globenewswire news

TORONTO, Ontario and HAIFA, Israel, June 25, 2026 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce today that its wholly owned U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), has entered into a binding memorandum of understanding (the “MOU”) setting out the principal commercial terms for a proposed definitive distribution agreement (the “Definitive Agreement”) with ExoLyra LLC, which operates as an arm’s length third party (“ExoLyra”).

The commercial terms outlined in the MOU, including territorial exclusivity, upfront exclusivity fees, minimum purchase commitments, funded market-entry obligations, regulatory responsibilities, and potential regional expansion rights, are intended to be incorporated into the Definitive Agreement, which the parties intend to execute within forty-five (45) calendar days. If completed, the Definitive Agreement will provide Exo-Top with its first structured commercial foothold for naïve MSC-derived exosome products.

“Exo-Top’s first commercial distribution framework is an important step in monetizing NurExone’s capabilities in naïve MSC-derived exosomes into near-term commercial opportunities,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “Mexico offers a strategic entry point into Latin America, combining a sizable domestic market, proximity to the United States, and an established private medical and wellness ecosystem. The MOU is structured to support active market entry through upfront exclusivity fees, funded launch activities, minimum purchase commitments, and performance-based exclusivity.”

“We are excited to partner with Exo-Top and support the advancement of innovative exosome-based products,” said Leah Gluck, Co-Founder and Director of Business Development of ExoLyra. “Our mission is to build a trusted distribution platform that provides healthcare, wellness, and aesthetics professionals with access to high-quality exosome solutions. We look forward to helping expand awareness, accessibility, and responsible adoption of these emerging technologies across the marketplace.”

Naïve MSC-derived exosomes are gaining attention across medical wellness, aesthetics, and regenerative-health markets because of their natural role in cellular communication and biological signaling. Exo-Top believes its MSC-derived exosomes offer a differentiated commercial opportunity due to their natural biological profile, relevance across multiple wellness and regenerative-health applications, and NurExone’s ability to support consistency through controlled bioproduction and quality standards. The global exosomes market is projected by third-party industry research to reach approximately US$1.2 billion by 2033¹.

The Company believes this structure supports a dual-track value strategy: near-term commercial opportunities through Exo-Top’s naïve MSC-derived exosome products and long-term therapeutic value creation through NurExone’s regulated ExoPTEN development pipeline.

Key Commercial Terms

The MOU sets out the principal commercial understandings that the parties intend to incorporate into the Definitive Agreement, including the following:

• Mexico Exclusivity and Regional Expansion Potential: ExoLyra will receive the exclusive right to market, import, and sell Exo-Top’s naïve exosome products in Mexico, together with a preferential right of negotiation for two years to secure exclusive distribution rights for Brazil and Panama. The terms will be negotiated in good faith based on regional demographic and clinical data. The Definitive Agreement will also provide non-exclusive global sales rights outside Mexico, subject to account pre-clearance and per-customer exclusivity mechanics. Outside Mexico, per-customer exclusivity may be triggered for pre-cleared international customers that purchase at least 90 units within a 90-day period, subject to annual maintenance of at least 150 units per year.
• Term and Operational Funding: Mexico exclusivity is expected to have an initial three-year term, with renewals for up to seven additional years, for a total possible term of 10 years, subject to satisfaction of applicable performance requirements. The MOU also provides that ExoLyra will fund its initial distribution and market penetration activities with available funds of no less than US$800,000, inclusive of the licensing fee.
• Upfront Exclusivity Fees and Funded Market Development: ExoLyra will pay Exo-Top a total non-refundable territorial exclusivity fee of US$180,000 for Mexico, payable as to US$40,000 upon execution of the Definitive Agreement and US$140,000 following written notice that the product is ready for commercial shipment. In addition, Exo-Top shall be entitled to an ongoing annual sales maintenance fee of US$100,000 starting at the beginning of Year 4. This structure reflects the high commercial value placed on Mexico’s rapidly expanding wellness and regenerative medicine market, which serves as a launchpad for broader Latin American adoption.
• Supply and Logistics Mechanics: The Definitive Agreement will establish standard commercial transfer pricing mechanics with annual adjustment rights tied to documented production cost fluctuations or inflationary changes, with shipments to be made FOB from Exo-Top’s primary U.S. facility.
• Minimum Purchase Commitments and Performance-Based Exclusivity: To maintain exclusivity in Mexico, ExoLyra will satisfy annual minimum purchase commitments at agreed transfer prices to be set out in the Definitive Agreement. These include minimum purchase commitments of 20,000 units during the first 18 months, 35,000 units in Year 2, 50,000 units in Year 3, and 60,000 units from Year 4 onward, subject to a 5% annual growth escalator up to a minimum performance ceiling of 70,000 units per year. At least 50% of the applicable annual minimums must be distributed directly within Mexico, helping ensure that exclusivity is tied to active local market penetration. The MOU also contemplates a 120-day cure period for financial or volumetric deficiencies before Exo-Top may convert the Mexico license to non-exclusive status or void it.
• Manufacturing, Quality, and Regulatory Responsibility: ExoLyra shall also assume responsibility for ensuring regulatory compliance in all active territories, including applicable marketing, importation, sale, distribution, storage, labeling and product classification requirements.
  
  

NurExone’s exosome strategy is designed to support two complementary value pathways: near-term commercial opportunities through Exo-Top’s naïve MSC-derived exosome products and regulated therapeutic development through loaded exosome-based drug candidates such as ExoPTEN. The naïve MSC-derived exosomes produced by Exo-Top also support NurExone’s broader platform capabilities, including the exosome-loading approach used in the Company’s therapeutic pipeline.

NurExone’s lead drug candidate, ExoPTEN, is being developed as a loaded exosome-based therapeutic candidate for acute spinal cord injury, optic nerve damage, and other central nervous system indications. ExoPTEN remains on a regulated drug development pathway, including IND-enabling activities and future clinical development, subject to applicable regulatory approvals.

About ExoLyra

ExoLyra has been established to support the distribution and commercialization of advanced exosome-based products. Through its partnership with Exo-Top, ExoLyra intends to develop distribution channels, build strategic relationships, and help make innovative regenerative and wellness technologies available to qualified providers and customers in approved territories.

About NurExone

NurExone is a TSX Venture Exchange (the “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, facilitate the Company’s 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, 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

Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: nurexone@russopartnersllc.com

Dr. Eva Reuter
Investor Relations - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

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” and similar expressions.

Forward-looking statements in this press release include, without limitation, statements relating to: the parties’ intention to negotiate and enter into the Definitive Agreement within the contemplated timeframe; the expected commercial, strategic and market-development benefits of the MOU and any Definitive Agreement; the expected implementation of the exclusivity fee, annual sales maintenance fee, minimum purchase commitments, Mexico exclusivity, preferential negotiation rights, global non-exclusive sales rights, account pre-clearance mechanics and per-customer exclusivity framework described in the MOU; the expected ability of ExoLyra to support market development, customer adoption, funding of market-entry activities and regulatory compliance in applicable territories; Exo-Top’s ability to supply products consistent with the contemplated commercial framework; the Company’s dual-track value strategy involving near-term commercialization of naïve MSC-derived exosome products and longer-term therapeutic development of ExoPTEN; and statements regarding the size and growth of the exosomes market based on third-party industry research.

Forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release, including assumptions regarding: the parties’ ability to negotiate and execute the Definitive Agreement on acceptable terms; the ability of the parties to perform their respective obligations under the MOU and any Definitive Agreement; the continued availability of capital, supply, personnel, manufacturing capacity and third-party services on commercially reasonable terms; the ability of the parties to comply with applicable regulatory, importation, sale, distribution, labeling, product-classification, storage and logistics requirements in relevant territories; and the continued relevance of the third-party market data and other publicly disclosed information relied upon by the Company.

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 the parties do not enter into the Definitive Agreement on the anticipated timeline or at all; the risk that the commercial terms contemplated by the MOU are not implemented, performed or realized as expected; regulatory, importation, classification, marketing, storage and distribution risks in Mexico and other jurisdictions; operational, supply-chain, manufacturing and quality-control risks; financing and market risks; dependence on counterparties and third-party collaborators; competitive and technological risks; 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.

________________
¹ https://www.grandviewresearch.com/press-release/global-exosomes-market