Protalix Announces Exchange and Discharge of Remaining 2018 Notes
May 24 2018 - 7:00AM
Protalix BioTherapeutics, Inc. (the “Company”) (NYSE American:PLX)
(TASE:PLX) announced today that $3.42 million of the aggregate
principal amount of the Company’s outstanding 4.5% Convertible
Senior Notes due 2018 (the “Notes”) will be exchanged for 2,613,636
shares of the Company’s common stock and $2.27 million in
cash. Additionally, the Company announced today that it has
delivered the necessary funds under the indenture governing the
Notes to effectively discharge the remaining outstanding
Notes. Additional details regarding the exchange can be found
in the Company’s Form 8-K to be filed with the Securities and
Exchange Commission.
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 entered into an ex-United States
partnership with Chiesi Farmaceutici S.p.A. for the development and
commercialization of pegunigalsidase alfa. Protalix maintains
full rights to pegunigalsidase alfa in the United States.
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. Factors that might cause material differences
include, among others: failure or delay in the commencement or
completion of our preclinical and clinical trials which may be
caused by several factors, including: 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 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; risks related to our ability
to maintain and manage our relationship with Chiesi Farmaceutici
and any other collaborator, distributor or partner; 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; 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
Marcy NanusSolebury Trout 646-378-2927
mnanus@soleburytrout.com
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