE Studies in COPD at ATS 2025

Analyses support Ohtuvayre® (ensifentrine) as a first-in-class selective dual
inhibitor of PDE3 and PDE4 for a broad COPD population

LONDON and RALEIGH, N.C., May 06, 2025 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces 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 is 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 and 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.

Poster P275: Ensifentrine Monotherapy Improved Lung Function and Reduced Exacerbation Rate and Risk in Symptomatic Patients With Moderate-to-Severe COPD
Presenter: Isaac Biney, MBChB, University of Tennessee Medical Center
Session: B52 – Hot Topics in COPD

Poster P283: Ensifentrine Improved Lung Function and Reduced Exacerbation Rate in Patients with COPD and Concomitant Type 2 Diabetes 
Presenter: Matthew Moll, MD, Brigham and Women’s Hospital 
Session: B52 – Hot Topics in COPD

Poster P284: Ensifentrine Improved Lung Function and Reduced Exacerbations in Patients with COPD and Concomitant Cardiac Disorders 
Presenter: Nirupama Putcha, MD, Johns Hopkins University 
Session: B52 – Hot Topics in COPD

Poster P285: Ensifentrine Monotherapy Reduced Dyspnea and Improved Quality of Life in Patients With Symptomatic, Moderate-to-Severe COPD 
Presenter: Michael Bradley Drummond, MD, University of North Carolina at Chapel Hill 
Session: B52 – Hot Topics in COPD

Poster P287: Ensifentrine Reduced Exacerbation Rate Regardless of FEV1 Improvement: A Post-hoc Pooled Analysis 
Presenter: George Washko, MD, Brigham & Women’s Hospital 
Session: B52 – Hot Topics in COPD

Poster P420: Tissue Distribution of 14C-Ensifentrine, a Novel Phosphodiesterase (PDE)3 and PDE4 Inhibitor, in Rats Following a Single Intravenous Dose 
Presenter: Margot Macdonald-Berko, Verona Pharma 
Session: A71 Epithelial Dysfunction, inflammation and cigarette smoke: Drivers of COPD and CF Pathogenesis

Poster P891: Prevalence of Pneumonia According to Age in Patients With COPD Treated With Inhaled Corticosteroids 
Presenter: Trishul Siddharthan, MD, University of Miami 
Session: C49 – What’s New in COPD Phenotyping and Management

Poster P919: Ensifentrine Improved Patient-reported Outcomes, Including Dyspnea, in Patients With COPD and Concomitant Cardiac Disorders 
Presenter: Michael Lester, MD, Vanderbilt University Medical Center 
Session: B30 – Advanced Modalities to Uncover Pathophysiologic Features in COPD

Poster P924: Effects of Ensifentrine, a Dual Phosphodiesterase (PDE)3 and PDE4 Inhibitor, on Lung Fibrosis in a Rat Bleomycin Model 
Presenter: Margot Macdonald-Berko, Verona Pharma 
Session: D29 – From Bench to Bedside: Unraveling Pulmonary Fibrosis Through Cellular Communication and Molecular Pathways

Poster P943: Ensifentrine Improved Respiratory Symptoms and Quality of Life in Patients With COPD and Concomitant Type 2 Diabetes 
Presenter: Auyon Ghosh, MD, Suny Upstate Medical University 
Session: B35 – ‘Omics and Outcomes: Translational Studies Across Lung Diseases

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries		 Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries		 Tel: +1-781-316-4424
tbcverona@tenbridgecommunications.com
Wendy Ryan  
   

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. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

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 www.veronapharma.com.

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 and future poster presentations and academic publications pertaining to Ohtuvayre.

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 efficacy of Ohtuvayre compared to competing drugs; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on April 29, 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.

Verona Pharma to Present Six Analyses of the Phase 3 ENHANCE Studies in COPD at CHEST 2024

Data support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4 in a broad COPD population

LONDON and RALEIGH, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces four oral presentations and two posters on 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 3 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.

“Ensifentrine is a remarkable addition to COPD therapy,” said William Stringer, MD, FCCP, Professor of Medicine in the David Geffen School of Medicine at UCLA. “It has the capacity to bronchodilate, reduce inflammation, augment mucociliary clearance, and reduce exacerbations in smokers and former smokers.”

Details of Verona Pharma’s presentations and posters are listed below and linked to the CHEST website. In addition, the Company will present five presentations that will highlight the unmet need in COPD based on real world claims data.

Oral presentation: Ensifentrine improved lung function, symptoms, and quality of life regardless of COPD severity
Presenter: Jessica Bon, MD, Wake Forest University School of Medicine
Session: Assessing Treatment Outcomes in Obstructive Lung Disease

Oral presentation: Ensifentrine, a novel COPD treatment, reduced COPD-related healthcare resource utilization over 48 weeks
Presenter: Emily Wan, MD, Brigham and Women’s Hospital and Harvard Medical School
Session: Emerging Treatments in Obstructive Lung Disease

Oral presentation: Ensifentrine improved lung function in patients with moderate to severe COPD: a pooled analysis from the Phase 3 ENHANCE trials
Presenter: Diego J. Maselli Caceres, MD, FCCP, Division of Pulmonary Diseases and Critical Care, UT Health San Antonio
Session: Emerging Treatments in Obstructive Lung Disease

Oral presentation: Ensifentrine improved lung function and reduced exacerbation rate and risk in patients with COPD regardless of smoking status
Presenter: Amy Dixon, PharmD, Verona Pharma
Session: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease

Poster 3513: Ensifentrine improved symptoms and quality of life in patients with moderate-to-severe COPD regardless of smoking status
Presenter: William Stringer, MD, FCCP, David Geffen School of Medicine at UCLA
Session: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease

Poster 4285: Ensifentrine improved symptoms and quality of life in patients with COPD regardless of bronchitis history
Presenter: Jill Ohar, MD, Wake Forest University School of Medicine
Session: Lung Disease Abstracts Posters

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor
Relations and Communications		 IR@veronapharma.com
Argot Partners
(US Investor Enquiries)		 Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries		 Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com
Leslie Humbel


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. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

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. 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. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

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 and future poster presentations and academic publications pertaining to Ohtuvayre.

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 efficacy of Ohtuvayre compared to competing drugs and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on August 8, 2024, 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.

Verona Pharma to Present Additional Analyses of Phase 3 ENHANCE Studies in COPD at ERS International Congress 2024

One oral presentation and three posters support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., Sept. 05, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces 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.

“These analyses provide further support for Ohtuvayre’s potential to benefit a broad population of patients with COPD,” said Jadwiga Wedzicha, MD, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK. “The non-steroidal anti-inflammatory effects with this novel therapy are particularly beneficial and I am very excited about the impact of Ohtuvayre on COPD.”

Details of Verona Pharma’s presentations and posters are listed below and linked to the ERS website:

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

For further information please contact:

   
Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
(US Investor Enquiries)		 Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries		 Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com
Leslie Humbel  


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. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

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. 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. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

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 and future poster presentations and academic publications pertaining to Ohtuvayre.

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 efficacy of Ohtuvayre compared to competing drugs and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on August 8, 2024, 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.

Verona Pharma Reports Results of Pilot Study of pMDI Ensifentrine in U.S. Patients Hospitalized with COVID-19

LONDON and RALEIGH, N.C., April 23, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces data from a pilot study of a pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine showed that ensifentrine was safe and well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed in the trial. One patient death was reported in the ensifentrine treatment group.

“Overall, the patients in this study recovered exceptionally well, as the mortality rate in the study was much lower than aggregate data from the hospital would have suggested over the same time period,” commented Mike Wells, MD, a pulmonologist and Principal Investigator at the University of Alabama at Birmingham Hospital.

Ensifentrine is a first-in-class product candidate with both bronchodilator and anti-inflammatory activities in one compound, currently in Phase 3 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”). 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.

Study Design

The study was a double-blind, placebo controlled, unpowered pilot study designed to evaluate inhaled ensifentrine on key outcomes in patients with COVID-19 when added on to standard of care therapies, which included remdesivir and dexamethasone. The study randomized 30 patients to receive ensifentrine and 15 to placebo.

  • Patient Population: 45 hospitalized patients with COVID-19. Single center study at University of Alabama at Birmingham.
  • Dose/Duration: patients randomized to receive 2 mg of pMDI ensifentrine or placebo, twice-daily for up to 29 days or until discharge if this occurred before 29 days. The clinical status of all patients was evaluated daily until discharge and at Day 29 and Day 60.
  • Primary endpoint: proportion of patients recovered (not hospitalized) from COVID-19 over 29 days.
  • Other endpoints included: safety and tolerability, time to recovery, proportion of patients with 1- and 2-point improvement on an ordinal scale, proportion of patients progressing to mechanical ventilation, duration of hospitalization, duration and incidence of oxygen use, re-hospitalization, and mortality.

Further information about this study can be found at www.clinicaltrials.gov, NCT04527471.

 

*Franciosi LG, et al., Lancet Respir Med 2013

For further information please contact:

   
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)		 Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)		 Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir  

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses.

Ensifentrine has demonstrated significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease (“COPD”). In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release, operational review, outlook and financial review contain forward-looking statements. All statements contained in this press release with respect to our operational review, outlook and financial review that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, the potential for ensifentrine to be a first-in-class phosphodiesterase 3 and 4 inhibitor and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, the potential of ensifentrine to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses, and the potential applications of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the novel coronavirus (COVID-19), which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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 Announces FDA Response to End-of-Phase 2 Briefing Package for Ensifentrine in COPD and Outlines Phase 3 ENHANCE Clinical Program

LONDON, May 14, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it has received written comments from the U.S. Food and Drug Administration (FDA) in response to its End-of-Phase 2 briefing package for nebulized ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The response supports Verona Pharma progressing with its planned Phase 3 clinical program, which is expected to start later in 2020. It is planned to be called the ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program.

The FDA’s comments follow its review of the End-of-Phase 2 briefing package that included data from 16 clinical trials involving over 1,300 subjects as well as supportive nonclinical and product development data. Verona Pharma has obtained clarity from the FDA on important features of the pivotal Phase 3 clinical program to support a New Drug Application (NDA) including: dose, primary and secondary endpoints, patient population and program design. Based on the FDA response, Verona Pharma is accelerating preparations for the Phase 3 clinical program to start later in 2020.

The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) will evaluate the efficacy and safety of twice daily nebulized ensifentrine as monotherapy and as an add-on to standard of care treatment with a single bronchodilator, either a LAMA, long acting muscarinic antagonist, or a LABA, long acting beta-agonist. The two study designs are essentially identical over 24 weeks but ENHANCE-1 will also evaluate longer-term safety.

  • Patient Population: Each of the studies will be expected to enroll approximately 800 moderate to severe, symptomatic COPD patients at sites primarily in the US and Europe.
  • Dose/Duration: Patients will receive 3 mg nebulized ensifentrine or nebulized placebo twice daily.
  • 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: Peak and trough FEV1 as well as COPD symptoms and health-related quality of life will be assessed through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS: COPD.
  • Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1.

“We are very pleased with the FDA’s response to our End-of-Phase 2 briefing package. Subject to securing additional funding, we look forward to starting our pivotal ENHANCE program later in 2020,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We continue to be very encouraged by the Phase 2 results that have demonstrated ensifentrine’s effects on lung function, COPD symptoms and quality of life as well as its favorable safety profile. We look forward to building on this positive data to support the potential submission of a NDA for ensifentrine for the maintenance treatment of COPD.”

Conference Call on June 1 at 7:30 a.m. EDT / 12:30 pm BST

Verona Pharma plans to present an overview of its ENHANCE program on an investor and analyst R&D webcast at 7:30 a.m. EDT / 12:30 p.m. BST on Monday June 1, 2020. The event will provide insight into the significant unmet need and challenges of treating COPD as well as further details of the ENHANCE program. In additional to members of Verona Pharma’s management team, the webcast will feature a panel of Key Opinion Leaders in the field of COPD to provide a clinician’s perspective. Analysts and investors will be invited to participate in a live webcast available on the Investors page of the Company’s website, www.veronapharma.com, where an audio replay will also be available for 30 days.

Verona Pharma continues to monitor the situation caused by the COVID-19 pandemic and its potential impact on its operational, planned clinical trials and the potential disruption to financial markets.

About COPD

COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organization estimates that it will become the third leading cause of death worldwide by 2030. The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as getting out of bed, showering, eating and walking. US sales of medicines used for chronic maintenance therapy of COPD were $9.6 billion in 2019. About 1.2 million US COPD patients on dual/triple inhaled therapy, long-acting beta-agonist (LABA)/long-acting muscarinic antagonist (LAMA) +/- inhaled corticosteroid (ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.

About Ensifentrine

Ensifentrine (RPL554) has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness, in Verona Pharma’s prior Phase 2 clinical studies in patients with moderate to severe COPD. In addition, ensifentrine showed further improved lung function and reduced lung volumes in patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people to date.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently evaluating three formulations of ensifentrine for the treatment of COPD in Phase 2 clinical trials: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the development of ensifentrine, the progress and timing of clinical trials, data and meetings with and written feedback from the FDA, the potential for ensifentrine to be a first-in-class phosphodiesterase 3 and 4 inhibitor, and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory activities in one compound, the potential for ensifentrine to have a significant impact on the treatment of COPD, estimates of medical costs for COPD and the number of symptomatic COPD patients, and the potential application of ensifentrine for the treatment of cystic fibrosis, asthma and other respiratory diseases.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the novel coronavirus (COVID-19). These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

For further information, please contact:

Verona Pharma plc Tel: +44 (0)20 3283 4200
David Zaccardelli, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications  
   
N+1 Singer
(Nominated Adviser and UK Broker)		 Tel: +44 (0)20 3283 4200
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance)  
Tom Salvesen (Corporate Broking)  
   
Optimum Strategic Communications
(European Media and Investor Enquiries)		 Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir  
   
Argot Partners
(US Investor Enquiries)		 Tel: +1 212-600-1902
verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron  

Verona Pharma to Present at LSX World Congress 2020

LONDON, Jan. 28, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that Piers Morgan, CFO of Verona Pharma, will present a corporate overview and host one-on-one meetings at the LSX World Congress taking place in London on February 4-5, 2020.

Presentation details are as follows:

Date:                         Tuesday, February 4, 2020
Time:                         1:45 PM GMT (8:45 AM EST)
Track:                         Inv€$table Biotech
Location:                         London, UK

For six years, the LSX World Congress has been bringing together executives in healthcare and life science strategy, investment, partnering and deal making. In 2020, over 1000 executives will come to London including the biotech industry’s C-suite, investors, pharma and healthtech teams, R&D leaders and KOLs.

About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently in Phase 2 development with three formulations of ensifentrine for the treatment of COPD: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the development of ensifentrine, the progress and timing of clinical trials and data, estimates of medical costs for COPD, ensifentrine as a first-in-class phosphodiesterase 3 and 4 inhibitor, and plans to develop ensifentrine for the treatment of cystic fibrosis and asthma.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our Phase 2b trial; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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.

For further information, please contact:

Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
David Moskowitz, VP Capital Markets Strategy & Investor Relations (Investor enquiries)
Victoria Stewart, Director of Communications (Media Enquiries)		  
   
Optimum Strategic Communications
(European Media and Investor Enquiries)		 Tel: +44 (0)20 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Hollie Vile  
   
Argot Partners
(US Investor Enquiries)		 Tel: +1 212-600-1902
verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron  

Verona Pharma Reports Positive Top-line Data in 4 Week Phase 2b COPD Study with Nebulized Ensifentrine on Top of Tiotropium Therapy

Primary endpoint met at all doses: ensifentrine produced clinically and statistically significant dose-dependent improvements in lung function

Clinically relevant secondary endpoints met, including progressive and statistically significant improvements in quality of life

Conference call scheduled for 6.00 am PST / 9.00 am EST / 2.00 pm GMT on Monday, January 13, 2020

LONDON, Jan. 13, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces positive top-line data from a 4 week, 416 patient, Phase 2b dose-ranging study evaluating nebulized ensifentrine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or placebo as an add-on treatment to tiotropium (Spiriva® Respimat®), a long acting anti-muscarinic (“LAMA”) bronchodilator, in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”).

The study met its primary endpoint of improved lung function, with ensifentrine added on to inhaled tiotropium, a LAMA commonly used to treat COPD. Ensifentrine produced a clinically and statistically significant, and dose-dependent improvement in peak forced expiratory volume in one second (“FEV1”)1 at week 4 compared to placebo added on to tiotropium.  

Highlights for ensifentrine as an add-on to tiotropium

  • Primary endpoint met at all doses: statistically significant and clinically meaningful improvement in lung function at week 4. Improvements ranged from 78 mL for the 0.375 mg dose (p=0.0368) to 124 mL for the 3.0 mg dose (p=0.0008). Effects were maintained over 4 weeks.
  • Dose-dependent improvements in lung function were observed on both peak FEV1 and FEV1 AUC 0-12 hours2.
  • Statistically significant improvement in average FEV1 AUC 0-12 hours of 87 mL for the 3.0 mg dose (p=0.0111) is supportive of twice daily dosing.
  • Clinically meaningful improvements in health-related quality of life (mean SGRQ-C3) were observed on top of tiotropium, exceeding the minimal clinically important difference (“MCID”) of 4 units compared to placebo at week 4, with the two highest doses also achieving statistical significance.
  • Ensifentrine was well tolerated at all doses with an adverse event profile similar to placebo.
  • These data support dose selection for Phase 3.

Gary Ferguson, MD, a pulmonary physician and Principle Investigator at the Pulmonary Research Institute of Southeast Michigan commented: “The strong effect on both bronchodilation and quality of life as an add-on to tiotropium is impressive and consistent with prior studies with ensifentrine. I am particularly interested to see the significant improvements in quality of life measurements over the 4 week treatment period. This is very important for patients that remain symptomatic despite using standard COPD medications.”

Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said: “We are delighted with these results in symptomatic COPD patients already on steady-state maintenance treatment with a long-acting LAMA bronchodilator. These data bring clarity to planning the design, including dose selection, endpoints and background therapy, of our Phase 3 program. We look forward to discussing these new and compelling data, together with the positive results from our previous clinical studies, in an End-of-Phase 2 meeting with the FDA planned for 2Q 2020. We are committed to demonstrating ensifentrine’s potential to produce sustained bronchodilation and anti-inflammatory effects in symptomatic COPD patients in Phase 3 trials, which we expect to start in 3Q 2020.”

Phase 2b Study Design
This 4 week randomized, double-blind, placebo-controlled dose-ranging Phase 2b trial enrolled a total of 416 patients with moderate to severe symptomatic COPD at 46 sites in the U.S. The trial was designed to evaluate the safety and efficacy of nebulized ensifentrine as an add-on to inhaled tiotropium, a long acting anti-muscarinic (“LAMA”) commonly used to treat patients with COPD.

Patients received nebulized ensifentrine at 4 dose levels: 0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for 4 weeks. The trial’s primary endpoint was improvement in lung function with ensifentrine after 4 weeks of treatment, as measured by peak FEV1, a standard measure of lung function. Key additional endpoints included other lung function measures, as well as measurements of symptoms associated with COPD and quality of life outcomes.

Full data from the Phase 2b study will be released at a subsequent scientific meeting, pending further data analysis. For further information on this clinical trial, please visit ClinicalTrials.gov, NCT03937479.

1 FEV1: Forced Expiratory Volume in one second, a standard measure of lung function
2 FEV1 AUC(0-12hr): Area Under the Curve over 0-12 hours post dose, calculated using the trapezoidal rule, divided by the observation time (12 hours) to report in mL, a measure of the aggregate effect over 12 hours
3SGRQ-C: St. George’s Respiratory Questionnaire is a validated instrument that measures impact on overall health, daily life, and perceived well-being in patients with COPD (i.e. change in frequency and severity of COPD symptoms, and impact on activities, social functioning and psychological disturbances related to airways disease)

Conference Call
Verona Pharma will host an investment community conference call today (Monday, January 13, 2020) at 6.00 am PST / 9.00 am EST / 2.00 pm GMT to discuss the Phase 2b study data. Analysts and investors may participate in the conference call using the conference ID: 2874368 and dialing the following numbers:

  • 866 940 4574 for callers in the United States
  • 0800 028 8438 for callers in the United Kingdom
  • 0800 181 5287 for callers in Germany

Those interested in listening to the conference call live via the internet may do so by visiting the “Events and Presentations” page on the “Investors” section of Verona Pharma’s website at www.veronapharma.com/investors/upcoming-events and clicking on the webcast link. Slides highlighting the data will also be posted to the “Events and Presentations” page.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

About COPD
COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organization estimates that it will become the third leading cause of death worldwide by 2030. The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as getting out of bed, showering, eating and walking. In the United States alone, the total annual medical costs related to COPD are projected to rise to $49 billion in 2020. About 1.2 million US COPD patients on dual/triple inhaled therapy, long-acting beta-agonist (LABA)/long-acting muscarinic antagonist (LAMA) +/- inhaled corticosteroid (ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.

About Ensifentrine
Nebulized ensifentrine (RPL554) has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness, in Verona Pharma’s prior Phase 2 clinical studies in patients with moderate to severe COPD. In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1250 people to date.

About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently in Phase 2 development with three formulations of ensifentrine for the treatment of COPD: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the development of ensifentrine, the progress and timing of clinical trials and data and meetings with the U.S. FDA, estimates of medical costs for COPD, the potential for ensifentrine to be a first-in-class phosphodiesterase 3 and 4 inhibitor, and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory activities in a single molecule, the distinct benefits of ensifentrine’s novel mechanism of action in treating COPD, and the potential application of ensifentrine for the treatment of cystic fibrosis, asthma and other respiratory diseases.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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.

For further information, please contact:

Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
David Moskowitz, VP Capital Markets Strategy & Investor Relations (Investor enquiries)
Victoria Stewart, Director of Communications (Media Enquiries)		  
   
N+1 Singer
(Nominated Adviser and UK Broker)		 Tel: +44 (0)20 3283 4200
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance)  
Mia Gardner (Corporate Broking)  
   
Optimum Strategic Communications
(European Media and Investor Enquiries)		 Tel: +44 (0)20 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Hollie Vile  
   
Argot Partners
(US Investor Enquiries)		 Tel: +1 212-600-1902
verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron  

Verona Pharma to Report 4 Week Phase 2b COPD Dose-ranging Study Results with Nebulized Ensifentrine on Top of Tiotropium Therapy

Data release and conference call on Monday January 13, 2020

LONDON, Jan. 10, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, will release results on Monday, January 13, 2020 at 5.00 am GMT from a Phase 2b dose-ranging study evaluating nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe COPD. Also on January 13, 2020, Jan-Anders Karlsson, PhD, CEO of Verona Pharma, will host an investment community conference call to discuss the data.

Conference call and Webcast Information

Analysts and investors may participate in the conference call by using the conference ID and numbers below:

Date: Monday, January 13, 2020
Time: 2.00 pm GMT / 9.00 am ET / 6.00 am PST
Conference Call ID: 2874368
  • 866 940 4574 for callers in the United States
  • 0800 028 8438 for callers in the United Kingdom
  • 0800 181 5287 for callers in Germany

A live webcast will be available on the Events and Presentations page on the Investors section of the Company’s website at www.veronapharma.com and an audio replay will be available there for 30 days. In addition, copies of the data slides and press release will be available on the Company’s website.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently in Phase 2 development with three formulations of ensifentrine for the treatment of COPD: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the development of ensifentrine, the progress and timing of clinical trials and data, estimates of medical costs for COPD, the potential for ensifentrine to be a  first-in-class phosphodiesterase 3 and 4 inhibitor, and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory activities in a single molecule, and the potential application of ensifentrine for the treatment of cystic fibrosis, asthma and other respiratory diseases.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our Phase 2b trial; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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.

For further information, please contact:

Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
David Moskowitz, VP Capital Markets Strategy & Investor Relations (Investor enquiries)
Victoria Stewart, Director of Communications (Media Enquiries)		  
   
N+1 Singer
(Nominated Adviser and UK Broker)		 Tel: +44 (0)20 3283 4200
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance)  
Mia Gardner (Corporate Broking)  
   
Optimum Strategic Communications
(European Media and Investor Enquiries)		 Tel: +44 (0)20 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Hollie Vile  
   
Argot Partners
(US Investor Enquiries)		 Tel: +1 212-600-1902
verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron  

Verona Pharma Appoints David Moskowitz as Vice President, Capital Markets Strategy & Investor Relations

LONDON, Jan. 07, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the appointment of David Moskowitz to the newly created position of Vice President, Capital Markets Strategy & Investor Relations. Mr. Moskowitz will oversee the Company’s investor relations activities and will also work with the senior leadership team to further develop Verona Pharma’s public market profile.

“We are delighted to welcome David to Verona Pharma,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “His experience and insights make him ideally suited to support our investor relations programme and goals. He will play an instrumental role in forming and implementing our IR strategy as we plan to start Phase 3 trials with first-in-class product candidate, ensifentrine, in 2020.”

Most recently, Mr. Moskowitz performed strategic advisory and investor relations work for emerging biopharmaceutical and molecular diagnostics companies in his private consulting practice. Prior to this role, Mr. Moskowitz served as Vice President, Investor Relations at both Trovagene and Biocept, public molecular diagnostic companies focused on the liquid biopsy testing market. He previously served as Director of Equity Research at Caris & Co. and as Head of Healthcare Research at Friedman Billings Ramsey. During his tenure in the financial services industry, Mr. Moskowitz also held analyst positions at UBS Warburg and Roth Capital Partners. In 2011, he received the StarMine Analyst Award as the top stock picker among U.S. Biotechnology Analysts. He earned his BS in Pharmacy from Rutgers University and his MBA in Finance and Pharmaceutical Industry Studies from Fairleigh Dickinson University.

About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently in Phase 2 development with three formulations of ensifentrine for the treatment of COPD: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the development of ensifentrine, the progress and timing of clinical trials and data, estimates of medical costs for COPD, ensifentrine as a first-in-class phosphodiesterase 3 and 4 inhibitor, and plans to develop ensifentrine for the treatment of cystic fibrosis and asthma.

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: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our Phase 2b trial; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 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.

For further information, please contact:

Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
David Moskowitz, VP Capital Markets Strategy & Investor Relations (Investor enquiries)
Victoria Stewart, Director of Communications (Media Enquiries)		  
   
N+1 Singer
(Nominated Adviser and UK Broker)		 Tel: +44 (0)20 3283 4200
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance)  
Mia Gardner (Corporate Broking)  
   
Optimum Strategic Communications
(European Media and Investor Enquiries)		 Tel: +44 (0)20 950 9144
verona@optimumcomms.com
Mary Clark / Eva Haas / Hollie Vile  
   
Argot Partners
(US Investor Enquiries)		 Tel: +1 212-600-1902
verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron