NurExone Reports New Preclinical Tissue-Analysis Data Supporting Potential Neuroprotective Effect of ExoPTEN in Acute Spinal Cord Injury Animal Model
Tissue analysis showed significantly higher numbers of myelin-positive cells in ExoPTEN-treated animals compared with
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TORONTO and HAIFA, Israel, Aug. 14, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (“NurExone” or the “Company“) (TSXV: NRX, OTCQB: NRXBF, FSE: J90), a biotechnology company developing exosome-based regenerative therapies, today announced new preclinical tissue-analysis results that provide additional biological support for ExoPTEN’s potential neuroprotective effect in an animal model of traumatic spinal cord injury.
The findings provide an important new biological dimension to the ExoPTEN’s efficacy profile.
NurExone has previously reported improved functional recovery in animals treated with ExoPTEN (press release dated July 8, 2025). In the current analysis, spinal cord tissue collected from those same animals and evaluated to assess biological markers associated with neurons and supporting structures. Two months after injury, ExoPTEN-treated animals showed significantly higher numbers of cells positive for Myelin Basic Protein (“MBP”), a key component of the protective coating surrounding nerve fibers, compared with controls in regions on both sides of the injury site.
These data further inform NurExone’s understanding of ExoPTEN’s potential mechanism of action and contribute to the scientific and regulatory foundation supporting the program as it advances through preclinical development toward potential clinical development.
“These results are important as we continue to gain biological rationale behind the functional recovery observed previously in ExoPTEN-treated animals,” said Dr. Tali Kizhner, Director of Research and Development at NurExone. “Nerve cells depend on a protective coating, much like electrical wires depend on insulation, to carry signals. Two months after injury, ExoPTEN-treated animals had significantly higher numbers of MBP-positive cells on both sides of the injury site compared with controls. These findings provide additional preclinical evidence supporting ExoPTEN’s potential neuroprotective effect and may help us better understand how ExoPTEN could support neural tissue preservation and recovery following injury.”
Analyzing the Biology of Functional Recovery
Acute spinal cord injuries can trigger a cascade of biological processes beyond the initial trauma that can contribute to further damage to nerve cells and their supporting structures. Protecting surviving neural tissue and the structures needed for nerve signaling is therefore an important therapeutic objective.
To study ExoPTEN’s mechanism of action within the injured spinal cord, the Company performed a broad immunohistochemical analysis using target tissues collected from a previously reported efficacy study. Three areas of the spinal cord were assessed independently: the injury area itself and regions rostral (toward the head) and caudal (toward the tail) to the injury site.
Researchers examined several markers associated with neurons and their supporting structures:
- NeuN, a marker associated with neuronal nuclei and cell bodies;
- NF200, a marker of neuronal axons and cell bodies; and
- MBP, a major component of myelin and a marker used to identify the myelin sheaths that insulate nerve fibers.
Two months after spinal cord injury, ExoPTEN-treated animals showed significantly higher numbers of MBP-positive cells compared with controls in regions on both sides of the injury. The differences were statistically significant in both the rostral region (p=0.01) and caudal region (p=0.04).
These findings provide additional preclinical evidence supporting ExoPTEN’s potential neuroprotective effect and may help biologically explain the functional improvement previously observed in treated animals.
Figure 1: ExoPTEN-Treated Spinal Cord Tissue Shows Higher Numbers of MBP-Positive Cells Compared with Controls
(A) Illustration of the spinal cord injury site and the two regions analyzed on either side of the injury: rostral, toward the head, and caudal, toward the tail.
(B) Representative microscopic image showing neuronal and myelin markers in spinal cord tissue. NeuN identifies neuronal nuclei and cell bodies (green), MBP identifies myelin (red), NF200 identifies neuronal axons and cell bodies (cyan), and DAPI identifies cell nuclei (dark blue).
(C) Quantitative analysis two months after spinal cord injury showing significantly higher numbers of MBP -positive cells in ExoPTEN-treated animals compared with controls in both the rostral (p=0.01) and caudal (p=0.04) regions, providing additional preclinical evidence supporting ExoPTEN’s potential neuroprotective effect.
About ExoPTEN
ExoPTEN is NurExone’s lead exosome-based therapeutic candidate for acute spinal cord injury. ExoPTEN uses bone marrow-derived naïve exosomes loaded with proprietary siRNA targeting PTEN and is being developed as a minimally invasive therapeutic approach intended to promote recovery following nerve injury.
Investor Awareness Engagement with BullVestor
The Company has entered into an advertising and investor awareness agreement with bullVestor Medien GmbH (“BullVestor”), an arm’s length party to the Company based in Austria, pursuant to which BullVestor will provide advertising, communications and investor awareness services in Austria, Germany and Switzerland. The agreement commences on August 10, 2026 and will run on a flexible month-to-month basis, terminable by the Company at the end of the then-current billing month; however, BullVestor will not commence providing any investor relations, promotional, investor awareness, advertising, marketing, distribution, media placement, digital media, direct marketing, database management, investor communications, social media, targeted advertising, retargeting, lead generation or related services unless and until the agreement has been accepted by the TSX Venture Exchange (“TSXV”), if such acceptance is required. BullVestor will be paid C$2,500 per month for the monthly awareness program and, if the Company elects to proceed with optional additional awareness campaigns, additional consideration of up to C$480,000 in the aggregate based on individual campaigns ranging from C$20,000 to C$60,000 per campaign. No optional additional awareness campaign will be commenced, and no additional fees will become payable, unless the Company has approved in writing the final scope, pricing, timing, channels, deliverables and campaign materials for such campaign and the Company has obtained any required prior acceptance of the TSXV. The consideration payable to BullVestor is payable solely in cash and does not include any securities of the Company. To the knowledge of the Company, BullVestor does not have any interest, directly or indirectly, in the securities of the Company, or any right or intent to acquire such an interest. The engagement remains subject to the acceptance of the TSXV.
About NurExone
NurExone is a 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, facilitate the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top 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, 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 often, but not always, identified by words and phrases such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “potential”, “designed to”, “goal”, “advance”, “develop”, “support”, “toward”, “roadmap”, and similar expressions.
Forward-looking statements in this press release include, without limitation, statements relating to: the interpretation, significance and potential implications of the Company’s preclinical tissue-analysis results; the potential neuroprotective or regenerative effects of ExoPTEN; the potential relationship between the observed tissue-level findings and previously reported functional recovery in animals treated with ExoPTEN; the Company’s understanding of ExoPTEN’s mechanism of action; the potential use of the results to support the scientific, regulatory and development foundation for the ExoPTEN program; the continued development of ExoPTEN for acute spinal cord injury and other potential central nervous system indications; the Company’s plans and expectations regarding preclinical development, clinical development, regulatory advancement, clinical trial planning, potential commercialization, platform opportunities, and the development of exosome-based regenerative therapies; the Company’s expectations regarding Exo-Top and its North American activity and growth strategy; the expected commencement, continuation, scope, acceptance and potential implementation of the Company’s investor awareness engagement with BullVestor; the Company’s ability to obtain any required acceptance of the TSXV for the BullVestor engagement; and the Company’s potential election to proceed with optional additional awareness campaigns.
Forward-looking statements are based on management’s current expectations, beliefs and assumptions as of the date of this press release, including assumptions regarding: the accuracy, reproducibility and significance of the preclinical results described in this press release; the validity of the methodologies used to generate and analyze the tissue-analysis data; the relevance of animal-model data to the development of ExoPTEN; the Company’s ability to continue preclinical and clinical development of ExoPTEN; the continued availability of capital, personnel, regulatory support, manufacturing capacity, third-party service providers and other resources on acceptable terms; the Company’s ability to manufacture, characterize and scale exosome-based therapeutic candidates; the Company’s ability to obtain and maintain applicable regulatory authorizations and advance toward clinical trials; the continued relevance of the Company’s publicly disclosed scientific and regulatory information; the ability of BullVestor to provide the services contemplated by the investor awareness agreement; the Company’s ability to obtain any required TSXV acceptance for the BullVestor engagement; and the absence of material adverse changes in applicable laws, regulations, regulatory guidance, market conditions or the Company’s business.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including, without limitation: the risk that the preclinical results described in this press release may not be reproducible or may not be predictive of results in future preclinical studies or clinical trials; the risk that ExoPTEN may not demonstrate safety or efficacy in humans; the risk that the observed tissue-level findings may not establish the mechanism of action, therapeutic benefit or clinical utility of ExoPTEN; risks associated with early-stage biotechnology development; risks associated with the design, timing, conduct, cost and outcome of preclinical studies and clinical trials; regulatory review and approval risks; manufacturing, scale-up, quality-control and technology-transfer risks; risks related to intellectual property protection and freedom to operate; reliance on third-party collaborators, service providers, manufacturers and suppliers; financing and capital-market risks; competition and technological change; risks that the BullVestor engagement may not be accepted by the TSXV, may not proceed as contemplated, may be amended or terminated, or may not achieve the intended investor awareness outcomes; risks associated with investor relations, promotional and market-making activities, including compliance with TSXV policies and applicable securities laws; and the risks described in the Company’s continuous disclosure filings available under its profile on SEDAR+, including the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s annual information form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca.
ExoPTEN is a preclinical therapeutic candidate and has not been approved for sale or use by any regulatory authority. Safety and efficacy have not been established in humans. There can be no assurance that the Company’s preclinical results will support regulatory submissions, clinical trial authorization, clinical development, regulatory approval or commercialization. Preclinical results may not be predictive of results in future preclinical studies or clinical trials. Readers are cautioned not to place undue reliance on forward-looking statements. Although the forward-looking statements contained in this press release are based upon assumptions that management believes to be reasonable as of the date hereof, 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 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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/200ee589-52b7-47f6-aeaf-229ee0a25d0f
