Calgary, Alberta--(Newsfile Corp. - November 24, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, released a corporate update and reported financial results for the quarter ended September 30, 2022.
"Obtaining U.S. FDA approval for our drug platform remains a priority for NurExone and we intend to continue working towards expediting this process by submitting a Pre-IND meeting request," said Dr. Lior Shaltiel, CEO of NurExone. "In addition to pursuing our regulatory objective, we are advancing other areas of our business, including securing more international collaborations with biotechnology companies and completing more key scientific initiatives. We have also strengthened our balance sheet by settling EnerSpar Corp.'s debts (the predecessor company to NurExone) that were incurred prior to our go-public listing."
U.S. Food and Drug Administration (FDA) Approval Roadmap
On October 19th, NurExone was informed by the U.S. FDA in an official response that the Company was beyond the stage of participating in an Initial Targeted Engagement for Regulatory Advice on CBER Products meeting and can proceed to request a Pre-Investigational New Drug (IND) meeting in connection with the development of ExoPTEN, NurExone's first ExoTherapy product. As a result, the Company plans to submit a Pre-IND meeting request to the U.S. FDA in January 2023.
A Pre-IND meeting offers applicants valuable information in regard to preparing complete IND applications, which can reduce the risk of a clinical hold, and planning and preparing clinical studies for their products. As a result, a Pre-IND meeting could potentially shorten the regulatory timeline for the launch of NurExone's ExoTherapy into the U.S. market.
Strategic Collaborations and Partnerships
The Company intends to continue establishing more strategic collaborations and partnerships to expand its technology portfolio and unlock new synergies in commercializing its exosome-based drug platform.
On July 18, 2022, NurExone signed a material transfer agreement with Yissum Research Development Company ("Yissum"), a wholly-owned subsidiary of the Hebrew University of Jerusalem Ltd., to transfer certain biological, chemical, and other tangible materials to Yissum for use by Prof. Tal Burstyn-Cohen and her team at the Hebrew University. Professor Burstyn-Cohen is an experienced researcher at the Hebrew University and leader of the Burstyn-Cohen Lab which researches molecular and cellular mechanisms that underlie tissue homeostasis in health. Under the agreement, NurExone will have an option to receive an exclusive license to the jointly owned results and related intellectual property (if any) that may arise from the research by Prof. Burstyn-Cohen, in the field of neurodegenerative diseases and CNS indications.
In addition, NurExone signed a letter of intent with denovoMATRIX GmbH ("denovoMATRIX"), a leading German developer of innovative technologies for cell therapies to collaborate on developing specialized coatings for NurExone's cell carriers for exosome production by denovoMATRIX's advanced screenMATRIX platform.Both parties aim to develop a mutually beneficial supply agreement, in which denovoMATRIX will develop and provide technologies in order to optimize the manufacturing processes of the Company's ExoTherapy, enabling large-scale exosome production.
The Company also signed a non-binding letter of intent with Nanometrix Ltd. ("Nanometrix"), a nanoparticle analysis company based in the U.K., as previously announced on October 12, 2022. Under the agreement, NurExone will collaborate with Nanometrix to obtain detailed information about the molecular profiling of exosomes and quantification of the siRNA cargo copy number per extracellular vesicle for NurExone's exosomes and cargo samples via Nanometrix's AI-driven software.
Furthermore, the Company recently participated in the 2022 Bio-Europe Conference, which was held in Leipzig, Germany to establish new business relationships with companies within the global biopharma industry.
Scientific Initiatives
NurExone intends to continue completing different scientific initiatives across various verticals to grow its technology platform. In September 2022, NurExone announced survey results that demonstrated the effectiveness of its proprietary small interfering RNA (siRNA) in inhibiting the expression phosphatase and tensin homolog (PTEN), which promotes axon regeneration and neural repair - key elements that enable healing for traumatic spinal cord injuries.
Additionally, the Company also announced the results of an internal productivity and quality pilot of its patent-pending process for 3D scaled-up exosome production, which indicated a boost in exosome productivity while improving cost-efficiency. This process will not only be integrated within NurExone's drug platform once finalized, but also commercialized, in which the Company will license it to other biopharmaceutical companies.
Completion of Debt Settlement
On November 8, 2022, NurExone completed securities for debt settlements, previously announced by the Company on September 1, 2022 and September 19, 2022. NurExone agreed to settle debts in the aggregate amount of CAD$136,155.83 with the issuance of 170,195 common shares of the Company at a deemed price of CAD$0.80 per share (including the issuance of 117,033 shares to James (Jay) Richardson, a director of the Company). The Company also agreed to settle additional debts in the aggregate amount of CAD$75,000 with the issuance of 178,571 common shares of the Company at a deemed price of CAD$0.42 per share.
Third Quarter Fiscal 2022 Financial Results
- Research and development expenses were US$0.42 million in the third quarter of 2022, compared to US$0.04 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 US$0.57 million in the third quarter of 2022, compared to US$0.23 million for the same period in 2021. The increase was mainly due to a US$0.10 million increase in service providers, an increase of US$0.10 million in salaries and share-based compensation (driven by an increase in headcounts), an increase of US$0.05 million in legal expenses, an increase of US$0.03 million in insurance expenses and an increase of US$0.06 million in fees and other expenses.
- Listing expenses were US$0.04 million in the third quarter of 2022. The listing expenses for the nine months ended period September 30, 2022, were US$2.08 million, as follows: 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, US$0.24 million for net liabilities of EnerSpar Corp., US$0.23 million for legal costs as associated with the completed reverse takeover transaction in the second quarter of 2022.
- Finance expenses, net, were US$0.38 million in the third quarter of 2022, compared to an income of US$0.07 million in the same period in 2021. The increase was primarily due to revaluation and a change in accounting policy for warrant derivatives.
- Net loss was US$1.10 million in the third quarter of 2022, or a loss of US$0.030 per share, compared to a net loss of US$0.26 million, or a loss of US$0.025 per share, in the third quarter of 2021.
2022 Financial Guidance
As at September 30, 2022, the Company had cash of $3.15 million (December 31, 2021 - $2.21 million) and working capital of $2.71 million (December 31, 2021 - $1.18 million). The Company had a deficit of $9.40 million as of September 30, 2022, (December 31, 2021 - $2.25 million).
NurExone expects that its current total cash position, together with recent financing, will support the company's ongoing operating activities into September 2023. This cash runaway guidance is based on the company's current operational plans and excludes any additional funding and any business development activities that may be undertaken. NurExone continues to assess all financing options that support its corporate strategy.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV 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 more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Investor Relations
Phone: +1 905-347-5569
Email: IR@nurexone.com
FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements", that reflect the Company's current expectations and projections about its future results. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: our ability to develop and commercialize product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our expectations regarding regulatory requirements; whether we will receive regulatory approvals in the United States; and future potential activities relating to letters of intent signed with each of denovoMATRIX and Nanometrix and the material transfer agreement with Yissum. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the Company's early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company's intellectual property, dependence on the Company's strategic partners and the risks discussed under the heading "Risk Factors" on pages 62 to 69 of the Company's Filing Statement dated May 12, 2022, available on the Company's SEDAR profile at www.sedar.com. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
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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