Full Press Release Details
Announces Grant of New Use Patents for the combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH
new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO),
Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042.
is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies.
excellent safety and tolerability is a perfect drug candidate to be combined with other MASH drugs, approved or in development.
Israel, Dec. 4, 2025 /PRNewswire/ - Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"),
a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today the grant
of a new Use Patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Rezdiffra
(MGL-3196, resmetirom) for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis
(MASH), and liver fibrosis in South Korea.
Galmed announced the grant of new use patent for a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom)
for MASH. The new patent extends Aramchol's patent protection worldwide to July 2042, strengthening its leadership in NASH/MASH
combination therapy.
patent grant comes at a pivotal moment in the NASH/MASH field, as the industry shifts toward combination therapies to address this complex
disease. As commercial interest in MASH is surging, with the limited mild to moderate efficacy demonstrated by monotherapies, initiation
of combination MASH clinical studies is necessary and imminent. We believe Aramchol's excellent safety and tolerability is a perfect
drug candidate to be combined with other MASH drugs, approved or in development. The grant of the Aramchol - Rezdiffra new patent
is an important step towards the advancement in this direction," said Allen Baharaff, CEO of Galmed Pharmaceuticals.
Galmed Pharmaceuticals Ltd.:
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are
also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth
strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic
indications and other innovative product candidates that align with our core expertise in drug development.
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. Forward-looking
statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga and
Metformin as a new fixed-dose combination treatment, how such 3-drug combination could potentially become a life-cycle IP strategy, the
expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. 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 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; the security, political and economic instability in the Middle East
that could harm our business, including due to the current security situation in Israel, risks relating to our digital asset management
strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price
may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition
in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty
regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign
tax purposes and those risks and uncertainties identified in Exhibit 99.2 to our Report of Foreign Private Issuer on Form 6-K filed with
the Securities and Exchange Commission ("SEC") on August 25, 2025. 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, 2024, filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." 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. 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.
further information: investor.relations@galmedpharma.com, +972-3-693-8448