Gain Therapeutics Announces Q2 2024 Financial Results and Corporate Update

Gain Therapeutics, Inc., a clinical-stage biotechnology firm, reported its financial results for the quarter ending June 30, 2024, and provided significant corporate updates. The company, which is listed on Nasdaq under the ticker GANX, is at the forefront of developing innovative allosteric small molecule therapies.

Gene Mack, the Interim CEO and CFO of Gain, highlighted the productive progress made during the second quarter of 2024, particularly with their lead candidate, GT-02287. This candidate is being developed as a potential treatment for Parkinson’s disease, addressing patients both with and without a GBA1 mutation. Mack expressed optimism about GT-02287's safety profile based on the results from the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies completed during this period. The company anticipates the full topline results from the MAD segment of the study by mid-August 2024. These promising findings reinforce their confidence in GT-02287 as a leading treatment for Parkinson’s disease. Gain also plans to present these findings at upcoming medical conferences this fall and aims to commence a Phase 1b study to assess GT-02287’s efficacy in actual Parkinson’s patients by the fourth quarter of 2024.

Key highlights from the second quarter of 2024 include the completion of dosing in the MAD portion of the Phase 1 trial and positive outcomes from the SAD portion. Additionally, preclinical data revealed an improvement in cognitive performance and daily activities with GT-02287 treatment in a mouse model of Parkinson’s disease, which was presented at the Federation of European Neuroscience Societies (FENS) Forum 2024 in Austria.

On the corporate front, Gene Mack was appointed as interim CEO and CFO, with Khalid Islam, Ph.D., the company's founder and Chairman, serving as Executive Chairman. Additionally, Gain successfully completed a public offering, generating approximately $10 million in net proceeds.

Looking ahead, Gain Therapeutics has several important milestones. These include the data lock for the MAD portion of the Phase 1 trial in mid-August 2024, with results expected shortly thereafter. The company will present a late-breaking abstract at the International Congress of Parkinson’s Disease and Movement Disorders from September 27 to October 1 and another abstract at Neuroscience 2024 from October 5 to October 9. Furthermore, the initiation of a Phase 1b trial to evaluate GT-02287 in Parkinson’s disease patients is anticipated in the fourth quarter of 2024.

Financially, Gain Therapeutics reported an increase in research and development expenses to $4.4 million for the quarter ended June 30, 2024, up from $4.0 million in the same period in 2023. This rise was mainly due to costs associated with the ongoing Phase 1 trial of GT-02287. General and administrative expenses remained stable at $3.7 million for the three months ended June 30, 2024, similar to the previous year’s expenses. The net loss reported for the quarter was $0.42 per share, a decrease from $0.62 per share in the same period in 2023.

The company’s cash and cash equivalents, along with marketable securities, totaled $16.9 million as of June 30, 2024, compared to $16.8 million at the end of 2023.

Gain Therapeutics leverages a cutting-edge drug discovery platform called Magellan™, which utilizes AI-supported structural biology, proprietary algorithms, and advanced computational models to identify new allosteric binding sites on disease-related proteins. This approach aims to discover novel small molecule modulators that can either restore or disrupt protein function. The platform's advanced capabilities allow Gain to accelerate drug discovery and develop new treatments for challenging conditions, including neurodegenerative diseases, rare genetic disorders, and oncology.