PDUFA Target Action Date for Ensifentrine of June 26, 2024  Finalizing commercial launch preparations Strong balance sheet supports commercialization and pipeline expansion Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST LONDON and RALEIGH, N.C., May 09, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (NASDAQ:VRNA) ("Verona Pharma" or the "Company"), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2024, and provides a corporate update. "As we approach the PDUFA target action date for ensifentrine of June 26, we are finalizing our preparations for a potential US launch in the third quarter of 2024," said David Zaccardelli, Pharm. D., President and Chief Executive Officer. "If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in more than 20 years, and we continue to work with the US Food and Drug Administration during their review. Our goal is to address the significant unmet need in COPD and provide a novel and effective treatment for patients that continue to experience symptoms, despite existing therapies. "We believe ensifentrine's bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD and we look forward to providing updates later this year on our planned clinical programs for a fixed-dose combination of ensifentrine and glycopyrrolate in COPD and ensifentrine in non-cystic fibrosis bronchiectasis. "With the financing announced this morning, we are pleased to have further strengthened our balance sheet and enhanced our financial flexibility as we prepare for the potential launch of ensifentrine with access to up to $650 million in addition to our existing cash of $255 million. We refinanced our $400 million debt facility to one with a lower overall cost of capital and favorable financial covenants. In addition, we have entered into a $250 million capped revenue interest sales transaction with repayment based on a percentage of future ensifentrine revenues. We expect these funds, along with existing cash, to support the Company's growth through the planned commercialization beyond 2026." Program Updates and Key Milestones The Company's near-term milestones include: The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") target action date for ensifentrine of June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the third quarter of 2024. In the second quarter of 2024, the Company continues to finalize key launch preparations including sales force deployment strategy, pricing, distribution and patient services, healthcare professional and patient engagement plans. In the second quarter of 2024, the Company will continue to highlight the burden of chronic obstructive pulmonary disease ("COPD") through the "Unspoken COPD" disease awareness campaign. Through the first quarter of 2024, 85% of targeted healthcare professionals ("HCPs") were reached with the campaign and over 2,000 HCPs engaged with the website. In May 2024, the Company will present eight posters including two mini oral symposia, at the American Thoracic Society International Conference ("ATS") 2024. The posters will highlight additional pooled analyses of the Phase 3 ENHANCE studies with ensifentrine for the treatment of COPD. A pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium' designed to highlight new breakthroughs. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase ("PDE") in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts. In the second half of 2024, the Company intends to submit an investigational new drug application ("IND") to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of a fixed-dose combination formulation of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist ("LAMA"), for the maintenance treatment of patients with COPD via delivery in a nebulizer. Also in the second half of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis ("NCFBE"), subject to clearance by the FDA. Financing and Recent Highlights In May 2024, the Company refinanced its $400 million debt facility and entered into a $250 million capped revenue interest sales transaction with Oaktree Capital and OMERS Life Sciences (collectively "the $650 million strategic financing"). Also in May 2024, the Company presented posters at the International Society for Pharmacoeconomics and Outcomes Research ("ISPOR") Annual International Conference 2024. Posters at ISPOR included claims data demonstrating exacerbations persist for patients even when they are receiving treatment regimens containing inhaled corticosteroids, resulting in a significant burden to the healthcare system. First Quarter 2024 Financial Results Cash position: Cash and cash equivalents at March 31, 2024, were $254.9 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at March 31, 2024, and funding expected to become available under the $650 million strategic financing facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved. R&D Expenses: Research and development ("R&D") expenses were $6.8 million for the first quarter ended March 31, 2024 (Q1 2023: $12.6 million). This decrease of $5.8 million was primarily due to expense of $7.2 million in the three months ended March 31, 2023 for finalizing all matters related to the Phase 3 ENHANCE program. As the program completed in 2023, no similar costs were incurred in 2024. This decrease was partially offset by $1.5 million of pre-approval active pharmaceutical ingredient manufacturing-related costs as well as an increase of $0.7 million in people related costs including share-based compensation. SG&A Expenses: Selling general and administrative expenses ("SG&A") were $20.4 million for the first quarter ended March 31, 2024 (Q1 2023: $9.6 million). The increase of $10.8 million was primarily due to an increase of $4.6 million related to marketing, commercial preparation and other pre-commercial activities, $1.1 million related to professional fees, consulting costs and other administrative expenses, which support our continued growth and evolution of our business, and $0.7 million related to the continued build-out of our information technology infrastructure. Additionally, people related costs increased by $4.1 million including share-based compensation as we increased our headcount in our commercial and support functions in preparation for the planned commercial launch. Net loss: Net loss was $25.8 million for the first quarter ended March 31, 2024 (Q1 2023: net loss $16.7 million). Conference Call and Webcast InformationVerona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, May 9, 2024, to discuss the first quarter 2024 financial results and the corporate update. To participate, please dial one of the following numbers and ask to join the Verona Pharma call: +1-833-816-1396 for callers in the United States +1-412-317-0489 for international callers A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the first quarter 2024 results press release will also be made available today on the Company's website. For further information please contact: Verona Pharma plc US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 Victoria Stewart, Senior Director of Investor Relations and Communications Argot Partners US Investor Enquiries Tel: +1-212-600-1902 Ten Bridge Communications International / US Media Enquiries Tel: +1-312-523-5016 Leslie Humbel