Exhibit
99.1
Galmed
Announces the Breakthrough Development of a Brain Penetrating New Formulation of its SCD1 inhibitor, Aramchol
| ● | 98%
of drugs do not reach the brain, as the blood–brain barrier (BBB) separates peripheral
blood circulation from the central nervous system (CNS). |
| | | |
| ● | Galmed
has developed, in collaboration with Barcode Nanotech, a unique proprietary formulation of
Aramchol which targets the brain. By crossing the BBB, this new Aramchol formulation could
become a disease modifying therapy for unmet chronic CNS diseases. |
| | | |
| ● | Stearoyl-CoA
desaturase (SCD1) has been identified as an important therapeutic target for CNS diseases
(Parkinson disease and dementia) which are characterized by the aggregation of the protein
α-synuclein (αSyn). In-vitro studies have demonstrated that Aramchol effectively
down-regulated αSyn-aggregation in a dose dependent manner. |
Ramat-Gan,
Israel, April 09, 2026 /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 breakthrough
development of a brain penetrating new formulation of Aramchol. Crossing of the blood-brain barrier (BBB) is an essential step to achieve
effective treatment effects in Parkinson disease (PD) and other CNS diseases. The new Aramchol formulation is characterized by sequestration
of the Aramchol in lipid nanoparticles which will be administered by subcutaneous injection for delivery across the BBB.
This
new Aramchol formulation was co-developed by Galmed and Barcode Nanotech, based on Barcode Nanotech’s unique and proprietary platform
which enables simultaneous screening of hundreds of different nanoparticle formulations in vivo, coupled with AI analysis tools to select
the optimal delivery vehicle to the brain.
There
are currently no disease-modifying therapies available for treatment of PD or related synucleinopathies such as multiple systems atrophy
(MSA) and dementia with Lewy bodies (DLB). These diseases are each characterized by presence of Lewy bodies enriched in αSyn protein
and are thus collectively known as synucleinopathies. Recent evidence from cell-based screens of αSyn toxicity has identified stearoyl-CoA
desaturase 1 (SCD1) as a potential target for treatment of synucleinopathies.
Based
on the evidence for the role of SCD1 inhibition in mitigating synucleinopathies, Galmed’s breakthrough medicinal chemistry work
converting Aramchol into a brain-penetrant SCD1 inhibitor position Aramchol as an attractive therapeutic asset for synucleinopathies
such as Parkinson disease, multiple systems atrophy (MSA), dementia and other CNS indications of unmet need.
Allen
Baharaff, Galmed’s Co-founder and CEO commented: “The largest challenge in developing innovative CNS therapeutics is delivering
these molecules to the brain. I am excited to report today the fruits of our collaboration with Barcode Nanotech, advancing our lead
compound Aramchol as a first in class brain penetrating SCD1 inhibitor. Based on our preliminary in-vitro data which demonstrated that
Aramchol dose-dependently down-regulated αSyn-aggregation as well as indicating that the treatment was not associated with toxicity,
we believe that treatment with Aramchol could prevent the pathophysiological cascade that leads to αSyn-aggregation which induces
a chronic inflammatory state that is associated with PD disease progression and severity. Subject to the regulatory advice we are now
seeking, we are planning to advance Aramchol to a PoC Ph1b/2 studies in PD patients in H2 2026”.
Ronen
Eavri Co-founder & CEO of Barcode Nanotech commented: “Barcode Nanotech has developed a library of novel lipids for RNA and
DNA, LNP-based delivery, through a unique in vivo & AI-based screening platform which allow simultaneously screening of hundreds
of different nanoparticle formulations. Based on our proprietary platform and lipids library we have identified a unique formulation
of Aramchol to cross the BBB and deliver the molecule to the brain. We look forward to continuing our collaboration with Galmed to develop
target-specific selective delivery vehicles of Aramchol to enable precise target-site activity and release of this promising drug”.
About
Galmed Pharmaceuticals Ltd.:
We
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.
About
Barcode Nanotech Ltd.:
Barcode
Nanotech develops delivery solutions for RNA & DNA therapies through a unique multiplexed discovery platform. The Company’s
proprietary NeoRNATM Targeting Technology enables efficient discovery and optimization of lipid-based nanoparticles (LNPs)
through in silico & in vivo mass-screening. The solution combines the design of thousands of new lipids and LNPs, advanced
AI tools and in vivo barcoding-based biodistribution analysis at a single cell resolution. Using this platform, Barcode has developed
unique LNPs that can direct RNA and other therapies to cells in the brain, kidney, lungs and additional target organs. The company has
an in-house lead drug development program and concurrently collaborates with biopharma companies to develop new therapies.
Forward-Looking
Statements:
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. 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, 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; and the security, political
and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel.
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.” 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.
CONTACT:
Galmed Pharmaceuticals Ltd.; investor.relations@galmedpharma.com +972-3-693-8448
