Galmed Pharmaceuticals Ltd 20-F for FY2024

Galmed Pharmaceuticals Ltd. (EOCN)

20-F 2025-04-02 For: 2024-12-31

Added on April 06, 2026

About this 20-F

Galmed Pharmaceuticals Ltd filed this 20-F on April 2, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $7.52M; compared with a net loss of $6.91M a year earlier
Diluted EPS: $8.08; down 73.1% from $30.00 a year earlier

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Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, par value NIS 0.15 per share		GLMD		Nasdaq Capital Market

Large accelerated filer ☐	Accelerated filer ☐	Non-accelerated filer ☒
		Emerging growth company ☐

PART I	5
ITEM 1. Identity of Directors, Senior Management and Advisers.	5
ITEM 2. Offer Statistics and Expected Timetable.	5
ITEM 3. Key Information.	5
ITEM 4. Information on the Company.	53
ITEM 4A. Unresolved Staff Comments.	89
ITEM 5. Operating and Financial Review and Prospects.	90
ITEM 6. Directors, Senior Management and Employees.	97
ITEM 7. Major Shareholders and Related Party Transactions.	120
ITEM 8. Financial Information.	121
ITEM 9. The Offer and Listing.	124
ITEM 10. Additional Information.	122
ITEM 11. Quantitative and Qualitative Disclosures About Market Risk.	135
ITEM 12. Description of Securities Other Than Equity Securities.	136

PART II	136
ITEM 13. Defaults, Dividend Arrearages and Delinquencies.	136
ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds.	136
ITEM 15. Controls and Procedures.	136
ITEM 16. [RESERVED]	137
ITEM 16A. Audit Committee Financial Expert.	137
ITEM 16B. Code of Ethics.	137
ITEM 16C. Principal Accountant Fees and Services.	138
ITEM 16D. Exemptions from the Listing Standards for Audit Committees.	138
ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.	139
ITEM 16F. Change in Registrant’s Certifying Accountant.	139
ITEM 16G. Corporate Governance.	139
ITEM 16H. Mine Safety Disclosure.	140
ITEM 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	141
ITEM 16J. Insider Trading Policies.	141
ITEM 16K. Cybersecurity.	141

PART III	141
ITEM 17. Financial Statements.	143
ITEM 18. Financial Statements.	142
ITEM 19. Exhibits	143

	●	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, or MASH, and fibrosis or in combination therapy;

	●	the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop;

	●	completion and receiving favorable results of any pre-clinical or clinical trial;

	●	regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling;

	●	the commercial launch and future sales of Aramchol and any future product candidates;

	●	our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product;

	●	our ability to achieve favorable pricing for Aramchol, or any other product candidate;

	●	third-party payor reimbursement for Aramchol, or any other product candidate;

	●	our estimates regarding anticipated capital requirements and our needs for additional financing;

	●	market adoption of Aramchol or any other product candidate by physicians and patients;

	●	the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate;

	●	our ability to obtain and maintain adequate protection of our intellectual property;

	●	the possibility that we may face third-party claims of intellectual property infringement;

	●	our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost;

	●	our ability to establish adequate sales, marketing and distribution channels;

	●	intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;

	●	our expectations regarding licensing, acquisitions and strategic operations;

	●	current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk;

	●	our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market;

	●	security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel; and

	●	those factors referred to in “Item 3.D. Risk Factors,” “Item 4. Information on the Company,” and “Item 5. Operating and Financial Review and Prospects”, as well as in this annual report on Form 20-F generally.

●	We are a biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future and may never be profitable.

●	We have not yet commercialized any products and we may never be able to do so, and even if we do, the products may not gain market acceptance.

●	We will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.

●	We are unable to estimate our long-term capital requirements due to uncertainties associated with the development and commercialization of Aramchol or any other product candidate. If we fail to obtain necessary funds for our operations, we will be unable to develop and commercialize Aramchol or any other product candidate.

●	We depend largely on the success of our lead product candidate, Aramchol, and we may not obtain regulatory approval of Aramchol.

●	Our activities to identify and, evaluate new indications and product candidates and expand our product portfolio may not be successful.

●	The clinical trial process is complex and expensive, and commencement and completion of clinical trials can be delayed or prevented for a number of reasons.

●	We are advancing the development of Aramchol in combination with other therapies, which exposes us to additional risks.

●	We may be forced to abandon development of Aramchol or any other product candidate which would have a material adverse effect on our business and may force us to cease operations.

●	We have historically developed Aramchol for the treatment of NASH, and there is significant uncertainty regarding the regulatory approval process. In addition, during 2022, we discontinued our open label part of the ARMOR Study and we do not currently expect to initiate the second part of the ARMOR Study.

	●	We have no manufacturing capacity and anticipate reliance on third-party manufacturers for Aramchol or any other product candidate.

	●	Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our current and potential future product candidates.

	●	We depend on third parties to conduct our clinical trials.

	●	The failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and protective could impact our ability to compete effectively.

	●	We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing, or increase the costs of commercializing, Aramchol or or any other product candidate.

	●	The market price of our ordinary shares is volatile and you may sustain a complete loss of your investment.

	●	If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the price of our ordinary shares and our ability to access the capital markets could be negatively impacted.

	●	Our U.S. shareholders may suffer adverse tax consequences due to our classification as a passive foreign investment company.

	●	Our headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military instability in Israel, such as the current war and security situation therein

	●	Provisions of Israeli law and our articles of association, or Articles, may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.

	●	Your rights, liabilities and responsibilities as a shareholder will be governed by Israeli law and differ in some material respects from those under U.S. law.

	●	commence any clinical trials for Aramchol and or any other product candidate and initiate additional research and development programs;

	●	seek regulatory approvals for Aramchol or any other product candidate;

	●	seek to in-license additional products or technologies to develop;

	●	expand our operational, financial and management systems and personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;

	●	hire additional management and other personnel; and

	●	move towards commercialization of Aramchol or any other product candidate.

	●	demonstrate a compelling and/or novel, pre-clinical, unique mechanism of action of Aramchol or any other product candidate;

	●	obtain adequate clinical results from and progress from the clinical development of Aramchol or any other product candidate;

	●	develop and obtain regulatory approvals in the countries and for the uses we intend to pursue for Aramchol or any other product candidate;

	●	contract for the manufacture of commercial quantities of Aramchol or any other product candidate by a current good manufacturing practice, or cGMP, compliant manufacturing facility at acceptable cost levels if marketing approval is received; and

	●	establish external, and potentially in the future, internal, sales and marketing capabilities to effectively market and sell Aramchol or any other product candidate in the United States and other countries.

	●	the timing and scope of regulatory approvals in the countries we intend to pursue with respect to the commercialization of Aramchol or any other product candidate, including the indications for which they are approved;

	●	the competitive environment;

	●	the ability for Aramchol or any other product candidate to be manufactured, whether by us or third parties, in compliance with applicable regulatory requirements, including cGMP;

	●	our ability to effectively promote Aramchol or any other product candidate, whether directly or using third parties, consistent with the approved indications and labeling in the countries in which we intend to pursue approval;

	●	the acceptance by the medical community of the safety and clinical efficacy of Aramchol or any other product candidate and their potential advantages over other therapeutic products;

	●	the development of a non-invasive method for diagnosing NASH as an alternative to the current gold standard of liver biopsy, which we view as a rate-limiting factor to complete market uptake because of its expense and its risks and discomfort to patients;

	●	the adequacy and success of distribution, sales and marketing efforts, including through strategic agreements with pharmaceutical and biotechnology companies; and

	●	the pricing and reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations and other plan administrators.

	●	exposure to unknown liabilities;

	●	incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

	●	higher than anticipated acquisition and/or integration costs;

	●	write downs of assets or goodwill or impairment charges;

	●	increased amortization expenses;

	●	difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

	●	impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

	●	the inability to retain our key employees or our other service providers or those of any acquired businesses.

	●	the progress and costs of our pre-clinical studies, clinical trials and other research and development activities;

	●	the regulatory pathway of Aramchol or any other product candidate;

	●	the scope, prioritization and number of our clinical trials and other collaboration, research and development programs;

	●	the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to Aramchol or any other product candidate;

	●	the costs of the development and expansion of our operational infrastructure;

	●	the costs and timing of obtaining regulatory approval for Aramchol or any other product candidate;

	●	the ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future licensing agreements;

	●	the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

	●	the costs and timing of securing manufacturing arrangements for clinical or commercial production;

	●	the costs of contracting with third parties to provide sales and marketing capabilities for us;

	●	the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;

	●	the magnitude of our general and administrative expenses;

	●	any cost that we may incur under future in- and out-licensing arrangements relating to Aramchol or any other product candidate;

	●	market conditions;

	●	our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and

	●	the security situation in Israel, which may exacerbate the magnitude of the factors discussed above.

	●	the number of product candidates in development;

	●	the size, duration and scope of existing and future clinical trials and pre-clinical studies;

	●	the regulatory pathway for the approval of Aramchol or any other product candidate;

	●	the results of our clinical trials, which are unpredictable in product candidate development;

	●	our ability to successfully commercialize Aramchol or any other product candidate, including securing commercialization and out-licensing agreements with third parties and favorable pricing and market share;

	●	the progress, success and cost of our clinical trials and research and development programs, including those associated with milestones and royalties;

	●	the costs, timing and outcome of regulatory review and obtaining regulatory approval of Aramchol or any other product candidate and addressing regulatory and other issues that may arise post-approval;

	●	the breadth of the labeling, assuming that Aramchol or any other product candidate are approved for commercialization by a relevant regulatory authority, which may not occur;

	●	our need, or decision, to acquire or in-license complementary technologies or new platform technologies or product candidates;

	●	the costs of enforcing our issued patents and defending intellectual property-related claims;

	●	the costs of investigating patents that might block us from developing potential product candidates;

	●	the costs of recruiting and retaining qualified personnel;

	●	the costs associated with contracting with third parties to manufacture the product and to perform other necessary services;

	●	our revenue, if any; and

	●	our consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated.

	●	difficulties obtaining regulatory authorization to commence a clinical trial or complying with regulatory requirements for clinical trials or with the conditions imposed by a regulatory authority regarding the scope, duration or conduct of a clinical trial;

	●	delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

	●	insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;

	●	difficulties in obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;

	●	challenges in recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including size and nature of patient population, proximity of patients to clinical sites, eligibility and exclusion criteria for the trial, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications;

	●	challenges in identifying or recruiting sufficient study sites or investigators for clinical trials;

	●	limitations on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees and external partners;

	●	delays in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee resources;

	●	impacts from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans; and

	●	lack of adequate funding to initiate or continue our clinical trials.

	●	irregularities in conducting a clinical trial, including by way of example, failure to conduct the clinical trial in accordance with regulatory requirements, in particular good clinical practice requirements, or GCP, or the FDA-authorized clinical protocols;

	●	negative findings upon inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;

	●	safety issues or lack of clinical drug activity or effectiveness; and

	●	lack of adequate funding to continue the clinical trials.

	●	we may not be able to demonstrate to the satisfaction of the applicable regulatory agencies that the product candidate is safe and effective for treatment of the targeted indication in patients;

	●	the results of clinical trials may not meet the level of statistical significance or clinical significance required by the applicable regulatory agencies for approval;

	●	the applicable regulatory agencies may disagree with the number, design, size, conduct or implementation of our clinical trials;

	●	the applicable regulatory agencies may not find the data from pre-clinical studies and clinical trials sufficient to demonstrate the clinical and other benefits outweigh its safety risks;

	●	the applicable regulatory agencies may disagree with our interpretation of data from pre-clinical studies or clinical trials;

	●	the applicable regulatory agencies may not accept data generated at our clinical trial sites;

	●	the data collected from pre-clinical studies and clinical trials may not be sufficient to support the submission of an NDA or similar regulatory application;

	●	the applicable regulatory agencies may not schedule an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the applicable regulatory agencies require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

	●	the applicable regulatory agencies may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;

	●	the applicable regulatory agencies may require simultaneous approval for both adults and children, which would delay required approvals, or we may have successful clinical trial results for adults, but not children, or vice versa;

	●	the applicable regulatory agencies may change their approval policies or adopt new regulations that may impede consideration or approval of our NDA, or similar regulatory application;

	●	the applicable regulatory agencies may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers, or suppliers of active pharmaceutical ingredients, or APIs, with which we enter into agreements for clinical and commercial supplies; and

	●	the applicable regulatory agencies may require post-marketing approval studies, such as Phase 4 clinical trials, in connection with Aramchol or any other product candidate.

	●	suspend or withdraw their approval of the product;

	●	require the addition of labeling statements, such as warnings, so-called “black box warnings,” contraindications or restrictions on the product’s intended use;

	●	require us to issue specific communications to healthcare professionals, such as “Dear Doctor” letters;

	●	issue negative publicity regarding the affected product, including safety communications;

	●	impose a risk evaluation and mitigation strategy (REMS), in the case of FDA, or similar risk management strategies in the case of foreign regulators;

	●	suspension or imposition of restrictions on operations, including costly new manufacturing requirements;

	●	refusal to approve pending applications or supplements to applications;

	●	suspension of any clinical trials;

	●	suspension or withdrawal of marketing approval;

	●	an injunction or imposition of civil or criminal penalties or monetary fines;

	●	seizure or detainment of products;

	●	banning or restriction of imports and exports;

	●	issuance of warning letters or untitled letters;

	●	suspension or imposition of restrictions on operations, including costly new manufacturing requirements; or

	●	refusal to approve pending applications or supplements to applications.

	●	different regulatory requirements for drug approvals in foreign countries;

	●	differing U.S. and foreign drug import and export rules;

	●	reduced protection for intellectual property rights in foreign countries;

	●	unexpected changes in tariffs, trade barriers and regulatory requirements;

	●	different reimbursement systems;

	●	economic weakness, including inflation, or political instability in particular foreign economies and markets;

	●	compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

	●	foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

	●	workforce uncertainty in countries where labor unrest is more common than in the United States;

	●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

	●	potential liability resulting from development work conducted by these distributors;

	●	business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, emergence of a pandemic, or other widespread health emergencies (or concerns over the possibility of such an emergency); and

	●	risks associated with clinical co-development agreements in other jurisdictions prior to or post-regulatory approval.

	●	demonstration of clinical safety and efficacy compared to other products;

	●	ability of physicians to accurately make a diagnosis in its early stages;

	●	the relative convenience and ease of administration;

	●	the prevalence and severity of any adverse side effects;

	●	limitations, warnings or contraindications contained in the product’s approved labeling;

	●	distribution and use restrictions imposed by the FDA, or other regulatory agencies, or agreed to by us as part of a mandatory or voluntary REMS;

	●	availability of alternative treatments, including, any competitive products already approved or expected to be commercially launched in the near future;

	●	pricing and cost effectiveness;

	●	the effectiveness of our, or any future collaborators’, sales and marketing strategies;

	●	our ability to obtain sufficient third-party coverage or reimbursement; and

	●	the willingness of patients to pay for drugs out of pocket in the absence of third-party coverage.

	●	a covered benefit under its health plan;

	●	safe, effective and medically necessary;

	●	appropriate for the specific patient;

	●	cost-effective; and

	●	neither experimental nor investigational.

●	The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or paying any remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, ordering or arranging for or recommending the purchase or order of any item or service for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. Liability may be established without a person or entity having actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it. This statute has been interpreted to apply broadly to arrangements between pharmaceutical manufacturers on the one hand and prescribers, patients, purchasers and formulary managers on the other. In addition, the Affordable Care Act amended the Social Security Act to provide that the U.S. government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. A conviction for violation of the Anti-kickback Statute requires mandatory exclusion from participation in federal health care programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and those activities may be subject to scrutiny or penalty if they do not qualify for an exemption or safe harbor.

●	The federal civil False Claims Act, or FCA, prohibits, among other things, knowingly presenting, or causing to be presented claims for payment of government funds that are false or fraudulent, or knowingly making, using or causing to be made or used a false record or statement material to such a false or fraudulent claim, or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. This statute also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. The FCA prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U.S. federal agencies are requiring nonmonetary remedial measures, such as corporate integrity agreements in FCA settlements. The U.S. Department of Justice announced in 2016 its intent to follow the “Yates Memo,” taking a far more aggressive approach in pursuing individuals as FCA defendants in addition to the corporations. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties assessed on a per false claim or statement basis. Government enforcement agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe products; engaging in promotion for “off-label” uses; and submitting inflated best price information to the Medicaid Rebate Program.

●	The federal False Statements Statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items, or services.