Gain Therapeutics Reports Financial Results for Third Quarter 2025 and Provides Corporate Update

Core Insights - Gain Therapeutics, Inc. has presented initial data from its Phase 1b study indicating that GT-02287 shows a disease-slowing effect in Parkinson's disease, consistent with preclinical models and its proposed mechanism of action [1][4][15] - The company completed enrollment of 21 participants in the Phase 1b study, surpassing the initial target of 15 participants, and has received approval to extend the study duration to 12 months [1][3][12] - Financial results for Q3 2025 show an increase in R&D expenses to $2.8 million, primarily due to ongoing clinical trials and unfavorable currency translation [9][10] Clinical Program Highlights - The Phase 1b study of GT-02287 in Parkinson's disease has shown that 16 out of 21 participants completed 90 days of dosing, with the remaining participants expected to finish by December 2025 [3][12] - Initial clinical findings presented at the 2025 MDS conference suggest improvements in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores after approximately 30 days of administration [3][4] - The Phase 1b study extension commenced in September 2025, allowing participants to continue treatment for a total of 12 months, with a focus on long-term safety and tolerability [1][12][17] Financial Performance - R&D expenses increased by $0.2 million to $2.8 million for Q3 2025 compared to the same period in 2024, attributed to ongoing clinical trials and currency translation effects [9] - General and Administrative (G&A) expenses rose by $0.1 million to $1.9 million for Q3 2025, driven by higher stock-based compensation and personnel costs [10] - The net loss for Q3 2025 was reported at $5.3 million, or $0.15 per share, an improvement from a net loss of $4.5 million, or $0.17 per share, in Q3 2024 [11][13] Upcoming Milestones - Analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available in Q4 2025 [2][4] - An IND submission to the FDA is anticipated by the end of 2025, facilitating the expansion into Phase 2 clinical development [12][18] - Results from the Phase 1b study extension are expected in the second half of 2026 [12]