NurExone Demonstrates Consistent Anti-Inflammatory Activity Across Three Separate Batches of Exosomes
New results strengthen the foundation for commercial naïve exosome supply and continued development of ExoPTEN
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TORONTO and HAIFA, Israel, Oct. 30, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory results demonstrating consistent anti-inflammatory activity across three batches of its naïve exosomes, supporting both its developing commercial supply business through Exo-Top Inc. (“Exo-Top”) and continued development of its lead therapeutic candidate, ExoPTEN.
Anti-inflammatory activity is a key biological property attracting interest in exosomes for applications ranging from skin health to tissue repair. NurExone’s latest results showed that three separately produced batches demonstrated similar and substantial anti-inflammatory activity. Two key proteins involved in inflammation, IL-6 and TNF-α, showed average reductions of approximately 88% and 57%, respectively. This anti-inflammatory activity shown in the laboratory supports the potential of NurExone’s exosomes for clinical applications where controlling inflammation is relevant to tissue protection, repair and regeneration.
“The anti-inflammatory properties of our exosomes have potential relevance for both our therapeutic development and commercial strategy,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “For ExoPTEN, these findings support the exosome component of our approach to acute spinal cord and optic nerve injuries. For Exo-Top, they provide additional evidence of product consistency as we begin manufacturing and work toward supplying naïve exosomes for applications such as skin and tissue care. Addressing batch-to-batch consistency, a critical unmet challenge in the exosome field, helps distinguish the quality and reliability we expect to bring to the exosome market.”
“Manufacturing biological drug substances is an exceptionally complex process governed by strict Chemistry, Manufacturing and Controls (“CMC”) regulatory requirements,” said Dr. Tali Kizhner, Director of Research and Development at NurExone. “As part of our CMC program for ExoPTEN, we have we have generated data regarding the physical characteristics and the composition of our exosomes, and now in their anti-inflammatory activity across production batches. This rigorous approach also supports the quality and reliability of the naïve exosomes we plan to supply commercially through Exo-Top.”
These achievements provide further positive support for the Company’s manufacturing foundation as it advances its U.S. production strategy in collaboration with Made Scientific, with a focus on scalability, consistent product characteristics and reproducible biological activity.
About the Study
Researchers evaluated the anti-inflammatory activity of three batches of NurExone’s bone marrow-derived mesenchymal stromal cell extracellular vesicles (BM-MSC EVs) using RAW 264.7 macrophages, a laboratory cell model commonly used to study inflammatory responses.
The macrophages were stimulated with lipopolysaccharide (LPS) to induce the secretion of pro-inflammatory cytokines. Cells were then treated with increasing concentrations of NurExone EVs. IL-6 and TNF-α levels in the culture supernatants were measured and expressed as percentages of the LPS-stimulated control, with dexamethasone included as a positive control.
All three tested batches showed dose-dependent suppression of IL-6 and TNF-α. At the highest EV concentration, average cytokine reductions reached approximately 88% and 57%, respectively, relative to the LPS-stimulated control.
The overall dose-response patterns were similar across batches, although some variability was observed, particularly for TNF-α at intermediate concentrations. These findings support batch-to-batch consistency of the measured biological activity.
Figure 1. Reproducibility of anti-inflammatory activity across three production batches of NurExone BM-MSC extracellular vesicles.
(A) IL-6 suppression and (B) TNF-α suppression in LPS-stimulated RAW 264.7 macrophages treated with increasing concentrations of NurExone EVs. Cytokine concentrations in culture supernatants are expressed as percentages of the LPS-stimulated control (mean ± standard deviation). Each dot represents the mean response of a different production batch (three batches in total, N=3). Dexamethasone was included as a positive control.
All three batches demonstrated similar dose-dependent anti-inflammatory responses, with relatively small variation at the highest concentrations tested. Average reductions reached approximately 88% for IL-6 and 57% for TNF-α at the highest concentration. Despite some variation at intermediate concentrations, particularly for TNF-α, the results demonstrated consistent biological activity across the three production batches. These in-vitro findings do not establish clinical anti-inflammatory efficacy.
About NurExone
NurExone is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve damage. Regulatory milestones, including obtaining the Orphan Drug Designation from the U.S. FDA and European EMA, facilitate the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company aims to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, X (formerly 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
Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: nurexone@russopartnersllc.com
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are based on expectations, estimates and projections as of the date of this press release and are generally identifiable by words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “continue,” “advance” and similar expressions.
Forward-looking statements in this press release include statements concerning: the potential for the reported in-vitro results to support the continued development of ExoPTEN and the Company’s proposed commercial supply of naïve exosomes through Exo-Top; the potential relevance of the Company’s exosomes to tissue protection, repair and regeneration and to skin and tissue-care applications; the potential for the Company to achieve reproducible biological activity and batch-to-batch consistency in future production; the advancement of the Company’s U.S. production strategy and its collaboration with Made Scientific; the Company’s plans to manufacture and supply naïve exosomes commercially; and the Company’s broader development, manufacturing, regulatory, clinical and commercialization plans for ExoPTEN and other exosome-based products.
These forward-looking statements are based on material assumptions including that: the reported laboratory data and the Company’s interpretation of those data are accurate and complete; the three tested batches and the in-vitro RAW 264.7 macrophage model provide information relevant to the measured biological activity; the reported dose-response patterns and cytokine reductions can be reproduced in additional batches, at larger scale and under future manufacturing conditions; the Company will be able to further develop, validate and scale its manufacturing processes and meet applicable quality, regulatory and manufacturing requirements; arrangements with Made Scientific and other collaborators will progress as contemplated; sufficient funding, materials, facilities, personnel and collaborators will be available on acceptable terms; demand for naïve exosomes will develop; and the Company will be able to advance ExoPTEN, Exo-Top and its other programs as currently contemplated.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including: the preliminary, limited and in-vitro nature of the reported results; the use of only three production batches and the variability observed at certain concentrations; the risk that the results will not be reproduced in additional batches, different assays, larger-scale production, animal studies or human studies; the risk that reduction of IL-6 or TNF-α in the reported model will not translate into clinical efficacy, safety, product quality, regulatory acceptance or commercial utility; variability inherent in biological materials and exosome manufacturing; process-development, scale-up, validation, contamination, quality-control, supply-chain, facility, equipment and personnel risks; the need for additional research, testing, technology transfer and regulatory work; the inability to obtain sufficient financing, materials, facilities, personnel, collaborators, customers or commercial orders; delays, changes or termination affecting the Company’s collaboration with Made Scientific or other counterparties; competition, technological change, intellectual-property risks and the absence of sufficient market demand; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s annual information form dated August 27, 2024 and other continuous disclosure documents available under the Company’s SEDAR+ profile, copies of which are available under the Company’s SEDAR+ profile at www.sedarplus.ca.
The laboratory results described in this press release are preclinical and in-vitro, are based on three production batches and do not establish clinical anti-inflammatory efficacy, safety in humans, commercial-scale manufacturing capability, regulatory compliance, product approval or commercial demand. ExoPTEN is an investigational product candidate, has not been approved for commercial use or for the treatment of any condition by any regulatory authority, and its safety and efficacy in humans have not been established. No assurance can be given that the Company will successfully scale or reproduce the reported results, obtain regulatory authorization, enter into commercial supply arrangements or generate revenue from Exo-Top. Although the Company believes that the expectations and assumptions reflected in the forward-looking statements are reasonable, there can be no assurance that the anticipated activities, benefits, demand or results will occur or be achieved. Readers should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of this press release, and the Company disclaims any obligation to update or revise them except as required by applicable 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.
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