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Mar 31, 2022
Verona Pharma Q1 2022 Earnings Report
Reported financial results for the first quarter ended March 31, 2022, and provided a corporate update.
Key Takeaways
Verona Pharma reported its Q1 2022 financial results, highlighting the progress of its Phase 3 ENHANCE clinical program and the addition of James Brady to the Board as a Non-Executive Director. The company is on track to report top-line data from ENHANCE-2 in Q3 2022 and from ENHANCE-1 around the end of the year. Verona Pharma believes its cash and cash equivalents will enable funding planned operating expenses and capital expenditure requirements through at least the end of 2023.
Enrollment in the Phase 3 ENHANCE clinical program is nearing completion, with approximately 90% of subjects randomized into ENHANCE-1 as of May 2, 2022.
Top-line data from ENHANCE-2 is expected in Q3 2022, and ENHANCE-1 data is expected around the end of 2022.
James Brady, former Chief Financial Officer of MedImmune, joined the board as a Non-Executive Director.
Cash and cash equivalents at March 31, 2022, were $132.8 million, expected to fund operations through at least the end of 2023.
Verona Pharma
Verona Pharma
Forward Guidance
Verona Pharma is focused on completing enrollment in ENHANCE-1 in Q2 2022, reporting top-line data from ENHANCE-2 in Q3 2022 and ENHANCE-1 around the end of 2022, and submitting an NDA to the FDA in the first half of 2023, conditional upon positive results.
Positive Outlook
- Completing enrollment of ENHANCE-1 in the second quarter of 2022.
- Reporting top-line data from ENHANCE-2 in the third quarter of 2022.
- Reporting top-line data from ENHANCE-1 around the end of 2022.
- Expecting to submit an NDA to the US Food and Drug Administration in the first half of 2023.
- Approximately 55-65% of subjects will be receiving background therapy in each study.
Challenges Ahead
- Sanctions and restrictions resulting from the Russia-Ukraine conflict may impact clinical trial activities.
- The COVID-19 pandemic continues to impact a number of clinical trial activities.
- Potential impacts on outsourced clinical research vendor’s ability to pay clinical trial sites in Russia.
- Potential impacts on the ability to supply ensifentrine and equipment to the sites in Russia.
- Potential impacts on validating trial data from Russian sites.