NurExone Announces Productivity and Quality Pilot Results of Patent-Pending Process for 3D Scaled Up Exosome Production

Calgary, Alberta--(Newsfile Corp. - October 26, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, announced today results of an internal productivity and quality pilot that was completed by the Company and the Technion - Israel Institute of Technology in Q2 2022 pursuant to the previously announced Sponsor Research Agreement, showing that its innovative and proprietary production process has the potential to boost exosome yields while increasing neuron regeneration potency, driving cost efficiencies in production. Regeneration of neurons and their axons is a key element of functional recovery from spinal cord injuries.

The production process is assigned to the Technion. 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 all indications. Based on the study results, the Company anticipates 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.

Exosomes, a key element of ExoTherapy, are derived from stem cells in bio-production processes. The Technion-developed process suggests that shear stress stimulation of stem cells during Three-Dimensional (3D) exosome production yields both increased secretion of exosomes and enhanced exosome potency. NurExone carried out a pilot study of the shear stress production process assessing productivity and quality outcomes under different flow regimes, compared to controls produced using current two-dimensional (2D) or state-of-the-art 3D production techniques.

Human Bone Marrow Mesenchymal Stem Cells (hBM-MSC) and Dental Pulp Stem Cells (DPSC) were evaluated. Results of exosome productivity and quality from the hBM-MSC cells, relevant for spinal cord injuries, are presented. Studies of DPSC cells, for other indications, have been described in a peer-reviewed publication in 2021.¹

NurExone's study results indicate that the shear stress production process, generally described in Figures 1 - 2, generates high yields of high-functionality exosomes. hBM-MSC cells exhibited a statistically significant 30-fold boost in exosome secretion (production) under a parallel flow process regime (Figures 1A - C). Moreover, in all of the studied mechanical stimulation variations, derived exosomes maintained size, size distribution and structural integrity (Figures 1B - C).

In terms of functionality, the studied shear stress stimulation regimes induced with hBM-MSC cells produced exosomes with a marked increase in potency for axon regeneration. This was evaluated through the key axon regeneration potency metrics of axon length, area and number of branches, demonstrating a 3-5 fold increase, compared to a control, in all three parameters.

"We made the remarkable discovery that shear stress on stem cells cultivated on a 3D scaffold significantly enhances exosome secretion," noted Professor Shulamit Levenberg, Chief Scientific Advisor to NurExone and Director of the Technion Center for 3D Bioprinting. "The quality and productivity results from the NurExone pilot confirm this process and suggest that it can be used to produce clinically relevant numbers of exosomes from different types of stem cells, with high integrity, functionality and potency."

Dr. Lior Shaltiel, CEO of NurExone, added, "We believe that this innovative and exclusive production process has the potential to increase exosome production yields and drive cost efficiencies. This will give the Company a competitive advantage if and when the exosomes and ExoTherapy are translated to the clinical setting."

For the potential treatment of traumatic spinal cord injury patients, NurExone's ExoTherapy intends to use proprietary exosomes as biologically-guided nanocarriers to deliver specialized siRNA therapeutic compounds to target areas. The delivered molecules promote an environment that induces a healing process at the target location.

Figure 1: Productivity and Size Analysis
Human Bone Marrow - Mesenchymal Cells

Figure 1A

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Figure 1B (graph chart on the left) and Figure 1C (graph chart on the right)

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Measurement of the secretion levels during production and the size distribution of the resulting exosomes from Human Bone Marrow - Mesenchymal Cells (hBM-MSC) under different flow regimes. Shear stress stimulation processes are indicated by orange columns.

EV secretion rate (left), size (middle) and size distribution of DPSCs under 2D, 3D static, 0.5 ml/min, or 1.0 ml/min conditions.

Side panel: EV secretion rate (left), size (middle) and size distribution of hBM-MSCs cultivated under 2D static, 3D static, 3D in-line and parallel scaffold perfusion.

Figure 2: Quality and Functionality Analysis (hBM-MSC)

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Potency of the exosomes produced by the process as measured by the standard metrics of axon regeneration. Different flow regimes were examined.

Upper panel: Representative immunofluorescence staining of rat DRG neurons untreated or treated with EVs derived from 3D static or flow conditions for 24 h. Neurons were βIII-tubulin-stained (green). Scale bar=200 µm. Shear stress stimulation processes are indicated by orange columns.

Lower panel: Axonal length, area, and branch number were quantified using the IMARIS software and compared among different groups. One-way ANOVA with post-hoc Tukey's multiple comparisons. *p < 0.05, **p < 0.01, ***p < 0.001, ****p < 0.0001.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is, through its wholly-owned subsidiary, Nurexone Biologic Ltd., 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 intends to translate 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 Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

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

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company's future plans and intellectual property, the scientific and development activities to be carried out by the company, the efficient production of exosome yields, future potential manufacturing and marketing activities and the treatment of certain conditions. 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.

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.

1. Stimulating Extracellular Vesicles Production from Engineered Tissues by Mechanical Forces, Shaowei Guo, Lior Debbi, Barak Zohar, Roee Samuel, Roni S. Arzi, Adina I. Fried, Tahel Carmon, Dudi Shevach, Idan Redenski, Inbar Schlachet, Alejandro Sosnik, and Shulamit Levenberg, Nano Letters 2021 21 (6), 2497-2504

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