Full Press Release Details
Completes Enrollment in
ENHANCE-1 48-week Subset
Complete with Full Enrollment Expected in January 2022
3 Program on Track to Report Top-line Data in 2022
N.C., January 5, 2022 - Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a
clinical-stage biopharmaceutical company focused on respiratory diseases, announces enrollment completed in the 48-week subset of the
ENHANCE-1 trial in December 2021. The ENHANCE-2 trial has completed screening with 788 subjects randomized as of January 4,
2022, and full enrollment is expected by the end of January 2022. The Phase 3 ENHANCE ("Ensifentrine as a Novel inHAled Nebulized
COPD thErapy") program is evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease
a significant milestone for Verona Pharma on our path to delivering ensifentrine to COPD patients," said David Zaccardelli, Pharm.D.,
President and Chief Executive Officer. "The fully enrolled 48-week subset of ENHANCE-1 is a critical driver of delivering top-line
data and we expect to complete enrollment of the 24-week subset of the ENHANCE-1 trial in the second quarter of 2022.
predict top-line data from ENHANCE-2 are expected in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. Conditional
upon positive results, the Company intends to file a New Drug Application ("NDA") with the US Food & Drug Administration
("FDA") in the first half of 2023. We look forward to reporting top-line data this year and working with the regulatory authorities
to bring our first-in-class product candidate to the millions of COPD patients worldwide who remain symptomatic."
not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2021, the Company expects to
report it had approximately $148.4 million in cash and cash equivalents as of December 31, 2021 (December 31, 2020: $188.0
million). Verona believes its cash and cash equivalents at December 31, 2021, expected cash receipts from the U.K. tax credit program
and funding expected to be available under the $30.0 million financing facility secured in November 2020, will enable the Company
to fund its planned operating expenses and capital expenditure requirements through at least the end of 2023.
a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies
in patients with COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality
of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving
more than 1,300 subjects to date.
About the ENHANCE program
double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) will evaluate the efficacy and safety of nebulized ensifentrine as
monotherapy and added onto a single bronchodilator, either a LAMA ("long acting muscarinic antagonist") or a LABA ("long
acting beta-agonist"), compared to placebo. The two study designs will replicate measurements of efficacy and safety data over
24 weeks and ENHANCE-1 will also evaluate longer-term safety over 48 weeks.
Further information about this study
can be found at www.clinicaltrials.gov, NCT04535986 (ENHANCE-1) and NCT04542057 (ENHANCE-2).
Forced Expiratory Volume in one second, a standard measure of lung function
For further information
| Verona Pharma plc | US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200 |
| Victoria Stewart, Director of Investor Relations and 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)203 882 9621 verona@optimumcomms.com |
| Mary Clark / Stella Lempidaki / Zoe Bolt |
(RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3"
and "PDE4"). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound.
Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator ("CFTR"), which is beneficial in reducing
mucous viscosity and improving mucociliary clearance. Ensifentrine's mechanism of action has the potential to alleviate respiratory
symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses.
has demonstrated statistically significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness,
in Verona Pharma's Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease ("COPD").
In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short-
and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well
tolerated in clinical trials involving more than 1,300 subjects to date.
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
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 continue to impact 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.
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 practice (GCP).
The COVID-19 pandemic
is disrupting supply chains, and employee retention and recruitment, globally and the Company is closely monitoring this situation and
will provide an update if it becomes aware of any meaningful disruption caused by the pandemic to the supply of ensifentrine and drug-related
products, equipment and services for its clinical trials.
Financial Disclosure Advisory
The expected financial
results discussed in this press release are unaudited and preliminary and do not present all information necessary for an understanding
of the Company's financial condition as of December 31, 2021 and its results of operations for the three months and year ended
December 31, 2021. The audit of the Company's financial statements for the year ended December 31, 2021, is ongoing and
could result in changes to the information set forth herein.
Forward-Looking Statements
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 assumptions underlying the Company's models on clinical trial recruitment and progress, including
the potential impact of the COVID-19 pandemic on such progress and on our business and operations and the Company's future financial
results, planned regulatory submissions and timing thereof, 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, expected 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, 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