NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90)
(“
NurExone” or the “
Company”) is
pleased to announce the formation of a U.S.-based subsidiary,
Exo-Top Inc. (“
Exo-Top”), that is expected to
advance good manufacturing practice (“
GMP”), fully
characterized exosome production. The establishment of Exo-Top is a
key step towards an independent and scalable supply of high-quality
exosomes for the Company’s future nanodrug pipeline and
collaboration opportunities following NurExone’s acquisition of a
Master Cell Bank (“
MCB”) of Mesenchymal Stem Cells
(“
MSC”).
Exosomes are increasingly recognized as a
revolutionary drug delivery system with inherent therapeutic
effects and capable of transporting therapeutic molecules -
including ribonucleic acid, proteins, and small molecules -
directly to target cells with high precision and minimal
invasiveness.1 The exclusive MCB provides Exo-Top with a
sustainable, cost-effective, and unique source of exosome-producing
cells, a foundation for the production of fully characterized
GMP-grade exosomes.
In addition to supporting NurExone’s internal
drug development efforts, Exo-Top will be positioned to supply
high-quality exosomes to other pharmaceutical companies, biotech
firms, and researchers worldwide, opening additional revenue
streams for the Company. By supplying GMP-grade exosomes for drug
delivery research and existing, non-U.S. Food and Drug
Administration (“FDA”)-regulated therapeutic or
cosmetic applications, Exo-Top creates new market opportunities
while advancing the broader adoption of MSC-based exosomes as a
transformative drug delivery system and a potentially regenerative
treatment via NurExone’s ExoTherapy platform.
The acquisition of the MCB and the formation of
Exo-Top will give NurExone greater control over its exosome
production process. Unlike companies that depend on third-party
cell sources, Exo-Top will operate independently, without external
licensing or royalty obligations, ensuring cost efficiency and
strategic flexibility as NurExone advances its development
pipeline.
Dr. Lior Shaltiel, CEO of NurExone commented:
“exosomes are rapidly emerging as the next frontier in drug
delivery and regenerative medicine, with the potential to transform
treatments for neurological disorders, oncology, longevity and
beyond. Establishing Exo-Top anchors our supply chain, accelerates
our drug development, and creates business opportunities through
exosome commercialization.”
Eran Ovadya, CFO of NurExone, added: “as part of
our growth strategy, we also plan to pursue an uplisting from the
OTC to a major U.S. exchange, subject to requisite regulatory
approval, to strengthen our market position and broaden investor
access.”
Exo-Top was established under the jurisdiction
of the State of Nevada. Basing Exo-Top in the U.S. offers key
advantages, including proximity to strategic partners, access to a
robust biopharma ecosystem, and increased market opportunities.
The Company will provide further updates as it
progresses with the formation and long-term production strategy of
Exo-Top.
About NurExone
NurExone Biologic Inc. is a TSX Venture Exchange
(“TSXV”) and OTCQB listed pharmaceutical company
that is developing a platform for biologically guided exosome-based
therapies to be delivered, minimally invasive, to patients who have
suffered Central Nervous System injuries. The Company’s first
product, ExoPTEN for acute spinal cord injury, was proven to
recover motor function in 75% of laboratory rats when administered
intranasally. ExoPTEN has been granted Orphan Drug Designation by
the FDA and European agency, European Medicines Agency. The
NurExone platform technology is expected to offer novel solutions
to drug companies interested in minimally invasive targeted drug
delivery for other indications.
For additional information and a brief
interview, please watch Who is NurExone?,
visit www.nurexone.com or follow NurExone
on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior ShaltielChief Executive Officer and
DirectorPhone: +972-52-4803034Email: info@nurexone.com
Oak Hill Financial Inc.2 Bloor Street, Suite
2900Toronto, Ontario M4W 3E2Investor Relations -
CanadaPhone:
+1-647-479-5803Email: info@oakhillfinancial.ca
Dr. Eva ReuterInvestor Relations -
GermanyPhone:
+49-69-1532-5857Email: e.reuter@dr-reuter.eu
Allele Capital PartnersInvestor Relations -
USPhone: +1
978-857-5075Email: aeriksen@allelecapital.com
FORWARD-LOOKING STATEMENTS
This press release contains certain
“forward-looking statements” that reflect the Company’s current
expectations and projections about its future results. Wherever
possible, words such as “may”, “will”, “should”, “could”, “expect”,
“plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or
“potential” or the negative or other variations of these words, or
similar words or phrases, have been used to identify these
forward-looking statements. Forward-looking statements in this
press release include, but are not limited to, statements relating
to: the intended benefits of Exo-Top’s establishment and the
acquisition of the MCB on the Company and its business; the Company
advancing its revenue-generating and collaboration opportunities;
the Company being able to produce, supply and commercialize
exosomes; the Company’s products being used for patient treatment;
broader adoption of exosomes in the field and cell therapy
applications; the Company’s future plans and expectations; NurExone
advancing its development pipeline; the Company’s plan to pursue an
uplisting and the benefits thereof; receipt of all requisite
regulatory approval; the Company providing further updates on
Exo-Top; and the NurExone platform technology offering novel
solutions to drug companies interested in minimally invasive
targeted drug delivery for other indications.
These statements reflect management’s current
beliefs and are based on information currently available to
management as at the date hereof. In developing the forward-looking
statements in this press release, we have applied several material
assumptions, including: Exo-Top’s establishment and the acquisition
of the MCB will have its intended benefits on the Company and its
business; the Company will advance its revenue-generating and
collaboration opportunities; the Company will be able to produce,
supply and commercialize exosomes; the Company’s products will be
used for patient treatment; there will be broader adoption of
exosomes in the field and cell therapy applications; the Company
will realize its future plans and expectations; the Company will
uplist to a major U.S. exchange and realize on the benefits
thereof; the Company will provide further updates on Exo-Top; the
Company will receive all requisite regulatory approval; and the
NurExone platform technology will offer novel solutions to drug
companies interested in minimally invasive targeted drug delivery
for other indications.
Forward-looking statements involve significant
risk, uncertainties and assumptions. Many factors could cause
actual results, performance or achievements to differ materially
from the results discussed or implied in the forward-looking
statements. These risks and uncertainties include, but are not
limited to risks related to: the Company’s early stage of
development; lack of revenues to date; government regulation;
market acceptance for its products; rapid technological change;
dependence on key personnel, and on the Company’s strategic
partners; the fact that preclinical drug development is uncertain,
and the drug product candidates of the Company may never advance to
clinical trials; the fact that results of preclinical studies and
early-stage clinical trials may not be predictive of the results of
later stage clinical trials; the uncertain outcome, cost, and
timing of product development activities, preclinical studies and
clinical trials of the Company; the uncertain clinical development
process, including the risk that clinical trials may not have an
effective design or generate positive results; the inability to
obtain or maintain regulatory approval of the drug product
candidates of the Company; the introduction of competing drugs that
are safer, more effective or less expensive than, or otherwise
superior to, the drug product candidates of the Company; the
initiation, conduct, and completion of preclinical studies and
clinical trials may be delayed, adversely affected or impacted by
unforeseen issues; the inability to obtain or maintain intellectual
property protection for the drug product candidates of the Company;
risks that the Company’s intellectual property and technology won’t
have the intended impact on the Company and/or its business; the
Company’s inability to carry out its pre-clinical trials and
realize upon the stated benefits of the pre-clinical trials; the
inability of the Company to realize on the benefits of exosomes;
the inability of the Company to produce and/or supply exosomes for
a wide range of applications; the inability of the Company’s
products to be used for patient treatment; the inability of the
Company to fulfill its intended future plans and expectations;
Exo-Top’s establishment and/or the acquisition
of the MCB will not have its intended benefits on the Company
and/or its business; the Company will be unable to advance its
revenue-generating and/or collaboration opportunities; the Company
will be unable to produce, supply and/or commercialize exosomes;
the Company’s products will not be used for patient treatment;
there will not be broader adoption of exosomes in the field and/or
cell therapy applications; the Company will not be able to uplist
to a major U.S. exchange and/or realize on the benefits thereof;
the Company will not provide further updates on Exo-Top; the
Company will not receive all requisite regulatory approval;
NurExone being unable to advance its development pipeline; the
NurExone platform technology not offering novel solutions to drug
companies interested in minimally invasive targeted drug delivery
for other indications; and the risks discussed under the heading
“Risk Factors” on pages 44 to 51 of the Company’s annual
information form dated August 27, 2024, a copy of which is
available under the Company’s SEDAR+ profile at www.sedarplus.ca.
These factors should be considered carefully, and readers should
not place undue reliance on the forward-looking statements.
Although the forward-looking statements contained in this press
release are based upon what management believes to be reasonable
assumptions, the Company cannot assure readers that actual results
will be consistent with these forward-looking statements. These
forward-looking statements are made as of the date of this press
release, and the Company assumes no obligation to update or revise
them to reflect new events or circumstances, except as required by
law.
Neither TSXV nor its Regulation Services
Provider (as that term is defined in the policies of the TSXV)
accepts responsibility for the adequacy or accuracy of this
release.
1
https://www.nature.com/articles/s12276-024-01201-6
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