TORONTO and TEL AVIV, Israel, May 24, 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 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.
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; the estimated growth of the market for acute spinal cord injuries; our goal to submit additional patent applications; and the entering into of new strategic collaborations.
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 29 to 36 of the Company's Annual Information Form dated March 30, 2023, 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.
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i https://www.researchandmarkets.com/reports/5140129/spinal-cord-trauma-treatment-global-strategic?utm_source=BW&utm_medium=PressRelease&utm_code=d8wc9q&utm_campaign=1552686+-+Global+Spinal+Cord+Trauma+Treatment+Industry+(2020+to+2027)+-+Key+Market+Trends+and+Drivers&utm_exec=jamu273prd
