Verona Pharma plc has today (October 17) announced that it has entered into a debt financing facility providing access of up to $150 million from Oxford Finance LLC.
The non-dilutive capital provides further financial flexibility and support for commercialization activities for ensifentrine, the company’s product candidate, which recently reported positive phase 3 data in the ENHANCE-2 trial in chronic obstructive pulmonary disease (COPD). The $150 million debt facility replaces the existing $30 million facility with Silicon Valley Bank (SVB).
New Drug Application
President and CEO of Verona, David Zaccardelli, said: “We believe the potential proceeds from this debt facility and from the U.K. tax credit program, along with our existing $231.7 million of cash at September 30, 2022, will provide more than three years of runway, funding the planned commercial launch of ensifentrine in the U.S.
“We have already begun the early stages of launch preparation and, pending positive ENHANCE-1 results, we intend to submit a New Drug Application in the US for nebulized ensifentrine in the first half of 2023, and if approved, plan to launch in 2024.”
Respiratory diseases
Adam Soller, managing director at Oxford, said: “Oxford is pleased to serve as a capital partner, supporting Verona Pharma’s development and commercialization activities for the unmet respiratory condition COPD and potentially other respiratory diseases.
“The promising results from the recent phase 3 ENHANCE-2 trial bolster ensifentrine’s prospects as a compelling therapy for millions of patients suffering from COPD worldwide.”
Regulatory milestones
Under the terms of the debt facility, Verona Pharma drew $10 million at closing, a portion of which was used to repay the existing debt facility, prepayment fees and other associated costs to SVB. An additional $10 million is immediately available to be drawn at Verona Pharma’s discretion.
The company may draw an additional $80 million in two separate tranches upon achievement of near-term clinical and regulatory milestones. An additional $50 million may be drawn subject to the approval of Oxford. Verona Pharma will pay interest only for the first 36 months, extendable to 48 months on achievement of certain milestones. The debt facility is scheduled to mature on October 1, 2027.