Gain Therapeutics, Inc. Stock Price, News & Analysis

Gain Therapeutics (NASDAQ:GANX) has announced the dosing of the first Parkinson's disease (PD) participant in its Phase 1b clinical trial of GT-02287, their lead allosteric small molecule therapy. The trial will evaluate safety and tolerability in up to 20 participants with GBA1-PD and idiopathic PD over three months.

The study follows a successful Phase 1 trial in healthy volunteers completed in Q3 2024, where GT-02287 showed favorable safety and achieved >50% increase in glucocerebrosidase (GCase) activity. Secondary endpoints for the Phase 1b trial include pharmacokinetics, GCase modulation, and biomarker levels in plasma and cerebrospinal fluid.

An interim analysis from the open-label, multi-center trial is expected by the end of Q2 2025.

Gain Therapeutics (GANX) announced that Dr. Joanne Taylor, Senior Vice President of Research, will present their clinical stage lead drug candidate GT-02287 at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases in Vienna, Austria.

The presentation, titled 'Clinical Stage Glucocerebrosidase Modulator, GT-02287, Shows Disease Modifying Potential In Preclinical Models Of Both GBA1 And Idiopathic Parkinson's Disease', will take place on April 5, 2025, at 6:10 PM CET in Hall B during the session on Advances in PD, LBD and MSA Drug Development.

Gain Therapeutics (NASDAQ: GANX) provided a shareholder update outlining key milestones for 2025, focusing on the clinical development of GT-02287, a potential disease-modifying therapy for Parkinson's disease. The company received approval to initiate a Phase 1b clinical trial following successful completion of healthy volunteer studies that showed a 53% increase in GCase activity.

The Phase 1b trial will enroll 15-20 individuals with GBA1 or idiopathic Parkinson's disease, with enrollment updates expected by Q1 2025 and interim analysis guidance in Q2 2025. The company held a productive pre-IND meeting with FDA in December 2024, with no significant regulatory hurdles identified.

As of September 30, 2024, the company had approximately $12M in cash, expected to be sufficient through the interim analysis of the Phase 1b trial. The company is exploring potential licensing partnerships and financing options while preparing for Phase 2 studies anticipated in H2 2025.

Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotechnology company focused on developing next-generation allosteric small molecule therapies, has announced its participation in two major investor conferences in February 2025.

CEO Gene Mack will deliver corporate presentations at:

• The BIO CEO & Investor Conference on February 11 at 1:15pm ET in the Plymouth Room at The New York Marriott Marquis
• The Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12 at 10:40am ET (virtual presentation)

Registered attendees can schedule one-on-one meetings with Gain management through the respective conference platforms. Investors unable to attend can request meetings by contacting ir@gaintherapeutics.com.

Gain Therapeutics, a clinical-stage biotechnology company, announced the formation of a Clinical Advisory Board (CAB) to support the development of its lead drug candidate, GT-02287, for Parkinson's disease. The CAB includes experts in trial design, genetics, and biomarkers and will assist in progressing GT-02287 through potential Phase 2 and Phase 3 clinical trials.

CEO Gene Mack emphasized the strategic importance of this step, expressing confidence in the CAB's collective expertise to advance the treatment. Key members include:

• Karl Kieburtz, M.D., M.P.H., a neurology professor with extensive experience in clinical trials and advisory roles.
• Roy Alcalay, M.D., M.S., Chief of the Movement Disorders Division at Tel Aviv Sourasky Medical Center, focusing on biomarkers and genetics.
• Samuel Broder, M.D., former Director of the National Cancer Institute, known for his work in developing anti-cancer agents and HIV treatments.
• Wilma D.J. Van de Berg, Ph.D., a senior translational neuroscientist specializing in neuropathology and biomarker research.

Gain Therapeutics (NASDAQ: GANX) has appointed Gene Mack as permanent President and Chief Executive Officer, effective January 6, 2025. Mack, who has served as CFO since April 2024 and interim CEO since June 2024, has also joined the Company's Board of Directors. Additionally, Gianluca Fuggetta has been promoted to Senior Vice President, Finance and Principal Financial Officer.

Mack brings over 25 years of life sciences experience spanning clinical research, financing, capital markets, investing, corporate strategy, and business development. His appointment comes as the company advances its lead candidate, GT-02287, through an ongoing Phase 1b trial in Parkinson's Disease during the first half of 2025, with potential Phase 2 activities planned for the second half of 2025.

Prior to joining Gain, Mack served as CFO at Imcyse SA (2021-2023) and OncoC4, following various CFO roles at development and commercial-stage biopharmaceutical companies. He also has experience as a senior publishing analyst covering biotechnology at investment banks including Gruntal & Co, Lazard, Mizuho, and HSBC.

Gain Therapeutics (NASDAQ: GANX) has received approval to initiate a Phase 1b clinical trial in Australia for GT-02287, its lead candidate for treating Parkinson's disease (PD). The trial follows a successful Phase 1 study where GT-02287 demonstrated safety, tolerability, and >50% increase in GCase activity. The Phase 1b trial will assess safety and tolerability in PD patients over three months of dosing at 13.5 mg/kg/day, along with biomarker evaluation.

The company expects to complete enrollment in spring 2025, with data anticipated by mid-2025. The trial will be conducted across seven Australian sites, focusing on both GBA1 and idiopathic Parkinson's disease patients. Secondary endpoints include pharmacokinetics, GCase modulation, and substrate levels in plasma and cerebrospinal fluid.

Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotechnology company, has announced its participation in Biotech Showcase 2025. Gene Mack, the Company's Chief Financial Officer and Interim Chief Executive Officer, will deliver a corporate presentation featuring their lead drug candidate GT-02287 and the Magellan Drug Discovery Platform.

The presentation is scheduled for Tuesday, January 14, at 9:30am PT in the Yosemite A track at the Hilton San Francisco Union Square. The Biotech Showcase, jointly produced by Demy-Colton and EBD Group, is an investor-focused conference that facilitates networking between executives and investors to promote therapeutic development and investment opportunities.

Gain Therapeutics (GANX) reported Q3 2024 financial results and provided updates on GT-02287, its lead candidate for Parkinson's disease treatment. The Phase 1 study showed a 53% increase in GCase activity with favorable safety in healthy volunteers. The company plans to initiate a Phase 1b trial in Parkinson's patients by end of 2024. Financial highlights include R&D expenses of $2.6M (up $0.3M YoY), G&A expenses of $1.8M (down $0.7M YoY), and cash position of $12M as of September 30, 2024. Net loss was $0.17 per share compared to $0.37 in Q3 2023.