TORONTO and HAIFA, Israel, Aug. 31, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biotechnology company developing exosome-based regenerative therapies, is pleased to announce its financial results for the second quarter ended June 30, 2026 (“Q2”), and to 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, 2026, 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.
Q2 2026 and Subsequent Highlights
- Proposed U.S. Manufacturing Collaboration and Technology Transfer: On August 12, 2026, the Company and Exo-Top entered into a binding memorandum of understanding (“MOU”) with New Jersey-based Made Scientific, Inc. establishing an interim framework for a proposed U.S. Good Manufacturing Practice (“GMP”) manufacturing collaboration for bone-marrow-derived exosomes. Technical documentation transfer has commenced. The parties are targeting initial GMP exosome batches in the first half of 2027, subject to execution of a definitive agreement, successful technology transfer, approved statements of work and satisfaction of applicable technical, quality, regulatory and stock-exchange requirements.
- Commercial Activity in Mexico: On June 24, 2026, subsidiary Exo-Top Inc. entered into a binding memorandum of understanding with ExoLyra LLC (“ExoLyra”) setting out the principal commercial terms for a proposed definitive distribution agreement, including exclusive rights to market, import and sell specified naïve MSC-derived exosome products in Mexico for an initial three-year term, supported by a US$180 thousand territorial exclusivity fee and minimum purchase commitments.
- ExoPTEN Development: The Company continued activities intended to support a potential investigational new drug (“IND”) submission in the first half of 2027, subject to completion of applicable preclinical, manufacturing, quality and regulatory work and regulatory review. The Company also expanded its preclinical data package, including results announced on August 14, 2026 showing statistically significant higher numbers of myelin-positive cells in ExoPTEN-treated spinal-cord-injury animal models compared with controls.
- Global Intellectual Property Portfolio Expansion: The Company expanded its international patent portfolio with a Notice of Patent Grant from the Korean Ministry of Intellectual Property on May 19, 2026, covering ExoPTEN, alongside the issuance of Australian Patent No. 2020303456 on April 27, 2026, covering extracellular vesicle bioproduction from stem cells.
- European Recognition & Program Advancement: On May 14, 2026, the Company was selected to advance to Stage 2 of the European Union-backed EIT Health Catapult Programme 2026, providing strategic mentoring and European investor exposure.
- Corporate Governance & Shareholder Meeting: Appointed Mr. David Stolick to the Board of Directors on July 28, 2026; and called an annual general and special meeting of shareholders for September 15, 2026 to ask shareholders to consider a proposed share consolidation of up to 30 pre-consolidation common shares for each one post-consolidation common share.
- Private Placement Financings:
- On June 26, 2026, the Company closed a non-brokered private placement of 1,012,573 units at C$0.62 per unit, for aggregate gross proceeds of approximately US$441 thousand (C$628 thousand), which the Company indicated would be used for general working capital purposes.
- Subsequent to quarter-end, on August 20, 2026, the Company closed an additional non-brokered private placement of 1,938,326 units at C$0.55 per unit, for aggregate gross proceeds of approximately US$762 thousand (C$1,066 thousand), which the Company indicated would be used for general working capital purposes.
Second Quarter 2026 Financial Results
- Research and development expenses, net, were US$0.75 million in the second quarter of 2026, compared to US$0.70 million in the same quarter of 2025. The increase was primarily driven by higher material purchases and development activity related to ExoPTEN product advancement.
- General and administrative expenses were US$0.93 million in the second quarter of 2026, compared to US$1.13 million in the same quarter of 2025. The decrease was mainly driven by reductions in professional services and legal costs, partially offset by share-based compensation expenses
- Net financial expenses were US$0.01 million in the second quarter of 2026, compared to US$0.02 million in the same period of 2025. The change was primarily driven by lower foreign currency translation adjustments and revaluation adjustments on royalty liabilities.
- Net loss for the second quarter of 2026 was US$1.68 million, compared to a US$1.85 million in the same quarter of 2025.
Management Commentary
“We are taking steps intended to address manufacturing scale-up and quality requirements across our therapeutic and commercial exosome platforms in a rigorous, validation-led manner. We are advancing U.S. tech transfer planning under our partnership with Made Scientific toward GMP-compliant manufacturing with initial exosome batches targeted for H1 2027. In parallel, we are expanding the ExoPTEN preclinical data set. Together, these steps are intended to support a potential IND submission in the first half of 2027 and, subject to regulatory authorization and completion of the required development activities, subsequent first-in-human evaluation,” 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 proceeds from the Company’s June and August 2026 private placements provide additional working capital to support ExoPTEN development and the Company’s operations, and we remain disciplined in aligning spending with the Company’s development and operational priorities,” said Eran Ovadya, Chief Financial Officer of NurExone Biologic Inc.
About NurExone
NurExone is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve damage. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitate the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: nurexone@russopartnersllc.com
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are often, but not always, identified by words and phrases such as “may”, “will”, “could”, “should”, “expect”, “intend”, “plan”, “anticipate”, “target”, “potential”, “proposed”, “subject to”, “position” and similar expressions.
Forward-looking statements in this press release include, without limitation, statements relating to: the Company’s plans and anticipated timing for technology transfer and initial GMP exosome batch production under the binding MOU with Made Scientific and the proposed definitive manufacturing collaboration contemplated thereby; negotiation and execution of a definitive agreement with Made Scientific and the expected scope and benefits of that collaboration; implementation, performance and expected benefits of the binding MOU with ExoLyra and any definitive distribution agreement entered into pursuant thereto, including commercial activities, territorial rights, fees and minimum purchase commitments; the Company’s planned activities and anticipated timing for a potential IND submission and subsequent first-in-human evaluation of ExoPTEN; the expected contribution of the Company’s preclinical results to its development and regulatory data package; the expected benefits of the Company’s intellectual-property portfolio and participation in the EIT Health Catapult Programme; the intended use of proceeds from the Company’s private placements; the proposed share consolidation and related shareholder and regulatory approvals; the expected scope, implementation and potential benefits of the Company’s bioprocess optimization initiative with Novasign GmbH; and the Company’s manufacturing, regulatory, clinical, commercialization and platform-development plans.
Forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release, including assumptions regarding: successful negotiation and execution of definitive agreements and statements of work; satisfactory completion of due diligence, technology transfer, process-development, validation, manufacturing, quality and regulatory activities; the availability of sufficient capital, personnel, manufacturing capacity, materials and third-party services on commercially reasonable terms; counterparties performing their obligations; preclinical results continuing to support the ExoPTEN development program; regulatory interactions and reviews proceeding on anticipated timelines; receipt of applicable shareholder and corporate approvals, regulatory approvals and acceptance of the TSXV; the Company’s ability to use financing proceeds as currently intended; and the accuracy and continued relevance of the Company’s publicly disclosed scientific, financial, manufacturing and regulatory information.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially, including, without limitation: the risk that definitive agreements or statements of work are not executed on acceptable terms or at all; technology-transfer, manufacturing scale-up, GMP, validation, quality-control and supply-chain risks; the risk that initial GMP batches are not produced within the targeted timeframe or do not satisfy applicable specifications; the risk that preclinical results are not predictive of clinical outcomes; the risk that an IND submission is delayed, not made or not authorized to proceed; the risk that first-in-human evaluation does not commence within the anticipated timeframe or at all; regulatory review and approval risks; financing, liquidity and market risks; dependence on counterparties, manufacturers, collaborators and suppliers; intellectual-property, competition and technological-change risks; the risk that the Novasign initiative does not proceed as contemplated or achieve its anticipated objectives; the risk that the commercial arrangements with ExoLyra or Made Scientific are not implemented or do not realize expected benefits; the risk that technology transfer is delayed, is not completed or does not produce the anticipated manufacturing outcomes; the risk that required shareholder or regulatory approvals, or acceptance of the TSXV, are not obtained; the risk that the proposed share consolidation is not approved by shareholders, is not accepted by the TSXV, is not implemented by the Board or does not result in the anticipated capital-markets benefits; and the risks described in the Company’s continuous disclosure filings available under the Company’s SEDAR+ profile at www.sedarplus.ca.
Readers are cautioned not to place undue reliance on forward-looking statements. Although the forward-looking statements contained in this press release are based on assumptions that management believes are reasonable as of the date hereof, actual results may differ materially. These forward-looking statements are made as of the date of this press release, and the Company undertakes no obligation to update or revise them except as required by applicable law.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
