This collaboration presents a promising opportunity to foster mutual between Galmed, its main sites and applicable clinics in underserved communities.
Noam Smetana, CEO of OnKai, commented, “I am excited about the possibility that this cutting-edge partnership will definitely have an effect on America’s underserved communities for years to come. We believe that our assignment with Galmed, as well as others at other stages of our portfolio, will particularly promote equity in physical exercise within the network of clinics with which we collaborate.
Allen Baharaff, CEO and President of Galmed Pharmaceuticals, said, “We are excited to use OnKai’s revolutionary AI generation in our trial. The application of OnKai’s AI platform is still emerging, but it is potentially disruptive for clinical trial conduct. Not only does this partnership allow us to have a diverse population in our trials, but it is also expected to result in faster approval and higher throughput. “
About Galmed Pharmaceuticals Ltd.
We are a clinical-stage biopharmaceutical company focusing on the progression of Aramchol to liver and fibroinflammatory diseases. We have focused almost exclusively on the progression of Aramchol for the treatment of NASH and are recently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibroinflammatory indications outside of liver disease. We also participated with the Hebrew University in the progression of Amyl-fiveMER, an artificial five-amino acid peptide.
Forward-Looking Statements:
Forward-looking statements relate to events, activities, trends or effects expected or expected as of the date they are made. Because forward-looking statements address matters that have not yet occurred, such statements are inherently related to dangers and uncertainties that may also cause our actual effects to differ materially from any long-term effects expressed or implied by forward-looking statements. Many items may also cause our actual activities or effects to differ materially from the activities and effects expected in the forward-looking statements, including, without limitation, our ability to identify, compare and complete any strategic opportunities that generate value for our shareholders; the schedule and charge for any preclinical or clinical trials, for our product applicants; the auction and reception of favorable effects of any preclinical or clinical trial; regulatory action related to Aramchol or any other product candidate through the US Food and Drug Administration, FDA, European Medicines Authority, or EMA, including, but not limited to, acceptance of a marketing authorization application, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the long-term sales and advertising pitch of Aramchol and any long-term product applicants; our ability to comply with all applicable post-market regulatory needs of Aramchol or any other product applicant in the countries in which we seek to market the product; our ability to discharge favorable charges for Aramchol or any other applicant for products; our expectations related to the non-alcoholic steatohepatitis, or NASH, ad market in patients or any other specific indication; reimbursement through a third party payer for Aramchol or any other candidate product; our estimates of anticipated capital needs and our need for additional financing; Advertising adoption of Aramchol or any other soliciting product through physicians and patients; the timing, title, or other facets of Aramchol’s or any other product applicant’s ad launch; our ability to download and maintain good enough coverage for our intellectual assets; the option that we may face claims of infringement of third party intellectual assets; our ability to manufacture our applicant products in advertised quantities, of sufficient quality or at the right price; our ability to identify good enough sales, marketing and distribution channels; intense festival in our industry, with a competition that has particularly greater financial, technological, research and progression, regulatory and clinical, manufacturing, market placement and sales, distribution and workforce resources than we do; the progression and approval for the use of Aramchol or any other applicant product for additional indications or in mixed therapy; our ability to maintain our regular inventory directory on the Nasdaq capital markets; and our expectations related to licences, acquisitions and strategic transactions. To us, those forward-looking statements are reasonable; however, such statements are only actual predictions and are subject to known and unknown dangers, uncertainties, and other issues that may also cause our or our industry’s actual effects, levels of activity, functionality, or achievements to differ materially from those expected by forward-looking statements. We discuss many of those dangers in our Annual Report on Form 20-F for the fiscal year ended December 31, 2022 filed with the SEC on March 29, 2023 in more detail under the heading “Risk Factors. ” Given those uncertainties, you deserve not to rely on forward-looking statements as predictions of long-term 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. We do not assume any legal responsibility to update or revise forward-looking statements to reflect events or events subsequent to the date they are made or to reflect the occurrence of unforeseen events. When comparing forward-looking statements, you deserve to be aware of those dangers and uncertainties.
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SOURCE Galmed Pharmaceuticals Ltd.
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