ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for charts Register for streaming realtime charts, analysis tools, and prices.

GANX Gain Therapeutics Inc

1.68
0.08 (5.00%)
27 Dec 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Gain Therapeutics Inc NASDAQ:GANX NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.08 5.00% 1.68 1.68 1.83 1.88 1.55 1.58 559,830 21:42:44

Form 8-K - Current report

14/11/2024 9:02pm

Edgar (US Regulatory)


0001819411false00018194112024-11-142024-11-14

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): November 14, 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.)

4800 Montgomery Lane, Suite 220

Bethesda, Maryland 20814

(Address of principal executive offices) (Zip Code)

(301) 500-1556

(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

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.

Item 2.02 Results of Operations and Financial Condition.

On November 14, 2024, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2024, and a 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.

Exhibit No.

    

Description

99.1

Gain Therapeutics, Inc. Press Release dated November 14, 2024

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: November 14, 2024

By:

/s/ Gene Mack

Name:

Gene Mack

Title:

Chief Financial Officer and Interim Chief Executive Officer

Exhibit 99.1

Graphic

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

Initiation of Phase 1b Study of GT-02287 in Parkinsons patients expected by end of 2024

BETHESDA, Md., November 14, 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 September 30, 2024, and provides a corporate update.

“The third quarter of 2024 marked substantial progress for Gain and the development of GT-02287, our lead candidate for the treatment of Parkinson’s disease in patients with or without the GBA1 mutation. Data from our Phase 1 study for GT-02287 presented recently at both the International Congress of Parkinson’s Disease and Movement Disorders and the Michael J Fox Foundation Annual Parkinson's Disease Therapeutics Conference demonstrated target engagement with a 53% increase in GCase activity along with favorable safety and tolerability in healthy volunteers. We believe these outcomes derisk the upcoming Phase 1b study in patients with Parkinson’s disease that remains on track to initiate before year end 2024.  We also submitted the pre-IND package for our upcoming meeting with the FDA scheduled before year end to facilitate the Phase 2 expansion of our clinical development plans for GT-02287 in 2025, moving us significantly closer to developing the first disease-modifying therapy for patients with Parkinson’s disease,” said Gene Mack, Interim CEO and CFO of Gain Therapeutics.

Third Quarter 2024 and Recent Corporate Highlights

Pipeline Updates

Announced positive results from the Multiple Ascending Dose (MAD) part of the Phase 1 study of GT-02287, the Company’s lead candidate being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from the study demonstrated the safety and tolerability of GT-02287 along with an increase in GCase activity of 53% in healthy volunteers. The positive results from the Phase 1 study and design of the upcoming Phase 1b clinical trial were featured at the following conferences:
oA late-breaker poster and oral presentation at The International Congress of Parkinson’s Disease and Movement Disorders in September 2024 in Philadelphia, PA.
oAn oral presentation at the Michael J. Fox Foundation’s 16th Annual Parkinson’s Disease Therapeutics Conference in October 2024 in New York, NY.
oA virtual webinar hosted by Gain Therapeutics in September 2024 that reviewed all the data from the study.
Presented preclinical data at the Neuroscience 2024 conference in October 2024 in Chicago, IL that the Company believes further elucidates the disease modifying potential of GT-02287 by evaluating the effect of withdrawing treatment in animal models and the improvement in mitochondrial health related to administration of GT-02287 .

oGT-02287 was shown to rescue deficits in neuromuscular function and motor coordination in animal models of GBA1 and idiopathic Parkinson’s disease models and to prevent the development of deficits in cognition and activities of daily living. Notably, withdrawal of GT-02287 for more than one week did not significantly affect performance in any of the tests, suggesting a disease modifying effect.
oGT-02287 reduced the level of mitochondrial reactive oxygen species (ROS) as well as ameliorating lysosomal pathology, reducing α-synuclein aggregation, and providing a neuroprotective effect. In an in vivo model in which mice were subjected to toxic insult by CBE and injection of α-synuclein preformed fibrils (PFFs) into the striatum – delayed administration of GT-02287 reduced levels of mitochondrial protein Miro1, an important maker for mitophagy; aggregated α-synuclein and plasma neurofilament light chain (NfL), a marker of neurodegeneration; as well as completely restoring motor function to control levels.
Presented poster in October 2024 in Barcelona, Spain highlighting the Company’s Magellan™ drug discovery platform to identify allosteric inhibitors targeting discoidin domain receptor 2 at the 36th EORTC-NCI-AACR Symposium.

Upcoming Milestones

Initiation of Phase 1b trial evaluating GT-02287 in Parkinson’s disease patients expected in Q4 2024
Pre-IND meeting with the U.S. Food and Drug Administration (FDA) anticipated by the end of 2024

Q3 2024 Financial Results

Research and development expenses increased by $0.3 million to $2.6 million for the three months ended September 30, 2024, as compared to $2.3 million for the three months ended September 30, 2023. The increase in research and development expenses was primarily related to costs associated with the Clinical Phase 1 trial of our lead program GT-02287 for the treatment of Parkinson’s Disease.

General and administrative expenses decreased by $0.7 million to $1.8 million for the three months ended September 30, 2024, as compared to $2.5 million for the three months ended September 30, 2023. The decrease in general and administrative expenses for the period was primarily attributable to a decrease in legal and professional fees relating to general corporate matters and a decrease in stock-based compensation expenses.

Net loss for the three months ended September 30, 2024, was $0.17 per share, basic and diluted, compared to $0.37 per share, basic and diluted, for the three months ended September 30, 2023.

Cash, cash equivalent and marketable securities were $12 million as of September 30, 2024, compared to $16.8 million as of December 31, 2023.

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 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme.

Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ 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 September 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 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

ajammu@gaintherapeutics.com

chuck@lifesciadvisors.com

Media Contacts:

Russo Partners

Nic Johnson and Elio Ambrosio

nic.johnson@russopartnersllc.com

elio.ambrosio@russopartnersllc.com

(760) 846-9256


GAIN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

 

Three Months Ended September 30, 

 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

 

Revenues:

 

  

 

  

 

  

 

  

Collaboration revenues

$

$

$

$

55,180

Other income

 

 

 

 

Total revenues

$

$

$

$

55,180

Operating expenses:

 

  

 

  

  

  

Research and development

 

(2,621,722)

 

(2,367,482)

(9,566,259)

(9,146,630)

General and administrative

 

(1,837,242)

 

(2,517,523)

(7,453,229)

(8,754,453)

Total operating expenses

 

(4,458,964)

 

(4,885,005)

(17,019,488)

(17,901,083)

Loss from operations

$

(4,458,964)

$

(4,885,005)

$

(17,019,488)

$

(17,845,903)

Other income/(expense):

 

  

 

  

 

  

 

  

Interest income, net

 

105,405

 

106,000

 

305,239

 

387,964

Foreign exchange gain/(loss), net

 

(121,139)

 

82,198

 

103,362

 

(20,839)

Loss before income tax

$

(4,474,698)

$

(4,696,807)

$

(16,610,887)

$

(17,478,778)

Income tax

 

(10,994)

(21,456)

 

(32,077)

 

(64,773)

Net loss

$

(4,485,692)

$

(4,718,263)

$

(16,642,964)

$

(17,543,551)

Net loss per shares:

 

  

 

  

 

  

 

  

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

$

(0.17)

$

(0.37)

$

(0.78)

$

(1.42)

Weighted average common shares - basic and diluted

 

26,531,747

 

12,701,401

 

21,273,422

12,342,031


GAIN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

    

September 30, 

    

December 31, 

2024

2023

Assets

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

12,049,522

$

11,794,949

Marketable securities - current

4,999,704

Tax credits

373,726

242,577

Prepaid expenses and other current assets

 

1,318,092

 

741,638

Total current assets

$

13,741,340

$

17,778,868

Non-current assets:

 

  

  

Property and equipment, net

$

119,610

$

125,962

Internal-use software

156,256

193,375

Operating lease - right of use assets

 

281,578

 

459,215

Restricted cash

 

33,873

 

34,021

Long-term deposits and other non-current assets

 

33,007

 

17,890

Total non-current assets

624,324

830,463

Total assets

$

14,365,664

$

18,609,331

Liabilities and stockholders' equity

Current liabilities:

 

  

 

  

Accounts payable

$

1,098,453

$

1,318,965

Operating lease liability - current

 

178,781

 

229,693

Other current liabilities

 

2,491,254

 

2,160,366

Deferred income - current

 

708,027

 

1,122,138

Loans - current

118,280

118,797

Total current liabilities

$

4,594,795

$

4,949,959

Non-current liabilities:

 

  

 

  

Defined benefit pension plan

$

323,266

$

307,454

Operating lease liability - non-current

 

96,222

 

229,855

Deferred income - non-current

65,869

94,786

Loans - non-current

376,130

449,053

Total non-current liabilities

861,487

1,081,148

Total liabilities

$

5,456,282

$

6,031,107

Stockholders’ equity

 

  

 

  

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of September 30, 2024 and December 31, 2023.

Common stock, $0.0001 par value: 50,000,000 shares authorized; 25,962,246 issued and outstanding as of September 30, 2024; 16,206,680 issued and outstanding as of December 31, 2023.

 

2,596

 

1,621

Additional paid-in capital

 

86,090,657

 

73,113,079

Accumulated other comprehensive income

 

242,810

 

247,241

Accumulated deficit

 

(60,783,717)

 

(38,516,197)

Loss for the period

 

(16,642,964)

 

(22,267,520)

Total stockholders’ equity

8,909,382

12,578,224

Total liabilities and stockholders’ equity

$

14,365,664

$

18,609,331


v3.24.3
Document and Entity information
Nov. 14, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Nov. 14, 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

1 Year Gain Therapeutics Chart

1 Year Gain Therapeutics Chart

1 Month Gain Therapeutics Chart

1 Month Gain Therapeutics Chart

Your Recent History

Delayed Upgrade Clock