Galmed Pharmaceuticals Ltd.
For the period ended Jul 8, 2026. Filed Jul 8, 2026.
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Jul 8, 2026 · Filed Jul 8, 2026
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Contents
Cautionary Note Regarding Forward-Looking Statements
This Form 6-K contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,” “project,” “forecast,” “continue” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included in, among other things, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below:
| ● | our ability to pursue, evaluate and complete any strategic alternative that yields value for our shareholders; |
| ● | 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; |
| ● | our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; |
| ● | 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 recognize the anticipated benefits of the acquisition of Colospan Ltd., or Colospan; |
| ● | expectations with respect to future performance and growth of Colospan |
| ● | Galmed’s and Colospan’s ability to execute our business plans and strategy and to receive regulatory approvals; |
| ● | 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” in our Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 31, 2026. |
We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 31, 2026, in greater detail under the heading “Risk Factors” and elsewhere in the Annual Report and this Form 6-K. In addition, additional risk factors relating to the business of Colospan, which we acquired on June 22, 2026 are included in the section entitled “Risk Factors” in our Report on Form 6-K filed with the SEC on June 8, 2026. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events.
All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this Report on Form 6-K. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.