Verona Pharma Presents Positive Phase 3 Analyses of Ohtuvayre® for 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 FEV ₁ 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

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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 ^TM (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.