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 Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. 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.
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, 2025, 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, 2025, 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.
Changes in 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 2025 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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ITEM 9B. OTHER INFORMATION
(a) None.
(b) During the fiscal quarter ended December 31, 2025, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement ” as each term is defined in Item 408(c) of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
The following table sets forth certain information regarding our current executive officers and directors, as of the date of this filing:
Name
Age
Principal Occupation/
Position Held With the Company
Gene Mack
52
President, Chief Executive Officer and Director
Gianluca Fuggetta
37
Senior Vice President Finance, Principal Financial Officer
Khalid Islam, Ph.D.
70
Founder and Chairman of the Board
Dov Goldstein, M.D.
58
Director
Hans Peter Hasler
70
Director
Gwen Melincoff
74
Director
Claude Nicaise, M.D.
73
Director
Jeffrey Riley
63
Director
Executive Officers
Gene Mack has served as our Chief Executive Officer and director since January 2025. Prior to that, Mr. Mack was our Interim Chief Executive Officer and Chief Financial Officer from June 2024 after joining the Company as our Chief Financial Officer (“CFO”) in April 2024. Prior to joining the Company, Mr. Mack was CFO of privately held Imcyse SA from October of 2021 to October of 2023. Prior to Imcyse, Gene was CFO at OncoC4 until September 2021, a privately held biotechnology company that spun out of Merck & Co’s (MSD) $475 million acquisition of OncoImmune in 2020 where he had also been CFO since September 2020. From May of 2019 to September 2020, Mr. Mack was CFO of BiomUp, US. From April of 2018 to December of 2018, Mr. Mack was CFO at Sellas Lifesciences Group Inc. (Nasdaq: SLS) through the company’s reverse merger with Galena Biopharma, Inc. Prior to Sellas, from April 2015 to April 2018, Mr. Mack was a consultant for a number of private and public biotechnology and pharmaceutical companies providing advisory and support for raising capital and business development transactions as well as implementing and managing all aspects of corporate finance, accounting, SEC reporting, legal affairs, treasury and investor/public relations. Formerly, Mr. Mack was a consultant and Senior Vice President and Chief Financial Officer of privately held Ascendia Pharmaceuticals and Nicox S.A. from 2015 through March 2018. Prior to Ascendia, Mr. Mack was Senior Director, Corporate Finance for Edge Therapeutics from 2013 to 2015 leading that company’s successful IPO efforts. From 2000 to 2013, Mr. Mack was a senior publishing analyst covering the life sciences sector at various banking institutions including Gruntal & Co, Lazard, and HSBC. Prior to his tenure on Wall Street, Mr. Mack completed research in biochemistry, at Cornell University Medical College and clinical neurology at Columbia University College of Physicians and Surgeons where he was part of a team investigating less invasive treatments for malignant gliomas and cerebrovascular disease including aneurysms, arteriovenous malformations and stroke. Mr. Mack received both his BS in Biochemistry and MBA in Finance from Fordham University. Our Board believes that Mr. Mack is qualified to serve as a director based on his extensive financial background and professional experience in the biotechnology industry.
Gianluca Fuggetta has served as Senior Vice President Finance and Principal Financial Officer of Gain Therapeutics since January 2025. He joined the Company in July 2022 and has held roles of increasing responsibility, including Finance Director, Senior Finance Director, Vice President of Finance, Principal Accounting Officer (since January 2023). Prior to joining Gain Therapeutics, Mr. Fuggetta worked at PwC from September 2013 to June 2022, where he gained extensive experience in audit and assurance services across multiple international offices, including Milan, New York, and Munich, ultimately serving as Assurance Manager. Mr. Fuggetta holds a Bachelor’s degree in Economics from Università Cattolica del Sacro Cuore and a Master’s degree in Accounting from Università Bocconi.
Non-Employee Directors
Khalid Islam, Ph.D. cofounded our company in 2017 and has served as Chairman of the Board since 2017. Dr. Islam has over 35 years of experience in the biotechnology and pharmaceutical industries. He is currently the Chairman of the Board of Fennec Pharmaceuticals Inc. and Minoryx Therapeutics S.L. From 2009 to 2014, Dr. Islam also served as Chairman and Chief Executive Officer of Gentium S.p.A, where, under his leadership, Defitelio was granted marketing authorization and the company went from a $25 million valuation to a $1 billion all-cash merger with Jazz Pharmaceuticals plc. From 1999 to 2008, he served as President and Chief Executive Officer of Arpida AG, where he
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transitioned the early-stage startup to a SWX-listed company and raised $300 million between their initial public offering and follow-ons. From 1987 to 1999, Dr. Islam held various positions at HMR & MMD (now Sanofi-Aventis). Prior to HMR & MMD, he worked in academia at Imperial College, University of London and Milan University, where he was a contract professor. He has also previously served as a director of Immunomedics Inc., Karolinska Development, MolMed S.p.A., OxThera AB, Rheoscience AS, PCovery AS, Adenium AS and C10 Pharma AS. He is an advisor to Kurma Biofund (Paris) and Indaco Ventures (Milan). Dr. Islam is a graduate of Chelsea College and received his Ph.D. from Imperial College, University of London. Our Board believes that Dr. Islam is qualified to serve as a director based on his extensive science background and professional experience.
Dov Goldstein, M.D. has served as a member of our Board since January 2021. Dr. Goldstein has over 20 years of experience in the financial management of various biotechnology and pharmaceutical companies. He currently serves as Chief Financial Officer of BioAge Labs, Inc. (Nasdaq: BIOA), a publicly traded biotechnology company. From January 2020 to June 2021, he served as Chief Financial Officer and Business Officer of Indapta Therapeutics. Dr. Goldstein served as Chief Executive Officer at RIGImmune. At Aisling Capital, a private investment firm, he served as Managing Partner, from 2014 to 2019, Partner from 2009 to 2014 and Principal from 2006 to 2009. Dr. Goldstein served as Chief Financial Officer and director of Loxo Oncology, between July 2014 and January 2015 and as its acting Chief Financial Officer from January 2015 to May 2015. From 2000 to 2005, Dr. Goldstein served as Chief Financial Officer of Vicuron Pharmaceuticals, which was acquired by Pfizer in September 2005. Prior to joining Vicuron, Dr. Goldstein was Director of Venture Analysis at HealthCare Ventures. Dr. Goldstein completed an internship in the Department of Medicine at Columbia-Presbyterian Hospital. Dr. Goldstein serves as a director of Coya Therapeutics, Inc. (Nasdaq: COYA). He served as a director of ADMA Biologics, Cempra (acquired by Melinta Therapeutics), Durata Therapeutics, Esperion Therapeutics, and Loxo Oncology. Dr. Goldstein received a B.S. from Stanford University, an M.B.A. from Columbia Business School, and an M.D. from Yale School of Medicine. Our Board believes that Dr. Goldstein is qualified to serve as a director based on his extensive science background and professional experience.
Hans Peter Hasler has served as a member of our Board since January 2021. Mr. Hasler has over 30 years of experience in the biotechnology and pharmaceutical industries. Mr. Hasler is the Founder and, until February 2020 served as Chief Executive Officer, of Vicarius Pharma AG, a privately held company that provides strategic options to non-European bio-pharma companies bringing late-stage assets to the European market. Mr. Hasler is Chairman of the Board of HBM Healthcare Investments AG in Switzerland, Director of the Board of Minerva Neuroscience Inc., Boston, nonexecutive Chairman of the Board of Shield Therapeutics PLC, London, and Chief Advisor of SBTech Advisory, a small asset scouting company located in Israel, Switzerland, and the USA. His prior experience includes Elan Corporation, where he was Chief Operating Officer, and Biogen, Inc., where his positions included Chief Operating Officer, Executive Vice President, Head of Global Neurology and International. Previously, Mr. Hasler was at Wyeth Pharmaceuticals as Senior Vice President, Chief Marketing Officer and Managing Director of Wyeth Group Germany and General Manager, Wyeth-Lederle Switzerland, Austria and ECE. Mr. Hasler holds a Federal Swiss Commercial Diploma and a Marketing Manager Certificate from the Swiss Institute of Business Economy SIB, Zurich, Switzerland. Our Board believes that Mr. Hasler is qualified to serve as a director based on his extensive science background and professional experience.
Gwen Melincoff has served as a member of our Board since January 2021. Ms. Melincoff is a seasoned business development and venture professional with over 25 years of deal making and management experience in the biotechnology and pharmaceutical industries. Ms. Melincoff is currently managing director at Gemini Advisors LLC, a biopharmaceutical consultancy (since 2013). Ms. Melincoff serves on the Board of Protalix Biotherapeutics, Inc., and in an advisory capacity at a number of pharmaceutical companies. From August 2017 through May 2025, she served on the Board of Collegium Pharmaceutical, Inc., April 2017 through June 2024 on the Board of Soleno Therapeutics, Inc., January 2017 through December 2018 on the Board of Kamada Ltd., the Board of Photocure ASA from April 2017 through June 2020 and from June 2014 through November 2016 on the Board of Tobira Therapeutics Inc. (acquired by Allergan plc). From August 2014 through September 2016, Ms. Melincoff previously served as Vice President of Business Development at BTG International Inc., a UK-specialist healthcare company. Prior to BTG, Ms. Melincoff was Senior Vice President of Corporate Development at Shire Plc (acquired by Takeda). Additionally, she led the Shire Strategic Investment Group, the venture capital arm of Shire Plc. Ms. Melincoff was Vice President of Business Development at Adolor Corporation and held executive positions at Eastman Kodak for over ten years in a number of their health care companies. Ms. Melincoff holds a B.S. in Biology from The George Washington University and an M.S. in Management and Health Care Administration from Pennsylvania State University. Ms. Melincoff has also attained the designation of Certified Licensing Professional (CLP™). Ms. Melincoff was named to the “Top Women in Biotech 2013” by Fierce Biotech and to the Powerlist 100 of Corporate Venture Capital in 2012
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and 2013. Our Board believes that Ms. Melincoff is qualified to serve as a director based on her extensive science background and professional experience.
Claude Nicaise, M.D. has served as a member of our Board since January 2021. Dr. Nicaise has more than 35 years of experience in the development and regulation of biotechnology and pharmaceutical industries. He is the founder of Clinical Regulatory Services, a company providing advice on clinical and regulatory matters to biotechnology companies. Dr. Nicaise serves on the board for Sarepta Therapeutics, Inc. (Nasdaq: SRPT), and is a member of its compensation committee, and is a member of their Research and Development committee since 2015. Dr. Nicaise is a board member of Chemomab Therapeutics Ltd (Nasdaq: CMMB) since 2021 and serves as its chair of the audit committee. Dr. Nicaise is also a member of Cassava Sciences, Inc. (Nasdaq: SAVA) since January 2024 and serves as the chairman of the board since September 2025. Dr. Nicaise was an Executive Vice President Regulatory at Ovid Therapeutics Inc., a company that develops medicines for orphan diseases of the brain. Dr. Nicaise was a Senior Vice President of Strategic Development and Global Regulatory Affairs at Alexion Pharmaceuticals from 2008 to 2014. From 1983 to 2008, Dr. Nicaise served in various positions of increasing responsibility at Bristol-Myers Squibb, including senior positions such as Vice President of Global Development, Vice President of Worldwide Regulatory Science and Strategy, and leadership positions in Oncology, Infectious Disease, and Neuroscience development. Dr. Nicaise received his M.D. from the Université Libre de Bruxelles in Belgium. Our Board believes that Dr. Nicaise is qualified to serve as a director based on his extensive science background and professional experience.
Jeffrey Riley has served as a member of our Board since May 2019. Mr. Riley has more than 25 years of experience in the biotechnology and pharmaceutical industries, during which he has negotiated numerous worldwide strategic corporate alliances, established joint ventures and assisted in venture financings to support product development. He is currently the Chief Executive Officer and Founder for Amphora Labs and Executive Chairman of Blink TBI. Over his career, he has served in various roles and responsibilities in big pharma (SmithKline Beecham and Pfizer), venture capital (Queensland Biocapital Fund / QIC) and numerous biotechnology companies in the capacity of business development and general management. From September 2021 until April 2025, he served as Chief Executive Officer and a director of Caravan Biologix, Inc. From March 2010 until December 2017, he served as the President, Chief Executive Officer and a director of Synthetic Biologics, Inc., a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal diseases. He has served as a member of several public and private boards of directors in the United States and Australia. Mr. Riley received a B.S. from Boise State University, an MBA/MIM from Arizona State University’s Thunderbird School of Global Management and has done advanced science work at the University of California, San Francisco and Berkeley. Our Board believes that Mr. Riley is qualified to serve as a director based on his extensive science background and professional experience.
Independence of the Board
As required under the Nasdaq listing standards, a majority of the members of a listed company’s Board must qualify as “independent,” as affirmatively determined by the Board. The Board consults with its external counsel to ensure that the Board’s determinations are consistent with relevant securities and other laws and regulations regarding the definition of “independent,” including those set forth in pertinent listing standards of Nasdaq, as in effect from time to time.
Consistent with these considerations, after review of all relevant identified transactions or relationships between each director, or any of his or her family members, and us, our senior management and our independent auditors, the Board has affirmatively determined that the following five directors are independent directors within the meaning of the applicable Nasdaq listing standards: Dr. Goldstein, Mr. Hasler, Ms. Melincoff, Dr. Nicaise and Mr. Riley. In making this determination, the Board found that none of these directors had a material or other disqualifying relationship with us. Mr. Mack was determined to not be independent since he serves as our President and Chief Executive Officer, and Dr. Islam was determined to not be independent due to his relationship with Minoryx.
Accordingly, a majority of our directors are independent, as required under applicable Nasdaq rules. In making this determination, our Board considered the applicable Nasdaq rules and the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our Board deemed relevant in determining their independence, including their beneficial ownership of our capital stock.
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Board Leadership Structure
The Chairman of our Board is Dr. Islam. The primary responsibilities of the Chairman of our Board are to: work with our Chief Executive Officer, Mr. Mack, to develop board meeting schedules and agendas; provide our Chief Executive Officer feedback on the quality, quantity and timeliness of the information provided to the Board; develop the agenda for and moderate executive sessions of the independent members of the Board; preside over board meetings; act as principal liaison between the independent members of the Board and the Chief Executive Officer; convene meetings of the independent directors as appropriate; and perform other duties as the Board may determine from time to time. Accordingly, Dr. Islam has substantial ability to shape the work of our Board.
We believe that separation of the positions of Chairman and Chief Executive Officer reinforces the independence of the Board in its oversight of our business and affairs and can enhance the effectiveness of our Board as a whole.
Role of the Board in Risk Oversight
One of the Board’s key functions is informed oversight of our risk management process. The Board does not have a standing risk management committee, but rather administers this oversight function directly through the Board as a whole, as well as through various Board standing committees that address risks inherent in their respective areas of oversight. In particular, our Board is responsible for monitoring and assessing strategic risk exposure, including a determination of the nature and level of risk appropriate for us. Our Audit Committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. The Audit Committee also monitors compliance with legal and regulatory requirements, in addition to oversight of cybersecurity risk management as well as incidental reports as matters arise. Our Nominating and Corporate Governance Committee monitors the effectiveness of our Corporate Governance Guidelines, including whether they are successful in preventing illegal or improper liability-creating conduct. Our Compensation Committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk-taking. It is the responsibility of the committee chairs to report findings regarding material risk exposures to the Board as quickly as possible. The Board has delegated to the Board’s chair the responsibility of coordinating between the Board and management with regard to the determination and implementation of responses to any problematic risk management issues.
Information Regarding Committees of the Board
Our Board has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee. The following table provides membership and meeting information for the fiscal year ended 2025 for each of the Board committees:
Nominating and
Corporate
Name
Audit
Compensation
Governance
Gene Mack
Khalid Islam, Ph.D.
Dov Goldstein, M.D.
X*
X
Hans Peter Hasler
X
X*
Gwen Melincoff
X
Claude Nicaise, M.D.
X
X
Jeffrey Riley
X
X*
Total meetings in fiscal year 2025
4
2
2
*
Committee Chairperson
Our Board has determined that each member of each standing committee meets the applicable Nasdaq rules and regulations regarding “independence,” and each member is free of any relationship that would impair his or her individual exercise of independent judgment with regard to us.
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Below is a description of each standing committee of our Board:
Audit Committee
The Audit Committee of the Board was established by the Board in accordance with Section 3(a)(58)(A) of the Exchange Act, to oversee our corporate accounting and financial reporting processes and audits of our financial statements. For this purpose, the Audit Committee performs several functions. The Audit Committee evaluates the performance of and assesses the qualifications of the independent auditors; determines and approves the engagement of the independent auditors; determines whether to retain or terminate the existing independent auditors or to appoint and engage new independent auditors; reviews and approves the retention of the independent auditors to perform any proposed permissible non-audit services; monitors the rotation of partners of the independent auditors on our audit engagement team as required by law; reviews and approves or rejects transactions between the company and any related persons; confers with management and the independent auditors regarding the effectiveness of internal control over financial reporting; establishes procedures, as required under applicable law, for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or auditing matters and the confidential and anonymous submission by employees of concerns regarding questionable accounting or auditing matters; and meets to review our annual audited financial statements and quarterly financial statements with management and the independent auditor, including a review of our disclosures under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our annual and quarterly reports filed with the SEC.
The Audit Committee is composed of three directors: Dov Goldstein (Chairperson), Hans Peter Hasler, and Jeffrey Riley . The Board has adopted a written Audit Committee charter that is available to stockholders on our website at https://www.gaintherapeutics.com/index.php/investors-media/governance-documents .
The Board reviews the Nasdaq listing standards definition of independence for Audit Committee members on an annual basis and has determined that all members of our Audit Committee are independent, as independence is currently defined in Rule 5605(c)(2)(A)(i) and (ii) of the Nasdaq Listing Rules.
The Board has also determined that Dr. Goldstein qualifies as an “audit committee financial expert,” as defined in applicable SEC rules. The Board made a qualitative assessment of Dr. Goldstein’s level of knowledge and experience based on a number of factors, including his formal education and experience as a chief financial officer for public reporting companies.
The Audit Committee is responsible for assisting our Board in its oversight of the integrity of our consolidated financial statements, the qualifications and independence of our independent auditors and our internal financial and accounting controls. The principal duties and responsibilities of our Audit Committee include, among other things:
● selecting a qualified firm to serve as the independent registered public accounting firm to audit our financial statements;
● helping to ensure the independence and performance of the independent registered public accounting firm;
● discussing the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the independent accountants, our interim and year-end operating results;
● developing procedures for employees to submit concerns anonymously about questionable accounting or audit matters;
● reviewing our policies on risk assessment and risk management;
● reviewing related party transactions; and
● obtaining and reviewing a report by the independent registered public accounting firm at least annually, that describes our internal quality control procedures, any material issues with such procedures, and any steps taken to deal with such issues when required by applicable law; and approving (or, as permitted, pre-approving) all audit and all permissible non-audit services, other than de minimis non-audit services, to be performed by the independent registered public accounting firm.
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Compensation Committee
The Compensation Committee is composed of three directors: Jeffrey Riley (Chairperson), Gwen Melincoff, and Claude Nicaise. All members of our Compensation Committee are independent, as independence is currently defined in Rule 5605(d)(2) of Nasdaq Listing Rules. The Board has adopted a written Compensation Committee charter that is available to stockholders on our website at https://www.gaintherapeutics.com/index.php/investors-media/governance-documents.
The Compensation Committee acts on behalf of the Board to review, recommend for adoption and oversee our compensation strategy, policies, plans and programs, including:
● establishment of corporate and individual performance objectives relevant to the compensation of our executive officers, directors and other senior management and evaluation of performance in light of these stated objectives;
● review and recommendation to the Board for approval of the compensation and other terms of employment or service, including severance and change-in-control arrangements, of our Chief Executive Officer, the other executive officers and directors; and
● administration of our equity compensation plans, pension and profit-sharing plans, deferred compensation plans and other similar plan and programs.
Compensation Committee Processes and Procedures
Typically, the Compensation Committee meets at least two times annually and with greater frequency if necessary. The agenda for each meeting is usually developed by the Chair of the Compensation Committee, in consultation with management. The Compensation Committee meets regularly in executive session. However, from time to time, various members of management and other employees as well as outside advisors or consultants may be invited by the Compensation Committee to make presentations, to provide financial or other background information or advice or to otherwise participate in Compensation Committee meetings. Mr. Mack, our Chief Executive Officer, may not participate in, or be present during, any deliberations or determinations of the Compensation Committee regarding his compensation.
The charter of the Compensation Committee grants the Compensation Committee full access to all books, records, facilities and personnel of the Company. In addition, under the charter, the Compensation Committee has the authority to obtain, at the expense of the Company, advice and assistance from compensation consultants and internal and external legal, accounting or other advisors and other external resources that the Compensation Committee considers necessary or appropriate in the performance of its duties. The Compensation Committee has direct responsibility for the oversight of the work of any consultants or advisers engaged for the purpose of advising the Committee. In particular, the Compensation Committee has the sole authority to retain, in its sole discretion, compensation consultants to assist in its evaluation of executive and director compensation, including the authority to approve the consultant’s reasonable fees and other retention terms. Under the charter, the Compensation Committee may select, or receive advice from, a compensation consultant, legal counsel or other adviser to the compensation committee, other than in-house legal counsel and certain other types of advisers, only after taking into consideration six factors, prescribed by the SEC and Nasdaq, that bear upon the adviser’s independence; however, there is no requirement that any adviser be independent.
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Historically, the Compensation Committee has made most of the significant adjustments to annual compensation, determined bonus and equity awards and established new performance objectives at one or more meetings held during the first quarter of the year. However, the Compensation Committee also considers matters related to individual compensation, such as compensation for new executive hires, as well as high-level strategic issues, such as the efficacy of our compensation strategy, potential modifications to that strategy and new trends, plans or approaches to compensation, at various meetings throughout the year. Generally, the Compensation Committee’s process comprises two related elements: the determination of compensation levels and the establishment of performance objectives for the current year. For executives other than the Chief Executive Officer, the Compensation Committee solicits and considers evaluations and recommendations submitted to the Compensation Committee by the Chief Executive Officer. In the case of the Chief Executive Officer, the evaluation of his performance is conducted by the Compensation Committee, which determines any adjustments to his compensation as well as awards to be granted. For all executives and directors as part of its deliberations, the Compensation Committee may review and consider, as appropriate, materials such as financial reports and projections, operational data, tax and accounting information, tally sheets that set forth the total compensation that may become payable to executives in various hypothetical scenarios, executive and director stock ownership information, company stock performance data, analyses of historical executive compensation levels and current company-wide compensation levels and recommendations of its compensation consultant, including analyses of executive and director compensation paid at other companies identified by the consultant.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee is composed of three directors: Hans Peter Hasler (Chairperson), Dov Goldstein and Claude Nicaise. All members of the Nominating and Corporate Governance Committee are independent, as independence is currently defined in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Board has adopted a written Nominating and Corporate Governance Committee charter that is available to stockholders on our website https://www.gaintherapeutics.com/index.php/investors-media/governance-documents.
The Nominating and Corporate Governance Committee is responsible for identifying, reviewing and evaluating candidates to serve as our directors (consistent with criteria approved by the Board), reviewing and evaluating incumbent directors, recommending to the Board for selection candidates for election to the Board, making recommendations to the Board regarding the membership of the committees of the Board, assessing the performance of management and the Board, and developing a set of corporate governance principles for us.
The Nominating and Corporate Governance Committee believes that candidates for director should have certain minimum qualifications, including the ability to read and understand basic financial statements, being over 35 years of age and having the highest personal integrity and ethics. The Nominating and Corporate Governance Committee also intends to consider such factors as possessing relevant expertise upon which to be able to offer advice and guidance to management, having sufficient time to devote to the affairs of the Company, demonstrated excellence in his or her field, having the ability to exercise sound business judgment and having the commitment to rigorously represent the long-term interests of our stockholders. However, the Nominating and Corporate Governance Committee retains the right to modify these qualifications from time to time. Candidates for director nominees are reviewed in the context of the current composition of the Board, the operating requirements of the Company and the long-term interests of our stockholders. In conducting this assessment, the Nominating and Corporate Governance Committee typically considers diversity (including gender, racial and ethnic diversity), age, skills and such other factors as it deems appropriate, given the current needs of the Board and us, to maintain a balance of knowledge, experience and capability.
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The Nominating and Corporate Governance Committee appreciates the value of thoughtful Board refreshment, and regularly identifies and considers qualities, skills and other director attributes that would enhance the composition of the Board. In the case of incumbent directors whose terms of office are set to expire, the Committee reviews these directors’ overall service to the Company during their terms, including the number of meetings attended, level of participation, quality of performance and any other relationships and transactions that might impair the directors’ independence. The Committee also takes into account the results of the Board’s self-evaluation, conducted annually on a group and individual basis. In the case of new director candidates, the Nominating and Corporate Governance Committee also determines whether the nominee is independent for Nasdaq purposes, which determination is based upon applicable Nasdaq listing standards, applicable SEC rules and regulations and the advice of counsel, if necessary. The Nominating and Corporate Governance Committee then uses its network of contacts to compile a list of potential candidates, but may also engage, if it deems appropriate, a professional search firm. The Nominating and Corporate Governance Committee conducts any appropriate and necessary inquiries into the backgrounds and qualifications of possible candidates after considering the function and needs of the Board. The Nominating and Corporate Governance Committee meets to discuss and consider the candidates’ qualifications and then selects a nominee for recommendation to the Board by majority vote.
The Nominating and Corporate Governance Committee will consider director candidates recommended by stockholders. The Nominating and Corporate Governance Committee does not intend to alter the manner in which it evaluates candidates, including the minimum criteria set forth above, based on whether or not the candidate was recommended by a stockholder. Stockholders who wish to recommend individuals for consideration by the Nominating and Corporate Governance Committee to become nominees for election to the Board may do so by delivering a written recommendation to the Nominating and Corporate Governance Committee at the following address: 4800 Montgomery Lane, Suite 220, Bethesda, Maryland, at least 120 days prior to the anniversary date of the mailing of our proxy statement for the last annual meeting of stockholders. Submissions must include the full name of the proposed nominee, a description of the proposed nominee’s business experience for at least the previous five years, complete biographical information, a description of the proposed nominee’s qualifications as a director and a representation that the nominating stockholder is a beneficial or record holder of our stock and has been a holder for at least one year. Any such submission must be accompanied by the written consent of the proposed nominee to be named as a nominee and to serve as a director if elected.
Code of Ethics
We have adopted a Code of Business Conduct and Ethics that applies to all of our officers, directors and employees. The Code of Business Conduct and Ethics is available on our website at https://www.gaintherapeutics.com/index.php/investors-media/governance-documents. If we make any substantive amendments to the Code of Business Conduct or we grant any waiver from a provision of the Code of Business Conduct to any executive officer or director, we will promptly disclose the nature of the amendment or waiver on our website.
Corporate Governance Guidelines
Our Board has adopted Corporate Governance Guidelines, a Code of Business Conduct and Ethics and charters for the Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee of our Board to assist the Board in the exercise of its responsibilities and to serve as a framework for the effective governance of the Company. You can access our current committee charters, our Corporate Governance Guidelines and our Code of Business Conduct and Ethics in the “Corporate Governance” section of the “Investors & Media” page of our website located at https://www.gaintherapeutics.com/index.php/investors-media/governance-documents or by writing to our Secretary at our offices at 4800 Montgomery Lane, Suite 220 Bethesda, Maryland 20814.
Insider Trading Policies
We have adopted an insider trading policy that governs the purchase, sale, and/or other transactions of our securities by our directors, officers and employees. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K for the fiscal year ended December 31, 2025. In addition, with regard to the Company’s trading in its own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements in all respects.
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ITEM 11. EXECUTIVE COMPENSATION
Compensation Overview
The following tables and accompanying disclosure set forth information about the compensation earned by our named executive officers during 2025. Our named executive officers include our principal executive officer, the two most highly compensated executive officers (other than our principal executive officer) serving as executive officers as of December 31, 2025, and the individuals who would otherwise be included but for the fact that such individual was not serving as an executive officer of ours as of December 31, 2025, as set forth below. Our named executive officers for 2025 who appear in the Summary Compensation Table are:
● Gene Mack, our former Chief Financial Officer who was promoted to our Interim Chief Executive Officer on June 25, 2024 and appointed as the permanent Chief Executive Officer on January 6, 2025; and
● Gianluca Fuggetta, who served as Vice President Finance and Principal Financial Officer from February 21, 2024 to April 5, 2024 and appointed Senior Vice President Finance and Principal Financial Officer on January 6, 2025.
SUMMARY COMPENSATION TABLE
The following table shows, as of the years ended December 31, 2025 and 2024, compensation awarded to or paid to, or earned by, our named executive officers.
SUMMARY COMPENSATION TABLE
Non-Equity
Incentive
Option
Plan
All Other
Name and Principal
Salary
Awards
Compensation
Compensation
Total
Position
Year
($) (1)
($) (2)
($) (3)
($)
($)
Gene Mack (4)
2025
500,000
802,819
150,000
14,320
(5)
1,467,139
Chief Executive Officer
2024
270,621
(6)
455,660
—
11,439
(5)
737,720
Gianluca Fuggetta (7)
2025
241,352
(8)
82,000
21,722
(8)
—
345,074
Principal Financial Officer
2024
204,488
(9)
139,565
23,857
(9)
—
367,910
(1) Salary amounts represent actual amounts earned with respect to 2025. See “Narrative to Summary Compensation Table–Annual Base Salary” below.
(2) In accordance with SEC rules, this column reflects the aggregate grant date fair value of the option awards granted during 2025 and 2024 computed in accordance with ASC 718 for stock-based compensation transactions. Assumptions used in the calculation of these amounts are included in Note 15 to our audited consolidated financial statements. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the options, the exercise of the options or the sale of shares of common stock underlying such options.
(3) Reflects performance-based cash bonuses paid to our named executive officers during the years ended December 31, 2025 and 2024. See “Non-Equity Incentive Plan Compensation” below for a description of the material terms of the program pursuant to which this compensation was earned.
(4) Mr. Mack joined the Company as our Chief Financial Officer on April 8, 2024. He was elevated to Interim Chief Executive Officer on June 25, 2024 and appointed permanent Chief Executive Officer on January 6, 2025.
(5) Amount reflects medical, dental and vision insurance premium amounts paid by us on behalf of Mr. Mack, as well as life, long-term disability, short-term disability and accidental death and dismemberment insurance premiums paid by us on his behalf.
(6) Mr. Mack received an annual base salary of $370,000 during his time as Interim Chief Executive Officer from June 25, 2024 to December 31, 2024 and Chief Financial Officer from April 8, 2024 through December 31, 2024.
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(7) Mr. Fuggetta served as our Principal Financial Officer from February 21, 2024 to April 5, 2024 until the appointment of Mr. Mack as Chief Financial Officer on April 8, 2024. Upon Mr. Mack’s elevation to Chief Executive Officer as of January 6, 2025, Mr. Fuggetta was appointed Senior Vice President Finance and Principal Financial Officer.
(8) Mr. Fuggetta received an annual base salary of CHF 200,000 and non-equity incentive plan compensation of CHF 18,000, which for reporting purposes has been converted into U.S. dollars at the 2025 average exchange rate of $1.207.
(9) Mr. Fuggetta received an annual base salary of CHF 180,000 and non-equity incentive plan compensation of CHF 21,000, which for reporting purposes has been converted into U.S. dollars at the 2024 average exchange rate of $1.136. Mr. Fuggetta received no additional compensation for his role as Principal Financial Officer from February 21, 2024 to April 5, 2024.
NARRATIVE TO SUMMARY COMPENSATION TABLE
Elements of Compensation
Our Board reviews compensation annually for all employees, including our named executive officers. In setting executive base salaries and bonuses and granting equity incentive awards, we consider compensation for comparable positions in the market, the historical compensation levels of our executives, individual performance as compared to our expectations and objectives, our desire to motivate our employees to achieve short- and long-term results that are in the best interests of our stockholders and a long-term commitment to our company.
Generally, our Board has historically determined the compensation of our executives, upon recommendation of the Compensation Committee. The Compensation Committee has reviewed and recommended to the Board for approval the compensation and other terms of employment of our Chief Executive Officer and evaluates the Chief Executive Officer’s performance in light of relevant corporate goals and objectives. Our Chief Executive Officer has typically discussed his recommendations for all other executives (other than himself) with the compensation committee and the Board. Based on those discussions and its discretion, the Compensation Committee has recommended the cash compensation of each executive officer to the Board, and the Board has then approved. The Compensation Committee administers our equity compensation plans and approves or recommends to the Board for approval awards made to our executives thereunder.
Annual Base Salary
The annual base salaries of our named executive officers are generally reviewed, determined and approved by the Board periodically upon the recommendation of the Compensation Committee in order to compensate our named executive officers for the satisfactory performance of duties to our company. Annual base salaries are intended to provide a fixed component of compensation to our named executive officers, reflecting their skill sets, experience, roles and responsibilities. Base salaries for our named executive officers have generally been set at levels deemed necessary to attract and retain individuals with superior talent.
The following table sets forth the annual base salaries for each of our named executive officers for the years indicated:
2025 Base
2026 Base
Salary
Salary
Name
($)
($)
Gene Mack (1)
500,000
520,000
Gianluca Fuggetta (2)
241,352
251,006
(1) Mr. Mack served as our Chief Financial Officer from April 8, 2024 to January 6, 2025. From June 25, 2024 to January 7, 2025, Mr. Mack also served as our Interim Chief Executive Officer, a role for which he received no additional compensation. He was appointed as our permanent Chief Executive Officer on January 6, 2025.
(2) Mr. Fuggetta was appointed our Senior Vice President Finance and Principal Financial Officer effective January 6, 2025. Mr. Fuggetta’s base salary has been converted from Swiss francs into U.S. dollars at the 2025 average exchange rate of $1.207.
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Non-Equity Incentive Plan Compensation
In accordance with the terms of their respective employment agreements, our named executive officers are eligible to receive discretionary annual bonuses of a percentage of each executive’s gross base salary based on individual performance, company performance or as otherwise determined appropriate, as determined by the Compensation Committee and the Board. The actual annual bonus earned in any particular year may be more or less than the target bonus based on the achievement of corporate and personal goals established and approved by the Compensation Committee and the Board, the achievement of which is determined at the discretion of the Compensation Committee and the Board. The executive officers must remain employed by the company through the date of payment in order to remain eligible for such annual bonus.
2025 Bonus
2026 Bonus
Target
Target
Name
(%)
(%)
Gene Mack (1)
50
50
Gianluca Fuggetta (2)
30
30
(1) Mr. Mack served as our Chief Financial Officer from April 8, 2024 to January 7, 2025. From June 25, 2024 to January 7, 2025, Mr. Mack also served as our Interim Chief Executive Officer, a role for which he received no additional compensation.
(2) Mr. Fuggetta served as our Principal Financial Officer from February 21, 2024 to April 5, 2024. He was appointed as our Senior Vice President Finance and Principal Financial Officer effective January 6, 2025.
In December 2025, the Compensation Committee completed an evaluation of our overall performance for 2025 and the named executive officers’ respective contributions in achieving this performance. The Compensation Committee’s review was based on company performance against corporate objectives previously approved by the Board. The Compensation Committee determined, at its own discretion, and upon its review of the company’s and Mr. Mack’s and Mr. Fuggetta’s performance against corporate objectives and based on additional achievements and their overall performance, that Mr. Mack had earned a bonus of $375,000, and Mr. Fuggetta had earned a bonus of CHF 60,000.
Equity-Based Incentive Awards
Our equity-based incentive awards granted to our named executive officers are designed to align our interests and those of our stockholders with those of our employees and consultants, including our executive officers.
Historically, we have used stock options as an incentive for long-term compensation to our executive officers because the options allow our executive officers to profit from this form of equity compensation only if our stock price increases relative to the option’s exercise price, which exercise price is set at the fair market value of our shares of common stock on the date of grant. We have also used restricted stock unit awards as long-term incentives for our executive officers, in combination with or without stock option awards.
Vesting of equity awards is generally tied to each officer’s continuous service with us and serves as an additional retention measure. We may grant equity awards at such times as our Board or Compensation Committee determines appropriate. Our executives generally are awarded an initial grant in the form of an option, at times accompanied by restricted stock units, in connection with their commencement of employment with us. Additional grants may occur periodically in order to specifically incentivize executives with respect to achieving certain corporate goals or to reward executives for exceptional performance.
All options are granted with an exercise price per share that is no less than the fair market value of our common stock on the date of grant of such award. Our option awards generally vest over a four-year period and may be subject to acceleration of vesting and exercisability under certain termination and change in control events. See “Outstanding Equity Awards at Fiscal Year End” for further information regarding option and stock awards granted during fiscal year 2025.
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Outstanding Equity Awards at Fiscal Year End
The following table sets forth certain information regarding outstanding equity awards granted to our named executive officers that remained outstanding as of December 31, 2025.
Option Awards
Number of
Number of
Securities
Securities
Underlying
Underlying
Option
Unexercised
Unexercised
Exercise
Option
Grant
Options (#)
Options (#)
Price
Expiration
Name
Date
Exercisable
Unexercisable
($)
Date
Gene Mack
01/06/25
—
271,325
(1)
2.44
01/06/35
Chief Executive Officer
03/20/25
—
200,000
(2)
2.29
03/20/35
04/05/24
83,333
(3)
116,667
(3)
3.56
04/05/34
Gianluca Fuggetta
03/20/25
—
50,000
(4)
2.29
03/20/35
Principal Financial Officer
03/21/24
21,874
(5)
28,126
(5)
4.37
03/21/34
03/23/23
10,312
(6)
4,688
(6)
4.84
03/23/33
07/01/22
8,532
(7)
1,468
(7)
3.47
06/30/32
(1) Subject to Mr. Mack’s continued service through each applicable vesting date, the option awards will vest and become exercisable 25% on January 6, 2026, with the remaining balance vesting and becoming exercisable in substantially equal monthly installments over the next three years left in the service period. The option awards have been granted from the 2022 Inducement Plan.
(2) Subject to Mr. Mack’s continued service through each applicable vesting date, the option awards will vest and become exercisable 25% on March 20, 2026, with the remaining balance vesting and becoming exercisable in substantially equal monthly installments over the next three years left in the service period. The option awards have been granted from the 2022 Inducement Plan.
(3) 25% of the option awards vested and became exercisable on April 5, 2025. Starting from May 5, 2025 the option awards started vesting in substantially equal monthly installments and will continue to vest on a monthly basis subject to Mr. Mack’s continued service through each applicable vesting date until the end of the four-year vesting period. The option awards have been granted from the 2021 Inducement Plan.
(4) Subject to Mr. Fuggetta’s continued service through each applicable vesting date, the option awards will vest and become exercisable 25% on March 20, 2026, with the remaining balance vesting and becoming exercisable in substantially equal monthly installments over the next three years left in the service period. The option awards have been granted from the 2022 Plan.
(5) 25% of the option awards vested and became exercisable on March 21, 2025. Starting from April 21, 2025 the option awards started vesting in substantially equal monthly installments and will continue to vest on a monthly basis subject to Mr. Fuggetta’s continued service through each applicable vesting date until the end of the four-year vesting period. The option awards have been granted from the 2022 Plan.
(6) 25% of the option awards vested and became exercisable on March 23, 2024. Starting from April 23, 2024 the option awards started vesting in substantially equal monthly installments and will continue to vest on a monthly basis subject to Mr. Fuggetta’s continued service through each applicable vesting date until the end of the four-year vesting period. The option awards have been granted from the 2022 Plan.
(7) 25% of the option awards vested and became exercisable on July 1, 2023. Starting from August 1, 2023 the option awards started vesting in substantially equal monthly installments and will continue to vest on a monthly basis subject to Mr. Fuggetta’s continued service through each applicable vesting date until the end of the four-year vesting period. The option awards have been granted from the 2022 Plan.
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The Company’s Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
We do not have any formal policy that requires us to grant, or avoid granting, equity-based compensation to our executive officers at certain times. Consistent with our annual compensation cycle, the Compensation, Corporate Governance and Nominating Committee has for several years granted annual equity awards to its executive officers and directors at the start of the new fiscal year. The timing of any equity grants to executive officers in connection with new hires, promotions, or other non-routine grants is tied to the event giving rise to the award (such as an executive officer’s commencement of employment or promotion effective date). As a result, in all cases, the timing of grants of equity awards, including stock options, occurs independent of the release of any material nonpublic information , and we do not time the disclosure of material nonpublic information for the purpose of affecting the value of equity-based compensation.
Other than as reflected in the table below, no stock options were issued to executive officers in fiscal year 2025 during any period beginning four business days before the filing of a periodic report or current report disclosing material non-public information and ending one business day after the filing or furnishing of such report with the SEC.
Percentage Change in the Closing Market
Price of the Securities Underlying the
Award Between the Trading Day Ending
Immediately Prior to the Disclosure
Number of
Exercise
of Material Nonpublic Information
Securities
Price of the
Grant Date
and the Trading Day Beginning
Grant
Underlying the
Award
Fair Value
Immediately Following the Disclosure
Name
Date
Award
($)
($)
of Material Nonpublic Information
Gene Mack
1/6/2025
271,325
2.44
474,819
( 0.5 )
%
Chief Executive Officer
Health and Welfare and Retirement Benefits
Our named executive officers are eligible to participate in benefits available generally to salaried employees, such as participation in our 401(k) plan in the United States, paid time off, and holiday, in each case on the same basis as our other employees.
The Compensation Committee periodically reviews the levels of benefits provided to executive officers to ensure that they remain reasonable and consistent with its compensation philosophy. Our Board may elect to adopt qualified or nonqualified benefit plans in the future, if it determines that doing so is in our best interests.
Perquisites
We generally do not provide significant perquisites or personal benefits to our executive officers.
Employment Agreements and Severance Benefits
We provide our executive officers with certain severance protections in their employment agreements in order to attract and retain an appropriate caliber of talent for such positions. Our employment agreements with the named executive officers and the severance provisions set forth therein are summarized below under “Employment Arrangements” and “Potential Payments and Benefits upon Termination or Change in Control.” Our Compensation Committee intends to periodically review the level of the benefits in these agreements.
Employment Arrangements
We are currently party to employment agreements with Messrs. Mack and Fuggetta in their roles as our current executive officers.
The agreements set forth the terms and conditions of each such individual’s employment with us, including base salary or fees for service, bonus opportunity and eligibility for employee benefits. Additionally, either in such agreements or in the ancillary agreements thereunder, our named executive officers have certain continuing obligations set forth in certain non-solicitation and non-competition provisions. Our agreements with Messrs. Mack and Fuggetta,
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set forth certain severance benefits upon a qualifying termination of employment. Any potential payments and benefits due upon a qualifying termination or a change in control are further described below under “Potential Payments and Benefits upon Termination or Change in Control.”
The employment or of our named executive officers may be terminated at any time subject to any applicable notice provisions and other terms of the respective agreements. In addition, each of our named executive officers has executed a form of our standard confidential information and inventions assignment agreement. The material terms of each agreement are described below.
Gene Mack
Chief Executive Officer
In connection with Mr. Mack’s appointment as our President and Chief Executive Officer, we entered into an amended and restated employment agreement with Mr. Mack, dated January 6, 2025 (the “Mack CEO Amendment”), pursuant to which Mr. Mack is entitled to an annual base salary of $500,000 and is eligible for an annual incentive cash bonus with a target payout of 50% of his annual base salary.
In the event of termination of Mr. Mack’s employment without “Cause”, by Mr. Mack for “Good Reason” or Mr. Mack’s employment terminates upon his death or “Disability” (as each such capitalized term is defined in the Mack CEO Amendment), in all cases subject to Mr. Mack entering into and not revoking a separation agreement, then he will be entitled to severance as follows: (i) an amount equal to his base salary in effect immediately prior to the termination date and (ii) for the period starting on the date of termination and ending 12 months after such date, or, in the event of a change of control, the period starting on the date of termination and ending 18 months after such date (the “Severance Period”), the cost of continuation coverage pursuant to COBRA or applicable state continuation coverage laws, for Mr. Mack and his eligible dependents who were covered under our health insurance plans as of the date of termination.
Alternatively, if Mr. Mack’s employment is terminated during a change of control period by us without “Cause” or by Mr. Mack for “Good Reason,” then he will be entitled to (i) the Pro-Rata Annual Bonus (as defined in the Amendment) and the amount of the Target Bonus (as defined in the Amendment) that would accrue during the Severance Period and (ii) acceleration of vesting of all outstanding unvested stock awards, including future stock options, RSUs, restricted stock and such other awards granted pursuant to our stock option and equity incentive award plans and any shares of stock issued upon exercise thereof. In either case, Mr. Mack’s receipt of severance payments and benefits is subject to Mr. Mack signing (and not revoking) a release of claims within the time period stated therein, but in no event later than sixty days after the termination.
In addition, the Mack CEO Amendment provides that Mr. Mack is eligible for equity incentive grants as determined by the Board in its sole discretion from time to time. Mr. Mack is also eligible to participate in our employee benefit plans, as may be maintained by us from time to time, on the same terms as other similarly situated employees of the Company.
Gianluca Fuggetta
In connection with his appointment as our Principal Financial Officer, we entered into an employment agreement with Mr. Fuggetta, effective January 1, 2025, whereby Mr. Fuggetta is entitled to receive an annual base salary of CHF 200,000 and is eligible to receive, as determined by the Board in its sole discretion, an annual incentive cash bonus with a target payout of 30% of his annual base salary. Further, if we terminate Mr. Fuggetta without good cause, we will pay to Mr. Fuggetta severance equal to six months base salary. If we terminate Mr. Fuggetta within 12 months following a change in control without good cause, the gross severance will equal to 12 months of his annual base salary.
Potential Payments Upon Termination or Change in Control
Our named executive officers are entitled to certain severance benefits upon certain qualified terminations of employment and upon certain qualified changes in control of the Company, each as summarized below.
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Gene Mack
In the event of termination of Mr. Mack’s employment by the Company without “Cause”, by Mr. Mack for “Good Reason” or Mr. Mack’s employment terminates upon his death or “Disability” (as each such capitalized term is defined in the Amendment), in all cases subject to Mr. Mack entering into and not revoking a separation agreement in a form acceptable to the Company, then he will be entitled to severance as follows: (i) an amount equal to his base salary in effect immediately prior to the termination date and (ii) for the period starting on the date of termination and ending 12 months after such date, or, in the event of a change of control, the period starting on the date of termination and ending 18 months after such date (the “Severance Period”), the cost of continuation coverage pursuant to COBRA or applicable state continuation coverage laws, for Mr. Mack and his eligible dependents who were covered under the Company’s health insurance plans as of the date of termination.
Alternatively, if Mr. Mack’s employment is terminated during a change of control period, as defined in the Mack Employment Agreement, by the Company without “Cause” or by Mr. Mack for “Good Reason,” then he will be entitled to (i) the Pro-Rata Annual Bonus (as defined in the Amendment) and the amount of the Target Bonus (as defined in the Amendment) that would accrue during the Severance Period and (ii) acceleration of vesting of all outstanding unvested stock awards, including future stock options, RSUs, restricted stock and such other awards granted pursuant to the Company’s stock option and equity incentive award plans and any shares of stock issued upon exercise thereof. In either case, Mr. Mack’s receipt of severance payments and benefits is subject to Mr. Mack signing (and not revoking) a release of claims within the time period stated therein, but in no event later than sixty days after the termination.
Gianluca Fuggetta
In the event of termination of Mr. Fuggetta’s employment by the Company without good cause (in accordance with art. 340c para. 2 Swiss Code of Obligation), Mr. Fuggetta is entitled to a gross severance equal to six (6) months base salary.
Alternatively, if Mr. Fuggetta’s employment is terminated during a change of control period, as defined in the Fuggetta Employment Agreement, by the Company without good cause (in accordance with art. 340c para. 2 Swiss Code of Obligation), Mr. Fuggetta is entitled to an additional six (6) months base salary for a total of twelve (12) months base salary.
Equity Incentive Agreements
Our equity incentive plans and award agreements thereunder also provide for certain protections in the event of specified termination and change in control events, as summarized below.
2020 Omnibus Incentive Plan (“Prior Plan”). Unless an award agreement provides otherwise, in the event of a change in control (as defined in the Prior Plan) and either an award is not assumed or substituted by the acquirer or it is assumed or substituted, but the participant’s employment is terminated without cause or for good reason (as such terms are defined in the Prior Plan) within 12 months following the change in control (a “Qualifying Termination”), (i) any unvested awards will become fully vested and exercisable (if applicable), and (ii) any applicable performance conditions will be deemed to be achieved at target performance levels.
2021 Inducement Plan . The 2021 Inducement Plan provides for the same treatment of outstanding awards in the event of a Qualifying Termination as provided under the Prior Plan, noted above.
In addition, the option and RSU agreements under the 2021 Inducement Plan provide that in the event that a participant’s employment is terminated by the Company without cause or due to the participant’s death or disability, subject to the execution and delivery of an effective release of claims, the shares subject to the options or RSUs that are scheduled to vest in the six months following the termination date will immediately vest on the date of termination.
2022 Plan. Unless an award agreement provides otherwise, under the 2022 Plan, in the event of a corporate transaction (as defined in the 2022 Plan) where outstanding awards are not assumed, continued, or substituted, awards held by current participants will vest in full contingent upon the effectiveness of the transaction, and any performance-vesting conditions will be deemed satisfied at 100% of the target level of performance.
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NON-EMPLOYEE DIRECTOR COMPENSATION
The following table sets forth information regarding compensation earned by or paid to our non-employee directors for the fiscal year ended December 31, 2025. Mr. Mack is a named executive officer whose compensation is included in the “Summary Compensation Table” and as described in the related narrative disclosure above. Mr. Mack does not receive any compensation for his service as a director.
Fees
Name
Earned or Paid in Cash ($)
Option Awards ($) (1)
Total ($)
Khalid Islam, Ph.D.
75,000
18,150
93,150
Dov Goldstein, M.D.
62,000
18,150
80,150
Hans Peter Hasler
58,500
18,150
76,650
Eric Richman (2)
34,274
4,840
39,114
Gwen Melincoff
45,000
18,150
63,150
Claude Nicaise, M.D.
50,000
18,150
68,150
Jeffrey Riley
60,500
18,150
78,650
(1) In accordance with SEC rules, this column reflects the aggregate grant date fair value of the option awards granted during the periods presented computed in accordance with ASC 718 for stock-based compensation transactions. Assumptions used in the calculation of these amounts are included in Note 15 to our consolidated financial statements. These amounts do not reflect the actual economic value that will be realized by the director upon the vesting of the options, the exercise of the options or the sale of the shares of common stock underlying such options.
(2) Mr. Richman resigned from the board of directors effective October 7, 2025.
The following table provides information regarding the number of shares of common stock underlying options granted to our non-employee directors that were outstanding as of December 31, 2025:
Option Awards
Outstanding at
Name
Year-End (#)
Khalid Islam, Ph.D.
83,770
Dov Goldstein, M.D.
70,558
Hans Peter Hasler
70,558
Eric Richman (1)
290,824
Gwen Melincoff
70,558
Claude Nicaise, M.D.
70,558
Jeffrey Riley
96,982
(1) Mr. Richman resigned from the board of directors effective October 7, 2025.
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
On September 20, 2022, we adopted a formal non-executive director compensation policy based upon market research and advice from our compensation consultant. Under our non-employee director compensation policy, each of our non-employee directors is eligible to receive cash and equity compensation for service on our Board and committees of our Board.
Cash Compensation
The non-employee director compensation policy provides our non-employee directors with the following cash compensation for their services:
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Annual Cash Retainer ($)
Annual retainer
40,000
Additional retainer for non-executive chairperson
35,000
Additional retainer for audit committee chair
17,000
Additional retainer for audit committee member
7,500
Additional retainer for compensation committee chair
13,000
Additional retainer for compensation committee member
5,000
Additional retainer for nominating and governance committee chair
11,000
Additional retainer for nominating and governance committee member
5,000
These retainers are payable in arrears in four equal quarterly installments within thirty days after the end of each calendar quarter, provided that the amount of such payment will be prorated for any portion of such quarter that the director is not serving on our Board. We also reimburse our directors for their reasonable out-of-pocket expenses in connection with attending our Board and Committee meetings.
Equity Compensation
In addition to cash compensation, each non-employee director is eligible to receive options under the 2022 Plan. Each option granted under the policy is a non-statutory stock option and has an exercise price per share equal to the fair market value of a share of common stock on the date of grant. Any options granted under this policy have a term of 10 years from the date of grant, subject to earlier termination in connection with a termination of the eligible director’s continuous service with us. Vesting schedules for equity awards are subject to the non-employee director’s continuous service on each applicable vesting date.
Upon the termination of the membership of the non-employee director on the board for any reason, his or her options granted under this policy shall remain exercisable for three months following his or her date of termination (or such longer period as the board may determine in its discretion on or after the date of grant of such options).
Notwithstanding any vesting schedule, for each non-employee director who remains in continuous service with us until immediately prior to the closing of a change in control (as such term is defined in our 2022 Plan), the shares subject to his or her then-outstanding initial or annual equity awards that were granted pursuant to this policy will become fully vested immediately prior to the closing of such change in control.
Initial Award
Each new non-employee director who first joins our Board will automatically, upon the date of his or her initial election or appointment to be a non-employee director, be granted an initial, one-time equity award of options to purchase 42,000 shares of common stock, referred to as the initial grant. One-third of each initial grant will vest on the first anniversary of the date of grant, with the remainder vesting in equal monthly installments thereafter until the third anniversary of the date of grant.
Annual Awards
On the date of each annual meeting of our stockholders, each non-employee director who continues to serve will automatically be granted an option to purchase 15,000 shares of common stock, which will vest in equal monthly installments over the 12 months following the date of grant, subject to (i) the non-employee director’s continuous service through each applicable vesting date and (ii) that no annual award will be granted to a non-employee director in the same calendar year that such director received his or her initial grant.
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Equity Compensation Plan Information
The following table provides information about the securities authorized for issuance under our equity compensation plans as of December 31, 2025:
(c) Number of
Securities Remaining
(a) Number of
Available for Future
Securities to be Issued
(b) Weighted Average
Issuance Under Equity
Upon Exercise of
Exercise Price of
Compensation Plans
Outstanding
Outstanding
(Excluding Securities
Options, Warrants
Options, Warrants
Reflected in Column
Plan Category
and Rights (1)
and Rights
(a)) (3)
Equity plans approved by stockholders (1)
3,031,980
3.59
1,693,335
Equity plans not approved by stockholders (2)
500,000
3.89
500,000
Total
3,531,980
3.64
2,193,335
(1) The equity plans approved by security holders are described in Note 15 — Equity Incentive Plans, to our financial statements for the year ended December 31, 2025 and include the Prior Plan and the 2022 Plan, which were approved by our stockholders.
(2) Consists of the 2021 Inducement Plan, as described in Note 15 — Equity Incentive Plans, to our financial statements for the year ended December 31, 2025.
(3) Includes the Prior Plan and 2022 Plan. Stock options or other stock awards granted under the Prior Plan that are forfeited, terminated, expired or repurchased become available for issuance under the 2020 Plan. In accordance with the terms of the 2022 Plan, the total number of shares of common stock reserved for issuance thereunder automatically increased on January 1st in an amount equal to 6.0% of the total number of shares of common stock outstanding on December 31st of the preceding year. Accordingly, on January 1, 2026, the number of shares of common stock available for issuance under the 2022 Plan increased by 2,524,428 shares, pursuant to these provisions. This increase is not reflected in the table above .
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth certain information regarding the ownership of our common stock as of March 13, 2026 by:
● each of our named executive officers;
● each of our directors; and
● all of our current executive officers and directors as a group.
At this time, there is no person or entity known by us to be the beneficial owners of more than five percent of our common stock.
We have determined beneficial ownership in accordance with the rules and regulations of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Except as indicated by the footnotes below, we believe, based on information furnished to us, that the persons and entities named in the table below have sole voting and sole investment power with respect to all shares that they beneficially own, subject to applicable community property laws.
Applicable percentage ownership is based on 42,488,578 shares of common stock outstanding as of March 13, 2026. In computing the number of shares beneficially owned by a person and the percentage ownership of such person, we deemed to be outstanding all shares subject to options or issuable pursuant to restricted stock units held by the person that are currently exercisable, or would vest or become exercisable based on service-based vesting conditions within 60 days of March 13, 2026. However, except as described above, we did not deem such shares outstanding for the purpose of computing the percentage ownership of any other person.
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Unless otherwise indicated, the address for each beneficial owner listed in the table below is c/o Gain Therapeutics, Inc., 4800 Montgomery Lane, Suite 220, Bethesda, Maryland 20814.
Beneficial Ownership (1)
Name of Beneficial Owner
Number of Shares
Percent of Total
Named Executive Officers and Directors:
Gene Mack (2)
263,175
*
Gianluca Fuggetta (3)
60,729
*
Khalid Islam (4)
1,012,054
2.38
%
Dov Goldstein (3)
68,058
*
Hans Peter Hasler (3)
68,058
*
Gwen Melincoff (3)
68,058
*
Claude Nicaise (3)
68,058
*
Jeffrey Riley (5)
124,482
*
All current executive officers and directors as a group (8 persons) (6)
1,732,672
4.08
%
*
Less than one percent.
(1) This table is based upon information supplied by officers, directors and principal stockholders and Schedules 13D and 13G filed with the SEC. Unless otherwise indicated in the footnotes to this table and subject to community property laws where applicable, we believe that each of the stockholders named in this table has sole voting and investment power with respect to the shares indicated as beneficially owned. Applicable percentages are based on 42,488,578 shares outstanding on March 13, 2026, adjusted as required by rules promulgated by the SEC.
(2) Consists of (a) 14,400 shares of common stock held by Mr. Mack and (b) 248,775 shares of common stock issuable upon the exercise of options that will vest within 60 days of March 13, 2026.
(3) Consists of shares of common stock issuable upon the exercise of options that are exercisable within 60 days of March 13, 2026.
(4) Consists of (a) 880,784 shares of common stock held by 1 MM & 1 PP AG, of which Dr. Islam is the ultimate shareholder and beneficial owner, (b) 50,000 shares of common stock held by Dr. Islam, and (c) 81,270 shares of common stock, held in Dr. Islam’s individual name, issuable upon the exercise of options granted to Dr. Islam that are exercisable within 60 days of March 13, 2026.
(5) Consists of (a) 30,000 shares of common stock held by Mr. Riley and (b) 94,482 shares of common stock issuable upon the exercise of options that are exercisable within 60 days of March 13, 2026.
(6) Consists of (a) 975,184 shares of our common stock held by our directors and current executive officer and (b) 757,488 shares of common stock issuable upon the exercise of options granted to our directors and current executive officers that are exercisable within 60 days of March 13, 2026 .
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
We describe below transactions and series of similar transactions, since the beginning of fiscal year 2024, with respect to which we were a party, will be a party, or otherwise benefited, in which:
● the amount involved exceeded or will exceed the lesser of (i) $120,000; or (ii) 1% of the average of our total assets as of December 31, 2024 and 2025, and
● any of our directors, executive officers or holders of more than 5% of any class of our capital stock at the time of such transaction, or any members of their immediate family, had or will have a direct or indirect material interest.
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Agreements with Our Directors and Officers
Separation Agreement with Matthias Alder
Mr. Alder’s service as our Chief Executive Officer ended effective June 25, 2024 and we entered into separation and general release agreement with Mr. Alder on June 27, 2024 (the “Separation Agreement”). Pursuant to the Separation Agreement, subject to Mr. Alder’s compliance with its terms Mr. Alder would (i) receive the amount of $525,000, which was equal to twelve (12) months of his base salary in effect immediately prior to the separation date, (ii) receive payment of Mr. Alder’s COBRA premiums for COBRA coverage for a period of twelve (12) months following the separation date (the “Severance Period”) if he timely elected COBRA coverage, (iii) be provided all of his outstanding, unvested equity awards vested to the extent that such awards would have vested over the twelve (12) month period following the separation date if he had remained continuously employed by the Company, (iv) be provided 180 days after the separation date to exercise vested options; and (v) during the Severance Period, we would continue to pay the amount of any life insurance and long-term disability insurance premiums that we were paying on the behalf of Mr. Alder prior to the separation date.
On September 18, 2024, Mr. Alder filed suit against us in the Circuit Court of Maryland for Montgomery County (the “Litigation”). On October 10, 2024, Mr. Alder amended the complaint in the Litigation to add Jeffrey Riley, a member of our Board, and Khalid Islam, Chairman of the Board, as defendants. In his suit, Mr. Alder alleges, among other things, that we breached the Separation Agreement and employment agreement with Mr. Alder by failing to pay certain severance amounts as well as violated non-disparagement obligations to Mr. Alder. We engaged in a mediation session on March 31, 2025, and reached an agreement in principle to settle the case and subsequently executed a settlement agreement resolving and releasing all claims as to all parties. The lawsuit was dismissed with prejudice on July 2, 2025.
Relationship with Minoryx
We have entered into a license agreement, dated December 20, 2017, or the Minoryx License Agreement, with Minoryx Therapeutics, S.L., a company organized under the laws of Spain, or Minoryx, pursuant to which we obtained exclusive worldwide license rights from Minoryx to use and exploit its intellectual property, including its SEE-Tx® discovery platform for the identification of non-competitive pharmacological chaperones and exclusive worldwide sublicense rights to certain IP licensed by Minoryx from the University of Barcelona and the Institució Catalana de Recerca i Estudis Avançats. Dr. Islam, one of our founders and Chairman of our Board, is the chairman of the board of directors of Minoryx, and as such, there may be times when there is a conflict of interest between us and Minoryx. As consideration for the license grant under the Minoryx License Agreement, we have agreed to pay Minoryx royalties on a product-by-product basis based on the licensed intellectual property used by us, ranging from a high single digit to low single digit percentage of net revenues of products during the royalty term commencing on the effective date of the Minoryx License Agreement and continuing until the 10th anniversary of the first product commercialization. Upon the expiration of the royalty term for a product or service in a country, the license with respect to the product or service, as the case may be, shall become royalty-free, fully-paid, irrevocable and perpetual. No payments were made pursuant to the Minoryx License Agreement during 2025 or 2024.
Employment Agreements
We have entered into employment agreements with our executive officers. Each of our executive officers has entered into a written employment agreement with us that provides for payment of base salary, target annual cash incentive compensation, eligibility for employee benefit programs and potential severance benefits. For more information regarding these agreements with our named executive officers, see “Executive Compensation.”
Severance Arrangements
The employment agreements we have entered into with our executive officers provide for certain severance arrangements. For more information regarding these arrangements with our executive officers, see “Executive Compensation-Potential Payments upon Termination or Change of Control.”
Executive and Director Compensation
We have granted equity awards to certain of our directors and executive officers. For more information regarding the options granted to our named executive officers and directors, see “Executive Compensation” and “Non-Employee Director Compensation.”
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Indemnification Agreements
We enter into separate indemnity agreements with each of our directors and officers, in addition to the indemnification provided for in our Bylaws. These indemnity agreements provide our directors and executive officers with contractual rights to indemnification and, in some cases, expense advancement in any action or proceeding arising out of their services as one of our directors or executive officers or as a director or executive officer of any other company or enterprise to which the person provides services at our request. These agreements provide, among other things, that we will indemnify the officer or director, under the circumstances and to the extent provided for in the agreement, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or may be made a party by reason of his or her position as a director, officer or other agent of the Company, and otherwise to the fullest extent permitted under Delaware law and our Bylaws. We also maintain directors’ and officers’ liability insurance.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Independent Registered Public Accounting Firm Fees
Our independent public accounting firm is Ernst & Young AG, Lugano, Switzerland (PCAOB Auditor ID: 1460). The following is a summary and description of fees for the fiscal years ended December 31, 2025 and 2024 billed to us by Ernst & Young AG. All services and fees described below were pre-approved by the Audit Committee.
Fiscal Year Ended
2025
2024
Audit Fees (1)
$
638,201
$
606,012
Tax Fees (2)
—
8,144
Total Fees
$
638,201
$
614,156
(1) “Audit Fees” represent the aggregate fees and expenses for professional services rendered in relation to the audit of our consolidated financial statements on Form 10-K and the review of our quarterly condensed consolidated financial statements on Form 10-Q, and the statutory audit fees of our Swiss subsidiary. It also includes professional services rendered in connection with issuance of consents included in registration statements and issuance of comfort letters.
(2) “Tax Fees” consist of fees and expenses for professional services mainly related to tax compliance and tax advice .
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Documents Filed as Part of this Report
(1) All Financial Statements
Index to Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 1460)
84
Consolidated Balance Sheets
85
Consolidated Statements of Operations
86
Consolidated Statements of Comprehensive Loss
87
Consolidated Statements of Changes in Stockholders’ Equity
88
Consolidated Statements of Cash Flows
89
Notes to Consolidated Financial Statements
90
(2) Financial Statement Schedules
All financial statement scheduled have been omitted, since the required information is not applicable or is not present in amounts sufficient to require submission of this schedule, or because the information required is in the consolidated financial statements and accompanying notes included in this Form 10-K.
(3) Exhibits Required by Item 601 of Regulation S-K
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
3.3
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Gain Therapeutics, Inc., filed with the Secretary of State of the State of Delaware on June 24, 2025.
8-K
001-40237
3.1
6/24/2025
4.1*
Description of Securities.
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
4.3
Form of Warrant.
8-K
001-40237
4.1
11/22/2023
4.4
Form of Private Warrant.
8-K
001-40237
4.2
11/22/2023
4.5
Form of Underwriter’s Warrant.
8-K
001-40237
4.3
11/22/2023
4.6
Form of Pre-Funded Warrant.
8-K
001-40237
4.4
11/22/2023
4.7
Warrant Agent Agreement by and between Gain Therapeutics, Inc. and Pacific Stock Transfer Company.
8-K
001-40237
4.5
11/22/2023
4.8
Form of Placement Agent Warrant.
8-K
001-40237
4.6
11/22/2023
4.9
Form of Warrant issued in July 2025 offering.
8-K
001-40237
4.1
7/17/2025
4.10
Form of Underwriter’s Warrant issued in July 2025 offering.
8-K
001-40237
4.2
7/17/2025
4.11
Form of Warrant Agent Agreement, by and between Gain Therapeutics, Inc. and Pacific Stock Transfer Company.
8-K
001-40237
4.3
7/17/2025
10.1+
Form of Indemnification Agreement for Officers and Directors .
S-1/A
333-253303
10.2
3/10/2021
10.2+
2020 Omnibus Incentive Plan .
S-1/A
333-253303
10.1
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
Form of Exchange Agreement .
S-1
333-253303
10.10
2/19/2021
10.7
Form of Placement Agent Warrant .
S-1
333-253303
10.11
2/19/2021
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Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit
Form
File No.
Exhibit
Filing Date
10.8 +
Gain Therapeutics Inc. 2021 Inducement Equity Incentive Plan Restricted Stock Unit Award Agreement.
S-8
333-266142
4.5
7/15/2022
10.9 +
Gain Therapeutics Inc. 2022 Equity Incentive Plan.
S-8
333-266142
4.6
7/15/2022
10.10 +
Gain Therapeutics Inc. RSU Award Grant Notice and Award Agreement (2022 Equity Incentive Plan).
S-8
333-266142
4.7
7/15/2022
10.11 +
Gain Therapeutics Inc. Stock Option Grant Notice and Award Agreement (2022 Equity Incentive Plan).
S-8
333-266142
4.8
7/15/2022
10.12
Form of Indemnification Agreement for Officers and Directors.
10-Q
001-40237
10.3
8/10/2023
10.13
Form of Indemnification Agreement for Officers and Directors.
10-Q
001-40237
10.3
11/14/2023
10.14
Form of Securities Purchase Agreement.
8-K
001-40237
10.1
11/22/2023
10.15+
Separation Agreement, by and between the Company and Matthias Alder, dated June 27, 2024.
10-Q
001-40237
10.2
11/14/2024
10.16
Distribution Agreement, by and between the Company and Oppenheimer & Co. Inc., dated September 6, 2024 .
8-K
001-40237
1.1
9/6/2024
10.17+
Amended and Restated Employment Agreement by and between the Company and Gene Mack, dated January 6, 2025.
8-K
001-40237
10.1
1/7/2025
10.18+
Employment Agreement, by and between the Company and Gianluca Fuggetta, dated March 24, 2025 .
10-K
001-40237
10.18
3/27/2025
10.19
Underwriting Agreement, dated July 16, 2025, by and between Gain Therapeutics, Inc. and Newbridge Securities Corporation.
8-K
001-40237
1.1
7/17/2025
19.1
Insider Trading Policy .
10-K
001-40237
19.1
3/27/2025
21.1
Subsidiaries of Registrant.
10-K
001-40237
21.1
3/27/2025
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 Principal Financial Officer.
32.1**
Section 906 Certification of Chief Executive Officer and Principal Financial Officer.
97.1+
Clawback Policy .
10-K
001-40237
97.1
3/26/2024
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).
+ Management contract or compensatory plan or arrangement.
* Filed herewith
** 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.
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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 26, 2026
By:
/s/ Gene Mack
Gene Mack
Chief Executive Officer
( Principal Executive Officer )
Date: March 26, 2026
By:
/s/ Gianluca Fuggetta
Gianluca Fuggetta
Senior Vice President Finance
( Principal Financial Officer and 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 Gene Mack 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.
Dated: March 26, 2026
/s/ Gene Mack
Gene Mack
Chief Executive Officer and Director
(Principal Executive Officer)
Dated: March 26, 2026
/s/ Gianluca Fuggetta
Gianluca Fuggetta
Senior Vice President Finance
(Principal Financial Officer and Principal Accounting Officer)
Dated: March 26, 2026
/s/ Khalid Islam
Khalid Islam
Chairman of the Board of Directors
Dated: March 26, 2026
/s/ Dov Goldstein
Dov Goldstein
Director
Dated: March 26, 2026
/s/ Hans Peter Hasler
Hans Peter Hasler
Director
Dated: March 26, 2026
/s/ Gwen Melincoff
Gwen Melincoff
Director
Dated: March 26, 2026
/s/ Claude Nicaise
Claude Nicaise
Director
Dated: March 26, 2026
/s/ Jeffrey Riley
Jeffrey Riley
Director
143