Gain Therapeutics, Inc. Stock Price, News & Analysis

Gain Therapeutics (NASDAQ:GANX), a clinical-stage biotech company, has announced a proposed public offering of common stock and warrants. The offering includes shares of common stock (or equivalents) and warrants to purchase common stock, with a 30-day option for the underwriter to purchase up to 15% additional shares and/or warrants.

The proceeds will fund the clinical and nonclinical development of GT-02287, their lead product candidate for neurodegenerative diseases, including GBA1 Parkinson's disease. Newbridge Securities Corporation is serving as the sole book-running manager. The offering will be made through a shelf registration statement previously filed with the SEC.

Gain Therapeutics (NASDAQ:GANX) has announced the successful completion of target enrollment in its Phase 1b clinical study of GT-02287 for Parkinson's Disease. The trial has enrolled 16 participants, exceeding the original goal of 15 participants ahead of schedule.

The company reports that analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) is now expected in Q4 2025, earlier than the initially planned Q1 2026. The screening window for additional participants has been extended through July 31st, 2025, responding to continued interest from clinicians and patients.

Importantly, the independent data monitoring committee (DMC) has recommended continuing the study with no changes in dose level, and no serious treatment emergent adverse events (TEAEs) have been reported. Gain is planning to approach Australian health authorities to extend the dosing period beyond the current 90-day protocol, with long-term chronic toxicology studies nearing completion.

Gain Therapeutics (NASDAQ: GANX), a clinical-stage biotech company focused on allosteric small molecule therapies, announced its CEO Gene Mack's participation in two upcoming investor conferences. Mack will engage in a virtual fireside chat at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 17 at 7:00 a.m. EST, and deliver a corporate presentation at BIO 2025 on June 18 at 1:45 p.m. EST at the Boston Convention Center. Investors can request one-on-one meetings through conference representatives or contact the company directly at ir@gaintherapeutics.com.

Gain Therapeutics (NASDAQ: GANX), a clinical-stage biotech company focused on developing next-generation allosteric small molecule therapies, has announced an upcoming oral presentation at the GBA1 Meeting 2025. The event will take place from June 5th-7th in Montreal, Canada. The company's Chief Medical Officer, Dr. Jonas Hannestad, will deliver the presentation on Thursday, June 5, 2025, at 11:20 p.m. EST.

Gain Therapeutics (NASDAQ: GANX) reported Q1 2025 financial results and provided updates on its clinical programs. The company has begun enrolling participants in its Phase 1b study of GT-02287, their lead drug candidate for Parkinson's disease treatment. The study will include 15-20 participants with Parkinson's disease, both with and without GBA1 mutations. Key financial metrics show R&D expenses decreased to $2.3M from $2.5M year-over-year, while G&A expenses increased to $2.1M from $1.9M. The company reported a net loss of $0.16 per share, improving from $0.22 in Q1 2024. Cash position stands at $9.1M as of March 31, 2025. Important upcoming milestones include a first biomarker analysis expected mid-2025, completion of the Phase 1b study in Q4 2025, and an IND submission to FDA by year-end.

Gain Therapeutics (NASDAQ: GANX) presented new preclinical data for GT-02287, their clinical-stage therapy for Parkinson's disease, at the IAPRD 30th World Congress. The study demonstrated GT-02287's neuroprotective properties in cultured rat mesencephalic dopaminergic neurons treated with MPP+, a mitochondrial toxin.

The research showed that GT-02287 improved both lysosomal and mitochondrial function, while reducing α-synuclein aggregation and preventing the release of mitochondrial cytochrome C, a cell death signal. These findings suggest GT-02287's potential as a disease-modifying therapy through its allosteric modulation of GCase and broader neuroprotective effects.

Gain Therapeutics (NASDAQ: GANX), a clinical-stage biotechnology company focused on developing next-generation allosteric small molecule therapies, has announced its participation in The Citizens Life Sciences Conference. The company's President and CEO, Gene Mack, will deliver a presentation on Thursday, May 8, 2025, at 12:00 p.m. EST in New York City.

The event will also feature one-on-one meetings with management, which can be arranged through Citizens representatives. A replay of the presentation will be made available on the Investors and Media section of Gain Therapeutics' website.

Gain Therapeutics (Nasdaq: GANX) has announced an upcoming oral poster presentation at the IAPRD 30th World Congress on Parkinson's Disease and Related Disorders. The event will take place from May 7th-10th in New York City.

The presentation will focus on GT-02287, the company's clinical-stage allosteric GCase modulator designed for treating Parkinson's Disease. Dr. Joanne Taylor, Senior Vice President of Research at Gain Therapeutics, will present findings demonstrating how GT-02287 protects dopaminergic neurons against mitochondrial toxin MPP+.

The presentation is scheduled for Saturday, May 10, 2025, during the Guided Poster Tour session from 8:00-9:00 a.m. EST. This showcase highlights Gain's progress in developing next-generation allosteric small molecule therapies.

Gain Therapeutics (GANX) presented new preclinical data and Phase 1b study design for GT-02287 at AD/PD 2025 Conference. The oral presentation revealed evidence of disease-modifying activity in both GBA1 and idiopathic Parkinson's disease models.

The preclinical data showed GT-02287's ability to rescue motor deficits and prevent complex behavioral deficits, with effects persisting after compound withdrawal. Several biomarkers including α-synuclein, IRE-1, LAMP-1, Miro1, phospho-Tau, and Iba-1 showed statistically significant reductions and maintained lower levels post-treatment.

The ongoing Phase 1b study is evaluating safety, tolerability, and pharmacokinetics in Parkinson's disease patients. An early biomarker analysis is scheduled for Q2 2025, with complete endpoint analysis expected in Q4 2025. The company anticipates completing enrollment by Q2 2025, with Phase 2 planning set to begin in H2 2025.