Verona Pharma PLC (VRNA, Financial), a clinical-stage biopharmaceutical company focused on respiratory diseases, announced its financial results for the third quarter ended September 30, 2023, on November 2, 2023. The company also provided a corporate update, highlighting the US FDA's acceptance of their New Drug Application (NDA) for ensifentrine, a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
Financial Highlights
Verona Pharma PLC (VRNA, Financial) reported a strong cash position of $257.4 million as of September 30, 2023, an increase from $227.8 million at the end of 2022. The company believes that its current cash and cash equivalents, expected cash receipts from the UK tax credit program, and the remaining $130.0 million funding expected to become available under the debt facility will enable it to fund planned operating expenses and capital expenditure requirements through at least the end of 2025.
Research and development (R&D) expenses for the third quarter ended September 30, 2023, were $3.0 million, a significant decrease from $9.8 million in the same period in 2022. This decrease was primarily due to a $7.9 million decrease in clinical trial and other development costs as all study conduct and analysis of the Phase 3 ENHANCE program was complete.
Selling, general and administrative expenses (SG&A) were $13.4 million for the third quarter ended September 30, 2023, up from $5.3 million in Q3 2022. This increase was primarily due to a $4.7 million increase in people-related costs, inclusive of share-based compensation, as well as an increase of $2.9 million for costs primarily related to preparations for a potential commercial launch.
The net loss for Q3 2023 was $14.7 million, slightly less than the $15.6 million reported in Q3 2022.
Corporate Updates
In August 2023, the US FDA accepted for review the company's NDA filing seeking US approval of ensifentrine for the maintenance treatment of patients with COPD. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2024.
The company recently presented additional analyses of data from the successful ENHANCE trials evaluating ensifentrine in COPD at ERS International Congress 2023 and CHEST Annual Meeting 2023. The analyses showed that ensifentrine demonstrated improvements in lung function and symptoms and quality of life endpoints and substantially reduced the rate and risk of COPD exacerbations regardless of background therapy, as well as reduced daily rescue medication use.
Verona Pharma PLC (VRNA, Financial) is planning to continue its commercial preparations across medical affairs, commercial operations, manufacturing, and IT as well as other departments to support the planned launch of ensifentrine in 2024, subject to the approval of the NDA.
Explore the complete 8-K earnings release (here) from Verona Pharma PLC for further details.
