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[8-K] Gain Therapeutics, Inc. Reports Material Event

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Gain Therapeutics (GANX) furnished a virtual KOL event presentation under Item 7.01 Regulation FD. On October 14, 2025, the company hosted “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287,” featuring Karl Kieburtz, M.D., M.P.H. (University of Rochester) and Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

The slide deck from the event was furnished as Exhibit 99.1. The information provided under Item 7.01, including Exhibit 99.1, is being furnished to the SEC and is not deemed filed or subject to Section 18 liability, nor incorporated by reference unless specifically referenced.

Gain Therapeutics (GANX) ha fornito una presentazione virtuale dell'evento KOL ai sensi dell'Art. 7.01 Regulation FD. Il 14 ottobre 2025, l'azienda ha ospitato "Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287", featuring Karl Kieburtz, M.D., M.P.H. (University of Rochester) e Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

La slide deck dell'evento è stata fornita come Exhibit 99.1. Le informazioni fornite ai sensi dell'Art. 7.01, inclusa Exhibit 99.1, sono messe a disposizione della SEC e non si considerano depositate né soggette alla responsabilità prevista dalla Sezione 18, né incorporate per riferimento a meno che non sia specificamente citato.

Gain Therapeutics (GANX) presentó una videoconferencia de KOL bajo el Artículo 7.01 Regulation FD. El 14 de octubre de 2025, la empresa organizó “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287,” con la participación de Karl Kieburtz, M.D., M.P.H. (University of Rochester) y Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

La diapositiva del evento se presentó como Exhibit 99.1. La información proporcionada bajo el Artículo 7.01, incluida Exhibit 99.1, se proporciona a la SEC y no se considera presentada ni sujeta a la responsabilidad de la Sección 18, ni incorporada por referencia a menos que se haga referencia específicamente.

Gain Therapeutics (GANX)는 Item 7.01 Regulation FD에 따른 가상 KOL 이벤트 발표를 제공했습니다. 2025년 10월 14일, 회사는 “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287”를 주제로 로체스터 대학교의 Karl Kieburtz 박사, M.P.H.와 Institute for Neurodegenerative Disorders의 Kenneth Marek 박사를 초청했습니다.

해당 이벤트의 슬라이드 데크는 Exhibit 99.1로 제공되었습니다. Item 7.01 아래의 정보와 Exhibit 99.1은 SEC에 제공되며, 특정 참조가 명시되지 않는 한 접수되었다고 간주되거나 Section 18 책임의 대상이 아니며 참조에 포함되지 않습니다.

Gain Therapeutics (GANX) a fourni une présentation virtuelle d'un événement KOL dans le cadre de l'article 7.01 Regulation FD. Le 14 octobre 2025, l'entreprise a organisé « Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287 », avec Karl Kieburtz, M.D., M.P.H. (University of Rochester) et Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

Le diaporama de l'événement a été fourni en tant qu'Exhibit 99.1. Les informations fournies en vertu de l'Item 7.01, y compris Exhibit 99.1, sont mises à la disposition de la SEC et ne sont pas réputées déposées ni soumises à la responsabilité de la Section 18, ni incorporées par référence à moins d'être spécifiquement référenciées.

Gain Therapeutics (GANX) hat eine virtuelle KOL-Veranstaltungspräsentation gemäß Item 7.01 Regulation FD bereitgestellt. Am 14. Oktober 2025 veranstaltete das Unternehmen „Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287“, mit Karl Kieburtz, M.D., M.P.H. (University of Rochester) und Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

Die Diashow der Veranstaltung wurde als Exhibit 99.1 vorgelegt. Die Informationen, die unter Item 7.01 bereitgestellt werden, einschließlich Exhibit 99.1, werden der SEC zur Verfügung gestellt und gelten weder als eingereicht noch unterliegen sie der Haftung gemäß Section 18, noch werden sie durch Bezugnahme einbezogen, es sei denn, sie werden ausdrücklich referenziert.

قدمت Gain Therapeutics (GANX) عرضًا افتراضيًا لحدث KOL بموجب البند 7.01 Regulation FD. في 14 أكتوبر 2025، استضافت الشركة فعالية بعنوان “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287,” بمشاركة Karl Kieburtz, M.D., M.P.H. (University of Rochester) و Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

تم تقديم شريحة العرض من الحدث ك Exhibit 99.1. المعلومات المقدمة بموجب البند 7.01، بما في ذلك Exhibit 99.1، تُقدم إلى SEC وليست مُعتبرة كإيداع أو خاضعة لمسؤولية القسم 18، ولا تُدرج بالمرجع إلا إذا أُشير إليها صراحة.

Gain Therapeutics (GANX) 在第7.01条 Regulation FD下提供了虚拟KOL活动演示。 2025年10月14日,公司举办了“Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287”研讨会,嘉宾为 Karl Kieburtz, M.D., M.P.H.(罗切斯特大学)和 Kenneth Marek, M.D.(神经退行性疾病研究所)。

该活动的幻灯片作为 Exhibit 99.1 提供。根据第7.01条提供的信息,包括 Exhibit 99.1,向SEC提供,并且不被视为已提交或受第18条责任约束,也不通过参考并入,除非特别提及。

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Gain Therapeutics (GANX) ha fornito una presentazione virtuale dell'evento KOL ai sensi dell'Art. 7.01 Regulation FD. Il 14 ottobre 2025, l'azienda ha ospitato "Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287", featuring Karl Kieburtz, M.D., M.P.H. (University of Rochester) e Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

La slide deck dell'evento è stata fornita come Exhibit 99.1. Le informazioni fornite ai sensi dell'Art. 7.01, inclusa Exhibit 99.1, sono messe a disposizione della SEC e non si considerano depositate né soggette alla responsabilità prevista dalla Sezione 18, né incorporate per riferimento a meno che non sia specificamente citato.

Gain Therapeutics (GANX) presentó una videoconferencia de KOL bajo el Artículo 7.01 Regulation FD. El 14 de octubre de 2025, la empresa organizó “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287,” con la participación de Karl Kieburtz, M.D., M.P.H. (University of Rochester) y Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

La diapositiva del evento se presentó como Exhibit 99.1. La información proporcionada bajo el Artículo 7.01, incluida Exhibit 99.1, se proporciona a la SEC y no se considera presentada ni sujeta a la responsabilidad de la Sección 18, ni incorporada por referencia a menos que se haga referencia específicamente.

Gain Therapeutics (GANX)는 Item 7.01 Regulation FD에 따른 가상 KOL 이벤트 발표를 제공했습니다. 2025년 10월 14일, 회사는 “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287”를 주제로 로체스터 대학교의 Karl Kieburtz 박사, M.P.H.와 Institute for Neurodegenerative Disorders의 Kenneth Marek 박사를 초청했습니다.

해당 이벤트의 슬라이드 데크는 Exhibit 99.1로 제공되었습니다. Item 7.01 아래의 정보와 Exhibit 99.1은 SEC에 제공되며, 특정 참조가 명시되지 않는 한 접수되었다고 간주되거나 Section 18 책임의 대상이 아니며 참조에 포함되지 않습니다.

Gain Therapeutics (GANX) a fourni une présentation virtuelle d'un événement KOL dans le cadre de l'article 7.01 Regulation FD. Le 14 octobre 2025, l'entreprise a organisé « Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287 », avec Karl Kieburtz, M.D., M.P.H. (University of Rochester) et Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

Le diaporama de l'événement a été fourni en tant qu'Exhibit 99.1. Les informations fournies en vertu de l'Item 7.01, y compris Exhibit 99.1, sont mises à la disposition de la SEC et ne sont pas réputées déposées ni soumises à la responsabilité de la Section 18, ni incorporées par référence à moins d'être spécifiquement référenciées.

Gain Therapeutics (GANX) hat eine virtuelle KOL-Veranstaltungspräsentation gemäß Item 7.01 Regulation FD bereitgestellt. Am 14. Oktober 2025 veranstaltete das Unternehmen „Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287“, mit Karl Kieburtz, M.D., M.P.H. (University of Rochester) und Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).

Die Diashow der Veranstaltung wurde als Exhibit 99.1 vorgelegt. Die Informationen, die unter Item 7.01 bereitgestellt werden, einschließlich Exhibit 99.1, werden der SEC zur Verfügung gestellt und gelten weder als eingereicht noch unterliegen sie der Haftung gemäß Section 18, noch werden sie durch Bezugnahme einbezogen, es sei denn, sie werden ausdrücklich referenziert.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): October 14, 2025

     
Gain Therapeutics, Inc.
(Exact Name of the Registrant as Specified in Charter)

 

Delaware   001-40237   85-1726310
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

4800 Montgomery Lane, Suite 220

Bethesda, Maryland 20814

(Address of principal executive offices) (Zip Code)

  

(301) 500-1556

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading symbol(s) Name of exchange on which registered
Common Stock, $0.0001 par value GANX The NASDAQ Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 7.01 Regulation FD

 

On October 14, 2025, Gain Therapeutics, Inc. (the “Company”) hosted a virtual key opinion leader (KOL) event, “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287” featuring Key Opinion Leaders (KOLs), Karl Kieburtz, M.D., M.P.H., Professor of Neurology, University of Rochester and Kenneth Marek, M.D., President and Senior Scientist, Institute for Neurodegenerative Disorders. The slide presentation presented at the event is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1Presentation
  
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  GAIN THERAPEUTICS, INC.
   
Date: October 14, 2025 By: /s/ Gene Mack
  Name: Gene Mack
  Title: Chief Executive Officer  

 

 

 

FAQ

What did Gain Therapeutics (GANX) disclose in this 8-K?

The company furnished a slide presentation from a virtual KOL event under Item 7.01 Regulation FD.

When did the GANX KOL event take place?

The event was held on October 14, 2025.

Who were the featured KOLs at the GANX event?

The event featured Karl Kieburtz, M.D., M.P.H. and Kenneth Marek, M.D..

What was the focus of the presentation related to GANX?

The program discussed biomarkers, clinical endpoints, and emerging data from GT-02287.

Where can I find the materials from the GANX KOL event?

The slide presentation is furnished as Exhibit 99.1.

Is the GANX KOL information filed or furnished?

It is furnished under Item 7.01, not deemed filed, and not subject to Section 18 liability.

What exhibits are included with this GANX 8-K?

Exhibits include 99.1 Presentation and 104 Cover Page Interactive Data File.
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