NurExone Announces Q4 and Full-year 2022 Financial Results and Provides Company Update, Highlighting 143.9% Scientific Research Investment Growth

TORONTO and TEL AVIV, Israel, March 30, 2023 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (the “Company” or “NurExone”) (TSXV: NRX) (FSE: J90) (NRX.V), a biopharmaceutical company developing biologically-guided exosome therapy (“ExoTherapy”) for patients with traumatic spinal cord injuries, has released its financial results for 2022, the first since it became public last June.

NurExone’s research and development investment grew by 143.9% from US$0.57 million in 2021 to US$1.39 million in 2022, due to increased activity in preclinical trials in the Company’s labs. The Company recently disclosed additional results from an internal preclinical study of its investigational drug, ExoPTEN, which demonstrated effective treatment of 75% of paralyzed rats suffering from spinal cord injuries (SCI).

NurExone, is working to develop ExoTherapy to target spinal cord injury, using its proprietary platform for producing and loading exosomes with pharmaceutical cargo targeting at first indication acute spinal cord injuries intranasally.

The Company has established itself as a unique company by possessing both a product in development, ExoPTEN, and an advanced platform for the production and loading of exosomes. It is listed on the TSX Venture Exchange and its shares also trade at the Frankfurt Stock Exchange and other German Stock Exchanges. 

During the year, the Company’s cash increased by 11.1%, from US$2.21 million in 2021 to US$2.46 million in 2022. In addition, the Company’s working capital stands at US$2.10 million, or a 78% increase over the US$1.18 million reported in 2021.

In 2022, the Company recorded losses, as compared to its previous year of operations, as a consequence of continued investment in research and development in pursuit of innovative therapeutic solutions to tackle spinal cord injuries.

The Company’s losses amounted to US$8.17 million, a 396.0% increase over 2021, when it registered a US$1.65 million loss, as a consequence of an increased investment in research and development activities and the reverse takeover (RTO) transaction related cost. The loss per share was $0.100.

It also recorded US$4.15 million in general and administrative expenses in 2022, which grew from US$1.14 million in 2021. The Company registered an estimated US$2.08 million in listing expenses when it went public on TSX Venture Exchange in June 2022. The listing expenses include US$1.61 million at a fair value for the reverse takeover acquisition of 2,536,000 EnerSpar Corp. shares at a share price of CAD $0.80 per share, US$0.24 million for net liabilities of EnerSpar Corp. and US$0.23 million for legal costs associated with the completed reverse takeover transaction in the second quarter of 2022.

Dr. Lior Shaltiel, CEO of NurExone, said, “We believe that exosomes are the future of drug delivery and NurExone is committed to advancing our unique exosome-based technology. We are breaking ground not only in treatment for recovery after spinal cord injury, but also by developing an exosome therapy platform that can be widely used by the medical industry to address many other illnesses. Our investment in cutting edge product development and a world-class team will allow us to deliver innovative solutions for patients in need.”

Fourth Quarter 2022 Financial Results

In Q4 2022, research and development expenses amounted to US$0.38 million, compared to US$0.30 million for the same period in 2021. The increase was largely attributable to the extensive research and development efforts required to continue the development of the siRNA- PTEN technology and other siRNA targets.

General and administrative expenses were reduced from US$0.46 million in the fourth quarter of 2022, compared to US$0.61 million for the same period in 2021. Financial expenses grew from US$0.01 million in Q4 2021 to US$0.17 million in Q4 2022, due to a change in accounting policy for warrant derivatives.

The Company completed a debt settlement on December 6, 2022, in the aggregate amount of CAD$46,523.69 with the issuance of 122,430 common shares of the Company at the market price of CAD$0.38 per share, as previously announced on November 24, 2022.

NurExone’s headcount as of December 31st, 2022 is 14 employees, or a 27% increase over the end of 2021. The largest department in the Company, currently, is the Scientific Development group. As of December 31^st, 2022 the Company included 6 full-time employees and 8 part-time employees.

Scientific Initiatives

On February 17, 2023, the Company announced interim results of an internal pre-clinical study of its proprietary ExoPTEN drug, that demonstrated significant motor, reflex and sensory improvement in rats following full transection (i.e., complete severing) of the spinal cord. 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 injuries.

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.

U.S. Patent 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 covers its cutting-edge ExoPTEN 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 include 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 strength.

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.

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For further information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034

Inbar Paz-Benayoun, Adv. Head of Communications and Investor Relations
Phone: +972-52-3966695
Email: info@nurexone.com

Investor Relations (Canada)
Phone: +1 905-347-5569
Email: IR@nurexone.com

To download NurExone’s Earnings Presentation, please visit https://nurexone.com/wp-content/uploads/2023/03/Nurexone-Q4-Full-Year-Fiscal-2022-Financial-Results-March-2023.pdf

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. When used in this press release, forward-looking statements can be identified by the use of words such as “may,” or by such words as “will,” “intend,” “believe,” “estimate,” “consider,” “expect,” “anticipate,” and “objective” and similar expressions or variations of such words. Forward-looking statements are, by their nature, not guarantees of the Company’s future operational or financial performance and are subject to risks and uncertainties and other factors that could cause the Company’s actual results, performance, prospects, or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. No representation or warranty is intended with respect to anticipated future results, or that estimates, or projections will be sustained.

Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions, and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this press release include, but are not limited to, statements relating to: our future plans and intellectual property; our scientific and development activities; future scientific activities and the treatment of certain conditions; the therapeutic benefits, effectiveness, and safety of our product candidates; and the estimated growth of the market for acute spinal cord injuries.

In developing the forward-looking statements in this press release, we have applied several material assumptions, including that the interim results are indicative of results that may be seen in future studies, third party sources of industry data represent reasonable estimates, our ability to retain key personnel, our ability to continue investing in research and development, our ability to secure available funding and to continue as a going concern; the general business and economic conditions of the industries and countries in which we operate; and our ability to execute on our business strategy.

Many risks, uncertainties, and other factors could cause the actual results of the Company to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the following: those risk factors identified under the heading “Risk Factors” on pages 62 to 69 of the Company’s Filing Statement dated May 12, 2022, a copy of which is available under the Company’s SEDAR profile at www.sedar.com; risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for our products; rapid technological change; dependence on key personnel; protection of our intellectual property; dependence on our strategic partners; overall economic conditions; competitive pressures; network restrictions; and other similar factors that may cause the actual results, performance or achievements to differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the press release or as of the date otherwise specifically indicated herein. Due to risks and uncertainties, events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required pursuant to applicable securities law. All forward-looking statements contained in the press release are expressly qualified in their entirety by this cautionary statement. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.