IND authorization paves the way for initiation of GT-02287 Phase 2 clinical development in the U.S., expected during 3Q26

FDA’s decision follows positive Phase 1 results for GT-02287 in both healthy volunteers and people with Parkinson’s disease demonstrating both biomarker and clinical evidence of activity with favorable safety and tolerability

GT-02287 is the first allosteric modulator developed from Gain’s Magellan™ AI drug discovery platform to receive IND clearance

BETHESDA, Md., June 29, 2026 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application for GT-02287. The FDA’s decision will allow initiation of the Company’s Phase 2 clinical development of GT-02287 in Parkinson’s disease with or without a GBA1 mutation in the U.S.

Both the Phase 1a and Phase 1b studies of GT-02287 were conducted in Australia. The sites in Australia are expected to also participate in the Phase 2 study along with new sites in the U.S. and select European centers.

"We appreciate the FDA’s guidance throughout the IND review process and look forward to initiating our Phase 2 study, which is anticipated to occur during 3Q26," said Gene Mack, President and CEO of Gain Therapeutics. "In clinical studies to date, GT-02287 demonstrated target engagement with favorable safety and tolerability. Additionally, recent feedback from trial participants across different clinical sites included anecdotal reports of improvements in smell and taste, balance or gait, and sleep. The FDA’s decision is a significant milestone for Gain and we believe it validates the extensive preclinical and clinical work supporting further development of GT-02287. We believe GT-02287 represents the next generation of differentiated therapeutics designed to address the underlying biology of Parkinson’s disease and move beyond symptomatic relief to create a new backbone of treatment that can slow or stop disease progression," concluded Mr. Mack.

The Company believes its Phase 1b extension data support the continued development of GT-02287 in Parkinson's disease, with continued safety and tolerability observed through five months of treatment. All 16 participants who entered the ongoing Phase 1b extension study remained on study at Day 150, and an independent Data Monitoring Committee recommended the study continue without modification. Biomarker analyses showed sustained target engagement, including an average 81% reduction in cerebrospinal fluid (CSF) glucosylsphingosine (GluSph) after 90 days in participants with elevated baseline levels, along with reductions in DOPA decarboxylase (DDC).