NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the
“Company” or “NurExone”), a pioneering biotechnology company,
released a corporate update and reported financial results for the
quarter ended September 30, 2023.
“I am pleased to report that we have reached a
new pivotal point for our proprietary ExoPTEN drug, primarily in
advancing our United States Food and Drug Administration regulatory
strategy and the commercialization of our exosome-based technology
portfolio,” said Dr. Lior Shaltiel, CEO of NurExone. “Most notably,
we have received Orphan-Drug Designation and completed our Pre-
Investigational New Drug meeting with the United States Food and
Drug Administration for our ExoPTEN drug, which potentially
expedites the process of launching our first ExoTherapy product to
the market. In addition, we have been awarded a grant of
approximately CAD$350,000 from the Israeli Innovation Authority as
part of our collaboration with a leading developer of stem
cell-based therapeutics that is focused on treating spinal cord
injuries.”
U.S. FDA Orphan Drug Designation and
Pre-Investigational New Drug Meeting
In recent months, the Company achieved several
milestones in advancing its United States Food and Drug
Administration (“U.S. FDA”) approval strategy. Most notably,
NurExone was granted Orphan-Drug Designation by the U.S. FDA for
its ExoPTEN therapy on October 26, 2023, which provides significant
benefits to the Company, including market exclusivity, financial
incentives, regulatory assistance and support with drug development
under certain terms and conditions(i). Furthermore, the Company
completed its Pre-Investigational New Drug meeting with the U.S.
FDA on August 29, 2023, enabling NurExone to potentially expedite
the regulatory process of initiating clinical trials. The Company
expects to submit an Investigational New Drug (“IND”) application
regarding the development of ExoPTEN by Q4 2024, and initiate Phase
1/2 human clinical studies in 2025.
Israeli Innovation Authority’s CAD$350K
Eureka Grant
NurExone was awarded a grant of approximately
CAD$350,000 (1 million New Israeli Shekels) by the Israel
Innovation Authority on October 11, 2023, as part of the
Israel-Canada bilateral Eureka program for a collaboration with
Canada-based Inteligex Inc. to develop an innovative hybrid therapy
tailored for the complex chronic spinal cord injury market. The
Company intends to enter additional strategic collaborations and
partnerships with other biopharma companies in commercializing its
technology portfolio.
Expansion of the Scientific Advisory
Board and Advisory Committee and Officer Appointment
As part of the Company’s strategy to advance its
drug development, NurExone appointed Professor Teodoro Forcht Dagi,
a renowned neurosurgeon, life science venture capitalist and
professor at the Mayo Clinic Alix School of Medicine as well as at
Queen’s University Belfast, to its esteemed Scientific Advisory
Board and Advisory Committee. Professor Teodoro Forcht Dagi will
contribute to NurExone by leveraging his expertise in the field of
neurosurgery and medical technology to provide valuable insights,
guidance, and strategic direction to the Company before entering
the clinical stage in the US. Moreover, he will assist in advancing
the development and implementation of NurExone’s innovative
technology for other neurosurgical indications and patient
care.
In the third quarter of 2023, the Company
appointed Eran Ovadya, the existing chief financial officer of the
Company, to also serve as secretary of the Company.
Private Placement
On September 6, 2023, the Company announced that
it closed the second and final tranche of its previously announced
non-brokered private placement (the “Private Placement”). In the
aggregate, the Company issued and sold 5,394,548 units of the
Company (each, a “Unit”) at a price of CAD$0.275 per Unit for
aggregate gross proceeds of CAD$1,483,500.70 (approximately US$1.09
million) under the Private Placement.
Each Unit consists of (i) one common share in
the capital of the Company (each, a “Common
Share”); (ii) one-half of one class A Common Share
purchase warrant (each whole class A Common Share purchase warrant,
a “Class A Warrant”); and (iii) one-half of one
class B Common Share purchase warrant (each whole class B Common
Share warrant, a “Class B Warrant”). Each Class A
Warrant entitles the holder thereof to purchase one Common Share at
a price of CAD$0.34 per Common Share for a period of 24 months from
the date of issuance and each whole Class B Warrant entitles the
holder thereof to purchase one Common Share at a price of CAD$0.48
per Common Share for a period of 36 months from the date of
issuance.
Option Grant
The Company also announces that it has granted
129,200 stock options (the “Options”) to its
newest director, Dr. Gadi Riesenfeld. Each Option entitles the
holder to acquire one Common Share at an exercise price of $0.32
per Common Share until July 6, 2023 in accordance with the
Company’s omnibus equity incentive plan. The Options and the Common
Shares issuable upon the exercise of the Options are subject to a
hold period of four months and one day from the date of grant of
the Options.
Growth Outlook for 2023 –
2024
The Company remains committed to commercializing
its exosome-based technology portfolio as well as expanding its
overall business and intends to execute on the following growth
initiatives:
- Submit IND application to the U.S.
FDA regarding the development of ExoPTEN by Q4 2024 and initiate
Phase 1/2 human clinical studies in 2025.
- Advance the scientific development
of NurExone’s ExoTherapy platform and exosome-based technology
portfolio through preclinical studies.
- Grow its intellectual property by
filing new patent applications with the U.S. Patent and Trademark
Office.
- Enter new strategic collaborations
or partnerships to capitalize on synergistic business opportunities
and license NurExone’s exosome-based technology platform.
- Continue to identify siRNA targets
in order to expand its portfolio of products and applications.
Third Quarter Fiscal 2023 Financial
Results
- Research and development expenses
were US$0.40 million in the third quarter of 2023, compared to
US$0.42 million in the same quarter in 2022. The increase was
largely attributable to the research and development efforts
towards pre-clinical activity and development of the siRNA- PTEN
technology and other siRNA targets.
- General and administrative expenses
were US$0.77 million in the third quarter of 2023, compared to
US$0.57 million in the same period in 2022. The increase was driven
by US$0.07 million for share-based compensation as non-cash
expenses, and US$0.15 million for business development
activities.
- There were no listing expenses
incurred in the third quarter of 2023, compared to US$0.04 million
in the same quarter in 2022, mainly associated with legal costs
following the completion of the reverse takeover transaction in the
second quarter of 2022.
- Financial (income) expenses were
(US$0.01) million in the third quarter of 2023, compared to US$0.02
million in the same period in 2022. The decrease was largely
attributable to deposit interest, revaluation of financial
derivatives, and exchange rate adjustments.
- Net loss was US$1.16 million in the
third quarter of 2023, compared to a net loss of US$1.04 million in
the same quarter in 2022.
As of September 30, 2023, the Company had cash
of US$1.14 million (December 31, 2022 - US$2.46 million) and
working capital of US$0.66 million (December 31, 2022 - US$2.11
million). The Company had an accumulated deficit of US$13.32
million as of September 30, 2023, (December 31, 2022 - US$10.42
million).
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed
pharmaceutical company that is developing a platform for
biologically-guided ExoTherapy to be delivered, non-invasively, to
patients who suffered traumatic spinal cord injuries. ExoTherapy
was conceptually demonstrated in animal studies at the Technion,
Israel Institute of Technology. NurExone is translating the
treatment to humans, and the company holds an exclusive worldwide
license from the Technion and Tel Aviv University for the
development and commercialization of the technology.
For additional information, please 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
Thesis Capital Inc.Investment Relation -
CanadaPhone: +1 905-347-5569Email: IR@nurexone.com
Dr. Eva ReuterInvestment Relation -
GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu
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 Company’s ExoTherapy drug, ExoPTEN, potential first-in-human
clinical trial for ExoPTEN, the completion of an IND application
regarding the development of ExoPTEN, the potential launch of a
product into the U.S. market upon completion of applicable
regulatory phases, the growth of the Company’s intellectual
property portfolio, and the intention enter into new strategic
collaborations and partnerships with other biopharma companies.
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 our ability to retain key personnel, our ability to
continue investing in research and development, our ability to
secure available funding and to continue as a going concern, the
general business and economic conditions of the industries and
countries in which we operate, our ability to execute on our
business strategy, that there will be certain amount of demand for
the Company’s potential product, inflation will remain stable, and
that the results of our studies reflect results that can be
extrapolated.
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 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 TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
i.
https://www.fda.gov/patients/rare-diseases-fda
NurExone Biologic (TG:J90)
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부터 5월(5) 2024 으로 6월(6) 2024
NurExone Biologic (TG:J90)
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부터 6월(6) 2023 으로 6월(6) 2024