Protalix BioTherapeutics Receives Listing Deficiency Letter from NYSE American
August 30 2019 - 4:15PM
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX),
a biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins including a
late-stage clinical product expressed through its proprietary plant
cell-based expression system, ProCellEx®, today announced that it
received a deficiency letter from NYSE American LLC (the “NYSE
American”) stating that the Company is not in compliance with the
continued listing standards as set forth in Section 1003(a)(i) –
(iii) of the NYSE American Company Guide (the “Company Guide”) as
it has reported a stockholders’ equity deficiency as of
June 30, 2019 and net losses in its five most recent fiscal
years ended December 31, 2018.
The letter has no immediate effect on the listing
of the Company’s common stock on the NYSE American. The
Company’s common stock will trade on the NYSE American while it
regains compliance with the continued listing standards.
Consistent with the rules set forth in the Company Guide, the
Company intends to submit a detailed plan of compliance advising
the NYSE American of the actions the Company has taken, or plans to
take, that would bring it into compliance with the continued
listing standards within 18 months of receipt of the letter.
“The new management team leading Protalix continues to review
the capital structure very carefully and is working diligently to
address the NYSE American’s requirements,” said Dror Bashan,
Protalix’s President and Chief Executive Officer. “Protalix
is evaluating and pursuing strategic alternatives to maximize
shareholder value through financing and partnerships.”
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based
expression system, ProCellEx®. Protalix’s unique expression
system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale manner.
Protalix’s first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the U.S. Food and Drug
Administration (FDA) in May 2012 and, subsequently, by the
regulatory authorities of other countries. Protalix has
licensed to Pfizer Inc. the worldwide development and
commercialization rights for taliglucerase alfa, excluding Brazil,
where Protalix retains full rights. Protalix’s development
pipeline includes the following product candidates: pegunigalsidase
alfa, a modified version of the recombinant human alpha-GAL-A
protein for the treatment of Fabry disease, which is currently in a
Phase 3 clinical trial (BALANCE study); and OPRX-106, an orally
delivered anti-inflammatory treatment and alidornase alfa for the
treatment of Cystic Fibrosis, both in Phase 2 clinical
trials. Protalix has partnered with Chiesi Farmaceutici
S.p.A., both in the United States and outside the United States,
for the development and commercialization of pegunigalsidase
alfa.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms “expect,”
“anticipate,” “believe,” “estimate,” “project,” “plan,” “should”
and “intend” and other words or phrases of similar import are
intended to identify forward-looking statements. These
forward-looking statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and
results to differ materially from the statements made. These
statements are based on our current beliefs and expectations as to
such future outcomes. Drug discovery and development involve
a high degree of risk and the final results of a clinical trial may
be different than the preliminary findings for the clinical
trial. Factors that might cause material differences include,
among others: risks related to our ability to identify and complete
strategic alternatives on attractive terms or at all within the
time period required to regain compliance with the continued
listing standards of the NYSE American; risks related to our
ability to continue as a going concern absent a refinancing or
restructuring; risks related to any transactions we may effect in
the public or private equity markets to raise capital to finance
future activities; failure or delay in the commencement or
completion of our preclinical and clinical trials which may be
caused by several factors, including: risks that the FDA will not
accept an application for accelerated approval of PRX-102 with the
data generated to date or will request additional data or other
conditions of our submission of any application for accelerated
approval of PRX-102; risks related to our ability to continue as a
going concern absent access to sources of capital we will need to
finance future research and development activities, general and
administrative expenses and working capital; risks related to any
capital raising transactions we may effect in the public or private
equity markets to raise capital to finance future research and
development activities, general and administrative expenses and
working capital; slower than expected rates of patient recruitment;
unforeseen safety issues; determination of dosing issues; lack of
effectiveness during clinical trials; inability to monitor patients
adequately during or after treatment; inability or unwillingness of
medical investigators and institutional review boards to follow our
clinical protocols; and lack of sufficient funding to finance
clinical trials; the risk that the results of the clinical trials
of our product candidates will not support our claims of
superiority, safety or efficacy, that our product candidates will
not have the desired effects or will be associated with undesirable
side effects or other unexpected characteristics; risks related to
our ability to maintain and manage our relationship with Chiesi
Farmaceutici and any other collaborator, distributor or partner;
risks related to the amount and sufficiency of our cash and cash
equivalents; risks related to the ultimate purchase by Fundação
Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase
intentions of the Brazilian Ministry of Health of the stated
amounts, if at all; risks related to the successful conclusion of
our negotiations with the Brazilian Ministry of Health regarding
the purchase of alfataliglicerase generally; risks related to our
commercialization efforts for alfataliglicerase in Brazil; risks
relating to the compliance by Fundação Oswaldo Cruz with its
purchase obligations and related milestones under our supply and
technology transfer agreement; risks related to the amount and
sufficiency of our cash and cash equivalents; risks related to the
amount of our future revenues, operations and expenditures; the
risk that despite the FDA’s grant of fast track designation for
pegunigalsidase alfa for the treatment of Fabry disease, we may not
experience a faster development process, review or approval
compared to applications considered for approval under conventional
FDA procedures; risks related to the FDA’s ability to withdraw the
fast track designation at any time; risks relating to our ability
to make scheduled payments of the principal of, to pay interest on
or to refinance our outstanding notes or any other indebtedness;
our dependence on performance by third party providers of services
and supplies, including without limitation, clinical trial
services; delays in our preparation and filing of applications for
regulatory approval; delays in the approval or potential rejection
of any applications we file with the FDA or other health regulatory
authorities, and other risks relating to the review process; our
ability to identify suitable product candidates and to complete
preclinical studies of such product candidates; the inherent risks
and uncertainties in developing drug platforms and products of the
type we are developing; the impact of development of competing
therapies and/or technologies by other companies and institutions;
potential product liability risks, and risks of securing adequate
levels of product liability and other necessary insurance coverage;
and other factors described in our filings with the
U.S. Securities and Exchange Commission. The statements
in this press release are valid only as of the date hereof and we
disclaim any obligation to update this information, except as may
be required by law.
Investor Contact
Alan Lada, Vice President Solebury Trout
617-221-8006alada@soleburytrout.com
Media Contact
Doug Russell
LaVoieHealthScience617-953-0120drussell@lavoiehealthscience.com
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