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Dec 31, 2021
Verona Pharma Q4 2021 Earnings Report
Verona Pharma's financial results for Q4 2021 were announced, along with a corporate update, highlighting the progress of the Phase 3 ENHANCE program.
Key Takeaways
Verona Pharma reported a net loss of $23.3 million for the fourth quarter ended December 31, 2021. The company's cash and cash equivalents were $148.4 million as of December 31, 2021. Enrollment was completed in ENHANCE-2 and the 48-week subset of ENHANCE-1, and ensifentrine met all safety objectives in a TQT study.
Completed enrollment in ENHANCE-2 with over 800 subjects.
Completed enrollment in the 48-week subset of ENHANCE-1 with approximately 400 subjects.
Ensifentrine met all safety objectives in a TQT study.
Cash and cash equivalents were $148.4 million at the end of 2021.
Verona Pharma
Verona Pharma
Forward Guidance
Verona Pharma expects 2022 to be a pivotal year, with top-line data expected from the ENHANCE program and plans to submit an NDA in the first half of 2023.
Positive Outlook
- Completing enrollment of approximately 400 subjects randomized in the 24-week subset of ENHANCE-1 around the end of the second quarter of 2022.
- Reporting top-line data from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022.
- Conditional upon positive results, expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the first half of 2023.
- Believes cash and cash equivalents at December 31, 2021, expected cash receipts from the U.K. tax credit program and funding expected to become available under $30.0 million debt facility, will enable to fund planned operating expenses and capital expenditure requirements through at least the end of 2023.
- Advancing global partnering strategy through strategic collaboration with Nuance Pharma.
Challenges Ahead
- Recent sanctions and other restrictions imposed on Russia and the COVID-19 pandemic and government and other measures continuing to impact a number of clinical trial activities.
- Potential impact of the COVID-19 pandemic on operations and clinical trials, in particular the timelines and costs of its Phase 3 clinical program ENHANCE.
- The COVID-19 pandemic is disrupting supply chains, and employee retention and recruitment, globally.
- If the U.S. or other countries impose further sanctions or other restrictions as a result of the current conflict between Russia and Ukraine, we may encounter problems transferring funds into Russia to pay the clinical trial sites, supplying ensifentrine and equipment to trial sites, or validating trial data, which would increase the cost and timelines of our Phase 3 program.
- The lengthy and expensive process of clinical drug development, which has an uncertain outcome.