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.investorroom.com/sec-filings.
Shareholders can obtain copies of Galmed's Annual Report on Form
20-F, free of charge, by making a request within a reasonable
period of time to Galmed's Investor Relations Department
at investor.relations@galmedpharma.com.
Galmed Pharmaceuticals Ltd.
We are a clinical stage biopharmaceutical company focused on the
development of Aramchol for liver and fibro-inflammatory diseases.
We have focused almost exclusively on developing Aramchol for the
treatment of NASH and are currently developing Aramchol for PSC and
exploring the feasibility of developing Aramchol for other
fibro-inflammatory indications outside of liver disease. We are
also collaborating with the Hebrew
University in the development of Amilo-5MER, a 5 amino acid
synthetic peptide.
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 our objectives plans
and strategies, as well as statements, other than historical facts,
that address activities, events or developments that we intend,
expect, project, believesor anticipate will or may occur in the
future. 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, our ability to pursue, evaluate and complete any
strategic alternative that yields value for our shareholders; the
timing and cost of our planned Primary Sclerosing Cholangitis, or
PSC, clinical trial and our pivotal Phase 3 ARMOR trial, or the
ARMOR Study, if re-initiated, for our product candidates, Aramchol
and Amilo-5MER, or for any other pre-clinical or clinical trials;
completion and receiving favorable results of our planned PSC
clinical trial and the ARMOR Study (if re-initiated) for Aramchol
or any other 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 FDA, the European Medicines Authority,
or EMA, or the Medicines and Healthcare Products Regulatory Agency,
or the MHRA, 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, Amilo-5MER or any other product candidate in the
countries in which we seek to market the product; our ability to
achieve favorable pricing for Aramchol, Amilo-5MER or any other
product candidate; our expectations regarding the commercial market
for PSC, non-alcoholic steato-hepatitis, or NASH (also known as
MASH), in patients or any other targeted indication; third-party
payor reimbursement for Aramchol, Amilo-5MER 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; the development and approval of the use of Aramchol or any
other product candidate for additional indications or in
combination therapy; 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 recent attacks
by Hamas and other terrorist organizations from the Gaza Strip and elsewhere in the region and
Israel's war against them and
military hostilities with Hezbollah on the northern border of
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, 2023 filed with the SEC
on April 4, 2024 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.
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SOURCE Galmed Pharmaceuticals Ltd.
