TEL
AVIV, Israel, Dec. 14,
2022 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a biopharmaceutical
company focused on the development of Aramchol and Amilo-5MER,
announced today that on December 13, 2022, it received a
letter from The Nasdaq Stock Market LLC ("Nasdaq"), notifying the
Company that it is eligible for an additional 180 calendar day
period, or until June 12, 2023, to regain compliance with the
Nasdaq's minimum $1 bid price per share requirement.
The Company was first notified by Nasdaq of its failure to
maintain a minimum bid price of $1 per share for 30
consecutive trading days under Nasdaq Listing Rule 5550(a)(2) on
June 17, 2022, and was given until
December 12, 2022 to regain
compliance. The Company did not regain compliance with the minimum
$1 bid price per share requirement
during the first 180-calendar-day compliance period and submitted a
written request to the Staff to afford it an additional 180-day
compliance period to cure the deficiency .
If at any time before June 12, 2023, the bid price of the
Company's ordinary shares closes at or above $1 per share
for a minimum of 10 consecutive trading days, the Company will
regain compliance with the Nasdaq Listing Rules, and the matter
will be closed.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a biopharmaceutical company
focused on the development of Aramchol. Historically, Galmed has
focused almost exclusively on developing Aramchol for the treatment
of liver disease. Galmed is also collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide.
Cautionary Note Regarding Forward-Looking Statements
This press release 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 U.S. Securities and Exchange
Commission (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 timing and cost of our any pre-clinical or
clinical trial, for our product candidates;completion and receiving
favorable results of any pre-clinical or clinical trial;the impact
of the COVID-19 pandemic on our operations;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;our
expectations regarding the commercial market for non-alcoholic
steato-hepatitis, or NASH, in patients or any other targeted
indication;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;the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy;our ability to maintain the listing of
our ordinary share on The Nasdaq Capital Market; andour
expectations regarding licensing, acquisitions and strategic
operations.
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, 2021
filed with the SEC on May 2, 2022 in
greater detail under the heading "Risk Factors" and elsewhere in
the Annual Report, in our Reports on Form 6-K filed with the SEC on
August 4, 2022 and November 16, 2022 and this press release. 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.