NurExone Biologic Inc. Announces Fourth Quarter and Full-Year 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

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.

Positive

• Successful completion of C$2.3M private placement strengthening capital position
• Advancement in ExoPTEN regulatory pathway towards IND application
• Expanded potential market with positive preclinical results in optic nerve damage treatment
• Establishment of in-house laboratory facilities enhancing research capabilities

Negative

• Increased net loss to US$5.04M in 2024 from US$3.64M in 2023
• Higher operating expenses with R&D costs up 21% and G&A expenses up 48%
• Low cash position of US$0.70M as of December 2024
• No revenue generation as company remains in R&D stage

TORONTO and HAIFA, Israel, April 10, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to provide a business update and reported financial results for the fourth quarter and financial year ended December 31, 2024.

The Company’s audited consolidated financial statements for the fiscal years ended December 31, 2024 and 2023 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.

Fourth Quarter Highlights and Significant Milestones

• Advancement of ExoPTEN Therapy: In Q4 2024, the Company achieved a significant milestone by advancing the regulatory pathway for ExoPTEN, its lead exosome-based therapy for acute Spinal Cord Injury. Building on successful preclinical advancements and productive interactions with the U.S. Food and Drug Administration (“FDA”), the Company is actively working to expedite the submission of an Investigational New Drug ("IND") application. This includes refining the necessary preclinical data, addressing FDA feedback, and ensuring all regulatory requirements are met to facilitate a smooth transition into clinical trials.​
• Supply Chain Reinforcement: The Company acquired a master cell bank, securing a reliable source of critical raw materials, strengthening its manufacturing process and supply chain in preparation for upcoming clinical studies and future patient treatments.
• R&D Expansion: The Company continued its research and development expansion by establishing in-house laboratory and office facilities, enhancing its research capabilities. The facility has been completed and fully operational since October 2024.
• Study of Second Indication for ExoPTEN Therapy: In Q4 2024, the Company announced results of an expanded preclinical study further demonstrating the potential of ExoPTEN for repairing optic nerve damage. This suggests a promising treatment pathway for glaucoma, the leading cause of irreversible blindness globally.
• Financial Strengthening: NurExone successfully raised approximately C$0.24 million in proceeds from the closing of a second tranche of a non-brokered private placement and warrant exercises, strengthening its financial position and supporting ongoing development initiatives, as follows:
  • Private Placement: In November 2024, the Company completed a second tranche of a non-brokered private placement, issuing 231,818 units at C$0.55 per unit, raising aggregate gross proceeds of C$127 thousand. Each unit comprised one common share and one common share purchase warrant exercisable at C$0.70, subject to acceleration.
  • Common Share Purchase Warrant Exercises: In Q4-2024, the Company received approximately C$114 thousand from the exercise of 324,77 common share purchase warrants at C$0.35 per warrant.
    

Dr. Lior Shaltiel, CEO of NurExone, stated: “Our progress in 2024 underscores our commitment to advancing exosome-based regenerative medicine. The groundwork laid this year, including key regulatory steps, R&D expansion, and financing activities, positions us well for the next phase of clinical development. We remain focused on bringing transformative therapies to patients.”

Eran Ovadya, CFO of NurExone, remarked: “Our strong financial management and recent capital raise of C$2.3 million have provided us with the necessary resources to advance our strategic priorities - most notably, the establishment of a U.S. production facility to accelerate our drug pipeline and preparing for an uplisting to a major U.S. exchange. With our current funding, we are well-positioned to support operations and achieve key development milestones in 2025.”

Full Year and Fourth Quarter 2024 Financial Results

• Research and development expenses, net, were US$1.87 million in 2024, compared to US$1.54 million in 2023. For Q4-2024, expenses were US$0.63 million, compared to US$0.30 million in the previous year, reflecting increased investment in preclinical and regulatory preparations.
• General and administrative expenses were US$3.14 million in 2024, compared to US$2.12 million in 2023. For Q4-2024, expenses were US$0.85 million, compared to US$0.40 million in the previous year, as the Company streamlined operations while continuing to support strategic growth.
• Financial income/expenses, net, were US$0.03 million of expense in 2024, compared to US$0.02 million of income in 2023. For the fourth quarter of 2024, financial expenses were US$0.06 million, compared to US$0.02 million in the previous year. The change was primarily due to fluctuations in currency exchange rates, and interest expenses.
• Net loss for 2024 was US$5.04 million, compared to US$3.64 million in 2023. For the fourth quarter of 2024, net loss was US$1.55 million, compared to US$0.74 million in the previous year. The change is primarily reflecting increased R&D spending and corporate development activities.
• Cash position: As of December 31, 2024, the Company had total cash and equivalents of US$0.70 million, compared to US$0.54 million as of December 31, 2023. The change is primarily attributed to capital raised through warrant exercises and private placements, offset by operational expenditures.
• The Company remains in the research and development stage and has not yet commercialized any products or generated significant revenue.

Corporate Updates

Closing of April 2025 Offering

The Company is pleased to announce that, further to its press release dated April 4, 2025 (the “April 4 Release”), it has received approval from the TSXV to close its non-brokered private placement (the “April 2025 Offering”) and has formally closed the April 2025 Offering effective today, raising aggregate gross proceeds of C$2,303,105 through the issuance of an aggregate of 3,543,238 Units at a price of C$0.65 per Unit. Capitalized terms not otherwise defined herein have the meanings attributed to them in the April 5 Release.

Each Unit consists of one Common Share and 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.

All securities issued under the April 2025 Offering are subject to a statutory hold period of four months and one day from the closing of the April 2025 Offering and applicable U.S. legends.

The Company intends to use the proceeds of the April 2025 Offering for working capital, ExoTop’s establishment of a U.S. production facility, and an uplisting to a major U.S. exchange, subject to requisite regulatory approval.

Engagement of POSITIVE Communications

The Company is pleased to announce that, subject to TSXV approval, it has retained the services of POSITIVE Communications (“POSITIVE”) to support the Company’s efforts to raise awareness and generate exposure for the Company and its achievements.

POSITIVE is a boutique public relations agency based in Tel Aviv, Israel. POSITIVE has been engaged for an initial six month term for a monthly fee of NIS 15,000, plus VAT.

Either party has the right to terminate the agreement upon providing 30-days’ notice POSITIVE does not currently have a direct or indirect interest in the securities of the Company. While POSITIVE has no intention of acquiring any additional securities of the Company at this time, it may do so in the future in compliance with applicable securities laws and TSXV policies.

Outlook for 2025

NurExone remains focused on advancing its exosome-based therapy pipeline, with key priorities including the completion of IND-enabling studies, engagement with regulatory agencies, and the initiation of first-in-human clinical trials. The Company is also working towards establishment of a U.S. footprint with GMP-compliant, fully characterized production, and exploring strategic partnerships to accelerate commercialization efforts.

About NurExone

NurExone Biologic Inc. is a 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

Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations – Canada
Phone: +1-647-479-5803
Email: info@oakhillfinancial.ca

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 use of proceeds from the April 2025 Offering; the Company receiving all regulatory approvals; the Company advancing towards clinical and commercial breakthroughs in regenerative medicine; the Company enhancing its presence in key markets; the Company’s plan to pursue an uplisting on a major U.S. stock exchange and the benefits thereof; the Company’s current expectations regarding future development plans, operational initiatives, and strategic objectives; the advancement of the Company’s therapeutic programs and clinical milestones; engagement with regulatory agencies; the expansion of infrastructure; potential commercial opportunities; POSITIVE will help the Company raise awareness, build its public reputation, generate exposure, and position it as a promising startup; the Company’s plan to launch an initial public offering; POSITIVE being engaged for six months; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

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 realizing on the benefits of exosomes; the Company will produce and supply exosomes for a wide range of applications; the ability of the Company’s products to be used for patient treatment; the Company fulfilling its intended future plans and expectations; there being growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; the Company carrying out its pre-clinical trials and realizing upon the benefits of the pre-clinical trials; the Company’s realizing upon the potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company maintaining its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will receive all regulatory approvals; the Company will use the proceeds from the April 2025 Offering as outlined herein; the Company will have clinical and commercial breakthroughs in regenerative medicine; the Company will enhance its presence in key markets; the Company will have the ability to uplist to a major U.S. exchange and realize on the benefits thereof; the Company will be able to realize its future development plans, operational initiatives, and strategic objectives; the Company’s ability to advance its therapeutic programs and clinical milestones; the Company’s ability to engage with regulatory agencies; the expansion of infrastructure; potential commercial opportunities; POSITIVE will have the ability to help the Company raise awareness, build its public reputation, generate exposure, and position it as a promising startup; the Company will have the ability to launch an initial public offering; POSITIVE will be engaged for six months; and the NurExone platform technology will offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

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; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the inability to obtain adequate financing; the inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to realize on the benefits of exosomes; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company’s products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the Company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the inability of the Company to collaborate with pharma companies; the Company’s inability to realize upon the stated potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company’s inability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and/or cell therapy applications; the Company’s inability to expand into further studies; the Company will not receive all required regulatory approvals; the Company will not use the proceeds from the April 2025 Offering as outlined herein; the Company will not have clinical and/or commercial breakthroughs in regenerative medicine; the Company will be unable to enhance its presence in key markets; the Company will not uplist to a major U.S. exchange and/or realize on the benefits thereof; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; the Company will not realize its future development plans, operational initiatives, and strategic objectives; the Company will not advance its therapeutic programs and clinical milestones; the Company will not engage with regulatory agencies; the company will not expand its infrastructure; no commercial opportunities for the Company to capitalize on; POSITIVE will not help the Company raise awareness, build its public reputation, generate exposure, or position it as a promising startup; the Company will not launch an initial public offering; POSITIVE not being engaged for six months; 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.

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ⁱ Spinal cord injury , Glaucoma

FAQ

What were NurExone's (NRXBF) key financial results for full-year 2024?

NurExone reported a net loss of US$5.04M, R&D expenses of US$1.87M, G&A expenses of US$3.14M, and ended with cash position of US$0.70M.

How much did NRXBF raise in its April 2025 private placement offering?

NurExone raised C$2.3M through the issuance of 3,543,238 Units at C$0.65 per unit, with each unit including one common share and one warrant exercisable at C$0.85.

What are the main development milestones for NRXBF's ExoPTEN therapy?

ExoPTEN advanced toward IND application submission, showed promising results for optic nerve damage treatment, and secured a master cell bank for manufacturing.

How will NRXBF use the proceeds from its April 2025 offering?

Proceeds will fund working capital, establishment of a U.S. production facility, and planned uplisting to a major U.S. exchange.