NurExone Forms Exo-Top Inc. in the U.S. for Exosome Manufacture and Commercialization

/EIN News/ -- TORONTO and HAIFA, Israel, Feb. 05, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (“NurExone” or the “Company”) is pleased to announce the formation of a U.S.-based subsidiary, Exo-Top Inc. (“Exo-Top”), that is expected to advance good manufacturing practice (“GMP”), fully characterized exosome production. The establishment of Exo-Top is a key step towards an independent and scalable supply of high-quality exosomes for the Company’s future nanodrug pipeline and collaboration opportunities following NurExone’s acquisition of a Master Cell Bank (“MCB”) of Mesenchymal Stem Cells (“MSC”).

Exosomes are increasingly recognized as a revolutionary drug delivery system with inherent therapeutic effects and capable of transporting therapeutic molecules - including ribonucleic acid, proteins, and small molecules - directly to target cells with high precision and minimal invasiveness.¹ The exclusive MCB provides Exo-Top with a sustainable, cost-effective, and unique source of exosome-producing cells, a foundation for the production of fully characterized GMP-grade exosomes.

In addition to supporting NurExone’s internal drug development efforts, Exo-Top will be positioned to supply high-quality exosomes to other pharmaceutical companies, biotech firms, and researchers worldwide, opening additional revenue streams for the Company. By supplying GMP-grade exosomes for drug delivery research and existing, non-U.S. Food and Drug Administration (“FDA”)-regulated therapeutic or cosmetic applications, Exo-Top creates new market opportunities while advancing the broader adoption of MSC-based exosomes as a transformative drug delivery system and a potentially regenerative treatment via NurExone’s ExoTherapy platform.

The acquisition of the MCB and the formation of Exo-Top will give NurExone greater control over its exosome production process. Unlike companies that depend on third-party cell sources, Exo-Top will operate independently, without external licensing or royalty obligations, ensuring cost efficiency and strategic flexibility as NurExone advances its development pipeline.

Dr. Lior Shaltiel, CEO of NurExone commented: “exosomes are rapidly emerging as the next frontier in drug delivery and regenerative medicine, with the potential to transform treatments for neurological disorders, oncology, longevity and beyond. Establishing Exo-Top anchors our supply chain, accelerates our drug development, and creates business opportunities through exosome commercialization.”

Eran Ovadya, CFO of NurExone, added: “as part of our growth strategy, we also plan to pursue an uplisting from the OTC to a major U.S. exchange, subject to requisite regulatory approval, to strengthen our market position and broaden investor access.”

Exo-Top was established under the jurisdiction of the State of Nevada. Basing Exo-Top in the U.S. offers key advantages, including proximity to strategic partners, access to a robust biopharma ecosystem, and increased market opportunities.

The Company will provide further updates as it progresses with the formation and long-term production strategy of Exo-Top.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”) and OTCQB listed pharmaceutical company that is developing a platform for biologically guided exosome-based therapies to be delivered, minimally invasive, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA and European agency, European Medicines Agency. The NurExone platform technology is expected to offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

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 - US
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 intended benefits of Exo-Top’s establishment and the acquisition of the MCB on the Company and its business; the Company advancing its revenue-generating and collaboration opportunities; the Company being able to produce, supply and commercialize exosomes; the Company’s products being used for patient treatment; broader adoption of exosomes in the field and cell therapy applications; the Company’s future plans and expectations; NurExone advancing its development pipeline; the Company’s plan to pursue an uplisting and the benefits thereof; receipt of all requisite regulatory approval; the Company providing further updates on Exo-Top; 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: Exo-Top’s establishment and the acquisition of the MCB will have its intended benefits on the Company and its business; the Company will advance its revenue-generating and collaboration opportunities; the Company will be able to produce, supply and commercialize exosomes; the Company’s products will be used for patient treatment; there will be broader adoption of exosomes in the field and cell therapy applications; the Company will realize its future plans and expectations; the Company will uplist to a major U.S. exchange and realize on the benefits thereof; the Company will provide further updates on Exo-Top; the Company will receive all requisite regulatory approval; 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, and 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 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; the inability of the Company to fulfill its intended future plans and expectations;

Exo-Top’s establishment and/or the acquisition of the MCB will not have its intended benefits on the Company and/or its business; the Company will be unable to advance its revenue-generating and/or collaboration opportunities; the Company will be unable to produce, supply and/or commercialize exosomes; the Company’s products will not be used for patient treatment; there will not be broader adoption of exosomes in the field and/or cell therapy applications; the Company will not be able to uplist to a major U.S. exchange and/or realize on the benefits thereof; the Company will not provide further updates on Exo-Top; the Company will not receive all requisite regulatory approval; NurExone being unable to advance its development pipeline; 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.

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¹ https://www.nature.com/articles/s12276-024-01201-6