Windtree Therapeutics Inc 2024年度报告

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549 FORM10-K ANNUAL REPORT PURSUANT TO SECTION 13OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year endedDecember 31, 2024 Or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition periodfrom_____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 or organization) 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: Title of each classTrading symbol(s)Name of exchange on which registeredCommon Stock, $0.001 par valueWINTTheNasdaqCapital 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 Securities Act.Yes☐No☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the 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 ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has beensubject to 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 toRule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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. Accelerated filer☐ Large accelerated filer☐ Smaller reporting company☒ Table of Contents 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 has filed a report on and attestation to its management’s assessment of the effectiveness of itsinternal control over financial reporting underSection 404(b) of the Sarbanes-Oxley Act(15 U.S.C. 7262(b)) by the registered publicaccounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrantincluded in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery 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 Exchange Act).Yes☐No☒ OnJune 28, 2024the aggregate market value of shares of voting and non-voting common equity held by non-affiliates of the registrant wasapproximately$1.9million (based on the closing price on The Nasdaq Capital Market on that date). In determining this amount, theregistrant has assumed solely for this purpose that all of its directors, executive officers and persons beneficially owning 10% or more of theoutstanding shares of common stock of the registrant may be considered to be affiliates. This assumption shall not be deemed conclusive asto affiliate status for this or any other purpose. As ofApril 15, 2025, there were3,555,953shares of the registrant’s common stock outstanding. Unless the context otherwise requires, all references to “we,” “us,” “our,” and the “Company” include Windtree Therapeutics, Inc., and itsconsolidated subsidiaries. WINDTREE THERAPEUTICS, INC.Table of Contents to Annual Report on Form 10-KFor the Fiscal Year EndedDecember 31, 2024RISK FACTOR SUMMARYCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSiiPART I1ITEM 1. BUSINESS.1ITEM 1A. RISK FACTORS.29ITEM 1B. UNRESOLVED STAFF COMMENTS.65ITEM 1C. CYBERSECURITY.66ITEM 2. PROPERTIES.66ITEM 3. LEGAL PROCEEDINGS.66ITEM 4. MINE SAFETY DISCLOSURES66PART II67ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUERPURCHASES OF EQUITY SECURITIES.67ITEM 6. [Reserved].67ITEM 7