Company: GANX
Filing Date: 2025-11-07
Form Type: S-3/A
Source: 0001104659-25-108472
Chunk: 10

Company: Gain Therapeutics, Inc.
Filing Date: 2025-11-07
Form: S-3/A
Chunk 10
---
 through the use of our Magellan™ platform;

•

our ability to develop, obtain regulatory approval for and commercialize our current and future product candidates;

•

our expectations regarding collaborations and other agreements with third parties and their potential benefits;

•

the timing of investigational new drug, or IND, submissions, initiation of preclinical studies and clinical trials, and timing of expected clinical results for our product candidates;

•

our success in early preclinical studies, which may not be indicative of results obtained in later studies or clinical trials;

•

the potential benefits of our product candidates;

•

our ability to identify patients with the diseases treated by our product candidates, and to enroll healthy volunteers and patients in clinical trials;

•

our ability to obtain, maintain and protect our intellectual property;

•

our reliance upon intellectual property licensed from third parties, including the license to use certain components of the Magellan™ platform;

•

our ability to identify, recruit and retain key personnel;

•

developments or projections relating to our competitors or our industry;

•

the impact of laws and regulations;

•

our expectations regarding government and third-party payor coverage and reimbursement;

•

our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups (“JOBS”) Act;

•

the impact of liquidity concerns at and failures of banks and other financial institutions, capital market instability, exchange rate fluctuations, supply chain disruptions and increases in commodity, energy and fuel prices;

<div align='center'>6</div>

TABLE OF CONTENTS

•

the impacts of pandemics or endemics on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers, and collaborators with whom we conduct business;

•

the impact of other global events, including political instability, natural disaster, events of terrorism and wars, including the war between Ukraine and Russia, and the corresponding tensions created from such conflict between Russia, the United States and countries in Europe as well as other countries such as China; and the conflict between Hamas and Israel;

•

the impacts of increased trade tariffs, import quotas or other trade restrictions or measures taken by the United States and other countries, including changes in U.S. trade policies that may be made by the presidential administration; and

•

other risks and uncertainties, including those listed in the “Risk Factors” section of this prospectus and the documents incorporated by reference herein.

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained