Company: GANX
Filing Date: 2025-07-15
Form Type: 424B5
Source: 0001104659-25-068103
Chunk: 42

Company: Gain Therapeutics, Inc.
Filing Date: 2025-07-15
Form: 424B5
Chunk 42
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. We may never generate revenues or, if we are able to generate revenues, achieve profitability.

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We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.

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If preclinical studies or clinical trials for our product candidates cannot be initiated or completed or if they are unsuccessful or delayed, we will be unable to meet our future development and commercialization goals.

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The disorders we seek to treat have low prevalence and it may be difficult to identify patients with these disorders, which may lead to delays in enrollment for our trials or slower commercial revenue, if approved.

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Our product candidates are novel and still in development. If we are unable to successfully develop, receive regulatory approval for and commercialize our current or future product candidates, our business will be harmed.

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We have not tested any of our product candidates in clinical trials. Success in early preclinical studies or clinical trials may not be indicative of results obtained in later preclinical studies and clinical trials.

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The approach we are taking to discover and develop our product candidates is novel and may never lead to marketable products.

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Clinical trials required for our product candidates are expensive and time-consuming, may face enrollment challenges and their outcome is uncertain.

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Our business and operations may be adversely affected by the evolving and ongoing COVID-19 global pandemic.

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We are subject to extensive and costly government regulation.

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Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.

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We rely on a license to use the technology underlying SEE-Tx technology platform 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.

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We intend to rely 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.

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We have identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future that may cause