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2026-07-16
2026-07-16
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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):
July 16, 2026
| |
|
|
| Gain Therapeutics, Inc. |
| (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 July 16, 2026, Gain Therapeutics, Inc. (the
“Company”) issued a press release and shareholder letter in which it announced, among other things, that its current cash
and cash equivalents are anticipated to fund the Company’s operations into the second quarter of 2027, based on current operating
plans, including the completion of the Phase 1b open-label extension in October 2026 and initiation of a Phase 2 clinical study during
the third quarter of 2026.
Cautionary Note Regarding 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. Such forward-looking statements include, but are not limited to, statements regarding the Company’s cash runway. 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, 2025, and other filings made with the SEC. All forward-looking statements are expressly qualified in their entirety
by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the
date of this release. The Company has no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking
statements, whether because of new information, future events or otherwise.
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: July 16, 2026 |
By: |
/s/ Gene Mack |
| |
|
Gene Mack |
| |
|
Chief Executive Officer |