TEL AVIV, Israel, April 4, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2023, with the U.S. Securities and Exchange Commission (the "SEC"). The report is available on the SEC's website, at www.sec.gov and Galmed's Investor Relations website, at https://galmedpharma.investo ...

Financial Performance - The company incurred a loss of approximately $17.4 million for the year ended December 31, 2022, and $7.2 million for the year ended December 31, 2023, with an accumulated deficit of $193.0 million as of December 31, 2023[39]. - The company has a history of operating losses and may never achieve profitability, as it has not yet demonstrated an ability to successfully commercialize any product candidate[39]. - As of December 31, 2023, the company had a net working capital of $10.5 million and cash and cash equivalents of $2.9 million, which is expected to support operations for more than 12 months[47]. - The company needs to raise substantial additional capital to fund operations and re-initiate the ARMOR Study, as well as develop Aramchol and Amilo-5MER[47]. - The public float was approximately $1.8 million as of March 27, 2024, limiting the amount of funds that can be raised through primary public offerings under the Baby Shelf Rule[50]. - The company may incur substantial costs in pursuing future capital financing, including investment banking fees and legal fees, which could adversely impact its financial condition[53]. - The company has outstanding pre-funded warrants to purchase 1,280,000 ordinary shares and warrants to purchase 5,200,000 ordinary shares, which could lead to dilution for existing shareholders[54]. Product Development and Regulatory Challenges - The company has not yet commercialized any products and may never be able to do so, with significant uncertainty surrounding the regulatory approval process for its lead product candidate, Aramchol[45]. - The company discontinued the open-label part of the ARMOR Study in 2022 and does not currently expect to initiate the second part of the study[45]. - The company expects to continue incurring significant research and development expenses, particularly if it re-initiates the ARMOR Study and initiates additional clinical trials[43]. - The company anticipates that its expenses will increase substantially as it seeks regulatory approvals and moves towards commercialization of its product candidates[40]. - The clinical trial process is complex and expensive, with potential delays due to regulatory requirements and recruitment challenges[65]. - Material delays have already been experienced in the ARMOR Study and ARREST Study, primarily due to slower than expected recruitment[67]. - The regulatory approval process for Aramchol, aimed at treating NASH, is uncertain and may require additional studies or changes in strategy, potentially increasing development costs[75]. - The company has invested almost all its resources in the development of Aramchol, making its business largely dependent on obtaining regulatory approval and successfully commercializing the product[77]. - The company has completed seven clinical trials of Aramchol, with no evidence of safety concerns, but future trials may reveal undesirable side effects[99]. - The company may need to conduct costly post-marketing studies or face restrictions on product use after approval[104]. - The company may face additional risks if it develops Aramchol in combination with other therapies, as the success of the combination depends on the approval of the other therapies[84]. - The FDA has indicated that results from the ARMOR Study must be unequivocal for a single Phase 3 study to support an NDA, which adds to the uncertainty of the approval process[74]. - The company has not received marketing approval for Aramchol in any jurisdiction, and the marketing approval process varies significantly across different countries[78]. - Any delays in clinical trials or additional studies could require substantial additional resources and extend the timeline for market approval[76]. Market and Competitive Landscape - The market price of the company's ordinary shares is volatile, and there is a risk of complete loss of investment for shareholders[37]. - The company faces intense competition in the market, with larger pharmaceutical companies having significantly greater resources and experience, which could render its product candidates non-competitive or obsolete[144]. - Key competitors in the NASH field include Novo Nordisk, Akero Therapeutics, Madrigal Pharmaceuticals, and Viking Therapeutics, with Madrigal Pharmaceuticals recently announcing FDA approval for Rezdiffra for NASH treatment[146]. - The company anticipates facing increasing competition as new drugs and advanced technologies enter the market, which could adversely affect its marketing and sales efforts[145]. - The commercial success of any approved product will depend on its acceptance by the medical community and healthcare payors[113]. Operational Risks and Challenges - The company is substantially dependent on its remaining employees to facilitate strategic transactions, and the loss of key employees could adversely affect its operations[30]. - The company may need to curtail growth plans or cut back on existing business if adequate funds are not available in a timely manner[52]. - The company may face operational challenges and delays in clinical trials due to reliance on third parties for conducting these trials[180]. - The company faces risks associated with international operations if product candidates are approved for commercialization outside the U.S.[108]. - The company may incur significant expenses and face integration difficulties when acquiring or in-licensing additional technologies or product candidates[91]. Legal and Compliance Issues - The company is subject to the Sarbanes-Oxley Act, requiring effective internal controls over financial reporting, and any deficiencies could harm its operating results and investor confidence[157]. - The company may need to improve its accounting systems and controls to comply with financial reporting requirements, and failure to do so could result in sanctions or delisting from the Nasdaq Capital Market[158]. - Compliance with healthcare and data privacy laws is critical; violations could lead to significant penalties, including administrative, civil, and criminal penalties, adversely affecting financial results[137]. - The company is subject to the General Data Protection Regulation (GDPR) and the UK GDPR, with potential fines up to €20 million or 4% of total worldwide annual turnover for non-compliance[140]. - The company may face substantial costs and distractions from enforcing patent rights in foreign jurisdictions, potentially affecting its business operations[195]. Economic and Market Conditions - The company's business and growth rates may be adversely affected by unfavorable economic conditions, including the impact of military conflicts and geopolitical events[217]. - Inflation increases costs for commodities, labor, and materials, which may adversely impact the company's financial condition and ability to secure financing[218]. - Future credit and financial market instability could affect the company's growth strategy and financial performance, making financing more difficult and costly[219]. - The market price of the company's ordinary shares has been volatile, influenced by factors such as clinical trial outcomes and regulatory approvals[220]. - The biotechnology sector, particularly on the Nasdaq Capital Market, has experienced extreme price fluctuations that may not correlate with the company's operating performance[222]. Environmental and Safety Concerns - The company may face substantial capital costs and operating expenses to comply with environmental, health, and safety regulations, which could be significant[120]. - The risk of accidental contamination or injury from hazardous materials used in operations cannot be eliminated, potentially leading to liability[120]. - Cybersecurity threats, including ransomware attacks, pose a risk to the company's operations and could disrupt drug development programs[118]. Future Outlook and Strategic Initiatives - The company announced a strategic investment in OnKai, Inc. in June 2023, indicating a focus on expanding into new anti-fibrotic indications[61]. - The company is exploring the expansion of Aramchol for other indications to enhance its pipeline and commercial potential, which may shift priorities for Aramchol in the future[164]. - Future collaborations with pharmaceutical or biotechnology companies are intended for the development and commercialization of product candidates, but success is uncertain[178].

Financial Position - As of September 30, 2023, the company reported current assets of $14.2 million, a decrease from $14.7 million at December 31, 2022, primarily due to a reduction in cash and cash equivalents from $2 million to $1.5 million[46]. - As of September 30, 2023, the company had cash and cash equivalents of approximately $1.5 million, short-term deposits of $1.9 million, and marketable debt securities of approximately $9.9 million, totaling approximately $13.4 million[65]. - The accumulated deficit as of September 30, 2023, was approximately $191.0 million, with positive working capital of approximately $12.1 million[64]. Operating Losses and Expenses - The company expects to continue incurring operating losses over the next several years and anticipates needing additional funds to further develop its research and development programs[47]. - General and administrative expenses are anticipated to increase due to costs associated with being a public company and compliance with Nasdaq and SEC requirements[53]. - Research and development expenses are expected to remain the primary expense as the company continues to develop Aramchol, with costs primarily driven by the number and duration of pre-clinical and clinical studies[49]. - Research and development expenses for the three and nine months ended September 30, 2023, were approximately $0.6 million and $2.4 million, representing decreases of 86% and 79% compared to $4.2 million and $11.6 million in the same periods of 2022[57]. - General and administrative expenses for the same periods were approximately $0.9 million and $2.9 million, reflecting decreases of 18% and 19% from $1.1 million and $3.6 million in 2022[59]. - The operating loss for the three and nine months ended September 30, 2023, was approximately $1.5 million and $5.3 million, a decrease of 72% and 65% compared to $5.4 million and $15.2 million in 2022[61]. - The net loss for the three and nine months ended September 30, 2023, was approximately $1.5 million and $4.9 million, representing decreases of 72% and 68% from $5.4 million and $15.2 million in 2022[63]. Cash Flow and Financing - The company experienced negative cash flow from operating activities of approximately $5.2 million for the nine months ended September 30, 2023, compared to negative cash flow of approximately $14.5 million for the same period in 2022[66]. - The company raised approximately $6.2 million in financing activities during the nine months ended September 30, 2023, primarily from a public offering in July 2023[68]. - The company plans to seek additional funding through various means, including debt or equity financings, to support ongoing research and development efforts[70]. Clinical Programs and Strategic Initiatives - The company initiated a new clinical program for Aramchol meglumine targeting Primary Sclerosing Cholangitis (PSC), with an estimated delay of 6-9 months in the initiation of the Phase 2 study due to the ongoing conflict in Israel[43]. - The ARMOR Study for Aramchol has transitioned to an open-label part, and the company does not expect to initiate the second part of the study in the near term[42]. - The company is no longer evaluating strategic alternatives following the initiation of the PSC clinical program and investment in OnKai[45]. - The company entered into a definitive agreement for a $1.5 million equity investment in OnKai Inc., which will enhance its strategic operations in underserved healthcare markets[44]. - The company holds approximately 23.9% of the outstanding share capital of OnKai following the recent investment round[44]. Compliance and Listing Requirements - Nasdaq notified the company on September 22, 2023, that it has 180 days to regain compliance with the minimum bid price requirement of $1.00 per share[82]. - The company must achieve a closing bid price of at least $1.00 for a minimum of 10 consecutive business days to regain compliance by March 18, 2024[82]. - If compliance is not regained by the deadline, the company may be eligible for an additional 180 days under certain conditions[82]. - Failure to meet Nasdaq's continued listing requirements could lead to delisting, negatively impacting the share price and liquidity[83]. - The company cannot assure that actions taken to restore compliance will stabilize the market price or improve liquidity of its ordinary shares[83].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of May 2023 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F GALMED PHARMACEUTICALS LTD. ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCH ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of November 2022 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of August 2022 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Fo ...

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q4 2021 Earnings Conference Call May 2, 2022 8:30 AM ET Company Participants Allen Baharaff - President and CEO Yohai Stenzler - Chief Accounting Officer Conference Call Participants Steven Seedhouse - Raymond James Kristen Kluska - Cantor Fitzgerald Naz Rahman - Maxim Group Operator Good day and welcome to the Galmed Conference Call to discuss Financial Results for the Fourth Quarter and Year-end 2021. Today’s conference is being recorded. Before we begin, please ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of eve ...

Financial Performance - The net loss for the twelve months ended December 31, 2021, was $32.5 million, or $1.32 per share, compared to a net loss of $28.8 million, or $1.35 per share, for the same period in 2020[5]. - Net loss for the year 2021 was $32,467 thousand, an increase of 13.9% compared to a net loss of $28,771 thousand in 2020[14]. - The total operating loss for the twelve months ended December 31, 2021, was $32.9 million, compared to $30.2 million for the same period in 2020[13]. Cash and Cash Equivalents - Cash and cash equivalents, restricted cash, short-term deposits, and marketable debt securities totaled $34.9 million as of December 31, 2021, down from $51.0 million as of December 31, 2020[10]. - Cash and cash equivalents at the end of 2021 decreased to $2,998 thousand from $7,060 thousand at the end of 2020, representing a decline of 57.5%[14]. - Total cash received from interest in 2021 was $562 thousand, down from $1,192 thousand in 2020, indicating a decline of 52.8%[14]. Research and Development - For the three months ended December 31, 2021, research and development expenses totaled $6.3 million, a decrease from $9.0 million for the same period in 2020[4]. - Research and development expenses for the twelve months ended December 31, 2021, were $27.2 million, compared to $26.1 million for the same period in 2020[5]. - The company is currently in a Phase 3 registrational study for its lead compound, Aramchol, targeting NASH and fibrosis[8]. General and Administrative Expenses - General and administrative expenses for the twelve months ended December 31, 2021, were $5.7 million, an increase from $4.1 million for the same period in 2020[4]. Financial Activities - Net cash used in operating activities for 2021 was $32,892 thousand, up from $26,287 thousand in 2020, reflecting a 25.2% increase[14]. - Net cash provided by investing activities in 2021 was $11,462 thousand, a decrease from $16,536 thousand in 2020[14]. - The company raised $8,147 thousand from the issuance of ordinary shares in an at-the-market offering in 2021[14]. - Proceeds from the sale of securities available for sale in 2021 amounted to $21,243 thousand, compared to $47,198 thousand in 2020, a decrease of 55.0%[14]. Other Financial Metrics - Financial income, net for the twelve months ended December 31, 2021, amounted to $0.4 million, down from $1.4 million for the same period in 2020[10]. - The company reported a depreciation and amortization expense of $42 thousand in 2021, slightly up from $39 thousand in 2020[14]. - Stock-based compensation expense for 2021 was $1,886 thousand, a decrease from $2,066 thousand in 2020[14]. - The company experienced a decrease in trade payables by $2,175 thousand in 2021, contrasting with an increase of $1,047 thousand in 2020[14]. Assets - Total assets decreased to $36.6 million as of December 31, 2021, from $52.4 million as of December 31, 2020[12].