Nurexone Biologic Inc Stock Price, News & Analysis

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.

NurExone Biologic has been invited to present at two major exosome science conferences in the United States this November. The company will participate in the American Academy for Extracellular Vesicles (AAEV) Conference in Houston from November 10-13 and the ISEV TECH Conference in Baltimore from November 21-23. These invitations highlight NurExone's growing influence in developing exosome-based therapies for spinal cord injuries and optic nerve damage. The conferences provide opportunities to showcase developments, connect with industry leaders, and establish a U.S. presence before entering clinical trials.

NurExone Biologic announced a non-brokered private placement of up to $2M, with a first tranche closing for $1.61M. The offering includes 3,636,363 units at $0.55 per unit, each comprising one common share and one purchase warrant. Warrants allow the purchase of one common share at $0.70 for 36 months, subject to acceleration if the average share price exceeds $1.05 for 10 consecutive trading days. Proceeds will be used for working capital. The offering may be a related party transaction but is expected to be exempt from certain formal requirements. All securities issued are subject to a statutory hold period of four months and one day.

NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) is set to participate in several prestigious conferences in October 2024, showcasing its advancements in exosome-based therapies for regenerative medicine. The company will sponsor and present at the World Orphan Drug Congress in Barcelona, highlighting its work on neuron regeneration for acute spinal cord injuries. Dr. Noa Avni will present at the Precision EV Forum 2024 in Cambridge, addressing translational challenges for therapeutic EVs. NurExone will also chair a session on GMP-compliant EV production.

Additionally, the company will present at the Israeli Society of Gene and Cell Therapy's meeting and the Bioprocess International Conference in Boston, where CEO Dr. Lior Shaltiel will discuss their ExoPTEN nanodrug for acute spinal cord injuries and other CNS conditions. These engagements aim to advance therapeutic exosomes and explore potential collaborations in the field.

NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) has announced promising results from a preclinical study of ExoPTEN for spinal cord injuries. The study demonstrated that ExoPTEN can effectively target and accumulate at injury sites up to one week after the injury occurred, potentially broadening the range of treatable patients and extending the window for effective treatment.

Key findings include:

• ExoPTEN showed strong homing capacity to injury sites even 7 days post-injury
• Later administration times resulted in higher levels of accumulation
• The highest accumulation was observed in subjects treated 7 days post-injury
• Results suggest a broad therapeutic window for intervention

These findings could significantly impact clinical trial design and patient care, offering hope for more flexible treatment regimens in spinal cord injury cases.