Gain Therapeutics (GANX) investor relations material

Executive summary

• FDA authorized IND for rexaceract, enabling advancement to Phase 2 clinical development for Parkinson's disease, with clinical studies completed and a Phase 1b study ongoing; final Phase 1b data expected in Q4 2026 and Phase 2 trial initiation planned for Q3 2026.

• Rexaceract's Phase 1b extension study showed durable, non-progression of symptoms through Day 360, especially in patients with high baseline CSF GluSph.

• Pipeline expanded with GT-04686 advancing toward IND-enabling studies, with initial indication selection expected by year-end.

• Leadership strengthened with promotions to Chief Scientific Officer and Chief Operating Officer.

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

Financial highlights

• Cash and cash equivalents were $13.1 million as of June 30, 2026, down from $20.8 million at December 31, 2025.

• Net loss for Q2 2026 was $4.68 million and for the six months ended June 30, 2026, was $10.28 million.

• Research and development expenses decreased year-over-year to $2.1 million for the quarter and $4.9 million for the half-year, mainly due to lower costs for rexaceract and pipeline optimization.

• General and administrative expenses increased to $2.5 million for the quarter and $5.1 million for the half-year, driven by higher professional fees and personnel costs.

• Weighted average shares outstanding increased to 42.9 million for the quarter, reflecting equity issuances.

Outlook and guidance

• Phase 2 clinical trial for rexaceract in Parkinson's disease expected to begin in Q3 2026, with FDA IND authorization received in June 2026.

• Final results from Phase 1b clinical study anticipated in Q4 2026.

• Current cash is expected to fund operations into Q2 2027; substantial doubt exists about the ability to continue as a going concern beyond that without additional financing.

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

• Research and development expenses are expected to increase as clinical programs advance.