Gain Therapeutics (GANX) investor relations material

Executive summary

• Advanced clinical development of lead candidate GT-02287 for Parkinson's disease, with promising biomarker and early clinical evidence presented at major conferences in early 2026.

• Ongoing Phase 1b study extension for GT-02287, with durable MDS-UPDRS scores and significant biomarker improvements observed.

• IND clearance for GT-02287 expected in Q2 2026, with Phase 2 trial initiation planned for Q3 2026.

• Presented new allosteric modulators, including GT-04686, showing efficacy in preclinical models and ready for IND-enabling studies.

• No product revenue to date; operations funded by equity offerings, grants, and ATM programs.

Financial highlights

• Net loss of $5.6 million for Q1 2026, or $0.13 per share, compared to $4.5 million, or $0.16 per share, in Q1 2025, driven by increased R&D and G&A expenses.

• R&D expenses rose to $2.8 million and G&A expenses to $2.6 million in Q1 2026, both up $0.5 million year-over-year, mainly due to GT-02287 program costs, professional fees, and FX impacts.

• Cash, cash equivalents, and marketable securities totaled $16.5 million as of March 31, 2026, down from $20.8 million at year-end 2025.

• Operating cash outflow of $4.7 million in Q1 2026; cash and equivalents decreased by $4.3 million during Q1 2026.

• Accumulated deficit reached $107.0 million as of March 31, 2026.

Outlook and guidance

• Current cash expected to fund operations into Q1 2027; substantial doubt exists about ability to continue as a going concern beyond that period without additional capital.

• Management is pursuing further equity/debt financing, cost optimization, and strategic collaborations.

• FDA clearance of IND for GT-02287 anticipated in Q2 2026, enabling Phase 2 clinical development in the US.

• Phase 2 clinical trial for GT-02287 in Parkinson's disease expected to start in Q3 2026.

• Results from the Phase 1b clinical study of GT-02287 expected in Q4 2026.