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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): July 9, 2024

     
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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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 Disclosure.

 

On July 9, 2024, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing the completion of dosing in the multiple ascending dose (MAD) of its Phase 1 study of GT-02287, a novel small molecule therapy for Parkinson’s Disease. A copy of the press release is attached hereto as Exhibit 99.1.

 

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 8.01. Other Events.

 

On July 9, 2024, the Company announced the completion of dosing in the multiple ascending dose (MAD) of its Phase 1 study of GT-02287, a novel small molecule therapy for Parkinson’s Disease. No discontinuations or serious adverse events were reported.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) The following Exhibit 99.1 is furnished with this report:

 

Exhibit 
No.
  Description
99.1   Gain Therapeutics, Inc. Press Release dated July 9, 2024.
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: July 9, 2024 By: /s/ Gene Mack
  Name: Gene Mack
  Title: Chief Financial Officer