NurExone Biologic Announces Advancements in Extracellular Vesicles Functionality with Enhanced Potency and Cellular Uptake for potentially better drug delivery

TORONTO and TEL AVIV, Israel, July 20, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) ("NurExone" or the "Company") is pleased to announce significant advancements in extracellular vesicles (EVs) functionality. Leveraging its proprietary and patented 3D-Flow production, the Company has achieved significantly enhanced EV functionality. These achievements include an amplified immuno-modulatory response which means helping the immune system to respond to injury and reducing the inflammation activity and in parallel, significantly improved cellular uptake, allowing NurExone's EVs better cell penetration, holding great promise for the Company's future EVs-based therapies.

Through state-of-the-art production methodologies, NurExone aims to unlock the full potential of EVs as powerful therapeutic tools. The Company's exclusive and unique 3D-Flow process involves culturing EVs on a 3D "scaffold" and subjecting the stem cells to flow-induced shear stress stimulation during production (Fig. 1A). This innovative technique, which was developed in the lab of Professor Shulamit Levenberg at the Technion (Haifa) and exclusively licensed to the Company, has already demonstrated increased yield in production¹. The current study, performed by the Company, assessed functional properties of EVs, cultured using different production techniques. The EVs derived from Human Bone Marrow Mesenchymal Stem Cells (hBM-MSC) and produced via 3D-Flow demonstrated a superior ability to decrease the inflammatory response of cells compared with a standard control and other production techniques (Fig. 1B), suggesting effectiveness in decreasing inflammation.

Furthermore, the groundbreaking 3D-Flow production has led to EVs with significantly improved cellular uptake, compared with EVs produced by other production techniques. This is critical to ensure targeted delivery of therapeutic cargo to specific cell types, maximizing the potential of EVs as drug delivery vehicles. (Fig.1C).

EVs have gained considerable attention in recent years due to their potential as natural therapeutic carriers. Demonstrating modulation of immune response, and superior uptake of EVs in the target cells will assist in moving from the laboratory to the clinical setting. NurExone is committed to further exploring the potency and therapeutic benefits of EVs produced through the 3D-Flow process using rigorous preclinical and clinical studies.

The Company's wholly-owned subsidiary, NurExone Biologic Ltd. has obtained an exclusive worldwide license from the Technion to develop and commercialize the production process for use for additional indications. Based on the study results, the Company is pursuing a patent application in the United States and other key markets under the Patent Cooperation Treaty (PCT). Once the production process is finalized, NurExone intends to monetize this technology by licensing it to other companies within the global biopharmaceutical industry in addition to implementing it within its proprietary drug platform.

Professor Shulamit Levenberg, Chief Scientific Advisor to NurExone and Director of the Technion Center for 3D Bioprinting expressed, "We are proud to showcase the remarkable immune modulation and increased cellular uptake of EVs achieved through the innovative 3D-Flow process. Together with previously demonstrated productivity benefits, these advancements are expected to enhance both the efficiency and the potency of EVs-based therapies."

Fig 1. Impact of Culturing Conditions on
Decrease in Inflammatory Response and Uptake of EVs

Figure 1: EVs obtained from MSCs cultured in 3D scaffolds under dynamic conditions (flow) (A) demonstrated the most substantial decrease in the inflammatory response of RAW 264.7 cells (B) and an increase in uptake in neuronal cells (ReN cells) (C) compared to EVs derived cultured under static conditions. EVs (8x10⁷ particles) were added to RAW 264.7 cells in 96 wells for ON. LPS (200 ng/ml) was added for 6 hr. Relative expression was assessed with qRT-PCR. HPRT was used as the expression internal control. Relative expression was compared to cells with either treatment or LPS alone (EVs or Anti-inflammatory treatment - Tempol) or LPS. Tempol is an anti-inflammatory reagent used as a positive control.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSX Venture Exchange-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, utilizing extracellular vesicles or exosomes, 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 further information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034

Inbar Paz-Benayoun
Adv. Head of Communications and Investor Relations
Phone: +972-52-3966695
Email: [email protected]

Investor Relations (Canada) Phone: +1 905-347-5569
Email: [email protected]

To download NurExone's Earnings Presentation, please visit:
https://nurexone.com/wp-content/uploads/2023/03/Nurexone-Q4-Full-Year-Fiscal-2022-Financial-Results-March-2023.pdf

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" that reflect the Company's current expectations and projections about its future development. When used in this press release, forward-looking statements can be identified by the use of words such as "may," or by such words as "will," "intend," "believe," "estimate," "consider," "expect," "anticipate," and "objective" and similar expressions or variations of such words. Forward-looking statements are, by their nature, not guarantees of the Company's future operational or financial performance and are subject to risks and uncertainties and other factors that could cause the Company's actual results, performance, prospects, or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. No representation or warranty is intended with respect to anticipated future results, or that estimates, or projections will be sustained.

Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions, and expected future developments, as well as the factors we believe are appropriate. Forward- looking statements in this press release include, but are not limited to, statements relating to: our future plans and intellectual property; our scientific and development activities; future scientific activities and the treatment of certain conditions; the therapeutic benefits, effectiveness, and safety of our product candidates; and the estimated growth of the market for acute spinal cord injuries.

In developing the forward-looking statements in this press release, we have applied several material assumptions, 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; and our ability to execute on our business strategy.

Many risks, uncertainties, and other factors could cause the actual results of the Company to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the following: those risk factors identified under the heading "Risk Factors" on pages 62 to 69 of the Company's Filing Statement dated May 12, 2022, a copy of which is available under the Company's SEDAR profile at www.sedar.com; risks related to the Company's early stage of development; lack of revenues to date; government regulation; market acceptance for our products; rapid technological change; dependence on key personnel; protection of our intellectual property; dependence on our strategic partners; overall economic conditions; competitive pressures; network restrictions; and other similar factors that may cause the actual results, performance or achievements to differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the press release or as of the date otherwise specifically indicated herein. Due to risks and uncertainties, events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required pursuant to applicable securities law. All forward-looking statements contained in the press release are expressly qualified in their entirety by this cautionary statement. 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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¹ https://www.newsfilecorp.com/release/141987/NurExone-Announces-Productivity-and-Quality-Pilot-Results-of-PatentPending-Process-for-3D-Scaled-Up-Exosome-Production

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