RegeneRx Receives Non-compliance Notice from NYSE Amex; Intends to Request Hearing
02 11월 2010 - 5:30AM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (the
“Company” or “RegeneRx”) announced today that on October 26, 2010,
the Company was notified by the Compliance Staff (“Staff”) of the
NYSE Amex LLC (the “Exchange”) that the Company has not timely
regained compliance with Section 1003(a)(iii) of the Exchange’s
Company Guide due to stockholders’ equity of less than $6,000,000.
As a result, the notice indicated that the Company’s securities are
subject to delisting from the Exchange unless the Company requests
a hearing before the Exchange’s Listing Qualifications Panel (the
“Panel”). As previously disclosed, by letter dated June 24, 2009,
the Staff granted the Company’s request for an extension to
evidence compliance with the Exchange’s stockholders’ equity
requirement through October 25, 2010.
RegeneRx intends to request a hearing before the Panel at which
it will request continued listing pending its return to compliance.
Based on the hearing request, it is expected that the Company’s
securities will remain listed and eligible for trading on the
Exchange until the Panel renders a decision following the hearing.
However, there can be no assurance that following the hearing the
Panel will grant the Company’s request for continued listing on the
Exchange.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic
peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection,
repair and regeneration. RegeneRx currently has three products
in clinical development.
RGN-352 is an injectable formulation to treat cardiovascular and
central nervous system diseases, as well as other medical
indications. RegeneRx is initially targeting RGN-352 for the
treatment of patients who have suffered an acute myocardial
infarction, or heart attack. Recent pre-clinical efficacy data
suggests that RGN-352 may also benefit patients with multiple
sclerosis and stroke. RegeneRx has successfully completed a Phase 1
clinical trial with RGN-352 in which the drug candidate was found
to be safe and well-tolerated. The company has initiated a Phase 2
clinical trial and expects to enroll the first patient by early
2011 at approximately 25 clinical sites in the U.S., Israel, and
Russia. RegeneRx is also supporting a Phase 1/2 physician-sponsored
clinical trial in patients with multiple sclerosis that is expected
to begin in early 2011. RegeneRx recently received a $3 million,
three-year development grant from the NIH to support the company’s
acute myocardial infarction program.
RGN-259 is a sterile, preservative-free topical eye drop for
ophthalmic indications. Based on recent human clinical data,
RegeneRx is currently supporting a physician-sponsored Phase 2 dry
eye study with RGN-259. Previously, seven patients with non-healing
corneal ulcers were treated with RGN-259 under compassionate use
INDs. Five had complete healing and two had substantial healing of
their wounds. Three additional patients with corneal defects,
called punctate keratitis, had no evidence of healing although they
did report reduction in eye inflammation and increased comfort.
RGN-137, a topical gel formulation, is currently being evaluated
by RegeneRx in a Phase 2 clinical trial for the treatment of the
orphan skin disease epidermolysis bullosa. Other potential uses for
RGN-137 include the treatment of chronic dermal wounds and
reduction of scar tissue. RegeneRx previously received $675,000 in
grants from the U.S. FDA to support this clinical trial.
The Company was awarded $733,438 under HR: 3590 – Patient
Protection and Affordable Care Act for development of these three
formulations discussed above. In addition to the pharmaceutical
product candidates described above, RegeneRx is pursuing the
commercial development of peptide fragments of Tβ4 for potential
cosmeceutical use. RegeneRx holds 75 issued patents and has 261
patent applications pending worldwide related to its products and
holds an exclusive worldwide license for Tβ4 from the National
Institutes of Health.
Forward-Looking
Statements
Any statements in this press release that are not historical
facts are forward-looking statements made under the provisions of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve risks and uncertainties that
could cause actual results to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. You are urged to consider
statements that include the words “plan,” “expect,” “intend,”
“will,” ”may,” or the negative of those words, or other similar
expressions or words, to be uncertain and forward-looking. Factors
that may cause actual results to differ materially from any future
results expressed or implied by any forward-looking statements
include the risk that we may not be successful in maintaining the
listing of our securities on the NYSE Amex and other risks and
uncertainties inherent in our business, including, without
limitation, the risk that our product candidates do not demonstrate
safety and/or efficacy in future clinical trials; risks related to
our ability to obtain financing to support our operations on
commercially reasonable terms; the progress, timing or success of
our clinical trials; difficulties or delays in development,
testing, obtaining regulatory approval for producing and marketing
our product candidates; regulatory developments; the size and
growth potential of the markets for our product candidates and our
ability to serve those markets; the scope and validity of patent
protection for our product candidates; competition from other
pharmaceutical or biotechnology companies; and other risks
described in the Company’s filings with the Securities and Exchange
Commission (“SEC”), including those identified in the “Risk
Factors” section of the annual report on Form 10-K for the year
ended December 31, 2009, and the quarterly report on Form 10-Q for
the quarter ended June 30, 2010, as well as other filings it makes
with the SEC. Any forward-looking statements in this press release
represent the Company’s views only as of the date of this release
and should not be relied upon as representing its views as of any
subsequent date. The Company anticipates that subsequent events and
developments may cause its views to change, and the Company
specifically disclaims any obligation to update this information,
as a result of future events or otherwise, except as required by
applicable law.
Regenerx Biopharm In (AMEX:RGN)
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Regenerx Biopharm In (AMEX:RGN)
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