Dr. Lior Shaltiel reports

NUREXONE BIOLOGIC'S U.S. SUBSIDIARY EXO-TOP AND FLORIDA-BASED BIOXTEK SIGN STRATEGIC LOI FOR EXOSOME MANUFACTURING AND COMMERCIALIZATION

Exo-Top Inc., Nurexone Biologic Inc.'s wholly owned U.S. subsidiary, has entered into a non-binding letter of intent (LOI) with BioXtek Inc., a Florida-based company, to explore a strategic partnership in the field of regenerative therapies for exosome manufacturing and commercialization.

The parties intend to negotiate a strategic partnership to support U.S. good manufacturing practice (GMP) manufacturing, clinical supply and potential commercialization of bone marrow-derived mesenchymal stem cell (MSC) exosomes in the United States and international markets. The collaboration is expected to combine Exo-Top's MSC master cell bank (MCB) and exosome production expertise with BioXtek's U.S. manufacturing infrastructure and commercialization capabilities to accelerate clinical and commercial exosome supply, and expand production capacity. In addition, the partnership is expected to address the growing demand for naive exosomes across multiple therapeutic areas, including the exosome-based regenerative aesthetics market, which is experiencing rapid growth and is projected to surpass $1.6-billion by 2034.

"This collaboration aims to strengthen our manufacturing readiness, accelerate our clinical timelines and create additional commercial opportunities for our exosome platform," said Dr. Lior Shaltiel, PhD, chief executive officer of Nurexone. "BioXtek brings an operational U.S. GMP facility and established manufacturing capabilities, while we contribute our proprietary know-how and MCB, which serves as a standardized source for our MSC exosomes."

"Nurexone has developed a highly compelling exosome platform and demonstrated strong consistency and quality in its production approach," said Dr. Bruce Werber, MD, chief executive officer of BioXtek. "By combining that with BioXtek's infrastructure and market presence, we believe this collaboration could help translate the technology into real-world applications and establish a leadership position in the rapidly emerging exosome market."

A key asset supporting the proposed collaboration is Nurexone's proprietary MCB, designed to enable batch consistency, efficient technology transfer and scalable GMP production.

Areas of exploration under the LOI:

• Strengthening MSC exosome manufacturing consistency and readiness: The parties will collaborate on manufacturing and quality processes to ensure consistent batch-to-batch production and facilitate GMP readiness.
• GMP supply of exosomes for the U.S. and international markets: Joint production and market strategies will focus on exosomes for wound care, pain management and orthopedic treatments. This initiative leverages Florida's Senate Bill 1768 (CS/CS/SB 1768), which permits the use of certain non-FDA (U.S. Food and Drug Administration) (as hereinafter defined) approved stem cell therapies that meet strict safety and defined regulatory standards. The collaboration may also support the supply of naive MSC exosomes to additional international markets, subject to applicable regulatory requirements.
• Accelerating planned clinical trials: BioXtek may support the manufacturing of naive exosomes for U.S. clinical trials of Nurexone's lead drug candidate, ExoPTEN, supporting a potential path toward FDA approval for treatments targeting acute spinal cord injury and optic nerve damage.

Proposed collaboration structure

Under the contemplated collaboration:

• Exo-Top will provide platform know-how and support technology transfer to BioXtek for the manufacturing of naive MSC exosomes.
• BioXtek may serve as a Florida-based GMP manufacturing and commercial partner for naive MSC exosome production and supply.
• BioXtek may receive customer-specific distribution rights for naive MSC exosomes.
• Exo-Top may utilize naive MSC exosomes manufactured under the collaboration in the development of its proprietary therapies and nanodrugs, which use loaded exosomes to deliver therapeutic cargo.

The LOI provides a framework for further discussions between the parties. Any potential strategic partnership remains subject to customary conditions, including due diligence, completion of remediation and readiness milestones, negotiation and execution of a definitive agreement, board approvals, and receipt of all required regulatory approvals, including from the TSX Venture Exchange.

Commercialization and applications

Exosomes represent a new frontier in therapeutic applications, regenerative beauty and wellness, enabling science-driven, minimally invasive treatments. Their rich cargo of growth factors, proteins and microRNAs is being explored for applications including skin rejuvenation, anti-aging, diabetic ulcers and hair regeneration.

Exo-Top and BioXtek intend to explore the potential supply and manufacturing of naive MSC exosomes for applications that may include wound care, pain management, orthopedics and other indications, subject to applicable regulatory requirements and the terms of any definitive agreement, if entered into. Any activities contemplated under the LOI would be conducted in compliance with applicable federal and state laws and regulatory oversight.

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 injury. Regulatory milestones, including obtaining the orphan drug designation, facilitates 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.

About BioXtek Inc.

BioXtek is a Florida-based clinical-stage company with expertise in research, clinical trials and GMP manufacturing of exosomes and other biological products. The company operates out of Pompano Beach, Fla., has an 11,000-square-foot facility with eight ISO cleanrooms, and has internal quality and manufacturing systems intended to support tissue processing and biologics related operations.

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