A Key Milestone for Therapeutic Exosome Production
TORONTO and HAIFA, Israel, Jan. 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) ("NurExone" or the "Company"), a developer of exosome-based therapies for regenerative medicine, is pleased to announce that it has acquired a master cell bank from a U.S. manufacturer for an undisclosed amount (the "Acquisition”). The Acquisition marks a major step in ensuring a stable and scalable supply chain for production of exosome-based therapies for clinical needs and eventual patient treatment.
The master cell bank provides a well-characterized, Good Manufacturing Practices ("GMP”) grade and exclusive source of human bone marrow mesenchymal stem cells ("MSCs”), the foundation for producing exosomes. The acquired master cell bank contains a large volume of high-concentration MSCs at their earliest stage (Passage Zero), ensuring the cells retain their therapeutic potential and remain potent over very long usage in exosome production. These are stored and handled under stringent U.S. Food and Drug Administration ("FDA”) guidelines and GMP, meeting the high-quality standards for clinical use. Exosomes, naturally occurring nanoparticles derived from human MSCs, play a key role in promoting healing and regeneration. This strategic Acquisition positions NurExone to advance revenue-generating opportunities that leverage exosomes both as a therapeutic agent and as a versatile drug delivery system for targeted applications across various indications.
Dr. Lior Shaltiel, CEO of NurExone, stated: "securing this high-quality master cell bank is a pivotal milestone for NurExone. It ensures access to the raw materials essential for advancing our innovative therapies. We negotiated a fixed-price cell purchase order that enables NurExone to avoid product royalty fees for the cell line and eliminate the annual licensing fees that companies based on commercial cells typically incur as they approach clinical trials. The Acquisition reflects our commitment to delivering minimally invasive, effective therapies designed to improve patient outcomes while unlocking the potential of exosomes as a targeted drug delivery platform.”
The Acquisition was executed at a strategic time as the FDA just approved the first-ever Mesenchymal Stromal Cell-based therapyi. This landmark decision underscores the transformative potential of Mesenchymal Stromal Cell-based therapies and allogeneic (donor-derived, rather than patient's own cells) treatments, paving the way for broader adoption in cell therapy applications and marking a major milestone in the field of regenerative medicine.
Yoram Drucker, Chairman of NurExone's Board, added: "the Acquisition underscores our dedication to building a sustainable foundation for our products and the future of exosome-based therapeutics. With this resource in place, we are well-positioned to meet the growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas as well as to collaborate with pharma companies looking to develop siRNA-based therapies which are loaded onto and delivered by our exosomes. Moreover, the ability to produce large quantities of high quality, GMP-manufactured exosomes may enable the Company to supply exosomes to companies for a wide range of applications - from dermal treatments to drug delivery development.”
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: [email protected]
Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations - Canada
Phone: +1-647-479-5803
Email: [email protected]
Dr. Eva Reuter
Investor Relations - Germany
Phone: +49-69-1532-5857
Email: [email protected]
Allele Capital Partners
Investor Relations - US
Phone: +1 978-857-5075
Email: [email protected]
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 benefits of the Acquisition, including the Company having a stable and scalable supply chain and providing the Company with the ability to advance revenue-generating opportunities; the benefits of exosomes; the Company being able to produce and supply exosomes for a wide range of applications; the Company's products being used for patient treatment; broader adoption in the field and cell therapy applications; the Company's future plans and expectations; growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; the Company collaborating with pharma companies; 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 ability of the Company to realize on the benefits of the Acquisition, including the Company having a stable and scalable supply chain and the Company advancing revenue-generating opportunities; the Company 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; there being broader adoption in the field and cell therapy applications; 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 collaborating with pharma companies; 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 expanding to further studies; the Company developing groundbreaking therapies for regenerative medicine in several 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 the Acquisition, including the Company not having a stable and/or scalable supply chain and/or the inability of the Company to advance its revenue-generating opportunities; 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 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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i https://www.biopharma-reporter.com/Article/2024/12/19/fda-approves-first-mesenchymal-stromal-cell-therapy/
