Galmed Pharmaceuticals Announces $1.9 Million Loss in Q3; Showcases Advancements in Pipeline
Financial Performance: Galmed Pharmaceuticals reported a net loss of $1.89 million for Q3 2025, a slight improvement from a loss of $1.91 million in Q3 2024, with increased R&D expenses and decreased administrative costs.
Pipeline Developments: The company is advancing its lead drug candidate, Aramchol Meglumine, for nonalcoholic steatohepatitis (NASH) and fibrosis, which showed promising results in a Phase 2b study and is now in a Phase 3 trial.
New Drug Candidate: Galmed is also developing Amilo-5MER, a peptide targeting chronic inflammation, currently in a Phase 1 trial for safety and tolerability, with potential applications in ulcerative colitis.
Collaborative Efforts: The company is collaborating on the MyBiotics program, which focuses on microbiome modulation for potential treatment of NASH and fibrosis.
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- Compliance Notice: Galmed Pharmaceuticals received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1 per share, necessitating compliance restoration within 180 days until July 28, 2026.
- Restoration Requirements: The company must maintain a closing bid price of at least $1 for a minimum of 10 consecutive business days; failure to do so may allow for an additional compliance period, contingent on meeting other listing requirements.
- Stock Price Impact: Following the notice, Galmed's stock price fell by 5.33% to $0.71, reflecting market sensitivity to compliance risks and potential implications for the company's future financing capabilities.
- Trading Impact: Despite the compliance notice, Galmed stated that it has no immediate effect on its trading on the Nasdaq Capital Market, indicating the company is actively managing its listing status.
- Compliance Notice: Galmed Pharmaceuticals received a letter from Nasdaq indicating non-compliance with the minimum bid price of $1.00 per share, requiring compliance within 180 days to avoid potential delisting risks.
- Compliance Period: The company has until July 28, 2026, to regain compliance; if the closing bid price reaches $1 for ten consecutive business days during this period, it will receive written confirmation of compliance, thus avoiding delisting.
- Market Impact: Although the notice does not immediately affect the company's Nasdaq listing, failure to regain compliance could negatively impact investor confidence and stock price.
- Strategic Development: Galmed focuses on the development of Aramchol for liver diseases and other related conditions, actively pursuing diversification of its product pipeline to address market competition.
- Compliance Notification: Galmed Pharmaceuticals received a compliance letter from Nasdaq indicating that its ordinary shares failed to meet the minimum bid price requirement of $1.00 per share, which could jeopardize its continued listing status.
- Grace Period: The company has been granted a 180-day grace period, from January 29, 2026, to July 28, 2026, during which it can regain compliance if its share price meets the required threshold for ten consecutive trading days.
- Potential Consequences: Failure to regain compliance by the end of the grace period may result in Galmed facing delisting from Nasdaq, which could negatively impact its financing capabilities and market confidence.
- Business Development Strategy: Despite compliance challenges, Galmed continues to actively advance the development of Aramchol, focusing on treatments for liver diseases and cardiometabolic conditions, demonstrating its long-term commitment to innovative drug development.

- Clinical Trial Launch: Galmed Pharmaceuticals announced the initiation of a Phase 1/2 clinical trial for the combination of Aramchol and Regorafenib in 2026, aimed at enhancing treatment efficacy for hepatocellular carcinoma and other GI cancers, marking a significant advancement in the company's liver disease treatment efforts.
- Scientific Rationale Strengthened: Research indicates that Aramchol significantly enhances Bayer's Regorafenib efficacy in GI cancer models through SCD1 inhibition, providing a solid scientific foundation for the upcoming clinical trial.
- Investor Value Enhancement: Positive outcomes from the clinical trial could lay the groundwork for expanding Galmed's oncology pipeline, potentially attracting more investor interest and increasing the company's overall market value.
- Industry Recognition: The acceptance of Galmed's latest research findings at the HEP-DART 2025 meeting underscores the significance of its work in liver disease treatment, further enhancing the company's competitive position in the market.

- Clinical Trial Success: Galimedix presented Phase 1 study results for GAL-101 at CTAD 2025, involving approximately 100 healthy volunteers, demonstrating excellent safety and tolerability with no dose-limiting adverse events, indicating the drug's potential in Alzheimer's treatment.
- Drug Penetration Capability: GAL-101 confirmed effective blood-brain barrier penetration with lumbar CSF concentrations after multiple doses, supporting a once-daily dosing regimen for future trials, which may enhance patient adherence to treatment.
- Future Research Planning: Following positive Phase 1 results, Galimedix is planning a Phase 2 proof-of-concept study in Alzheimer's disease, expected to include cognitive functional endpoints and biomarkers to capture early signs of cognitive improvement.
- Technological Innovation: As a small molecule targeting misfolded amyloid beta monomers to prevent toxic aggregate formation, GAL-101 shows broad application prospects in treating Alzheimer's disease, dry age-related macular degeneration, and glaucoma.
- Patent Protection Extension: Galmed Pharmaceuticals has secured a new use patent for Aramchol in South Korea, extending global patent protection to 2042, thereby reinforcing its market leadership in the non-alcoholic steatohepatitis (NASH) sector.
- Clinical Readiness: As a first-in-class candidate ready for Phase 3 trials, Aramchol has demonstrated significant fibrosis improvement in clinical studies, indicating its potential in treating complex diseases.
- Combination Therapy Outlook: The new patent covers the combination therapy of Aramchol and Rezdiffra, aligning with the industry's shift towards combination therapies, which is expected to drive the initiation of clinical studies and meet market demand for effective treatments.
- Safety Advantage: Aramchol's excellent safety and tolerability make it an ideal candidate for combination with other MASH drugs, potentially enhancing its market acceptance and driving sales growth.









