Gain Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses decreased $1.4 million year-over-year to $1.4 million for the three months ended September 30, 2026, compared to $2.8 million in the same period in 2025.
• General and administrative expenses decreased $0.1 million year-over-year to $1.8 million for the three months ended September 30, 2026, compared to $1.9 million in the same period in 2025.
• Net loss per share (basic and diluted) was $0.07 for the three months ended September 30, 2026, compared to $0.15 per share in the same period in 2025.
• Cash and cash equivalents were $11.7 million as of September 30, 2026, down from $20.8 million as of December 31, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $13.2 million, compared to $14.2 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $13.4 million, compared to $15.6 million for the same period in 2025.
• Total liabilities were $3.1 million as of September 30, 2026, compared to $4.3 million as of December 31, 2025.
• Total stockholders' equity was $10.2 million as of September 30, 2026, compared to $18.6 million as of December 31, 2025.

Guidance and Future Outlook:

• The Phase 2 clinical trial of rexaceract is expected to initiate during Q1 2027 following a comprehensive redesign and submission of a new protocol in Q4 2026.
• The company plans to select an initial therapeutic indication to advance GT-04686 into the clinic, with the target indication expected in Q4 2026.
• Management anticipates achieving additional potential clinical and regulatory milestones throughout the remainder of 2026.

Business Segments and Product Lines:

• Rexaceract: Long-term open-label data from the Phase 1b trial presented in October 2026 showed no progression of Parkinson's disease motor symptoms after 12 months of dosing.
• Rexaceract: MDS-UPDRS motor scores demonstrated stability compared to baseline among 12 evaluable participants who completed 12 months of daily oral administration.
• Rexaceract: Participants with high and low baseline levels of glucosylsphingosine (GluSph) in cerebrospinal fluid showed stabilization of motor scores after 12 months.
• Rexaceract: Preliminary data indicated the drug was generally well tolerated over 12 months, with no new safety signals and a lower incidence of treatment-emergent adverse events in the nine-month open-label extension compared to the initial three-month administration.
• Rexaceract: Perceived benefits included improvements in sense of smell and taste (four instances), balance or gait (four instances), and sleep (three instances).
• GT-04686: The company is building a differentiated GCase-targeting platform with multiple undisclosed preclinical assets targeting lysosomal storage disorders, metabolic diseases, and solid tumors.
• Pipeline Funding: The lead Parkinson's disease program received early development funding support from The Michael J. Fox Foundation, The Silverstein Foundation for Parkinson's with GBA, and the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 and Innosuisse.

Management Commentary and Tone:

• CEO Gene Mack stated the third quarter marked an important period of progress, validating the disease-modifying hypothesis for rexaceract in Parkinson's disease.
• Management believes rexaceract has the potential to shift the treatment paradigm beyond symptom management.
• The addition of Jeanette Weidner as Vice President, Finance, is intended to support strategic operations for the company's next phase of corporate and clinical development.

Other Key Points:

• The Innosuisse grant awarded under the Swiss Accelerator program expired in April 2026, partially offsetting the decrease in R&D expenses.
• The Phase 1b study for rexaceract enrolled participants across seven sites in Australia.
• Rexaceract is an orally administered, brain-penetrant small molecule beta-glucocerebrosidase (GCase) positive allosteric modulator.
• Preclinical models showed rexaceract could rescue deficits in motor function and gait, with washout experiments suggesting potential to slow or stop disease progression.
• The company has 44,324,134 shares of common stock issued and outstanding as of September 30, 2026.