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Indicate by check mark if the registrant is not required to file reports pursuant to Section13 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 Section13 or 15(d)of the Securities Exchange Act of 1934 duringthe preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for the past90days:Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12months (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-accelerated filer, a smaller reporting company or an emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule12b-2 of theExchange Act. Large accelerated filer☐ Accelerated filer☐ Non-accelerated filer☒ Smaller reporting company☒ 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 orrevised 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 of the effectiveness of its internal control overfinancial reporting under Section404(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.Yes☐ 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 filingreflect 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-based compensation received by anyof 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 Rule12b-2 of the Act). Yes☐No☒ The aggregate market value of the common equity held by non-affiliates of the registrant on June30, 2024, based on the closing price on that date of $0.98 pershare, was approximately $3,094,103. As of March18, 2025, there were6,126,778shares of the registrant’s ClassA common stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE Portions of the proxy statement for the 2025 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report to the extentdescribed herein. TABLE OF CONTENTS ItemDescriptionPagePART I6ITEM 1.BUSINESS6ITEM 1A.RISK FACTORS38ITEM 1B.UNRESOLVED STAFF COMMENTS58ITEM 1C.CYBERSECURITY58ITEM 2.PROPERTIES59ITEM 3.LEGAL PROCEEDINGS59ITEM 4.MINE SAFETY DISCLOSURES59PART II60ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATEDSTOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES60ITEM 6.[RESERVED]60ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIALCONDITION AND RESULTS OF OPERATIONS61ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKETRISK70ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA70ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ONACCOUNTING AND FINANCIAL DISCLOSURE70ITEM 9A.CONTROLS AND PROCEDURES70ITEM 9B.OTHER INFORMATION71ITEM 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENTINSPECTIONS71PART III72ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE72ITEM 11.EXECUTIVE COMPENSATION72ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS ANDMANAGEMENT AND RELATED STOCKHOLDER MATTERS72ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, ANDDIRECTOR INDEPENDENCE72ITEM 14.PRINCIPAL ACCOUNTING FEES AND SERVICES72PART IV73ITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES73ITEM 16.FORM 10-K SUMMARY76SIGNATURES84 In this Annual Report on Form10-K, (“Form 10-K”) unless otherwise specified, references to “we,”“us,” “our,” “Helius” or “the Company” mean Helius Medical Technologies,Inc. and its whollyowned subsidiaries, Helius Medical, Inc. (“HMI”), Helius Medical Technologies (Canada), Inc.(“HMC”) and Revelation Neuro, Inc. (“Revelation Neuro”) unless the context otherwise requires.Our financial statements are prepared in accordance with accounting principles generally accepted inthe United States (“U.S. GAAP”). FORWARD-LOOKING STATEMENTS This Annual Report on Form10-K includes certain statements that may constitute “forward-lookingstatements.” All statements contained in this Form 10-K, other than statements of historical facts, thataddress events or developments that the Company expects to occur, are forward-looking




