NurExone Announces Binding MOU with Made Scientific for U.S. GMP Manufacturing and Commercial Supply Partnership
The Signed MOU Targets Initial GMP Exosome Batches in H1 2027 to Support NurExone’s Clinical Pipeline and Planned Commercial Production
TORONTO and HAIFA, Israel, Aug. 13, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (“NurExone” or the “Company“) (TSXV: NRX, OTCQB: NRXBF, FSE: J90), a biotechnology company developing exosome-based regenerative therapies, today announced that its wholly owned U.S. subsidiary, Exo-Top Inc. (“Exo-Top“), together with the Company, has signed a binding memorandum of understanding (“MOU“) with Made Scientific, Inc. (“Made Scientific”) to establish an exclusive U.S. Good Manufacturing Practice (“GMP”) manufacturing and commercial exosome supply partnership to support NurExone’s clinical and commercial activities.
The proposed partnership brings together two companies with a shared vision for building scalable U.S. manufacturing infrastructure to support exosome-based therapeutics and commercial exosome products – two rapidly growing markets.
Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (“CDMO“) which operates a 60,000-square-foot U.S. FDA and EU GMP Annex 1 compliant facility in Princeton, New Jersey.
The parties intend to immediately begin the transfer of NurExone technology in parallel with negotiation of a definitive partnership agreement, with a target of initiating first GMP exosome batches in H1 2027.
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“Partnering with highly regarded organizations is essential to building world-class manufacturing around novel therapeutic approaches, including exosome-based therapies,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “This allows us to focus on what we do best and create shareholder value, while working with specialized partners to support execution. Made Scientific is an ideal strategic partner because of its manufacturing capabilities, operational expertise, and shared long-term vision. Together, we have an opportunity to establish a U.S. manufacturing and commercialization platform to accelerate NurExone’s therapeutic pipeline, including lead candidate ExoPTEN, while creating a foundation for company revenue, commercial growth and leadership in the emerging exosome market.”
Syed T. Husain, Chairman and CEO of Made Scientific, commented, “NurExone has developed a differentiated exosome platform with significant clinical and commercial potential. This collaboration combines NurExone’s innovative bone marrow-derived exosome platform with Made Scientific’s manufacturing and regulatory expertise, creating an integrated pathway to bring exosome-based therapies from development through commercial supply.”
The proposed collaboration builds on NurExone’s broader manufacturing strategy, including bioprocess optimization with Novasign GmbH announced on July 30, 2026. Together, these initiatives are intended to strengthen the infrastructure supporting both NurExone’s therapeutic pipeline and future commercial exosome activities, positioning the Company for long-term, sustainable commercial success.
Under the binding MOU, Made Scientific will serve as NurExone’s exclusive U.S. partner for the manufacturing and aseptic fill-finish of NurExone’s bone marrow-derived exosomes. The MOU contemplates that the definitive agreement, if executed, will feature an initial term of five (5) years, with options for successive five-year renewals. If the parties do not execute a definitive agreement within six months of MOU execution, the MOU and ongoing obligations, including exclusivity grants, will automatically terminate, subject to specified surviving obligations.
Update Regarding BioXtek Letter of Intent
The Company also announced that Exo-Top has mutually agreed with Florida-based BioXtek Inc. (“BioXtek”) not to proceed with the non-binding Letter of Intent (“LOI“) previously announced on April 7, 2026. This decision follows NurExone’s strategic pivot to consolidate its U.S. GMP exosome manufacturing infrastructure under the proposed collaboration with Made Scientific. NurExone and BioXtek intend to explore potential collaborative business opportunities outside of direct production in the near future.
About Made Scientific
Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical- and commercial-supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors. For more information, visit www.madescientific.com.
About NurExone
NurExone 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 damage. Regulatory milestones, including obtaining the Orphan Drug Designation, support the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company intends to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top 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: [email protected]
Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: [email protected]
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: [email protected]
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are often, but not always, identified by words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “potential”, “target”, “designed to”, “goal”, “subject to”, “contemplate” and similar expressions, or statements that events, conditions or results “may”, “could”, “would”, “should” or “will” occur or be achieved.
Forward-looking statements in this press release include, without limitation, statements relating to: the proposed collaboration with Made Scientific; the negotiation, execution, timing and terms of any definitive agreement; the expected scope, objectives and potential benefits of the MOU and proposed definitive agreement; the technology transfer, process establishment, manufacturing, aseptic fill-finish, quality, regulatory, commercial supply and distribution activities contemplated by the MOU; the target timing for initiating first GMP exosome batches; the ability of the parties to complete due diligence, approve SOWs, enter into definitive documentation, satisfy applicable technical, quality, regulatory, commercial, securities law and stock exchange requirements, and operationalize the proposed collaboration; the potential role of Made Scientific as a U.S. manufacturing partner; the potential use of the proposed collaboration to support NurExone’s clinical pipeline, Exo-Top activities, potential future commercial exosome activities and broader manufacturing strategy; the expected relationship between the proposed collaboration, Exo-Top and the Company’s previously announced bioprocess optimization initiative with Novasign; the potential commercialization of exosome products in jurisdictions where legally permitted; the potential exploration of business opportunities with BioXtek outside of direct production; and the Company’s development, regulatory, manufacturing, commercialization and platform opportunities.
Forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release, including assumptions regarding: the ability of NurExone, Exo-Top and Made Scientific to proceed with the MOU and negotiate and enter into a definitive agreement on acceptable terms, or at all; the successful completion of due diligence; the approval and performance of applicable SOWs; the continued willingness and ability of each party to proceed with the proposed collaboration; the availability of required personnel, capital, materials, equipment, manufacturing capacity, cleanroom availability, quality systems, technical information and third-party services on commercially reasonable terms; the ability to complete technology transfer, process establishment, scale-up, quality-control and release activities; the continued accuracy and relevance of the Company’s manufacturing, scientific, regulatory and commercial plans; the ability to satisfy applicable regulatory, securities law, stock exchange and commercial requirements; the ability to maintain required intellectual property, confidentiality and regulatory protections; and the absence of material adverse technical, regulatory, commercial, legal, market, financing or operational developments.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially, including, without limitation: the risk that a definitive agreement with Made Scientific may not be entered into on the timeline contemplated or at all; the risk that the MOU may terminate if a definitive agreement is not executed within the six-month period contemplated by the MOU; the risk that the proposed collaboration may not proceed as currently contemplated or may be terminated, delayed or restructured; due diligence, negotiation, documentation, SOW approval and approval risks; technology transfer, manufacturing scale-up, process development, quality-control, batch release, supply chain, raw material, equipment, facility, cleanroom availability, storage, logistics and cost risks; regulatory review, clinical development and commercialization risks; the risk that products may not be approved, authorized, commercially viable or legally marketable in one or more jurisdictions; the risk that anticipated manufacturing capacity, timelines, cost efficiencies, batch timing, commercial supply arrangements or revenue opportunities may not be achieved; risks related to exclusive arrangements, rights of first refusal or rights of first offer; dependence on third-party collaborators, manufacturers, suppliers, distributors and service providers; risks related to intellectual property, confidential information, data, know-how and regulatory documentation; financing and market risks; competition and technological change; general biotechnology and early-stage development risks; the risk that preclinical results may not be predictive of clinical results; and the risks described in the Company’s continuous disclosure filings available under its profile on SEDAR+, including the risks described under the heading “Risk Factors” in the Company’s annual information form and other public disclosure documents.
Readers are cautioned not to place undue reliance on forward-looking statements. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, forward-looking statements are not guarantees of future performance, and actual results may differ materially from those expressed or implied by such statements. Forward-looking statements are made as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.
Neither the 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.
