Non-dilutive capital funds planned launch of ensifentrine for COPD
LONDON and RALEIGH, North Carolina, Oct. 17, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces that it has entered into a debt financing facility (“Loan Facility”) allowing the Company to access up to $150 million dollars from Oxford Finance LLC (“Oxford”). Non-dilutive capital provides additional financial flexibility and support for commercialization of ensifentrin, the first-in-class product candidate, which recently reported positive Phase 3 data in the ENHANCE-2 trial in lung disease Chronic Obstructive Disease (“COPD”). . The $150 million credit facility replaces the existing $30 million facility with Silicon Valley Bank (“SVB”).
“We believe the potential proceeds from this credit facility and the UK tax credit program, together with our $231.7 million in existing cash as of September 30, 2022, will provide over 3 years of runway, funding the planned commercial launch of ensifentrine in the United States,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We have already begun the initial stages of launch preparation and, pending positives from ENHANCE-1, we intend to submit a US New Drug Application for nebulized ensifentrine in the first half of 2023, and if approved, we expect to launch in 2024.”
“Oxford is delighted to serve as a capital partner, supporting Verona Pharma’s development and commercialization activities for the unmet respiratory disease COPD and potentially other respiratory diseases,” said Adam K. Soller, Chief Executive Officer of Oxford. “The promising results of the recent ENHANCE-2 Phase 3 trial reinforce ensifentrine’s prospects as a compelling treatment for millions of COPD patients worldwide.
Under the terms of the credit facility, Verona Pharma drew $10 million at closing, a portion of which was used to repay the existing credit facility, prepayment charges and other costs associated with SVB. An additional $10 million is immediately available for withdrawal at Verona Pharma’s discretion. The Company can draw an additional $80 million in two separate tranches upon reaching near-term clinical and regulatory milestones. An additional $50 million can be drawn subject to Oxford’s approval. Verona Pharma will only pay interest for the first 36 months, extendable to 48 months upon the achievement of certain milestones. The credit facility matures on October 1, 2027.
For more information, please contact:
|Verona Pharma plc||Such. USA: +1-833-417-0262
Such. UK: +44 (0)203 283 4200
|Victoria Stewart, Director of Investor Relations and Communications||[email protected]|
(Requests from US Investors)
|Kimberly MinarovichCarrie McKim|
|Optimal strategic communications
(International media and requests from European investors)
|Tel: +44 (0)203 882 9621
|Mary Clark / Rebecca Noonan / Zoe Bolt|
About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory disease that combines bronchodilator and anti-inflammatory activities in a single compound. The Company is evaluating nebulized ensifentrine in its ENHANCE Phase 3 clinical program (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for the maintenance treatment of COPD. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating statistically significant and clinically meaningful improvement in lung function. Additionally, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of ensifentrine are in phase 2 development for the treatment of COPD: the dry powder inhaler (“DPI”) and the pressurized metered-dose inhaler (“pMDI”). Ensifentrin has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.
About Oxford Finance LLC
Oxford Finance is a specialist finance company that provides senior secured loans to public and private life sciences and healthcare companies worldwide. For more than 20 years, Oxford has provided flexible financing solutions to its clients, enabling these businesses to maximize their equity by leveraging their assets. Since 2002, Oxford has funded over $9 billion in loans. Oxford is headquartered in Alexandria, Virginia, with additional offices in California (San Diego, Palo Alto, and Los Angeles) and the major metropolitan areas of Boston and New York. For more information, visit oxfordfinance.com.
This press release contains forward-looking statements. All statements in this press release that do not relate to historical facts should be considered forward-looking statements, including, but not limited to, statements regarding the intended use of proceeds from the loan, the sources of financing for the planned commercial launch of ensifentrine, the period of cash provided by the financing sources and the full financing of the commercial launch, and the timing of the submission of a new drug application and the launch market for ensifentrine.
These forward-looking statements are based on management’s current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to differ materially from our expectations expressed or underestimated. forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete the development and commercialization of ensifentrin, which may not be available and which may cause us to delay, reduce or eliminate our development or commercialization efforts; our company’s confidence in the success of ensifentrine, our only product candidate in development; economic, political, regulatory and other risks associated with international operations; the long and costly process of developing and commercializing clinical drugs, the outcome of which is uncertain; serious, adverse or unacceptable side effects associated with ensifentrine, which could impair our ability to develop or commercialize ensifentrine; potential delays in subject recruitment, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not succeed in developing ensifentrine for multiple indications; our ability to obtain approval and commercialize ensifentrine in several large pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third party service providers and licensees; our inability to realize the anticipated benefits under the licenses we have granted to third parties to develop and commercialize ensifentrine, our future growth and our ability to compete depend on the retention of our key personnel and the recruitment of additional qualified personnel; material differences between our “main” data and the final data; our dependence on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and risks relating to such parties’ ability to successfully develop and commercialize ensifentrine; lawsuits relating to patents covering ensifentrine and the possibility that our patents may be declared invalid or unenforceable; litigation related to our patent and know-how licenses with third parties for the development and commercialization of ensifentrine; changes to our tax rates, unavailability of certain tax credits or reliefs, or exposure to additional tax obligations or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for earlier periods; and our vulnerability to natural disasters, global economic factors, geopolitical actions and unexpected events, including health epidemics or pandemics such as the COVID-19 pandemic, and conflicts such as the Russian-Ukrainian conflict, which has and could continue to have a negative impact on our Business. These and other important factors under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and our other reports filed with the Securities and Exchange Commission, could cause actual results will differ materially from those indicated by the forward-looking statements made in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. Although we may choose to update these forward-looking statements at some time in the future, we disclaim any obligation to do so, even if subsequent events change our views. These forward-looking statements should not be taken to represent our views as of any date subsequent to the date of this press release.