Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces it
and its wholly-owned subsidiary, Verona Pharma, Inc. (the
“Company”), have entered into a debt financing facility (“debt
facility”) providing the Company with access to up to $400 million
from funds managed by Oxford Finance LLC (“Oxford”) and Hercules
Capital, Inc. (NYSE: HTGC) (“Hercules”) (collectively, the
“Lenders”). The debt facility provides non-dilutive capital and
further financial flexibility to support Verona Pharma’s continued
growth, including the planned commercial launch of ensifentrine,
Verona Pharma’s first-in-class product candidate, which is under
review by the US Food and Drug Administration for the maintenance
treatment of chronic obstructive pulmonary disease (“COPD”). The
debt facility replaces the existing facility of up to $150 million
with an affiliate of Oxford.
Under the terms of the debt facility, the
Company drew $50 million at closing, and may draw, subject to
certain conditions precedent, an additional $100 million upon
approval of ensifentrine, $150 million in two separate tranches
upon achievement of certain net sales milestones and, subject to
the approval of the Lenders, $100 million to support strategic
initiatives. Verona Pharma will pay only interest on the
outstanding loans under the debt facility for the first 53 months
with the outstanding principal of the loans under the debt facility
amortized over the subsequent 7 months. The $20 million drawn and
fees and associated costs due to Oxford on the discharge of the
existing debt facility will be paid to Oxford on closing of the
debt facility.
“We are pleased to have secured access to this
expanded and flexible facility with Oxford, who has trusted us with
debt finance over the past year, and having Hercules join as an
additional financing partner. This new facility, along with our
existing cash, which was $257.4 million at September 30, 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,
Pharm. D., President and Chief Executive Officer. “We look forward
to the Prescription Drug User Fee Act (“PDUFA”) target action date
of June 26, 2024.”
“We are thrilled to announce our expanded
financial support for our existing client, Verona Pharma,” said
Adam K. Soller, Managing Director at Oxford. “As we anticipate
their first potential approval of the company’s lead product
candidate, ensifentrine, for the maintenance treatment of patients
with COPD, our increased loan facility underscores our commitment
to advancing ground-breaking solutions for respiratory health.”
“We are excited to collaborate with Verona
Pharma as they take the next step in their important mission of
bringing a novel treatment to COPD patients worldwide,” said
Michael McMahon, Director of Healthcare and Life Sciences with
Hercules. “Verona Pharma has many of the underpinnings Hercules
looks for when partnering with companies: the combination of an
experienced team, a novel, efficacious treatment and, most
importantly, the potential to address a large, underserved patient
population,” added Kristen Kosofsky, Senior Managing Director of
Healthcare and Life Sciences with Hercules.
For further information please contact:
Verona Pharma plc |
US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 |
Victoria Stewart, Senior Director of Investor Relations and
Communications |
IR@veronapharma.com |
Argot PartnersUS Investor Enquiries |
Tel: +1-212-600-1902verona@argotpartners.com |
Ten Bridge CommunicationsInternational / US Media
Enquiries |
Tel: +1-312-523-5016tbcverona@tenbridgecommunications.com |
Leslie Humbel |
|
About Verona Pharma
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of chronic respiratory
diseases with significant unmet medical needs. If successfully
developed and approved, Verona Pharma’s product candidate,
ensifentrine, has the potential to become the first non-steroidal
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one molecule.
The Company has evaluated nebulized ensifentrine in its Phase 3
clinical program ENHANCE (“Ensifentrine as a Novel inHAled
Nebulized COPD thErapy”) for COPD maintenance treatment.
Ensifentrine met the primary endpoint in both ENHANCE-1 and
ENHANCE-2 trials demonstrating statistically significant and
clinically meaningful improvements in lung function. In addition,
ensifentrine substantially reduced the rate and risk of COPD
exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In
the third quarter of 2023, the US Food and Drug Administration
accepted for review the Company’s NDA for ensifentrine for the
maintenance treatment of patients with COPD and assigned a PDUFA
target action date of June 26, 2024. Two additional
formulations of ensifentrine have been evaluated in Phase 2 trials
for the treatment of COPD: dry powder inhaler (“DPI”) and
pressurized metered-dose inhaler (“pMDI”). Ensifentrine has
potential applications in cystic fibrosis, non-cystic fibrosis
bronchiectasis, asthma and other respiratory diseases. For more
information, please visit www.veronapharma.com
About Oxford Finance LLC
Oxford Finance LLC is a specialty finance firm
providing senior secured loans to public and private life sciences
and healthcare services companies worldwide. For over 20 years,
Oxford has delivered flexible financing solutions to over 700
companies, allowing borrowers to maximize their equity by
leveraging their assets. Since 2002, Oxford has originated more
than $11 billion in loans. Oxford is headquartered in Alexandria,
Virginia, with additional offices serving the greater San Diego,
San Francisco, Boston and New York City metropolitan areas. For
more information, visit https://oxfordfinance.com.
About Hercules Capital,
Inc.
Hercules Capital, Inc. (NYSE: HTGC) is the
leading and largest specialty finance company focused on providing
senior secured venture growth loans to high-growth, innovative
venture capital-backed companies in a broad variety of technology,
life sciences and sustainable and renewable technology industries.
Since inception (December 2003), Hercules has committed more than
$18 billion to over 640 companies and is the lender of choice for
entrepreneurs and venture capital firms seeking growth capital
financing. Companies interested in learning more about financing
opportunities should contact info@htgc.com, or call
650.289.3060.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements regarding the debt facility providing non-dilutive
capital and further financial flexibility to support Verona
Pharma’s continued growth, including the planned commercial launch
of ensifentrine, statements regarding the future availability of
future draws under the debt facility, the potential for
ensifentrine to be the first therapy for the treatment of
respiratory diseases to combine bronchodilator and non-steroidal
anti-inflammatory benefits in one compound, and the potential of
ensifentrine in the treatment of cystic fibrosis, non-cystic
fibrosis bronchiectasis, asthma and other respiratory diseases, as
well as the potential of the DPI and pMDI formulations of
ensifentrine.
These forward-looking statements are based on
management's current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from our expectations expressed or implied by the forward-looking
statements, including, but not limited to, the following: our
limited operating history; our need for additional funding to
complete development and commercialization of ensifentrine, which
may not be available and which may force us to delay, reduce or
eliminate our development or commercialization efforts; the
reliance of our business on the success of ensifentrine, our only
product candidate under development; economic, political,
regulatory and other risks involved with international operations;
the lengthy and expensive process of clinical drug development,
which has an uncertain outcome; serious adverse, undesirable or
unacceptable side effects associated with ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; we may not be successful in developing ensifentrine
for multiple indications; our ability to obtain approval for and
commercialize ensifentrine in multiple major 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 licenses granted by us to third parties to develop and
commercialize ensifentrine, our future growth and ability to
compete depends on retaining our key personnel and recruiting
additional qualified personnel; material differences between our
“top-line” data and final data; our reliance on third parties,
including clinical research organizations, clinical investigators,
manufacturers and suppliers, and the risks related to these
parties’ ability to successfully develop and commercialize
ensifentrine; lawsuits related to patents covering ensifentrine and
the potential for our patents to be found invalid or unenforceable;
lawsuits related to our licensing of patents and know-how with
third parties for the development and commercialization of
ensifentrine; changes in our tax rates, unavailability of certain
tax credits or reliefs or exposure to additional tax liabilities or
assessments could affect our profitability, and audits by tax
authorities could result in additional tax payments for prior
periods; and our vulnerability to natural disasters, global
economic factors, geo-political actions and unexpected events,
including health epidemics or pandemics like the COVID-19 pandemic,
and conflicts such as the Russia-Ukraine conflict, which has and
may continue to adversely impact our business. These and other
important factors under the caption “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2022, as
updated in our Quarterly Reports on Form 10-Q for the quarters
ended March 31, 2023, June 30, 2023 and September 30, 2023 and our
other reports filed with the SEC, could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
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