Category: RNS

LONDON and RALEIGH, N.C., Aug. 15, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announced today the closing of its upsized public offering of 14,260,000 American Depositary Shares (“ADSs”), each representing eight ordinary shares of Verona Pharma, nominal value £0.05 per share, at a price to the public of $10.50 per ADS, which includes the exercise in full by the underwriters of their option to purchase an additional 1,860,000 ADSs. The aggregate gross proceeds from the offering were approximately $150 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Verona Pharma. All ADSs in the offering were offered by Verona Pharma.

Jefferies, Piper Sandler & Co. and Truist Securities acted as the book-running managers for the offering. BTIG, H.C. Wainwright & Co. and Wedbush PacGrow acted as co-managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by the Company with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2021 and declared effective on March 29, 2021 (the “Registration Statement”). A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering was filed with the SEC on August 9, 2022. The final prospectus supplement relating to the offering was filed with the SEC on August 11, 2022 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326 or by e-mail at TruistSecurities.prospectus@Truist.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

No prospectus will be made available in connection with the matters contained in this announcement and no such prospectus is required in accordance with Regulation (EU) 2017/1129 (the “EU Prospectus Regulation”) or the EU Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018, as amended from time to time (the “EUWA”) (the “UK Prospectus Regulation”) to be published.

This announcement is for information purposes only and is directed only at persons whose ordinary activities involve acquiring, holding, managing and disposing of investments (as principal or agent) for the purposes of their business and who have professional experience in matters relating to investments and are: (a) if in a member state of the European Economic Area (the “EEA”) (each a “Relevant State”), qualified investors within the meaning of article 2(e) of the EU Prospectus Regulation (“Qualified Investors”); or (b) if in the United Kingdom, qualified investors within the meaning of article 2(e) of the UK Prospectus Regulation who are also (i) persons who fall within the definition of “investment professional” in article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), or (ii) persons who fall within article 49(2)(a) to (d) of the Order, or (c) persons to whom it may otherwise be lawfully communicated (all such persons referred to in (i), (ii) and (iii) above together being referred to as “Relevant Persons”).

Any investment or investment activity to which this announcement relates is available only to Qualified Investors in the Relevant States, and to Relevant Persons in the United Kingdom, and will be engaged in only with Qualified Investors in Relevant States and Relevant Persons in the United Kingdom. This announcement must not be acted on or relied on by persons in a Relevant State who are not Qualified Investors, or persons in the United Kingdom who are not Relevant Persons.

For further information please contact:

LONDON and RALEIGH, N.C., Aug. 10, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announced today the pricing of its upsized public offering of 12,400,000 American Depositary Shares (“ADSs”), each representing eight ordinary shares of Verona Pharma, nominal value £0.05 per share, at a price of $10.50 per ADS, for aggregate gross proceeds of $130.2 million before deducting underwriting discounts and commissions (the “Offering”). All ADSs in the Offering are being offered by Verona Pharma. In addition, Verona Pharma has granted the underwriters a 30-day option to purchase up to an additional 1,860,000 ADSs at the public offering price, less the underwriting discount and commission. The Offering is expected to close on August 15, 2022, subject to the satisfaction of customary closing conditions.

Jefferies, Piper Sandler & Co. and Truist Securities are acting as the book-running managers for the Offering. BTIG, H.C. Wainwright & Co. and Wedbush PacGrow are acting as co-managers for the Offering.

The Offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by the Company with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2021 and declared effective on March 29, 2021 (the “Registration Statement”). A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the Offering was filed with the SEC on August 9, 2022. The final prospectus supplement relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the Offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326 or by e-mail at TruistSecurities.prospectus@Truist.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

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, the completion of the Offering.

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 the Company’s actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. The 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.

No prospectus will be made available in connection with the matters contained in this announcement and no such prospectus is required in accordance with Regulation (EU) 2017/1129 (the “EU Prospectus Regulation”) or the EU Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018, as amended from time to time (the “EUWA”) (the “UK Prospectus Regulation”) to be published.

This announcement is for information purposes only and is directed only at persons whose ordinary activities involve acquiring, holding, managing and disposing of investments (as principal or agent) for the purposes of their business and who have professional experience in matters relating to investments and are: (a) if in a member state of the European Economic Area (the “EEA”) (each a “Relevant State”), qualified investors within the meaning of article 2(e) of the EU Prospectus Regulation (“Qualified Investors”); or (b) if in the United Kingdom, qualified investors within the meaning of article 2(e) of the UK Prospectus Regulation who are also (i) persons who fall within the definition of “investment professional” in article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), or (ii) persons who fall within article 49(2)(a) to (d) of the Order, or (c) persons to whom it may otherwise be lawfully communicated (all such persons referred to in (i), (ii) and (iii) above together being referred to as “Relevant Persons”).

Any investment or investment activity to which this announcement relates is available only to Qualified Investors in the Relevant States, and to Relevant Persons in the United Kingdom, and will be engaged in only with Qualified Investors in Relevant States and Relevant Persons in the United Kingdom. This announcement must not be acted on or relied on by persons in a Relevant State who are not Qualified Investors, or persons in the United Kingdom who are not Relevant Persons.

For further information please contact:

LONDON and RALEIGH, N.C., Aug. 09, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announced a proposed underwritten public offering of 10 million American Depositary Shares (“ADSs”), each representing eight ordinary shares of Verona Pharma, nominal value £0.05 per share (the “Offering”). All ADSs in the Offering will be offered by Verona Pharma. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the offering. In addition, Verona Pharma intends to grant the underwriters of the Offering a 30-day option to purchase up to an additional 1.5 million ADSs at the public offering price, less the underwriting discount and commission.

Jefferies, Piper Sandler & Co. and Truist Securities are acting as the book-running managers for the Offering.

The Offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by the Company with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2021 and declared effective on March 25, 2021 (the “Registration Statement”). A preliminary prospectus supplement and the accompanying base prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the Offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326 or by e-mail at TruistSecurities.prospectus@Truist.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

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, the completion, timing and size of the Offering and statements regarding the expectation that the underwriters will be granted an option to purchase additional ADSs.

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 the Company’s actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. The 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.

No prospectus will be made available in connection with the matters contained in this announcement and no such prospectus is required in accordance with Regulation (EU) 2017/1129 (the “EU Prospectus Regulation”) or the EU Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018, as amended from time to time (the “EUWA”) (the “UK Prospectus Regulation”) to be published.

This announcement is for information purposes only and is directed only at persons whose ordinary activities involve acquiring, holding, managing and disposing of investments (as principal or agent) for the purposes of their business and who have professional experience in matters relating to investments and are: (a) if in a member state of the European Economic Area (the “EEA”) (each a “Relevant State”), qualified investors within the meaning of article 2(e) of the EU Prospectus Regulation (“Qualified Investors”); or (b) if in the United Kingdom, qualified investors within the meaning of article 2(e) of the UK Prospectus Regulation who are also (i) persons who fall within the definition of “investment professional” in article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), or (ii) persons who fall within article 49(2)(a) to (d) of the Order, or (c) persons to whom it may otherwise be lawfully communicated (all such persons referred to in (i), (ii) and (iii) above together being referred to as “Relevant Persons”).

Any investment or investment activity to which this announcement relates is available only to Qualified Investors in the Relevant States, and to Relevant Persons in the United Kingdom, and will be engaged in only with Qualified Investors in Relevant States and Relevant Persons in the United Kingdom. This announcement must not be acted on or relied on by persons in a Relevant State who are not Qualified Investors, or persons in the United Kingdom who are not Relevant Persons.

For further information please contact:

 

Ensifentrine met primary and secondary endpoints of evaluating lung function in Phase 3 ENHANCE-2 trial for COPD

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

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

LONDON and RALEIGH, N.C., Aug. 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 June 30, 2022, and provides a corporate update.

In a separate press release issued earlier today, Verona Pharma announced positive top-line results from its Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). The ENHANCE-2 trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated with safety results similar to placebo.

David Zaccardelli, Pharm. D., President and Chief Executive Officer, said: “We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible. These data, along with results from our ongoing Phase 3 trial, ENHANCE-1, which are on track to be reported around the end of 2022, if similarly positive, are expected to support the submission of a New Drug Application to the US Food and Drug Administration in the first half of 2023. We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD.”

Program Updates and Key Milestones

Based on current models of study progression, the Company’s near-term milestones include:

• Reporting top-line data from ENHANCE-1 around the end of 2022.
• Conditional upon positive results, the Company 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.

With the recent sanctions and other government restrictions resulting from the Russia-Ukraine conflict and the COVID-19 pandemic continuing to impact a number of clinical trial activities, the Company continues to closely monitor these timelines.

Second Quarter and Recent Highlights

Clinical

• 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.
• In May 2022, the Company presented a successful thorough QT analysis demonstrating ensifentrine had no clinically relevant effect on the QT interval or cardiac conduction at the American Thoracic Society International Conference (“ATS”) 2022. The abstract is published on the ATS website and in the peer reviewed publication, American Journal of Respiratory and Critical Care Medicine.
• In June 2022, the Company completed enrollment in ENHANCE-1 with more than 800 subjects randomized.

Second Quarter 2022 Financial Results

• Cash position: Cash and cash equivalents at June 30, 2022, were $111.5 million (March 31, 2022: $132.8 million). The Company believes cash and cash equivalents at June 30, 2022, expected cash receipts from the U.K. tax credit program and funding expected to become available under the $30.0 million debt facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2023.
• R&D Expenses: Research and development (“R&D”) expenses were $15.0 million for the second quarter ended June 30, 2022 (Q2 2021: $20.6 million). The decrease of $5.6 million was primarily due to a $4.2 million decrease in clinical trial and other development costs as we progressed to the later stages of our Phase 3 ENHANCE program and a $1.9 million decrease in share-based compensation.
• SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $5.5 million for the second quarter ended June 30, 2022 (Q2 2021: $8.0 million). The decrease of $2.5 million was primarily due to a decrease in share-based compensation.
• Net loss: Net loss was $17.8 million for the second quarter ended June 30, 2022 (Q2 2021: net loss $22.1 million).

Conference Call and Webcast Information

Verona Pharma will host an investment community webcast and conference call at 8:30 a.m. EDT / 1:30 p.m. BST on Tuesday, August 9, 2022, to discuss the ENHANCE-2 results, its second quarter financial results and the corporate update.

To participate, please dial one of the following numbers and reference conference ID 2165062:

• Link to ENHANCE-2 and second quarter 2022 results call
• +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 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. 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 continues to monitor the impact of the COVID-19 pandemic on its operations and clinical trials, in particular the timelines and costs of its Phase 3 clinical program ENHANCE. 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 subjects, 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 in an effort to ensure the safety of study participants, minimize risks to study integrity, and maintain compliance with good clinical practice.

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.

Russia-Ukraine Conflict

Verona Pharma is conducting ENHANCE-1 at a number of clinical trial sites in Russia and Europe (but not including Ukraine). The sanctions and other restrictions imposed by the U.S. and other countries as a result of the current conflict between Russia and Ukraine are impacting, and may continue to impact, the Company’s outsourced clinical research vendor’s ability to pay the clinical trial sites and investigators in Russia and may impact the vendor’s ability to supply ensifentrine and equipment to the sites and validate their trial data. If the conflict extends into other countries in Europe where the Company’s clinical trials are being conducted, its clinical trial activities in those countries may also be impacted. The Company is closely monitoring the Russia-Ukraine conflict and will provide an update if it becomes aware of any meaningful disruption to the cost and timelines of our Phase 3 program or its plans to submit an NDA for ensifentrine.

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 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 and the Russia-Ukraine conflict on such progress and on our business and operations and the Company’s future financial results, 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 $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 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)

Statistically significant improvements in key measures of lung function

42% reduction in rate of exacerbations over 24 weeks

Well tolerated with safety results similar to placebo

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

LONDON and RALEIGH, N.C., Aug. 09, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), today announces its top-line Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). The ENHANCE-2 trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations.

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) combining bronchodilator and anti-inflammatory activities in one compound.

Highlights

• Study population (n=789):
  • Subject demographics and disease characteristics were well balanced between treatment groups.
  • Approximately 52% of subjects received background COPD therapy, either a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist (“LABA”). Additionally, approximately 15% 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 average FEV₁ area under the curve 0-12 hours post dose at week 12 was 94 mL (p<0.0001) for ensifentrine.
  • Statistically significant and clinically meaningful improvements with ensifentrine demonstrated across all subgroups including gender, age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV₁ reversibility, and geographic region.
• Secondary endpoints of lung function met:
  • Placebo corrected, increase in peak FEV₁ of 146 mL (p<0.0001) 0-4 hours post dose at week 12.
  • Placebo corrected, increase in morning trough FEV₁ of 49 mL (p=0.0017) at week 12, confirming twice daily dosing regimen.
• Exacerbation rate reduced:
  • Subjects receiving ensifentrine demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo (p=0.0109).
  • Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 42% (p=0.0088).
• COPD symptoms and Quality of Life (“QOL”):
  • Daily symptoms and QOL as measured by E-RS** Total Score and SGRQ** Total Score in the ensifentrine group improved from baseline to greater than the minimal clinically important difference (“MCID”) of -2 units and -4 units, respectively, at week 24. Improvements in these measures were seen as early as 6 weeks and showed continued improvement at 12 and 24 weeks, numerically exceeding placebo at each measurement. Statistical significance was not achieved due to improvements observed in the placebo group over time.
• Favorable safety profile:
  • Ensifentrine was well tolerated with safety results similar to placebo, including occurrence of pneumonia, gastrointestinal and cardiovascular adverse events.

^{*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: “Ensifentrine has demonstrated clear improvements in lung function in addition to favorable safety results. I am extremely excited by the clinically meaningful 42% reduction in the rate of exacerbations observed over 24 weeks in these symptomatic patients, many receiving background therapy. Based on these meaningful results, I believe ensifentrine, if approved, will be an important new class of bronchodilator and non-steroidal anti-inflammatory therapy for COPD patients providing a much needed alternative to existing treatments.”

David Zaccardelli, Pharm. D., Verona Pharma’s President and Chief Executive Officer, said: “We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible. These data, along with results from our ongoing Phase 3 trial, ENHANCE-1, which is on track to be reported around the end of 2022, if similarly positive, are expected to support the submission of a New Drug Application to the US Food and Drug Administration in the first half of 2023. We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD.”

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

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 Tuesday, August 9, 2022, to discuss the ENHANCE-2 results.

Analysts and investors may participate by dialing one of the following numbers and reference conference ID 2165062:

• Link to ENHANCE-2 call
• +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 ENHANCE-2 results press release will also be made available today on the Company’s website.

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 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.

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 also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

COVID-19 Impact

Verona Pharma continues to monitor 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 subjects, 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.

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.

Russia-Ukraine Conflict

Verona Pharma is conducting ENHANCE-1 at a number of clinical trial sites in Russia and Europe (but not including Ukraine). The sanctions and other restrictions imposed by the U.S. and other countries as a result of the current conflict between Russia and Ukraine are impacting, and may continue to impact, the Company’s outsourced clinical research vendor’s ability to pay the clinical trial sites and investigators in Russia and may impact the vendor’s ability to supply ensifentrine and equipment to the sites and validate their trial data. If the conflict extends into other countries in Europe where the Company’s clinical trials are being conducted, its clinical trial activities in those countries may also be impacted. The Company is closely monitoring the Russia-Ukraine conflict and will provide an update if it becomes aware of any meaningful disruption to the cost and timelines of our Phase 3 program or its plans to submit an NDA for ensifentrine.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, the assumptions underlying the Company’s models on clinical trial enrollment and progress, including the potential impact of the COVID-19 pandemic on such progress and on our business and operations and the Company’s future financial results, planned regulatory submissions and timing thereof, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, 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, 2021and 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.

 

Second quarter 2022 financial results and corporate update

LONDON and RALEIGH, N.C., Aug. 08, 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 top-line Phase 3 data from its ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial of nebulized ensifentrine and its financial results for the second quarter ended June 30, 2022 on August 9, 2022. The Company will host an investment community webcast and conference call at 8:30 a.m. EDT / 1:30 p.m. BST to discuss these data and financial results and to provide a corporate update.

Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System, will join Verona Pharma’s management team on the call to provide his perspective on the trial results and answer questions related to the ENHANCE-2 data.

The Company previously announced it would hold an investment community conference call on August 15, 2022, to discuss the Company’s second quarter financial results and provide a corporate update. This press release updates the date, time and call-in information for such call.

To participate, please dial one of the following numbers and reference conference ID 2165062:

• Link to ENHANCE-2 and second quarter 2022 results call
• +1-888-317-6003 for callers in the United States
• +1-412-317-6061 for international callers

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

For further information please contact:

About the ENHANCE program

The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluate 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 will also evaluate 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. 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., July 29, 2022 (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 second quarter ended June 30, 2022 on Monday, August 15, 2022 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update.

To participate, please dial one of the following numbers and reference conference ID 5684286:

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

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

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Two additional formulations of ensifentrine are 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.

Top-line data expected from ENHANCE-2 in Q3 2022 and ENHANCE-1 around the end of 2022

LONDON and RALEIGH, N.C., June 09, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-1 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). This concludes enrollment in the Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program. Top-line data are expected from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022.

“We are pleased to complete enrollment in the Phase 3 ENHANCE program with more than 1,600 subjects randomized across the two trials, ENHANCE-1 and ENHANCE-2,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Attaining our recruitment targets across multiple international sites during the ongoing pandemic is a significant achievement and we would like to thank the patients and healthcare professionals who helped us reach this important milestone.”

“We are on track to report top-line data from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. As stated in our first quarter results, the top-line data from both ENHANCE trials will include the primary endpoint, 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, as well as key secondary endpoints including measurements of COPD symptoms and health-related quality of life, including ER-S and SGRQ endpoints, as well as overall safety data. We look forward to reporting these results and working with the regulatory authorities to address the urgent need for a novel treatment for COPD.”

Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior 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. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 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 (“long acting muscarinic antagonist”) or a LABA (“long acting beta-agonist”), compared to placebo. 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: Moderate to severe, symptomatic, COPD patients at sites primarily in the U.S. and Europe.
• Dose/Duration: Patients are 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 as measured by forced expiratory volume* in one second (“FEV₁”) over 12 hours with ensifentrine after 12 weeks of treatment.
• Key Secondary Endpoints: COPD symptoms and health-related quality of life through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS, and additional lung function endpoints including peak and morning trough FEV₁.
• Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1.

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

^* FEV₁: Forced Expiratory Volume in one second, a standard measure of lung function

For further information please contact:

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with chronic obstructive pulmonary disease (“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 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 1,400 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.

COVID-19 Impact

Verona Pharma continues to monitor 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 subjects, 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.

Russia-Ukraine Conflict

Verona Pharma is conducting its ENHANCE-1 program at a number of clinical trial sites in Russia and Europe (but not including Ukraine). The sanctions and other restrictions imposed by the U.S. and other countries as a result of the current conflict between Russia and Ukraine may impact our outsourced clinical research vendor’s ability to pay the clinical trial sites in Russia, to supply ensifentrine and equipment to the sites, or validate their trial data. If the conflict extends into other countries in Europe where our clinical trials are being conducted, our clinical trial activities in those countries may also be impacted. The Company is closely monitoring the Russia-Ukraine conflict and will provide an update if it becomes aware of any meaningful disruption to the cost and timelines of our Phase 3 program or our plans to submit an NDA for ensifentrine.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, the assumptions underlying the Company’s models on clinical trial enrollment and progress, including the potential impact of the COVID-19 pandemic on such progress and on our business and operations and the Company’s future financial results, planned regulatory submissions and timing thereof, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our clinical trials; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, 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, our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

LONDON and RALEIGH, N.C., June 06, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), today announces it will host an in-person KOL event for analysts and investors on Thursday, June 16, 2022, at 8:00 AM ET, in New York.

Verona Pharma’s KOL event will feature presentations from management and a discussion with key opinion leaders on the COPD treatment landscape, including unmet needs, the treatment paradigm, and how ensifentrine could potentially help to address these issues. Key opinion leaders, Igor Bajaktarevic, MD, Medical Director, COPD Program, UCLA Division of Pulmonary & Critical Care Medicine and Jill Ohar, MD, Professor of Medicine, Wake Forest University, will share their perspectives.

Verona Pharma expects to announce top-line Phase 3 ENHANCE data in COPD in the third quarter of 2022 and around the end of 2022.

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.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on respiratory diseases. 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. Top-line data are expected in the third quarter of 2022 and around the end of 2022.

If successfully developed and approved, 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. 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

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 a first-in-class phosphodiesterase 3 and 4 inhibitor and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

For further information please contact:

LONDON and RALEIGH, N.C., May 25, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces that Chris Martin, Senior Vice President of Commercial, will present a company overview at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 1:30 PM ET / 6:30 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.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on respiratory diseases. 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. Top-line data are expected in the third quarter of 2022 and around the end of 2022.

If successfully developed and approved, 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. 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.

For further information please contact: