NurExone to Showcase Breakthrough in Facial Nerve Regeneration at ISEV 2025

Exosome-Based ExoPTEN Targets Three High-Value Nerve Injury Indications

/EIN News/ -- TORONTO and HAIFA, Israel, April 24, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) a preclinical-stage biotechnology company pioneering exosome-based therapies for central nervous system injuries is presenting new data at the 2025 International Society for Extracellular Vesicles (ISEV) Annual Meeting being held in Vienna April 24-27.

The ISEV presentation will feature facial nerve regeneration, marking the Company’s third therapeutic indication, alongside its ongoing programs in spinal cord injury and optic nerve regeneration. In a preclinical model of facial nerve injury, NurExone’s lead candidate, ExoPTEN was shown to promote significant functional recovery and regeneration. These findings open, for the first time, a new potential therapeutic avenue for peripheral nerve injury conditions such as Bell's palsy, Ramsay Hunt Syndrome (Herpes Zoster Oticus), and other infections that damage the facial nerve. Approximately 30% of patients affected by these conditions experience long-term functional impairment, including facial asymmetry, synkinesis, chronic tearing, and difficulties with eating or speaking ¹. This new indication may allow NurExone to enter a third multi-billion dollar addressable market².

The study, conducted in collaboration with the Levenberg lab at the Israel Institute of Technology led by Ayelet Lotan, MD-PhD candidate, is being presented at ISEV. Partially sponsored by NurExone, the preclinical study was conducted independently in an academic setting and offered potential confirmation of PTEN downregulation as a strategy to promote axon regrowth and facial nerve regeneration. 

Prof. Shulamit Levenberg, PhD, Co-Founder of NurExone, Director of the Technion Center for 3D Bioprinting added “I’m thrilled to see yet another indication, facial nerve regeneration, emerge from our early pioneering work on ExoPTEN. It’s deeply rewarding to watch this science evolve from academic discovery into a drug pipeline with real clinical potential.”

ExoPTEN, will also be featured in a poster presentation by Dr. Isabelle Solomon and Dr. Sharon Baumgarten-Soueid entitled “Exosome platform: ExoPTEN as a breakthrough therapy for acute spinal cord injury, nerve regeneration and beyond”. In two validated spinal cord injury models, ExoPTEN improved motor, sensory, and structural outcomes. The Company is preparing to submit an Investigational New Drug (IND) application for ExoPTEN in the indication of acute SCI.

“We have already shown three indications which can be addressed by the same ExoPTEN drug. This attests to its therapeutic breadth," said Dr. Tali Kizhner Director of Research and Development at NurExone. She added “A single manufacturing process serving multiple high-value indications significantly enhances the economic model, and positions us to deliver scalable impact across the nerve regeneration landscape.”

NurExone’s ExoTherapy platform enables precise, minimally-invasive delivery of therapies to injured tissues using exosomes as an advanced delivery system. With a growing body of preclinical data and an IND in preparation for acute spinal cord injury, the company is advancing toward clinical translation in several high-impact indications.

The current findings are part of a granted U.S. patent owned by the Technion, for which the company holds a worldwide exclusive license. This patent has also been granted in several other countries, including Japan, Russia, and Israel, with additional applications pending worldwide. The patent allows the company to enforce and apply the technology for various indications related to nerve injury

About NurExone

NurExone Biologic Inc. 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 injury, both multi-billion-dollar markets ⁱ . 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

Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations – Canada
Phone: +1-647-479-5803
Email: info@oakhillfinancial.ca

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: the Company receiving all regulatory approvals; the Company advancing towards clinical and commercial breakthroughs in regenerative medicine; the Company enhancing its presence in key markets; the advancement of the Company’s therapeutic programs and clinical milestones; the Company will present its preclinical findings at ISEV, as outlined herein; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for SCI; the Company is advancing toward clinical translation in several high-impact indications; 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: the Company realizing on the benefits of exosome loaded drugs in regenerating or repairing damaged nerves; 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 maintaining its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will receive all regulatory approvals; the Company will have clinical and commercial breakthroughs in regenerative medicine;  the Company will be able to realize its future development plans, operational initiatives, and strategic objectives; the Company’s ability to advance its therapeutic programs and clinical milestones; the Company’s ability to present its preclinical findings at ISEV, as outlined herein; the results of the Company’s preclinical trials and its ability to be a promising treatment pathway for SCI; the Company’s ability in advancing toward clinical translation in several high-impact indications; 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 will not receive all required regulatory approvals; 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 NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; the Company will not realize its future development plans, operational initiatives, and strategic objectives; the Company will not advance its therapeutic programs and clinical milestones; the Company will not engage with regulatory agencies; the Company will not present its preclinical findings at ISEV, as outlined herein; the results of the Company’s preclinical trials not being a promising treatment pathway for SCI; the Company not advancing toward clinical translation in several high-impact 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

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¹ Peitersen, E. (2002). Bell's palsy: the spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies. Acta Otolaryngol Suppl, (549), 4–30. Available at: Europe PMC
² https://www.openpr.com/news/3929404/bell-s-palsy-treatment-market-forecast-to-2030-advancements