Protalix BioTherapeutics Focuses on Evaluating and Pursuing Alternatives to Maximize Shareholder Value through Refinancing & ...
August 22 2019 - 8:45AM
Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE:
PLX), a biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins expressed
through its proprietary plant cell-based expression system,
ProCellEx®, today announced that it has engaged a first-tier
financial advisory firm to assist the Company in evaluating and
pursuing strategic alternatives to maximize stakeholder value.
Dror Bashan, Protalix’s President and Chief
Executive Officer commented, “We have three key initiatives as a
management team which include improving our capital structure,
pursuing strategic partnerships and alliances and actively moving
our pipeline toward commercialization.” The Company also
reported that it is actively pursuing potential partnering
discussions for its other pipeline candidates, OPRX-106, an
orally-delivered anti-inflammatory treatment, and alidornase alfa,
a modified form of recombinant DNase (rhDNASE), as well as
partnerships with other company’s compounds combined with
Protalix’s ProCellEx® platform.
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; OPRX-106, an
orally-delivered anti-inflammatory treatment; alidornase alfa for
the treatment of Cystic Fibrosis; and others. 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 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
617-221-8006 alada@soleburytrout.com
Media Contact
Doug Russell
LaVoieHealthScience617-953-0120drussell@lavoiehealthscience.com
Source: Protalix BioTherapeutics,
Inc.
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