Gain Therapeutics | 8-K: FY2026 Q2 Revenue: USD 0

Revenue: As of FY2026 Q2, the actual value is USD 0.

EPS: As of FY2026 Q2, the actual value is USD -0.11.

EBIT: As of FY2026 Q2, the actual value is USD -4.572 M.

Financial Performance for Three Months Ended June 30, 2026

Research and Development (R&D) Expenses

Research and development expenses for Gain Therapeutics, Inc. decreased by $0.6 million to - $2,138,204 for the three months ended June 30, 2026, compared to - $2,758,973 for the same period in 2025. This reduction was primarily due to lower costs associated with the lead program compound GT-02287 (rexaceract) and pipeline optimization, along with reduced R&D personnel expenses, partially offset by an expired grant and unfavorable foreign exchange currency translation.

General and Administrative (G&A) Expenses

General and administrative expenses increased by $0.2 million to - $2,543,448 for the three months ended June 30, 2026, up from - $2,330,553 for the three months ended June 30, 2025. This increase was mainly attributed to higher professional fees, increased personnel costs, and unfavorable foreign exchange currency translation.

Net Loss

Net loss for the three months ended June 30, 2026, was - $4,675,571, an improvement from - $5,809,087 for the three months ended June 30, 2025.

Cash and Cash Equivalents

Cash and cash equivalents totaled $13,084,144 as of June 30, 2026, which is a decrease from $20,837,628 as of December 31, 2025.

Operational Metrics and Corporate Updates

Pipeline Updates - Rexaceract (GT-02287)

Gain Therapeutics, Inc. presented additional data from the Phase 1b clinical study of rexaceract at the 3rd International GBA1 Meeting 2026, demonstrating restoration of glucocerebrosidase (GCase) biology and supporting its disease-modifying potential. As of May 2026, all 16 participants in the Phase 1b nine-month extension remained on study, having completed five months of dosing, with MDS-UPDRS scores remaining stable and durable across the overall study population after 150 days of treatment, particularly benefiting participants with elevated baseline CSF GluSph.

Pipeline Updates - GT-04686

GT-04686 is advancing towards IND-enabling studies and clinical development, with current efforts focused on program optimization and data generation. Gain Therapeutics, Inc. expects to select the initial therapeutic indication for GT-04686, its second allosteric modulator from the Magellan™ AI drug discovery platform, by year-end.

Regulatory Updates

The U.S. Food and Drug Administration (FDA) completed its review of an Investigational New Drug (IND) application for rexaceract, paving the way for the initiation of Phase 2 clinical development in the U.S. Rexaceract is the first allosteric modulator from Gain Therapeutics, Inc.’s Magellan™ AI drug discovery platform to receive IND clearance.

Management Changes

Dr. Joanne Taylor was promoted to Chief Scientific Officer, and Terenzio Ignoni was promoted to Chief Operating Officer, strengthening the company’s scientific leadership and operational execution.

Outlook / Guidance

Gain Therapeutics, Inc. anticipates the commencement of a Phase 2 clinical trial for rexaceract in Parkinson’s disease in Q3 2026. The company also projects final results from the Phase 1b clinical study of rexaceract for Q4 2026. Additionally, the initial target indication for GT-04686 is expected to be announced in Q4 2026.