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BETHESDA, Md. - Gain Therapeutics, Inc. (NASDAQ: GANX) announced that its lead drug candidate, GT-02287, showed positive results in a Phase 1 clinical study for the treatment of Parkinson's disease. The study, which enrolled 72 healthy volunteers, confirmed the drug's safety and tolerability across all doses and age groups, including participants over 50 years of age.
GT-02287, an orally administered molecule aimed at treating Parkinson's with or without a GBA1 mutation, was found to be present in the cerebrospinal fluid, indicating central nervous system (CNS) exposure. The study also demonstrated peripheral target engagement, which is crucial for the drug's therapeutic effect. Following these results, Gain Therapeutics plans to initiate a Phase 1b trial with Parkinson's patients in the fourth quarter of 2024, aiming to further confirm safety and obtain proof of mechanism through biomarkers.
The company's Chief Medical Officer, Jonas Hannestad, M.D., Ph.D., expressed optimism about the upcoming trial, expecting to have patient data by mid-2025. Interim CEO and CFO Gene Mack highlighted the significance of CNS exposure and target engagement observed in the study.
GT-02287 works by modulating the protein enzyme glucocerebrosidase (GCase), which is often impaired in Parkinson's disease due to GBA1 gene mutations or age-related stress factors. Preclinical models have shown that the drug can improve motor and cognitive functions, suggesting a potential to slow the disease's progression.
Gain Therapeutics' research has received funding support from The Michael J. Fox Foundation for Parkinson's Research, The Silverstein Foundation for Parkinson's with GBA, and the Eurostars-2 joint program with the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency.
The information in this article is based on a press release statement from Gain Therapeutics.
In other recent news, Gain Therapeutics has reported promising results for its Phase 1 clinical trial of the investigational drug '287, intended to treat Parkinson's disease. The company disclosed its second quarter financials for 2024, with operating expenses of $8.2 million and a cash balance of $16.9 million, sufficient to fund operations into the second half of 2025. Oppenheimer maintained an Outperform rating on Gain Therapeutics, adjusting the price target to $8.00 from the previous $9.00. H.C. Wainwright also kept a Buy rating with the same price target, reflecting confidence in GT-02287's progress and future prospects.
Gain Therapeutics has successfully completed the dosing in the multiple ascending dose portion of the Phase 1 clinical trial involving 32 healthy volunteers. The company is also preparing to commence a three-month Phase 1b study of '287 involving 20-30 patients with a genetic disorder, GBA1-PD, in the fourth quarter of 2024.
On the corporate front, Gain Therapeutics has seen a shift in leadership, with CFO Gene Mack assuming the role of interim CEO, supported by Khalid Islam, Ph.D., the founder and Chairman of the company's Board of Directors, as Executive Chairman. The company also plans to offer and sell shares of its common stock in a public offering, with Titan Partners Group acting as the sole bookrunner.
Furthermore, 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 with the MVLS requirement.
InvestingPro Insights
As Gain Therapeutics, Inc. (NASDAQ: GANX) forges ahead with its promising drug candidate GT-02287 for Parkinson's disease, its financial health and market performance are key factors for investors to consider. According to InvestingPro data, Gain Therapeutics currently holds a market capitalization of $34.22 million. Despite the potential in their clinical developments, the company's financial metrics indicate some challenges. They have a negative price-to-earnings (P/E) ratio of -0.99, reflecting that the company is not currently generating profits. Additionally, the company's gross profit for the last twelve months as of Q2 2024 stands at a negative $11.44 million, underscoring the cost challenges the company faces.
InvestingPro Tips for Gain Therapeutics reveal a mix of financial strengths and weaknesses. On the positive side, the company holds more cash than debt on its balance sheet and has liquid assets that exceed short-term obligations, providing some financial stability in the near term. However, analysts have concerns, anticipating a sales decline in the current year and not expecting the company to be profitable within the same timeframe. The stock price has experienced significant volatility, with a strong return over the last month, yet it has taken a substantial hit over the last six months.
For investors looking to make an informed decision on Gain Therapeutics, there are additional InvestingPro Tips available. These tips provide deeper insights into the company's financials and market performance, which could be particularly relevant given the company's current stage of clinical development and the inherent risks involved in the biotech industry. As of now, there are 10 more InvestingPro Tips listed for GANX, which can be found at https://www.investing.com/pro/GANX.
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