Akero Therapeutics Inc 2024年度报告

(Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1) has filed all reports required to befiled by Section 13 or 15(d) of the Securities Exchange Act of 1934duringthe preceding 12 months (or for such shorterperiod that the registrantwas required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically everyInteractive Data Filerequired to be submitted and posted pursuantto Rule 405of Regulation S-T (§ 232.405 of this chapter)during the preceding 12 months (or for such shorter period that theregistrant was required tosubmit 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 anemerging growth company. See the definitionsof “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company”in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial 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 its internal control overfinancial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the 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 financial statements of the registrant included in the filing reflectthe 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-based compensation received by any ofthe 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☒ The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was $1,569,636,109as of June 30, 2024 (based on a closing priceof $23.46 per share as quoted by the Nasdaq Global Select Market as of such date). In determining the market value of non-affiliate common stock, shares of the registrant’scommon stock beneficially owned by officers, directors and affiliates have been excluded. This determination of affiliate status is not necessarily a conclusive determinationfor other purposes. Documents Incorporated by Reference: Part III of this Annual Report on Form 10-K incorporates by reference certain information from the registrant’s definitive Proxy Statement for its 2025 annual meetingof shareholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’sfiscal year end of December 31, 2024. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to befiled as part of this Form 10-K. SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors”in this Annual Report on Form 10-K. The principal risks and uncertainties affecting our business includes: •Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made moredifficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients withmetabolic dysfunction-associated steatohepatitis (“MASH,” formerly known as nonalcoholic steatohepatitis), significantcompetition for recruiting such patients in clinical trials, and restrictions on patients and investigators related to outbreaksof infectious diseases or public health crises.•We face substantial competition, which may result in others discovering, developing or commercializing products before ormore successfully than us.•Failures or delays in the commencement or completion of, or ambiguous or negative results from our planned clinical trialsof our product candidates, could result in increased costs to us and could delay, prevent, or limit our ability to generaterevenue and continue our business.•Clinical development is uncertain and our clinical trials for efruxifermin (“EFX”) and any future product candidates mayexperience delays, which would adversely affect ou