Gain Therapeutics, Inc.

We lease 1,402 square feet that we use for our biology laboratory and 245 square feet that we use for a warehouse space in a multi-tenant building in Cluster II Building in the Parc Cientific de Barcelona, Spain. This lease expires in March 2026.

We lease 1,417 square feet of office space in a multi-tenant building in Torre D Building in the Parc Cientific de Barcelona, Spain that we use for our drug discovery and research activities. This lease expires in December 2030.

We believe our current facilities, including the terms and conditions of the relevant lease agreements, are adequate to operate our businesses as currently conducted. However, as we continue to expand our operations, we may need to lease additional or alternative facilities.

• The approach we are taking to discover and develop our product candidates is novel and may never lead to marketable products.
• We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
• Clinical trials required for our product candidates are expensive and time-consuming, and their outcome is uncertain.
• We have limited experience as a company conducting clinical trials and may be unable to complete pivotal clinical trials for any product candidates we may develop.
• We may conduct certain of our clinical trials for our product candidates outside of the U.S. which, among other risks, exposes us to the possibility that the FDA and other comparable foreign regulatory authorities may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
• If we decide to pursue a Fast Track Designation or comparable foreign regulatory procedures for some of our product candidates, it may not lead to a faster development or regulatory review or approval process.
• If we decide to seek Orphan Drug Designation for some of our product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity.
• We do not have, and may never obtain, the regulatory approvals we need to market our product candidates.
• Our product candidates may cause serious adverse events (“SAEs”) or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
• Even if approved, our products will be subject to extensive post-approval regulation.
• Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.
• Risks Related to Our Financial Condition and Capital Requirements; Competition
• We will need to raise additional capital which may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates, and additional capital may not be available on favorable terms or at all which may force us to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations.
• We face intense competition in the markets targeted by our product candidates. Many of our competitors have substantially greater resources than we do and we expect that all our product candidates under development will face intense competition from existing or future drugs.
• Competition and technological change may make our product candidates and technologies less attractive or obsolete.
• Our business and operations may be adversely affected by health epidemics or pandemics.
• Risks Related to Our Intellectual Property
• We rely on a license to use the technology that is material to our business and if the agreements underlying the licenses were to be terminated or if other rights that may be necessary for commercializing our intended products cannot be obtained, it would halt our ability to market our products and technology as well as have an immediate material adverse effect on our business, operating results and financial condition.
• Our success depends substantially upon our ability to obtain and maintain intellectual property protection relating to our products and technologies.
• If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected.
• We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
• If we infringe the rights of third parties, we could be prevented from selling products or forced to pay damages and defend against litigation.
• Risks Related to Third Parties and Collaborators
• We currently rely on, and intend to rely on in the future, third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
• We currently rely on and intend to rely in the future on third parties to manufacture the compounds used in our studies, and we intend to rely on them for the manufacture of any approved products for commercial sale. If these third parties do not manufacture our product candidates in sufficient quantities and at an acceptable cost, clinical development and commercialization of our product candidates could be delayed, prevented or impaired.
• Failure by our third-party manufacturers to comply with the regulatory guidelines set forth by the FDA or comparable foreign regulatory authorities with respect to our product candidates could delay or prevent the completion of clinical trials, the approval of any product candidates or the commercialization of our products.
• Corporate and academic collaborators may take actions to delay, prevent, or undermine the success of our products.
• Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
• International trade policies, including tariffs, sanctions and trade barriers may adversely affect our current and future business, financial condition, results of operations and prospects.
• Data provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading, or incomplete.
• General Risk Factors
• As a public company, we are obligated to develop and maintain proper and effective controls over financial reporting. If we fail to maintain proper and effective system of internal controls over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired which could harm our operating results, investors’ views of us and, as a result, the value of our securities.
• Global and macroeconomic conditions, including economic, political and social instability, could adversely affect our financial condition or results of operations.
• The global credit and financial markets have recently experienced extreme volatility and disruptions including severely diminished liquidity and credit availability, disruptions in access to bank deposits and lending
• We will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.
• We depend upon our key personnel and our ability to attract and retain qualified employees.
• Our future growth and success will depend in large part on our continued ability to attract, retain, manage and motivate our employees. The loss of the services of a significant portion of our workforce or any member of our senior management or the inability to hire or retain qualified personnel could adversely affect our ability to execute our business plan and harm our operating results.
• The competition for qualified personnel in the pharmaceutical field is intense and there is a limited pool of qualified potential employees. Due to the intense competition for talent, we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel. We may also face increased costs in attracting and retaining personnel as a result of heightened global inflation.
• To incentivize valuable employees to join and remain at our company, in addition to salary and other employee benefits, we have provided stock option and restricted stock unit awards that vest over time and in some instances, subject to the achievement of performance milestones. The value to employees of such awards may be significantly affected by movements in our stock price and current market conditions and extreme stock price volatility may diminish our ability to incentivize employees through the use of such awards.
• If we are unsuccessful in our recruitment and retention efforts, our business may be adversely affected.
• Under applicable employment laws, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
• Our relationships with customers, physicians, and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws and other healthcare laws and regulations including comparable foreign laws and regulations. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
• Coverage and adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for us to sell profitably, if approved.
• Healthcare legislative reform measures may have a negative impact on our business and results of operations.
• If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
• We are subject to U.S. and certain foreign anti-corruption, anti-money laundering, export and import controls, and sanctions laws and regulations. Non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
• Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.
• We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies, contractual and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class actions) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
• Issues relating to the use of AI and machine learning could adversely affect our business and operating results.
• If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
• Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
• We have been, and in the future may be, involved in legal proceedings that may have a negative impact on our business.
• Risks Related to Ownership of Our Common Stock
• The market price for our common stock has been and likely will continue to be volatile, and your investment in our securities could decline in value.
• We incur and will continue to incur costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
• We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors.
• We are currently listed on the Nasdaq Global Market. If we are unable to maintain listing of our securities on the Nasdaq Global Market or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities.
• all, and may result in the potential loss of confidence by investors, suppliers, and employees and lead to fewer business development opportunities. Additionally, the market price of our common stock may decline further, and stockholders may lose some or all of their investment.
• Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
• Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
• We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment.
• Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
• The rights of the holders of our securities may be impaired by the potential issuance of preferred stock.
• If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
• Anti-takeover provisions in our organizational documents and Delaware law might discourage or delay attempts to acquire us that you might consider favorable.
• Our Amended Charter provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders and federal district courts will be the sole and exclusive forum for Securities Act claims, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
• Provisions in our organizational documents regarding exculpation and indemnification of our directors and officers may result in substantial expenditures by us and may discourage lawsuits against our directors and officers.