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Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549 FORM 10-K ☐ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIESEXCHANGE ACT OF 1934 For the fiscal year endedDecember 31, 2024 Or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIESEXCHANGE ACT OF 1934 For the transition period from_____to_____ CommissionFile Number: 001-39290 WINDTREE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) 94-3171943(I.R.S. EmployerIdentification No.)18976-3622(Zip Code) Delaware(State or other jurisdiction of incorporation ororganization)2600 Kelly Road, Suite 100Warrington, Pennsylvania(Address of principal executive offices) Registrant’s telephone number, including area code:(215) 488-9300 Securities registered pursuant to Section 12(b) of the Act: Name of exchange on whichregisteredThe Nasdaq Capital Market Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the SecuritiesAct. Yes☐No☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) ofthe Exchange Act. Yes☐No☐ 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 Act of 1934 during the preceding 12 months (or for such shorter period that theregistrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days. Yes☐No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required tobe submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months(or for such shorter period that the registrant was required to submit such files). Yes☐No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acceleratedfiler, smaller reporting company, or an emerging growth company. See the definitions of “large acceleratedfiler,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. Large accelerated filer☐ Accelerated filer☐ Non-accelerated filer☐ Emerging growth company☐ Table of Contents If an emerging growth company, indicate by check mark if the registrant has elected not to use the extendedtransition period for complying with any new or revised financial accounting standards provided pursuant toSection 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’sassessment of the effectiveness of its internal control over financial reporting under Section 404(b) of theSarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued itsaudit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financialstatements of the registrant included in the filing reflect the correction of an error to previously issued financialstatements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysisof incentive-based compensation received by any of the registrant’s executive officers during the relevantrecovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the ExchangeAct). Yes☐No☐ On June 28, 2024 the aggregate market value of shares of voting and non-voting common equity held by non-affiliates of the registrant was approximately $1.9 million (based on the closing price on The Nasdaq CapitalMarket on that date). In determining this amount, the registrant has assumed solely for this purpose that all of itsdirectors, executive officers and persons beneficially owning 10% or more of the outstanding shares of commonstock of the registrant may be considered to be affiliates. This assumption shall not be deemed conclusive as toaffiliate status for this or any other purpose. As of April 15, 2025, there were 3,555,953 shares of the registrant’s common stock outstanding. Unless the context otherwise requires, all references to “we,” “us,” “our,” and the “Company” include WindtreeTherapeutics, Inc., and its consolidated subsidiaries. WINDTREE THERAPEUTICS, INC. Table of Contents to Annual Report on Form 10-KFor the Fiscal Year Ended December 31, 2024 RISK FACTOR SUMMARYCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS ITEM 1. BUSINESS.ITEM 1A. RISK FACTORS.ITEM 1B. UNRESOLVED STAFF COMMENTS.ITEM 1C. CYBERSECURITY.ITEM 2. PROPERTIES.ITEM 3. LEGAL PROCEEDINGS.ITEM 4. MINE SAFETY DISCLOSURES ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATEDSTOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES.ITEM 6. [Reserved].ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANC