Full Press Release Details
Verona Pharma Reports First Quarter 2021 Financial
Results and Provides Corporate Update
ENHANCE Phase 3 program enrollment continues
on track to complete in 2H21
Board strengthened with NED appointment of Lisa
Conference call today at 9:00 a.m. EDT / 2:00
LONDON and RALEIGH, N.C., April 29, 2021
- 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 three months ended March 31, 2021, and provides a corporate
"The first quarter of 2021 set a positive
tone for what we expect to be another exciting year of substantial progress for Verona Pharma," said David Zaccardelli, Pharm. D.,
President and Chief Executive Officer. "Patient recruitment is ongoing in our Phase 3 ENHANCE ("Ensifentrine as a Novel inHAled
Nebulized COPD thErapy") clinical program. Based on our projections, we continue to expect to complete enrollment in both studies
in the second half of 2021 and to report top-line data from ENHANCE-2 in the first half of 2022 and from ENHANCE-1 in the second half
"We have already reported results from two
clinical studies this year. In February, we reported positive Phase 2 results with the pressurized metered-dose inhaler ("pMDI")
formulation of ensifentrine in moderate to severe COPD patients, and, last week, we reported that data from a pilot study with pMDI ensifentrine
showed that ensifentrine added on to standard of care was well tolerated in patients hospitalized with COVID-19. The study was not powered
to identify statistically significant efficacy outcomes and no benefit with ensifentrine added on to standard of care was observed.
In addition to this clinical progress, we strengthened
our board with the Non-Executive Director appointment of Lisa Deschamps, Senior Vice President, Chief Business Officer, Novartis Gene
Therapies. Lisa's strategic and commercial expertise will be valuable as we progress ensifentrine through Phase 3 trials and prepare
for commercialization."
Quarter and Recent Highlights
Upcoming Key Milestones
The Company's near-term milestones include:
First Quarter 2021 Financial Results
Call and Webcast Information
Verona Pharma will host an investment
community conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, April 29, 2021 to discuss the first quarter 2021
financial results and the corporate update.
Analysts and investors may participate by dialing
one of the following numbers and reference conference ID 7429971:
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 an audio replay will be
available there for 30 days. An electronic copy of the first quarter 2021 results press release will also be made available today on
the Company's website. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of
the Company's securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
For further information please contact:
| Verona Pharma plc | US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200 |
| Victoria Stewart, Director of Communications | info@veronapharma.com |
| Argot Partners (US Investor Enquiries) | Tel: +1-212-600-1902 verona@argotpartners.com |
| Kimberly Minarovich / Michael Barron | |
| Optimum Strategic Communications (International Media and European Investor Enquiries) | Tel: +44 (0)203 950 9144 verona@optimumcomms.com |
| Mary Clark / Eva Haas / Shabnam Bashir |
Verona Pharma is a clinical-stage biopharmaceutical
company focused on developing and commercializing 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 diseases that combines bronchodilator and anti-inflammatory activities in one compound.
The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized
COPD thErapy") for COPD maintenance treatment. Two additional formulations of ensifentrine are in Phase 2 development 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.
Verona Pharma is closely monitoring the potential
impact of the COVID-19 pandemic on its operations and clinical trials, in particular the timelines and costs of its Phase 3 ENHANCE clinical
program. The pandemic and government and other measures in response are impacting a number of clinical trial activities and the Company
will provide an update if it becomes aware of any meaningful disruption caused by the pandemic to its clinical trials.
To help protect the health and safety of the patients,
caregivers and healthcare professionals involved in its clinical trials, as well as its employees and independent contractors, the Company
continues to follow guidance from the FDA and other health regulatory authorities regarding the conduct of clinical trials during the
COVID-19 pandemic to ensure the safety of study participants, minimize risks to study integrity, and maintain compliance with good clinical
Verona Pharma is closely monitoring
activities at the Company's contract manufacturers associated with clinical supply for the ongoing clinical trials, and is
satisfied that appropriate plans and procedures are in place to ensure uninterrupted future supply of ensifentrine to the clinical
trial sites, subject to potential limitations on their operations and on the supply chain due to the COVID-19 pandemic. The Company
is continuing to monitor this situation and will provide an update if it becomes aware of any meaningful disruption caused by the
pandemic to the clinical supply of ensifentrine for its clinical trials.
Verona Pharma has also implemented measures to
help keep the Company's employees, families, and local communities healthy and safe. All employees are working remotely and all
business travel has been restricted.
Forward-Looking Statements
This press release contains forward-looking statements.
All statements contained in this press release with respect to our operational review, outlook and financial review that do not relate
to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the
development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, the potential
for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects
in one compound, the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well
as the potential of the DPI and pMDI formulations of ensifentrine, the impact of the COVID-19 pandemic on our business and operations
and the Company's future financial results, the funding we expect to become available under the $30.0 million debt financing facility and from cash receipts
from U.K. tax credits, and the sufficiency of cash and cash equivalents.
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; potential delays in enrolling patients, which could adversely affect our research
and development efforts and the completion of our clinical trials; 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, and third-party service providers; 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; and lawsuits related to patents covering ensifentrine and the potential for our
patents to be found invalid or unenforceable; 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 and other unexpected
events, including health epidemics or pandemics like the COVID-19 pandemic, 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, 2020, 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