NurExone Advances Optic Nerve Injury Program Toward Larger-Animal Study, Following Positive Preclinical Results

ExoPTEN improved retinal responses in injured rat eyes, but the proposed rabbit study still depends on funding and regulatory approvals.

Rhea-AI Summary

NurExone (NRXBF) announced positive preclinical optic nerve injury results supporting plans to advance its program into larger-animal studies.

In a rat optic nerve crush model, ExoPTEN improved retinal electrical responses versus injured control eyes at the higher light level tested (p = 0.04). Naïve exosomes, which carry no added therapeutic cargo, reached approximately 5 microvolts, the measurable-response threshold; ExoPTEN exceeded it and controls remained below it. No statistically significant difference between the treatments was reported. The model does not reproduce all features of human glaucoma.

NurExone plans a rabbit study to assess delivery, dosing, tolerability and safety, subject to final protocol development, funding and regulatory approvals. Separately, its corrected RedChip agreement has a 180-day term beginning September 30, 2026, following TSXV approval, rather than the previously disclosed 90-day term.

Positive

• Minor pointExoPTEN improved retinal responses versus injured PBS controls at the higher tested light level (p = 0.04).
• Minor pointNaïve exosomes reached approximately 5 microvolts at the higher tested light level; injured PBS controls remained below that threshold.
• Minor point. Forward-looking: it has not happened yet and may not happen.Planned rabbit study would assess delivery, dosing, tolerability and safety in a larger eye model.

Negative

• Minor pointRabbit study design and initiation remain subject to final protocol development, funding and regulatory approvals.
• Minor pointRat optic nerve crush model does not reproduce all features of human glaucoma.
• Minor pointNo statistically significant difference between ExoPTEN and naïve exosomes was reported in the figure.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Preclinical Results at Sheba Medical Center Demonstrate Retinal Recovery with NurExone’s Exosome-based Lead Candidate

TORONTO and HAIFA, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies, today announced new preclinical findings demonstrating the therapeutic benefits of its naïve exosomes (exosomes without added therapeutic cargo) and lead pharmaceutical drug candidate ExoPTEN in optic nerve injury models. The studies were conducted in collaboration with Prof. Ygal Rotenstreich’s team at the Goldschleger Eye Institute at Sheba Medical Center. The new data supports the advancement of the Company’s optic nerve injury program into larger-animal studies, including a planned rabbit model, marking a key milestone toward potential human clinical evaluation.

Key Study Findings:

• Measurable retinal activity following injury: NurExone’s naïve exosomes and ExoPTEN showed encouraging signs of preserving or restoring retinal activity following optic nerve injury. Treated eyes showed measurable electrical responses to light, while injured eyes in a control group showed much weaker responses.
• Statistically significant improvement with ExoPTEN: ExoPTEN-treated eyes showed a statistically significant improvement in retinal response compared with injured eyes in the control group. This provides further evidence supporting ExoPTEN's potential to protect or restore neural function following injury.
• Biological activity observed with both NurExone naive exosome and ExoPTEN formulations - Rats treated with NurExone's naïve exosomes or ExoPTEN produced measurable retinal activity above the control group, supporting both the intrinsic biological activity of NurExone’s naïve exosomes and the therapeutic rationale for ExoPTEN as the Company’s lead regenerative candidate.
  
  

The latest findings build on NurExone’s previously announced optic nerve injury studies showing signs of structural preservation, retinal ganglion cell survival and functional recovery following optic nerve injury.

Management Commentary

“Diseases affecting the retina and optic nerve are among the leading causes of blindness and vision impairment worldwideⁱ”, noted Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “We are seeing measurable retinal responses with our proprietary naïve exosomes following injury, and a statistically significant improvement with ExoPTEN compared with the control group at higher light intensities. Together, these findings support the expansion of this program into our proposed rabbit study, which is intended to provide additional information concerning delivery, dosing, tolerability and safety in a larger eye model. The design and initiation of that study remain subject to final protocol development, funding and regulatory approvals.”

“Optic nerve damage often leads to permanent vision loss because the connection between the eye and the brain has a very limited ability to repair itself,” commented Prof. Rotenstreich. “In this study, treated eyes showed clear, measurable retinal activity following injury. These preclinical findings support the continued development of a potential new treatment approach for serious vision-threatening conditions and other conditions involving optic nerve damage.”

The optic nerve injury program further validates ExoPTEN development strategy. ExoPTEN has shown encouraging preclinical results in spinal cord injury, the Company’s lead indication, as well as in optic nerve injury, a vision-threatening condition with substantial unmet medical need. In both programs, the Company is evaluating ExoPTEN as a potential therapeutic candidate designed to support neural repair following injury.

Study Summary

Researchers used an optic nerve crush model in rats, in which the nerve connecting the eye to the brain is deliberately injured. This model helps researchers study the effects of optic nerve injury and possible treatments; it does not reproduce all features of human glaucoma. The study compared uninjured eyes with injured eyes treated with a control solution (phosphate-buffered saline, or PBS), naïve exosomes or ExoPTEN.

Retinal function was assessed using electroretinography (ERG), a test that measures the retina’s electrical response to light. At the higher of the two light levels tested, the average response in the naïve exosome group reached approximately 5 microvolts (µV)—the study’s threshold for a measurable retinal response—while the ExoPTEN group exceeded it. The PBS control group remained below this threshold. ExoPTEN-treated eyes showed a statistically significant improvement in retinal response compared with PBS-treated injured eyes (p = 0.04, one-way ANOVA with Dunnett’s correction).

Figure 1. Naïve Exosomes and ExoPTEN Show Measurable Retinal Activity Above Control Following Optic Nerve Injury

Figure 1 depicts STR-ERG amplitudes in rats subjected to optic nerve crush and treated with PBS, naïve exosomes, or ExoPTEN. The Y-axis shows STR amplitude in microvolts, reflecting retinal ganglion cell-related function. The X-axis displays the experimental groups in different light intensities.

ONC means optic nerve crush; EXO means naïve exosomes; EXOPTEN means ExoPTEN; and No ONC means uninjured eyes.

The graph compares average retinal electrical responses at two levels of dim light. The vertical axis shows response strength in microvolts; the horizontal axis shows the light levels, with separate bars for each group. Taller bars indicate stronger average responses. At the higher light level of 0.00062 cdS/mm², At normal (no ONC) and recovered treated eyes (ONC+EXO, ONC+EXOPTEN) pass the threshold of real measured retinal response (5µV). Moreover, ExoPTEN-treated injured eyes showed a statistically significant increase in response compared with the negative control group, PBS-treated injured eyes (p = 0.04). Naïve exosome-treated eyes had an intermediate average response, while uninjured eyes had the highest. No statistically significant difference between ExoPTEN and naïve exosomes is reported in this figure.

About the Goldschleger Eye Institute at Sheba Medical Center

The Goldschleger Eye Institute at Sheba Medical Center is a leading Israeli ophthalmology center providing advanced clinical care and research across major areas of eye disease, including retinal, optic nerve, glaucoma, corneal and neuro-ophthalmic conditions. Sheba Medical Center is recognized internationally as one of Israel’s leading medical centers and a major hub for medical innovation, translational research and advanced patient care.

Corrective Disclosure

The Company wishes to correct disclosure in its September 18, 2026 press release concerning its investor awareness engagement with RedChip Companies, Inc. (“RedChip”), an arm’s-length service provider based in Maitland, Florida. The Company previously stated that its non-exclusive investor relations agreement with RedChip was dated September 8, 2026 and had an initial 90-day term beginning on the later of September 8, 2026 and the date of acceptance by the TSX Venture Exchange (the “TSXV”); however, the agreement was dated September 15, 2026 and has a 180-day term beginning on September 30, 2026 following TSXV approval.

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, 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 high 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, 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 referred to as “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 Company’s intention to continue development of its optic nerve injury program; the planned advancement of the program to larger-animal studies, including a rabbit model; the proposed evaluation of delivery, dosing, tolerability and safety in future studies; the potential advancement of ExoPTEN toward human clinical evaluation; the potential therapeutic application of ExoPTEN for optic nerve injury, including conditions involving damage to the optic nerve; the Company’s broader development, regulatory and clinical plans for ExoPTEN; acceptance of the RedChip agreement by TSXV; the expected commencement and timing of the services to be provided by RedChip; and the Company’s plans to develop and commercialize exosome-based therapies, exosome products and targeted delivery systems.

These forward-looking statements are based on material assumptions including that: the reported preclinical results and the Company’s interpretation of those results are accurate; the Company will be able to finalize appropriate protocols for further preclinical studies; required funding, personnel, facilities, materials, collaborators and regulatory or institutional authorizations will be available on acceptable terms; future studies will be initiated and completed as currently contemplated; results from future studies will support continued development; the Company will be able to manufacture ExoPTEN in the quantities and to the standards required for further development; that TSXV will accept the RedChip agreement on terms acceptable to the Company; that RedChip will provide the services in accordance with the agreement; and the Company will be able to obtain any regulatory authorizations required to advance ExoPTEN toward clinical evaluation.

Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including: the early-stage nature of the Company’s development programs; the risk that the reported findings may not be confirmed in additional studies; the risk that results from rat models may not be reproduced in larger animals or may not predict safety or efficacy in humans; limitations associated with preclinical study design, sample size and statistical analysis; delays or changes in study design, timing or execution; the inability to secure sufficient financing, personnel, research capacity, materials or collaborators; manufacturing, scale-up and product-characterization risks; the inability to obtain required institutional, ethical or regulatory authorizations; adverse or inconclusive results from future studies; intellectual-property and technology risks; competition and technological change; the possibility that TSXV will not accept the RedChip agreement, or will require amendments or impose conditions; 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 preclinical findings described in this press release relate to animal models and should not be interpreted as demonstrating safety or efficacy in humans. ExoPTEN has not been approved for commercial use or for the treatment of optic nerve injury or any other condition by any regulatory authority. 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 studies, development activities 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.

ⁱhttps://www.clinicaltrialvanguard.com/news/nurexone-advances-vision-restoration-at-arvo-2025/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39728eb3-ed4c-43f7-b2de-af10fbc5b34a

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did NurExone's ExoPTEN optic nerve injury study show?

ExoPTEN-treated rat eyes showed statistically significant improvement in retinal electrical responses versus injured PBS-treated controls at the higher light level tested (p = 0.04). ExoPTEN exceeded the approximately 5-microvolt measurable-response threshold, while the injured control group remained below it.

What is the next step for NurExone's optic nerve injury program?

NurExone plans a rabbit study to obtain additional information on delivery, dosing, tolerability and safety in a larger eye model. Its design and initiation remain subject to final protocol development, funding and regulatory approvals.

How did NurExone correct the dates of its RedChip investor relations agreement?

The RedChip agreement was dated September 15, 2026, not September 8, 2026. Its 180-day term began September 30, 2026, following TSXV approval, replacing the previously disclosed initial 90-day term beginning on the later of September 8, 2026 and TSXV acceptance.