Zacks Small Cap Research – Initiating Coverage of NRXBF – Technologist

By Brad Sorensen, CFA

OTC:NRXBF

READ THE FULL NRXBF RESEARCH REPORT

NurExone (OTC:NRXBF) is a clinical stage biotech company that is developing an off-the-shelf, non-invasive and novel treatment for the reversal or reduction of paralysis following spinal cord injury using exosome-based (membrane-bound extracellular vesicles) patent-pending technology. But that one sentence description fails to appropriately describe the vast potential that we see developing in the company.

Briefly, the first part of that description should not be taken lightly. The company is endeavoring to restore function to patients that have lost the ability to control portions of their bodies, such as the ability to walk or breath on their own, due to a spinal cord injury—injuries for which there are no known treatments. According to the World Health Organization there are an estimated 250,000–500,000 people globally that suffer from spinal cord injuries annually, with 90% of these injuries stemming from traumatic causes such as vehicle accidents, workplace incidents, or sports-related mishaps.

NurExone is developing a product known as ExoPTEN that is designed to treat patients with acute spinal cord injuries and these numbers suggest a potential market for ExoPTEN of approximately 50,000 new cases globally per year—an enormous market potential with patients eager to have the opportunity to return to some form of normalcy and dramatically improve their quality of life.

It was the test results from the use of ExoPTEN that sparked our enthusiasm for the company, because the initial test results are, in our view, truly remarkable. This isn’t a potential treatment that was arrived at quickly or easily as research began at the University level and was conducted between January 2017 and May 2020, including testing the use of intranasal administration of exosomes driven from mesenchymal stem cells loaded with siRNA. Testing targeted a complete spinal cord transection in rats, which is the strictest animal testing model, successfully demonstrating significant functional recovery. The company notes that the technology is successfully proven in additional preclinical studies, demonstrating that intranasal administration of ExoPTEN led to significant motor improvement, sensory recovery, and faster urinary reflex restoration. As mentioned, the research began at the University level and the Company has been granted an exclusive worldwide license from the Technion and Tel Aviv University, which includes a patent application, to develop and commercialize the technology. In addition, the Company has developed its own intellectual property and now has five families of patents.

That would be enticing enough to look further into NurExone but the technology used to repair the spinal cord can be used to repair numerous central nervous system injuries and has the potential to be licensed to major pharmaceutical companies to offer an improved drug delivery system that inherently carries therapies to a targeted area. For example, the company recently announced some exciting test results regarding the treatment of the use of the same ExoPTEN-therapy for the glaucoma market conducted at an Eye Institute in one of the world’s leading hospitals.

As a final note before getting into the science behind the treatments, which we believe, for investors willing to learn about it, will explain why we are so enthusiastic about the potential provided by NurExone, the company received the Orphan Drug Designation for ExoPTEN in 2023. This designation was created by the FDA which noted that supporting the development and evaluation of new treatments for rare diseases is a key priority for the agency. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:

• Tax credits for qualified clinical trials

• Exemption from user fees

• Potential seven years of market exclusivity after approval

This is another feather in the cap of NurExone and we encourage investors to look further into NRXBF and understand the science and potential behind these exciting developments.

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