NurExone Receives U.S. Patent Allowance for Exosome Manufacturing, Strengthening Supply Chain Readiness

TORONTO and HAIFA, Israel, Sept. 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a pioneering biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent covering the Company’s proprietary process for producing exosomes, natural cell-free nanoparticles derived from stem cells. The patent is part of an extensive international patent family, securing broad global protection and strengthening the company’s worldwide market position.

“This U.S. patent allowance secures long-term protection for our proprietary manufacturing process,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “With patent coverage in place and the recent acquisition of a Good Manufacturing Practice (“GMP”)-grade Master Cell Bank, we have reinforced the core elements of our supply chain. Combined with independent benchmarking that demonstrated the stronger regenerative potential of our exosomes, this milestone strengthens our path towards first-in-human trials and future commercial positioning.”

Prof. Shulamit Levenberg, lead inventor and NurExone Scientific Advisor, added: “This technology, which originated in my lab at the Technion, represents a unique and scalable method of manufacturing stem-cell derived exosomes. The allowance of this patent validates years of research and ensures that NurExone retains lasting intellectual property as it advances into clinical and commercial phases.”

The patent secures exclusive rights to NurExone’s 3D scaffold and shear-stress based bioreactor system, enabling scalable, reproducible exosome production. Together with the GMP-grade Master Cell Bank acquired in December 2024, this milestone establishes a robust foundation for NurExone’s clinical supply chain and the planned launch of Exo-Top Inc.’s commercial-scale production and business-to-business supply of naïve exosomes. The patented manufacturing process is under an exclusive worldwide license to NurExone from the Technion Research and Development Foundation, Ltd.

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 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: long-term protection of the Company’s intellectual property and manufacturing process; the Company’s exosomes having strong regenerative potential; the Company launching first-in-human clinical trials; future commercial positioning of the Company; the Company’s manufacturing methods and scalability; the Company advancing to clinical and commercial phases; Exo-Top Inc. launching commercial-scale production and business-to-business exosome supply; 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 will have long-term protection of its intellectual property and manufacturing process; the Company’s exosomes will have strong regenerative potential; the Company will launch first-in-human clinical trials; the Company and Exo-Top Inc. will advance into clinical and commercial phases, launch commercial-scale production and business-to-business exosome supply, achieve scalability and advance their manufacturing methods; 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; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs; the Company’s inability to have long-term protection of its intellectual property and/or manufacturing process; the Company’s exosomes will be not be regenerative; the Company will be unable to launch first-in-human clinical trials; the Company and Exo-Top Inc. will be unable to advance into clinical and/or commercial phases, launch commercial-scale production and/or business-to-business exosome supply, achieve scalability and/or advance their manufacturing methods; 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

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