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Sep 30, 2023
Verona Pharma Q3 2023 Earnings Report
Verona Pharma reported its financial results for Q3 2023 and provided a corporate update. The US FDA accepted the NDA filing for ensifentrine for maintenance treatment of COPD with a PDUFA Target Action Date of June 26, 2024.
Key Takeaways
Verona Pharma reported a net loss of $14.7 million for the third quarter ended September 30, 2023. Cash and cash equivalents were $257.4 million as of September 30, 2023. The FDA accepted the NDA for ensifentrine with a PDUFA target action date of June 26, 2024.
FDA accepted NDA filing for ensifentrine for maintenance treatment of COPD with a PDUFA Target Action Date of June 26, 2024.
Commercial launch preparations are underway, supported by a strong balance sheet.
The company presented further analyses from the Phase 3 ENHANCE trials, demonstrating improvements in lung function, symptoms, and quality of life, and reduced COPD exacerbations.
Verona Pharma launched the ‘unspoken COPD’ disease awareness campaign at the CHEST Annual Meeting.
Forward Guidance
Verona Pharma plans to continue its commercial preparations across multiple departments to support the planned launch of ensifentrine in 2024, subject to FDA approval. The company is also developing a fixed-dose combination formulation with ensifentrine and glycopyrrolate, with plans to submit an IND application in the second half of 2024. Additionally, the company plans to commence a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis in the second half of 2024, subject to FDA clearance.
Positive Outlook
- Continued commercial preparations for ensifentrine launch in 2024.
- Development of a fixed-dose combination formulation with ensifentrine and glycopyrrolate.
- Planned submission of an IND application in the second half of 2024.
- Planned Phase 2 clinical trial for nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis.
- Cash runway through at least the end of 2025.
Challenges Ahead
- Launch of ensifentrine is subject to FDA approval.
- Development of fixed-dose combination formulation depends on a feasible formulation being developed.
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