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 third
quarter ended September 30, 2023, and provides a corporate update.
“In August, the US Food and Drug Administration
("FDA") accepted for review our New Drug Application ("NDA")
seeking 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. “The Agency assigned a Prescription Drug User Fee Act
("PDUFA") target action date of June 26, 2024, and is not currently
planning to hold an advisory committee meeting to discuss the
application.
“The NDA acceptance brings us a step closer to
our goal of delivering ensifentrine to a broad population of
patients suffering from COPD and we look forward to working with
the FDA during their review. If approved, ensifentrine is expected
to be the first novel mechanism available for the treatment of COPD
in more than 10 years. We believe the bronchodilator and
non-steroidal anti-inflammatory activity of ensifentrine has the
potential to change the treatment paradigm for COPD.
“Following the end of the quarter, we hosted an
investor meeting during which the Company's senior management team
and key opinion leader, Cedric “Jamie” Rutland, MD, FCCP, discussed
the COPD treatment landscape and provided an overview of our
commercial preparations for the US launch of ensifentrine, if
approved. The Company also shared a detailed overview of the
current COPD market, unmet treatment needs, launch access,
distribution, reimbursement strategies and plans for field
deployment.
“The Company recently presented further analyses
from the Phase 3 ENHANCE trials at the European Respiratory Society
International Congress and at CHEST Annual Meeting. The analyses
showed that ensifentrine demonstrated improvements in lung function
and symptoms and quality of life endpoints and substantially
reduced the rate and risk of COPD exacerbations regardless of
background therapy, as well as reduced daily rescue medication
use.
“Also at CHEST, we launched the ‘unspoken COPD’
disease awareness campaign. The campaign highlights the severe
impact COPD has on patients’ daily life and encourages healthcare
professionals to engage in deeper conversations to fully understand
the impact of COPD on each patient in their practice.”
Program Updates and Key
Milestones
The Company’s near-term planned milestones include:
- In the fourth
quarter of 2023, the Company plans to continue its commercial
preparations across medical affairs, commercial operations,
manufacturing and IT as well as other departments to support the
planned launch of ensifentrine in 2024, subject to the approval of
the NDA.
- The Company
is developing a fixed-dose combination formulation with
ensifentrine and glycopyrrolate, a long-acting muscarinic
antagonist (“LAMA”), for the maintenance treatment of patients with
COPD via delivery in a nebulizer. If a feasible formulation is
developed, in the second half of 2024, the Company plans to submit
an investigational new drug (“IND”) application to the FDA and, if
cleared, initiate a Phase 2 clinical trial assessing the safety and
efficacy of the fixed-dose combination formulation in COPD
patients.
- Also in the
second half of 2024, if the FDA approves the Company’s NDA for
ensifentrine as a maintenance treatment of COPD, the Company plans
to commence a Phase 2 clinical trial to assess the efficacy and
safety of nebulized ensifentrine in patients with non-cystic
fibrosis bronchiectasis, subject to clearance by the FDA.
Third Quarter and Recent
Highlights
- In August 2023,
the FDA accepted for review the Company's NDA filing seeking US
approval of ensifentrine for the maintenance treatment of patients
with COPD. The FDA assigned a PDUFA target action date of June 26,
2024, and is not currently planning to hold an advisory committee
meeting to discuss the application.
- In September
2023, Christina Ackermann joined the board as a Non-Executive
Director. Ms. Ackermann has over 25 years of legal and management
experience across the pharmaceutical, device and consumer products
industries. Most recently, she served as Executive Vice President,
General Counsel and Global President Ophthalmic Pharmaceuticals at
Bausch + Lomb Corporation, where she was responsible for strategic
planning and worldwide commercialization of pharmaceutical
prescription assets across the portfolio as well as global legal
affairs.
- The Company
recently presented additional analyses of data from the successful
ENHANCE trials evaluating ensifentrine in COPD at ERS International
Congress 2023 and CHEST Annual Meeting 2023. Also, at CHEST Annual
Meeting, the Company launched a disease awareness campaign
highlighting how many COPD patients struggle to talk about their
condition.
Third Quarter 2023 Financial
Results
- Cash
position: Cash and cash equivalents at September 30, 2023,
were $257.4 million (December 31, 2022: $227.8 million). The
Company believes cash and cash equivalents at September 30, 2023,
expected cash receipts from the UK tax credit program and the
remaining $130.0 million funding expected to become available under
the 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 $3.0 million for the third quarter ended September 30, 2023
(Q3 2022: $9.8 million). This decrease was primarily due to a $7.9
million decrease in clinical trial and other development costs as
all study conduct and analysis of the Phase 3 ENHANCE program was
complete, whereas in the same period in the prior year significant
costs were incurred associated with the then ongoing study conduct.
The third quarter 2023 clinical trial and other development costs
also include the impact of $2.2 million of credits received
related to the final financial reconciliation of a Phase 3 ENHANCE
program supplier. This decrease was partially offset by an increase
of $0.7 million in people related costs, inclusive of share-based
compensation.
- SG&A
Expenses: Selling, general and administrative expenses
(“SG&A”) were $13.4 million for the third quarter ended
September 30, 2023 (Q3 2022: $5.3 million). This increase was
primarily due to a $4.7 million increase in people related
costs, inclusive of share-based compensation, as well as an
increase of $2.9 million for costs primarily related to
preparations for a potential commercial launch including the build
out of the distribution network and work related to payer and
disease education as well as advancing the commercial and
information technology infrastructure of the Company.
- Net
loss: Net loss was $14.7 million for the third quarter
ended September 30, 2023 (Q3 2022: $15.6 million).
Conference Call and Webcast
Information
Verona Pharma will host an investment community
webcast and conference call at 9:00 a.m. EDT / 1:00 p.m. GMT on
Thursday, November 2, 2023, to discuss the third 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 third 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 third 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 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 non-cystic fibrosis bronchiectasis, 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 decision on the approval of the NDA
for ensifentrine and the assigned PDUFA target action date, the
planned US commercial launch of ensifentrine and timing thereof and
the advancement of commercialization preparations in support of the
launch, the potential for ensifentrine to be the first novel
mechanism available for the treatment of COPD in more than 10 years
and the first therapy for the treatment of respiratory diseases to
combine bronchodilator and non-steroidal anti-inflammatory benefits
in one compound, the planned development of a fixed-dose
combination formulation of ensifentrine and glycopyrrolate for the
treatment of COPD and the planned development and potential of
ensifentrine in the treatment of non-cystic fibrosis bronchiectasis
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
remaining $130 million funding we expect to become available under
the debt facility and from cash receipts from UK tax credits, and
the sufficiency of our 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 fund our operations.
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.
Verona Pharma plc
Consolidated Financial
Summary
(unaudited)
(in thousands, except per share
amounts)
|
|
Three months ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Operating expenses |
|
|
|
|
Research
and development |
|
$ |
2,958 |
|
|
$ |
9,838 |
|
Selling,
general and administrative |
|
|
13,353 |
|
|
|
5,290 |
|
Total operating expenses |
|
|
16,311 |
|
|
|
15,128 |
|
Operating loss |
|
|
(16,311) |
|
|
|
(15,128) |
|
Other income/(expense) |
|
|
|
|
Research
and development tax credit |
|
|
(309) |
|
|
|
2,127 |
|
Interest
income |
|
|
3,390 |
|
|
|
779 |
|
Interest
expense |
|
|
(401) |
|
|
|
(116) |
|
Foreign
exchange (loss)/gain |
|
|
(1,012) |
|
|
|
(3,245) |
|
Total other income/(expense), net |
|
|
1,668 |
|
|
|
(455) |
|
Loss before income taxes |
|
|
(14,643) |
|
|
|
(15,583) |
|
Income
tax expense |
|
|
(44) |
|
|
|
(64) |
|
Net loss |
|
$ |
(14,687) |
|
|
$ |
(15,647) |
|
|
|
|
|
|
Weighted-average shares outstanding – basic and diluted |
|
|
638,239 |
|
|
|
544,134 |
|
Loss per
ordinary share – basic and diluted |
|
$ |
(0.02) |
|
|
$ |
(0.03) |
|
|
|
Sep-30 |
|
Jun-30 |
|
|
|
2023 |
|
|
|
2023 |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
257,366 |
|
|
$ |
270,727 |
|
Total
assets |
|
$ |
292,470 |
|
|
$ |
303,929 |
|
Shareholders’ equity |
|
$ |
263,533 |
|
|
$ |
273,093 |
|
|
|
|
|
|
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