Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
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.
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.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term as defined in Exchange Act Rule 13a-15(f) and 15d-15(f). Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive officer and principal financial officer, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.
As of December 31, 2022, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Based on this assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting was effective.
Attestation Report of Independent Registered Public Accounting Firm
This Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal controls over financial reporting. 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;
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● 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; and
● 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.
ITEM 9B. OTHER INFORMATION
Not applicable.
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PART III
ITEM 10. 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 2023 Annual Meeting of Shareholders, or the Proxy Statement, which is expected to be filed no later than 120 days after December 31, 2022.
Code of Ethics
Our board of directors has adopted the Gain Therapeutics, Inc. Code of Business Conduct and Ethics, or Code of Ethics, that applies to all officers, directors and employees. This includes our principal executive officer, principal financial officer and principal accounting officer or controller or persons performing similar functions. The nominating and corporate governance committee is responsible for overseeing the Code of Ethics and must approve any waivers of the Code of Ethics for our employees, executive officers and directors. The Code of Business Conduct and Ethics is available on our website at www.gaintherapeutics.com. If we make any substantive amendments to the Code of Ethics or grant any waiver from a provision of the Code of Ethics to the principal executive officer, principal financial officer and principal accounting officer or controller or persons performing similar functions, we will promptly disclose the nature of the amendment or waiver on our website. Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this Annual Report.
ITEM 11. EXECUTIVE COMPENSATION
Information required by the items is incorporated by reference to the information set forth in the sections titled “Executive Compensation” and “Director Compensation” in the Proxy Statement.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Information required by this item is incorporated by reference to the information set forth in the sections titled “Securities Authorized for Issuance Under Equity Compensation Plans” and “Security Ownership of Certain Beneficial Owners and Management” in the Proxy Statement.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
Information required by this item is incorporated by reference to the information set forth in the sections titled “Information Regarding the Board of Directors and Corporate Governance – Independence of the Board of Directors” and “Transactions with Related Persons” in the Proxy Statement.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
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 .
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PART IV
ITEM 15. 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.
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(3) Exhibits.
Incorporated by Reference
Exhibit
Number
Exhibit
Form
File No.
Exhibit
Filing Date
3.1
Amended and Restated Certificate of Incorporation of Gain Therapeutics, Inc.
8-K
001-40237
3.1
3/17.2021
3.2
Amended and Restated Bylaws of Gain Therapeutics, Inc.
8-K
001-40237
3.2
3/17/2021
4.1
Description of Securities.
10-K
001-40237
4.1
3/25/2022
4.2
Investors’ Rights Agreement, dated as of July 20, 2020, by and among Gain Therapeutics, Inc. and certain holders of its capital stock .
S-1
333-253303
4.2
2/19/2021
10.1+
Form of Indemnification Agreement for Officers and Directors .
S-1/A
333-253303
10.3
3/10/2021
10.2+
2020 Omnibus Incentive Plan .
S-1/A
333-253303
10.2
3/10/2021
10.3+
Gain Therapeutics, Inc. 2021 Inducement Equity Incentive Plan .
8-K
001-40237
10.1
12/28/2021
10.4+
Form of Stock Option Agreement under the 2021 Inducement Plan .
8-K
001-40237
10.2
12/28/2021
10.5
Minoryx Agreement between Minoryx Therapeutics, S.L. and GT Gain Therapeutics SA .
S-1
333-253303
10.3
2/19/2021
10.6+
Executive Employment Agreement, effective as of July 20, 2020, between Gain Therapeutics, Inc. and Eric I. Richman .
S-1
333-253303
10.4
2/19/2021
10.7+
Executive Employment Agreement, effective as of November 2, 2020, between Gain Therapeutics, Inc. and Salvatore Calabrese .
S-1
333-253303
10.8
2/19/2021
10.8+
Executive Employment Agreement, effective as of October 15, 2021, between Gain Therapeutics, Inc. and Matthias Alder.
10-K
001-40237
10.8
03/25/2022
10.9
Form of Exchange Agreement .
S-1
333-253303
10.10
2/19/2021
10.10
Form of Placement Agent Warrant .
S-1
333-253303
10.11
2/19/2021
10.11
Controlled Equity Offering SM Sales Agreement, dated May 18, 2022, between Gain Therapeutics, Inc. and Cantor Fitzgerald & Co.
S-3
333-265061
1.2
5/18/2022
10.12 +
Gain Therapeutics Inc. 2021 Inducement Equity Incentive Plan Restricted Stock Unit Award Agreement.
S-8
333-266142
4.5
7/15/2022
10.13 +
Gain Therapeutics Inc. 2022 Equity Incentive Plan.
S-8
333-266142
4.6
7/15/2022
10.14 +
Gain Therapeutics Inc. RSU Award Grant Notice and Award Agreement (2022 Equity Incentive Plan).
S-8
333-266142
4.7
7/15/2022
10.15 +
Gain Therapeutics Inc. Stock Option Grant Notice and Award Agreement (2022 Equity Incentive Plan).
S-8
333-266142
4.8
7/15/2022
10.16 +
Transition Agreement, between Gain Therapeutics, Inc. and Eric Richman, dated September 19, 2022.
8-K
001-40237
10.1
9/19/2022
10.17 +
Consulting Agreement, between Gain Therapeutics, Inc. and Eric Richman, dated September 20, 2022 (included as Exhibit A to the Transition Agreement).
8-K
001-40237
10.2
9/19/2022
10.18 +
Amended and Restated Employment Agreement, between Gain Therapeutics, Inc. and Matthias Alder, dated September 20, 2022.
8-K
001-40237
10.3
9/19/2022
21.1+
Subsidiaries of Registrant .
S-1
333-253303
4.2
2/19/2021
23.1*
Consent of Independent Registered Public Accounting Firm.
24.1*
Power of Attorney (included in the signature pages attached to this Annual Report on Form 10-K).
31.1*
Section 302 Certification of Chief Executive Officer.
31.2*
Section 302 Certification of Chief Financial Officer.
32.1**
Section 906 Certification of Chief Executive Officer and Chief Financial Officer.
101.INS*
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.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
Filed herewith.
+ Management contract or compensatory plan or arrangement.
* Filed herewith
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** This certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
ITEM 16. FORM 10-K SUMMARY
None.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
GAIN THERAPEUTICS, INC.
(Registrant)
Date: March 23, 2023
By:
/s/ Matthias Alder
Matthias Alder
Chief Executive Officer
( Principal Executive Officer )
Date: March 23, 2023
By:
/s/ Salvatore Calabrese
Salvatore Calabrese
Chief Financial Officer
( Principal Financial Officer )
Date: March 23, 2023
By:
/s/ Gianluca Fuggetta
Gianluca Fuggetta
Senior Director, Corporate Reporting
( Principal Accounting Officer )
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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.
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.
Dated: March 23, 2023
/s/ Matthias Alder
Matthias Alder
Chief Executive Officer and Director
(Principal Executive Officer)
Dated: March 23, 2023
/s/ Salvatore Calabrese
Salvatore Calabrese
Chief Financial Officer
(Principal Financial Officer)
Dated: March 23, 2023
/s/ Gianluca Fuggetta
Gianluca Fuggetta
Senior Director, Corporate Reporting
(Principal Accounting Officer)
Dated: March 23, 2023
/s/ Khalid Islam
Khalid Islam
Chairman of the Board of Directors
Dated: March 23, 2023
/s/ Dov Goldstein
Dov Goldstein
Director
Dated: March 23, 2023
/s/ Han Peter Hasler
Hans Peter Hasler
Director
Dated: March 23, 2023
/s/ Gwen Melincoff
Gwen Melincoff
Director
Dated: March 23, 2023
/s/ Claude Nicaise
Claude Nicaise
Director
Dated: March 23, 2023
/s/ Eric I. Richman
Eric I. Richman
Director
Dated: March 23, 2023
/s/ Jeffrey Riley
Jeffrey Riley
Director
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.