Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the
“Company”), a clinical-stage biopharmaceutical company focused on
respiratory diseases, announces its financial results for the
second quarter ended June 30, 2023, and provides a corporate
update.
“In June, we submitted a New Drug Application
(“NDA”) to the US Food and Drug Administration (“FDA”) for approval
of ensifentrine for the maintenance treatment of patients with
chronic obstructive pulmonary disease ("COPD"),” said David
Zaccardelli, Pharm. D., President and Chief Executive Officer.
“This brings us an important step closer towards providing this
novel compound to the millions of symptomatic COPD patients in need
of a new effective treatment approach. The FDA is expected to make
a decision on acceptance of the NDA in the third quarter."
“Also in June, the American Journal of
Respiratory and Critical Care Medicine ("AJRCCM"), published
results from the successful Phase 3 ENHANCE trials. The data
demonstrated ensifentrine improved lung function, symptoms and
quality of life and substantially reduced the rate and risk of COPD
exacerbations with a favorable safety profile. We are looking
forward to presenting additional analyses from the ENHANCE program
at the European Respiratory Society International Congress and at
CHEST Annual Meeting later this year."
Program Updates and Key
Milestones
The Company’s near-term planned milestones include:
- In the third
quarter of 2023, the US FDA is expected to make a decision on
acceptance of the Company's NDA for inhaled ensifentrine for the
maintenance treatment of patients with COPD.
- Also in the
third quarter of 2023, the Company plans to continue to advance its
commercialization efforts across medical affairs, marketing,
commercial operations, IT and CMC as well as other departments to
support the planned launch of ensifentrine in 2024, subject to the
approval of the NDA.
- In the second
half of 2023, the Company plans to present further analyses from
the Phase 3 ENHANCE trials at the European Respiratory Society
International Congress 2023 and at CHEST Annual Meeting 2023.
- Also in the
second half of 2023, the Company plans to host an analyst meeting
providing an overview of its commercial launch plans.
Second Quarter and Recent
Highlights
- In June 2023,
the Company submitted a NDA to the US FDA for ensifentrine for the
maintenance treatment of patients with COPD.
- Also in June
2023, the American Journal of Respiratory and Critical Care
Medicine (“AJRCCM”) published results from the successful Phase 3
ENHANCE trials evaluating ensifentrine in COPD.
- In May 2023, the
Company presented 12 abstracts and a symposium on expanded analyses
of the ENHANCE studies with ensifentrine for the treatment of COPD
at the American Thoracic Society International Conference ("ATS")
2023. The abstracts are published on the ATS website and in the
AJRCCM.
Second Quarter 2023 Financial
Results
- Cash
position: Cash and cash equivalents at June 30, 2023, were
$270.7 million (December 31, 2022: $227.8 million). The Company
believes cash and cash equivalents at June 30, 2023, expected cash
receipts from the UK tax credit program and funding expected to
become available under the $150.0 million debt facility, will
enable Verona Pharma to fund planned operating expenses and capital
expenditure requirements through at least the end of 2025,
including the commercial launch of ensifentrine in the US, if
approved.
- R&D
Expenses: Research and development (“R&D”) expenses
were a net reversal of $2.5 million for the second quarter ended
June 30, 2023 (Q2 2022: costs of $15.0 million). R&D expenses
were significantly lower in 2023 versus in 2022 as study conduct in
the Phase 3 ENHANCE program completed late in 2022 with data
analysis and wind-down expenses in Q2 2023. In addition, the
Company favorably resolved a matter with a supplier, as well as
certain disputed invoices, in Q2 2023 resulting in the reversal of
approximately $6.3 million of costs accrued in prior periods, which
resulted in net negative R&D expense for the three months ended
June 30, 2023.
- SG&A
Expenses: Selling general and administrative expenses
(“SG&A”) were $12.4 million for the second quarter ended June
30, 2023 (Q2 2022: $5.5 million). This increase was primarily due
to a $5.0 million increase in people related costs, inclusive
of share-based compensation, as well as an increase of
$1.7 million for costs related to the build out of commercial
and information technology infrastructure in preparation for a
potential commercial launch. The Company expects SG&A expenses
to continue to be the main driver of expense as Verona Pharma
prepares for a potential commercial launch in 2024.
- Net
loss: Net loss was $8.8 million for the second quarter
ended June 30, 2023 (Q2 2022: net loss $17.8 million).
Conference Call and Webcast
Information
Verona Pharma will host an investment community
webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on
Thursday, August 3, 2023, to discuss the second quarter 2023
financial results and the corporate update.
To participate, please dial one of the following
numbers and ask to be placed into the Verona Pharma second quarter
earnings call:
- +1-833-816-1396
for callers in the United States
- +1-412-317-0489
for international callers
A live webcast will be available on the Events
and Presentations link on the Investors page of the Company's
website, www.veronapharma.com, and the audio replay will be
available for 90 days. An electronic copy of the second quarter
2023 results press release will also be made available today on the
Company’s website.
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: +1-312-523-5016
tbcverona@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 be the first non-sterodial
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one compound.
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 second quarter of 2023, Verona Pharma submitted a New Drug
Application (“NDA”) to the US Food and Drug Administration (“FDA”)
for ensifentrine for the maintenance treatment of patients with
COPD. Two additional formulations of ensifentrine have been
evaluated in Phase 2 studies for the treatment of COPD: dry powder
inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”).
Ensifentrine has potential applications in cystic fibrosis, asthma
and other respiratory diseases. For more information, please visit
www.veronapharma.com.
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 our operational review, outlook and financial
review, the timing of the FDA’s decisions on the acceptance and
approval of the NDA for ensifentrine, the development of
ensifentrine and plans to release data from the ENHANCE trials at
future scientific conferences, upcoming events and presentations,
the planned US commercial launch of ensifentrine and timing thereof
and the advancement of commercialization efforts in support of the
launch, 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,
asthma and other respiratory diseases, as well as the potential of
the DPI and pMDI formulations of ensifentrine, the funding we
expect to become available under the $150.0 million debt financing
facility and from cash receipts from UK tax credits, and the
sufficiency of cash and cash equivalents, and the cash runway
period provided by the sources of financing through to at least the
end of 2025 and expected to fully fund the planned commercial
launch.
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 and June 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.
Verona Pharma plc
Consolidated Financial
Summary
(unaudited)
(in thousands, except per share
amounts)
|
|
Three months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Operating expenses |
|
|
|
|
Research
and development |
|
$ |
(2,474 |
) |
|
$ |
14,982 |
|
Selling,
general and administrative |
|
|
12,439 |
|
|
|
5,526 |
|
Total operating expenses |
|
|
9,965 |
|
|
|
20,508 |
|
Operating loss |
|
|
(9,965 |
) |
|
|
(20,508 |
) |
Other income/(expense) |
|
|
|
|
Research
and development tax credit |
|
|
(1,934 |
) |
|
|
5,409 |
|
Interest
income |
|
|
3,402 |
|
|
|
165 |
|
Interest
expense |
|
|
(740 |
) |
|
|
(91 |
) |
Foreign
exchange gain/(loss) |
|
|
740 |
|
|
|
(2,662 |
) |
Total other income, net |
|
|
1,468 |
|
|
|
2,821 |
|
Loss before income taxes |
|
|
(8,497 |
) |
|
|
(17,687 |
) |
Income
tax expense |
|
|
(310 |
) |
|
|
(79 |
) |
Net loss |
|
$ |
(8,807 |
) |
|
$ |
(17,766 |
) |
|
|
|
|
|
Weighted-average shares outstanding – basic and diluted |
|
|
634,469 |
|
|
|
484,778 |
|
Loss per
ordinary share – basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
Jun-30 |
|
Mar-31 |
|
|
|
2023 |
|
|
|
2023 |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
270,727 |
|
|
$ |
291,415 |
|
Total
assets |
|
$ |
303,929 |
|
|
$ |
323,146 |
|
Shareholders’ equity |
|
$ |
273,093 |
|
|
$ |
276,749 |
|
|
|
|
|
|
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