17:09:14 EDT Tue 21 May 2024
Enter Symbol
or Name
USA
CA



Nurexone Biologic Inc
Symbol NRX
Shares Issued 42,855,159
Close 2023-05-23 C$ 0.30
Market Cap C$ 12,856,548
Recent Sedar Documents

Nurexone spends $370,000 (U.S.) on R&D in Q1

2023-05-24 12:56 ET - News Release

Dr. Lior Shaltiel reports

NUREXONE REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Nurexone Biologic Inc. has released its financial results for the quarter ended March 31, 2023.

"The Company is successfully achieving key milestones for our investigational ExoPTEN drug and, in parallel, developing an exosome therapy platform that can be widely used by the medical industry to address many other illnesses," Dr. Lior Shaltiel, CEO of NurExone. "We believe that the hybrid product-platform model will drive revenue through partnerships, licensing, and commercialization."

Key Business Highlights

Intellectual Property Portfolio Expansion

On January 12, 2023, the Company received a notice of allowance from the United States Patent and Trademark Office for U.S. Patent Application NO. 17/042,441. The patent that has tuned to a granted Patent in the U.S. on May 16th, covers its cutting-edge Exo-PTEN technology and its drug composition as well as methods for non-invasive intranasal administration of the Company's exosome-based treatment for treating neuronal injury or damage. NurExone currently has a portfolio of intellectual property, which includes the allowed U.S. patent, two Patent Cooperation Treaty (PCT) patent applications that cover the production and composition of matter of our exosomes, and four provisional patents that document loading techniques and siRNA target sequences. As the Company scales, NurExone intends to continue expanding its patent portfolio in order to strengthen its competitive moat.

Promising Pre-Clinical Study Results

On March 20, 2023, the Company disclosed results of an internal pre-clinical study of its proprietary ExoPTEN drug with its proprietary exosome loading technology, which demonstrated effective treatment of 75% of paralyzed rats suffering from spinal cord injuries. These rats regained hind limb reflex, some motor function, and sensory control. The results of the study suggest that ExoPTEN has the potential to generate functional recovery in the central nervous system, which enables NurExone to capitalize on the US$2.9 billion market for acute spinal cord injuriesi.

On February 17, 2023, the Company announced the first interim results of the pre-clinical study of ExoPTEN, that demonstrated significant motor, reflex and sensory improvement in rats following full transection (i.e., complete severing) of the spinal cord. In addition, the Company's pre-clinical loading efficiency study demonstrated that its proprietary loading technology has the potential to serve as an efficient process for loading therapeutic molecular cargo into exosomes, allowing NurExone to establish a cost-effective large-scale exosome production method.

Growth Outlook for 2023

The Company aims to execute the following growth initiatives to advance the Company's strategy of commercializing its ExoPTEN drug product, establishing a platform for ExoTherapy production and expanding its overall business:

Submit a Pre-IND meeting request with the U.S. Federal Drug and Administration

Obtain Orphan Drug Designation for its flagship drug product

File new patent applications with the U.S. Patent and Trademark Office, which cover new siRNA sequences against potential targets for addition neuronal indication in the Central Nervous Nystem (CNS)

Enter into new strategic collaborations or partnerships to potentially unlock business synergies and commercialize NurExone's exosome platform technology.

First Quarter Fiscal 2023 Financial Results

Research and development expenses were US$0.37 million in the first quarter of 2023, compared to US$0.28 million in the same quarter in 2022. The increase was largely attributable to the research and development efforts towards pre-clinical activity and development of the siRNA- PTEN technology and other siRNA targets.

General and administrative expenses were US$0.35 million in the first quarter of 2023, compared to US$1.95 million in the same period in 2022. The decrease was largely attributable to costs relating to the reverse takeover transaction that occurred in Q2 2022.

Financial (income) expenses were (US$0.01) million in the first quarter of 2023, compared to US$0.09 million in the same period in 2022. The decrease was largely attributable to costs relating to fundraising in 2022 prior to the reverse takeover transaction, financial derivatives, and exchange rate adjustments.

Net loss was US$0.70 million in the first quarter of 2023, compared to a net loss of US$2.31 million in the first quarter of 2022.

As of March 31, 2023, the Company had cash of US$1.59 million (December 31, 2022 - US$2.46 million) and working capital of $1.33 million (December 31, 2022 - $2.11 million). The Company had an accumulated deficit of US$11.12 million as of March 31, 2023, (December 31, 2022 - US$10.42 million).

Amendment of Options

On May 23, 2023, the board of directors of the Company approved the amendment of the exercise price of 3,706,595 outstanding options issued pursuant to the Company's equity incentive plan (the "Options") from an exercise price of $0.80 per share to $0.33 per share (the "Option Amendment"). Other than the Option Amendment, all other terms of the Options remain the same. The Option Amendment is subject to approval of the Company's shareholders at the Company's annual and special meeting of shareholders scheduled for June 28, 2023 (the "Meeting"). In addition, 1,666,595 of the Options are held by insiders of the Company and the Option Amendment in respect of such Options will be subject to disinterested shareholder approval at the Meeting. The Option Amendment is also subject to approval from the TSX Venture Exchange.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSX Venture Exchange-listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries.

ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. NurExone is translating the treatment to humans, and the Company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.

We seek Safe Harbor.

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