Category: RNS

LONDON and RALEIGH, N.C., July 20, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will report its financial results for the second quarter ended June 30, 2023 on Thursday, August 3, 2023 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 ask to join the Verona Pharma call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

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

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 chronic 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 non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the second quarter of 2023, Verona Pharma submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ensifentrine for the maintenance treatment of patients with COPD. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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.

Ensifentrine improved lung function, symptoms and quality of life and reduced exacerbations in data published in high impact peer reviewed journal

LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).

The publication reports results from Verona Pharma’s successful ENHANCE trials demonstrating improvements with ensifentrine in lung function, symptoms and quality of life measures, as well as a substantial reduction in the rate and risk of COPD exacerbations and a favourable safety profile. The manuscript, entitled ‘Ensifentrine, a Novel PDE3 and PDE4 Inhibitor for the Treatment of COPD: Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Trials (The ENHANCE Trials)’, is available online here and will be published in an upcoming issue of AJRCCM. It follows announcements of top-line data from the ENHANCE-1 and ENHANCE-2 trials in December and August 2022, respectively.

Data from the ENHANCE program formed the basis of Verona Pharma’s New Drug Application (“NDA”), which was submitted in June 2023 to the US Food and Drug Administration (“FDA”) for the approval of ensifentrine for the maintenance treatment of patients with COPD.

Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years.

“Despite available treatment regimens, millions of patients with COPD continue to struggle with debilitating, uncontrolled symptoms from this progressive condition and physicians are looking to novel treatment options to improve patient outcomes,” said Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System. “The ENHANCE trials demonstrate ensifentrine’s outstanding ability to reduce the rate and risk of COPD exacerbations and to provide meaningful improvements in lung function and symptoms in a broad COPD population. I believe ensifentrine, with its novel bronchodilator and non-steroidal anti-inflammatory activity, has the potential to change the treatment paradigm for COPD patients.”

About the ENHANCE program

The two randomized, double-blind, placebo-controlled trials (ENHANCE-1 and ENHANCE-2) evaluated the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and approximately 20% of subjects received inhaled corticosteroids with their long-acting bronchodilator. The two trials replicated measurements of efficacy and safety data over 24 weeks and ENHANCE-1 also evaluated long-term safety and exacerbations over 48 weeks.

• Patient Population: ENHANCE-1 and ENHANCE-2 trials included 763 and 790 moderate to severe, symptomatic, COPD subjects, respectively, at sites primarily in North America and Europe.
• Dose/Duration: Subjects were randomized to receive a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks in ENHANCE-2 and 24 or 48 weeks in ENHANCE-1.
• Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV₁ AUC 0-12 hours post dose at week 12.
• Secondary and Other Endpoints: Lung function endpoints including peak and morning trough FEV₁, COPD symptoms and health-related quality of life through 24 weeks via SGRQ and E-RS questionnaires, and exacerbation rate and risk over 24 weeks and in the 48 week subset of ENHANCE-1.
• Safety: Assessed over 24 weeks in both trials and over 48 weeks in 370 subjects in ENHANCE-1.

For further information please contact:

About the American Journal of Respiratory and Critical Care Medicine

The American Journal of Respiratory and Critical Care Medicine, also known as the “Blue Journal”, is a leading peer reviewed journal published by the American Thoracic Society. The publication focuses on human biology and disease, as well as animal and in vitro studies that contribute to the understanding of pathophysiology and treatment of diseases that affect the respiratory system and critically ill patients.

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In the Phase 3 ENHANCE-1 and ENHANCE-2 clinical trials, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 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 chronic 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 non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the second quarter of 2023, Verona Pharma submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ensifentrine for the maintenance treatment of patients with COPD. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in 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 potential for ensifentrine to be the first novel mechanism available for the treatment of COPD in over 10 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, and the potential to change the treatment paradigm for COPD patients, the ability of ensifentrine to reduce the rate and risk of COPD exacerbations and to provide meaningful improvements in lung function and symptoms in a broad COPD population, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

LONDON and RALEIGH, N.C., June 27, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces the submission of a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”).

Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in over 10 years.

“Millions of symptomatic COPD patients in the US are in urgent need of new treatment options,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “The NDA submission for ensifentrine is a significant milestone towards our goal of bringing this potential first-in-class therapy to COPD patients and we look forward to working with the FDA during their review.”

The NDA contains data from the positive Phase 3 ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.

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 chronic 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 non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the second quarter of 2023, Verona Pharma submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ensifentrine for the maintenance treatment of patients with COPD. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 potential for ensifentrine to be the first novel mechanism available for the treatment of COPD in over 10 years and the first non-steroidal therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory benefits in one compound, the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

LONDON and RALEIGH, N.C., May 24, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces that senior management will present a company overview at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:00 AM EDT / 1:00 PM BST.

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

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Verona Pharma expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the second quarter of 2023. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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.

NDA submission on schedule for Q2 2023

12 abstracts and one symposium expanding on successful Phase 3 ENHANCE data to be presented at American Thoracic Society 2023

Strong balance sheet to support commercial launch preparations

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

LONDON and RALEIGH, N.C., May 09, 2023 (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 first quarter ended March 31, 2023, and provides a corporate update.

“We recently had a pre-New Drug Application (“NDA”) meeting with the US Food and Drug Administration (“FDA”) and are on schedule to submit the NDA in the second quarter of 2023,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We believe we are aligned on the content of the NDA for ensifentrine for the maintenance treatment of Chronic Obstructive Pulmonary Disease (“COPD”), which will comprise data from the successful Phase 3 ENHANCE studies and other completed ensifentrine clinical studies including data from approximately 3,000 subjects.

“As announced earlier this month, we are looking forward to presenting additional analyses from the ENHANCE studies at the American Thoracic Society International Conference (“ATS”) taking place May 19-24. We will present 12 abstracts and a clinical trials symposium on subgroup data and pooled analyses from ENHANCE-1 and ENHANCE-2 covering exacerbations, symptoms, quality of life, use of rescue medication, healthcare utilization and safety. An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. We will be hosting a webcast and conference call on Tuesday, May 23, to discuss these data.

“Alongside our progress, Nuance Pharma, our development partner in Greater China, enrolled the first subject in its Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China. This is a significant milestone and we are excited about the potential of ensifentrine to address the urgent global need for a novel therapy for COPD. We look forward to updating you on their progress.”

Program Updates and Key Milestones

The Company’s near-term planned milestones include:

• Presentation of 12 abstracts and one symposium demonstrating positive efficacy, symptom, quality of life and safety data from the ENHANCE Phase 3 clinical studies with nebulized ensifentrine in COPD at ATS in May 2023. The Company is holding an investment community webcast and conference call at 4:00 p.m. EDT / 9:00 p.m. BST on Tuesday, May 23, 2023, to discuss these data. To participate, please dial one of the following numbers and ask to join the Verona Pharma call:
  •   +1-833-816-1396 for callers in the United States
  •   +1-412-317-0489 for international callers

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

• Submission of an NDA to the US FDA in the second quarter of 2023 for inhaled ensifentrine for the maintenance treatment of patients with COPD.

First Quarter and Recent Highlights

Corporate

• In April 2023, the Company held a pre-NDA meeting with the FDA. The submission, comprising data from the Phase 3 ENHANCE studies and other completed ensifentrine clinical studies including data from approximately 3,000 subjects, is on schedule for the second quarter of 2023.
• Also in April 2023, the Company’s development partner in Greater China, Nuance Pharma, enrolled the first subject in its pivotal Phase 3 clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. In 2021, Verona Pharma entered into an agreement with Nuance Pharma for exclusive rights to develop and commercialize ensifentrine in Greater China, with future potential milestone payments up to $179 million plus royalties.

First Quarter 2023 Financial Results

• Cash position: Cash and cash equivalents at March 31, 2023, were $291.4 million (December 31, 2022: $227.8 million). The Company believes cash and cash equivalents at March 31, 2023, expected cash receipts from the UK tax credit program and funding expected to become available under the $150.0 million debt facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2025 including the commercial launch of ensifentrine in the US, if approved.
• R&D Expenses: Research and development (“R&D”) expenses were $12.6 million for the first quarter ended March 31, 2023 (Q1 2022: $17.6 million). This decrease was primarily due to a $5.1 million decrease in clinical trial and other development costs as the Phase 3 ENHANCE program is in the final stages of completing data analysis whereas in the same period in the prior year significant costs were occurred associated with active enrollment.
• SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $9.6 million for the first quarter ended March 31, 2023 (Q1 2022: $7.4 million). This increase was primarily due to a $2.7 million increase in people related costs, inclusive of share-based compensation, as well as an increase of $0.8 million for costs related to the build out of commercial infrastructure in preparation for a potential commercial launch. The increases were partially offset by a non-recurring $2.0 million charge related to the modification of the assignment and license agreement with Ligand UK Development Limited, which was incurred in the three months ended March 31, 2022.
• Net loss: Net loss was $16.7 million for the first quarter ended March 31, 2023 (Q1 2022: net loss $24.8 million).

Conference Call and Webcast Information

Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Tuesday, May 9, 2023, to discuss the first quarter 2023 financial results and the corporate update.

To participate, please dial one of the following numbers and ask to be placed into the Verona Pharma first quarter earnings call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the first quarter 2023 results press release will also be made available today on the Company’s website.

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 our operational review, outlook and financial review, the development of ensifentrine and plans to release data from the ENHANCE trials at future scientific conferences, upcoming events and presentations, planned regulatory submissions and timing thereof, including the timing of submission of an NDA for ensifentrine and our expectations regarding the content of the submission, the planned US commercial launch of ensifentrine, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine, ensifentrine’s compelling benefit risk profile, the funding we expect to become available under the $150.0 million debt financing facility and from cash receipts from UK tax credits, and the sufficiency of cash and cash equivalents, and the cash runway period provided by the sources of financing through to at least the end of 2025 and expected to fully fund the planned commercial launch.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Verona Pharma plc
Consolidated Financial Summary
(unaudited)
(in thousands, except per share amounts)

 

12 Abstracts and one Symposium further support potential of ensifentrine,
a first-in-class, selective, dual inhibitor of PDE3 and PDE4

Conference call May 23 at 4:00 p.m. EDT / 9:00 p.m. BST

LONDON and RALEIGH, N.C., May 02, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces 12 abstracts, including a mini symposium, and a clinical trials symposium, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2023. An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium ‘Breaking News: Clinical Trial Results in Pulmonary Medicine’ reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. Verona Pharma will host a webcast and conference call on Tuesday, May 23, 2023, to review these data.

The abstracts include subgroup data and pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively, covering exacerbations, use of rescue medication and healthcare utilization. Abstracts highlight reductions in the rate and risk of exacerbations with ensifentrine in pooled sub-group analyses of ENHANCE-1 and ENHANCE-2 and a mini symposium discussing the improvements in lung function and reductions in exacerbation rate and risk demonstrated in ENHANCE-2.

Antonio Anzueto, MD, Professor of Medicine and Section, Chief of Pulmonary at South Texas Veterans Healthcare System, commented: “These additional analyses from the ENHANCE studies further demonstrate ensifentrine’s potential to become a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD. The reduction in the rate and risk of exacerbations across subgroups is exciting. Combined with the significant improvements in lung function, symptom and quality of life measures, as well as the favorable safety profile, these data confirm ensifentrine’s potential to change the treatment paradigm for COPD patients.”

David Zaccardelli, Pharm. D., Verona Pharma’s President and Chief Executive Officer, said: “We are looking forward to providing additional analyses of the positive results from the Phase 3 ENHANCE trials that highlight key areas of interest for physicians. These data further support the potential for ensifentrine to provide a much needed treatment for the millions of symptomatic COPD patients.”

Conference Call and Webcast Information

Verona Pharma will host an investment community webcast and conference call at 4:00 p.m. EDT / 9:00 p.m. BST on Tuesday, May 23, 2023, to discuss the Phase 3 ENHANCE data presented at ATS 2023.

To participate, please dial one of the following numbers and ask to be placed into the Verona Pharma investor call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

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

Details of Verona Pharma’s abstracts and the symposia are listed below and linked to the ATS website.

Clinical Trials Symposium: Effect of Ensifentrine, a novel PDE3 and PDE4 inhibitor, on lung function, symptoms and exacerbations in patients with COPD: The ENHANCE Trials
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: B13 – Breaking News: Clinical Trial Results in Pulmonary Medicine

Mini Symposium: Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function and Reduces Exacerbation Rate and Risk in Phase 3 ENHANCE-2 Trial
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: C15 – Emerging COPD Diagnostics and Treatments

Abstract: P101 – Twice-daily, Nebulized Ensifentrine Produced Significant Improvement in Week 12 Lung Function: Subgroup Analysis in the Phase 3 Trial ENHANCE-2
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: B22 – New Treatments and Novel Targets for COPD and Alpha-1

Abstract: P102 – Ensifentrine Reduced Healthcare Resource Utilization in Subjects With COPD: Results From ENHANCE-2, a Phase 3 Trial of Ensifentrine, a Dual PDE3/4 Inhibitor
Participant: Igor Barjaktarevic, MD, Medical Director, COPD Program, UCLA Division of Pulmonary & Critical Care Medicine
Session: B22 – New Treatments and Novel Targets for COPD and Alpha-1

Abstract: P166 – Treatment With Ensifentrine, a Dual PDE3 and PDE4 Inhibitor, Significantly Reduced Exacerbation Rate and Risk in Subjects With COPD: Sub-group Results from the Phase 3 Trial, ENHANCE-2
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P167 – Ensifentrine, a Dual Inhibitor of PDE3 and PDE4, Reduces the Risk of Exacerbation Regardless of Background Medication Use: A Sub-group Analysis of ENHANCE-2, a Phase 3 Trial
Participant: Gary T. Ferguson, MD, Director of the Pulmonary Research Institute of Southeast Michigan
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P168 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, in Moderate and Severe COPD: Symptoms, Quality of Life and Health Status From the Phase 3 Trial ENHANCE-2
Participant: Tara Rheault, Senior Vice President, R&D, Verona Pharma
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P171 – Safety Results From Dual PDE3/4 Inhibitor Ensifentrine: Gastrointestinal and Cardiovascular Safety From a 24-week Phase 3 Trial, ENHANCE-2
Participant: Thomas Siler, MD, President at Midwest Chest Consultants
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P172 – Twice-daily, Nebulized Ensifentrine Significantly Improves Lung Function: Sub-group Analysis in the Phase 3 Trial, ENHANCE-1
Participant: Thomas Siler, MD, President at Midwest Chest Consultants
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P173 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function, Symptoms, Quality of Life and Reduces Exacerbation Rate and Risk in Patients With COPD: Results From Replicate Phase 3 Trials
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P174 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function, Symptoms, Quality of Life and Reduces Exacerbation Rate and Risk in the ENHANCE-1 Phase 3 Trial of Ensifentrine in COPD
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P175 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Significantly Improves COPD Symptoms and Quality of Life in the Phase 3 ENHANCE-1 Trial
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P176 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Significantly Reduces Annualized Exacerbations and Delays the Time to First Exacerbation in COPD: Pooled Sub-Group Analyses of ENHANCE-1 and ENHANCE-2 Phase 3 Trials
Participant: Igor Barjaktarevic, MD, Medical Director, COPD Program, UCLA Division of Pulmonary & Critical Care Medicine
Session: C40 – Clinical Trials and Novel Interventions in COPD

For further information please contact:

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In Phase 2 clinical studies in 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. In the Phase 3 ENHANCE-1 and ENHANCE-2 clinical trials, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Verona Pharma expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the second quarter of 2023. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 plans to release data from the ENHANCE trials at ATS 2023, planned regulatory submissions and timing thereof, including the timing of submission of an NDA for ensifentrine, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets, including the US; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events may adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, 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 25, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will report its financial results for the first quarter ended March 31, 2023 on Tuesday, May 9, 2023 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 ask to join the Verona Pharma call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

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

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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.

LONDON and RALEIGH, N.C., April 10, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its development partner, Nuance Pharma, has dosed the first subject in its ENHANCE – China Phase 3 trial for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).

In August 2022, Nuance Pharma received clearance from the Center of Drug Evaluation (“CDE”) for its Investigational New Drug (“IND”) application to conduct both Phase 1 and Phase 3 studies with ensifentrine for the maintenance treatment of COPD in mainland China. Nuance Pharma initiated a Phase 1 trial with ensifentrine in healthy volunteers in March 2023.

“We are pleased our development partner, Nuance Pharma, has begun pivotal studies in COPD with ensifentrine in mainland China,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “This is a significant milestone and, based on our recent highly positive Phase 3 results in COPD, we are excited about the potential of ensifentrine to address the urgent global need for a novel therapy for COPD.”

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for exclusive rights to develop and commercialize ensifentrine in Greater China, with future potential milestone payments up to $179 million plus royalties.

Further information about these trials can be found at www.clinicaltrials.gov, ENHANCE – China Phase 3 trial (RPL554 – CPC001; NCT05743075), Phase 1 trial (RPL554 – AHC001; NCT05758428).

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Verona Pharma expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the second quarter of 2023. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.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, planned regulatory submissions and timing thereof, including the timing of submission of an NDA for ensifentrine, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to address the urgent global need for a novel therapy for COPD, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

 

Transformational results in Phase 3 ENHANCE program for COPD

NDA submission expected Q2 2023

Strong balance sheet to support planned US commercial launch

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

LONDON and RALEIGH, N.C., March 07, 2023 (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, 2022, and provides a corporate update.

“2022 was a momentous year for Verona Pharma and most importantly for the millions of patients suffering from chronic obstructive pulmonary disease (“COPD”),” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Supported by the groundbreaking results from our Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trials, we believe ensifentrine, if approved, has the potential to change the treatment paradigm for COPD.

“With about 50% of patients experiencing symptoms for more than 24 days per month, physicians are in need of new and effective COPD therapies. The success of the ENHANCE trials advances us closer to providing ensifentrine to COPD patients, with its novel mechanism of action delivering bronchodilation and non-steroidal anti-inflammatory effects in one compound. The totality of data from clinical trials, in particular our top-line data from the ENHANCE program including improvements in lung function, symptoms and quality of life measures, and remarkable reduction in the rate and risk of COPD exacerbations, combined with ensifentrine’s favorable safety profile, support our belief in the pioneering potential of ensifentrine.

“Our clinical success enabled us to significantly strengthen our financial position through an upsized $150 million equity offering in August and a $150 million debt financing facility in October. We expect these funds to extend our cash runway through at least the end of 2025.

“Alongside our progress in 2022, our development partner Nuance Pharma received clearance from China’s Center for Drug Evaluation to begin Phase 1 and Phase 3 studies with ensifentrine for COPD in mainland China. Nuance Pharma are developing and commercializing ensifentrine in Greater China and we look forward to providing future updates.

“2023 is expected to be another pivotal year for Verona Pharma as we continue preparing for the planned commercial launch of ensifentrine in the US in 2024, if approved. We expect to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the second quarter of 2023 and to release additional information from the ENHANCE trials at upcoming scientific conferences.”

Program Updates and Key Milestones

The Company’s near-term milestones include:

• Submitting an NDA to the US FDA in the second quarter of 2023 for inhaled ensifentrine for the maintenance treatment of patients with COPD.

Fourth Quarter and Recent Highlights

Clinical

• In December 2022, the Company reported positive top-line Phase 3 data from its ENHANCE-1 trial. The trial successfully met its primary and key secondary endpoints demonstrating significant improvements in lung function, symptoms and quality of life measures. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated over 24 and 48 weeks.Pooled exacerbation data from ENHANCE-1 and ENHANCE-2 trials demonstrated that ensifentrine treatment resulted in a statistically significant 40% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to placebo. Additionally, ensifentrine significantly decreased the risk of a moderate/severe exacerbation by 41%.

Corporate

• In October 2022, the Company completed a $150 million debt financing facility with Oxford Finance. This replaced the $30 million facility with Silicon Valley Bank and is available upon achievement of certain clinical and regulatory milestones and other conditions.

Fourth Quarter 2022 Financial Results

• Cash position: Cash and cash equivalents at December 31, 2022, were $227.8 million (December 31, 2021: $148.4 million). Between January 1, 2023 and March 3, 2023, the Company sold 2,540,173 ADS’s under its ATM facility receiving net proceeds of $56.9 million. After giving effect to these proceeds, our pro forma cash and equivalents at December 31, 2022, was $284.7 million. The Company believes cash and cash equivalents at December 31, 2022, the proceeds from the recent ATM sales, expected cash receipts from the UK tax credit program and funding expected to become available under the $150.0 million debt facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2025 including the commercial launch of ensifentrine in the US, if approved.
• R&D Expenses: Research and development (“R&D”) expenses were $6.8 million for the fourth quarter ended December 31, 2022 (Q4 2021: $22.7 million). This decrease of $15.9 million was primarily due to a $16.7 million decrease in clinical trial and other development costs as the Company progressed to the later stages of the Phase 3 ENHANCE program.
• SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $8.3 million for the fourth quarter ended December 31, 2022 (Q4 2021: $5.8 million). The increase of $2.5 million was primarily due to a $1.4 million increase in people-related costs and $0.5 million in commercial preparation costs.
• Net loss: Net loss was $10.5 million for the fourth quarter ended December 31, 2022 (Q4 2022: net loss $23.3 million).

Full Year 2022 Financial Results

• Revenue: Revenue of $0.5 million for the year ended December 31, 2022 is related to sales of clinical supply materials to Nuance (full year 2021: $40.0 million).
• R&D Expenses: R&D expenses were $49.3 million for the year ended December 31, 2022 (full year 2021: $79.4 million), a decrease of $30.1 million. This decrease was primarily driven by a decrease in clinical trial and other development costs of $27.9 million as the ENHANCE studies were nearing completion in 2022 and a $4.2 million decrease in share-based compensation charges.
• SG&A Expenses: SG&A expenses were $26.6 million for the year ended December 31, 2022 (full year 2021: $33.9 million), a decrease of $7.3 million. This decrease was driven primarily by a $7.1 million decrease in share-based compensation charges.
• Net loss: Net loss was $68.7 million for the year ended December 31, 2022 (full year 2021: $55.6 million).

Conference Call and Webcast Information

Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on Tuesday, March 7, 2023, to discuss the fourth quarter and full year 2022 financial results and the corporate update.

To participate, please dial one of the following numbers and ask to be placed into the Verona Pharma third quarter earnings call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the fourth quarter and full year 2022 results press release will also be made available today on the Company’s website.

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 our operational review, outlook and financial review, the development of ensifentrine and plans to release data from the ENHANCE trials at future scientific conferences, planned regulatory submissions and timing thereof, including the timing of submission of an NDA for ensifentrine, the planned US commercial launch of ensifentrine in 2024, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine, ensifentrine’s compelling benefit risk profile, the funding we expect to become available under the $150.0 million debt financing facility and from cash receipts from UK tax credits, and the sufficiency of cash and cash equivalents, and the cash runway period provided by the sources of financing through to at least the end of 2025 and expected to fully fund the planned commercial launch.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, 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. 21, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), 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, 2022 on Tuesday, March 7, 2023 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 ask to join the Verona Pharma call:

• +1-833-816-1396 for callers in the United States
• +1-412-317-0489 for international callers

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

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 chronic 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 has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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.