On Tuesday, Gain Therapeutics (NASDAQ:GANX) shares maintained a Buy rating with a steady price target of $5.00, following confirmation of key outcomes from its Phase 1 (P1) study. The clinical trial met all three primary objectives, including the safety and tolerability of the drug at the highest dose without any discontinuations, the drug's ability to reach the cerebral spinal fluid (CSF), and most notably, its target engagement.
The study's results suggest that the drug, GT-02287, is activating Glucocerebrosidase (GCase), an enzyme that could potentially modify the progression of Parkinson's disease (PD). This assumption is based on preclinical models and data previously presented by Gain Therapeutics.
The drug's target engagement, even in healthy subjects, is seen as a significant achievement, especially considering that these subjects typically do not have disrupted GCase signaling.
The successful target engagement paves the way for the next phase of research, a planned Phase 1b study involving 15 PD patients, set to commence in the fourth quarter of 2024. If GT-02287 shows GCase activation and correlates with other neuroprotective biomarkers as in preclinical models, it could be recognized as a disease-modifying drug for PD.
Gain Therapeutics is expected to have sufficient capital to support its operations into the third quarter of 2025, which will cover the period through the anticipated Phase 1b data release by mid-2025. The company is scheduled to present its Phase 1 data at two upcoming conferences, which could potentially attract investor attention, particularly regarding the drug's target engagement and GCase activation. The Phase 1b trial is expected to follow these events later in the year.
In other recent news, analyst firms H.C. Wainwright, BTIG, and Oppenheimer have maintained positive ratings on Gain Therapeutics, reflecting confidence in the drug's progress and future prospects.
The company's Q2 financials for 2024 revealed operating expenses of $8.2 million and a cash balance of $16.9 million, expected to fund operations into the second half of 2025. Gain Therapeutics is preparing to initiate a three-month Phase 1b study of GT-02287 in the fourth quarter of 2024, involving 20-30 patients with a genetic disorder, GBA1-PD.
Despite these positive developments, Gain Therapeutics has been notified by Nasdaq that it no longer meets the minimum Market Value of Listed Securities required for continued listing. The company has until January 7, 2025, to regain compliance.
Moreover, Gain Therapeutics plans to offer and sell shares of its common stock in a public offering, with Titan Partners Group acting as the sole bookrunner. These are among the recent developments in Gain Therapeutics' ongoing efforts to advance its research and development of therapies for challenging diseases.
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