Verona Pharma plc: Preparing for a Potential Landmark Launch of Ensifentrine in COPD

Published on September 24, 2024 | Ticker: VRNA

Verona Pharma plc (NASDAQ:VRNA) is a biopharmaceutical company focused on developing and commercializing innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs. The company's lead product candidate, ensifentrine, is an investigational, first-in-class, inhaled, selective, small molecule and dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4), combining bronchodilator and non-steroidal anti-inflammatory activities in one compound.

In the first quarter of 2024, Verona Pharma continued to make excellent progress on preparations for the planned commercialization of ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The company reported a net loss of $25.8 million for the quarter, compared to a net loss of $16.7 million in the same period of 2023. Research and development costs decreased to $6.8 million from $12.6 million in the prior year quarter, primarily due to the completion of the Phase 3 ENHANCE program in 2023. However, selling, general and administrative expenses increased to $20.4 million from $9.6 million, driven by increased investments in commercial preparation activities, professional fees, and IT infrastructure.

Verona Pharma's cash and cash equivalents stood at $254.9 million as of March 31, 2024. The company recently strengthened its balance sheet and enhanced its financial flexibility through a $650 million strategic financing arrangement with Oaktree Capital and OMERS. This includes a $400 million debt facility and a $250 million capped revenue interest sales transaction, providing the company with a runway beyond 2026 to support the planned commercial launch of ensifentrine and its development programs.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2024 for the review of Verona Pharma's New Drug Application (NDA) seeking approval of ensifentrine for the maintenance treatment of COPD. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. Verona Pharma is finalizing its activities for a potential U.S. launch of ensifentrine in the third quarter of 2024, subject to regulatory approval.

Ensifentrine has the potential to be the first novel inhaled mechanism available for the maintenance treatment of COPD in over 20 years. In the Phase 3 ENHANCE program, ensifentrine demonstrated statistically significant and clinically meaningful improvements in lung function, as well as substantial reductions in the rate and risk of COPD exacerbations, with a favorable safety profile. If approved, Verona Pharma believes ensifentrine could change the treatment paradigm for COPD, a disease that affects more than 390 million patients worldwide and is the third leading cause of death globally.

Verona Pharma is finalizing key aspects of its commercial launch preparation, including sales force deployment strategy, pricing, distribution, patient services programs, healthcare professional and patient engagement plans, and strengthening its internal data infrastructure capabilities. The company's disease awareness campaign, Unspoken COPD, has reached 85% of targeted healthcare providers (HCPs) and engaged over 2,000 HCPs with the campaign website in the first quarter of 2024.

In addition to the planned U.S. launch of ensifentrine, Verona Pharma is working to initiate two Phase 2 programs in the second half of 2024. The first is the development of a fixed-dose combination formulation of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), for the maintenance treatment of COPD. The second is a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis, a severe chronic condition that affects up to 500,000 patients in the U.S. and for which there is currently no approved therapy.

Verona Pharma will be presenting pooled analyses from the ENHANCE Phase 3 studies in 8 posters, including 2 oral symposia, at the upcoming American Thoracic Society (ATS) conference. The presentations will highlight additional data on ensifentrine's improvements in lung function, symptoms, quality of life, and reductions in COPD exacerbations.

The company's financial position remains strong, with $254.9 million in cash and cash equivalents as of March 31, 2024. Verona Pharma reported a net loss of $25.8 million for the first quarter of 2024, compared to a net loss of $16.7 million in the same period of the prior year. Research and development costs decreased to $6.8 million from $12.6 million, while selling, general and administrative expenses increased to $20.4 million from $9.6 million, reflecting the company's focus on commercial preparation activities.

Looking ahead, Verona Pharma is well-positioned for a successful launch of ensifentrine, pending regulatory approval. The company's confidence is based on the novel profile of ensifentrine, the significant unmet need in COPD, its extensive commercial preparations, and the deep experience and capabilities of the Verona team. With a strong balance sheet, a robust pipeline, and a promising lead candidate, Verona Pharma is poised to potentially transform the treatment landscape for COPD patients.

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