NurExone Accepted into ARMI’s BioFab Startup Lab Strengthening U.S Position in Regenerative Manufacturing

Rhea-AI Summary

NurExone (OTCQB: NRXBF) was accepted into the ARMI BioFab Startup Lab under the federally supported BioFabUSA program on Nov 3, 2025. The program aims to accelerate translation of regenerative innovations into scalable, commercially viable manufacturing.

The company said participation could support plans by its U.S. subsidiary Exo-Top to develop a GMP-compliant facility for naive exosome production and may enhance its value proposition to strategic partners and shareholders.

TORONTO and HAIFA, Israel, Nov. 03, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) announced today that it has been accepted to the BioFab Startup Lab, part of the Advanced Regenerative Manufacturing Institute (ARMI) and its BioFabUSA program.

The federally-supported program, launched through a grant from the U.S. Economic Development Administration, helps early-stage biotechnology companies accelerate the translation of regenerative innovations into scalable and commercially viable manufacturing.

Recent legislation and federal initiatives, including a White House Bioeconomy Executive Orderⁱ, have identified biomanufacturing as a strategic national capability for the U.S. and a new pillar of advanced manufacturingⁱⁱ.

Dr. Lior Shaltiel, CEO of NurExone, noted: "Biofabrication is becoming the industrial foundation of next-generation medicine. Federal support for programs like this reflects how U.S. priorities are expanding beyond semiconductors and clean energy toward biomanufacturing. The ARMI ecosystem and infrastructure have the potential to yield longer-term commercial benefits for the Company in GMP-grade U.S. exosome production and to accelerate the time to market for our products."

NurExone’s U.S. subsidiary, Exo-Top Inc., is advancing plans for the establishment of a GMP-compliant facility dedicated to naive exosome production. The Company believes participation in ARMI’s program will enhance its value proposition to strategic partners and shareholders.

Biofabrication is the process of using living cells and biological materials to manufacture tissues and therapeutic products. It bridges the gap between scientific discovery and industrial production, creating the foundation for a new generation of regenerative medicine technologies.

About ARMI | BioFabUSA

The Advanced Regenerative Manufacturing Institute (ARMI) is a non-profit consortium bringing together industry, academia, and government to enable large-scale manufacturing of engineered tissues and regenerative medicine products. Its six-month BioFab Startup Lab program provides early-stage companies with access to facilities, mentorship, and biomanufacturing resources that bridge the gap between discovery and market.

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. 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 benefits of the Company’s acceptance into the BioFab Startup Lab program; the Company strengthening its intellectual property in exosome production and its path toward GMP-grade production and accelerating its time to market for exosome-based therapies; Exo-Top Inc. advancing plans to establish a GMP-compliant facility dedicated to naive exosome production; 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’s acceptance into the BioFab Startup Lab program will have its intended benefits on the Company and its business; the Company will strengthen its intellectual property in exosome production and its path toward GMP-grade production and accelerate its time to market for exosome-based therapies; Exo-Top Inc. will advance its plans to establish a GMP-compliant facility dedicated to naive exosome production; and the NurExone platform technology offering 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 will not advance towards clinical and/or commercial realization; the Company’s acceptance into the BioFab Startup Lab program will not have its intended benefits on the Company and/or its business; the Company will not strengthen its intellectual property in exosome production and/or its path toward GMP-grade production and/or be unable to accelerate its time to market for exosome-based therapies; Exo-Top Inc. will not advance its plans to establish a GMP-compliant facility dedicated to naive exosome production; 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 https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/
ⁱⁱ https://bidenwhitehouse.archives.gov/ostp/news-updates/2024/11/15/white-house-releases-report-on-growing-u-s-biomanufacturing-capacity-for-the-american-bioeconomy/

FAQ

What does NurExone (NRXBF) acceptance into ARMI’s BioFab Startup Lab mean for the company?

Acceptance provides access to ARMI resources and federal BioFabUSA support intended to help scale regenerative manufacturing capabilities.

When was NurExone announced as accepted into the ARMI BioFab Startup Lab?

The company announced acceptance on November 3, 2025.

How could ARMI participation affect NurExone’s plans for a U.S. GMP exosome facility?

NurExone said participation could support and accelerate plans by its U.S. subsidiary Exo-Top to establish a GMP-compliant naive exosome production facility.

Will NurExone’s ARMI acceptance change its regulatory status or approvals?

The announcement does not state any regulatory approvals or changes; it describes access to ARMI infrastructure and support for scaling manufacturing.

How might ARMI membership influence NRXBF shareholder value?

The company said participation may enhance its value proposition to strategic partners and shareholders, without providing quantified financial guidance.

What is the BioFabUSA program that NurExone joined through ARMI?

BioFabUSA is a federally supported program, funded via a U.S. Economic Development Administration grant, aimed at accelerating commercialization of regenerative biomanufacturing.