Gain Therapeutics Q1 R&D and G&A Costs Rise by $0.5M; GT-02287 Shows 81% Biomarker Reduction

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Gain Therapeutics increased R&D expenses by $0.5 million to $2.8 million and G&A costs by $0.5 million to $2.6 million in Q1, driven by its GT-02287 Parkinson’s program. The Phase 1b extension showed an 81% average CSF glucosylsphingosine reduction after 90 days, with FDA IND clearance expected in Q2 2026.

1. Q1 Financial Performance

In the quarter ended March 31, 2026, Gain Therapeutics increased R&D expenses by $0.5 million to $2.8 million and G&A expenses by $0.5 million to $2.6 million, reflecting higher program costs, personnel expenses and unfavorable currency translation.

2. Phase 1b Clinical Results

The Phase 1b extension of GT-02287 enrolled 16 participants, with 14 completing 150 days of dosing. Participants with elevated CSF glucosylsphingosine saw an average 81% reduction after 90 days, and MDS-UPDRS scores remained stable, supporting potential disease-modifying effects.

3. Upcoming Milestones

Gain anticipates FDA clearance of its IND in Q2 2026, enabling U.S. Phase 2 trials of GT-02287 to begin in Q3 2026. Final Phase 1b results are expected in Q4 2026 at the International GBA1 Meeting in Phoenix.

4. GT-04686 Discovery Progress

GT-04686, a novel glucocerebrosidase allosteric modulator identified via the Magellan™ platform, has shown in vitro and in vivo activity—including increased GCase activity and motor function restoration in Parkinson’s models—and is ready for IND-enabling studies.

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