Dr. Lior Shaltiel reports

NUREXONE STRENGTHENS PATH TO CLINICAL TRIALS FOR EXOPTEN WITH NEW MANUFACTURING PROCESS VALIDATION

Nurexone Biologic Inc., on May 22, 2025, presented new manufacturing process data at the fourth annual meeting of the Israeli Society for Extracellular Vesicles Research (ISEVR), a conference dedicated to cutting-edge exosome science. Additionally, the company will seek shareholder approval of its amended and restated omnibus incentive plan at the its upcoming annual general and special meeting being held on June 18, 2025.

Manufacturing process validation

The company's presentation showcased promising early data on the viability and potency of cells from its proprietary master cell bank (MCB). The MCB represents a valuable and key strategic asset in advancing GMP-compliant (good manufacturing practices) manufacturing of exosomes for the company's lead therapeutic candidate, ExoPTEN, as well as for its subsidiary, Exo-Top Inc. "The findings suggest strong economic potential, indicating that the MCB may support an extended number of production batches maximizing its value and utility," commented Dr. Tali Kizhner, research and development director of Nurexone.

She further noted: "By validating a scalable and potent manufacturing platform, we are strengthening our clinical readiness and taking a significant step toward delivering meaningful impact to patients suffering from traumatic nerve injuries once considered to be irreversible. It is very rewarding to see our exosome-based therapy platform have the potential to evolve from academic innovation to commercial scalability."

In addition to confirming the robust growth performance of the mesenchymal stem cells (MSCs), cells exhibit population doubling time (PDT) of 20.4 hours plus or minus 1.56 for up to nine passages. The PDT of cells, which refers to the time it takes for the number of cells to double, is utilized to investigate cell growth dynamics and serves as a measure for assessing the proliferative capacity of MSCs. The shorter the population doubling time, the stronger the proliferative capacity of the cells. The new data highlight recent advancements in both upstream and downstream manufacturing processes, demonstrating consistent exosome yields and preserved biological potency across multiple production runs. Nurexone intends to transfer the manufacturing process to its wholly owned United States-based subsidiary, Exo-Top, which will be responsible for establishing GMP-compliant MSC-driven exosome production to support both clinical trials and future commercial supply.

Jacob Licht, recently appointed chief executive officer of Exo-Top, stated: "The cells from the MCB serve as the biological moulds from which exosomes are produced and cell quality is key for consistency, scalability and therapeutic reliability. Early manufacturing data suggests that these proprietary cells will provide a strong foundation for establishing a robust, U.S.-based infrastructure to support Nurexone's clinical pipeline and could position Exo-Top as a leader in clinical-grade exosome production and supply."

ExoPTEN is being developed as a first-in-class, exosome-based therapy targeting high-impact neurological indications, including acute spinal cord injury, optic nerve damage, facial nerve injury and additional conditions, such as traumatic brain injury.

Nurexone expects to initiate a first in human clinical trial of ExoPTEN in 2026 and is continuing to expand its manufacturing capabilities to support broader development of exosome-based regenerative therapies.

Amended and restated omnibus plan

At the meeting, disinterested shareholders of the company are being asked to consider and, if thought advisable, to pass, with or without variation, an ordinary resolution to ratify, confirm and approve the omnibus plan. The circular was mailed to shareholders of the company on May 20, 2025, and includes the full text of the omnibus plan. The omnibus plan has since been amended in accordance with certain comments provided by the TSX Venture Exchange.

The TSX-V amendments to the omnibus plan are mostly housekeeping alterations and do not affect the rights of the company's securityholders.

Substantively, the following text was deleted from Section 2.4.3 of the omnibus plan, " ... and in the event all of the convertible securities of the company are exercised/converted after the date hereof and on or before the effective date, such 10-per-cent amount could be a maximum of 10,409,936."

Section 2.4.3 of the omnibus plan now notes that the maximum number of common shares reserved for issuances and settlement of restricted share units (RSUs) (as defined in the omnibus plan) and restricted shares (as defined in the omnibus plan) are fixed at 10 per cent of the issued and outstanding common shares as at the date of implementation of the omnibus plan on an undiluted basis. Section 2.4.3 now reads, "Subject to adjustments pursuant to Article 7 hereof, the maximum number sf Shares that may be available and reserved for issuance and settlement of RSUs and restricted shares in the aggregate shall be fixed at 10 per cent of the issued and outstanding shares as of the effective date, which is currently anticipated to be 7,800,791."

Except as described above, the circular and the omnibus plan remain unchanged from the version that was mailed to shareholders of the company. A copy of the omnibus plan incorporating the TSX-V amendments is available on SEDAR+. Shareholders may also contact the company to request free printed copies of the omnibus plan with the TSX-V amendments.

About Nurexone Biologic Inc.

Nurexone is a TSX-V-, 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, both multibillion-dollar markets. Regulatory milestones, including obtaining the orphan drug designation, facilitates the 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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