NurExone Announces Expansion of ExoPTEN Patent Coverage with Notice of Allowance for Japanese Patent Application

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TORONTO and HAIFA, Israel, June 11, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company developing regenerative medicine therapies, is pleased to announce that the Japan Patent Office recently issued a Notice of Allowance for an ExoPTEN patent, covering innovative Extracellular Vesicles (EVs) comprising a phosphatase and tensin homolog (“PTEN”) inhibitor and their application use. The Company’s ExoPTEN drug, currently under development, aims to promote nerve growth and regeneration after acute spinal cord injury by inhibiting the PTEN protein.

The patent, titled “Vesicles Comprising a PTEN Inhibitor and Uses of Same”, was originally submitted by the Technion Research and Development Foundation Ltd. (“Technion”) and Ramot at Tel Aviv University Ltd. It is the first patent licensed by NurExone from Technion and describes a fundamental element of the Company’s ExoPTEN nanodrug under development for acute spinal cord injury.

Dr. Bat-Ami Gotliv, Patent Attorney for NurExone, stated, “The allowance of this patent application in Japan safeguards NurExone’s technology in a vital Asian market. This approval, alongside the corresponding patents granted in the United States of America and Russia, underscores the novelty and inventive step of NurExone’s technology.”

Dr. Lior Shaltiel, CEO of NurExone, explained, “This patent, which belongs to the ExoPTEN family in our extensive IP portfolio, is included in the exclusive worldwide licensing from the Technion. We are making progress using ExoPTEN, our first nanodrug, and other newly developed technologies as we move towards clinical trials in humans and commercialization.”

Mr. Yoram Drucker, Co-Founder, Chairman and VP Strategic Development, elaborated, “We see Japan as an important territory for our products and technology. This expands our potential market to the Far East, and if we succeed in showing benefits in other Central Nerve System indications, we may dramatically increase our market potential.”

A Notice of Allowance represents the final stage prior to the grant, pending the Company’s payment of the registration fees.

Amending and Extension Agreement with BullVestor

Further to the Company’s press release dated January 17, 2024, the Company and bullVestor Medien GmbH (“BullVestor”) have entered into an amending agreement (the “Amending Agreement”) to the investor relations agreement dated January 9, 2024 (the “IR Agreement”) pursuant to which BullVestor will continue to provide investor relations services to the Company until May 15, 2025, at a monthly rate of C$59,000. The Amending Agreement is subject to TSX Venture Exchange (“TSXV”) approval. Pursuant to the terms and conditions of the Amending Agreement, either party may terminate the IR Agreement on 15 days’ notice.

Under the IR Agreement, as amended, BullVestor assists with and enhances awareness of the Company’s products and services using advertising and communications, some of which may constitute investor relations activities pursuant to the policies of the TSXV. The advertising and communications will occur in German-speaking countries (Germany, Austria, and Switzerland).

The consideration does not include any securities of the Company. BullVestor does not have any interest, directly or indirectly, in the Company or its securities, or any right or intent to acquire such an interest.

Aside from the IR Agreement, as amended, the Company does not have any relationship with BullVestor. BullVestor is located in Austria.

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 LinkedInTwitterFacebook, 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 IR Agreement, as amended, including the term, fees and deliverables thereunder; the Company paying the required registration fee; the focus of the Company’s drug products; the patent safeguarding NurExone’s technology; the Company making progress using these technologies to move to commercialization of their products; and the NurExone platform technology offering novel solutions to drug 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 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; the Amending Agreement being approved by the TSXV; the IR Agreement, as amended, having the intended impact on the Company and its business; the Company will pay the registration fees prior to the deadline; the patent safeguarding NurExone’s technology; the Company’s drug products will have their intended benefits and effects; the Company will make progress using these technologies and move to 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; and the NurExone platform technology will offer 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; risk that the Company will not pay the registration fees prior to the deadline or at all; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; 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.