BETHESDA, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that it will host a virtual key opinion leader (KOL) event, “Understanding GCase Substrates in Parkinson’s Disease: Perspectives on Biomarkers and Disease Modification, Contextualizing emerging biomarker data from the Phase 1b clinical stud ...

Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD) KOL event planned for early January to discuss the results; registration information herein BETHESDA, Md., Dec. 18, ...

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgency to invest now [1][13] - The energy demands of AI technologies are highlighted, with data centers consuming as much energy as small cities, leading to concerns about power grid strain and rising electricity prices [2][3] Investment Opportunity - A specific company is presented as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI [3][7] - This company is characterized as a "toll booth" operator in the AI energy boom, benefiting from the surge in demand for electricity driven by AI advancements [4][5] Market Position - The company is noted for its unique position in the market, being debt-free and holding a significant cash reserve, which is nearly one-third of its market capitalization [8] - It also has a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth engines in the AI sector [9][10] Future Trends - The article discusses the broader trends of onshoring and U.S. LNG exports, positioning the company as a beneficiary of these developments under the current political climate [6][14] - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, reinforcing the importance of investing in AI-related companies [12] Conclusion - The narrative concludes with a strong call to action for investors to engage in the AI market, emphasizing the potential for significant returns within a 12 to 24-month timeframe [15][19]

Core Insights - Gain Therapeutics, Inc. announced promising preclinical data for its lead drug candidate GT-02287, which shows potential as a disease-modifying therapy for Parkinson's disease (PD) by enhancing mitochondrial and lysosomal health [1][2][7] Preclinical Data - GT-02287 demonstrated a reduction in mitochondrial stress and improved neuronal survival in rat dopaminergic neurons treated with MPP+, a mitochondrial toxin [3] - In a mouse PD model, GT-02287 decreased staining for MIRO1, indicating improved mitochondrial health [4] - The drug facilitated the trafficking of glucocerebrosidase (GCase) to mitochondria, enhancing mitochondrial function in patient-derived fibroblasts with GBA1 mutations [5][6] Mechanism of Action - The drug acts throughout the disease cascade resulting from dysfunctional GCase, contributing to neuroprotection by restoring GCase function and reducing neuroinflammation and neuronal death [2][6][7] - GT-02287's effects on mitochondrial health were highlighted as a significant aspect of its mechanism, addressing previously open questions in PD research [2][4] Clinical Development - GT-02287 is currently in a Phase 1b clinical trial for PD, with early observations suggesting disease-modifying effects consistent with preclinical findings [9] - The trial aims to evaluate safety and tolerability after 3 months of dosing, with an extension allowing treatment for up to 12 months [9] Funding and Support - The development of GT-02287 has received funding from notable organizations, including The Michael J. Fox Foundation and the Eurostars-2 joint program [10]

Core Insights - Gain Therapeutics, Inc. (GANX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3] - The Zacks rating system is based on the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years [1][2] Earnings Outlook - The recent upgrade indicates a positive outlook for Gain Therapeutics' earnings, suggesting potential buying pressure and an increase in stock price [3][5] - Rising earnings estimates correlate strongly with stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [4][5] Earnings Estimate Revisions - For the fiscal year ending December 2025, Gain Therapeutics is expected to earn -$0.65 per share, unchanged from the previous year [8] - Over the past three months, the Zacks Consensus Estimate for Gain Therapeutics has increased by 1.1%, indicating a positive trend in earnings estimates [8] Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7] - Gain Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10]

Financial Performance - Net loss for the three months ended September 30, 2025, was $5,284,373, compared to a net loss of $4,485,692 for the same period in 2024, indicating an increase in loss of approximately 17.8%[16] - For the nine months ended September 30, 2024, the net loss was $16,642,964, compared to a net loss of $15,623,518 for the same period in 2025, indicating a decrease in losses year-over-year[31] - The company incurred net losses of $5.3 million and $15.6 million for the three and nine months ended September 30, 2025, respectively, with negative cash flows from operations of $13.8 million during the nine months[186] - The company has not generated any revenue from product sales and has incurred significant operating losses and negative cash flows from operations[212] - The company has not yet received approval for or commercialized any products or technologies, and does not expect to generate revenue from sales in the near term[212] Assets and Liabilities - Total current assets decreased from $11,602,478 as of December 31, 2024, to $10,517,268 as of September 30, 2025, a decline of approximately 9.36%[13] - Total liabilities increased from $4,784,310 as of December 31, 2024, to $5,062,250 as of September 30, 2025, representing an increase of about 5.8%[13] - Total stockholders' equity decreased from $7,339,574 as of December 31, 2024, to $5,909,430 as of September 30, 2025, a decline of approximately 19.4%[13] - Cash and cash equivalents decreased from $10,385,863 as of December 31, 2024, to $8,807,353 as of September 30, 2025, a reduction of about 15.2%[13] - As of September 30, 2025, the Company has cash and cash equivalents of $8.8 million, which is insufficient to fund estimated operating and capital expenditures for at least the next 12 months[50] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $7,865,493, down from $9,566,259 for the same period in 2024, a decrease of about 17.8%[16] - Research and development expenses for the three months ended September 30, 2025, increased to $2.8 million, a rise of $0.2 million compared to the same period in 2024, primarily due to ongoing clinical trials[203] - For the nine months ended September 30, 2025, research and development expenses decreased to $7.9 million, down $1.7 million from $9.6 million in the same period in 2024, attributed to research grant income and tax credits[204] - The company’s clinical stage product candidate, GT-02287, is being developed for the treatment of Parkinson's disease, with positive early results from a Phase 1b clinical study presented in October 2025[36] - The Phase 1b clinical study of GT-02287 showed that participants experienced stabilization and trending improvements in their MDS-UPDRS scores after 90 days of administration[36] Capital and Financing - The company has primarily funded its operations through equity financings and research grants, indicating reliance on external capital for continued operations[47] - The company reported net proceeds from the issuance of shares in ATM offerings of $615,515 for the nine months ended September 30, 2024, and $4,910,240 for the same period in 2025, showing a significant increase in capital raised[31] - The Company completed a public offering in July 2025, raising gross proceeds of $7.0 million, with net proceeds of $6.0 million after offering expenses[137] - The company raised gross proceeds of $11.5 million from a public offering in June 2024, which included $1.2 million in underwriting commissions and expenses[147] - The company plans to finance its cash needs through public and private equity offerings, debt financings, and collaborations, but may face challenges in obtaining favorable terms[187] Operational Challenges - The Company has significant doubt about its ability to continue as a going concern due to current liquidity issues and lack of expected revenues[50] - The company has not generated any product revenues and does not expect to do so in the foreseeable future[190] - The company anticipates needing to raise additional capital to fund operations beyond the first quarter of 2026 due to projected cash outflows[186] - Management is reviewing the cost structure to optimize expenditures and improve the overall cash burn rate, including research and development expenses[51] Tax and Income - Income taxes increased to $549 thousand for the three months ended September 30, 2025, compared to $11 thousand for the same period in 2024, primarily due to higher corporate taxes in Australia[92] - Income taxes were $791 thousand for the nine months ended September 30, 2025, compared to $32 thousand in the same period of 2024[211] Currency and Foreign Exchange - The company experienced a foreign exchange loss of $26,170 for the three months ended September 30, 2025, compared to a gain of $229,047 for the same period in 2024[20] - Accumulated currency translation adjustments as of September 30, 2025, amounted to $835,949, compared to $41,247 as of December 31, 2024[57] - The Company has not utilized any foreign currency hedging strategies, exposing it to foreign currency risk[57] Stock and Compensation - The total stock-based compensation expense for the nine months ended September 30, 2025, was $1.4 million, compared to $2.0 million for the same period in 2024[158] - The Company issued 1,204,325 stock options during the nine months ended September 30, 2025, with a weighted average exercise price of $2.28[154] - The weighted average grant date fair value of stock options granted in the nine months ended September 30, 2025, was $1.63[156] - As of September 30, 2025, unrecognized compensation costs associated with stock options grants were $3.5 million, expected to be recognized over 3.5 years[154] Legal and Compliance - The Company recorded an accrual of $0.53 million related to litigation against the former CEO, which was dismissed on July 2, 2025[165]

Financial Performance - Gain Therapeutics reported a net loss of $0.15 per share for Q3 2025, an improvement from a loss of $0.17 per share in Q3 2024[11] - Net loss for Q3 2025 was $5,284,373, compared to a net loss of $4,485,692 in Q3 2024, representing a 17.8% increase in losses year-over-year[22] - Net loss per share attributable to common stockholders for Q3 2025 was $(0.15), compared to $(0.17) in Q3 2024[22] - The company reported a loss before income tax of $4,735,085 for Q3 2025, compared to $4,474,698 in Q3 2024[22] Expenses - Research and Development (R&D) expenses increased by $0.2 million to $2.8 million in Q3 2025, compared to $2.6 million in Q3 2024, primarily due to ongoing Phase 1b clinical trial costs[9] - General and Administrative (G&A) expenses rose by $0.1 million to $1.9 million for Q3 2025, attributed to higher stock-based compensation and personnel costs[10] - Total operating expenses for Q3 2025 were $4,785,777, an increase of 7.3% compared to $4,458,964 in Q3 2024[22] - Research and development expenses for the nine months ended September 30, 2025, were $7,865,493, down 17.8% from $9,566,259 in the same period of 2024[22] Clinical Trials - The Phase 1b study for GT-02287 in Parkinson's disease exceeded its enrollment target, with 21 participants enrolled, surpassing the original target of 15[8] - Approximately 80% of participants in the Phase 1b study expressed interest in continuing into the study extension phase[2] - Initial clinical data presented indicated a disease-slowing effect of GT-02287, with improvements in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores observed after 90 days of dosing[8] - The company received approval from Australian health authorities to extend the Phase 1b study duration to a total of 12 months[8] - The analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available in Q4 2025[3] - An IND submission to the FDA is anticipated by the end of 2025 to facilitate expansion into Phase 2 clinical development of GT-02287[8] Financial Position - Cash and cash equivalents were reported at $8.8 million as of September 30, 2025, down from $10.4 million as of December 31, 2024[11] - Cash and cash equivalents as of September 30, 2025, were $8,807,353, a decrease from $10,385,863 as of December 31, 2024[24] - Total assets decreased to $10,971,680 as of September 30, 2025, from $12,123,884 as of December 31, 2024[24] - Total liabilities increased to $5,062,250 as of September 30, 2025, compared to $4,784,310 as of December 31, 2024[24] - The accumulated deficit as of September 30, 2025, was $81,194,908, up from $60,783,717 as of December 31, 2024[24] Stock Information - Weighted average common stock outstanding for Q3 2025 was 34,998,060, an increase from 26,531,747 in Q3 2024[22]

Core Insights - Gain Therapeutics, Inc. has presented initial data from its Phase 1b study indicating that GT-02287 shows a disease-slowing effect in Parkinson's disease, consistent with preclinical models and its proposed mechanism of action [1][4][15] - The company completed enrollment of 21 participants in the Phase 1b study, surpassing the initial target of 15 participants, and has received approval to extend the study duration to 12 months [1][3][12] - Financial results for Q3 2025 show an increase in R&D expenses to $2.8 million, primarily due to ongoing clinical trials and unfavorable currency translation [9][10] Clinical Program Highlights - The Phase 1b study of GT-02287 in Parkinson's disease has shown that 16 out of 21 participants completed 90 days of dosing, with the remaining participants expected to finish by December 2025 [3][12] - Initial clinical findings presented at the 2025 MDS conference suggest improvements in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores after approximately 30 days of administration [3][4] - The Phase 1b study extension commenced in September 2025, allowing participants to continue treatment for a total of 12 months, with a focus on long-term safety and tolerability [1][12][17] Financial Performance - R&D expenses increased by $0.2 million to $2.8 million for Q3 2025 compared to the same period in 2024, attributed to ongoing clinical trials and currency translation effects [9] - General and Administrative (G&A) expenses rose by $0.1 million to $1.9 million for Q3 2025, driven by higher stock-based compensation and personnel costs [10] - The net loss for Q3 2025 was reported at $5.3 million, or $0.15 per share, an improvement from a net loss of $4.5 million, or $0.17 per share, in Q3 2024 [11][13] Upcoming Milestones - Analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available in Q4 2025 [2][4] - An IND submission to the FDA is anticipated by the end of 2025, facilitating the expansion into Phase 2 clinical development [12][18] - Results from the Phase 1b study extension are expected in the second half of 2026 [12]

Core Viewpoint - The focus is on long-term investment in growth markets, particularly in AI and biotech, while also exploring undervalued stocks with significant potential [1] Investment Focus - The investment strategy emphasizes a volatile portfolio with a concentration on semiconductor, mining, and biotech sectors [1] - The portfolio includes a diverse range of market capitalizations, from megacap to microcap [1] Investment Style - The investment approach is inspired by Warren Buffett but is applied to riskier investments [1] - The investor does not engage in cryptocurrency, banking, ETFs, retirement funds, or real estate [1] Market Coverage - The primary focus is on the U.S. market, with occasional coverage of European or Canadian stocks [1] Professional Background - The investor holds a Master's Degree in Law and serves as the deputy director general in a leading European sector organization [1]

Core Insights - Gain Therapeutics, Inc. is presenting its lead drug candidate GT-02287 at the Society for Neuroscience annual meeting, focusing on its potential in treating Parkinson's disease [1][2] Company Overview - Gain Therapeutics is a clinical-stage biotechnology company specializing in the discovery and development of allosteric small molecule therapies [7] - The company is advancing GT-02287, which targets the lysosomal enzyme glucocerebrosidase (GCase) and is currently in a Phase 1b clinical trial for Parkinson's disease [7][5] Drug Candidate Details - GT-02287 is an orally administered small molecule that acts as an allosteric modulator, restoring GCase function impaired by GBA1 mutations or age-related stress [2] - Preclinical studies indicate that GT-02287 can reduce neuroinflammation, neuronal death, and restore motor function in models of both GBA1-PD and idiopathic PD [3][2] Clinical Trial Progress - A Phase 1 study showed favorable safety and tolerability, with increased GCase activity in participants receiving GT-02287 [4] - The ongoing Phase 1b trial aims to evaluate safety and tolerability over 3 months, with early observations suggesting disease-modifying effects [5] Funding and Support - Gain Therapeutics has received funding from The Michael J. Fox Foundation, The Silverstein Foundation, and the Eurostars-2 program, indicating strong support for its Parkinson's disease program [6] Research and Development Approach - The company utilizes its Magellan™ platform to discover novel allosteric small molecule modulators, targeting various disorders including neurodegenerative diseases and rare genetic disorders [8]