PDUFA Target Action Date for Ensifentrine of
Finalizing commercial launch preparations
Strong balance sheet supports commercialization and pipeline expansion
Conference call today at
“As we approach the PDUFA target action date for ensifentrine of
“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
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 theAmerican 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 theInternational Society for Pharmacoeconomics and Outcomes Research (“ISPOR”) AnnualInternational 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 atMarch 31, 2024 , and funding expected to become available under the$650 million strategic financing facility, will enableVerona 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 endedMarch 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 endedMarch 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 endedMarch 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 endedMarch 31, 2024 (Q1 2023: net loss$16.7 million ).
Conference Call and Webcast Information
To participate, please dial one of the following numbers and ask to join the
- +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:
US Tel: +1-833-417-0262 | |
IR@veronapharma.com | |
Tel: +1-212-600-1902 verona@argotpartners.com | |
Ten | Tel: +1-312-523-5016 tbcverona@tenbridgecommunications.com |
About
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
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
Consolidated Financial Summary (unaudited) (in thousands, except share and per share amounts) | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
Operating expenses | ||||||||
Research and development | 6,764 | 12,610 | ||||||
Selling, general and administrative | 20,434 | 9,589 | ||||||
Total operating expenses | 27,198 | 22,199 | ||||||
Operating loss | (27,198 | ) | (22,199 | ) | ||||
Other income/(expense) | ||||||||
Research and development tax credit | 585 | 2,313 | ||||||
Interest income | 3,378 | 2,677 | ||||||
Interest expense | (1,586 | ) | (293 | ) | ||||
Foreign exchange (loss)/gain | (219 | ) | 932 | |||||
Total other income, net | 2,158 | 5,629 | ||||||
Loss before income taxes | (25,040 | ) | (16,570 | ) | ||||
Income tax expense | (754 | ) | (173 | ) | ||||
Net loss | $ | (25,794 | ) | $ | (16,743 | ) | ||
Weighted-average shares outstanding – basic and diluted | 645,701,197 | 621,450,900 | ||||||
Loss per ordinary share – basic and diluted | $ | (0.04 | ) | $ | (0.03 | ) | ||
Mar-31 | Mar-31 | |||||||
2024 | 2023 | |||||||
Cash and cash equivalents | $ | 254,882 | $ | 291,415 | ||||
Total assets | $ | 289,912 | $ | 323,146 | ||||
Shareholders’ equity | $ | 224,988 | $ | 276,749 | ||||
Source:
2024 GlobeNewswire, Inc., source