Company: GANX
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001558370-25-007747
Chunk: 7

Company: Gain Therapeutics, Inc.
Filing Date: 2025-05-14
Form: 10-Q
Item: Part II, Item 1L
Chunk 7
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Item 1. Legal Proceedings.

As previously disclosed, the Company and two members of its board of directors were named as defendants in a lawsuit filed in the Circuit Court of Maryland for Montgomery County by Matthias Alder, the Company’s former Chief Executive Officer. Following mediation, on May 13, 2025 the parties reached an agreement in principle to settle the case and subsequently executed a settlement agreement which, if not revoked during a 7-day revocation period, will become effective on May 20, 2025 and require dismissal of the lawsuit.

Item 1A. Risk Factors.

Our operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025. Other than as set forth below, no material changes to such risk factors have occurred during the quarter ended March 31, 2025:

International trade policies, including tariffs, sanctions and trade barriers may adversely affect our current and future business, financial condition, results of operations and prospects.

We operate in a global economy, which includes utilizing third-party suppliers in certain countries outside the United States. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects.

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical testing and the manufacture of our materials for our product candidates, including our active pharmaceutical ingredients (“APIs”) and certain excipients, as well as for manufacture of any products that we may commercialize, if approved. Such materials for our product candidates are currently manufactured in China