Galmed Pharmaceuticals Ltd. (GLMD): Business Model Canvas [Dec-2025 Updated]

You're digging into the mechanics of a clinical-stage play, and the Business Model Canvas for Galmed Pharmaceuticals Ltd. shows a classic high-risk, high-reward structure centered on Aramchol for MASH. Honestly, the near-term focus is capital-they closed 2025 with about \$19.2 million in the bank, but that cash is funding a burn rate near \$1.5 million per quarter year-to-date 2025, mostly for that crucial Phase 3 ARMOR trial. This breakdown maps out their key R&D activities, the strategic alliances they need to succeed, and precisely where their revenue streams, like the \$9.3 million raised in 2025 equity financing, are coming from, so you can judge the runway for yourself.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Key Partnerships

You're looking at the network of external relationships Galmed Pharmaceuticals Ltd. (GLMD) is building to support its pipeline, especially the expansion of Aramchol into oncology and the pursuit of new delivery systems. These alliances are critical given the company's financial profile, which showed a net loss of approximately $2.5 million for the three months ended June 30, 2025, and a cash balance of approximately $20.7 million as of that date.

Academic Research Collaborations and Co-Development

Galmed Pharmaceuticals Ltd. is actively engaging academic institutions to validate Aramchol's potential beyond its initial focus. The collaboration with Virginia Commonwealth University (VCU), formalized under a Sponsored Project Agreement, targets a major unmet need in oncology: overcoming drug resistance in gastrointestinal (GI) cancers. The project investigates Aramchol's role in preclinical models of colorectal and hepatocellular (liver) cancers.

The tangible results from this research pipeline are already informing strategy. Top-line results from the joint research showed that a three-drug combination involving Aramchol and Bayer's drug, Stivarga® (regorafenib), significantly reduced hepatic tumor growth in mice models. This synergistic effect is key, as it could provide a life-cycle intellectual property strategy when Stivarga's main European patent expires in August 2028 and the U.S. patent in July 2032.

The planned next step for this co-development is significant:

• The combination of Aramchol and Stivarga® with Metformin is expected to enter Phase 1b clinical trials early 2026.
• The VCU collaboration is part of Galmed Pharmaceuticals Ltd.'s strategic move to advance Aramchol into oncological indications outside of NASH and fibrosis.

Strategic Alliances and Investments

Galmed Pharmaceuticals Ltd. has made targeted investments to secure access to technology that improves clinical trial efficiency and explores new therapeutic avenues. The partnership with OnKai Inc. is a prime example of this, focusing on patient recruitment for diverse populations.

Here are the key figures related to the OnKai strategic investment:

The platform's goal is to facilitate faster clinical trial enrollment, which is crucial for a company that reported a net loss of approximately $2.0 million in Q3 2025 and needs to move its pipeline forward efficiently. The company raised approximately $7.6 million during 2025 through its ATM facility as of June 30, 2025, providing a buffer for these strategic activities.

Galmed Pharmaceuticals Ltd. also has other key strategic relationships outlined in its business model:

• Proteas Health: Partnership focused on AI-driven biomarker development.
• Madrigal Pharmaceuticals: Collaboration via new use patents for combination MASH therapy. (Note: Madrigal Pharmaceuticals reported $212.8 million in Rezdiffra™ net sales for Q2 2025, indicating the competitive MASH landscape Galmed is entering.)

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Key Activities

Galmed Pharmaceuticals Ltd. focuses its key activities on advancing Aramchol through clinical development and expanding its pipeline, underpinned by financial management and intellectual property defense.

Conducting the Phase 3 ARMOR trial for Aramchol in MASH and fibrosis

The activity centers on generating and analyzing data from the Aramchol program, which has a history of clinical evaluation.

• Aramchol acid advanced through six clinical trials, including Phase 3, enrolling 661 subjects to establish safety and efficacy in MASH.
• Phase 3 ARMOR open-label results at week 48 showed fibrosis improvement in 65% of patients (paired assessment) and 100% (AI assessment).
• Biomarker analysis from the Phase 3 ARMOR study identified a 70-Protein PD Signature observed at Week 12 post-treatment.
• The ARMOR study was discontinued in the aftermath of COVID-19.

Advancing new Aramchol formulations (sublingual and subcutaneous) for broader indications

This involves reformulating the lead compound to improve patient compliance and commercial viability.

• The N-methylglucamine (meglumine) salt formulation, Aramchol Meglumine, received NCE patent protection extending until 2035.
• Aramchol Meglumine 400 mg granules demonstrated bioavailability approximately 5-fold greater than Aramchol free acid 300 mg tablets.
• Aramchol Meglumine 200 mg granules demonstrated bioavailability approximately 3-fold greater than Aramchol free acid 300 mg tablets.
• The 200 mg once-daily regimen is anticipated to be optimal for subsequent trials, moving from twice-daily dosing.
• To date, 82 healthy subjects have received Aramchol meglumine under a clinical trial application in the United Kingdom.

Expanding the pipeline with Amilo-5MER Phase 1 trial for chronic inflammatory diseases

Galmed Pharmaceuticals Ltd. is progressing its secondary pipeline asset, Amilo-5MER, through initial human trials.

The First-in-Human Phase 1 trial for Amilo-5MER, assessing safety, tolerability, and pharmacokinetics in healthy volunteers, is ongoing. The study planned to enroll up to 64 healthy subjects, including 56 young males and 8 elderly male and female subjects.

Securing and defending intellectual property, like the Aramchol combination therapy patents

Protecting the core asset, Aramchol, through patent grants is a critical ongoing function.

Galmed Pharmaceuticals Ltd. secured a new use patent in South Korea on December 4, 2025, for an Aramchol and Rezdiffra combination therapy. This patent extends Aramchol's protection worldwide until July 2042. This follows a patent granted in March 2025 that secured protection through September 2039 for the same combination. Research also showed a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced GI tumor cell killing in-vivo and in-vitro.

Executing a new digital asset management and treasury strategy

Financial management activities include capital raising and strategic structural changes to support operations.

The company announced a Digital Asset Management Strategy on August 25, 2025. Key financial metrics as of late 2025 reflect this treasury focus:

The company's stock was down 67.1% Year-to-Date up to the close on November 18, 2025, with a market capitalization of just $5.86 million as of December 4, 2025.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Key Resources

You're looking at the core assets Galmed Pharmaceuticals Ltd. (GLMD) is relying on to drive value in late 2025. It's all about the drug candidate and the capital supporting the science, plain and simple.

The most critical resource is Aramchol Meglumine, which you should know is a first-in-class, liver-targeted SCD1 modulator, specifically a synthetic fatty acid-bile acid conjugate molecule. This asset is what everything else is built around. The clinical validation supporting this asset is substantial, stemming from extensive work across six clinical trials, up to Phase 3, which have enrolled a total of 661 patients, establishing its overall excellent tolerability and safety profile. Furthermore, the company is actively developing new formulations; for instance, the Phase 1 Bioavailability (BA) study (AM-001) showed that 400mg of the meglumine granules achieved a bioavailability approximately 5-fold greater than the 300mg free acid tablets.

Financial stability, while always under pressure in this sector, is currently anchored by the balance sheet. As of September 30, 2025, Galmed Pharmaceuticals Ltd. held approximately $19.2 million in cash and cash equivalents, short term deposits, restricted cash, and marketable debt securities. This is a stronger position than the approximately $15.4 million reported at the end of December 2024. To support this, the company raised approximately $9.3 million during 2025 through its equity line and ATM facilities. The current burn rate is reported to be about $1.5 million per quarter. Honestly, that cash position, combined with virtually no debt, gives them a strong liquidity cushion, reflected in a current ratio of 7.98 as of Q3 2025.

Intellectual property forms the protective moat around Aramchol. The portfolio is extensive, but the most recent strategic win is a new use patent granted in South Korea for the combination of Aramchol with Madrigal Pharmaceuticals' Rezdiffra, extending worldwide patent protection for this combination therapy until July 2042. This is a big deal for long-term valuation. The R&D team is the engine executing on this IP, specializing in the core focus areas.

Here's a quick look at the financial context surrounding the R&D investment for the third quarter of 2025:

The specialized R&D team is focused on expanding Aramchol's utility beyond its initial NASH/MASH indication. This team is actively pursuing development for specific oncological and cardiometabolic indications. For example, recent joint research with Virginia Commonwealth University (VCU) showed that a 3-drug combination involving Aramchol, Stivarga®, and Metformin significantly enhanced the killing of gastrointestinal tumor cells in-vivo and in-vitro. The plan is to advance this into a Phase 1/2 clinical trial for metastatic colorectal cancer, hepatocellular carcinoma, and cholangiocarcinoma in early 2026.

You can see the key components of the drug candidate's progress laid out here:

• Aramchol is a first-in-class SCD1 modulator.
• Safety/Tolerability established in 661 patients.
• Fibrosis improvement of 65% at week 48 (paired) in ARMOR study.
• New formulation shows 5-fold greater BA at 400mg dose.
• IP protection extends until July 2042 for key combination use.
• R&D spending for Q3 2025 was $1.1 million.

The team's expertise is the bridge between the molecule and these new indications. They are currently seeking to advance development for oncological indications outside of NASH and fibrosis, while also pursuing cardiometabolic opportunities. Finance: draft 13-week cash view by Friday.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Value Propositions

You're looking at the core value Galmed Pharmaceuticals Ltd. (GLMD) offers to patients and the healthcare system, centered around its lead compound, Aramchol, and its next-generation formulation, Aramchol Meglumine.

Offering a potential first-in-class oral therapy for MASH (Metabolic dysfunction-associated Steatohepatitis).

Galmed Pharmaceuticals Ltd. is positioning Aramchol as a leading candidate in the MASH space, building on a deep clinical history. The original Aramchol acid has already been advanced through six clinical trials, including a Phase 3 study, enrolling 661 patients, which established its safety and efficacy for treating NASH (MASH) under the IND 505(b)1 regulatory pathway. Furthermore, Galmed Pharmaceuticals Ltd. secured a new Use Patent in South Korea for a combination therapy involving Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH and liver fibrosis, extending protection worldwide until July 2042.

Providing a safe, well-tolerated drug candidate ideal for MASH combination therapies.

A key value component is the established safety profile. Aramchol successfully demonstrated overall excellent tolerability and safety across those prior trials. This profile is critical because Galmed Pharmaceuticals Ltd. believes the optimum treatment for MASH will be combination therapy. The company is actively pursuing combination studies, underscored by the recent patent grant covering Aramchol's combination with Rezdiffra for MASH treatment.

Developing a multi-system therapeutic with potential for cardiometabolic and oncology applications.

The value proposition extends beyond the liver. Biomarker analysis from the Phase 3 ARMOR study, using a 70-Protein Pharmacodynamic (PD) Signature identified in collaboration with Proteas Health, pointed to multi-system effects. Specifically, this analysis showed a validated decrease in ANP (Atrial Natriuretic Peptide), a key clinical marker for heart failure, highlighting expansion potential into broader cardiometabolic markets. Also, Galmed Pharmaceuticals Ltd. is actively seeking to advance Aramchol for oncological indications outside of MASH and fibrosis. On November 17, 2025, Galmed Pharmaceuticals Ltd. announced that a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cell killing in-vivo and in-vitro.

Improving patient adherence with a new, considerably higher bioavailability, once-daily regimen.

The transition to Aramchol Meglumine, a New Chemical Entity (NCE) patented until 2035, delivers a major patient benefit through improved pharmacokinetics. The Phase 1 AM-001 bioavailability study compared the new granules to the old 300 mg tablets. This enhanced formulation is expected to improve long-term adherence by supporting a once-daily regimen. The data from the 30 healthy volunteers in the AM-001 study clearly supports this shift:

This improved exposure profile also carries a financial value proposition, as Galmed Pharmaceuticals Ltd. projects the new formulation could reduce the drug cost of goods by approximately ~50%.

Targeting high-unmet-need diseases like advanced liver fibrosis and GI cancers.

The focus is squarely on areas with significant unmet need. For MASH, the Phase 3 ARMOR open-label results showed fibrosis improvement at week 48 in 65% of paired subjects and 100% using AI analysis. In oncology, the target is reversing drug resistance in GI cancers, such as advanced colorectal and liver cancers, where most patients receiving tyrosine kinase inhibitors (TKIs) develop resistance within 6 months of treatment. Galmed Pharmaceuticals Ltd. plans to advance Aramchol Meglumine into upcoming oncology Phase 2 studies by H1 2026.

Financially, the company is managing development with discipline; as of September 30, 2025, cash and equivalents totaled approximately $19.2 million, following approximately $9.3 million raised during 2025.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so your relationships with key scientific and financial stakeholders are everything right now. Galmed Pharmaceuticals Ltd. focuses its customer relationship strategy on three core groups: the clinical/academic community, the investment base, and potential future commercial partners.

High-touch, direct engagement with key opinion leaders and clinical investigators

Galmed Pharmaceuticals Ltd. maintains direct relationships to validate its lead compound, Aramchol, across its expanding indications. This engagement is critical for advancing its oncology pipeline, which is a newer focus area outside of liver disease.

• Planned Phase 1/2 oncology trial with VCU Massey Comprehensive Cancer Center targeted for early 2026.
• Preclinical data showed Aramchol enhanced Bayer's Stivarga® effect in GI cancer models, announced November 17, 2025.
• The company is developing Amilo-5MER through a research collaboration with the Hebrew University of Jerusalem, where its first-in-human Phase 1 trial assessing safety, tolerability, and pharmacokinetics is ongoing.

Investor relations and communication to maintain confidence during the clinical-stage phase

Maintaining investor confidence is paramount for a clinical-stage company. Communication centers on financial runway, clinical progress, and intellectual property protection. The company filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, on April 2, 2025.

Here's the quick math on the current financial position as of late 2025:

The Annual General Meeting of Shareholders was held on October 28, 2025. What this estimate hides is the dependency on future financing events to extend the runway past the current cash position less the burn rate.

Collaborative research relationships with academic centers for pre-clinical and clinical studies

Galmed Pharmaceuticals Ltd. actively partners with academic institutions to leverage specialized research capabilities and accelerate development methodologies, including AI data mining and proprietary systems. These relationships are key to expanding Aramchol's utility.

• Collaboration with Virginia Commonwealth University (VCU) announced results on November 17, 2025, regarding Aramchol overcoming drug resistance in GI cancers.
• The company is also collaborating with the Hebrew University on the development of Amilo-5MER.
• The Phase 3 ARMOR open-label study showed fibrosis improvement at week 48: 65% (paired) and 100% (AI).

Future commercial licensing negotiations with major pharmaceutical companies

The strategy involves securing IP protection and demonstrating synergistic effects to attract major partners for commercialization, especially for combination therapies. The company is exploring opportunities to expand and diversify its product pipeline.

Key data points related to potential future commercial relationships include:

• New Use Patent granted in South Korea on December 4, 2025, for Aramchol in combination with Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for MASH and fibrosis.
• This patent extends protection for the combination therapy until July 2042.
• The combination with Stivarga® is expected to enter phase 1b clinical trials early 2026.
• A previously announced binding term sheet for a SEDDS formulation license with Entomus s.r.o. was terminated in August 2025.

Finance: draft 13-week cash view by Friday.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Channels

You're looking at how Galmed Pharmaceuticals Ltd. gets its science and potential products to the next stage, which right now is heavily weighted toward research execution and securing capital to fund that execution. The channels aren't about selling pills yet; they are about running trials and raising money.

Global network of Contract Research Organizations (CROs) for clinical trial execution

Galmed Pharmaceuticals Ltd. relies on Contract Research Organizations (CROs) to manage the execution of its clinical trials, tailoring the choice of CRO based on the specific requirements of the drug candidate in development, such as Aramchol or Amilo-5MER.

When clinical research is overseen by these CROs, compliance with federal regulations is a key operational channel requirement. This includes adherence to:

• 21 C.F.R. parts 50 (Informed Consent)
• 21 C.F.R. parts 54 (Financial Conflicts of Interest by Investigators)
• 21 C.F.R. parts 56 (Institutional Review Boards or IRBs)
• 21 C.F.R. parts 58 (Good Laboratory Practices)
• 21 C.F.R. part 312 (Investigational New Drug Applications)

Academic and institutional research centers (e.g., VCU) for early-stage discovery and trials

The connection to academic centers is a vital channel for advancing early-stage data, particularly in novel indications like oncology. Galmed Pharmaceuticals Ltd. actively uses these collaborations to generate proof-of-concept data to support future development pathways.

Key activity with Virginia Commonwealth University (VCU) in 2025 included:

The Research and development expenses for Galmed Pharmaceuticals Ltd. in the third quarter ended September 30, 2025, were approximately $1.1 million, an increase from approximately $0.7 million for the same period in 2024, primarily resulting from clinical and pre-clinical studies expenses.

Future out-licensing agreements with pharmaceutical partners for commercialization and distribution

While Galmed Pharmaceuticals Ltd. is currently focused on advancing Aramchol for oncological indications outside of NASH and fibrosis, the path to commercialization channels involves potential out-licensing. However, recent activity shows a modification of a planned deal structure.

In August 2025, Galmed Pharmaceuticals Ltd. terminated a binding term sheet with Entomus s.r.o. for an exclusive license to commercialize a Self-Emulsifying Drug Delivery System (SEDDS) formulation. Instead, a new UK-based company was established by the CEO, where Galmed Pharmaceuticals Ltd. is contemplating acquiring up to a 20% stake.

At-the-Market (ATM) and equity facilities for capital raising from investors

Financing the clinical development pipeline is a critical channel for Galmed Pharmaceuticals Ltd. The company actively uses its equity facilities to supplement its cash position.

Key capital raising metrics for 2025:

• Total raised through equity line and ATM facilities during 2025 was approximately $9.3 million (as of Q3 2025 report).
• The company raised $6.5 million since the beginning of 2025 (as of Q1 2025 report).
• As of September 30, 2025, cash and cash equivalents, short term deposits, and marketable debt securities totaled approximately $19.2 million.
• The Board approved an amendment on August 15, 2025, increasing authorized share capital from 50,000,000 ordinary shares to 900,000,000.
• Ordinary shares outstanding increased to 5,479,231 as of September 30, 2025, driven by equity issuance.

The company's burn rate was minimal, approximately $1.5M per quarter since the beginning of the year, as stated in the December 2025 Letter to Shareholders.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Segments

Galmed Pharmaceuticals Ltd. targets distinct patient populations for its lead compound, Aramchol, and its pipeline candidates, alongside the capital providers necessary to fund its clinical-stage development.

The primary patient segment centers on those afflicted with Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH, and associated liver fibrosis. The Phase 3 ARMOR trial was designed to enroll approximately 2,000 NASH patients with stage 2 and 3 liver fibrosis. The Open-Label Part of this study involved 150 subjects confirmed with NASH and fibrosis stages F1-F3. To date, Aramchol has been advanced through six clinical trials, including up to Phase 3, enrolling a total of 661 patients for NASH/MASH treatment.

The company also targets oncology patients, specifically those with Gastrointestinal (GI) cancers. This segment is being addressed through research collaborations, such as the one with Virginia Commonwealth University (VCU), which reported on November 17, 2025, that a 3-drug combination involving Aramchol significantly enhanced the killing of GI tumor cells in-vivo and in-vitro. Galmed Pharmaceuticals Ltd. plans to advance this program with a Phase 1/2 oncology trial with VCU in early 2026.

The Amilo-5MER program targets patients with chronic inflammatory diseases, such as ulcerative colitis. Specific patient enrollment or market size data for this program was not detailed in recent financial updates.

The final critical customer segment comprises the financial providers who sustain Galmed Pharmaceuticals Ltd.'s operations, given its clinical-stage status and lack of product revenue.

Here's a look at the capital structure and financing activity as of late 2025:

The reliance on external funding is clear, as management stated significant additional capital will be needed to advance the pipeline. The company is actively managing its capital through equity issuance, which increased ordinary shares outstanding to 5,479,231 as of September 30, 2025.

Key characteristics of the investor segment include:

• Institutional investors hold 76.14% of the stock.
• Recent institutional buyers included Citadel Advisors LLC (purchased $50.49K worth in last 24 months).
• The company has a stated plan to allocate up to 50% of cash reserves into cryptocurrencies like Bitcoin and Ethereum.
• The stock has a 52-week range as of early December 2025 between a low of $0.74 and a high of $3.61.
• The stock price on December 4, 2025, was $1.13.

Finance: review cash runway based on $1.5M quarterly burn against $19.2M cash by end of next week.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Cost Structure

The Cost Structure for Galmed Pharmaceuticals Ltd. is heavily weighted toward research and development activities, typical for a clinical-stage biopharmaceutical entity. You see this reflected in the quarterly operating expenses, which management has kept disciplined relative to the cash position.

Here's a quick look at the reported operating expenses for the third quarter ended September 30, 2025:

The company has maintained a consistent operational outlay throughout 2025, which you can track through the cash burn rate. This rate is a critical metric for managing runway.

• High cash burn rate, approximately $1.5 million per quarter year-to-date 2025.

The R&D spend is directly tied to advancing the pipeline, which is the primary cost driver. This includes significant outlay for ongoing studies of Aramchol.

• Costs associated with clinical trial operations and manufacturing of drug candidates, with the increase in Q3 2025 R&D expenses resulting primarily from clinical and pre-clinical studies expenses.

Furthermore, Galmed Pharmaceuticals Ltd. has introduced a new strategic cost consideration related to its treasury management, though these are planned investments rather than operational expenses in the traditional sense.

• Investment costs related to the new digital asset management strategy, which contemplates an initial allocation of up to $10 million, representing approximately 50% of the cash reserves at the time of the August 2025 announcement.

Finance: draft 13-week cash view by Friday.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Galmed Pharmaceuticals Ltd. (GLMD) as of late 2025. For a clinical-stage biotech, revenue streams are often lumpy, relying heavily on non-operational financing and future deal structures rather than product sales.

Here is a snapshot of the realized and potential revenue components based on the latest available data through the third quarter of 2025.

The primary realized cash inflow during 2025 has been from capital markets activities, which is typical for a company advancing a lead asset like Aramchol through late-stage trials.

Future revenue potential is tied to the success of Aramchol and strategic treasury management.

• Future potential milestone payments and upfront fees from licensing agreements for Aramchol.
• Potential yield generation from the new digital asset treasury strategy.

Regarding the licensing potential, Galmed Pharmaceuticals Ltd. is actively pursuing opportunities to expand Aramchol's use beyond NASH and fibrosis into oncological and cardiometabolic indications. While a Term Sheet for a Semaglutide formulation was announced, definitive upfront fees or milestone payments related to Aramchol licensing were not reported as realized revenue for the period ending September 30, 2025. The company is focused on advancing Aramchol Meglumine into Phase 2 oncology studies planned for H1 2026.

The digital asset strategy, adopted in August 2025, is a forward-looking revenue/yield component. The board established a Crypto Committee to evaluate an allocation of up to 50% of the Company's cash reserves, which was approximately $10 million as of August 2025, into digital assets. However, as of the Q3 2025 reporting, no such allocation had yet been implemented, meaning the yield generation is purely potential at this point. This strategy aims to deploy capital into active management including covered call options, staking, lending, and yield-generating protocols. Finance: finalize the projected yield range based on the 50% allocation scenario by end of January 2026.