Full Press Release Details
Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
Positive Phase 2 results with pMDI ensifentrine
Enrollment ongoing in ENHANCE Phase 3
Up to $30 million debt finance facility
increases financial flexibility
Conference call today at 9:00 a.m. EST
LONDON and RALEIGH, N.C., February 25,
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 fourth quarter and full year
ended December 31, 2020, and provides a corporate update.
"2020 was a transformative year for
Verona Pharma," said David Zaccardelli, Pharm. D., President and Chief Executive Officer. "We started the year with
positive data from a Phase 2b trial where nebulized ensifentrine demonstrated clinically meaningful improvements in lung function
and quality of life measures when added-on to single bronchodilator therapy. In May, we received End-of-Phase 2 guidance from the
U.S. Food and Drug Administration on the design of our Phase 3 ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy")
clinical development program and, in September, we began enrollment. This progress was made possible by strong support from the
investment community through our $200 million private placement completed in July.
"2021 is already off to a great start
with the recently announced positive Phase 2 clinical results with the pMDI formulation of ensifentrine in moderate to severe COPD
patients. We anticipate top-line data from the pilot COVID-19 study of ensifentrine in the second quarter of 2021. In addition,
patient enrollment in the ENHANCE program is ongoing and we expect to complete enrollment in both studies in the second half of
2021. Based on our recruitment projections, top-line data from ENHANCE-2 is expected in the first half of 2022 and from ENHANCE-1
in the second half of 2022."
Quarter and Recent Highlights
Upcoming Key Milestones
The Company's near-term milestones
Fourth Quarter and Full Year 2020 Financial
Call and Webcast Information
Verona Pharma will host an investment community
conference call at 9:00 a.m. EST/2:00 p.m. GMT on Thursday, February 25, 2021 to discuss the fourth quarter and full year 2020 financial results and the corporate
Analysts and investors may participate
by dialing one of the following numbers and reference conference number: 7681320:
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 fourth quarter and full year 2020 results 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 currently in Phase 2 development for the treatment of COPD: dry powder inhaler ("DPI") and pressurized metered-dose
inhaler ("pMDI"). Ensifentrine is being evaluated in a pilot clinical study in patients hospitalized with COVID-19
and has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.
To help protect the health and safety
of the patients, caregivers and healthcare professionals involved in its ongoing clinical trials of ensifentrine, 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 practice (GCP). The Company continues to review
this guidance and the effect of the COVID-19 pandemic on its operations and clinical trials and will provide an update if it
becomes aware of any meaningful disruption caused by the pandemic to its clinical trials.
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, operational review,
outlook and financial review contain 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 a first-in-class phosphodiesterase
3 and 4 inhibitor and 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, COVID-19, 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 Term
Loan 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 novel coronavirus (COVID-19), 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