AI Earnings Predictions for Gain Therapeutics Inc. (GANX)

EX-99.1

2 ganx-20260811xex99d1.htm

EX-99.1

Exhibit 99.1

Gain Therapeutics Reports Financial Results for Second Quarter 2026 and Provides Corporate Update

BETHESDA, Md., August 11, 2026 -- 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 reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

“The second quarter marked an important period of execution for Gain, highlighted by FDA authorization of our IND for rexaceract, which positions us to advance into Phase 2 clinical development,” said Gene Mack, President and CEO of Gain Therapeutics. “The encouraging biomarker and clinical data generated to date continue to support the potential disease-modifying properties of rexaceract, and we were pleased to further share these findings with the scientific community at the 3rd International GBA1 Meeting. We believe these data further strengthen the therapeutic rationale for rexaceract across both idiopathic and GBA1 Parkinson’s disease.”

Mr. Mack continued, “We remain focused on completing the ongoing nine-month extension of our Phase 1b study, with final data expected to be presented at the International Congress of Parkinson’s Disease and Movement Disorders in Korea in October 2026, while advancing preparations for our Phase 2 clinical program. As of June 30, 2026, 14 of the 16 participants that elected to enroll in the Phase 1b nine-month extension had completed Day 270 with seven of those crossing the Day 360 mark. To date, MDS-UPDRS scores continue to demonstrate that patients with high baseline CSF GluSph experience an early and durable response to rexaceract that persists through Day 270 and Day 360, while the overall patient group continues to benefit from non-progression of their Parkinson’s symptoms through Day 360. We continue to believe rexaceract has the potential to shift the treatment paradigm beyond symptom management by addressing the underlying biology of Parkinson’s disease, and we look forward to achieving additional clinical and regulatory milestones throughout the remainder of the year.”

Second Quarter 2026 and Recent Corporate and Pipeline Highlights

Pipeline Updates

Rexaceract

●Presented additional data from the Phase 1b clinical study of rexaceract (GT-02287) that supported its disease-modifying potential via demonstrating the restoration of glucocerebrosidase (GCase) biology at the 3rd International GBA1 Meeting 2026 in May 2026 in Phoenix, AZ.

oAs of May 2026, all 16 participants enrolled in the Phase 1b, nine-month extension remained on study and had completed five months of dosing (Day 150).

oMDS-UPDRS scores remained stable and durable across the overall study population after 150 days of treatment with rexaceract.

oParticipants with elevated baseline levels of glucosylsphingoshine (GluSph) in cerebrospinal fluid (CSF) continued to benefit more than those with low baseline levels of GluSph in CSF after 150 days of dosing with rexaceract, with a difference of 4.8 points in the sum of MDS-UPDRS Part II and Part III scores between the two groups at Day 150.

oParticipants provided unsolicited descriptions of perceived benefit after 90 days of dosing with rexaceract. Perceived benefits most commonly described included four instances of improved sense of smell and taste, four instances of improved balance or gait, and three instances of improved sleep.

●Rexaceract accepted as the International Nonproprietary Name (INN) for GT-02287, establishing the compound's official generic name as it continues to advance through clinical development.

GT-04686

●GT-04686 is moving towards IND-enabling studies and ultimately, clinical development.

oCurrent activities are focused on optimizing the program and generating the data necessary to support IND-enabling studies.

oThe advancement of GT-04686 presents an opportunity to bolster the Company’s pipeline and create additional long-term value for shareholders.

oInitial therapeutic indication for GT-04686 expected to be selected by year end.

oGT-04686 is the second allosteric modulator developed from Gain’s Magellan™ AI drug discovery platform that is planned for entry into the clinic.

Corporate Updates

Regulatory

●The U.S. Food and Drug Administration (FDA) completed its review of an Investigational New Drug (IND) application for rexaceract.

oAcceptance of the IND submission paves the way for initiation of rexaceract Phase 2 clinical development in the U.S., expected during Q3 2026.

oThe acceptance follows positive Phase 1 results for rexaceract in both healthy volunteers and people with Parkinson’s disease demonstrating both biomarker and clinical evidence of activity with favorable safety and tolerability.

oRexaceract is the first allosteric modulator developed from Gain’s Magellan™ AI drug discovery platform to receive IND clear

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