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2025-06-30
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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):
June 30, 2025
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|
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| Gain Therapeutics, Inc. |
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|
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| (Exact name of registrant as specified in
its charter) |
| Delaware |
|
001-40237 |
|
85-1726410 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
4800 Montgomery Lane, Suite 220
Bethesda, Maryland 20814
(Address of principal executive offices, including zip code)
(301)
500-1556
(Registrant’s telephone number, including area code)
N/A
(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:
| Title
of Each Class: |
|
Trading
Symbol |
|
Name
of Each Exchange on which
Registered |
| Common Stock, par value $0.0001 per share |
|
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)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 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. |
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| Dated: June 30, 2025 |
By: |
/s/
Gene Mack |
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|
Gene Mack |
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|
Chief Executive Officer |
