NurExone Provides Corporate Update

July 13, 2022 8:00 AM EDT | Source: NurExone Biologic Inc.

  • Developing the first-of-its-kind technology drug platform for a bio-guided exosome-based product known as ExoTherapy to treat trauma to the spinal cord, brain and other central nerve system indications
  • Global spinal cord injury therapeutics market expected to reach US$9.61 billion by 2028
  • Exclusive worldwide license from two leading Israeli universities proven in preclinical studies to develop and commercialize exosome-based technology
  • Company to host first investor webinar on July 14, 2022 at 12:00 PM (EST) since its go-public listing on the TSX Venture Exchange

Bnei-Brak, Israel--(Newsfile Corp. - July 13, 2022) - NurExone Biologic Inc. (TSXV: NRX) ("NurExone" or the "Company"), a biopharmaceutical company developing biologically-guided exosome therapy for patients with traumatic spinal cord injuries, is pleased to provide the following corporate update.

NurExone Investor Webinar

The Company will be hosting its first investor webinar since completing its go-public listing on the TSX Venture Exchange to discuss its recent developments and growth outlook - refer to the details below:

Date: Thursday, July 14, 2022
Time: 12:00 PM EST
Registration Link: https://us02web.zoom.us/webinar/register/WN_63_7xbMnQWSSlIfEa7aX3g
Presenter: Lior Shaltiel, Chief Executive Officer of NurExone

A presentation will be conducted during the first half of the webinar, followed by a Q&A session during which the CEO of NurExone will answer investor questions.

Market Opportunity

Spinal cord injury (SCI) is one of the leading causes of disability worldwide.1 SCIs can lead to permanent functional damage, often resulting in long-term complications, which require expensive treatments and long-term care.

As of 2016, 85% of spinal cord treatment was provided through surgery, which procedure alone costs nearly US$150,000 on average.2 Those living with SCIs incur high yearly expenses for healthcare - ranges from roughly US$300,000 to US$1,000,000 depending on the severity of the injury.3 Given the exorbitant cost of spinal surgery procedures and the associated healthcare expenses, there is high demand for a non-invasive off-the-shelf medication for SCI treatment. Additionally, the global SCI therapeutics market is expected to grow at a CAGR of 17.84% to reach US$9.61 billion by 2028.4

These industry statistics underscore the need for innovative treatments that recover function reducing the enormous economic burden of SCI.

ExoTherapy & ExoPTEN: A revolutionary approach to treating Spinal Cord Injury

With the goal of creating a revolutionary drug platform, Nurexone has created ExoTherapy, an innovative 'off-the-shelf' exosome-based product. This has led to the development of ExoPTEN, the Company's first ExoTherapy that will be administered intranasally. A therapeutic siRNA compound, delivered by the exosome, will be used to prevent the expression of PTEN, a protein that blocks nerve regeneration. The administration of ExoPTEN enables the re-establishment of neural activity and reverses damage to the spinal cord, healing the person's SCI effectively.

The development of the ExoPTEN is built based on licensed technology from Tel Aviv University and the Technion, Israel's Institute of Technology, two of Israel's leading universities that are proven in preclinical studies. Research from both universities tested the treatment on rats and found spinal cord nerve regeneration despite complete lesions of the spinal cord. Treatment from the technology can lead to significant motor improvement, sensory recovery, and more. Overall, ExoPTEN offers the potential of a full repair, over-the-counter use, non-invasive consumption, and immune evasion.

Intellectual Property and License Agreements

NurExone's licensed technology was invented by Professor Shulamit Levenberg and Mr. Shaowei Guo from Technion University along with Professor Daniel Offen and Mr. Nissim Perets from Tel Aviv University. The patent of the invention (PCT/IL/2019/0503550) titled, "Vehicles Comprising a PTEN inhibitor and Uses of Same" was submitted in 2018 and filed with the Israel Patent Office in 2019.

The Company's wholly-owned Israeli subsidiary, NurExone Biologic Ltd., has entered into an exclusive worldwide license agreement with Technion Research and Development Foundation Ltd., a subsidiary of Technion University and Ramot, Tel Aviv University's technology transfer company in 2020 to oversee the development, clinical studies, and commercialization of their patented Exosome-based technology.

The licensed intellectual property portfolio consists of the following patent applications:

  • PCT/IL2019/050355 - submitted in March 2019 documents pharmaceutical compositions comprising membrane vesicles, including ESVs including those referred to as exosomes, loaded with an exogenous PTEN inhibitor
  • PCT/IL2020/050641 - submitted in June 2020 documents methods and systems for enhanced production and/or secretion of extracellular vesicles from at least one three-dimensional porous scaffold having a population of stem cells cultured thereon, utilizing various shear stress conditions on a variety of stem cells

In 2021, Nurexone's Research and Development ("R&D") team submitted three provisional patent applications in 2021, as a result of the Company's scientific R&D activities.

Furthermore, the Company signed a Sponsor Research Agreement with Technion University in February 2021 to conduct research titled, "siRNA-PTEN modified exosomes for spinal cord regeneration". The agreement has been prolonged until the end of the third quarter of 2023.

Subsequently, NurExone signed a new Service Agreement with Professor Shulamit Levenberg's lab until the end of 2022 to research new portfolio products.

Collaborations

On July 11, 2022, the Company announced the signing of a Collaboration Agreement with Polyrizon Ltd, a leading biotech company based in Israel. Under the Agreement, Polyrizon will develop a robust intranasal delivery formulation that is tailored for effective administration of NurExone's exosome-based product.

NurExone plans to establish more strategic collaborations and new production partnerships and will provide an update as they materialize.

Strategy Outlook

The Company looks to execute the following growth initiatives:

  • Reach a stage of Pre-Investigational New Drug Application (Pre-IND) meeting with the regulatory agencies in the U.S., mainly the Food and Drug Administration (FDA) for Phase I/Iia development stage
  • File several new patents to expand the Company's competitive moat
  • Finalize product characterization
  • Establish scaled up exosomes' production pilot
  • Complete an informal non-binding consultation (INTERACT) meeting with the Center for Biologics Evaluation and Research at FDA
  • Open a full scale lab facility for Research and Development in early 2023
  • Conduct external In-vivo experiments

"Spinal cord injury can have devastating consequences to individuals," said Lior Shaltiel, CEO of NurExone. "We have developed a specialized therapy that in the animal model enabled the rats to walk again. Our mission now is to transfer this therapy to humans and to deliver healing and recovered functionality to the thousands of patients who suffer acute spinal cord injuries each year. Currently, we see a gap in the market where surgeries are the primary method of treatment after trauma to the spinal cord and we intend to create the first-of-its kind drug platform that leverages exosome-based technology as an alternative minimally invasive treatment. Moving forward, our goal is to obtain approval from leading health regulatory agencies and scale-up the production of our products."

About NurExone

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 for development and commercialization of the technology.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
info@nurexone.com
+972-52-4803034

Investor Relations
IR@nurexone.com
+1 905-347-5569

READER ADVISORY

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

The securities set forth herein have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws, and may not be offered or sold in the United States or to, or for the account or benefit of, United States persons absent registration or any applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company's future plans, market size and growth, research and product development, the potential to treat SCI using the Company's products, intellectual property protection and potential future collaborations and execution on its current growth initiatives. 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. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof.

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 and dependence on the Company's strategic partners. 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.

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438886/
  2. https://www.persistencemarketresearch.com/market-research/spinal-cord-trauma-treatment-market.asp

https://www.flintrehab.com/cost-of-spinal-cord-injury/

  1. https://www.christopherreeve.org/living-with-paralysis/costs-and-insurance/costs-of-living-with-spinal-cord-injury
  2. https://www.medgadget.com/2022/05/spinal-cord-injury-therapeutics-market-report-2022-to-register-a-cagr-of-17-84-to-reach-us-9611-8-million-by-2028-teva-pharmaceutical-industries-ltd-abbvie-inc-pfizer-inc-dr-reddys-labora.html

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/130729

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