# EDGAR Filing Document

**Accession Number:** 0001819411
**File Stem:** 0001104659-25-064145
**Filing Date:** 2025-6
**Character Count:** 5719
**Document Hash:** d1e3a0a6c4f8b8744b6f5caf28a29288
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-064145.hdr.sgml**: 20250630

**ACCESSION NUMBER**: 0001104659-25-064145

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250630

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20250630

**DATE AS OF CHANGE**: 20250630

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Gain Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001819411
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 851726310
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40237
- **FILM NUMBER:** 251092504

**BUSINESS ADDRESS:**
- **STREET 1:** 4800 HAMPDEN LANE
- **STREET 2:** SUITE 200
- **CITY:** BETHESDA
- **STATE:** MD
- **ZIP:** 20814
- **BUSINESS PHONE:** (301) 500-1556

**MAIL ADDRESS:**
- **STREET 1:** 4800 HAMPDEN LANE
- **STREET 2:** SUITE 200
- **CITY:** BETHESDA
- **STATE:** MD
- **ZIP:** 20814

?xml version='1.0' encoding='ASCII'?

**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): **June 30, 2025**

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| |
|:---|
| **Gain Therapeutics, Inc.** |
| (Exact name of registrant as specified in its charter) |

---

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40237** | **85-1726410** |
| (State or Other Jurisdiction <br> of Incorporation) | (Commission <br> File Number) | (I.R.S. Employer <br> Identification No.) |

---

**4800 Montgomery Lane** **, Suite 220**

 **Bethesda, Maryland** **20814**

(Address of principal executive offices, including zip code)

 **(<u>301</u>) <u>500-1556</u>**

(Registrant's telephone number, including area code)

**<u>N/A</u>**

(Former name or former address, if changed since last report)

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:

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| | | |
|:---|:---|:---|
| **Title of Each Class:** | **Trading Symbol** | **Name of Each Exchange on which<br> Registered** |
| Common Stock, par value $0.0001 per share | GANX | The Nasdaq Stock Market LLC |

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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) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ⌧

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 8.01. Other Events.**

On June 30, 2025, Gain Therapeutics, Inc. (the "Company") announced an update on the progress of its ongoing Phase 1b clinical study evaluating the safety and tolerability of GT-02287 in people with Parkinson's Disease with or without a GBA1 mutation. The study, which aimed to enroll 15-20 participants, reached 16 participants on June 30, 2025, despite a two-month delay in protocol implementation. In addition, the independent data monitoring committee met recently and recommended to continue the study with no changes in dose level, concluding no serious treatment emergent adverse events have occurred.

The faster-than-anticipated enrollment means all those participants will reach their 90-day visit in time to facilitate biomarker analysis of all cerebrospinal fluid ("CSF") samples taken by fourth quarter of 2025 instead of the first quarter of 2026. Based on the greater relevance of CSF biomarkers as proof of drug activity, and considering the new timeline, the Company is expected to provide full results on 90-day biomarker evidence from all CSF and blood samples together during 4Q 2025, which is also earlier than originally planned.

Additionally, to facilitate the continued interest on the part of clinicians and patients currently aware of the Phase 1b study in Australia, the Company will extend the screening window for participants through July 31, 2025. The Company is also planning to approach the local health authorities in Australia to extend the dosing period of the Phase 1b beyond the 90-day period currently allowed in the protocol. Long-term chronic toxicology studies required to support this extension of dosing are near completion, and the Company is expected to provide an update on the progress of the extension before the end of 3Q25. The Company believes that the extension of the Phase 1b will also better inform Phase 2 protocol design and planning for early 2026.

**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.

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| | | |
|:---|:---|:---|
|  | **GAIN THERAPEUTICS, INC.** | **GAIN THERAPEUTICS, INC.** |
| Dated: June 30, 2025 | By: | /s/ Gene Mack |
|  |  | Gene Mack |
|  |  | Chief Executive Officer |

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