维罗纳 2025年季度报告

For the quarterly period endedJune 30, 2025OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Actof 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subjectto such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required tosubmit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and“emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of July 31, 2025, the registrant had689,536,966ordinary shares, nominal value £0.05 per share, outstanding, which if all held in ADS form,would be represented by86,192,121American Depositary Shares, each representing eight (8) ordinary shares. SUMMARY RISK FACTORS Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this QuarterlyReport on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our ADSs. The principal risks anduncertainties affecting our business include the following: •Our pending acquisition by Merck may not be completed within the expected timeframe, or at all, and significant delay or the failure tocomplete the acquisition could adversely affect our business and the market price of our ADSs;•The announcement and pendency of our acquisition by Merck could adversely affect our business, prospects, financial condition, andresults of operations;•We have a limited operating history and may not generate sufficient product revenue to sustain profitability;•We may need additional funding to complete development and commercialization of any future product candidates and to continue tocommercialize Ohtuvayre. If we are unable to raise capital when needed, or if a failure of any financial institution where we maintain ourcash and cash equivalents prevents or delays us from accessing uninsured funds, we could be forced to delay, reduce or eliminate ourproduct development programs or commercialization efforts;•The terms of our credit facility place restrictions on our operating and financial flexibility, and our existing and any future indebtednesscould adversely affect our ability to operate our business;•Changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affectour profitability, and audits by tax authorities could result in additional tax payments for prior periods;•We depend solely on the success of ensifentrine, which was recently approved by the FDA as Ohtuvayre. If we are unable to continue tocommercialize Ohtuvayre, or successfully develop ensifentrine for other indications, our ability to generate revenue and our financialcondition will be adversely affected;•We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development andcommercialization of our product candidates;•Our product and product candidates may have serious adverse, undesirable or unacceptable side effects which may delay or preventmarketing approval;•If we are unable to enroll patients in our clinical trials for other indications, or enrollment is slower than anticipated, our research anddevelopment efforts could be adversely affected;•We may become exposed to costly and damaging liability claims, either when testing ensifentrine in the clinic or at the commercial stage,and our product liability insurance may not cover all damages from such claims;•Regulatory approval processes are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtainregulatory approval for our product candidates, our business will be substantially harmed;•Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our productcandidates and may affect the prices we may set;•Our business operations and current and f