windtree therapeutics inc 2025年季度报告

For the transition periodfrom_____to_____ WINDTREE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2600 Kelly Road, Suite 100Warrington,Pennsylvania(Address of principal executive offices) Registrant’s telephone number, including area code:(215)488-9300Securities registered pursuant to Section 12(b) of the Act: was required to submit such files).Yes☒No☐ Non-accelerated filer☒Smaller reporting company☒Emerging growth company☐ complying with 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☒ Financial Statements As of March 31, 2025(unaudited) and December 31, 2024 For the Three Months Ended March 31, 2025and 2024 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) Notes to Condensed Consolidated Financial Statements (unaudited) Management’s Discussion and Analysis of Financial Condition and Results of Operations Controls and Procedures PART II - OTHER INFORMATIONLegal ProceedingsItem 1A.Risk Factors 1995. Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially fromany future results expressed or implied by the forward-looking statements. We caution you therefore against relying on any of these of such risks and uncertainties, which potentially could have a material adverse effect on our development programs, business and/oroperations, include, but are not limited to the following: our estimates regarding future results of operations, financial position, research and development costs, capitalrequirements, and our needs for additional financing; how long we can continue to fund our operations with our existing cash and cash equivalents;changes in market conditions, general economic conditions, and the banking sector, and potential constraints in the potential impairment of our intangible assets on our condensed consolidated balance sheet, which could lead tomaterial impairment charges in the future; our ability to repay indebtedness;potential delays and uncertainties in our anticipated timelines and milestones and additional costs associated with theimpact of the evolving events in the Israel-Gaza region,the ongoing military conflict between Russian and Ukraine,and trade and political tensions between the United States, or the U.S., andthe People’s Republic of China on ourclinical trial operations; regulatory approval and the criteria for success in such trials; clinical trials; 2 delays, interruptions or failures in the manufacture and supply of our product candidates;the plans of our licensee, Lee’s Pharmaceutical (HK) Ltd., and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., the rate and degree of market acceptance of our product candidates, and our ability to serve those markets;the success of competing therapies and products that are or may become available;our ability to limit our exposure under product liability lawsuits;our ability to obtain and maintain intellectual property protection for our product candidates;recently enacted and future legislation, including but not limited to, the Inflation Reduction Act of 2022,regarding thehealthcare system in the U.S. or the healthcare systems in foreign jurisdictions;our ability to recruit or retain key scientific, commercial or management personnel or to retain our executive officers;our ability to secure electronically stored work product, including clinical data, analyses, research, communications,and other materials necessary to gain regulatory approval of our product candidates, including those acquired from escalation or expansion; andour ability to successfully implement our new business strategy to generate revenue through acquisitions of small companies and their FDA-approved products.Pharmaceutical, biotechnology, and medical technology companies have suffered significant setbacks conducting clinical trials, evenafter obtaining promising earlier preclinical and clinical data. In addition, data obtained from clinical trials are susceptible to varying any obligation to publicly update any forward-looking statements or to publicly announce revisions to any of the forward-lookingstatements, whether as a result of new information, future events or otherwise.You should also read carefully the factors described in the “Risk Factors” included in Part II, Item 1A of this Quarterly Report on Form10-Q in conjunction with Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2024,to better Trademark NoticeAEROSURF®,AFECTAIR®,SURFAXIN®,SURFAXIN LS™,WINDTREE THERAPEUTICS® (logo),WINDTREETHERAPEUTICS™, andWINDTREE™are registered and common law trademarks of Windtree Therapeutics, Inc. (Warrington, We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditio