AI智能总结
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying 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 has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of theregistrant included 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).☐ As of June 28, 2024, the last business day of the registrant’s last completed second quarter, there wasnoestablished public market forthe registrant’s common stock. As of April 15, 2025, there were8,193,398shares of the registrant’s common stock, par value $0.01 per share, issued and outstanding. TABLE OF CONTENTS SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this Annual Report on Form 10-K (the “Annual Report”) of Apimeds Pharmaceuticals US, Inc. are“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statementsinvolve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report, includingstatements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans andobjectives of management are forward-looking statements. These statements are subject to risks and uncertainties (some of which arebeyond our control) and are based on information currently available to our management. Words such as “anticipate,” “believe,”“estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,”“ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. The events and circumstances reflected in our forward-looking statements may not occur and actual results could This Annual Report contains market data and industry forecasts that were obtained from industry publications. These data involvea number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We have notindependently verified any third-party information. While we believe the market position, market opportunity and market size All written and oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified intheir entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely on the forward-looking statements we make or that are made on our behalf as predictions of future events. We undertake no obligation and specifically We encourage you to read the management’s discussion and analysis of our financial condition and results of operations and ourfinancial statements contained in this Annual Report. There can be no assurance that we will in fact achieve the actual results ordevelopments we anticipate or, even if we do substantially realize them, that they will have the expected consequences to, or effects PART I Item 1. Business We are a clinical stage biopharmaceutical company in the process of developing Apitox, an intradermally administered bee venom-based toxin. Our focus is primarily on developing innovative therapies that address inflammation and pain management symptomsassociated with knee OA and, to a lesser extent, MS. Apitox is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) inSouth Korea as “Apitoxin” for the treatment of OA. Apimeds US is not associ