NurExone Biologic Inc. Announces Second Quarter 2025 Financial Result

(“NurExone” or the “Company”), a preclinical-stage biotechnology company pioneering exosome-based therapies for central nervous system injuries, is pleased to announce its financial results for the second quarter ended June 30, 2025 (“Q2”), and provide a corporate update on its recent activities and upcoming milestones.

The Company’s full set of unaudited condensed interim consolidated financial statements for the six months ended June 30, 2025, and accompanying management's discussion and analysis can be accessed by visiting the Company’s website at www.nurexone.com and its SEDAR+ profile at www.sedarplus.ca.

Key Business Highlights

  • C$2.3 million raised through Private Placement: On April 10, 2025, NurExone completed a non-brokered private placement of 3,543,238 units (each, a “April 2025 Unit”) at a price of C$0.65 per April 2025 Unit, raising gross proceeds of approximately C$2.3 million (the “April 2025 Offering”). Each April 2025 Unit consisted of (i) one common share in the capital of the Company (each, a “Common Share”), and (ii) one Common Share purchase warrant (each, a “April 2025 Warrant”). Each April 2025 Warrant entitles the holder thereof to purchase one Common Share at a price of C$0.85 per Common Share for a period of 36 months. The proceeds from the April 2025 Offering will be used primarily for working capital, and also to support general corporate purposes and clinical development activities.

  • Research and development and regulatory pathway. On May 30, 2025, at the American Spinal Injury Association (“ASIA”) Annual Meeting, the Company outlined plans to initiate a Phase 1/2a trial of ExoPTEN for acute spinal cord injury in 2026, subject to regulatory clearances.

  • Clinical readiness and manufacturing. On June 4, 2025, NurExone reported new manufacturing process validation data derived from its proprietary Master Cell Bank, supporting scalability and consistency of exosome production and intended tech transfer to U.S. subsidiary Exo-Top Inc. (“Exo-Top”) for Good Manufacturing Practices (“GMP”) manufacturing.

  • Strategic programs and visibility. On June 20, 2025, the Company was accepted into Advanced Regenerative Manufacturing Institute’s (“ARMI”) HealthTech Hub Accelerator to support U.S. growth and manufacturing strategy. During Q2, the Company also participated in investor and scientific venues, including the spinal cord injuries Investors Symposium (co-presented by the Christopher & Dana Reeve Foundation) on June 27, 2025.

Second Quarter 2025 Financial Results

  • Research and development expenses, net, were US$0.70 million in the second quarter of 2025, compared to US$0.51 million in the same quarter of 2024. The increase was primarily due to US$0.09 million in higher service provider costs and related stock-based compensation, US$0.06 million in materials and other costs, and US$0.04 million in salaries and employee stock-based compensation.

  • General and administrative expenses were US$1.13 million in the second quarter of 2025, compared to US$0.81 million in the same quarter of 2024. The increase was mainly driven by US$0.14 million in salaries and employee stock-based compensation, US$0.13 million in higher service provider costs and related stock-based compensation, and US$0.05 million in fees and other costs.

  • Net financial expenses were US$0.02 million in the second quarter of 2025, compared to US$0.01 million in the same period of 2024.

  • Net loss for the second quarter of 2025 was US$1.85 million, compared to a US$1.33 million in the same quarter of 2024.

Corporate Highlights and Business Update

  • GMP-Readiness: Advanced manufacturing readiness anchored by the Company’s Master Cell Bank.

  • Tech Transfer & Investigational New Drug Application (“IND”) Pathway: Continued planning for U.S. tech transfer to Exo-Top, progressed pre-IND/IND-enabling activities and towards first-in-human evaluation, subject to regulatory review.

  • Preclinical Package Expansion: Broadened the preclinical package with additional analyses, yielding a robust, decision-relevant body of evidence aligned with the development plan.

  • Scientific & Strategic Engagements: Presented findings at leading spinal cord forums (ASIA Annual Meeting and a Christopher & Dana Reeve Foundation forum) and were selected for ARMI’s HealthTech Hub Accelerator to support U.S. strategy and partnerships.

Management Commentary

“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,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone.

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,” said Eran Ovadya, Chief Financial Officer of NurExone.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com 

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NurExone Biologic Announces Preclinical Evidence of Structural Repair in Injured Spinal Cord Tissue following ExoPTEN Treatment