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Gain Therapeutics

Bethesda, United States · Biotechnology, Health Care, Therapeutics

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 and other neurodegenerative diseases is currently being evaluated in a Phase 1 clinical trial. With its Magellan drug discovery platform, Gain is transforming drug discovery by i

Key facts

Headquarters
Bethesda, United States
Employees
32
Industries
Biotechnology, Health Care, Therapeutics
Status
Public (GANX)
Website
gaintherapeutics.com
LinkedIn
Company page

Recent activity at Gain Therapeutics

  • : SEC 8-K (8.01): On October 1, 2026, Gain Therapeutics, Inc. announced the presentation of a poster at the International Congress of Parkinson’s Disease and Movement Disorders, scheduled for October 4-8, 2026, in Seoul, Korea. The poster details long-term open-label extension data from their Phase 1b clinical study of rexaceract, indicating stabilization of MDS-UPDRS scores over 360 days, which supports its potential as a disease-modifying treatment for Parkinson’s disease. As of August 31, 2026, only 1 of the 13 evaluable patients has yet to complete the full 12-month dosing, with the data demonstrating no meaningful progression in motor symptoms. The company plans to submit a Phase 2 study protocol to the FDA soon and initiate the trial in Q1 2027, reflecting a positive trajectory for rexaceract's development in treating Parkinson’s disease.
  • : SEC 8-K (5.02): On September 22, 2026, Gianluca Fuggetta, the Principal Financial Officer of Gain Therapeutics, Inc., resigned to pursue other opportunities, with his resignation effective September 30, 2026. Subsequently, on September 24, 2026, Gene Mack, the current President and CEO, was appointed as the interim Chief Financial Officer effective October 1, 2026. The Company is actively searching for a permanent replacement for the principal financial officer role. Mr. Mack's compensation and other material terms will remain unchanged during this interim period.
  • : SEC 8-K (8.01): On July 16, 2026, Gain Therapeutics, Inc. issued a press release regarding its financial status, indicating that its cash and cash equivalents are expected to support operations into the second quarter of 2027. This announcement included details about ongoing projects, such as the completion of a Phase 1b open-label extension in October 2026 and the initiation of a Phase 2 clinical study during the third quarter of 2026. The release includes forward-looking statements about the company's financial outlook and operational plans, emphasizing potential risks and uncertainties associated with these predictions.
  • : SEC 8-K (8.01): On June 29, 2026, Gain Therapeutics, Inc. announced that the U.S. FDA has authorized its Investigational New Drug application for GT-02287, allowing the initiation of Phase 2 clinical development for treating Parkinson's disease. This follows previous Phase 1a and 1b studies conducted in Australia, with plans to include new U.S. and European sites in the Phase 2 study expected to commence in the third quarter of 2026. This development signifies a strategic step forward for the Company in addressing Parkinson's disease and demonstrates potential for future therapeutic advancements.
  • : SEC 8-K (8.01): On May 26, 2026, Gain Therapeutics, Inc. announced interim clinical and biomarker data from Part 2 of its ongoing Phase 1b study of GT-02287 in Parkinson's disease patients. The data, presented at the 3rd International GBA1 Meeting on May 22-23, highlights safety and effectiveness metrics, with 16 of 19 participants continuing into the nine-month extension phase. Notably, the treatment led to an 81% reduction in elevated glucosylsphingosine levels after 90 days, indicative of improved symptoms in Parkinson's patients. The findings support the drug's continued development, with considerable perceived benefits reported by participants. The proposed Phase 2 trial will further evaluate treatment effects and validate the preliminary results.
  • : SEC 8-K (8.01): On March 18, 2026, the Company issued a press release regarding its participation at the AD/PD 2026 International Conference focused on Alzheimer's and Parkinson's diseases. The oral presentation showcased new clinical data from a Phase 1b study of GT-02287, aimed at demonstrating its disease-modifying effects in certain types of Parkinson's disease. Notably, Dr. Jonas Hannestad presented that out of 19 participants in Part 1, 16 opted for the ongoing nine-month extension, with significant improvements observed in biomarker levels after treatment. The findings also indicated the potential benefits of GT-02287 correlated with baseline biochemical markers in cerebrospinal fluid, reflecting a promising avenue for future neurological treatment. The conference is being held from March 17-21, 2026, in Copenhagen, Denmark.
  • : SEC 8-K (7.01): On February 3, 2026, Gain Therapeutics, Inc. published slides on its website as part of an investor presentation, which is being disclosed under Item 7.01 of Form 8-K. The presentation outlines the Company's business and provides key information intended for security holders, serving to communicate recent developments and strategies. This disclosure is significant for investors as it may affect their perception of the Company's performance and future prospects. The filing emphasizes that the shared information is not considered 'filed' under the relevant sections of the Exchange Act, thereby limiting liability. This move shows the Company's commitment to transparency with its investors.
  • : SEC 8-K (8.01): On December 18, 2025, Gain Therapeutics, Inc. announced through a press release the exploratory endpoint results from its Phase 1b clinical study of GT-02287 in patients with Parkinson's Disease. The study, which included 21 participants, demonstrated that all individuals with elevated levels of glucosylsphingosine (GluSph) in cerebrospinal fluid experienced significant decreases towards healthy levels after 90 days of treatment. 15 out of 19 participants opted to continue into a nine-month extension of the study, expected to be completed in September 2026. The findings support continued dosing and showcase the drug's favorable safety and tolerability profile, indicating strategic progress in treating Parkinson's disease and solidifying the company's financial capacity to support this research through the end of 2026.
  • : SEC 8-K (8.01): On November 28, 2025, Gain Therapeutics, Inc. filed a prospectus supplement related to its at-the-market offering program, permitting the sale of up to $35,530,980.56 of its common stock, with Oppenheimer & Co. Inc. serving as the sales agent. As part of this offering, the company has already sold $14,469,019.44 of common stock under the related Equity Distribution Agreement, which dates back to September 6, 2024. The legal opinion validating this stock sale, provided by Lowenstein Sandler LLP, is attached as an exhibit. This filing is significant for investors as it updates them about the company’s capital-raising initiatives and the status of its registration statement, which became effective on November 26, 2025.
  • : SEC 8-K (8.01): On November 28, 2025, Gain Therapeutics, Inc. entered into a material definitive agreement regarding its 'at the market offering' program. Through this program, the company will offer and sell up to $35,530,980.56 of its common stock, with Oppenheimer & Co. Inc. acting as the sales agent. As of this date, Gain Therapeutics has already sold an aggregate amount of $14,469,019.44 under the existing Equity Distribution Agreement that was established on September 6, 2024. This capital raise is intended to support ongoing business operations and growth initiatives.

Leadership

  • Gianluca Fuggetta, Vice President of Finance
  • Gene Mack, Chief Executive Officer
  • Jonas Hannestad, Chief Medical Officer

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Employee benefit plans

Gain Therapeutics files 1 employee benefit plan with the U.S. Department of Labor, including a retirement plan. The next plan year renews in Dec 2026.

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About Gain Therapeutics: questions and answers

What does Gain Therapeutics do?

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 and other neurodegenerative diseases is currently being evaluated in a Phase 1 clinical trial. With its Magellan drug discovery platform, Gain is transforming drug discovery by i

Where is Gain Therapeutics headquartered?

Gain Therapeutics is headquartered in Bethesda, United States.

How many employees does Gain Therapeutics have?

Gain Therapeutics has about 32 employees.

Who leads Gain Therapeutics?

Gianluca Fuggetta is a Vice President of Finance at Gain Therapeutics.

What is the latest news on Gain Therapeutics?

On Oct 01, 2026, SEC 8-K (8.01): On October 1, 2026, Gain Therapeutics, Inc. announced the presentation of a poster at the International Congress of Parkinson’s Disease and Movement Disorders, scheduled for October 4-8, 2026, in Seoul, Korea. The poster details long-term open-label extension data from their Phase 1b

Is Gain Therapeutics a public company?

Yes. Gain Therapeutics is publicly traded under the ticker GANX.

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