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United States

Securities and Exchange Commission

Washington, D.C. 20549

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Form 40-F

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☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934

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OR

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☒ ANNUAL REPORT PURSUANT TO SECTION 13(a) OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

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For the fiscal year ended December 31, 2023

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Commission File Number 001-39032

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Profound Medical Corp.

(Exact name of Registrant as specified in its charter)

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Ontario, Canada

(Province or other jurisdiction of incorporation or organization)

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3841

(Primary Standard Industrial Classification Code Number (if applicable))

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Not Applicable

(I.R.S. Employer Identification Number (if applicable))

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2400 Skymark Avenue, Unit 6, Mississauga, Ontario L4W 5K5 (647) 476-1350

(Address and telephone number of Registrant’s principal executive offices)

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Profound Medical (U.S.) Inc.

9160 Forum Corporate Parkway, Suite 359, Fort Myers FL 33905

(647)-476-1350

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(Name, address (including zip code) and telephone number (including area code) of agent for service in the United States)

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Securities registered or to be registered pursuant to Section 12(b) of the Act:

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| ​ |  | ​ |
Title of each class Common Shares |  | Trading Symbol(s) PROF |  | Name of each exchange on which registered The Nasdaq Stock Market LLC

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Securities registered or to be registered pursuant to Section 12(g) of the Act.

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Not Applicable

(Title of Class)

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Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

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Not Applicable

(Title of Class)

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For annual reports, indicate by check mark the information filed with this Form:

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☒ Annual information form |  | ☒ Audited annual financial statements

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Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

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Common Shares as of December 31, 2023: |  | 21,370,565

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (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 past 90 days.

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Yes ☒ No ☐

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Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

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Yes ☒ No ☐

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 12b-2 of the Exchange Act.

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Emerging growth company |  | ☒

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If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐

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† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

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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 over financial 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. ☐

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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 reflect the correction of an error to previously issued financial statements. ☐

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Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

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FORM 40-F

Principal Documents

The following documents, filed as Exhibits 99.1 through 99.3 hereto, are hereby incorporated by reference into this Annual Report on Form 40-F:

| ● | Annual Information Form of Profound Medical Corp. (the “Company”) for its fiscal year ended December 31, 2023 (the “AIF”);

| ● | Management’s Discussion and Analysis of the Company for its fiscal year ended December 31, 2023 (the “MD&A”); and

| ● | Consolidated Financial Statements of the Company for its fiscal year ended December 31, 2023 (the “Annual Financial Statements”).

In addition, the certifications and consents required by Form 40-F are filed as Exhibits 99.4 through 99.6 hereto.

Disclosure Controls and Procedures

The information under the heading “Disclosure Controls and Procedures and Internal Controls over Financial Reporting” in the MD&A is incorporated by reference herein.

Management’s Annual Report on Internal Control Over Financial Reporting

The information under the heading “Disclosure Controls and Procedures and Internal Controls over Financial Reporting” in the MD&A is incorporated by reference herein.

Attestation Report of the Registered Public Accounting Firm

The Company is an “emerging growth company” as defined in Rule 12b-2 of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”) and accordingly is not required to provide an attestation report of the registered public accounting firm for the year ended December 31, 2023.

Changes in Internal Control Over Financial Reporting

The information under the heading “Disclosure Controls and Procedures and Internal Controls over Financial Reporting” in the MD&A is incorporated by reference herein.

Identification of Audit Committee

The information under the heading “Item 17. Audit Committee Information” in the AIF is incorporated by reference herein.

Audit Committee Financial Expert

The Company’s board of directors has determined that each of Cynthia Lavoie, Murielle Lortie and Arthur Rosenthal, members of its audit committee, is an “audit committee financial expert” (as such term is defined in Form 40-F) and that each member is “independent” (as defined in the listing standards of The Nasdaq Stock Market LLC (“Nasdaq”)).

Code of Ethics

The Company has adopted a “code of ethics” (as that term is defined in Form 40-F), entitled “Code of Business Conduct and Ethics” (the “Code of Ethics”), that applies to all of its directors, officers and employees. A copy of the Code of Ethics is available on our website at www.profoundmedical.com. All amendments to the Code of Ethics, and all waivers of the Code of Ethics with respect to the Company’s principal executive officer, principal financial officer and principal accounting officer or controller, or persons performing similar functions, will be posted promptly on our website. In addition, we will provide to any person without charge, upon request, a copy of such Code of Ethics by contacting: Rashed Dewan, Chief Financial Officer, Profound Medical Corp., 2400 Skymark Avenue, Unit 6, Mississauga, Ontario L4W 5K5, Telephone: (647) 476-1350.

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Information contained or otherwise accessed through the Company’s website or any other website, other than those documents filed as exhibits hereto, does not form part of this Annual Report on Form 40-F, and any reference to the Company’s website herein is as an inactive textual reference only.

Principal Accountant Fees and Services

The information under the heading “Item 17. Audit Committee Information—External Auditor Service Fees (By Category)” in the AIF and Schedule “A” Profound Medical Corporation Audit Committee Charter is incorporated by reference herein. None of the audit-related fees, tax fees and other fees listed under such heading were approved by the audit committee pursuant to a waiver of its pre-approval policies in accordance with paragraph (c)(7)(i)(C) of Rule 2-01 of Regulation S-X in 2023 or 2022.

Notices Pursuant to Regulation BTR

None.

Mine Safety Disclosure

Not Applicable.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not Applicable.

Recovery of Erroneously Awarded Compensation

Not Applicable.

Comparison with Nasdaq Governance Rules

As a “foreign private issuer” (as such term is defined in Rule 3b-4 under the Exchange Act) whose common shares are listed on Nasdaq, we are permitted to follow certain home country corporate governance practices instead of certain requirements of the Nasdaq rules. We intend to adopt and approve material changes to equity incentive plans in accordance with Toronto Stock Exchange (“TSX”) listing rules, which do not impose a requirement of shareholder approval for such actions. In addition, we intend to follow the TSX listing rules in respect of private placements instead of Nasdaq requirements to obtain shareholder approval for certain dilutive events (such as issuances that will result in a change of control, certain transactions other than a public offering involving issuances of a 20% or greater interest in us and certain acquisitions of the stock or assets of another company) and the minimum quorum requirement for a shareholders meeting. Under Nasdaq listing rules, the required minimum quorum for a shareholders meeting is 33 1/3% of the outstanding common shares, and our minimum quorum requirement is only 10% of the total number of voting rights attaching to all outstanding common shares.

Undertaking

The Company undertakes to make available, in person or by telephone, representatives to respond to inquiries made by the U.S. Securities and Exchange Commission (“Commission”) staff, and to furnish promptly, when requested to do so by the Commission staff, information relating to: the securities registered pursuant to Form 40-F; the securities in relation to which the obligation to file an annual report on Form 40-F arises; or transactions in said securities.

Consent to Service of Process

The Company has previously filed an amended Form F-X, dated as of March 3, 2022, in respect of its common shares, the class of securities in relation to which the obligation to file this Annual Report on Form 40-F arises. Any future change to the name or address of the Company’s agent for service of process will be communicated promptly to the Commission by a future amendment to the Form F-X referencing the file number of the relevant filing of the Company.

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SIGNATURES

Pursuant to the requirements of the Exchange Act, the Company certifies that it meets all of the requirements for filing on Form 40-F and has duly caused this Annual Report on Form 40-F to be signed on its behalf by the undersigned, thereto duly authorized.

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| PROFOUND MEDICAL CORP.
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| By: | /s/ Rashed Dewan
|  | Rashed Dewan
​ | ​ | Chief Financial Officer
| Dated: | March 7, 2024

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EXHIBITS

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97.0 | ​ | Profound Medical Corp.’s Clawback Policy
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99.1 |  | Annual Information Form, dated March 7, 2024, of the Company for its fiscal year ended December 31, 2023
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99.2 | ​ | Management’s Discussion and Analysis of the Company for its fiscal year ended December 31, 2023
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99.3 | ​ | Consolidated Financial Statements of the Company for its fiscal year ended December 31, 2023
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99.4 | ​ | Certifications required by Rule 13a-14(a) or Rule 15d-14(a), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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99.5 | ​ | Certifications required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of United States Code, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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99.6 | ​ | Consent of Independent Registered Public Accounting Firm (PCAOB ID: 271)
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101.INS | ​ | Inline XBRL Instance Document
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101.SCH | ​ | Inline XBRL Taxonomy Extension Schema Document
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101.CAL | ​ | Inline XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF | ​ | Inline XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB | ​ | Inline XBRL Taxonomy Extension Label Linkbase Document
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101.PRE | ​ | Inline XBRL Taxonomy Extension Presentation Linkbase Document
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104 | ​ | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

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