Nurexone Biologic Inc - NRXBF STOCK NEWS

NurExone Biologic has been named to the 2025 TSX Venture 50™, a prestigious ranking of top-performing companies on the TSX Venture Exchange. The company stands out as the only biotech firm among three life sciences companies receiving this recognition, demonstrating its leadership in exosome-based therapies and regenerative medicine for central nervous system injuries.

The company achieved remarkable performance metrics, including 110% share price appreciation and 209% market cap growth. The TSX Venture 50™ selection process evaluated 1,605 listed issuers, with chosen companies showing exceptional performance across various metrics. In 2024, the selected companies averaged 207% share price appreciation.

Key achievements include progress in developing ExoPTEN, their proprietary exosome therapy for acute spinal cord injuries, and establishing U.S. subsidiary Exo-Top Inc. to enhance exosome production capabilities. The TSXV platform serves as a important foundation for early-stage, high-growth companies, with 80% of 2024's Venture 50™ companies operating internationally.

NurExone Biologic (TSXV: NRX) (OTCQB: NRXBF) has announced its upcoming presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in New Orleans from May 7-10, 2025. The company will showcase its innovative ExoPTEN therapy, presenting robust preclinical data that demonstrates significant improvements in motor and sensory functions in spinal cord injury animal models through minimally invasive treatment.

This presentation aligns with NurExone's U.S. expansion strategy, following the recent launch of its U.S. subsidiary, Exo-Top, which will focus on producing GMP-grade exosomes for both research and therapeutic applications. The company aims to supply these exosomes for its own product development and to third parties, strengthening its position in the U.S. market.

Dr. Tali Kizhner, Director of R&D, emphasized the importance of presenting to leading experts, while CFO Eran Ovadya highlighted how participation in prestigious events like ISCT 2025 supports their U.S. listing aspirations and strategy to increase shareholder value.

NurExone Biologic (TSXV: NRX) (OTCQB: NRXBF) has announced the formation of Exo-Top Inc., a U.S.-based subsidiary focused on GMP-grade exosome production. This strategic move follows NurExone's acquisition of a Master Cell Bank of Mesenchymal Stem Cells, providing a sustainable source for exosome production.

The new subsidiary will support NurExone's internal drug development and supply exosomes to pharmaceutical companies, biotech firms, and researchers worldwide, creating additional revenue streams. Exo-Top will operate independently without external licensing or royalty obligations, ensuring cost efficiency and strategic flexibility.

The company plans to pursue an uplisting from OTC to a major U.S. exchange, subject to regulatory approval. Established in Nevada, Exo-Top's U.S. location offers advantages including proximity to strategic partners and access to a robust biopharma ecosystem.

NurExone Biologic has successfully raised C$1.2 million through two financing initiatives: a C$479,917.76 non-brokered private placement of 856,996 units at C$0.56 per unit, and C$727,755.04 from the exercise of 2,140,456 Class A Warrants at C$0.34 per warrant.

The private placement units include one common share and one warrant, with each warrant exercisable at C$0.70 for 36 months, subject to acceleration conditions. The company will use the proceeds for working capital purposes.

Additionally, NurExone has appointed Dr. Tali Kizhner as Director of R&D. Dr. Kizhner brings over 15 years of experience in R&D and manufacturing, having previously worked at Biond Biologics and led FDA- and EMEA-approved treatments development at Protalix Biotherapeutics.

NurExone Biologic (TSXV: NRX, OTCQB: NRXBF) has acquired a master cell bank from a U.S. manufacturer for an undisclosed amount. The acquisition provides a GMP-grade source of human bone marrow mesenchymal stem cells (MSCs) for producing exosome-based therapies.

The master cell bank contains high-concentration MSCs at Passage Zero stage, ensuring long-term therapeutic potential. The cells are stored under FDA guidelines and GMP standards for clinical use. This strategic move positions NurExone to advance revenue-generating opportunities in therapeutic applications and drug delivery systems.

The fixed-price purchase agreement eliminates product royalty fees and annual licensing fees typically associated with commercial cells. The timing aligns with the FDA's recent approval of the first Mesenchymal Stromal Cell-based therapy, potentially paving the way for broader adoption in regenerative medicine.

NurExone Biologic has announced promising results from an expanded preclinical study of ExoPTEN for optic nerve damage repair. The study, conducted with the Goldschleger Eye Institute at Sheba Medical Center, showed significant recovery in treated eyes using a rodent model of optic nerve crush.

Key findings include:

• Treated eyes regained nearly normal retinal activity
• Clear recovery of signal transmission compared to untreated controls
• Enhanced survival of retinal ganglion cells
• Successful validation through OCT scans

The Optic Nerve Disorders treatment market is projected to grow from $5.54 billion in 2023 to $11.5 billion by 2032, with a CAGR of 8.46%. The company plans to advance to a larger animal study to validate these findings.

NurExone Biologic reported its Q3 2024 financial results with a net loss of US$1.25 million, compared to US$1.16 million in Q3 2023. R&D expenses increased to US$0.50 million from US$0.40 million year-over-year, while G&A expenses rose slightly to US$0.78 million. The company's cash position strengthened to US$2.52 million as of September 30, 2024, up from US$0.54 million at end-2023, primarily due to private placements and warrant exercises generating approximately US$5.98 million. The company received European Medicines Agency's Orphan Medicinal Product Designation for its ExoPTEN therapy for acute spinal cord injury treatment.

NurExone Biologic has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for its ExoPTEN therapy, designed to treat acute spinal cord injury. This designation provides significant benefits, including 10 years of market exclusivity upon approval, access to grants, and reduced costs for scientific advice. The therapy targets approximately 20,000 new cases of acute spinal cord injury annually in the European Union. ExoPTEN uses mesenchymal stem cell-derived extracellular vesicles loaded with siRNA targeting PTEN protein to promote nerve regeneration and functional recovery. This designation follows a similar recognition from the FDA, strengthening NurExone's global market position.

NurExone Biologic has completed the final tranche of its non-brokered private placement, raising $127,499.90 through the issuance of 231,818 Units at $0.55 per Unit. The total offering raised aggregate proceeds of $1,737,647.45 through 3,159,359 Units. Each Unit includes one Common Share and a Warrant exercisable at $0.70 for 36 months. The company will use proceeds for working capital and general corporate purposes. Additionally, NurExone has retained Independent Trading Group and Oak Hill Financial for market-making and advisory services at monthly fees of $5,000 and $10,000 respectively.