Category: RNS

LONDON and RALEIGH, N.C., July 25, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that it will report its financial results for the second quarter ended June 30, 2024 on Thursday, August 8, 2024 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update.

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

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

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

For further information please contact:

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre^TM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Ohtuvayre is indicated for the maintenance treatment of COPD allowing for broad use in COPD patients

First inhaled COPD treatment providing bronchodilation and non-steroidal anti-inflammatory effects

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

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”

The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.

The Company is fully staffed to launch and expects Ohtuvayre to be available in the third quarter 2024 through an exclusive network of accredited specialty pharmacies.

Conference Call
Verona Pharma will host an investment community conference call at 8:30 a.m. EDT / 1:30 p.m. BST on Thursday, June 27, 2024 to discuss the US approval of Ohtuvayre. To participate, please dial one of the following numbers and ask to join the Verona Pharma call:

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

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

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

Important Safety Information

Indication

Ohtuvayre is a prescription medicine used to treat COPD in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both.

What is the most important information I should know about Ohtuvayre?

Ohtuvayre can cause serious side effects, including:

• Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Ohtuvayre and call your healthcare provider right away or go to the nearest hospital emergency room right away.
• Mental health problems including suicidal thoughts and behavior. You may experience mood or behavior changes when taking Ohtuvayre. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood.

Do not use Ohtuvayre to treat sudden breathing problems. Always have a rescue inhaler with you.

Who Should Not use Ohtuvayre?

Do not use Ohtuvayre if you have had an allergic reaction to ensifentrine or any of the ingredients in Ohtuvayre.

What should I tell my healthcare provider before using Ohtuvayre?

Before you use Ohtuvayre, tell your healthcare professional if you have or have had a history of mental health problems including depression and suicidal behavior; have liver problems; are pregnant or plan to become pregnant; are breastfeeding. It is not known if Ohtuvayre may harm your unborn baby. It is not known if the medicine in Ohtuvayre passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of Ohtuvayre?

The most common side effects of Ohtuvayre include back pain, high blood pressure, bladder infection and diarrhea.

These are not all the possible side effects of Ohtuvayre. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This summary does not include all the information about Ohtuvayre and is not meant to take the place of a discussion with your healthcare provider about your treatment.

For further information, please see the full Prescribing Information, including the Patient Information Leaflet.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About COPD

Chronic obstructive pulmonary disease (“COPD”) refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis. More than 390 million people worldwide are living with COPD, and more than 8.6 million Americans are treated chronically^1-2. Symptoms include increased shortness of breath, frequent coughing (with and without mucus), wheezing, tightness in the chest and unusual tiredness. Approximately 50% of COPD patients experience almost daily symptoms³. There is no cure for COPD and despite available treatment options, it is the third leading cause of death globally.

¹Adeloye D, et al. Lancet Respir Med. 2022;10(5):447-458

²Verona IQVIA Ensifentrine Market Research

³Phreesia 2022 COPD Patient Survey

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

For further information please contact:

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits, efficacy, and approval of our drug Ohtuvayre, including, but not limited to, statements relating to the potential to change the treatment paradigm for COPD patients, the anticipated timing of commercial availability and our ability to successfully market and sell Ohtuvayre.

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 Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on May 10, 2024, 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, except as required under applicable law. 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.

PDUFA Target Action Date for Ensifentrine of June 26, 2024

 Finalizing commercial launch preparations

Strong balance sheet supports commercialization and pipeline expansion

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

LONDON and RALEIGH, N.C., May 09, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2024, and provides a corporate update.

“As we approach the PDUFA target action date for ensifentrine of June 26, we are finalizing our preparations for a potential US launch in the third quarter of 2024,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in more than 20 years, and we continue to work with the US Food and Drug Administration during their review. Our goal is to address the significant unmet need in COPD and provide a novel and effective treatment for patients that continue to experience symptoms, despite existing therapies.

“We believe ensifentrine’s bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD and we look forward to providing updates later this year on our planned clinical programs for a fixed-dose combination of ensifentrine and glycopyrrolate in COPD and ensifentrine in non-cystic fibrosis bronchiectasis.

“With the financing announced this morning, we are pleased to have further strengthened our balance sheet and enhanced our financial flexibility as we prepare for the potential launch of ensifentrine with access to up to $650 million in addition to our existing cash of $255 million. We refinanced our $400 million debt facility to one with a lower overall cost of capital and favorable financial covenants. In addition, we have entered into a $250 million capped revenue interest sales transaction with repayment based on a percentage of future ensifentrine revenues. We expect these funds, along with existing cash, to support the Company’s growth through the planned commercialization beyond 2026.”

Program Updates and Key Milestones

The Company’s near-term milestones include:

• The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date for ensifentrine of June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the third quarter of 2024.
• In the second quarter of 2024, the Company continues to finalize key launch preparations including sales force deployment strategy, pricing, distribution and patient services, healthcare professional and patient engagement plans.
• In the second quarter of 2024, the Company will continue to highlight the burden of chronic obstructive pulmonary disease (“COPD”) through the “Unspoken COPD” disease awareness campaign. Through the first quarter of 2024, 85% of targeted healthcare professionals (“HCPs”) were reached with the campaign and over 2,000 HCPs engaged with the website.
• In May 2024, the Company will present eight posters including two mini oral symposia, at the American Thoracic Society International Conference (“ATS”) 2024. The posters will highlight additional pooled analyses of the Phase 3 ENHANCE studies with ensifentrine for the treatment of COPD. A pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.
• In the second half of 2024, the Company intends to submit an investigational new drug application (“IND”) to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of a fixed-dose combination formulation of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), for the maintenance treatment of patients with COPD via delivery in a nebulizer.
• Also in the second half of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”), subject to clearance by the FDA.

Financing and Recent Highlights

• In May 2024, the Company refinanced its $400 million debt facility and entered into a $250 million capped revenue interest sales transaction with Oaktree Capital and OMERS Life Sciences (collectively “the $650 million strategic financing”).
• Also in May 2024, the Company presented posters at the International Society for Pharmacoeconomics and Outcomes Research (“ISPOR”) Annual International Conference 2024. Posters at ISPOR included claims data demonstrating exacerbations persist for patients even when they are receiving treatment regimens containing inhaled corticosteroids, resulting in a significant burden to the healthcare system.

First Quarter 2024 Financial Results

• Cash position: Cash and cash equivalents at March 31, 2024, were $254.9 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at March 31, 2024, and funding expected to become available under the $650 million strategic financing facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved.
• R&D Expenses: Research and development (“R&D”) expenses were $6.8 million for the first quarter ended March 31, 2024 (Q1 2023: $12.6 million). This decrease of $5.8 million was primarily due to expense of $7.2 million in the three months ended March 31, 2023 for finalizing all matters related to the Phase 3 ENHANCE program. As the program completed in 2023, no similar costs were incurred in 2024. This decrease was partially offset by $1.5 million of pre-approval active pharmaceutical ingredient manufacturing-related costs as well as an increase of $0.7 million in people related costs including share-based compensation.
• SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $20.4 million for the first quarter ended March 31, 2024 (Q1 2023: $9.6 million). The increase of $10.8 million was primarily due to an increase of $4.6 million related to marketing, commercial preparation and other pre-commercial activities, $1.1 million related to professional fees, consulting costs and other administrative expenses, which support our continued growth and evolution of our business, and $0.7 million related to the continued build-out of our information technology infrastructure. Additionally, people related costs increased by $4.1 million including share-based compensation as we increased our headcount in our commercial and support functions in preparation for the planned commercial launch.
• Net loss: Net loss was $25.8 million for the first quarter ended March 31, 2024 (Q1 2023: net loss $16.7 million).

Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, May 9, 2024, to discuss the first quarter 2024 financial results and the corporate update.

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

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

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the first quarter 2024 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 biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”) and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, financial review, program updates and key milestones, the timing of the approval of the NDA for ensifentrine for the maintenance treatment of COPD, the development of ensifentrine in other formulations and for other indications and planned regulatory submissions and timing thereof, including the timing of submission of an IND for a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, for the maintenance treatment of patients with COPD and the timing of clinical studies to assess ensifentrine in patients with NCFBE, the planned US commercial launch of ensifentrine in 2024, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, NCFBE, 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 our $650 million strategic financing facility, and the sufficiency of cash and cash equivalents, and the cash runway period provided by the sources of financing to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved.

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 ability to operate our business due to restrictions from our $400 million debt financing facility and any other existing or future indebtedness; our need for additional funding to complete development and commercialization of any future product candidates or development and commercialization of other formulations or target indications of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our product development programs or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine in other formulations or 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, 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, 2023, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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. Although management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. 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, except as required by law. 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.

Non-dilutive funding will support planned US commercial launch and expansion of ensifentrine’s clinical activities

Cash runway extended beyond 2026

LONDON and RALEIGH, N.C., May 09, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces it and its wholly-owned subsidiary, Verona Pharma, Inc. (“VPI” and together with Verona Pharma, the “Company”), have entered into strategic financing agreements providing access to up to $650 million from funds managed by Oaktree Capital Management, L.P. (“Oaktree”) and OMERS Life Sciences (“OMERS”).

The agreements provide non-dilutive capital and additional financial flexibility ahead of Verona Pharma’s planned US launch of ensifentrine and will support the Company’s continued growth. Ensifentrine is currently under review by the US Food and Drug Administration (“FDA”), and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of chronic obstructive pulmonary disease in more than 20 years.

The strategic financing was led by Oaktree and is comprised of the following:

• Debt facility: Up to $400 million in term loans available in five separate tranches via a term loan facility (“debt facility”).
• Revenue interest purchase and sale agreement (“RIPSA”): Up to $250 million in funding from the sale of a redeemable interest in future ensifentrine-related revenue, which is capped at 1.75x of the amount funded.

The debt facility replaces the existing facility of up to $400 million with funds managed by Oxford Finance LLC and Hercules Capital, Inc. (NYSE: HTGC).

Under the terms of the debt facility, VPI is drawing $55 million at closing, and may draw, subject to certain conditions, an additional $70 million upon FDA approval of ensifentrine, $175 million in two separate tranches upon achievement of certain net sales milestones and, subject to the approval of the Lenders, $100 million to support strategic initiatives. VPI will pay only interest on the outstanding loans under the five-year debt facility on a quarterly basis with all amounts outstanding due at maturity. Approximately $52 million of the loans drawn at closing will be used to repay in full the existing facility, including to pay fees and associated costs thereunder.

Under the terms of the RIPSA, VPI will receive $100 million upon FDA approval of ensifentrine and will be eligible to draw an additional $150 million upon the achievement of certain net sales milestones. The revenue interest financing rate is 5% and 6.5% of certain proceeds the Company receives from licensees that the Company may engage during the term of the RIPSA outside of the US and in the US, respectively, and 6.5% of global net sales of ensifentrine by the Company. The total revenue interest financing payable by the Company to Oaktree and OMERS is capped at 1.75x of the amount actually funded, with the ability to redeem the RIPSA at lower multiples within the first three years from funding.

“As we finalize preparations for the potential US approval and commercial launch of ensifentrine, we are pleased to be working with Oaktree and OMERS who are aligned with our view of ensifentrine’s importance to the COPD community and its commercial opportunity. This strategic agreement, with access to up to $650 million, allows us to further strengthen our cash position and improve our financial flexibility,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “These funds, together with our existing cash of $255 million, are expected to support the Company through commercialization and growth beyond 2026.”

“We believe ensifentrine’s impressive clinical data generated to date and unique mechanism of action position it well to become a paradigm-shifting advancement in the maintenance treatment of COPD, a condition with continued unmet need,” said Aman Kumar, Co-Portfolio Manager for Oaktree’s Life Sciences Lending platform. “This strategic investment in Verona Pharma underscores Oaktree’s commitment to provide flexible capital solutions to innovative life sciences companies that are working on bringing important therapies to patients and providers worldwide.”

Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction. Latham & Watkins LLP served as legal counsel to Verona Pharma. Sullivan & Cromwell LLP served as legal counsel to Oaktree.

For further information please contact:

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

About Oaktree

Oaktree is a leader among global investment managers specializing in alternative investments, with $192 billion in assets under management as of March 31, 2024. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,200 employees and offices in 23 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/.

About OMERS Life Sciences and OMERS

OMERS Life Sciences provides royalty financings and other non-dilutive solutions to biopharma companies and academic institutions, supporting their efforts to address unmet medical needs and improve the quality of life of patients around the world.

OMERS is a jointly sponsored, defined benefit pension plan, with 1,000 participating employers ranging from large cities to local agencies, and over 600,000 active, deferred and retired members. Our members include union and non-union employees of municipalities, school boards, local boards, transit systems, electrical utilities, emergency services and children’s aid societies across Ontario. OMERS teams work in Toronto, London, New York, Amsterdam, Luxembourg, Singapore, Sydney and other major cities across North America and Europe – serving members and employers, and originating and managing a diversified portfolio of high-quality investments in bonds, public and private credit, public and private equity, infrastructure and real estate.

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 debt facility providing non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the planned commercial launch of ensifentrine, statements regarding the future availability of future draws under the debt facility, the timing of repayment and termination of the existing facility, the ability of Verona Pharma to reach certain net sales milestones, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential for ensifentrine to be the first novel inhaled mechanism for the maintenance treatment of chronic obstructive pulmonary disease in more than 20 years and the potential of ensifentrine in the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics, 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, 2023, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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.

PDUFA Target Action Date of June 26, 2024

Eight posters including two oral presentations support potential of ensifentrine,
an investigational, first-in-class, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., May 02, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at the American Thoracic Society International Conference (“ATS”) 2024. Pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.

Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the US FDA, and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.

The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 demonstrating statistically significant improvements in lung function across both primary and secondary endpoints. In a pre-specified endpoint, ensifentrine substantially reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The posters will summarize the efficacy and safety endpoints of ensifentrine when added to a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist/inhaled corticosteroids (“LABA/ICS”), reductions in the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations, and the impact of ensifentrine on improving dyspnea. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.

Frank Sciurba, MD, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, commented: “These pooled analyses from the ENHANCE studies provide further evidence of ensifentrine’s potential to become an important therapy in a broad population of COPD patients. The substantial reduction in exacerbation rate and risk with ensifentrine is particularly exciting for patients and physicians.”

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

Late-Breaking Mini Symposium: Ensifentrine Reduces Exacerbation Frequency and Delays Progression from Gold B to Gold E
Presenter: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B14 – Late Breaking Abstracts: Science that will impact clinical care

Mini Symposium: Ensifentrine added on to LAMA Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects with Moderate-to-Severe COPD 
Presenter: Mark Dransfield, MD, University of Alabama Birmingham & Birmingham VA Medical Center
Session: C95 – New clinical trial results in chronic lung disease

Poster: P624 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Reduced Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD Regardless of Baseline Blood Eosinophils
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P625 – Ensifentrine Added on to LABA/ICS Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects With Moderate-to-Severe COPD
Presenter: Nathan Marchetti, MD, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P704 – Improvements in Breathlessness, COPD Symptoms and Quality of Life Reported With Ensifentrine in a Pooled Analysis of the ENHANCE Trials
Presenter: Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester
Session: A101 – Full metal jacket targeting COPD and chronic airways disease

Poster: P901 – Ensifentrine Added on to LAMA Therapy Improved COPD Symptoms and Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Ravi Kalhan, MD, Pulmonology and Critical Care, Northwestern University
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P909 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Improved Dyspnea in Subjects With Symptomatic, Moderate-to-Severe COPD Over 24 Weeks
Presenter: Donald Mahler, MD, Valley Regional Hospital in Claremont
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P911 – Ensifentrine Added on to LABA/ICS Therapy Reduced Dyspnea and Improved Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Antonio Anzueto, MD, Medicine/Pulmonary Critical Care, South Texas Veterans Healthcare System
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, and the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in a pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

For further information please contact:

 

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 relating to the timing of the FDA’s potential approval of the NDA for ensifentrine by the PDUFA date of June 26, 2024, or at any other time, statements regarding the potential for ensifentrine to be the first novel inhaled mechanism available for the maintenance treatment of COPD in over 20 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory effects in one molecule, and the potential of ensifentrine to become an important therapy in a broad population of COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases, and the potential of the DPI and pMDI formulations of ensifentrine.

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

 

LONDON and RALEIGH, N.C., April 25, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that it will report its financial results for the first quarter ended March 31, 2024 on Thursday, May 9, 2024 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update.

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

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

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

For further information please contact:

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com

LONDON and RALEIGH, N.C., March 04, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces Mr. Andrew Fisher has today joined the Company as General Counsel, and member of the Executive Management Team.

Mr. Fisher is an accomplished lawyer with more than 25 years of experience in the life sciences industry. He brings a wealth of legal and strategic expertise supporting global, pre-clinical and clinical development, manufacturing and commercialization including launching four pulmonary therapies. Most recently, he founded and led a consulting practice focused on providing strategic advice to start-up companies. Previously, from 2001 until 2018, he was an early team member at United Therapeutics Corporation where he served for 17 years holding roles of increasing responsibility including Executive Vice President, Chief Strategy Officer and Deputy General Counsel while leading successful patent defense strategy. During this period, the company grew from an early-stage business to a company with 850 employees, a market capitalization of $4.7 billion and five marketed products. He has a JD from George Washington University and a BA from University of Michigan.

“We are delighted to welcome Andy to Verona,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “His broad expertise and leadership spanning all areas of legal affairs in commercial life sciences and intellectual property portfolio management and strategy will be highly valuable as we finalize preparations for the planned US commercialization of ensifentrine, if approved, later this year.”

Verona Pharma also announces that Ms. Claire Poll is retiring as General Counsel, effective March 4, 2024.

Dr. Zaccardelli added: “We would like to thank Claire for her leadership and recognise her significant contributions to Verona Pharma’s successful development since its inception. During this time, she played a key role in the Company’s growth by providing guidance through our NASDAQ listing, several financings and the progression of our novel product candidate, ensifentrine, through clinical trials into review for potential US approval.”

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, 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., Feb. 15, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that it will report its financial results for the fourth quarter and full year ended December 31, 2023 on Thursday, February 29, 2024 and host an investment community conference call at 9:00 a.m. EST / 2:00 p.m. GMT to discuss these financial results and provide a corporate update.

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

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

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

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com

LONDON and RALEIGH, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) announces Mr. Michael Austwick has today joined the board as a Non-Executive Director.

Mr. Austwick brings a wealth of strategic and operational experience in the biopharmaceutical industry including more than 15 years of respiratory expertise in leadership roles across the US, China, Europe and Japan. Most recently, he served as CEO at Vectura, and previously as Nordic General Manager and Head of the Global Respiratory Franchise at Novartis and as Head of US Respiratory and Vice President Global Inhaled Respiratory at AstraZeneca. Mr. Austwick has led the development and commercialization of more than 10 brands, covering inhaled and biologic assets at a country and global level. He has an MSc in Information Management from the University of Hull and a BSc in Management and Systems from City University, London.

“We are delighted to welcome Michael to the Board,” said Dr. David Ebsworth, Chairperson of Verona Pharma. “His deep respiratory development and commercialization expertise, spanning the full value chain, will add to the breadth of experience of the Board as we prepare for the US launch of ensifentrine, if approved, later this year.”

Verona Pharma also announces that Mr. Rishi Gupta, Partner at OrbiMed, has stepped down from the board as a Non-Executive Director effective January 31, 2024.

Dr. Ebsworth added: “We would like to thank Rishi for his numerous contributions to Verona Pharma’s successful development over the past 7 years. During this time, he has overseen the Company’s listing on NASDAQ, the completion of several financings and the progression of our novel product candidate, ensifentrine, through Phase 3 clinical trials into review for potential US approval.”

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, 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., Jan. 03, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces that senior management will present a company overview at the 42^nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 4:30 PM PST / 12:30 AM GMT.

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

For further information please contact:

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.