Dr. Lior Shaltiel reports
NUREXONE DEMONSTRATES REPRODUCIBLE, DOSE-DEPENDENT VISION RECOVERY IN PRECLINICAL GLAUCOMA MODEL
Nurexone Biologic Inc. has released new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma.
The study was conducted in collaboration with Prof. Ygal Rotenstreich team at the Goldschleger Eye Institute at Sheba Medical Center, one of the world's leading hospitals. It demonstrated that ExoPTEN's biological activity increases with higher dosing levels in animals with optic nerve injury, resulting in consistent and measurable recovery of visual function. The findings show that ExoPTEN's regenerative effect is reproducible, quantifiable and scales with dose.
"Reproducibility is the key challenge in science, and now we have a first validation of the results," said Prof. Michael Belkin, professor emeritus of ophthalmology at Tel Aviv University and scientific adviser to Nurexone. "These results confirm that ExoPTEN has the potential impact of a true therapeutic, producing reproducible repair of damaged optic nerves in small animals, advancing our ability to address vision loss in patients with optic nerve damage, such as glaucoma and related conditions."
Dr. Tali Kizhner, director of research and development at Nurexone, added: "We are seeing a clear, dose-dependent effect of ExoPTEN in the eye, with stronger functional recovery at higher doses. It highlights the one-two punch of our platform: exosomes that reach and protect neural tissue, and the siRNA cargo that switches on the regenerative response. This dose-response data marks an essential step toward future clinical trials and brings us closer to translating this therapy to patients."
This dose-response study, the third independent investigation of ExoPTEN's activity in optic nerve injury, complements the previously announced results from June, 2024, and December, 2024, which showed structural preservation and survival of retinal ganglion cells.
The optic nerve crush (ONC) model used in these experiments mimics the nerve damage that occurs in glaucoma, one of the leading causes of irreversible blindness. The researchers led by Prof. Rotenstreich, tested low and high doses of ExoPTEN delivered by extrachoroidal injection directly to the eye.
Functional measurements of retinal activity using scotopic threshold response electroretinography (STR-ERG) showed that both ExoPTEN doses improved visual signal strength in animals with optic nerve injury, with the high-dose group achieving response amplitudes comparable with those of uninjured eyes. This result demonstrates substantial functional recovery and provides clear evidence of a dose-dependent therapeutic effect that aligns with ExoPTEN's proposed biological mechanism.
"This collaboration opens a new treatment avenue for blinding glaucoma and other ophthalmological indications," commented Prof. Rotenstreich.
Warrant accelerations
In addition, the company is pleased to announce that further to its press releases dated Aug. 28, 2023, Sept. 6, 2023, and Jan. 5, 2024, the company is accelerating the expiration date (i) 2,515,456 Class B common share (as defined herein) purchase warrants issued and outstanding from the private placement which closed in tranches on Aug. 25, 2023, and Sept. 6, 2023, and (ii) 5,653,073 common share purchase warrants issued and outstanding from the private placement which closed on Jan. 4, 2024.
Each September, 2023, warrant is exercisable at a price of 48 cents per September, 2023, warrant and each January, 2024, warrant is exercisable at a price of 35 cents per January, 2024, warrant. If all of the September, 2023, warrants and January, 2024, warrants are exercised, the company will receive total gross proceeds of approximately $3.2-million. All funds received from exercises will be used for general corporate and working capital purposes.
The acceleration triggers were met after the daily volume-weighted average trading price of the company's common shares on the TSX Venture Exchange equalled or exceeded for a period of 20 consecutive trading days, in the case of the September, 2023, warrants, 83 cents, and in the case of the January, 2024, warrants, 80 cents.
Pursuant to the terms of the warrants and following the occurrence of the acceleration event, the company has provided notice to the warrant holders, thereby accelerating the expiry of the warrants. The warrants will now expire at 5 p.m. (Calgary time) on Nov.
7, 2025, which is 30 days from the date of the acceleration notice. If the warrants are not exercised by such time, they will expire and be of no further force or effect.
Approximately 89
per cent of the warrants are held by United States-based investors. The underlying shares issued upon exercise of these warrants will remain restricted under applicable U.S. securities laws.
Positive
communications
agreement extended
Further to the company's press release dated April 10, 2025, the company has, subject to TSXV approval, amended its agreement with Positive Communications to: (i) extend the term to July 10, 2026, through the additional of a nine-month extension, and (ii) to add a monthly expense reimbursement of up to a maximum amount of NIS 15,000 plus VAT (value-added tax) in addition to the monthly fee of NIS 15,000 plus VAT.
Either party has the right to terminate the agreement upon providing 30 days of 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 TSX-V policies.
About Nurexone
Biologic Inc.
Nurexone Biologic is a TSX-V, 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 multibillion-dollar markets. Regulatory milestones, including obtaining the orphan drug designation, facilitates the road map toward 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 United States subsidiary, to anchor its North American activity and growth strategy.
We seek Safe Harbor.
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