Verona Pharma Reports TQT Study Successfully Demonstrated No Clinically Relevant Effect on Cardiac Conduction

Study Supports Ongoing Phase 3 Program and Planned NDA Submission

LONDON and RALEIGH, N.C., Dec. 16, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces ensifentrine met all safety objectives in a thorough QT (“TQT”) study designed to evaluate effects, if any, of ensifentrine on cardiac conduction in healthy individuals. No clinically relevant changes in measures of cardiac conduction including QTcF, PR and QRS intervals were observed with either 3 mg or 9 mg inhaled ensifentrine dose at any time point over 24 hours.

The U.S. Food and Drug Administration (“FDA”) requires a TQT study to support most New Drug Applications for potential new medications. The protocol was reviewed by the FDA prior to commencing the study, and these results will support the planned submission for ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).

David Zaccardelli, Pharm. D., President and CEO of Verona Pharma said: “These data bring us a step closer to a planned NDA submission for ensifentrine. We continue to evaluate the first-in-class treatment in our ongoing ENHANCE Phase 3 clinical trial program in COPD and expect to report results in 2022.”

Study Design

The randomized, double-blind, crossover TQT study evaluated the effect of therapeutic and supratherapeutic doses of nebulized ensifentrine on measures of cardiac conduction compared with placebo in healthy volunteers. Moxifloxacin was included as a positive control.

  • Population: 32 healthy volunteers
  • Dose/Duration: Participants received the following treatments as a single dose in separate periods in random sequence:
    • 9 mg of nebulized ensifentrine
    • 3 mg of nebulized ensifentrine
    • placebo
    • 400 mg of oral moxifloxacin
  • Primary endpoint: Placebo-corrected change from baseline in QTcF (ΔΔQTcF).

For further information please contact:

   
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 882 9621
verona@optimumcomms.com
Mary Clark / Stella Lempidaki / Zoe Bolt  

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 TQT study results supporting the planned submission of ensifentrine for the maintenance treatment of COPD, the progress and timing of clinical trials and data, the potential of ensifentrine as a first-in-class 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, 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 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, our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, 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 Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Enrollment in ENHANCE-1 48-week subset and ENHANCE-2 expected to complete around year-end 2021

ENHANCE Phase 3 program on track to report top-line data in 2022

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

LONDON and RALEIGH, N.C., Nov. 09, 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 September 30, 2021, and provides a corporate update.

“During the third quarter, we continued to make substantial progress on patient recruitment in our Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) clinical program,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are excited to report patient enrollment is nearing completion and expect that by the end of November both the 800 patient ENHANCE-2 trial and the 400 patient 48-week subset of the ENHANCE-1 trial will be approximately 95% enrolled.

“We are pleased with our ability to advance recruitment in these international, multi-site clinical trials during a global pandemic. Although the pace of enrollment is expected to slow due to the approaching holiday season and the continued effects of the COVID-19 pandemic, we still expect to complete enrollment in ENHANCE-2 and the 48-week subset of ENHANCE-1 around year-end 2021. We expect to report top-line data from ENHANCE-2 mid-year 2022 and from ENHANCE-1 around the end of 2022.”

Program Updates and Key Milestones

As of November 8, 2021, ENHANCE-2 had approximately 90% of patients randomized into the study. Including those patients currently entered in the run-in period, we expect ENHANCE-2 to be approximately 95% enrolled by the end of November 2021.

The 48-week subset of ENHANCE-1 is a critical driver of delivering top-line data. As of November 8, 2021, this subset had approximately 95% of patients randomized into the study.

The Company’s near-term milestones include:

  • In mid-November, Ms. Caroline Diaz will join Verona Pharma as Senior Vice President of Regulatory Affairs, bringing more than 18 years of experience in both large and small pharmaceutical companies across key regions. Ms. Diaz has served at ReViral as Vice President, Regulatory Affairs, and, previously, as Vice President, Regulatory and Quality at Dova Pharmaceuticals where she built the regulatory function from the ground up and led regulatory strategy development and implementation efforts resulting in the first marketing approvals for the company.
  • In December 2021, the Company expects to report results from a 32-patient thorough QT study to evaluate the effect of ensifentrine on measures of cardiac conduction, which the Company is carrying out in support of a potential NDA submission.
  • Based on our current models of forecasted recruitment and study progress the Company expects:
    • Enrollment of ENHANCE-2 and the 48-week subset of ENHANCE-1 to complete around year-end 2021. Enrollment in the full ENHANCE-1 trial is expected to complete in the second quarter of 2022.
    • Top-line data for ENHANCE-2 mid-year 2022 and for ENHANCE-1 around the end of 2022.
    • Should COVID-19 related challenges increase further, our models predict top-line data for ENHANCE-2 would be expected in the third quarter of 2022 and for ENHANCE-1 in the first quarter of 2023. With the COVID-19 pandemic and government and other measures continuing to impact a number of clinical trial activities, including contractor staffing issues and disruptions to supply chains globally, the Company continues to closely monitor these timelines.

Third Quarter and Recent Highlights

Clinical

  • In October 2021, the Company presented Phase 2 data demonstrating the positive effect of a pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in COPD at the CHEST Annual Meeting 2021. Data from Part B of the two-part study, first reported in February 2021, showed ensifentrine delivered by pMDI over one week provided statistically significant, clinically meaningful and dose-dependent improvements in lung function and was well tolerated. The data with delivery via pMDI are consistent with results for dry powder inhaler (“DPI”) and nebulizer formulations of ensifentrine and underline the suitability of ensifentrine for delivery to the lung via all three primary inhalation delivery platforms.
  • In September 2021, the Company presented an abstract describing the results of a Phase 1 study assessing the effect of CYP2C9 inhibitor, fluconazole, on the pharmacokinetics of ensifentrine in healthy individuals at the European Respiratory Society International Congress (“ERS”) 2021. Ensifentrine is primarily metabolized via the hepatic route by the cytochrome P450 enzyme, CYP2C9. Results from the study demonstrated co-administration of fluconazole had a less than 2-fold, not clinically relevant, effect on pharmacokinetic measures of the maximum concentration and area under the curve for ensifentrine.

Third Quarter 2021 Financial Results

  • Cash position: Cash and cash equivalents at September 30, 2021, were $166.5 million (June 30, 2021: $146.0 million). We believe our cash and cash equivalents at September 30, 2021, expected cash receipts from the U.K. tax credit program and funding expected to become available under the $30.0 million debt financing facility secured in November 2020, will enable us to fund our planned operating expenses and capital expenditure requirements through at least the end of 2023.
  • Revenue: Revenue for the third quarter ended September 30, 2021, was $40.0 million (Q3 2020: $nil). This revenue was recognized from our agreement with Nuance Pharma for the development and commercialization of ensifentrine in Greater China (the “Nuance Agreement”).
  • R&D Expenses: Research and development (“R&D”) expenses were $22.6 million for the third quarter ended September 30, 2021 (Q3 2020: R&D expenses $12.8 million). The increase of $9.8 million was primarily due to costs associated with the Phase 3 ENHANCE program partially offset by a reduction in share-based compensation charges.
  • S,G&A Expenses: Selling, general and administrative expenses (“S,G&A”) were $10.9 million for the third quarter ended September 30, 2021 (Q3 2020: S,G&A expenses $8.3 million). This increase of $2.6 million was driven primarily by costs relating to the Nuance Agreement, partially offset by a reduction in costs relating to the July 2020 PIPE financing.
  • Net profit/(loss): Net profit was $11.1 million for the third quarter ended September 30, 2021 (Q3 2020: net loss $18.9 million) and the net cash generated by operating activities for the quarter was $22.8 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 Tuesday, November 9, 2021 to discuss the third quarter 2021 financial results and the corporate update.

Analysts and investors may participate by dialing one of the following numbers and reference conference ID 7220560:

  • +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. An electronic copy of the third quarter 2021 results press release will also be made available today on the Company’s website. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

For further information please contact:

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Stella Lempidaki / Zoe Bolt  

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 continue to impact a number of clinical trial activities and the Company will provide an update if it becomes aware of any meaningful disruption caused by the pandemic to its clinical trials.

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).

The COVID-19 pandemic is disrupting supply chains, and employee retention and recruitment, globally and the Company is closely monitoring this situation and will provide an update if it becomes aware of any meaningful disruption caused by the pandemic to the supply of ensifentrine and drug-related products, equipment and services for its clinical trials.

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 assumptions underlying the Company’s models on clinical trial recruitment and progress, including the potential impact of the COVID-19 pandemic on such progress and on our business and operations and the Company’s future financial results, 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, anticipated management changes, the funding we expect to become available under the $30.0 million debt financing facility and from cash receipts from U.K. tax credits, and the sufficiency of cash and cash equivalents.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to 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 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, our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, 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

       
  Three months ended September 30,
    2021       2020  
       
Revenue $ 40,000     $  
Operating expenses      
Research and development   22,560       12,820  
Selling, general and administrative   10,883       8,284  
Total operating expenses   33,443       21,104  
Operating profit/(loss)   6,557       (21,104 )
Other income/(expense)      
Benefit from R&D tax credit   4,749       2,338  
Interest income   4       13  
Interest expense   (86 )      
Fair value movement on warrants   40       (978 )
Foreign exchange gain / (loss)   (86 )     844  
Total other income, net   4,621       2,217  
Profit/(loss) before income taxes   11,178       (18,887 )
Income tax expense   (127 )     (44 )
Net profit/(loss) $ 11,051     $ (18,931 )
       
Weighted-average shares outstanding – basic   475,334,354       344,809,792  
Weighted-average shares outstanding -diluted   515,819,439       344,809,792  
       
Profit / (loss) per ordinary share – basic $ 0.02     $ (0.05 )
Profit / (loss) per ordinary share – diluted $ 0.02     $ (0.05 )
       
  Sep-30   Dec-31
    2021       2020  
       
Cash and cash equivalents $ 166,547     $ 187,986  
Total assets $ 201,560     $ 204,206  
Equity $ 168,202     $ 184,854  
       

 

Verona Pharma Announces November 2021 Investor Conference Participation

LONDON and RALEIGH, N.C., Nov. 01, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Pharm. D., President and Chief Executive Officer, will present at the following investor conferences in November 2021:

Stifel 2021 Virtual Healthcare Conference
Date: Monday, November 15
Time: 9:20 AM EST / 2:20 PM GMT

Jefferies London Healthcare Conference
Date: Thursday, November 18
Time: 3:00 AM EST / 8:00 AM GMT

Piper Sandler 33rd Annual Virtual Healthcare Conference
Date: Monday, November 29
Presentation available on-demand starting at 10:00 AM EST / 3:00 PM GMT on Monday, November 22

A webcast of each conference presentation 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:

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Stella Lempidaki / Zoe Bolt  

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.

Verona Pharma to Report Third Quarter 2021 Financial Results and Provide Corporate Update

LONDON and RALEIGH, N.C., Oct. 26, 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 and nine months ended September 30, 2021 on Tuesday, November 9, 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 7220560:

  • +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:

Verona Pharma plc US Tel: +1-833-417-0262

UK Tel: +44 (0)203 283 4200

Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Stella Lempidaki / Zoe Bolt  

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.

Verona Pharma to Present Phase 2 Data with pMDI Ensifentrine in COPD at CHEST 2021

Bronchodilation demonstrated with pMDI, consistent with DPI and nebulizer formulations

LONDON and RALEIGH, N.C., Oct. 13, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the presentation of Phase 2 data demonstrating the positive effect of a pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”) at CHEST Annual Meeting (“CHEST”) 2021 taking place on October 17-20. The data are published in the CHEST Annual Meeting on-line supplement.

Data from Part B of the two-part study, first reported on February 2, 2021, showed ensifentrine delivered by pMDI over one week provided statistically significant, clinically meaningful and dose-dependent improvements in lung function and was well tolerated with an adverse advent profile similar to placebo. The data are consistent with results for dry powder inhaler (“DPI”) and nebulizer formulations of ensifentrine.

Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the treatment of COPD with top-line results expected in 2022.

The randomized, double-blind, placebo-controlled two-part Phase 2 study evaluated pMDI ensifentrine for the treatment of moderate to severe COPD after a single dose and repeat doses over 7 days. Part A of the study evaluated the pharmacokinetic profile, safety and efficacy following a single dose of ensifentrine over 5 dose levels in a parallel group design. Part B of the study was designed to evaluate the efficacy, safety and pharmacokinetic profile of ensifentrine given twice daily over 7 days compared with placebo. Patients (N=28) who completed Part A were randomized to receive 3 doses of ensifentrine (300, 1000 or 3000 mcg) or placebo in a complete block crossover design. The primary endpoint in Part B was the change from baseline in peak forced expiratory volume in one second (“FEV1”) over 4 hours post-dose after 7 days of treatment compared with placebo.

Details of Verona Pharma’s abstract, describing results from Part B, are listed below and linked to the CHEST website.

E-poster: 4213 Ensifentrine, a dual PDE3 and 4 inhibitor, provides effective bronchodilation in patients with COPD when administered twice daily over 7 days via pMDI
Presenter: Tara Rheault, Vice President of Research and Development, Verona Pharma
Session: COPD Abstract Posters 5

For further information please contact:

   
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Stella Lempidaki / Zoe Bolt  

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 statistically significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease (“COPD”). In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date.

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 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.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to 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 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, our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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 Presents Pharmacokinetic Data with Ensifentrine at the European Respiratory Society International Congress 2021

Results demonstrate co-administration of fluconazole has minimal effect on ensifentrine pharmacokinetics

LONDON and RALEIGH, N.C., Sept. 02, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces an abstract describing a drug-drug interaction study assessing the effect of CYP2C9 inhibitor, fluconazole, on the pharmacokinetics of nebulized ensifentrine in healthy individuals has been published by the European Respiratory Society (“ERS”) International Congress 2021. The abstract is available on the ERS website and will appear in a supplement of the peer reviewed journal, European Respiratory Journal.

Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) and is primarily metabolized via the hepatic route by the cytochrome P450 enzyme, CYP2C9. Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) with top-line results expected in 2022.

The Phase 1, open label, 29-patient study demonstrated co-administration of oral, steady-state fluconazole with inhaled ensifentrine was well tolerated and had a minimal, not clinically relevant, effect on the pharmacokinetic profile of ensifentrine.

Details of Verona Pharma’s abstract are listed below and linked to the ERS website.

E-poster 2137: The effect of fluconazole on the pharmacokinetics of ensifentrine in healthy individuals
Participant: Tara Rheault, Vice President of Research and Development, Verona Pharma
Pre-Congress Content: Pharmacology of airway diseases: clinical and laboratory studies

For further information please contact:

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
 
Victoria Stewart, Director of Investor Relations
and Communications
info@veronapharma.com  
     
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
 
Kimberly Minarovich / Michael Barron    
     
Optimum Strategic Communications
(International Media and European Investor
Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
 
Mary Clark / Karl Hard / Elakiya Rangarajah    

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 statistically significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease (“COPD”). In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date.

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 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.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to 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 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, our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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 to Present at H.C. Wainwright 23rd Annual Global Investment Conference

LONDON and RALEIGH, N.C., Aug. 31, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Pharm. D., President and Chief Executive Officer, will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7:00 AM EDT / 12:00 PM BST on Monday, September 13, 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.

   
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Karl Hard / Elakiya Rangarajah  

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.

Verona Pharma Reports Second Quarter 2021 Financial Results and Provides Corporate Update

ENHANCE Phase 3 program on track to report top-line data in 2022

Up to $219 million strategic collaboration with Nuance Pharma in Greater China

Conference call today at 8:30 a.m. EDT / 1:30 p.m. BST

LONDON and RALEIGH, N.C., Aug. 05, 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 June 30, 2021, and provides a corporate update.

“During the second quarter, we continued steady progress on patient recruitment in our Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) clinical program,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Patient enrollment in both ENHANCE-1 and ENHANCE-2 continues across our international clinical trial sites. Over the past quarter, numerous COVID-19 related challenges, including new variants and increased infection and hospitalization rates across a number of countries, have put pressure on our recruitment timelines. We have implemented various mitigation strategies to address these challenges. Based on our current models, our projections for reporting top-line data are in-line with previous guidance, with ENHANCE-2 expected to report in the first half of 2022 and ENHANCE-1 in the second half of 2022. Should COVID-19 related challenges continue to increase, we predict top-line data would be expected in the third quarter of 2022 from ENHANCE-2 and the fourth quarter of 2022 from ENHANCE-1.

“In addition to our clinical progress, we are pleased to have executed on our strategy to partner ensifentrine outside the US. In June, we announced a strategic collaboration with Nuance Pharma, a Shanghai-based specialty pharmaceutical company, with a potential value of up to $219 million, to which we granted the rights to develop and commercialize ensifentrine in Greater China. The collaboration highlights ensifentrine’s potential clinical value to respiratory patients globally and provides us with additional funds to support our efforts to develop and bring ensifentrine to patients in need. Nuance Pharma intends to meet with China’s National Medical Products Administration to develop a plan to file an Investigational New Drug application for the treatment of COPD and we look forward to reporting on the progress.”

Program Updates and Key Milestones

As of the end of July, ENHANCE-2 had 63% of patients randomized into the study. Including those patients currently entered in the run-in period, we expect ENHANCE-2 to be approximately 70% enrolled by the end of August. Additionally, at the end of July, the 48-week subset in ENHANCE-1 had 70% of patients randomized into the study. Including those patients currently entered in the run-in period, we expect the 48-week subset in ENHANCE-1 to be approximately 80% enrolled by the end of August. Completing recruitment of the 48-week subset in ENHANCE-1 is a critical driver of the timeline for reporting top-line data from the study.

The Company’s near-term milestones include:

  • In September, the Company will present an abstract describing the results of a study that assessed the effect of fluconazole on the pharmacokinetics of ensifentrine in healthy individuals at the European Respiratory Society International Congress (“ERS”) 2021.
  • In October, the Company will present an abstract at CHEST Annual Meeting 2021: a follow-up from Verona Pharma’s Phase 2 trial investigating the pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in COPD, which was reported in February 2021.
  • Based on our current models of forecasted recruitment and study progress, ENHANCE-2 is expected to report top-line data in the first half of 2022 and ENHANCE-1 in the second half of 2022. Should COVID-19 related challenges continue to increase, our models predict top-line data would be expected in the third quarter of 2022 from ENHANCE-2 and the fourth quarter of 2022 from ENHANCE-1. With the COVID-19 pandemic and government and other measures continuing to impact a number of clinical trial activities, the Company continues to closely monitor these timelines.

Second Quarter and Recent Highlights

Clinical

  • In May 2021, three abstracts highlighting new analyses from Phase 2b clinical trials with nebulized ensifentrine for the treatment of COPD were presented at the American Thoracic Society International Conference (“ATS”) 2021. The abstracts were published on the ATS website and in the peer reviewed publication, American Journal of Respiratory and Critical Care Medicine. The new subgroup analysis demonstrated the positive effect of ensifentrine on severe and moderate COPD subgroups from the 4-week Phase 2b study first reported by the Company in January 2020 with nebulized ensifentrine as a maintenance treatment for COPD.
  • In April 2021, the Company published its Phase 2b clinical results with nebulized ensifentrine added on to maintenance bronchodilator therapy in symptomatic COPD patients in the peer reviewed journal, International Journal of Chronic Obstructive Pulmonary Disease. The 416-patient study, reported in January 2020, was the second of two large Phase 2b trials with nebulized ensifentrine for this indication. The study met its primary endpoint demonstrating that ensifentrine produced 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.
  • In April 2021, the Company reported results from its pilot study in patients hospitalized with COVID-19 with a pMDI formulation of ensifentrine demonstrating ensifentrine added on to standard of care was well tolerated. 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 plan to conduct further studies of ensifentrine in the treatment of COVID-19.

Corporate

  • In June 2021, Verona Pharma and Nuance Pharma entered into a $219.0 million strategic collaboration to develop and commercialize ensifentrine in Greater China. Under the terms of the agreement, Verona Pharma granted Nuance Pharma the exclusive rights to develop and commercialize ensifentrine in Greater China. In return, Verona Pharma received an aggregate $40.0 million upfront payment consisting of $25.0 million in cash and an equity interest valued at $15.0 million in Nuance Biotech, the parent company of Nuance Pharma, as of June 9, 2021. Verona Pharma is eligible to receive future milestone payments of up to $179.0 million, triggered upon achievement of certain clinical, regulatory, and commercial milestones as well as tiered double-digit royalties on net sales in Greater China.

Second Quarter 2021 Financial Results

  • Cash position: Cash and cash equivalents at June 30, 2021, were $146.0 million (March 31, 2021: $169.6 million). In July 2021, the Company received the $25.0 million upfront payment from Nuance Pharma and $8.0 million in a U.K. tax credit. The Company believes our cash and cash equivalents at June 30, 2021, together with the recently received $25.0 million Nuance payment, the recent and anticipated future receipts from the U.K. tax credit program and funding expected to become available under the $30.0 million debt financing facility secured in November 2020 will enable us to fund our planned operating expenses and capital expenditure requirements through at least 2023.
  • R&D Expenses: Research and development (“R&D”) expenses were $20.6 million for the second quarter ended June 30, 2021 (Q2 2020: R&D expenses $7.8 million). The increase of $12.8 million was primarily due to costs associated with the Phase 3 ENHANCE program as well as an increase in share-based compensation charges.
  • G&A Expenses: General and administrative expenses (“G&A”) were $8.0 million for the second quarter ended June 30, 2021 (Q2 2020: G&A expenses $3.2 million). This increase of $4.8 million was driven primarily by an increase in share-based compensation charges, partially offset by executive change costs in 2020.
  • Net loss: Net loss was $22.1 million for the second quarter ended June 30, 2021 (Q2 2020: net loss $9.0 million) and the net cash used in operating activities for the quarter was $20.2 million.

Conference Call and Webcast Information

Verona Pharma will host an investment community conference call at 8:30 a.m. EDT / 1:30 p.m. BST on Thursday, August 5, 2021 to discuss the second quarter 2021 financial results and the corporate update.

Analysts and investors may participate by dialing one of the following numbers and reference conference ID 8333487:

  • +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. An electronic copy of the second quarter 2021 results press release will also be made available today on the Company’s website. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

For further information please contact:

   
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Karl Hard / Elakiya Rangarajah  

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 continue to impact a number of clinical trial activities and the Company will provide an update if it becomes aware of any meaningful disruption caused by the pandemic to its clinical trials.

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.

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 assumptions underlying the Company’s models on clinical trial recruitment and progress, including the potential impact of the COVID-19 pandemic on such progress and on our business and operations and the Company’s future financial results, 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 timing of Nuance Pharma filing an Investigational New Drug application with China’s National Medical Products Administration and the funding we expect to receive from the strategic collaboration with Nuance Pharma, the funding we expect to become available under the $30.0 million debt financing facility and from cash receipts from U.K. tax credits, and the sufficiency of cash and cash equivalents.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to 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 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, our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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

       
  Three months ended June 30,
    2021       2020  
Operating expenses      
Research and development $ 20,563     $ 7,811  
General and administrative   7,985       3,172  
Total operating expenses   28,548       10,983  
Operating loss   (28,548 )     (10,983 )
Other income / (expense)      
Benefit from R&D tax credit   3,836       1,786  
Interest income   3       34  
Interest expense   (85 )      
Fair value movement on warrants   2,711       89  
Foreign exchange gain / (loss)   40       51  
Total other income, net   6,505       1,960  
Loss before income taxes   (22,043 )     (9,023 )
Income tax expense   (25 )     (15 )
Net loss $ (22,068 )   $ (9,038 )
       
Weighted average shares outstanding   470,786,767       106,360,580  
       
Loss per ordinary share — basic and diluted $ (0.05 )   $ (0.08 )
       
  June 30   December 31
    2021       2020  
       
Cash, cash equivalents and short term investments $ 146,035     $ 187,986  
Total assets $ 218,502     $ 204,206  
Equity $ 154,397     $    184,854  
       

 

Verona Pharma Announces August 2021 Virtual Investor Conference Participation

LONDON and RALEIGH, N.C., July 27, 2021 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Pharm. D., President and Chief Executive Officer, will present at the following virtual investor conferences in August 2021:

BTIG Virtual Biotechnology Conference
Date: Monday, August 9
Time: 1:30 PM EDT / 6:30 PM BST

12th Annual Wedbush PacGrow Healthcare Virtual Conference
Date: Wednesday, August 11
Time: 3:30 PM EDT / 8:30 PM BST
Panel: Breathless and Under Pressure – Innovative Inhaled Treatments For Respiratory Diseases

41st Annual Canaccord Genuity Growth Conference
Date: Thursday, August 12
Time: 11:00 AM EDT / 4:00 PM BST

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

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Karl Hard / Elakiya Rangarajah  

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.

Verona Pharma to Report Second Quarter 2021 Financial Results and Provide Corporate Update

LONDON and RALEIGH, N.C., July 22, 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 and six months ended June 30, 2021 on Thursday, August 5, 2021 and host an investment community conference call at 8:30 a.m. EDT / 1:30 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 8333487:

  • +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:

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications info@veronapharma.com
   
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Kimberly Minarovich / Michael Barron  
   
Optimum Strategic Communications
(International Media and European Investor Enquiries)
Tel: +44 (0)203 950 9144
verona@optimumcomms.com
Mary Clark / Karl Hard / Elakiya Rangarajah  

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.