Verona Pharma PLC (LON:VRP) (NASDAQ:VRNA) outlined plans for the coming months as it updated on a busy start to the year and confirmed it is financially well placed.
The company is focused on developing discoveries such as ensifentrine for respiratory conditions such as chronic obstructive pulmonary disease (COPD).
The focus going forward is on the preparation for what’s called an end-of-phase II meeting with the US Food & Drug Administration to discuss Verona’s success in delivering the drug using a nebuliser.
Scheduled for this quarter, the formal written response from the American regulator will guide the design of a phase III study.
In the meantime, the group wants to secure capital to underwrite said clinical assessment. It cautioned, however, that fundraising in the current environment, with capital markets in a state of flux, will be more difficult than anticipated.
The company has enjoyed success developing ensifentrine to be used not just via a nebuliser, but also using the two popular methods of handheld delivery – dry powder and pressurised metered-dose inhalers (pMDI).
Clinical progress has been rapid on all fronts since the start of the year. Last month it reported positive efficacy and safety data with a single dose of the pressurised metered-dose inhaler formulation of its drug.
In January, Verona released positive top-line data from a phase IIb clinical study with nebulised ensifentrine added on to a bronchodilator called tiotropium.
As of the end of March, the company had cash of £20.8mln. Earlier this month it received £7.3mln in the form of an R&D tax credit. As you’d expect from a company investing heavily in drug development, Verona was loss-making – to the tune of £9.6mln at the post-tax level for the first three months of 2020.
Turning to the issue of the coronavirus (COVID-19) outbreak and its impact on the business, investors were told results from Part-B of a clinical trial to assess pMDI formulation won’t be announced this year.
Verona is also assessing the potential impact of the outbreak on its planned phase III programme for the nebulised form of the drug.
Its partners, meanwhile, have reassured on the integrity of the supply chain.
“We continue to monitor the situation caused by the COVID-19 pandemic and its potential impact on our operational and financing goals and will provide an update as and when further information becomes available,” Verona chief executive, David Zaccardelli said in the first-quarter update.