Tillkännagivande • Jul 28
Galmed Pharmaceuticals Ltd. Announces Breakthrough Development Of Dispersible Film Delivery (ODF) Brain Penetrating Formulation Of Its SCD1 Inhibitor Aramchol For Parkinson's Disease Galmed Pharmaceuticals Ltd. had reported significant progress in development of new Aramchol orally dispersible film (ODF) formulation. Aramchol meglumine is the only SCD1 inhibitor with an established clinical safety profile and confirmed blood-brain barrier (BBB) penetration. In order to improve patient convenience and long-term treatment adherence by Parkinson patients affected by dysphagia, an ODF formulation was developed demonstrating ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. Aramchol's ODF is characterized by rapid buccal and sublingual absorption and reduced first-pass hepatic metabolism, designed to maximize drug exposure within the brain. The data demonstrate ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. In addition to enhancing CNS drug delivery, Aramchol's proprietary ODF formulation directly addresses one of the most common clinical challenges in Parkinson's disease (PD). Up to 80% of patients develop dysphagia during disease progression, making conventional tablets and liquid formulations increasingly difficult to swallow and contributing to poor treatment adherence. Aramchol's rapidly dissolving ODF formulation dissolves within seconds without water, eliminates the need to swallow conventional tablets or liquids, thus simplifying administration and possibly improving long-term treatment adherence. The inhibition of stearoyl-CoA desaturase 1 (SCD1) is a novel disease approach in Parkinson's Disease, that targets the cause of neurodegeneration. Growing evidence identifies SCD1 as a central regulator of lipid metabolism that contributes to a-synuclein aggregation, Lewy body formation, and neuronal dysfunction. Unlike currently approved therapies that primarily improve motor symptoms through dopaminergic replacement, Aramchol targets SCD1-related biological mechanisms associated with disease progression. As previously reported, Galmed's in-vitro data demonstrated that Aramchol dose-dependently down-regulated aSyn aggregation as well as indicating that the effect was not associated with toxicity. Galmed's ODF formulation of Aramchol represents a dual innovation: a mechanism-based approach to slowing disease progression combined with patient-friendly drug delivery that addresses dysphagia affecting Parkinson's patients. Galmed believes that the development of a clinically characterized SCD1 inhibitor with a CNS-optimized drug delivery formulation represents a differentiated strategy in a therapeutic area where disease-modifying treatment options remain limited, positioning Aramchol's PD program as an ideal out-licensing candidate. Tillkännagivande • Jul 23
Galmed Pharmaceuticals Ltd., Annual General Meeting, Aug 26, 2026 Galmed Pharmaceuticals Ltd., Annual General Meeting, Aug 26, 2026. Location: 16 abba hillel silver rd., ramat gan, 5250608., Israel Tillkännagivande • Jul 16
Galmed Pharmaceuticals Ltd. Develops Novel LNP Cardiac Targeted Formulation Of Aramchol Galmed Pharmaceuticals Ltd. has developed, in collaboration with Barcode Nanotech, a unique proprietary lipid nanoparticles (LPNs) novel formulation of Aramchol that penetrates the heart tissue and redirects Aramchol's biodistribution away from liver-hepatocytes to the heart's muscle. Cardiac fibrosis is a major driver of chronic heart failure, the leading cause of death globally, responsible for an estimated 20.5 million deaths in 2025. Aramchol's anti-fibrotic effects were demonstrated in the liver in a Phase 3 (open label part) MASH study as well as in human heart organoids and in-vivo lung and heart models. Traditional Aramchol formulation results in 80-90% accumulation in the liver and has limited effect on the heart. The new LPNs Aramchol formulation which selectively targets the heart tissue could potentially become a disease modifying therapy for cardiac fibrosis and unmet cardiac diseases. Galmed Pharmaceuticals Ltd. announced the breakthrough development of a new Aramchol-based lipid nanoparticles formulation (LNP) for targeted delivery to the heart. Further advancing the previously reported development of Aramchol's nanocarrier-enabled targeted formulations, Galmed has developed a novel LNP formulation of Aramchol, based on FDA approved lipids, that penetrates the heart tissue. The development work, a collaboration between Galmed and Barcode Nanotech, applies advanced formulation science, in vivo screening, and AI-enabled analysis which aims to identify optimal vehicles for precise cardiac delivery. The platform enables in vivo screening of hundreds of nanoparticle candidates to support the identification of formulations with potentially improved targeting, biodistribution, and functional performance. By adapting this platform to cardiac applications, the companies aim to develop cardiac-targeted therapies delivered through LNPs that can selectively engage relevant cell populations, including fibroblasts and other disease-driving cardiac cells. These efforts are intended to support both Aramchol-based cardiac programs and future therapeutic candidates built on the same delivery technology. Cardiac fibrosis is a major contributor to heart failure progression and remains an area of significant unmet medical need. Despite advances in cardiovascular care, no therapies directly prevent or reverse cardiac fibrosis, highlighting the need for novel therapeutic approaches. The goal of the Galmed – Barcode collaboration is to open a new route for disease-modifying therapies in cardiovascular medicine, where efficient and selective delivery to the heart tissue remains a major challenge. Barcode Nanotech has developed a library of novel lipids for RNA and DNA, LNP-based delivery, through a unique in vivo & AI-based screening platform which allow simultaneously screening of hundreds of different nanoparticle formulations. Our proprietary lipid library and screening platform capabilities enable the development of Aramchol's selective delivery LNP formulation to the heart. We now focus on the development of modified LNPs to target specific cardiac cell types. We believe this work may create the basis for a new generation of cardiac therapies, with Aramchol serving as an important first example of what our platform can achieve. Tillkännagivande • Jun 09
Galmed Pharmaceuticals Ltd. (NasdaqCM:GLMD) agreed to acquire Cologuard for $4.5 million. Galmed Pharmaceuticals Ltd. (NasdaqCM:GLMD) agreed to acquire Cologuard for $4.5 million from shareholders of Colospan and Boaz Assaf on June 8, 2026. Under the terms of the definitive agreement, Colospan shareholders and SAFE holders will receive $2.5 million in cash to Selling Shareholders and certain SAFE investors and $2.0 million in Galmed ordinary shares at closing, subject to customary adjustments and escrow. Upon closing, Colospan will become a wholly owned subsidiary of Galmed, repositioning it as a GI-focused medtech and biopharmaceutical platform.
The transaction is subject to approval of merger agreement by target board and approval of offer by acquirer board. The deal has been unanimously approved by the board. The transaction is subject to customary closing conditions and is expected to close in Q2 2026.
ROTH Capital Partners, LLC acted as financial advisor and Meitar Liquornik Geva Leshem Tal & Co acted as legal advisor for Galmed Pharmaceuticals Ltd. Matri Meiri Wacht & Co acted as legal advisor for Cologuard. Tillkännagivande • Jun 02
Tissue Dynamics and Galmed Pharmaceuticals Unveil Unknown Metabolic Pathway for Cardiac Fibrosis and Heart Failure and Support the Development of Aramchol for Cardiac Fibrosis Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using a human cardiac organoid model, revealing disease biology that is not accessible through conventional animal models. In inflammatory human cardiac organoids, the combination of Aramchol Meglumine and a selective PPARa agonist reduced fibrotic burden by approximately 4-fold. Tissue Dynamics Ltd. and Galmed Pharmaceuticals Ltd. announced results from a preclinical study evaluating a combination of Aramchol Meglumine, an SCD1 inhibitor, and a selective PPARa agonist. The study identified a previously unrecognized metabolic pathway involved in the progression of cardiac fibrosis and heart failure and demonstrated that the two-drug combination effectively targets this mechanism. Progressive cardiac fibrosis, driven by ischemic injury or age-related metabolic dysfunction, results in pathological scarring of the heart muscle, leading to tissue stiffening and impaired systolic and diastolic function. Cardiac fibrosis is a major contributor to heart failure progression and remains an area of significant unmet medical need. Despite advances in cardiovascular care, no therapies directly reverse established cardiac fibrosis, highlighting the need for novel therapeutic approaches. One of the major challenges in cardiac drug development is the substantial physiological and metabolic differences between rodent and human hearts. As a result, findings from animal models often fail to translate successfully into human clinical outcomes. Using its robotic DynamiX platform and advanced human cardiac organoid models, Tissue Dynamics identified a novel human-specific metabolic mechanism that would not have been readily detectable using conventional animal models. The study demonstrated that a combination of Aramchol Meglumine and a selective PPARa agonist modulates two key pathological processes—mitochondrial stress and associated lipogenesis—that contribute to the development and progression of cardiac fibrosis and heart failure. Leveraging Tissue Dynamics' machine-learning platform, researchers identified and validated a previously unknown metabolic pathway underlying the synergistic effects of the combination therapy. In inflammatory human cardiac organoids, the treatment reduced fibrotic burden by approximately fourfold. Tillkännagivande • May 15
Galmed Pharmaceuticals Ltd. Announces Results from First-In-Man Pharmacokinetics Study of Oral Formulation of Aramchol Meglumine Galmed Pharmaceuticals Ltd. announced major milestone results from a Phase 1 PK study in healthy subjects (Study AM-001). The overall objective of the study was to identify the dose of Aramchol meglumine (AM) administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid (AA) tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater (approximately 5-fold and 3-fold respectively) than that from Aramchol free acid tablets. An additional PK study (AM-003) comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. Aramchol down-regulates stearoyl CoA desaturase 1 (SCD1) in hepatocytes and in hepatic stellate cells (HSC's) and other tissues including various cancers. Metabolic-dysfunction associated steatohepatitis (MASH) (previously called non-alcoholic steatohepatitis (NASH)) is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. In Phase 2 and Phase 3 (open label part) clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. To date approximately 600 adults have received single or multiple doses of Aramchol free acid, including approximately 240 healthy subjects and 360 patients with MASH. Tillkännagivande • Apr 10
Galmed Pharmaceuticals Ltd. Announces Breakthrough Development of Brain Penetrating New Formulation of Aramchol Galmed Pharmaceuticals Ltd. announced the breakthrough development of a brain penetrating new formulation of Aramchol. 98% of drugs do not reach the brain, as the blood–brain barrier (BBB) separates peripheral blood circulation from the central nervous system (CNS). Galmed has developed, in collaboration with Barcode Nanotech, a unique proprietary formulation of Aramchol which targets the brain. By crossing the BBB, this new Aramchol formulation could become a disease modifying therapy for unmet chronic CNS diseases. Stearoyl-CoA desaturase (SCD1) has been identified as an important therapeutic target for CNS diseases (Parkinson disease and dementia) which are characterized by the aggregation of the protein a-synuclein (aSyn). In-vitro studies have demonstrated that Aramchol effectively down-regulated aSyn-aggregation in a dose dependent manner. Crossing of the blood-brain barrier (BBB) is an essential step to achieve effective treatment effects in Parkinson disease (PD) and other CNS diseases. The new Aramchol formulation is characterized by sequestration of the Aramchol in lipid nanoparticles which will be administered by subcutaneous injection for delivery across the BBB. This new Aramchol formulation was co-developed by Galmed and Barcode Nanotech, based on Barcode Nanotech's unique and proprietary platform which enables simultaneous screening of hundreds of different nanoparticle formulations in vivo, coupled with AI analysis tools to select the optimal delivery vehicle to the brain. There are currently no disease-modifying therapies available for treatment of PD or related synucleinopathies such as multiple systems atrophy (MSA) and dementia with Lewy bodies (DLB). These diseases are each characterized by presence of Lewy bodies enriched in aSyn protein and are thus collectively known as synucleinopathies. Recent evidence from cell-based screens of aSyn toxicity has identified stearoyl-CoA desaturase 1 (SCD1) as a potential target for treatment of synucleinopathies. Based on the evidence for the role of SCD1 inhibition in mitigating synucleinopathies, Galmed's breakthrough medicinal chemistry work converting Aramchol into a brain-penetrant SCD1 inhibitor position Aramchol as an attractive therapeutic asset for synucleinopathies such as Parkinson disease, multiple systems atrophy (MSA), dementia and other CNS indications of unmet need. Tillkännagivande • Dec 09
Galmed Pharmaceuticals Ltd. Announces Acceptance of Late-Breaking Abstract to Be Presented at HEP-DART 2025 Meeting Galmed Pharmaceuticals Ltd. announced the presentation of a late breaking abstract for its lead drug candidate, Aramchol at HEP-DART 2025 Meeting. Previously, Galmed announced that Aramchol significantly enhances Bayer's regorafenib effect in GI cancer models to kill GI tumor cells. SCD1 inhibition augments regorafenib (Stivarga) activity through ATM-AMPK-autophagy signaling. These findings provide the scientific and translational rationale for the initiation of a Phase 1/2 clinical trial of the combination of standard of care regorafenib with the SCD1 inhibitor Aramchol in HCC and other GI cancers. Once a recommended Phase 2 dose is found, Galmed plans to add a dose expansion cohort that will include Metformin and will evaluate the 3-drugs' combination efficacy. Tillkännagivande • Dec 04
Galmed Announces Grant of New Use Patents for the Combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for Mash Galmed announced Grant of New Use Patents for the combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH. The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042. Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause the actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any Other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol and any other product candidate; ability to obtain and maintain adequate protection of intellectual property; the possibility that they may face third-party claims of intellectual property infringement; ability to manufacture product candidates in commercial quantities, at an adequate quality or at an acceptable cost; ability to establish adequate sales, marketing and distribution channels; intense competition in industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than the expectations regarding licensing, acquisitions and strategic operations; current or future favorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the security, political and economic instability in the Middle East that could harm its business, including due to the current security situation in Israel, risks relating to digital asset management strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign tax purposes and those risks and uncertainties identified in Exhibit 99.2 to Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission ("SEC") on August 25, 2025. Tillkännagivande • Nov 19
Galmed Pharmaceuticals Ltd. Announces Meaningful Top Line Results from AM-001 Study of Aramchol Meglumine Galmed Pharmaceuticals Ltd. announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability (BA) Study of Aramchol meglumine. The AM-001 study was designed to help identify the optimal doses for advancing Aramchol meglumine into the upcoming oncology Phase 2 studies planned for H1 2026. The study compared the relative BA of Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The study results demonstrated that the BA of Aramchol from the Aramchol meglumine granules is considerably greater than that from Aramchol free acid tablets. The BA of 400mg and 200mg Aramchol meglumine granules were approximately 5-fold and 3-fold respectively, from that of the Aramchol free acid 300 mg tablets. To date, Galmed has successfully advanced Aramchol through six clinical trials (up to Phase 3) enrolling 661 patients, establishing both its overall excellent tolerability, safety and efficacy in treating NASH (MASH) under the IND 505(b)1regulatory pathway. In addition, 82 healthy subjects to date have received Aramchol meglumine under a clinical trial application (CTA) in the United Kingdom. Tillkännagivande • Sep 22
Galmed Pharmaceuticals Ltd., Annual General Meeting, Oct 28, 2025 Galmed Pharmaceuticals Ltd., Annual General Meeting, Oct 28, 2025. Location: 16 abba hillel silver rd ramat gan, 5250608, Israel Tillkännagivande • May 27
Galmed Identifies Proprietary Biomarker Signature for Aramchol, Unlocking Multi-Billion-Dollar Expansion Potential Beyond Nash Galmed Pharmaceuticals Ltd. announced a major scientific and strategic milestone: the discovery of a proprietary pharmacodynamic (PD) blood-based biomarker signature for its lead candidate, Aramchol -- the industry's most clinically advanced stearoyl-CoA desaturase 1 (SCD1) inhibitor. This newly characterized biomarker profile, derived from plasma samples in the Phase 3 ARMOR study (MASH/NASH), offers critical insights into Aramchol's multi-system therapeutic potential, well beyond its initial liver-focused applications. The PD signature not only confirms on-target biological activity but also points toward potential broader disease-modifying capabilities in cardiometabolic and inflammatory conditions. In addition, as part of growth strategy, are actively pursuing opportunities to expand and diversify product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with core expertise in drug development. Tillkännagivande • May 06
Galmed Pharmaceuticals Ltd. Announces First Time Results in Oncology Studies Galmed Pharmaceuticals Ltd. announced that results from studies at Virginia Commonwealth University (VCU) show that an Aramchol and Bayer's Regorafenib drug combination significantly reduced hepatic tumor growth in mice models. The cell killing effect in-vitro and in-vivo was due to increased autophagy and death receptor signaling. In addition, Regorafenib and Aramchol interact to suppress tumor growth in hepatoma models without normal tissue toxicities. A combination of Bayer's RegorafenIB and Aramchol could potentially become a cost-effective first line treatment forHCC and other liver and colorectal cancers. The mechanisms by which the combination of Aramchol and Regorafenib kills tumor cells provide the scientific foundation for a Phase Ib clinical trial in GI tumors. The company look forward to taking these findings forward in a new clinical program, alongside the recently announced Semaglutide GLP-1 sublingual development. Tillkännagivande • Apr 15
Galmed Pharmaceuticals Ltd. Unveils Novel Pharmacodynamic Blood Markers for Aramchol Galmed Pharmaceuticals Ltd. announced the unveiling of novel pharmacodynamic (PD) blood markers for its lead compound, Aramchol, the industry's most clinically advanced SCD1 inhibitor. These newly identified biomarkers shed fresh light on Aramchol's potential far beyond its role in NASH (MASH) therapy--offering a deeper understanding of the drug candidate's biochemical impact and presenting an exciting opportunity to enhance clinical decision-making and expand into additional disease areas. Such an assay, once validated, could bolster Galmed's forthcoming clinical trials by further de-risking development and allowing clinicians to evaluate drug response in real time. By enabling pharmaceutical companies to verify safety and efficacy profiles--including proof of mechanism--Proteas Health's solutions are designed to reduce clinical trial risk and accelerate pathways to commercialization, making it an integral partner in modern drug development. Tillkännagivande • Apr 10
Galmed Pharmaceuticals Ltd. Announces Positive Part 1 Results from the AM-001 Study of Aramchol Meglumine, an Enhanced Formulation of the Most Clinically Advanced SCD1 Inhibitor Galmed Pharmaceuticals Ltd. announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine. Galmed has successfully advanced Aramchol acid through six clinical trials (up to Ph3) enrolling 661 subjects, establishing both its overall safety and its efficacy in treating NASH (MASH). Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumines under a new IND, leveraging cross-reference to the substantial preclinical and clinical data amassed in recent years for Aramchol. Based on these outcomes, 200 mg once daily appears to be the optimal dose for subsequent clinical trials. Tillkännagivande • Mar 20
Galmed Pharmaceuticals Ltd. Secures New Patent Grant Extending Aramchol's Patent Protection to 2039, Strengthening Leadership in Nash/Mash Combination Therapy Galmed Pharmaceuticals Ltd. announced the grant of a new patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Resmetirom (MGL-3196, Rezdiffra) for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis. NASH is a chronic liver condition characterized by multiple intertwined pathologies - excessive liver fat, metabolic dysfunction, and fibrosis. Recent regulatory developments underscore the need for multi-faceted treatment approaches: in March 2024, the FDA approved Rezdiffra (Resmetirom) as the first-ever drug for NASH patients with liver fibrosis, a milestone that validates the therapeutic potential in this space. However, experts widely agree that no single agent is likely to fully treat NASH, given its complex pathogenesis, and that combination therapy will be key to effective management. The newly granted patent covering Aramchol with Resmetirom - a thyroid hormone receptor-b agonist that reduces liver fat - exemplifies this strategy by pairing two selective compounds with complementary actions. Galmed's confidence in Aramchol's role in combination treatment is supported by encouraging clinical results. In the Open-Label phase of Galmed's Phase 3 ARMOR study, NASH patients treated with Aramchol (300mg twice daily) achieved a high rate of fibrosis improvement. These interim results demonstrate Aramchol's robust anti-fibrotic effect in humans, addressing one of the major challenges in NASH treatment. Tillkännagivande • Sep 25
Galmed Pharmaceuticals Ltd. Publishes Results from Aramchol Phase 3 Open Label Part in Hepatology Galmed Pharmaceuticals Ltd. announced that the one-year results of the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) have been published in Hepatology. Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement. Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and activities. Aramchol, by targeting this single receptor, induces a cascade of events that leads to two main changes; in hepatocytes, Aramchol elevates the fatty acids oxidation (or in other words – fat burn) and influences AMPK, which results also in reducing glycemic parameters; and in hepatic stellate cells, Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD-1), resulting in a direct effect on fibrogenesis. Galmed has long believed that the optimum treatment for MASH will be combination therapy. The company further believes that Aramchol’ s unique mechanism of action differentiates itself from others in the competitive landscape, potentially positioning it to work as a potent anti-fibrotic compound alongside effective treatments in both approved and pre-approval stages. Tillkännagivande • Aug 31
Galmed Pharmaceuticals Ltd. announced that it expects to receive $9.999793 million in funding from Yorkville Advisors Global LP Galmed Pharmaceuticals Ltd. announced that it has entered into a Standby Equity Purchase Agreement with new investor, YA II PN, Ltd. managed by Yorkville Advisors Global LP to issue 31,566 Ordinary Shares par value of $1.80 per share at an issue price of $316.79 per share for the gross proceeds of approximately $9,999,793 on August 30, 2024. The Commitment Shares shall be issued in four equal installments, of which 7,892 Commitment Shares were issued on the date of execution of the Purchase Agreement and the remaining 23,674 Commitment Shares will be issued in three equal installments 90 calendar days following the due date of the immediately preceding installment until all four installments have been issued. The Ordinary Shares are being offered and sold pursuant to an exemption from the registration requirements of the Securities Act, under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.
On the same day, the company issued 7,892 ordinary shares at an issue price of CAD 316.79 per share for the gross proceeds of CAD 2,500,107 in its first tranche. New Risk • Aug 22
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 24% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Shareholders have been substantially diluted in the past year (209% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€1.72m market cap, or US$1.92m). Tillkännagivande • Jun 08
Galmed Pharmaceuticals Ltd., Annual General Meeting, Jul 10, 2024 Galmed Pharmaceuticals Ltd., Annual General Meeting, Jul 10, 2024. Location: offices of meitar law offices, 16 abba hillel silver rd, 5250608, ramat gan Israel Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Ran Oren was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. New Risk • Nov 04
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 140% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (140% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€1.49m market cap, or US$1.60m). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Tillkännagivande • Sep 27
Galmed Pharmaceuticals Ltd. Announces Allowance of New Patent for Aramchol for the Treatment of Pulmonary and Dermal Fibrosis Galmed Pharmaceuticals Ltd. announced the allowance of a Japanese patent related to treatment of pulmonary and dermal fibrosis. A similar patent was already granted in Mexico. The approval of the patent in the US and the rest of the world is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until November 2037. Previously, Galmed reported results showing significant anti-fibrotic effects of Aramchol in a pre-clinical model of lung fibrosis. Treatment with Aramchol resulted in statistically significant fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment. Findings were seen across all important indicators for the severity of fibrosis including hydroxyproline (a marker for collagen deposition in the fibrotic tissue) P< 0.05, Ashcroft score P < 0.005, % CPA (Percentage Collagen Proportionate Area of the lung) P < 0.001, and immunohistochemistry (type I collagen and a SMA) P < 0.005 for both staining. Tillkännagivande • Sep 24
Galmed Pharmaceuticals Announces Receipt of Nasdaq Minimum Bid Price Notification Galmed Pharmaceuticals Ltd. announced that the Company received a letter from the Nasdaq Listing Qualifications (the "Letter"), indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Further, the Rules also provide the Company a compliance period of 180 calendar days to regain compliance. According to the Letter, the Company has from September 18, 2023, or until March 18, 2024, to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180 day period, the closingbid price of its ordinary shares is at least $1 for a minimum of ten consecutive business days, in which case the Company will be provided with a written confirmation of compliance and this matter will be closed. In the event the Company does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional time if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the end of the 180-day period, the Nasdaq's staff will notify the Company that its ordinary shares are subject to delisting. The Letter has no immediate effect on the Company's Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, Galmed's ordinary shares will continue to trade on the Nasdaq Capital Market. Tillkännagivande • Sep 14
Galmed Pharmaceuticals Ltd., Annual General Meeting, Sep 20, 2023 Galmed Pharmaceuticals Ltd., Annual General Meeting, Sep 20, 2023, at 17:00 Israel Standard Time. Location: 16 Tiomkin St., Tel Aviv 6578317, Israel. Tel - Aviv Israel New Risk • Jul 25
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 9.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 9.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Market cap is less than US$100m (€14.1m market cap, or US$15.6m). New Risk • Jul 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 335% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (335% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$10m net loss in 3 years). Market cap is less than US$100m (€9.40m market cap, or US$10.6m). 
