Form 8-K - Current report

0001819411false00018194112024-08-082024-08-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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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): August 8, 2024

Gain Therapeutics, Inc.

(Exact Name of the Registrant as Specified in Charter)

Delaware		001-40237		85-1726310
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

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4800 Montgomery Lane, Suite 220

Bethesda, Maryland 20814

(Address of principal executive offices) (Zip Code)

[phone]

(Registrant’s telephone number, including area code)

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(s)	Name of exchange on which registered
Common Stock, $0.0001 par value	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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

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Item 2.02 Results of Operations and Financial Condition.

On August 8, 2024, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024, and business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information and exhibit be deemed incorporated by reference into any of the Company’s filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The exhibits listed below are furnished as part of this Current Report on Form 8-K.

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Exhibit No.		Description
99.1	​	Gain Therapeutics, Inc. Press Release dated August 8, 2024
104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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.
Date: August 8, 2024	By:	/s/ Gene Mack
	Name:		Gene Mack
	Title:		Chief Financial Officer and Interim Chief Executive Officer

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Exhibit 99.1

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Gain Therapeutics Reports Financial Results for Second Quarter 2024 and Provides Corporate Update

Topline Results From MAD Phase 1 Study of GT-02287 on Track for August 2024 With Full Presentation at Upcoming Medical Conferences in Early Q4 2024

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Initiation of Phase 1b Study of GT-02287 in Parkinson’s Disease Patients Anticipated in Q4 2024

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BETHESDA, Md., August 8, 2024 -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reports financial results for the quarter ended June 30, 2024, and provides a corporate update.

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“The second quarter of 2024 proved to be productive for Gain, as we made significant progress in advancing our lead candidate GT-02287,” said Gene Mack, Interim CEO and CFO of Gain. “We are encouraged by results to date, from both the SAD and MAD studies completed in the second quarter, demonstrating GT-02287’s favorable safety profile. As we eagerly await the full topline results from the MAD part of the study expected this month, we remain confident in the potential of GT-02287 to become a lead treatment for Parkinson’s disease in patients with or without a GBA1 mutation. We look forward to presenting our findings at medical conferences this fall and advancing GT-02287 into a Phase 1b study to evaluate its efficacy in actual Parkinson’s patients in the fourth quarter of 2024. Finally, we believe we are well-positioned to continue executing on our near-term clinical milestones, with the goal of delivering a life-changing therapy to patients in need.”

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Second Quarter 2024 and Recent Corporate Highlights

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Pipeline Updates

●

Announced the completion of dosing in the Multiple Ascending Dose (MAD) portion of the Phase 1 trial of GT-02287, the Company’s lead candidate being evaluated for the treatment of Parkinson’s disease in patients with or without a GBA1 mutation;

●

Announced positive results from the Single Ascending Dose (SAD) portion of the Phase 1 trial of GT-02287; and

●

Presented preclinical data demonstrating an improvement in cognitive performance and activities of daily living with GT-02287 treatment in a mouse model of Parkinson’s disease in a late-breaking poster presentation at the Federation of European Neuroscience Societies (FENS) Forum 2024 held in Austria.

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Corporate Updates

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●

Announced appointment of Gene Mack as interim CEO and Chief Financial Officer. Khalid Islam, Ph.D., founder and Chairman of the Company’s Board of Directors, is serving as Executive Chairman; and

●

Completed an underwritten public offering that resulted in approximately $10.0 million of net proceeds.

Upcoming Milestones

●

Data lock for the MAD portion of the Phase 1 trial for GT-02287 in healthy volunteers will occur in mid-August with topline results expected soon after;

●

Presentation of late-breaking abstract at International Congress of Parkinson’s Disease and Movement Disorders from September 27th through October 1st;

●

Presentation of abstract at Neuroscience 2024 from October 5th through October 9th; and

●

Initiation of Phase 1b trial evaluating GT-02287 in actual Parkinson’s disease patients expected in Q4 2024.

Q2 2024 Financial Results

Research and development expenses increased by $0.4 million to $4.4 million for the three months ended June 30, 2024, as compared to $4.0 million for the three months ended June 30, 2023. The increase in research and development expenses was primarily related to costs associated with the ongoing Clinical Phase 1 trial of our lead program GT-02287 for the treatment of Parkinson’s Disease in patients with or without a GBA1 mutation.

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General and administrative expenses for the three months ended June 30, 2024, were $3.7 million, consistent with the expenses for the three months ended June 30, 2023. General and administrative expenses mainly consist of legal and professional fees relating to general corporate matters, share-based compensation expenses and employee’s termination benefits expenses.

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Net loss for the three months ended June 30, 2024, was $0.42 per share, basic and diluted, compared to $0.62 per share, basic and diluted, for the three months ended June 30, 2023.

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Cash, cash equivalent and marketable securities were $16.9 million as of June 30, 2024, compared to $16.8 million as of December 31, 2023.

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About Gain Therapeutics, Inc.

Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate GT-02287 for the treatment of Parkinson’s disease with or without a GBA1 mutation, is currently being evaluated in a Phase 1 clinical trial.

Leveraging AI-supported structural biology, proprietary algorithms, and supercomputer-powered physics-based models, the company’s Magellan™ drug discovery platform can identify novel allosteric binding sites on disease-implicated proteins, pinpointing pockets that cannot be found or drugged with current technologies. Its AI and machine-learning tools and virtual screening capabilities leverage the emerging on-demand compound libraries covering vast chemical spaces of over five trillion compounds to identify and select suitable small molecule hits for experimental validation.

Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.

Forward-Looking Statements

This release 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, risks associated with market conditions and the satisfaction of customary closing conditions related to the offering and uncertainties related to the offerings and the use of proceeds from the offerings. 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 prospectus supplement to be filed with the SEC, and the documents incorporated by reference therein, including the Company’s Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended June 30, 2024. 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

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as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:

Apaar Jammu and Chuck Padala

[e-mail]

[e-mail]

Media Contacts:

Russo Partners

Nic Johnson and Elio Ambrosio

[e-mail]

[e-mail]

[phone]

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GAIN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

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Three Months Ended June 30,

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Six Months Ended June 30,

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2024

​

2023

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2024

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2023

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Revenues:

​

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​

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​

​

​

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Collaboration revenues

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$

—

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$

—

​

$

—

​

$

55,180

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Other income

​

​

—

​

​

—

​

​

—

​

​

—

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Total revenues

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$

—

​

$

—

​

$

—

​

$

55,180

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​

​

​

​

​

​

​

​

​

​

​

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Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

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Research and development

​

​

(4,437,631)

​

​

(3,987,943)

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​

(6,944,537)

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​

(6,779,148)

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General and administrative

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​

(3,745,193)

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(3,743,171)

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(5,615,987)

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(6,236,930)

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Total operating expenses

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(8,182,824)

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(7,731,114)

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(12,560,524)

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(13,016,078)

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​

​

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Loss from operations

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$

(8,182,824)

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$

(7,731,114)

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$

(12,560,524)

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$

(12,960,898)

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​

​

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Other income/(expense):

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​

​

​

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Interest income, net

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​

84,531

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129,929

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​

199,834

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​

281,964

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Foreign exchange gain/(loss), net

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(43,576)

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(60,195)

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224,501

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(103,037)

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Loss before income tax

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$

(8,141,869)

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$

(7,661,380)

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$

(12,136,189)

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$

(12,781,971)

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Income tax

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(1,209)

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(26,589)

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(21,083)

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(43,317)

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Net loss

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$

(8,143,078)

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$

(7,687,969)

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$

(12,157,272)

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$

(12,825,288)

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Net loss per shares:

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Net loss per share attributable to common stockholders - basic and diluted

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$

(0.42)

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$

(0.62)

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$

(0.65)

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$

(1.05)

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Weighted average common shares - basic and diluted

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​

19,215,582

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12,387,089

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18,600,683

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12,157,969

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GAIN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

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	​	​	​	​	​	​	​
​		June 30,			December 31,
​	​	2024		​	2023		​
Assets	​	​	​	​	​	​	​
Current assets:	​	​	​	​	​	​	​
Cash and cash equivalents	​	$	16,936,315	​	$	11,794,949	​
Marketable securities - current	​	​	—	​	​	4,999,704	​
Tax credits	​	​	313,248	​	​	242,577	​
Prepaid expenses and other current assets	​	​	1,289,316	​	​	741,638	​
Total current assets	​	$	18,538,879	​	$	17,778,868	​
​	​	​	​	​	​	​	​
Non-current assets:	​	​	​	​	​	​	​
Property and equipment, net	​	$	123,930	​	$	125,962	​
Internal-use software	​	​	158,149	​	​	193,375	​
Operating lease - right of use assets	​	​	325,879	​	​	459,215	​
Restricted cash	​	​	31,803	​	​	34,021	​
Long-term deposits and other non-current assets	​	​	17,547	​	​	17,890	​
Total non-current assets	​	​	657,308	​	​	830,463	​
Total assets	​	$	19,196,187	​	$	18,609,331	​
​	​	​	​	​	​	​	​
Liabilities and stockholders' equity	​	​	​	​	​	​	​
Current liabilities:	​	​	​	​	​	​	​
Accounts payable	​	$	2,046,832	​	$	1,318,965	​
Operating lease liability - current	​	​	186,846	​	​	229,693	​
Other current liabilities	​	​	3,468,254	​	​	2,160,366	​
Deferred income - current	​	​	710,001	​	​	1,122,138	​
Loans - current	​	​	111,051	​	​	118,797	​
Total current liabilities	​	$	6,522,984	​	$	4,949,959	​
​	​	​	​	​	​	​	​
Non-current liabilities:	​	​	​	​	​	​	​
Defined benefit pension plan	​	$	298,428	​	$	307,454	​
Operating lease liability - non-current	​	​	134,321	​	​	229,855	​
Deferred income - non-current	​	​	80,364	​	​	94,786	​
Loans - non-current	​	​	375,352	​	​	449,053	​
Total non-current liabilities	​	​	888,465	​	​	1,081,148	​
Total liabilities	​	$	7,411,449	​	$	6,031,107	​
​	​	​	​	​	​	​	​
Stockholders’ equity	​	​	​	​	​	​	​
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of June 30, 2024 and December 31, 2023.	​	​	—	​	​	—	​
Common stock, $0.0001 par value: 50,000,000 shares authorized; 25,172,573 issued and outstanding as of June 30, 2024; 16,206,680 issued and outstanding as of December 31, 2023.	​	​	2,518	​	​	1,621	​
Additional paid-in capital	​	​	84,710,747	​	​	73,113,079	​
Accumulated other comprehensive income	​	​	12,462	​	​	247,241	​
Accumulated deficit	​	​	(60,783,717)	​	​	(38,516,197)	​
Loss for the period	​	​	(12,157,272)	​	​	(22,267,520)	​
Total stockholders’ equity	​	​	11,784,738	​	​	12,578,224	​
Total liabilities and stockholders’ equity	​	$	19,196,187	​	$	18,609,331	​

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Document and Entity information	Aug. 08, 2024
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Aug. 08, 2024
Entity File Number	001-40237
Entity Registrant Name	Gain Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-1726310
Entity Address, Address Line One	4800 Montgomery Lane
Entity Address, Adress Line Two	Suite 220
Entity Address, City or Town	Bethesda
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20814
City Area Code	301
Local Phone Number	500-1556
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	GANX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Central Index Key	0001819411
Amendment Flag	false

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