GANX 8-K: Item 7.01 KOL event slides on GT-02287 furnished

Rhea-AI Filing Summary

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.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

99.1	Presentation
104	Cover 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.