Gain Therapeutics Files 8-K Report

TL;DR

Gain Therapeutics filed an 8-K on 12/18/25 for 'Other Events' - details TBD.

AI Summary

On December 18, 2025, Gain Therapeutics, Inc. filed an 8-K report. The filing indicates "Other Events" as the primary item of disclosure, with no specific details provided in the provided text regarding the nature of these events, any associated financial figures, or involved parties.

Why It Matters

This filing signifies a material event for Gain Therapeutics, Inc., requiring disclosure to investors and the public, though the specific nature of the event is not detailed in this excerpt.

Risk Assessment

Risk Level: low — The filing itself is a standard disclosure document with no immediate indication of negative financial or operational impact.

Key Players & Entities

• Gain Therapeutics, Inc. (company) — Registrant
• December 18, 2025 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.0001 — ch Registered Common Stock, par value $0.0001 per share GANX The Nasdaq Stock Mar

Filing Documents

• tm2533810d1_8k.htm (8-K) — 28KB
• 0001104659-25-122353.txt ( ) — 193KB
• ganx-20251218.xsd (EX-101.SCH) — 3KB
• ganx-20251218_lab.xml (EX-101.LAB) — 33KB
• ganx-20251218_pre.xml (EX-101.PRE) — 22KB
• tm2533810d1_8k_htm.xml (XML) — 4KB

01. Other Events

Item 8.01. Other Events. On December 18, 2025, Gain Therapeutics, Inc. (the "Company") issued a press release announcing results in exploratory endpoint from its Phase 1b clinical study of GT-02287 in people with Parkinson's Disease ("PD"). All individuals with elevated levels of glucosylsphingosine ("GluSph") in the cerebrospinal fluid ("CSF") displayed large decreases back towards levels observed in healthy individuals after 90 days of treatment with GT-02287. The change observed in GluSph in CSF was a prespecified exploratory endpoint of this Phase 1b study. Part 1 (90 days of dosing) of the ongoing Phase 1b study has concluded. The Phase 1b study enrolled 21 participants, 19 completed the 90-day dosing period, and 15 (79%) chose to continue in the nine-month extension (Part 2) portion of the study that is anticipated to conclude in September 2026. Consistent with the initial Phase 1b data presented at the International Congress of Parkinson's Disease and Movement Disorders in October 2025, GT-02287 continues to be generally well-tolerated over 90 days of dosing at plasma exposures within the projected therapeutic range. The data monitoring committee has recommended that the Phase 1b study continue with no changes. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and central nervous system exposures in the projected therapeutic range, and target engagement with an increase in glucocerebrosidase ("GCase") activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson's disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across seven sites in Australia, is to evaluate the safety and tolerability of GT-02287 after three months of dosing in people with PD. The Phase 1b study extension allows participants to continue to be treated with GT-02

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company's current or future product candidates including GT-02287; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287, including any extension studies; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; and the potential therapeutic and clinical benefits of the Company's product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, please refer to the Company's Form 10-K for the year ended December 31, 2024. All forward-looking statements are

View Full Filing

View this 8-K filing on SEC EDGAR