Company Overview

Verona Pharma is a biopharmaceutical company developing ensifentrine, an inhaled therapy for chronic obstructive pulmonary disease (COPD). Ensifentrine combines bronchodilator and anti-inflammatory effects in one compound. If approved, ensifentrine would be the first new class of COPD medication in over 20 years.

In August 2023, the FDA accepted Verona’s application seeking approval of ensifentrine. A decision is expected by June 2024. Ensifentrine met its primary endpoints in two late-stage trials, demonstrating improved lung function and reduced COPD exacerbations. Verona believes ensifentrine has potential to change the COPD treatment landscape.

Financial Results

In Q1 2024, Verona reported:

• R&D expenses of $6.8 million, down from $12.6 million in Q1 2023 due to completion of ensifentrine trials.

• SG&A expenses of $20.4 million, up from $9.6 million, driven by pre-commercialization activities.

• Net loss of $25.8 million compared to $16.7 million.

• Cash balance of $255 million as of March 2024. Cash runway expected through at least end of 2026.

Key Developments

• In December 2023, Verona secured a $400 million credit facility to support the ensifentrine launch if approved.

• A fixed-dose combination of ensifentrine and a LAMA bronchodilator is under development for COPD, with plans to start Phase 2 trials in 2024.

• A Phase 2 trial of ensifentrine in non-CF bronchiectasis is planned for 2H 2024.

• Verona’s partner Nuance Pharma started Phase 3 trials of ensifentrine in China in April 2023.

Outlook

Verona is focused on commercializing ensifentrine in the US if approved. Key upcoming catalysts are the FDA approval decision expected by June 2024 and the planned ensifentrine launch in 2H 2024 if approved. Additional pipeline programs could provide further upside. Cash balance expected to fund operations through at least end of 2026.