Category: RNS

$40 million upfront including $25 million cash and $15 million in equity in Nuance Biotech (parent company)

Up to $179 million in potential clinical, regulatory, and commercial milestone payments plus tiered double-digit royalties

Nuance Pharma is responsible for all costs related to development and commercialization of ensifentrine in China

LONDON and RALEIGH, N.C. and SHANGHAI, China, June 10, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) and Nuance Pharma Limited (“Nuance Pharma”), today announce that the companies have entered into an agreement granting Nuance Pharma, a Shanghai-based specialty pharmaceutical company, the rights to develop and commercialize ensifentrine in Greater China (mainland China, Taiwan, Hong Kong and Macau). Ensifentrine 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. Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”), with sites in the US, Europe and South Korea.

“We are extremely excited about the formation of this strategic partnership with Nuance Pharma to further the development and future commercialization of ensifentrine in Greater China,” said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. “Nuance Pharma’s highly talented leadership team has deep experience developing and commercializing respiratory products across China and we look forward to working with them to bring ensifentrine to this important market.”

“Ensifentrine is an ideal fit for Nuance Pharma’s portfolio, given our focus on developing and commercializing innovative products for the Chinese market,” commented Mark G. Lotter, CEO and Co-Founder of Nuance Biotech. “With proven expertise in developing and commercializing global brands, including many leading respiratory products, I have confidence in the Nuance Pharma team’s ability to develop and commercialize ensifentrine in Greater China.”

Under the terms of the agreement, Verona Pharma has granted Nuance Pharma the exclusive rights to develop and commercialize ensifentrine in Greater China. In return, Verona Pharma will receive an upfront payment of $25 million in cash and an equity interest currently valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma. Verona Pharma is eligible to receive future milestone payments of up to $179 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones. Verona Pharma is also entitled to tiered double-digit royalties as a percentage of net sales in Greater China.

Nuance Pharma will be responsible for all costs related to clinical development and commercialization in Greater China. A joint steering committee will be established to ensure ensifentrine’s clinical development in the region aligns with Verona Pharma’s overall global development and commercialization strategy. Nuance Pharma intends to file a Clinical Trial Application with the China Food and Drug Administration later this year and begin clinical studies for the treatment of COPD in Greater China thereafter.

For further information please contact:

About Ensifentrine

Ensifentrine (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.

Ensifentrine has demonstrated 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.

About Verona Pharma

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.

About Nuance Pharma

Nuance Pharma is a Shanghai-based late clinical-stage biopharmaceutical company focused on licensing, developing and commercializing globally innovative therapies with the mission of addressing critical unmet medical needs in China and other emerging Asia Pacific markets. Its world-class clinical and regulatory teams, visionary approach to business development and integrated commercial platforms enable Nuance Pharma to continuously accelerate the access of innovative treatments to patients. Since its inception in 2014, Nuance Pharma has assembled a portfolio of promising clinical-stage drug candidates for respiratory, pain and iron deficiency anemia. The company has targeted these therapeutic areas based on the severity of the unmet medical needs, the size of the at-risk patient population, and the emergence of innovative products worldwide.

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 milestone payments, royalties and other financial terms of the collaboration agreement with Nuance Pharma, our and Nuance Pharma’s ability to bring ensifentrine to market in China, the timing of Nuance Pharma filing a Clinical Trial Application with the China Food and Drug Administration and beginning clinical studies for the treatment of COPD in China, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases.

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 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.

 

LONDON and RALEIGH, N.C., May 25, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Chief Executive Officer and President, will present a company overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 9:00 AM ET.

A webcast of the event will be available for 90 days on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com.

About Verona Pharma

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.

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. 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. 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.

Posters highlight ensifentrine’s safety profile and its potential to improve lung function and quality of life irrespective of COPD severity

LONDON and RALEIGH, N.C., May 04, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces three abstracts highlighting new analyses from Phase 2b clinical trials with nebulized ensifentrine in chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2021. The abstracts are published on the ATS website and in the peer reviewed publication, American Journal of Respiratory and Critical Care Medicine.

The abstracts include a new subgroup analysis evaluating the effect of ensifentrine by COPD severity from the 4-week Phase 2b study, first reported by Verona Pharma on January 13, 2020, with nebulized ensifentrine as a maintenance treatment for COPD. Nebulized ensifentrine added on to maintenance tiotropium (Spiriva^® Respimat^®), a long-acting muscarinic antagonist (“LAMA”) bronchodilator, demonstrated clinically and statistically significant dose-dependent improvements in lung function at all doses. In addition, ensifentrine showed significant and progressive improvements in quality of life.

The subgroup analysis demonstrated that ensifentrine showed similar improvement in lung function and quality of life in both severe and moderate COPD subgroups. Improvements in both subgroups were clinically meaningful after 4 weeks of treatment. In addition, health-related quality of life as measured by St. George’s Respiratory Questionnaire: COPD (“SGRQ-C”) improved in all patients regardless of COPD severity.

In a further safety subgroup analysis from the Phase 2b trial with nebulized ensifentrine added on to maintenance tiotropium, ensifentrine also demonstrated a gastrointestinal and cardiovascular safety profile similar to placebo.

In addition to the analysis by COPD severity, Verona Pharma will highlight consolidated safety data with nebulized ensifentrine in COPD from two 4-week Phase 2b trials, ensifentrine added on to maintenance tiotropium and a monotherapy study first reported on March 26, 2018. Ensifentrine demonstrated a cardiovascular safety profile similar to placebo with no evidence of any meaningful effect on vital signs, cardiac repolarization or other ECG parameters.

Details of Verona Pharma’s three abstracts are listed below with links to the ATS website.

Abstract: A2254 – Effect of Ensifentrine on Lung Function and Health-Related Quality of Life (QoL) by COPD Severity: Analysis from a Phase 2b Dose Ranging Study
Participant: Tara Rheault, Vice President of Research and Development
Session: TP40 – COPD Clinical Trials and Therapies

Abstract: A2255 – Safety of Dual PDE3/4 Inhibitor Ensifentrine Added to Tiotropium: Gastrointestinal and Cardiovascular Adverse Events from a Four-Week Randomized, Controlled Trial
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: TP40 – COPD Clinical Trials and Therapies

Abstract: A2256 – Cardiovascular Safety Profile of Ensifentrine in Patients with COPD: Results from Two Four-Week, Dose-Ranging, Randomized, Placebo-Controlled Trials
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: TP40 – COPD Clinical Trials and Therapies

For further information please contact:

About Ensifentrine

Ensifentrine (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.

Ensifentrine has demonstrated 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.

About Verona Pharma

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.

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 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, and 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.

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 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.

ENHANCE Phase 3 program enrollment continues on track to complete in 2H21

Board strengthened with NED appointment of Lisa Deschamps

Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST

LONDON and RALEIGH, N.C., April 29, 2021 (GLOBE NEWSWIRE) — 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 update.

“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 of 2022.

“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.”

First Quarter and Recent Highlights

Clinical

• In April 2021, Verona Pharma reported that results from the pilot study with pMDI ensifentrine showed 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 clinical efficacy benefit with ensifentrine added on to standard of care was observed. The Company does not currently plan to conduct further studies of ensifentrine in the treatment of COVID-19.
• In February 2021, Verona Pharma announced positive Phase 2 efficacy and safety data with pMDI ensifentrine in patients with moderate to severe COPD. The primary and secondary lung function endpoints were achieved and the data support further evaluation of twice-daily dosing. All three inhaled formulations have demonstrated statistically significant improvements in lung function in COPD patients, supporting the broad potential of ensifentrine delivered via nebulizers and handheld inhalers.

Corporate

• In March 2021, Ms. Lisa Deschamps joined the board as a Non-Executive Director. Ms. Deschamps is Senior Vice President, Chief Business Officer, of Novartis Gene Therapies. She has significant global and US experience in bringing respiratory and other specialized therapeutic area products to the market.

Upcoming Key Milestones

The Company’s near-term milestones include:

• Presenting three abstracts demonstrating positive safety, symptom and quality of life data from Phase 2b clinical studies with nebulized ensifentrine in COPD at the American Thoracic Society International Conference (“ATS”) here in May 2021.

• Based on recruitment projections, the Company expects to complete enrollment in both Phase 3 trials, ENHANCE-1 and ENHANCE-2, with the nebulized formulation of ensifentrine for the maintenance treatment of COPD in the second half of 2021. With the pandemic and government and other measures in response impacting a number of clinical trial activities, the Company continues to monitor these timelines.
• Longer term, based on forecasted recruitment and study progress, the Company expects to announce top-line data from ENHANCE-2 in the first half of 2022 and from ENHANCE-1 in the second half of 2022.

First Quarter 2021 Financial Results

• Cash position: Cash and cash equivalents at March 31, 2021, were $169.6 million (December 31, 2020: $188.0 million). The Company believes our cash and cash equivalents at March 31, 2021, together with funding expected to become available under the $30.0 million debt financing facility secured in November 2020 and from cash receipts from U.K. tax credits, will enable us to fund our planned operating expenses and capital expenditure requirements into 2023.
• R&D Expenses: Research and development (“R&D”) expenses were $13.6 million for the first quarter ended March 31, 2021 (Q1 2020: R&D expenses $7.6 million). The increase was primarily due to costs associated with the Phase 3 ENHANCE program as well an increase in share-based compensation charges.
• G&A Expenses: General and administrative expenses (“G&A”) were $9.3 million for the first quarter ended March 31, 2021 (Q1 2020: G&A expenses $6.9 million). This increase was driven by an increase in share-based compensation charges, partially offset by executive change costs in the prior period.
• Net loss: Net loss was $21.3 million for the first quarter ended March 31, 2021 (Q1 2020: net loss $12.3 million).

Conference 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:

• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 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 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:

About Verona Pharma

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.

COVID-19 Impact

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 practice (GCP).

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 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

Ensifentrine improves lung function and quality of life when added to maintenance tiotropium

LONDON and RALEIGH, N.C., April 27, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces publication of efficacy and safety results from a previously reported Phase 2b clinical trial with nebulized ensifentrine added on to maintenance bronchodilator therapy in symptomatic chronic obstructive pulmonary disease (“COPD”) patients. The study results were published in the leading peer reviewed journal, International Journal of Chronic Obstructive Pulmonary Disease.

The publication reports on results from the 4-week 416-patient study, first reported by Verona Pharma on January 13, 2020, where nebulized ensifentrine added on to maintenance tiotropium (Spiriva^® Respimat^®), a long-acting muscarinic antagonist (“LAMA”) bronchodilator, met the primary endpoint demonstrating clinically and statistically significant dose-dependent improvements in lung function at all doses. In addition, clinically relevant secondary endpoints were met including statistically significant and clinically meaningful improvements in quality of life compared to placebo added on to tiotropium over 4 weeks of treatment. Ensifentrine demonstrated a safety profile similar to placebo.

Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase (“PDE”) 3 and 4 that has been shown to act both as a bronchodilator and anti-inflammatory agent in a single compound.

The new publication is entitled “A dose-ranging study of the novel inhaled dual PDE 3 and 4 inhibitor ensifentrine in patients with COPD receiving maintenance tiotropium therapy” and is available here. Further information about this study can be found at www.clinicaltrials.gov, NCT03937479.

Gary T. Ferguson, MD, Director of the Pulmonary Research Institute of Southeast Michigan and Principal Investigator in the Phase 2b study that evaluated ensifentrine added on to tiotropium commented: “These data in symptomatic COPD patients on maintenance bronchodilator therapy, combined with ensifentrine’s unique mode of action, support its potential as a novel COPD therapy. The improvements in patient quality of life and lung function when added to tiotropium highlight the potential of this novel mechanism of action.”

For further information please contact:

About Ensifentrine

Ensifentrine (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.

Ensifentrine has demonstrated 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.

About Verona Pharma

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.

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 the development of ensifentrine, 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 activities in one compound, and 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.

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 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 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.

LONDON and RALEIGH, N.C., April 21, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will report its financial results for the three months ended March 31, 2021 on Thursday, April 29, 2021 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update.

To participate, please dial one of the following numbers and reference conference ID 7429971:

• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 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.

For further information please contact:

About Verona Pharma

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.

 

LONDON and RALEIGH, N.C., March 02, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces, effective March 1, 2021, Ms. Lisa Deschamps has joined the board as a Non-Executive Director.

Ms. Deschamps is Senior Vice President, Chief Business Officer, of Novartis Gene Therapies (GTx) where she is responsible for strategic planning and worldwide commercialization of pipeline and in-market assets across the gene therapy portfolio. This includes managing significant revenue growth targets and profitability margins worldwide.

Prior to this role, Ms. Deschamps was the Head of the Global Neuroscience Franchise. During her 25-year career at Novartis, she has successfully brought small molecules, biologics and gene therapies from the clinic to commercialization. Throughout her tenure, Ms. Deschamps has gained significant global and US experience in bringing respiratory and other specialized therapeutic area products to the marketplace. In addition, she has extensive experience in the exploration of potential acquisition and partnering opportunities.

“We are delighted to welcome Lisa to the Board,” said Dr. David Ebsworth, Chairperson of Verona Pharma. “Her wealth of leadership, strategic and commercial expertise will be valuable as we progress ensifentrine through Phase 3 trials and prepare for commercialization.”

Ms. Deschamps serves on a number of commercial and development executive teams within the Novartis enterprise. She has an MBA in General Management from NYU Stern School of Business and a BBA in marketing from IONA College, Hagan School of Business.

For further information, please contact:

About Verona Pharma

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.

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. 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. 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.

LONDON and RALEIGH, N.C., March 01, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Chief Executive Officer and President, will present a company overview at the H.C. Wainwright Global Life Sciences Conference. The presentation will be available on-demand starting at 7:00 AM ET on Tuesday, March 9, 2021.

A webcast of the event will be available for 90 days on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com.

About Verona Pharma

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.

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. 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. 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.

 

Positive Phase 2 results with pMDI ensifentrine in COPD

Enrollment ongoing in ENHANCE Phase 3 program

 Up to $30 million debt finance facility increases financial flexibility

Conference call today at 9:00 a.m. EST / 2:00 p.m. GMT

LONDON and RALEIGH, N.C., Feb. 25, 2021 (GLOBE NEWSWIRE) — 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.”

Fourth Quarter and Recent Highlights

Clinical

• In February 2021, Verona Pharma announced positive Phase 2 efficacy and safety data with pMDI ensifentrine in patients with moderate to severe COPD. The primary and secondary lung function endpoints were achieved and the data support twice-daily dosing.
• In January 2021, the Company completed enrollment of 45 patients in its pilot clinical study evaluating the efficacy and safety of pMDI ensifentrine in U.S. patients hospitalized with COVID-19. Top-line results are expected in the second quarter of 2021.
• In October 2020, the Company presented favorable symptom and quality of life data from a Phase 2b clinical trial with nebulized ensifentrine in COPD at CHEST Annual Meeting 2020. The posters highlighted ensifentrine’s potential to provide rapid benefits to symptomatic patients.

Financial

• In November 2020, the Company entered into a debt financing facility for up to $30 million with Silicon Valley Bank. The non-dilutive capital provides further financial flexibility to support pre-commercialization activities for ensifentrine.
• In October 2020, Verona Pharma delisted from the AIM Market of the London Stock Exchange in an effort to enhance liquidity of trading by combining all transactions on the Nasdaq Global Market (“Nasdaq”) and to reduce costs through removing duplicative listing and compliance fees. The Company’s American Depositary Shares remain publicly traded on Nasdaq.

Upcoming Key Milestones

The Company’s near-term milestones include:

• Reporting top-line data from a pilot clinical study evaluating the pMDI formulation of ensifentrine in U.S. patients hospitalized with COVID-19 in the second quarter of 2021.
• Based on recruitment projections, the Company expects to complete enrollment in both Phase 3 trials, ENHANCE-1 and ENHANCE-2, with the nebulized formulation of ensifentrine for the maintenance treatment of COPD in the second half of 2021.
• Longer term, based on forecasted recruitment, the Company expects to announce top-line data from ENHANCE-2 in the first half of 2022 and ENHANCE-1 in the second half of 2022.

Fourth Quarter and Full Year 2020 Financial Results

• Cash position: Cash, cash equivalents and short term investments at December 31, 2020, were $188.0 million (December 31, 2019: $40.8 million). We believe our cash and cash equivalents at December 31, 2020, together with funding expected to become available under the $30.0 million debt financing facility secured in November and from cash receipts from U.K. tax credits, will enable us to fund our planned operating expenses and capital expenditure requirements into 2023.
• R&D Expenses: Research and development (“R&D”) expenses were $16.4 million for the fourth quarter ended December 31, 2020 (Q4 2019: $7.2 million) and $44.5 million for the year ended December 31, 2020 (full year 2019: $42.4 million). The increase of $2.1 million was primarily attributable to an increase in share-based compensation charges and salary and related costs as we expanded the clinical development team.
• G&A Expenses: General and administrative expenses (“G&A”) were $11.3 million for the fourth quarter ended December 31, 2020 (Q4 2019: G&A expenses $2.3 million) and $29.8 million for the year ended December 31, 2020 (full year 2019: G&A expenses $10.0 million), an increase of $19.8 million. This increase was primarily due to share-based compensation charges, severance costs, salaries, higher Director and Officers insurance premiums and costs related to the private placement.
• Net loss: Net loss was $24.8 million for the fourth quarter ended December 31, 2020 (Q4 2019: net loss $9.5 million) and $65.1 million for the year ended December 31, 2020 (full year 2019: net loss $40.6 million).

Conference 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 update.

Analysts and investors may participate by dialing one of the following numbers and reference conference number: 7681320:

• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 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 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:

About Verona Pharma

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.

COVID-19 Impact

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 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 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

LONDON and RALEIGH, N.C., Feb. 18, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will report its financial results for the fourth quarter and full year ended December 31, 2020 on Thursday, February 25, 2021 and host an investment community conference call at 9:00 a.m. EST / 2:00 p.m. GMT to discuss these financial results and provide a corporate update.

To participate, please dial one of the following numbers and reference conference ID 7681320:

• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 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 an audio replay will be available there for 90 days.

For further information, please contact:

About Verona Pharma

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. The Company raised gross proceeds of $200 million through a private placement in July 2020 and expects the funds to support its operations and Phase 3 clinical program into 2023. 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.