Dr. Lior Shaltiel reports
EXO-TOP, NUREXONE'S WHOLLY OWNED U.S. SUBSIDIARY, ENTERS INTO BINDING MOU FOR NAIVE EXOSOME DISTRIBUTION IN MEXICO
Nurexone Biologic Inc.'s wholly owned U.S. subsidiary, Exo-Top Inc., has entered into a binding memorandum of understanding setting out the principal commercial terms for a proposed definitive distribution agreement with ExoLyra LLC, which operates as an arm's-length third party.
The commercial terms outlined in the MOU, including territorial exclusivity, upfront exclusivity fees, minimum purchase commitments, financed 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 45 calendar days. If completed, the definitive agreement will provide Exo-Top with its first structured commercial foothold for naive MSC-derived (mesenchymal stem cell) exosome products.
"Exo-Top's first commercial distribution framework is an important step in monetizing Nurexone's capabilities in naive 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 health care, 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."
Naive MSC-derived exosomes are gaining attention across medical wellness, aesthetics and regenerative-health markets because of their natural role in cellular communication and biological signalling. 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 $1.2-billion (U.S.) by 2033.
The company believes this structure supports a dual-track value strategy: near-term commercial opportunities through Exo-Top's naive 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:
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Mexico exclusivity and regional expansion potential: ExoLyra will receive the exclusive right to market, import and sell Exo-Top's naive 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 preclearance and per-customer exclusivity mechanics. Outside Mexico, per-customer exclusivity may be triggered for precleared international customers that purchase at least 90 units within a 90-day period, subject to annual maintenance of at least 150 units per year.
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Term and operational financing: 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 finance its initial distribution and market penetration activities with available funds of no less than $800,000 (U.S.), inclusive of the licensing fee.
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Upfront exclusivity fees and financed market development: ExoLyra will pay Exo-Top a total non-refundable territorial exclusivity fee of $180,000 (U.S.) for Mexico, payable as to $40,000 (U.S.) upon execution of the definitive agreement and $140,000 (U.S.) following written notice that the product is ready for commercial shipment. In addition, Exo-Top shall be entitled to a continuing annual sales maintenance fee of $100,000 (U.S.) 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 launch pad for broader Latin American adoption.
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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 (free on board) from Exo-Top's primary U.S. facility.
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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-per-cent annual growth escalator up to a minimum performance ceiling of 70,000 units per year. At least 50 per cent 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 licence to non-exclusive status or void it.
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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, labelling and product classification requirements.
Nurexone's exosome strategy is designed to support two complementary value pathways: near-term commercial opportunities through Exo-Top's naive MSC-derived exosome products and regulated therapeutic development through loaded exosome-based drug candidates such as ExoPTEN. The naive 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 (investigational new drug) activities and future clinical development, subject to applicable regulatory approvals.
About Nurexone Biologic Inc.
Nurexone is a TSX Venture Exchange, OTCQB and Frankfurt Stock Exchange-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 road map toward clinical trials in the United States 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.
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