TORONTO and HAIFA, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“ 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 first quarter ended March 31, 2025, and provides a corporate update on its recent activities and upcoming milestones.
The Company’s full set of unaudited condensed interim consolidated financial statements for the three months ended March 31, 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
- Inclusion in the 2025 TSX Venture 50™ list of top-performing companies on the exchange
On February 19, 2025, NurExone announced its inclusion in the 2025 TSX Venture 50™, a prestigious annual ranking of the top-performing companies on the TSX Venture Exchange (“TSXV”). NurExone is the only biotech company, and one of two life sciences companies, to receive this designation, highlighting NurExone’s leadership in the emerging field of exosome-based therapies and regenerative medicine for central nervous system injuries. This recognition also highlights NurExone’s strong market performance and strategic advances in the past year, including 110% share price appreciation and a 209% increase in market cap.
- Formation of U.S. Subsidiary, Exo-Top Inc.
On February 4, 2025, NurExone established Exo-Top Inc. (“Exo-Top”), a wholly owned U.S.-based subsidiary focused on the production and commercialization of exosomes. Exo-Top will operate independently, free from external licensing or royalty obligations, providing strategic flexibility and cost efficiency as NurExone advances its therapeutic pipeline and establishes new commercial collaborations. In April 2025, biotech industry veteran, Mr. Jacob Licht, was appointed Chief Executive Officer of Exo-Top.
- C$480 thousand raised through Private Placement
On January 21, 2025, the Company completed a non-brokered private placement of 856,996 units at $0.56 per unit, raising approximately C$480 thousand. Each unit consisted of one common share in the capital of the Company (“Common Share”) and one Common Share purchase warrant (“Warrant”) exercisable at $0.70 per Common Share for a period of 36 months, subject to certain acceleration provisions as discussed in the January 21, 2025, press release.
- C$866 thousand raised through Warrant Exercises
On January 21, 2025, following the Company providing the outstanding class A Warrant (each, a “Class A Warrant”) holders an acceleration notice on December 17, 2024 that the Class A Warrant acceleration trigger was met, 2,140,456 Class A Warrants were exercised at a price of $0.34 per Class A Warrant, raising approximately C$728 thousand in gross proceeds.
Additionally, the Company raised approximately C$138 thousand through the full exercise of 393,625 Warrants at $0.35 per Warrant.
First Quarter 2025 Financial Results
- Research and development expenses, net, were US$0.62 million in the first quarter of 2025, compared to US$0.23 million in the same quarter in 2024. The increase was primarily due to US$0.20 million in non-cash stock-based compensation and US$0.19 million in higher subcontractor, materials, and related costs.
- General and administrative expenses were US$1.08 million in the first quarter of 2025, compared to US$0.70 million in the same quarter in 2024. The increase was primarily due to US$0.20 million in non-cash stock-based compensation and US$0.18 million in higher legal and professional services.
- Net Finance income was US$0.02 million in the first quarter of 2025, compared to finance income of US$0.01 million in the same period in 2024, primarily due to the revaluation of royalty liability.
- Net loss for the first quarter of 2025 was US$1.68 million, compared to a net loss of US$0.92 million in the same quarter of 2024.
Corporate Highlights and Business Update
- C$2.3 million raised through Private Placement: On April 22, 2025, NurExone completed a non-brokered private placement of 3,543,238 units, raising gross proceeds of approximately C$2.3 million (the “April 2025 Offering”). Each Unit consisted of (i) one Common Share, and (ii) one Warrant. Each 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 to advance clinical development activities, including the ExoPTEN program, and to support general corporate and operational purposes.
- Advancement of ExoPTEN Program: The Company reported significant momentum across its development pipeline. Investigational new drug-enabling studies for ExoPTEN, NurExone’s lead exosome-based therapy, is expected to enter first-in-human trials in 2026. In parallel, the Company showcased new preclinical data on optic nerve regeneration at the 2025 Association for Research in Vision and Ophthalmology Annual Meeting and unveiled promising results in facial nerve repair at the 2025 International Society for Extracellular Vesicles Annual Conference (together, the “Conferences”). The data presented at the Conferences demonstrate functional recovery across multiple injury models and continue to validate the broad therapeutic potential of the ExoPTEN platform.
CEO Commentary
“We’ve now demonstrated functional recovery with minimally invasive administration of ExoPTEN across spinal cord, optic nerve, and facial nerve injuries—each representing large, high-value markets,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “As we advance our scientific programs, we’re also preparing for first-in-human trials, and are focusing on building a robust foundation across manufacturing, regulatory, and strategic partnerships.”
CFO Commentary
“Our financial results for the first quarter reflect disciplined investment in our clinical programs and infrastructure,” said Eran Ovadya, Chief Financial Officer of NurExone. “The successful private placement and warrant exercises have strengthened our cash position, enabling us to advance the ExoPTEN program and scale our manufacturing capabilities. We remain committed to prudent financial management as we progress toward key value-driving milestones in 2025, including a planned uplisting to a major U.S. stock exchange.”
About NurExone
NurExone Biologic Inc. 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 injury, both multi-billion-dollar markets i . Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the 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 Inc., a U.S. subsidiary, 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
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the Company maintaining all regulatory approvals; the Company advancing towards clinical and commercial breakthroughs in regenerative medicine; the Company enhancing its presence in key markets; the advancement of the Company’s therapeutic programs and clinical milestones; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for spinal cord injury (“SCI”); the Company developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN having the potential to address vision loss and improve patient lives; the Company is advancing toward clinical translation in several high-impact indications; the intended benefits of Exo-Top’s establishment; Exo-Top will operate independently; the use of proceeds from the April 2025 Offering; the data presented at the Conferences continue to validate the broad therapeutic potential of the ExoPTEN platform; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the Company will be able to successfully carry out its preclinical studies and progress its drug product candidates toward human clinical trials; that its exosome-based technologies, including ExoTherapy and ExoPTEN, will demonstrate potential in regenerating or repairing damaged nerves and addressing vision loss; that the Company’s product candidates will ultimately be safe and effective for patient treatment; that the Company will be able to realize on the anticipated benefits of its preclinical programs and proprietary technology platforms; that there will be growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; that the Company will be able to execute on its business and development plans, including advancing its therapeutic programs, achieving clinical milestones, and expanding into additional indications; that the Company will be able to maintain key strategic relationships and attract qualified personnel; that the Company will obtain the necessary regulatory approvals without unexpected delays or limitations; that the regenerative medicine and targeted drug delivery markets will continue to evolve in a manner that supports the Company’s growth and commercialization objectives; the Company will have the ability to advance toward clinical translation in several high-impact indications; that Exo-Top’s establishment will have the intended benefits on the Company and its business; that Exo-Top will have the ability to operate independently; the Company will use the proceeds from the April 2025 Offering as outlined herein; the data presented at the Conferences validating the broad therapeutic potential of the ExoPTEN platform; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development and lack of revenues to date; the uncertainty of preclinical research and the risk that the Company’s product candidates may never advance to clinical trials; preclinical and early-stage clinical results may not be predictive of outcomes in later-stage trials; the uncertain outcome, cost, and timing of product development activities, including preclinical studies and clinical trials; delays or failures in the design, initiation, conduct, or completion of clinical trials; the inability to obtain or maintain required regulatory approvals in a timely manner or at all; the Company’s NurExone technology platform, including the possibility that its exosome-based therapies may not be safe, effective, or commercially viable; the inability of the Company’s drug product candidates to be successfully used for patient treatment; manufacturing and supply chain challenges, including the inability to produce or supply exosomes at scale for research or clinical use; market uncertainty and the risk that the Company’s products will not achieve market acceptance or broader adoption in regenerative medicine or cell therapy applications; the introduction of competing products that are safer, more effective, more affordable, or otherwise superior to the Company’s candidates; the Company being unable to obtain, maintain, or enforce adequate intellectual property protection for the its technologies; the Company’s intellectual property or proprietary technology may not achieve its intended impact; the Company’s reliance on the expertise and continued contributions of key personnel; the Company’s dependence on strategic partners, including pharmaceutical collaborators, and the risk of being unable to enter into or maintain such partnerships; the Company’s inability to execute on its development plans, operational goals, and strategic objectives; the inability to expand into additional therapeutic areas or pursue further studies as anticipated; the Company’s inability to engage effectively with regulatory agencies throughout the development and approval process; the possibility that the results of preclinical trials will not provide a promising treatment pathway for spinal cord and optic nerve injury or other indications; the risk that there may not be growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the Company’s inability to enhance its presence in key markets; the need for additional financing, which may not be available on favorable terms or at all; Exo-Top’s establishment will not have the intended benefits on the Company and/or its business; Exo-Top will not operate independently; the Company will not use the proceeds from the April 2025 Offering as outlined herein; the data presented at the Conferences not validating the broad therapeutic potential of the ExoPTEN platform; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by 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.
