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Gain Therapeutics (GANX) investor relations material
Gain Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Focused on developing small molecule therapeutics for CNS, lysosomal storage, and metabolic disorders using the Magellan™ platform, with lead candidate GT-02287 for Parkinson's disease showing positive Phase 1b results, including disease-slowing effects and safety profile.
Enrollment in the Phase 1b study for GT-02287 exceeded targets, with 21 participants and most opting for a 12-month extension; analysis of functional and biomarker changes at 90 days is expected in Q4 2025.
No product revenue to date; operations funded by equity offerings and research grants.
Substantial doubt exists about ability to continue as a going concern beyond Q1 2026 without additional capital.
Financial highlights
Net loss of $5.3M for Q3 2025 and $15.6M for the nine months ended September 30, 2025, both improved from prior year periods; net loss per share for Q3 2025 was $0.15, compared to $0.17 in Q3 2024.
Research and development expenses rose to $2.8M in Q3 2025, mainly due to clinical trial costs and currency translation; general and administrative expenses increased to $1.9M.
Cash and cash equivalents were $8.8M as of September 30, 2025, down from $10.4M at year-end 2024.
Accumulated deficit reached $96.8M as of September 30, 2025.
Operating cash outflows for the nine months were $13.8M, a decrease from $15.4M in the prior year.
Outlook and guidance
Current cash expected to fund operations into Q1 2026; additional financing required for continued operations.
Full 90-day analysis of functional and biomarker data from the Phase 1b study is expected in Q4 2025, with extension results anticipated in the second half of 2026.
IND submission to the FDA is planned by year-end 2025 to enable Phase 2 clinical development in the US.
Management is pursuing equity/debt financing, cost optimization, and strategic collaborations.
90-day biomarker data implications
Cash runway to Phase 2 IND submission
Impact of 12-month extension on Phase 2 design
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Next Gain Therapeutics earnings date
Q4 202527 Mar, 2026
Next Gain Therapeutics earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
Gain Therapeutics Inc. is a biotechnology firm engaged in the research and development of innovative therapies aimed at treating diseases caused by protein misfolding, with a focus on rare genetic diseases and neurological disorders. Utilizing its Site-Directed Enzyme Enhancement Therapy (SEE-Tx) platform, the company identifies allosteric sites on misfolded proteins to discover proprietary small molecules that can bind to these sites, thereby restoring proper protein folding and addressing the underlying disease. Gain Therapeutics' lead product candidate is GT-02287, which targets GBA1 Parkinson's disease. Additionally, the company is advancing structurally targeted allosteric regulator candidates for a range of conditions, including Morquio B, GM1 gangliosidosis, neuronopathic Gaucher disease, GBA1 Parkinson's, Krabbe, and Mucopolysaccharidosis type 1 diseases. Gain Therapeutics is headquartered in Bethesda, Maryland, and its shares are listed on the NASDAQ under the ticker symbol GANX.
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