Gain Therapeutics issues letter to shareholders

Gain Therapeutics releases the following letter to stockholders from its President and Chief Executive Officer Matthias Alder. “With the start of a new year, I want to take a moment to reflect on Gain’s progress over the last 12 months and to share our strategy and plans for 2024… In 2023, we advanced GT-02287 through preclinical development and initiated the company’s first clinical trial in September 2023 on time and on plan… The SAD/MAD part of the Phase 1 clinical trial is expected to be completed by mid-2024 with results expected to be reported in the second half of the year. In Q3 2024, we plan to start treatment of a cohort of 12-15 Parkinson’s patients as an extension of the ongoing Phase 1 clinical trial to establish a biomarker-based clinical proof of concept… In 2023, we made several data presentations of results of our GBA1 program in preclinical models of Parkinson’s disease and Alzheimer’s disease… We presented additional data on our allosteric GCase modulators at the March 2023 International Conference on Alzheimer’s and Parkinson’s Diseases. In that poster presentation, we showed results that we believe support the disease-modifying potential of allosteric GCase regulators for the treatment of Alzheimer’s disease… During the course of 2023, we significantly upgraded our computational drug discovery platform. The platform now provides for an integrated, efficient workflow of existing and newly added tools and programming technologies that enable the identification of new binding sites on proteins and screening of the 50+ billion chemical spaces… Based on the added capabilities and expanded application, we feel that the original platform name SEE-Tx no longer adequately represents our platform technology. Magellan, the name of our next-generation platform, reflects its enhanced capabilities that enable the exploration of new protein biology and a vast chemical space to discover new allosteric small molecule therapies… Based on our operational plans, we are now positioned to fund our operations into 2025… In 2024, we expect to achieve a series of important value inflection points with Gain, which are summarized below: Q1 2024: Poster and Platform Presentation of new data in preclinical model of Parkinson’s disease at WORLDSymposium. Start of MAD cohort in Phase 1 clinical trial with GT-02287. Q2 2024; Completion of MAD cohort of Phase 1 clinical trial; potential for showing effect on GCase levels and activation. Q3 2024: Start of Parkinson’s patient cohort in Phase 1 clinical trial. Q4 2024 / Q1 2025 Completion of patient cohort; potential to show biomarker-based clinical proof of concept.”