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FORM 10-K ☐ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934 ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934 Commission File Number 001-38174 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 15(d) of the 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) ofthe Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was requiredto file such reports), and (2) has been subject 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 besubmitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period thatthe 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-accelerated filer,a smaller reporting company, 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 ExchangeAct. Large accelerated filer☐Non-accelerated filer☐ 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 to Section13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment ofthe effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act bythe registered public accounting 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 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 analysis ofincentive-based compensation received by any of the registrant’s executive officers during the relevant recoveryperiod 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 The aggregate market value of the voting and non-voting common equity held by non-affiliates computed byreference to the price at which the common equity was last sold, or the average bid and asked price of such commonequity, as of the last business day of the registrant’s most recently completed second fiscal quarter (March 28, 2024)was approximately $131,670,000 million. Affiliates for the purpose of this item refers to the issuer’s executive officers and directors and/or any persons orfirms (excluding those brokerage firms and/or clearing houses and/or depository companies holding issuer’ssecurities as record holders only for their respective clients’ beneficial interest) owning 10% or more of the issuer’scommon stock, both of record and beneficially. Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latestpracticable date: 7,727,243 shares as of December 18, 2024, all of one class of common stock, $0.001 par value. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Company’s Proxy Statement for the Annual Meeting of Stockholders expected to be filed in January2025 are incorporated by reference in Part III of this Report. Citius Pharmaceuticals, Inc. TABLE OF CONTENTS PagePART I1 Item 1.Business1Item 1A.Risk Factors26Item 1B.Unresolved Staff Comments51Item 1C.Cybersecurity52Item 2.Properties52Item 3.Legal Proceedings52Item 4.Mine Safety Disclosures52 PART II53 Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities53Item 6.[Reserved]53Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations53Item 7A.Quantitative and Qualitative Disclosures About Market Risk59Item 8.Financial Statements and Supplementary Data59Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information60Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections60 PART III Item 10.Directors, Executive Officers and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters61Item 13.Certain Relationships and Related Transactions, and Director I