TORONTO and HAIFA, Israel, Nov. 24, 2023 (GLOBE NEWSWIRE) -- 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 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

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 . 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.

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