Verona cuts $400m loan deal as it preps COPD drug for market

Verona Pharma's David Zaccardelli
Verona Pharma

David Zaccardelli, Verona Pharma’s president and chief executive

Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD).

The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.

It can also draw another $100 million to support “strategic initiatives”, and $150 million in two separate tranches upon achievement of certain net sales milestones, according to an update posted this morning. The financing represents a big increase on an earlier $150 million facility with an affiliate of Oxford, which has been replaced by the new arrangement.

Verona filed for approval of ensifentrine last year on the strength of clinical data showing significant improvements in lung function with the drug in COPD patients, as well as a reduction in COPD exacerbations – sudden worsening of symptoms that can lead to patients becoming hospitalised.

The phosphodiesterase (PDE) 3 and 4 inhibitor is vying to become the first in a new class of COPD therapies, providing bronchodilation and anti-inflammatory properties in one drug.

Pooled data from the ENHANCE-1 and ENHANCE-2 studies of ensifentrine added to background treatment with either a long-acting beta agonist (LABA) or long-acting muscarinic antagonist (LAMA) – which are standard bronchodilator therapies for COPD – showed a 40% reduction in the COPD exacerbation rate over 24 weeks.

Around one in five subjects were also taking corticosteroids, so were already receiving therapy targeting both bronchodilation and inflammation.

“This new facility, along with our existing cash, which was $257.4 million at [30th September] 2023, provides us with additional financial flexibility to support Verona Pharma’s continued growth, including the planned launch of ensifentrine in the US, if approved,” said David Zaccardelli, the company’s president and chief executive.

“We look forward to the [FDA] target action date of [26th June] 2024,” he added.

Apollo swells its Series C to $260m

Another Anglo-US biotech – Apollo Therapeutics – also had fundraising news this morning, announcing a $33.5 million extension of its recent third-round financing that takes the total to $260 million.

The Series C financing was led by Patient Square Capital, with participation by new investors including M&G plc and two of the largest US public pension plans, along with existing investors including Rock Springs Capital.

The proceeds are being used to advance its pipeline, which includes IL-18 targeting antibody camoteskimab, which was originally developed by AstraZeneca and licensed from Avalo Therapeutics in 2022.