NurExone Biologic Announces Preclinical Evidence of Structural Repair in Injured Spinal Cord Tissue following ExoPTEN Treatment

C$0.78 Million Private Placement Successfully Closed

TORONTO and HAIFA, Israel, Aug. 20, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to announce new preclinical imaging results providing anatomical evidence consistent with structural repair of spinal cord following treatment with ExoPTEN.

An imaging-based analysis of animals treated with ExoPTEN after a spinal cord injury showed more organized spinal cord tissue compared to untreated controls. A functional assessment of this same cohort showing that 100% of animals in a higher-dose group regained motor function was published in July 2025.

“The data from the MRI with Diffusion Tensor Imaging (“MRI-DTI”) indicates that the injured spinal cords showed greater structural integrity and tissue organization when treated with ExoPTEN in the animal model. Importantly, those structurally preserved spinal cords strengthen the accumulating evidence of ExoPTEN neuroprotective and regeneration-promoting activity following spinal cord injury,” said Dr. Kineret Taler, Head of Preclinical Studies.

Unmet Need in Spinal Cord Injury and Evidence of Spinal Cord Repair

Spinal cord injury is life-altering and imposes a substantial healthcare and economic burden. Current treatments focus on stabilizing patients but do not repair damaged tissue. ExoPTEN is designed to support nerve repair and restore function. NurExone continues preparations for its first-in-human clinical trial of ExoPTEN, subject to regulatory approval.

MRI-DTI is an advanced imaging technique that maps the movement of water molecules in tissue, providing a detailed view of microstructural integrity beyond conventional MRI and effectively shows a spinal cord’s wiring.

Two key parameters are used:

1. Fractional Anisotropy (“FA”): Indicates alignment and preservation of nerve fibers. Higher FA values indicate stronger structural integrity.
2. Mean Diffusivity (“MD”): Reflects microscopic tissue architecture. Lower MD values indicate healthier cellular structure and less disruption from injury.

In ExoPTEN-treated animals, FA values were higher and MD values were lower near the injury site, suggesting more organized, structurally intact tissue.

In Figure 1A, computer-generated MRI-DTI 3D images trace the “threads” of the spinal cord. The green lines represent the direction of nerve fibers and the red arrows mark the injury site. The top row (Control) shows the injury area as frayed and disrupted in both top and side views. The bottom row (ExoPTEN-treated) shows more tracts running through the injured area.

Figures 1B and 1C show normalized FA values (Figure 1B) and MD values (Figure 1C) showing significant differences between ExoPTEN-treated and control spinal cords, indicating better structural integrity and the tissue’s microscopic architecture in the ExoPTEN-treated spinal cords.

CEO Dr. Lior Shaltiel commented, “This new analytic evidence, together with previously reported functional studies demonstrating recovered walking function in small animals, creates robust, support of the strong preclinical profile of ExoPTEN in spinal cord injury.”

Private Placement

The Company is also pleased to announce that, subject to TSX Venture Exchange (“TSXV”) approval, it has closed a non-brokered private placement of 1,258,072 units (“Units”) at a price of C$0.62 per Unit for aggregate gross proceeds of C$780,004.64 (the “Offering”). The Company intends to use the proceeds of the Offering for working capital purposes.

CFO Eran Ovadya added: “This limited financing round provides us with additional resources to support our ongoing operations and drive the continued development of ExoPTEN. Notably, the round included participation from existing investors who expressed their confidence in NurExone by increasing their holdings. As we advance toward our first-in-human studies, we remain committed to prudent financial management and to creating long-term value for our stakeholders.”

Terms of the Offering

Each Unit consisted of (i) one common share in the capital of the Company (each, a “Common Share”), and (ii) one-half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one Common Share at a price of C$0.80 per Common Share for a period of 36 months, subject to acceleration. If the daily volume weighted average trading price of the Common Shares on the TSXV for any period of 20 consecutive trading days equals or exceeds C$1.70, the Company may, upon providing written notice to the holders of the Warrants (the “Acceleration Notice”), accelerate the expiry date of the Warrants to the date that is 45 days following the date of the Acceleration Notice. If the Warrants are not exercised by the accelerated expiry date, the Warrants will expire and be of no further force or effect.

Closing of the Offering is subject to receipt of all necessary regulatory approvals, including the TSXV, and all securities issued under the Offering are subject to a statutory hold period of four months and one day from the closing of the Offering and applicable U.S. legends.

About NurExone

NurExone Biologic Inc. 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 injury, both multi-billion-dollar marketsⁱ. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the 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 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

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. 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. Forward-looking statements in this press release include, but are not limited to, statements relating to: completing the Offering on the terms indicated herein; the Company receiving all regulatory approvals; the use of proceeds from the Offering; the Company the Company advancing towards clinical and commercial breakthroughs in regenerative medicine; the Company’s aims to launch first-in-human clinical trials; the Company preparing regulatory submissions; the intended benefits of ExoPTEN; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: realizing on the benefits of exosomes; the Company will produce and supply exosomes for a wide range of applications; the ability of the Company’s products to be used for patient treatment; the Company fulfilling its intended future plans and expectations; there being growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; the Company carrying out its pre-clinical trials and realizing upon the benefits of the pre-clinical trials; the Company’s realizing upon the potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company maintaining its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will complete the Offering on the terms indicated herein; the Company will receive all regulatory approvals; the Company will use the proceeds from the Offering as outlined herein; the Company will have clinical and commercial breakthroughs in regenerative medicine; the Company will enhance its presence in key markets; the Company will prepare the requisite regulatory submissions; the Company will launch first-in-human clinical trials; ExoPTEN will have its intended benefits; and the NurExone platform technology will offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

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; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the inability to obtain adequate financing; the inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to realize on the benefits of exosomes; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company’s products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the Company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the inability of the Company to collaborate with pharma companies; the Company’s inability to realize upon the stated potential for exosome- loaded drugs in regenerating or repairing damaged nerves; the Company’s inability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and/or cell therapy applications; the Company’s inability to expand into further studies; the Company’s inability to complete the Offering on the terms indicated herein or at all; the Company will not receive all required regulatory approvals; the Company will not use the proceeds from the Offering as outlined herein; the Company will not have clinical and/or commercial breakthroughs in regenerative medicine; the Company will be unable to enhance its presence in key markets; the Company will not uplist to a major U.S. exchange and/or realize on the benefits thereof; the Company will not prepare regulatory submissions; the Company will not launch first-in-human clinical trials; ExoPTEN will not have its intended benefits; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; 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, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca . 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 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.

ⁱ Spinal cord injury, Glaucoma

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/faccedd3-99ca-41b2-b072-b8a2fb0e66f5

Figure 1 - MRI-DTI results

A - DTI tracts images of PBS (1,2) and ExoPTEN x15 (3,4) treated spinal cords in ventral (1,3) and lateral (2,4) views. Rostral side is to the left and caudal to the right. Dashed white line represents the approximate compression area. B – normalized FA values. A significant differences were shown between ExoPTEN x15 treated rats and control PBS treated rats ( ****p value < 0.0001, paired t-test). C – normalized MD values . A significant differences were shown between ExoPTEN x15 treated rats and control PBS treated rats ( ***p value = 0.0002, paired t-test).

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.