Nurexone Biologic Inc Stock Price, News & Analysis

NurExone Biologic (OTCQB: NRXBF) has announced promising preclinical results for its ExoPTEN treatment for spinal cord injury. The study demonstrated that 100% of animals in the high-dose group regained motor function, compared to 50% in the medium-dose group and only 1 out of 6 rats in the control group.

Using the advanced CatWalk XT system for precise measurements, researchers observed significant improvements in multiple walking parameters. High-dose treated animals showed enhanced balance, strength, coordination, and weight bearing during walking, with larger paw print areas, greater maximal contact area, wider base of support, and extended paw contact duration. Importantly, the high dose was well-tolerated with no observed side effects.

The company plans to conduct additional studies exploring alternative dosing regimens while advancing manufacturing process optimization as it prepares for regulatory submissions and first-in-human clinical trials.

NurExone Biologic Inc. (NRXBF) has been accepted into the prestigious HealthTech Hub Accelerator Program in Boston, operated by ARMI and Mass General Brigham. This strategic move supports NurExone's U.S. expansion following the establishment of Exo-top Inc., its U.S. subsidiary for GMP-compliant exosome manufacturing. The HTH program, funded at no cost to participants, will help NurExone validate U.S. clinical relevance and strengthen commercialization strategies. Additionally, the company announced shareholder approval of its amended Omnibus Plan, a hybrid 10% rolling and 10% fixed share-based compensation plan, replacing the previous 20% fixed plan. The new plan allows for increased securities issuance to insiders up to 20% and includes options, restricted shares, and RSUs. The company also granted 1,125,000 RSUs to officers and directors, vesting after one year.

NurExone Biologic Inc. (NRXBF) has presented new manufacturing process validation data for its ExoPTEN therapy at the ISEVR conference on May 22, 2025. The data revealed strong performance of cells from the company's Master Cell Bank (MCB), showing a population doubling time of 20.4hr±1.56 for up to 9 passages, indicating robust proliferative capacity. The MCB validation strengthens NurExone's path toward GMP-compliant manufacturing of exosomes for ExoPTEN, their lead therapeutic candidate targeting neurological conditions including spinal cord injury. The company plans to transfer manufacturing to its U.S. subsidiary, Exo-Top, and aims to initiate first human clinical trials in 2026. Additionally, NurExone is seeking shareholder approval for an amended omnibus incentive plan at their upcoming June 18, 2025 meeting, with minor TSXV-requested amendments to the plan's share reservation provisions.

NurExone Biologic announced its plans to initiate Phase 1/2a clinical trials in 2026 for ExoPTEN, their innovative exosome-based therapy for acute spinal cord injuries. Professor Nahshon Knoller, senior clinical advisor and former Director at Sheba Medical Center, will present the trial plans and preclinical results at the American Spinal Injury Association annual meeting. The Phase 1 trial will evaluate safety in up to 18 patients, followed by a Phase 2a randomized, double-blind, placebo-controlled trial with 10-15 patients. ExoPTEN, which has received Orphan Drug Designation from both FDA and EMA, uses mesenchymal stem cell-derived exosomes loaded with PTEN-targeting siRNA to promote neural regeneration. Preclinical studies have demonstrated significant recovery in motor and sensory function in rat models.

NurExone Biologic Inc. (NRXBF) reported its Q1 2025 financial results and corporate updates. The company raised total funds of C$3.65 million through various initiatives including private placements and warrant exercises. Q1 financial highlights show increased R&D expenses of US$0.62 million (vs US$0.23M in Q1 2024) and G&A expenses of US$1.08 million (vs US$0.70M in Q1 2024), resulting in a net loss of US$1.68 million. Notable achievements include inclusion in the 2025 TSX Venture 50™ list with 110% share price appreciation, formation of U.S. subsidiary Exo-Top Inc., and advancement of ExoPTEN program with promising preclinical results in spinal cord, optic nerve, and facial nerve injuries. The company plans to initiate first-in-human trials for ExoPTEN in 2026 and is pursuing an uplisting to a major U.S. stock exchange.

NurExone Biologic Inc. (NRXBF) presented promising preclinical data on optic nerve regeneration at the ARVO 2025 conference in Salt Lake City. The study, led by Prof. Ygal Rotenstreich, demonstrated that ExoPTEN successfully restored retinal activity and improved optic nerve structure in rat models with optic nerve compression.

The company is advancing its ExoTherapy™ platform, which includes programs for spinal cord and facial nerve regeneration. Previous preclinical spinal cord studies showed ExoPTEN restored motor function in 75% of animals following complete transection. The company is now proceeding to study the therapy in a glaucoma model, targeting a condition that causes significant economic burden to healthcare systems.

NurExone Biologic (NRXBF) has announced breakthrough findings in facial nerve regeneration using their ExoPTEN therapy, marking their third therapeutic indication alongside spinal cord injury and optic nerve regeneration programs. Preclinical studies demonstrated significant functional recovery in facial nerve injury models, potentially addressing conditions like Bell's palsy and Ramsay Hunt Syndrome.

The research, conducted at the Israel Institute of Technology, validates PTEN downregulation as a strategy for axon regrowth. The therapy could target a market where approximately 30% of patients experience long-term functional impairment. The company's ExoTherapy platform utilizes exosomes for precise, minimally-invasive delivery of treatments to injured tissues.

NurExone is preparing an Investigational New Drug (IND) application for ExoPTEN in acute spinal cord injury. The technology is protected by a U.S. patent owned by the Technion, with worldwide exclusive licensing to NurExone, and has been granted in Japan, Russia, and Israel.

NurExone Biologic (TSXV: NRX) (OTCQB: NRXBF) has appointed Jacob Licht as CEO of Exo-Top Inc., its wholly owned subsidiary, and as Vice President of Corporate Development. Exo-Top will serve as a U.S.-based GMP-compliant exosome manufacturing facility, important for NurExone's global supply chain and commercialization strategy.

Licht brings over 20 years of biotech and specialty pharmaceuticals experience, having led transactions worth $1 billion across mergers, acquisitions, licensing, and asset sales. His previous roles include VP positions at Lantheus Medical Imaging, Bavarian Nordic, and Emergent BioSolutions.

Additionally, NurExone has completed its continuance from Alberta to Ontario, following shareholder approval at its June 3, 2024 meeting.

NurExone Biologic (NRXBF) reported its Q4 and full-year 2024 financial results, highlighting progress in its ExoPTEN therapy development for acute Spinal Cord Injury. The company's net loss widened to US$5.04M in 2024 from US$3.64M in 2023, with Q4 2024 net loss at US$1.55M.

Key developments include advancement of ExoPTEN's regulatory pathway towards IND application, establishment of in-house laboratory facilities, and promising preclinical results for treating optic nerve damage. The company's cash position stood at US$0.70M as of December 31, 2024.

Financial highlights show R&D expenses increased to US$1.87M in 2024 (vs US$1.54M in 2023), while G&A expenses rose to US$3.14M (vs US$2.12M). The company recently closed an April 2025 Offering raising C$2.3M through private placement at C$0.65 per unit, with proceeds intended for working capital, U.S. production facility establishment, and planned uplisting to a major U.S. exchange.