NurExone Strengthens Path to Clinical Trials for ExoPTEN with New Manufacturing Process Validation
- Strong cell viability data with population doubling time of 20.4hr±1.56 for up to 9 passages, indicating efficient cell growth
- Master Cell Bank validation supports extended production batches, maximizing economic value
- Consistent exosome yields and preserved biological potency demonstrated across multiple production runs
- Company on track for first human clinical trials of ExoPTEN in 2026
- None.
Company Is also Seeking Shareholder Approval of Amended and Restated Omnibus Plan
TORONTO and HAIFA, Israel, June 04, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to announce that on May 22, 2025, it presented new manufacturing process data at the 4th annual meeting of the Israeli Society for Extracellular Vesicles Research (“ISEVR”), a conference dedicated to cutting-edge exosome science. Additionally, the Company will seek shareholder approval of its amended and restated omnibus incentive plan (the “Omnibus Plan”) at the its upcoming annual general and special meeting being held on June 18, 2025 (the “Meeting”).
Manufacturing Process Validation
The Company’s presentation showcased promising early data on the viability and potency of cells from its proprietary Master Cell Bank (“MCB”). The MCB represents a valuable and key strategic asset in advancing good manufacturing practices (“GMP”)-compliant manufacturing of exosomes for the Company’s lead therapeutic candidate, ExoPTEN, as well as for its subsidiary, Exo-Top Inc. (“Exo-Top”). “The findings suggest strong economic potential, indicating that the MCB may support an extended number of production batches maximizing its value and utility”, commented Dr. Dr. Tali Kizhner, Research and Development Director of NurExone.
She further noted: “by validating a scalable and potent manufacturing platform, we are strengthening our clinical readiness and taking a significant step toward delivering meaningful impact to patients suffering from traumatic nerve injuries once considered to be irreversible. It is very rewarding to see our exosome-based therapy platform have the potential to evolve from academic innovation to commercial scalability.”
In addition to confirming the robust growth performance of the mesenchymal stem cells (“MSCs”), Cells exhibit population doubling time (PDT) of 20.4hr±1.56 for up to 9 passages. The PDT of cells, which refers to the time it takes for the number of cells to double, utilized to investigate cell growth dynamics, and serves as a measure for assessing MSCs’ proliferative capacity (Sci Rep. 2021;11(1):3403). The shorter the population doubling time, the stronger the proliferative capacity of the cells. the new data highlights recent advancements in both upstream and downstream manufacturing processes, demonstrating consistent exosome yields and preserved biological potency across multiple production runs. NurExone intends to transfer the manufacturing process to its wholly owned U.S.-based subsidiary, Exo-Top, who will be responsible for establishing GMP-compliant MSC driven exosome production to support both clinical trials and future commercial supply.
Jacob Licht, recently appointed CEO of Exo-Top, stated: “the cells from the MCB serve as the biological molds from which exosomes are produced and cell quality is key for consistency, scalability, and therapeutic reliability. Early manufacturing data suggests that these proprietary cells will provide a strong foundation for establishing a robust, U.S.-based infrastructure to support NurExone’s clinical pipeline and could position Exo-Top as a leader in clinical-grade exosome production and supply.”
ExoPTEN is being developed as a first-in-class, exosome-based therapy targeting high-impact neurological indications, including acute spinal cord injury, optic nerve damage, facial nerve injury, and additional conditions such as traumatic brain injury.
NurExone expects to initiate a first in human clinical trial of ExoPTEN in 2026 and is continuing to expand its manufacturing capabilities to support broader development of exosome-based regenerative therapies.
Amended and Restated Omnibus Plan
At the Meeting, disinterested shareholders of the Company are being asked to consider and, if thought advisable, to pass, with or without variation, an ordinary resolution to ratify, confirm, and approve the Omnibus Plan. The Circular was mailed to shareholders of the Company on May 20, 2025, and includes the full text of the Omnibus Plan attached as Schedule “A” thereto. The Omnibus Plan has since been amended (the “TSXV Amendments”) in accordance with certain comments provided by the TSX Venture Exchange (the “TSXV”).
The TSXV Amendments to the Omnibus Plan are mostly "housekeeping" alterations, and do not affect the rights of the Company's securityholders.
Substantively, the following text was deleted from Section 2.4.3 of the Omnibus Plan:
“….and in the event all of the convertible securities of the Company are exercised/converted after the date hereof and on or before the Effective Date, such
Section 2.4.3 of the Omnibus Plan now notes that the maximum number of common shares reserved for issuances and settlement of RSUs (as defined in the Omnibus Plan) and Restricted Shares (as defined in the Omnibus Plan), are fixed at
“Subject to adjustments pursuant to Article 7 hereof, the maximum number of Shares that may be available and reserved for issuance and settlement of RSUs and Restricted Shares in the aggregate, shall be fixed at
Except as described above, the Circular and the Omnibus Plan remain unchanged from the version that was mailed to shareholders of the Company. A copy of the Omnibus Plan incorporating the TSXV Amendments is available on SEDAR+ at www.sedarplus.com. Shareholders may also contact the Company to request free printed copies of the Omnibus Plan with the TSXV Amendments.
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
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 results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for SCI; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for SCI; the Company developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN having the potential to address SCI and improve patient lives; the Company is advancing toward clinical translation in several high-impact indications; the Company’s exosome-based therapy platform have the potential to evolve from academic innovation to commercial scalability; Exo-Top will be responsible for establishing GMP-compliant MSC driven exosome production; Exo-Top’s proprietary cells will provide a strong foundation for establishing a robust, U.S.-based infrastructure to support NurExone’s clinical pipeline; NurExone expects to initiate a first in Human clinical trial of ExoPTEN in the second half of 2026; the Meeting; disinterested shareholder approval of the Omnibus Plan at the Meeting; the ability of shareholders to receive physical copies of the Omnibus Plan; all other statements relating to the Omnibus Plan; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health.
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 realize 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 will fulfill 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 will carry out its pre-clinical trials and realize upon the benefits of the pre-clinical trials; the Company having the ability to maintain 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 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; the Company’s exosome-based therapy platform having the ability to evolve to commercial scalability; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for SCI; the Company developing groundbreaking therapies for regenerative medicine in several indications; Exo-Top will have the ability to establish GMP-compliant MSC driven exosome production; Exo-Top’s proprietary cells will have the ability to provide a strong foundation for establishing a robust, U.S.-based infrastructure to support NurExone’s clinical pipeline; NurExone will have the ability to initiate a first in Human clinical trial of ExoPTEN in the second half of 2026; the Company will receive approval of the Omnibus Plan; the Meeting will be conducted as scheduled; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health
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; the Company’s inability to receive disinterested shareholder approval of the Omnibus Plan; 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 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; the Company not developing groundbreaking therapies for regenerative medicine in several indications; the Company does not advance toward clinical translation in several high-impact indications; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health; the Company’s exosome-based therapy platform will not evolve to commercial scalability; Exo-Top will not establish GMP-compliant MSC driven exosome production; Exo-Top’s proprietary cells will not provide a strong foundation for establishing a robust, U.S.-based infrastructure to support NurExone’s clinical pipeline; NurExone will not initiate a first in Human clinical trial of ExoPTEN in the second half of 2026; 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 Spinal cord injury, Glaucoma
FAQ
What is NurExone's ExoPTEN therapy and what conditions does it target?
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