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Item 9A. Controls and Procedures

2024-03-26 compared with 2023-03-23 · 26 added, 38 removed, 123 unchanged (34% of the section changed)

2 unchanged sentences

We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2022.

Based upon the evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Our management, with the participation of our Chief Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2023.

Based upon the evaluation, our Chief Executive Officer and Principal Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures.

7 unchanged sentences

We are not required to engage our independent audit firm to perform an audit of the effectiveness of our internal controls over financial reporting for as long as we are an “emerging growth company” pursuant to the provisions of the JOBS Act.

Previously Reported Material Weakness

As previously disclosed, in connection with the audit of our financial statements as of and for the year ended December 31, 2021, we identified a material weakness in our internal control over financial reporting related to lack of adequate procedures and controls to ensure that accurate financial statements can be prepared and reviewed on a timely basis.

The material weakness did not result in any material misstatements to the Company’s previously issued financial statements, nor the financial statements in this Form 10-K.

The Company’s management is committed to maintaining a strong internal control environment.

In response to the identified material weakness, management, with the oversight of the Audit Committee of the Board of Directors, took comprehensive actions to improve our internal control over financial reporting and remediate the material weakness such as:

● Increased and hired additional personnel in the accounting function with the appropriate technical knowledge and expertise for financial reporting purposes;

● Implemented a more streamlined process for the preparation and review of financial information;

● Implemented strengthened, formalized and documented policies and internal control procedures which have been assessed as effective based on management’s testing;

● Successfully implemented an ERP system to automate certain processes, including a purchase requisition system, budgeting and reporting.

In connection with its review of disclosure and procedures as of December 31, 2022, management concluded that the previously identified material weakness has been remediated.

Changes in Internal Control Over Financial Reporting

Except for the changes in connection with the remediation of the previously identified material weakness discussed above, there have been no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during the fourth quarter of 2022 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

There have been no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

OTHER INFORMATION

Not applicable .

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

Information required by this item is incorporated by reference to the information set forth in the sections titled “Information about Our Board of Directors” and “Information about Our Executive Officers”, “Corporate Governance, “Delinquent Section 16(a) Reports”, and “Corporate Governance – Committees of the Board of Directors” in our definitive proxy statement to be filed with the SEC on Schedule 14A in connection with our 2024 Annual Meeting of Shareholders, or the Proxy Statement, which is expected to be filed no later than 120 days after December 31, 2023.

If the Proxy Statement is not filed with the SEC within 120 days after the end of our most recent fiscal year, we will provide such information by means of an amendment to this Annual Report on Form 10-K.

Code of Ethics

14 unchanged sentences

Information required by this item is incorporated by reference to the information set forth in the section titled “Independent Registered Public Accounting Firm Fees and Services” in the Proxy Statement .

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a) Financial Statements, Financial Statement Schedules and Exhibits.

(1) Financial Statements.

The financial statements required by Item 15(a) are filed as part of this Annual Report under Item 8, “Financial Statements and Supplementary Data.”

(2) Financial Statement Schedules.

All financial statement schedules are omitted as the required information is not applicable or the information is presented in the consolidated financial statements or related notes.

(3) Exhibits.

Incorporated by Reference

4 unchanged sentences

and certain holders of its capital stock .

Form of Warrant.

Form of Private Warrant.

Form of Underwriter’s Warrant.

Form of Pre-Funded Warrant.

Warrant Agent Agreement by and between Gain Therapeutics, Inc.

and Pacific Stock Transfer Company.

Form of Placement Agent Warrant.

Form of Indemnification Agreement for Officers and Directors .

12 unchanged sentences

Form of Placement Agent Warrant .

Controlled Equity Offering SM Sales Agreement, dated May 18, 2022, between Gain Therapeutics, Inc.

and Cantor Fitzgerald & Co.

Gain Therapeutics Inc.

12 unchanged sentences

and Matthias Alder, dated September 20, 2022.

Emloyment Agreement, by and between the Company and Evan Ballantyne, dated April 10, 2023.

Separation Agreement and Release, by and between GT Gain Therapeutics SA and Salvatore Calabrese, dated April 27, 2023.

Form of Indemnification Agreement for Officers and Directors.

Form of Securities Purchase Agreement.

Subsidiaries of Registrant .

2 unchanged sentences

Section 302 Certification of Chief Executive Officer.

Incorporated by Reference

Section 302 Certification of Chief Financial Officer.

Section 906 Certification of Chief Executive Officer and Chief Financial Officer.

Clawback Policy

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

18 unchanged sentences

March 26, 2024

/s/ Salvatore Calabrese

Salvatore Calabrese

Chief Financial Officer

( Principal Financial Officer )

March 23, 2023

/s/ Gianluca Fuggetta

Gianluca Fuggetta

Senior Director, Corporate Reporting

( Principal Accounting Officer )

Finance Vice President

( Principal Financial Officer and Principal Accounting Officer )

POWER OF ATTORNEY

We, the undersigned directors and officers of Gain Therapeutics, Inc., hereby severally constitute and appoint Matthias Alder and Salvatore Calabrese, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, all amendments to this Annual Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

We, the undersigned directors and officers of Gain Therapeutics, Inc., hereby severally constitute and appoint Matthias Alder and Gianluca Fuggetta, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, all amendments to this Annual Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.

5 unchanged sentences

March 26, 2024

/s/ Salvatore Calabrese

Salvatore Calabrese

Chief Financial Officer

(Principal Financial Officer)

March 23, 2023

/s/ Gianluca Fuggetta

Gianluca Fuggetta

Senior Director, Corporate Reporting

(Principal Accounting Officer)

Finance Vice President

(Principal Financial Officer and Principal Accounting Officer)

March 26, 2024

5 unchanged sentences

March 26, 2024

/s/ Han Peter Hasler

/s/ Hans Peter Hasler

Hans Peter Hasler

10 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures