Category: RNS

Statistically significant improvements in lung function, symptoms and quality of life

36% reduction in rate of exacerbations over 24 weeks

Well tolerated safety profile over 48 weeks

NDA submission planned for 1H 2023

Conference call today at 8:30 a.m. EST / 1:30 p.m. GMT

LONDON and RALEIGH, N.C., Dec. 20, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), today announces positive results of its Phase 3 ENHANCE-1 trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). The ENHANCE-1 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.

Ensifentrine is a first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one compound.

Highlights

• Study population (n=763):
  • Subject demographics and disease characteristics were well balanced between treatment groups.
  • Approximately 66% of subjects received background COPD therapy, either a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist (“LABA”). Additionally, approximately 21% of all subjects received inhaled corticosteroids (“ICS”) with concomitant LAMA or LABA.
• Primary endpoint met (FEV₁* AUC 0-12 hr):
  • Placebo corrected, change from baseline in FEV₁ area under the curve 0-12 hours post dose at week 12 was 87 mL (p<0.0001) for ensifentrine.
  • Demonstrated consistent improvements in all subgroups including gender, age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV₁ reversibility and geographic region.
• Key secondary endpoints of lung function, symptoms and quality of life measures met:
  • Placebo corrected, increase in peak FEV₁ of 147 mL (p<0.0001) 0-4 hours post dose at week 12.
  • Daily symptoms as measured by E-RS** Total Score in the ensifentrine group improved from baseline to greater than the minimal clinically important difference (“MCID”) of -2 units with a statistically significant improvement compared to placebo at week 24. Improvements in symptoms were early and sustained with statistical significance versus placebo at weeks 6, 12 and 24.
  • Quality of Life (“QOL”) as measured by SGRQ** Total Score in the ensifentrine group improved from baseline to greater than the MCID of -4 units with a statistically significant improvement compared to placebo at week 24. Improvements in QOL were early and sustained with statistical significance versus placebo at weeks 6, 12 and 24.
  • Placebo corrected, increase in morning trough FEV₁ of 35 mL (p=0.0421) at week 12, supporting twice daily dosing regimen.
• Exacerbation rate and risk reduced:
  • Subjects receiving ensifentrine demonstrated a 36% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks (p=0.0505) compared to those receiving placebo.
  • Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 38% (p=0.0378).
  • Pooled exacerbation data from ENHANCE-1 and ENHANCE-2, ensifentrine demonstrated a 40% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks (p=0.0012) compared to those receiving placebo. Additionally, ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 41% (p=0.0008).
• Favorable safety profile:
  • Ensifentrine was well-tolerated with very few events occurring in more than 1% of subjects and greater than placebo over 24 and 48 weeks.

^{*FEV₁: Forced Expiratory Volume in one second, a standard measure of lung function
**E-RS, Evaluating Respiratory Symptoms, and SGRQ, St. George’s Respiratory Questionnaire, are validated patient reported outcome tools}

Antonio Anzueto, MD, Professor of Medicine and Section, Chief of Pulmonary at South Texas Veterans Healthcare System, commented: “These exciting results demonstrate ensifentrine’s potential to become a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD. The 36% reduction in the rate of exacerbations observed over 24 weeks in symptomatic patients is impressive. 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 very pleased by the successful outcome of our Phase 3 ENHANCE-1 study, bringing us another step closer to providing a much needed novel therapy for COPD patients. The totality of the ENHANCE data including improvements in lung function, symptoms, quality of life measures and reduction in exacerbations, coupled with the consistent, favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. We plan to submit a New Drug Application to the US Food and Drug Administration in the first half of 2023. We would like to thank all the patients and investigators for their participation in the ENHANCE program and we look forward to keeping you updated on our progress.”

Verona Pharma plans to release additional information from the ENHANCE trials at upcoming scientific conferences.

Conference Call and Webcast Information

Verona Pharma will host an investment community conference call at 8:30 a.m. EST / 1:30 p.m. GMT on Tuesday, December 20, 2022, to discuss the ENHANCE-1 results.

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

• Link to ENHANCE-1 call
• +1-866-652-5200 for callers in the United States
• +1-412-317-6060 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 ENHANCE-1 results press release will also be made available today on the Company’s website.

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 the ENHANCE program

The two randomized, double-blind, placebo-controlled studies (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 ICS. The two study designs replicated measurements of efficacy and safety data over 24 weeks and ENHANCE-1 also evaluated longer-term safety over 48 weeks.

• Patient Population: Each trial included approximately 800 moderate to severe, symptomatic, COPD patients in both studies 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 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, and exacerbations at 24 weeks.
• Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1.

Further information about the ensifentrine Phase 3 program can be found at www.clinicaltrials.gov, NCT04535986 (ENHANCE-1) and NCT04542057 (ENHANCE-2).

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company 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 of COPD exacerbations in ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler and pressurized metered-dose inhaler. Ensifentrine also 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 future scientific conferences, the goals and design of clinical trials, planned regulatory submissions and timing thereof, including the timing of submission of an NDA to the FDA for ensifentrine, 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 impact of ensifentrine for COPD patients and the treatment of COPD, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling subjects, 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, 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, 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.

LONDON and RALEIGH, N.C., Dec. 19, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces it will report top-line Phase 3 data from its ENHANCE-1 trial of nebulized ensifentrine on Tuesday, December 20, 2022. The Company will host an investment community webcast and conference call at 8:30 a.m. EST / 1:30 p.m. GMT to discuss these data.

To participate, please dial one of the following numbers and ask to join the Verona Pharma conference call:

• Link to ENHANCE-1 call
• +1-866-652-5200 for callers in the United States
• +1-412-317-6060 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 the ENHANCE program

The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluated the efficacy and safety of nebulized ensifentrine in subjects with COPD over 24 weeks. The primary endpoint of both studies is improvement in lung function, as measured by average forced expiratory volume in one second (“FEV₁”) area under the curve (“AUC”) 0-12 hours post dose at week 12. Key secondary endpoints comprise measurements of COPD symptoms and health-related quality of life measures. ENHANCE-1 has also evaluated longer-term safety over 48 weeks. Further information about the program can be found at www.clinicaltrials.gov, NCT04535986 (ENHANCE-1) and NCT04542057 (ENHANCE-2).

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. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. 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.

Access to up to $400 million expected to provide cash runway through at least 2025

Top-line Phase 3 ENHANCE-1 data expected around the end of 2022

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

LONDON and RALEIGH, N.C., Nov. 09, 2022 (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, 2022, and provides a corporate update.

“We have significantly strengthened our financial position with access up to approximately $400 million, through our cash on hand and recently announced $150 million debt facility from Oxford Finance,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We expect these funds to extend our cash runway through at least the end of 2025, supporting the ongoing pre-commercialization activities for ensifentrine and the planned commercial launch in the United States.

“Ensifentrine demonstrated consistent positive effects across primary and secondary endpoints of lung function including subgroups in the Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial. Additional analyses demonstrated positive effects of ensifentrine in reducing rates of exacerbations across clinically relevant subgroups. We are very encouraged by these data and look forward to reporting our ENHANCE-1 results around the end of the year.

“Alongside our clinical progress, Nuance Pharma, our development partner, received clearance from China’s Center for Drug Evaluation (“CDE”) to begin Phase 1 and Phase 3 studies with ensifentrine for chronic obstructive pulmonary disease (“COPD”) in mainland China. Nuance Pharma is responsible for developing and commercializing ensifentrine in Greater China and we look forward to providing future updates.”

Program Updates and Key Milestones

The Company’s near-term milestones include:

• Reporting top-line data from ENHANCE-1 around the end of 2022.

• Conditional upon positive results, Verona Pharma expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the first half of 2023 for inhaled ensifentrine for the maintenance treatment of COPD.

Third Quarter and Recent Highlights

Clinical

• In October 2022, the Company reported additional positive Phase 3 ENHANCE-2 results demonstrating ensifentrine reduced rates of moderate and severe COPD exacerbations across all subgroups analyzed over 24 weeks. Results of the subgroup analyses confirmed effects consistent with the 42% reduction in the rate of moderate to severe exacerbations observed in the overall population compared to placebo. ENHANCE-2 was not powered for exacerbation rate.

• In August 2022, the Company reported positive top-line Phase 3 data from ENHANCE-2. The trial successfully met its primary endpoint and secondary endpoints evaluating lung function. Ensifentrine also significantly reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated with safety results similar to placebo.

Corporate

• During the third and early fourth quarter, Verona Pharma completed financings valued at up to $300 million with an upsized $150 million equity offering in August and a $150 million debt financing facility with Oxford Finance in October. The $150 million debt facility replaces the existing $30 million facility with Silicon Valley Bank and is available upon achievement of certain clinical and regulatory milestones and other conditions. The September 30 cash balances, together with potential draws from the debt facility and expected cash receipts from the UK tax credit program, are expected to finance the planned commercial launch of nebulized ensifentrine for COPD maintenance treatment in the US through at least the end of 2025.

• During the third quarter, Verona Pharma expanded the senior leadership team with appointments across marketing, market access, commercial operations, IT, HR and finance.

• In August 2022, Verona Pharma’s development partner, Nuance Pharma, received clearance from the China CDE to begin Phase 1 and Phase 3 studies with ensifentrine for COPD in mainland 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.

Third Quarter 2022 Financial Results

• Cash position: Cash and cash equivalents at September 30, 2022, were $231.7 million (June 30, 2022: $111.5 million). The Company believes cash and cash equivalents at September 30, 2022, 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.

• R&D Expenses: Research and development (“R&D”) expenses were $9.8 million for the third quarter ended September 30, 2022 (Q3 2021: $22.6 million). The decrease of $12.8 million was primarily due to a $12.5 million decrease in clinical trial and other development costs as the Company progressed to the later stages of the Phase 3 ENHANCE program and a $0.6 million decrease in share-based compensation.

• SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $5.3 million for the third quarter ended September 30, 2022 (Q3 2021: $10.9 million). The decrease of $5.6 million was primarily due to a $4.0 million non-recurring expense associated with the Nuance Agreement in 2021 and a $1.6 million decrease in share-based compensation.

• Net loss: Net loss was $15.6 million for the third quarter ended September 30, 2022 (Q3 2021: net profit $11.1 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 Wednesday, November 9, 2022, to discuss the third quarter 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:

• +1-866-652-5200 for callers in the United States

• +1-412-317-6060 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 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 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. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. ENHANCE-1 is expected to report around the end of 2022. 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 our operational review, outlook and financial review, the development of ensifentrine and the progress and timing of clinical trials and data, the assumptions underlying the Company’s models on clinical trial progress, 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 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 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 the fully funding of the 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; potential delays in enrolling subjects, 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, 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, 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

(unaudited)

 

LONDON and RALEIGH, N.C., Nov. 02, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces that senior management will participate in the following conferences in November 2022:

Stifel 2022 Healthcare Conference
Date: Tuesday, November 15, 2022
Time: 9:45 AM EST / 2:45 PM GMT
Location: New York, NY

Jefferies London Healthcare Conference
Date: Thursday, November 17, 2022
Time: 3:35 AM EST / 8:35 AM GMT
Location: London, UK

34th Annual Piper Sandler Healthcare Conference
Date: Tuesday, November 29, 2022
Time: 10:30 AM EST / 3:30 PM GMT
Location: New York, NY

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:

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. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. ENHANCE-1 is expected to report around the end of 2022. 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.

LONDON and RALEIGH, N.C., Oct. 26, 2022 (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 third quarter ended September 30, 2022 on Wednesday, November 9, 2022 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:

• +1-866-652-5200 for callers in the United States
• +1-412-317-6060 for international callers

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

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. ENHANCE-1 is expected to report around the end of 2022. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. 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.

Non-dilutive capital finances planned launch of ensifentrine for COPD

LONDON and RALEIGH, N.C., Oct. 17, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces it has entered into a debt financing facility (“debt facility”) providing the Company with access to up to $150 million from Oxford Finance LLC (“Oxford”). The non-dilutive capital provides further financial flexibility and support for commercialization activities for ensifentrine, the Company’s first-in-class product candidate, which recently reported positive Phase 3 data in the ENHANCE-2 trial in chronic obstructive pulmonary disease (“COPD”). The $150 million debt facility replaces the existing $30 million facility with Silicon Valley Bank (“SVB”).

“We believe the potential proceeds from this debt facility and from the U.K. tax credit program, along with our existing $231.7 million of cash at September 30, 2022, will provide more than 3 years of runway, funding the planned commercial launch of ensifentrine in the US,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We have already begun the early stages of launch preparation and, pending positive ENHANCE-1 results, we intend to submit a New Drug Application in the US for nebulized ensifentrine in the first half of 2023, and if approved, plan to launch in 2024.”

“Oxford is pleased to serve as a capital partner, supporting Verona Pharma’s development and commercialization activities for the unmet respiratory condition COPD and potentially other respiratory diseases,” said Adam K. Soller, Managing Director at Oxford. “The promising results from the recent Phase 3 ENHANCE-2 trial bolster ensifentrine’s prospects as a compelling therapy for millions of patients suffering from COPD worldwide.”

Under the terms of the debt facility, Verona Pharma drew $10 million at closing, a portion of which was used to repay the existing debt facility, prepayment fees and other associated costs to SVB. An additional $10 million is immediately available to be drawn at Verona Pharma’s discretion. The Company may draw an additional $80 million in two separate tranches upon achievement of near-term clinical and regulatory milestones. An additional $50 million may be drawn subject to the approval of Oxford. Verona Pharma will pay interest only for the first 36 months, extendable to 48 months on achievement of certain milestones. The debt facility is scheduled to mature on October 1, 2027.

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

About Oxford Finance LLC

Oxford Finance is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. Since 2002, Oxford has funded over $9 billion in loans. Oxford is headquartered in Alexandria, Virginia, with additional offices in California (San Diego, Palo Alto, and Los Angeles) and the greater Boston and New York City metropolitan areas. For more information, visit oxfordfinance.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 expected use of the proceeds from the debt facility, the sources of financing for the planned commercial launch of ensifentrine, the cash runway period provided by the sources of financing and the fully funding of the commercial launch, and the timing of a New Drug Application submission for and commercial launch 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 and commercialization, 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 subjects, 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, 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, 2021, and our other reports filed with the Securities and Exchange Commission, 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., Oct. 14, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces additional exacerbation* subgroup analyses from the Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial in chronic obstructive pulmonary disease (“COPD”). Top-line results from the trial are available on Verona Pharma’s website here.

As previously reported, in the overall study population, ensifentrine demonstrated a 42% reduction in the rate of moderate to severe exacerbations over 24 weeks compared to those receiving placebo (p=0.0109). Results of the subgroup analyses confirmed positive effects consistent with the exacerbation reduction observed in the overall population across all subgroups analyzed over 24 weeks. ENHANCE-2 was not powered for exacerbation rate in subgroups.

Exacerbation rate reduction by subgroup

*An exacerbation was defined as a worsening of symptoms (two major or one major and one minor) requiring minimum of three days treatment with oral/systemic steroids and/or antibiotics or hospitalization

**Background medication included either a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist (“LABA”). Approximately 15% of subjects also received inhaled corticosteroids (“ICS”)

“We are very encouraged by the meaningful and consistent reductions in rates of COPD exacerbations across all subgroups analyzed,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Despite treatment with available therapies, many COPD patients continue to experience exacerbations, which are estimated to cause approximately 1.9 million emergency department visits and 740,000 hospitalizations per year in the United States alone. Pending assessment of the results from our ongoing Phase 3 trial, ENHANCE-1, which is on track to read out around the end of 2022, these exacerbation data will be included in the New Drug Application in the US, which we expect to submit in the first half of 2023.”

Verona Pharma plans to release additional information from ENHANCE-2 at upcoming scientific conferences.

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) 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-2 clinical trial, 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 more than 2,200 subjects to date.

About the ENHANCE program

The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluate 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 up to approximately 20% of subjects may receive ICS. The two study designs replicate measurements of efficacy and safety data over 24 weeks and ENHANCE-1 also evaluates longer-term safety over 48 weeks.

• Patient Population: Approximately 800 moderate to severe, symptomatic, COPD subjects in both studies 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 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, and exacerbations at 24 weeks.
• Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 subjects in ENHANCE-1.

ENHANCE-1 completed enrollment in the 48-week subset in December 2021 and in the 24-week subset in June 2022. Further information about the ensifentrine Phase 3 program can be found at www.clinicaltrials.gov, NCT04535986 (ENHANCE-1) and NCT04542057 (ENHANCE-2).

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements including, but not limited to, statements regarding the development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, planned regulatory submissions and timing and content thereof, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development and commercialization, 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 subjects, 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, 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, 2021, and our other reports filed with the Securities and Exchange Commission, 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., Aug. 29, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces that senior management will present a company overview at the H.C. Wainwright 24^th Annual Global Investment Conference on Monday, September 12, 2022 at 2:00 PM ET / 7:00 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 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. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. 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

LONDON and RALEIGH, N.C., Aug. 24, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, continues its preparation for commercialization with appointments of Matthew Casbon, Vice President of Sales, Marketing and Training, and Matthew Rysavy, Vice President of Market Access and Trade. They each bring approximately 25 years of commercialization expertise spanning marketing, sales, training, market access, trade and business development across a variety of therapeutic areas.

Chris Martin, Senior Vice President of Commercial, said: “We are very pleased to welcome Mr. Casbon and Mr. Rysavy to Verona Pharma at this exciting time of Company growth and progression. Last week, we reported positive Phase 3 results from our ENHANCE-2 trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). We expect to report the results from our ongoing Phase 3 trial, ENHANCE-1, around the end of the year. If similar positive results are achieved, we plan to submit a New Drug Application to the US Food and Drug Administration in the first half of 2023. The leadership skills and wealth of experience of Mr. Casbon and Mr. Rysavy in launching novel therapeutics will be very valuable as we refine our go to market strategy for ensifentrine and begin our commercialization preparations.”

Mr. Casbon brings over 25 years of commercial healthcare experience to Verona Pharma. Previously, he served as Chief Business Officer of Target RWE, a real-world evidence solutions provider, where he was instrumental in building the business development function and completing a Series C financing. Prior to this, Mr. Casbon was at Circassia Pharmaceuticals, a global respiratory pharmaceutical and device company, serving as the Senior Vice President, Global Strategic Marketing, Training and Global Research Sales. Mr. Casbon was Associate Vice President of Marketing at Salix Pharmaceuticals until its acquisition by Valeant Pharmaceuticals and Business Director for the Cystic Fibrosis Franchise at Solvay Pharmaceuticals, where he spent over 13 years until Abbott Laboratories purchased the company. He received a Bachelor of Arts in Speech Communication from West Chester University.

Mr. Rysavy has over 24 years of pharmaceutical experience with 13 years in Market Access & Trade roles covering a broad range of products, channel management, and distribution strategies. Prior to Verona Pharma, Mr. Rysavy served as Head of Market Access and Trade at BioDelivery Sciences International, where he was responsible for building the Market Access team to support existing and launch products. He was instrumental in developing key contracting and distribution strategies for the company. Previously, Mr. Rysavy was Director of Market Access at US World Meds/HEMA Biologics where he was responsible for securing formulary access to the company’s new and existing products. Throughout his career, he has launched multiple products in Market Access roles working closely with major Pharmacy Benefit Management’s (PBM) and Payers across the US. Mr. Rysavy spent 13 years in roles of increasing responsibility at Salix Pharmaceuticals after starting his career at Johnson and Johnson. He received a Bachelor of Liberal Studies (BLS) degree from Iowa State University.

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. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

LONDON and RALEIGH, N.C., Aug. 19, 2022 (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 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 chronic obstructive pulmonary disease (“COPD”) in mainland China.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma with a potential value of up to $219 million, granting Nuance Pharma exclusive rights to develop and commercialize ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). In return, Verona Pharma received an upfront payment of $25 million in cash and an equity interest valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma. In addition, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater China.

“We are pleased our development partner, Nuance Pharma, has received IND approval to begin pivotal studies in COPD with ensifentrine in mainland China,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “This is an important milestone and, based on our recent positive Phase 3 results from our ENHANCE-2 trial in COPD, we remain confident about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD.”

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

About Nuance Pharma

Nuance Pharma is a patient-centric and innovation focused biopharmaceutical company, with both clinical and commercial stage assets. Founded by Mark Lotter in 2014, with the mission to address critical unmet medical needs in Greater China and Asia Pacific, Nuance’s portfolio represents a differentiated combination of commercial stage and innovative pipeline assets across respiratory, pain management, emergency care and iron deficiency anemia. Focusing on specialty care, Nuance deploys the Dual Wheel model that incubates a late clinical stage innovative portfolio, while maintaining a self-sustainable commercial operation.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding milestone payments, royalties and other financial terms of the collaboration agreement with Nuance Pharma, the timing of Nuance Pharma beginning clinical studies for the treatment of COPD in China, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectations expressed or implied by the forward-looking statements including, but not limited to, the following: our limited operating history; 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 ENHANCE Phase 3 program or our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our or Nuance Pharma’s research and development efforts and the completion of our or Nuance Pharma’s clinical trials; we may not be successful in developing ensifentrine for multiple indications; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers or development partners; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; and our vulnerability to natural disasters, global economic and geo-political 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 Verona Pharma’s Annual Report on Form 10-K filed with the SEC on March 3, 2022, and Verona Pharma’s 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 the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing Verona Pharma’s views as of any date subsequent to the date of this press release.