Earnings summaries and quarterly performance for Gain Therapeutics.
Executive leadership at Gain Therapeutics.
Board of directors at Gain Therapeutics.
Research analysts covering Gain Therapeutics.
Recent press releases and 8-K filings for GANX.
Gain Therapeutics, Inc. Provides Corporate Update and GT-02287 Clinical Progress
GANX
New Projects/Investments
Guidance Update
- Gain Therapeutics, Inc. (GANX) provided a corporate update on February 3, 2026, detailing the progress of its lead program, GT-02287, for Parkinson's Disease.
- The company plans to initiate Phase 2 clinical evaluation for GT-02287 in 2H 2026, following the completion of Phase 1b initial 90-day dosing in 4Q25.
- Phase 1b results for GT-02287 showed statistically significant biomarker evidence of disease modifying effect, including an average 81% reduction in CSF GluSph and a 6.17-point improvement in MDS-UPDRS Parts II and III scores in patients with elevated baseline CSF GluSph.
- As of September 30, 2025, Gain Therapeutics reported a cash position of $8.8 million.
3 days ago
Gain Therapeutics Provides Update on GT02287 Phase 1b Study for Parkinson's Disease
GANX
New Projects/Investments
Product Launch
Guidance Update
- Gain Therapeutics' GT02287 demonstrated biomarker evidence of modulating GCase activity in the brain, leading to a reduction in glucosylsphingosine, a substrate implicated in Parkinson's pathophysiology. This reduction in CSF glucosylsphingosine after 90 days of treatment is considered a biomarker of treatment response and removal of a toxic substrate.
- In Part 1 of the Phase 1b study, completed in November 2025, patients treated with GT02287 showed an average improvement of 2.2 points on the MDS-UPDRS Part 2 and Part 3 combined scores over 90 days.
- The company expects final results from the Phase 1b study extension around September 2026 and plans to initiate a Phase 2 study in the second half, early part of the third quarter of 2026.
Jan 6, 2026, 3:00 PM
Gain Therapeutics Updates on GT-02287 Phase 1b Study Results
GANX
New Projects/Investments
Guidance Update
- Gain Therapeutics (GANX) announced positive biomarker data from Part 1 of its Phase 1b open-label safety and tolerability study for GT-02287 in Parkinson's disease.
- The study demonstrated that GT-02287 decreased elevated glucosylsphingosine levels in cerebrospinal fluid (CSF) after 90 days of treatment, indicating a biological effect and reduction of a toxic substrate in the brain.
- A correlation was observed between decreased CSF glucosylsphingosine and improvements in UPDRS scores, suggesting potential clinical benefit, though based on small numbers.
- The company expects to initiate a Phase 2 study for GT-02287 in the second half, early part of the third quarter of 2026, with final results from the ongoing Phase 1b extension (Part 2) anticipated around September 2026.
Jan 6, 2026, 3:00 PM
Gain Therapeutics Announces Positive GT-02287 Phase 1b Clinical Study Results and Funding Update
GANX
New Projects/Investments
Guidance Update
- Gain Therapeutics, Inc. reported that its Phase 1b clinical study of GT-02287 for Parkinson's Disease showed large decreases in elevated glucosylsphingosine (GluSph) levels in the cerebrospinal fluid (CSF) of participants after 90 days of treatment.
- GT-02287 was generally well-tolerated, and 15 out of 19 participants (79%) completing the initial dosing period opted to continue in the nine-month extension study, anticipated to conclude in September 2026.
- The company confirmed it has a capital position to fund operations through the end of the Phase 1b extension and year-end 2026.
Dec 18, 2025, 2:00 PM
Gain Therapeutics Announces Positive Phase 1b Clinical Study Results for GT-02287
GANX
New Projects/Investments
- Gain Therapeutics announced positive results from its Phase 1b clinical study of GT-02287 for Parkinson's Disease, demonstrating CNS target engagement and a reduction in glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint.
- This marks the first time a GCase modulator has demonstrated a reduction of GluSph in CSF in Parkinson's Disease patients, suggesting increased GCase activity in the brain which is expected to impact disease progression.
- GT-02287 was generally well-tolerated over 90 days of dosing, and the data monitoring committee recommended continuing the study with no changes.
- The company has a capital position sufficient to fund operations through the end of the Phase 1b extension and year-end 2026.
- The nine-month extension of the Phase 1b study is anticipated to conclude in September 2026, with longer follow-up data to be presented at the AD/PD™ conference in March 2026.
Dec 18, 2025, 12:00 PM
Gain Therapeutics Reports Q3 2025 Financial Results and Provides Clinical Update
GANX
Earnings
Guidance Update
New Projects/Investments
- Gain Therapeutics reported a net loss of $0.15 per share for the third quarter ended September 30, 2025, compared to $0.17 per share for the same period in 2024.
- As of September 30, 2025, cash and cash equivalents were $8.8 million. The company also completed an underwritten public offering, resulting in approximately $7.1 million of net proceeds.
- The company completed enrollment of 21 participants in its Phase 1b study for GT-02287 in Parkinson's Disease during Q3 2025. Initial data suggests GT-02287 has a disease-slowing effect, with a full 90-day analysis expected in Q4 2025.
Nov 12, 2025, 9:06 PM
Gain Therapeutics Discusses GT-02287 Emerging Data and Clinical Development Plans
GANX
New Projects/Investments
- Gain Therapeutics, Inc. hosted a virtual Key Opinion Leader (KOL) event on October 14, 2025, to discuss emerging data from its Parkinson's Disease candidate, GT-02287.
- Initial data from the Phase 1b trial of GT-02287, which enrolled 21 participants, showed a favorable safety profile with 85% of treatment-emergent adverse events (TEAEs) being mild and no serious adverse events (SAEs) as of September 3, 2025.
- The trial's initial MDS-UPDRS data indicated mean improvement by Day 90, suggesting a slower, non-acute therapeutic effect for GT-02287.
- The company anticipates an IND filing by the end of 2025 and plans to initiate Phase 2a in 1H26, with final Phase 1b extension results expected in 2H26.
Oct 14, 2025, 8:56 PM
GAIN Therapeutics Provides Update on GT-2287 Parkinson's Disease Program
GANX
New Projects/Investments
Guidance Update
- GAIN Therapeutics (GANX) held a KOL event on October 14, 2025, to discuss its lead program, GT-2287, for Parkinson's Disease, particularly in patients with a GBA1 genetic mutation.
- The ongoing Phase 1b study of GT-2287 in Parkinson's patients has completed enrollment with 21 participants as of early September. The 90-day dosing period will conclude by the end of 2025, with full safety, tolerability, PK, and UPDRS data expected.
- Preliminary data from the Phase 1b study indicates GT-2287 is overall safe and well-tolerated, with 85% of adverse events being mild. Early observations show a mean improvement in MDS UPDRS scores by day 90.
- Biomarker data, including alpha-synuclein, is anticipated later in Q4 2025. A Phase 2 placebo-controlled study is planned to begin in Q2 2026, with the Investigational New Drug (IND) application submission expected by the end of 2025.
Oct 14, 2025, 8:00 PM
Gain Therapeutics to Host KOL Event on GT-02287 for Parkinson's Disease
GANX
New Projects/Investments
- Gain Therapeutics (GANX) will host a virtual Key Opinion Leader (KOL) event on October 14th, 2025, at 4:00 p.m. EST, to discuss emerging data from its lead drug candidate, GT-02287, for Parkinson's disease.
- The event will feature KOLs Karl Kieburtz, M.D., M.P.H., and Kenneth Marek, M.D., who will contextualize data from the Phase 1b clinical study of GT-02287.
- Initial data from the Phase 1b study in Parkinson's disease patients indicates GT-02287 was generally well tolerated, with no treatment-emergent serious adverse events, and showed trending improvements in MDS-UPDRS scores.
- GT-02287 is an orally administered, brain-penetrant small molecule that aims to restore glucocerebrosidase (GCase) function, with preclinical data suggesting it may have the potential to slow or stop the progression of Parkinson's disease.
Oct 9, 2025, 11:00 AM
Gain Therapeutics Presents Interim Phase 1b Data for GT-02287 in Parkinson's Disease
GANX
New Projects/Investments
- Gain Therapeutics presented interim data from its Phase 1b clinical study of GT-02287 for Parkinson's disease, reporting improvement in MDS-UPDRS scores in the first 9 participants after 90 days of dosing.
- GT-02287 was generally well-tolerated with no treatment-emergent serious adverse events, and plasma exposures were within the projected therapeutic range.
- The data monitoring committee recommended continuation of the study, and Australian health authorities approved a Phase 1b study extension for up to 12 months.
- The company will host a webinar on October 14 at 4 p.m. ET to discuss these results further.
Oct 6, 2025, 12:15 PM
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more