Company: GANX
Filing Date: 2025-10-06
Form Type: 8-K
Source: 0001104659-25-097153
Chunk: 0

Company: Gain Therapeutics, Inc.
Filing Date: 2025-10-06
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Information

On October 6, 2025,
Gain Therapeutics, Inc. (the “ Company”) presented preliminary data from the Company’s ongoing Phase 1b clinical
study of GT-02287 in people with Parkinson’s disease (“ PD”) with or without a GBA1 mutation at the International Congress
of Parkinson’s Disease and Movement Disorders.

Preliminary Findings

After 90 days of dosing,
GT-02287 has been safe and generally well tolerated, with no treatment-emergent serious adverse events observed. A transient increase
in alkaline phosphatase and other liver enzymes has been observed in some participants and normalized despite ongoing dosing. Of the 21
study participants, two are treatment-naïve, two are on deep brain stimulation, and 18 are on levodopa and/or dopamine agonists or
other PD drugs.

Mean MDS-UPDRS scores
at baseline were 5.8, 7.4, and 24.7 for Parts I, II, and III, respectively. Several participants experienced an improvement in their
UPDRS Part II and III scores after 90 days of dosing with GT-02287 while mean Part I scores remained unchanged. The mean improvement
in Parts II and III by Day 90, which was not observed by Day 30, suggests that GT-02287 has a disease-slowing effect, consistent with
the preclinical models in vivoand the proposed mechanism of action of GT-02287, supporting continued development. The plasma pharmacokinetics
(PK) profile was consistent across all 14 participants sampled, was within the projected therapeutics range, and comparable to exposures
observed in healthy volunteers in the Phase 1 study.

At two different meetings,
the data monitoring committee has recommended continuation of the study and more recently, Australian health authorities have approved
the Phase 1b study extension for patients who can now be treated for up to 12 months.

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.                       
  Dated: October 6, 2025      By:                                 /s/ Gene  
                              Name: Gene Mack                               
                              Title: Chief Executive Officer