NurExone Biologic Inc. Announces Second Quarter 2025 Financial Results

Executive Summary

• NurExone Biologic Inc. released its financial results for the second quarter ended June 30, 2025, reporting a net loss of US$1.85 million, an increase from US$1.33 million in the same period of 2024.
• The company highlighted a C$2.3 million private placement completed in April 2025, raising gross proceeds of approximately C$2.3 million to support working capital and clinical development.
• Key operational updates include plans to initiate a Phase 1/2a trial of ExoPTEN for acute spinal cord injury in 2026, validation of manufacturing processes for scalability, and acceptance into the Advanced Regenerative Manufacturing Institute’s HealthTech Hub Accelerator.

Key Details

• Financial Results (Q2 2025 vs. Q2 2024):
  • Net Loss: US$1.85 million (vs. US$1.33 million).
  • R&D Expenses: US$0.70 million (vs. US$0.51 million), driven by higher service provider costs, materials, and stock-based compensation.
  • G&A Expenses: US$1.13 million (vs. US$0.81 million), driven by salaries, stock-based compensation, and service provider costs.
  • Net Financial Expenses: US$0.02 million (vs. US$0.01 million).
• Financing Details (April 2025 Offering):
  • Structure: Non-brokered private placement of 3,543,238 units.
  • Price: C$0.65 per unit.
  • Gross Proceeds: Approximately C$2.3 million.
  • Warrant Terms: Each unit included one common share purchase warrant exercisable at C$0.85 per share for a period of 36 months.
  • Use of Proceeds: Working capital, general corporate purposes, and clinical development activities.
• Clinical & Regulatory Updates:
  • Trial Timeline: Plans to initiate a Phase 1/2a trial of ExoPTEN for acute spinal cord injury in 2026, subject to regulatory clearances.
  • IND Pathway: Continued progress on pre-IND/IND-enabling activities and U.S. tech transfer to subsidiary Exo-Top Inc. for GMP manufacturing.
  • Preclinical Data: Expanded preclinical package with additional analyses to support the development plan.
• Manufacturing & Operations:
  • Process Validation: Reported new manufacturing process validation data from the proprietary Master Cell Bank, supporting scalability and consistency of exosome production.
  • Tech Transfer: Progressing toward tech transfer to Exo-Top for GMP manufacturing.
• Strategic Partnerships & Events:
  • ARMI Accelerator: Accepted into the Advanced Regenerative Manufacturing Institute’s (ARMI) HealthTech Hub Accelerator on June 20, 2025, to support U.S. growth and manufacturing strategy.
  • Conferences: Presented at the American Spinal Injury Association (ASIA) Annual Meeting (May 30, 2025) and the Christopher & Dana Reeve Foundation’s Spinal Cord Injuries Investors Symposium (June 27, 2025).

Notable Quotes

• Dr. Lior Shaltiel, CEO: “We are de-risking scale and quality in a rigorous, validation-led manner through our Master Cell Bank–based manufacturing process and advancing U.S. tech transfer planning toward GMP-compliant manufacturing at Exo-Top. In parallel, we are expanding the ExoPTEN preclinical data set. Together, these steps are intended to position ExoPTEN for first-in-human evaluation, subject to regulatory review.”
• Eran Ovadya, CFO: “In Q2, we continued to advance our preparations and operating activities, with expenses tracking in line with plan. The April 2025 Offering further strengthened our cash position to support ExoPTEN and the Company’s operations, and we remain disciplined in aligning spending with milestone objectives.”