Dr. Lior Shaltiel reports

NUREXONE ANNOUNCES CLINICAL TRIAL PLANS FOR ACUTE SPINAL CORD INJURY THERAPY AT ANNUAL MEETING OF AMERICAN SPINAL INJURY ASSOCIATION

Nurexone Biologic Inc. senior clinical adviser Prof. Nahshon Knoller, MD, will be presenting at the prestigious annual meeting of the American Spinal Injury Association (ASIA), where he will discuss the company's plans for future clinical trials in 2026 in the field of acute spinal cord injuries (SCI) for ExoPTEN, a first-in-class exosome-based therapy, as well as results from the company's preclinical studies.

Nurexone expects to initiate a phase 1/2a clinical trial in 2026 marking a major milestone in the advancement of regenerative therapies for central nervous system injuries.

Adult patients with traumatic SCI between spinal levels C5 and T10, classified as ASIA Grade A or B, will be enrolled in the 2026 SCI trial. These patients will be treated within three to seven days postinjury. Phase 1 will be a dose-escalation study evaluating safety in up to 18 patients, followed by a phase 2a randomized, double-blind, placebo-controlled trial measuring functional recovery in 10 to 15 patients.

At the 2025 ASIA meeting, Prof. Knoller, a renowned neurosurgeon and former director of the spinal trauma unit at Sheba Medical Center, the Middle East's largest hospital and ranked by Newsweek as one of the 10 leading hospitals in the world, will provide updates on the 2026 SCI trial, as well as results from the company's other preclinical studies.

Prof. Knoller commented: "It is a real honour for a preclinical-stage company to be invited to present at ASIA. This is one of the most respected gatherings in the SCI field, and our inclusion highlights the strength and relevance of the ExoPTEN program and the impressive results we have obtained as a minimally invasive approach to treat SCI. Moreover, it reflects the scientific quality and the clinical need behind what Nurexone is advancing."

Dr. Lior Shaltiel, chief executive officer of Nurexone, highlighting the significance of the company's transition into clinical trials stated that: "This is the first time we are publicly outlining our clinical plans for ExoPTEN, and it is an important step forward for the company. We've made meaningful progress in validating our science and building the foundation for clinical readiness. As we prepare for first-in-human studies, we remain focused on advancing this program and with a clear view of its potential to address a critical unmet need in spinal cord injury."

ExoPTEN is based on mesenchymal stem cell-derived exosomes loaded with siRNA targeting PTEN, a molecular inhibitor of neural regeneration through the mTOR pathway. Delivered via intranasal and intrathecal routes, ExoPTEN is designed to reduce cell death and promote axonal regrowth in the acute postinjury phase. The therapy has been granted orphan drug designation by both the United States Food and Drug Administration and European Medicines Agency.

Preclinical studies to be presented by Prof. Knoller at ASIA showed robust recovery of motor, sensory and structural function in rat models of complete spinal cord transection and compression. MRI, BBB scoring, von Frey testing and histology have confirmed the therapeutic effects of ExoPTEN. Fluorescent labeling has shown that exosomes effectively homed to the injury site for up to seven days postinjury. Being invited to present these findings at ASIA underscores the company's emergence as an innovator in neuroregeneration.

The 2025 ASIA meeting will be held on June 2 to June 4, 2025, in Scottsdale, Ariz. This meeting is the leading clinical and academic conference dedicated to SCI care and research.

Investor Summit Virtual -- June 10, 2025

Nurexone Biologic will be participating in the Q2 Investor Summit Virtual on June 10, 2025, with a presentation scheduled for 2:00 PM EDT. The Investor Summit is an exclusive event focused on connecting investors with promising microcap companies that are poised for growth. Investors will have the opportunity to engage directly with company leadership and hear from industry experts. To register for the complementary event, please visit the event's website and click on "Registration."

About Nurexone Biologic Inc.

Nurexone Biologic is 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 United States 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.

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