NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90)
(the “
Company” or “
NurExone”) is
pleased to announce significant advancements in their manufacturing
process of exosomes. Exosomes, which are naturally released by
cells, hold immense promise for regenerative medicine and they are
at the heart of the Company’s innovative ExoPTEN product, which is
being developed for the treatment of acute spinal cord injury and
glaucoma.
In a recent study, NurExone focused on ensuring
that the Company’s exosome production process could consistently
deliver reliable products. The study compared exosomes produced
from bone marrow-derived mesenchymal stem cells (MSCs) from two
different donors. Despite a natural variability in the starting
material, the exosomes showed consistent yields measured in
concentration of exosomes (Fig. A) and similar size distribution
(Fig. B), demonstrating the reliability of NurExone's production
methods.
"The exosome production process must be stable
to ensure the same quality of exosomes every time, even when the
stem cell material comes from different donors," notes Dr. Noa
Avni, Director of Research and Development at NurExone, and She
continues, "our tests and analysis have clearly shown that this is
possible using our proprietary technology, which will allow
large-scale mass production without genetic manipulation".
To ensure the exosomes are not only consistent
but also effective at targeting damaged tissue, NurExone conducted
further tests using an advanced animal model of spinal cord injury.
Exosomes from the different donors were administered to rats with
spinal cord compression injuries and compared with an untreated
control group. The newly produced exosomes demonstrated excellent
and comparable homing abilities to the injured area (Fig. C).
NurExone also investigated the effectiveness of
exosomes produced using different culture methods, comparing 2D
culture conditions with NurExone’s scalable 3D culture systems.
Testing showed that both methods produced exosomes with similar
homing and targeting capabilities (Fig. D). NurExone’s patented 3D
culture is expected to facilitate commercial mass production of
exosomes.
Dr. Lior Shaltiel, Chief Executive Officer at
NurExone, emphasized the importance of these findings stating that
"ensuring consistency across different donors and culture systems
while maintaining targeting and homing ability is crucial and will
allow our exosomes to serve as an excellent, targeted system for
drug delivery.” He continued, “NurExone's ongoing achievements in
establishing a robust, scalable exosome manufacturing process will
pave the way to regenerative medicine treatments for a variety of
clinical indications developed by NurExone independently as well as
with future collaboration partners.”
Fig. 1: Analysis of Properties and Homing
Capability of Exosomes Produced from Different Donors
About NurExone Biologic
Inc.
NurExone Biologic Inc. is a TSXV listed
pharmaceutical company that is developing a platform for
biologically-guided exosome-based therapies to be delivered,
non-invasively, 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. The NurExone platform
technology is expected to offer novel solutions to drug companies
interested in noninvasive targeted drug delivery for other
indications.
For additional information, please
visit www.nurexone.com or follow NurExone
on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel Chief Executive Officer and
Director Phone: +972-52-4803034 Email: info@nurexone.com
Thesis Capital Inc. Investment Relation - Canada
Phone: +1 905-347-5569 Email: IR@nurexone.com
Dr. Eva Reuter Investment Relation - Germany
Phone: +49-69-1532-5857 Email: e.reuter@dr-reuter.eu
Allele Capital Partners Investment Relation - US
Phone: +1 978-857-5075 Email: 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 advancements in the manufacturing process of exosomes; exosomes
holding immense promise for regenerative medicine; the reliability
of the Company’s production methods; the Company having flexibility
in optimizing its exosome production method; exosomes serving as an
excellent, targeted system for drug delivery; the Company paving
the way to regenerative medicine treatments for a variety of
clinical indications by the Company and with future collaboration
partners; and the NurExone platform technology offering novel
solutions to drug companies interested in noninvasive 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 the general business and economic conditions
of the industries and countries in which we operate; the general
market conditions; the ability to secure additional funding;
partnerships having their intended impact on the Company and its
business; patents safeguarding NurExone’s technology; the Company’s
drug products having its intended benefits and effects; the Company
making progress through new partnerships and technologies to move
towards commercialization of their products; the Company’s
intellectual property and technology being novel and inventive; the
intellectual property having the intended impact on the Company and
its business; exosomes becoming an ideal and natural choice for
drug delivery; the Company making advancements in the manufacturing
process of exosomes; exosomes holding immense promise for
regenerative medicine; the Company’s production methods continuing
to be reliable; the Company will have flexibility in optimizing its
exosome production method; exosomes will serve as an excellent,
targeted system for drug delivery; the Company will pave the way to
regenerative medicine treatments for a variety of clinical
indications by the Company and with future collaboration partners;
and the NurExone platform technology offering novel solutions to
drug companies.
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; protection of the Company’s
intellectual property; dependence 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 potential
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 potential inability to obtain adequate
financing; the potential inability to obtain or maintain
intellectual property protection for the drug product candidates of
the Company; the NurExone platform technology being unable to offer
novel solutions to drug companies; 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
realize upon partnerships; risk that the exosomes will not become
an ideal and/or natural choice for drug delivery; risk that the
company will be unable to make advancements in the manufacturing
process of exosomes; risk that exosomes will not be a viable option
in regenerative medicine; risk that the Company’s production
methods will become unreliable; risk that the Company will not have
flexibility in optimizing its exosome production method; risk that
exosomes will not serve as a targeted system for drug delivery;
risk that the Company will be unable to pave the way to
regenerative medicine treatments for a variety of clinical
indications by the Company and/or with future collaboration
partners; risk that the NurExone platform technology will be unable
to offer novel solutions to drug companies interested in
noninvasive targeted drug delivery for other indications; and the
risks discussed under the heading “Risk Factors” on pages 29 to 36
of the Company’s Annual Information Form dated March 30, 2023, 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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/f13f2b37-b9f4-4d39-9990-a6d5f7a2f474
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