NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.

Fourth Quarter Highlights and Significant Milestones

  • On October 26, 2023, the Company received a response from the Food and Drug Administration (“FDA”), advising that pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), the orphan-drug designation (“ODD”) request of mesenchymal stem cell (“MSC”) derived small extracellular vesicles (“EVs”) loaded with short and modified interfering RNA (“siRNA”) against the phosphatase and tensin homolog (“PTEN”) protein is granted for treatment of acute Spinal Cord Injury ("SCI”). This achievement is expected to profoundly shape the Company’s regulatory and go-to-market strategies for ExoPTEN. ODD offers substantial benefits, including market exclusivity and protection upon drug approval (in addition to existing IP protection), financial incentives, regulatory assistance, and developmental support. Overall, this designation serves to incentivize and facilitate the development of treatments for rare diseases, thereby enhancing patient access to therapies
  • On March 1, 2024, the Company commenced the setup of in-house laboratories and offices to bolster its research and development capabilities, subsequent to entering into lease and construction agreements. Completion of these initiatives is anticipated by the end of June 2024.
  • The Company announced on March 22, 2024, its engagement in animal experiments through a Contract Research Organization (“CRO”) as part of the preclinical testing phase for the submission of an Investigational New Drug (“IND") application to the FDA. This is aimed at assessing the safety and efficacy of the ExoPTEN drug before proceeding to clinical trials involving human subjects, which are anticipated to commence in 2025. This engagement followed the completion of a Pre-Investigational New Drug (“Pre-IND”) meeting with the FDA regarding the manufacturing, preclinical, and clinical development plan of ExoPTEN, NurExone’s inaugural ExoTherapy product, and subsequent receipt of a written response from the FDA.
  • On March 27, 2024, the Company announced a total of approximately C$4.0 million proceeds from the exercise of both accelerated and non-accelerated warrants from the issuance of 10,423,629 common share purchase warrants. 9,684,993 warrants were exercised at a cash price of C$0.38, 556,818 warrants were exercised at a price of C$0.34, and 181,818 warrants were exercised at a price of C$0.48.Dr. Lior Shaltiel, CEO of NurExone, stated, "Our emphasis on research and development in 2023, coupled with the expansion of our Intellectual Property (“IP”) portfolio, the ODD for ExoPTEN, and the growth of the ExoTherapy platform, are laying the groundwork for the accelerated introduction of minimally invasive regenerative medicine."Eran Ovadya, CFO of NurExone, remarked, "Due to the ongoing support and confidence of our investors, the Company is confident that its current total existing funds, augmented by the recently completed exercise of warrants, will support ongoing operating activities through the end of 2024."

Full Year and Fourth Quarter 2023 Financial Results

  • The Company is still in the research, development, and growth stage. The Company has not commercialized any products or generated any significant revenues, or become cash flow positive, and will continue to be reliant on the ability to finance its activities by raising additional equity or debt until profitability is achieved.
  • Research and development expenses were US$1.54 million in 2023, compared to US$1.39 million in 2022. For the fourth quarter of 2023, expenses were US$0.31 million, compared to US$0.39 million in the previous year.The increase of US$0.15 million in 2023, compared to 2022, was primarily due to the extensive research and development efforts required to continue the development of the ExoPTEN technology and other siRNA targets.
  • General and administrative expenses were US$2.12 million in 2023, compared to US$4.15 million in 2022. For the fourth quarter of 2023, expenses were US$0.40 million, compared to US$0.46 million in the previous year.The decrease of US$2.03 million in 2023, compared to 2022, was primarily due to the reduction in professional services, mainly attributable to the transition to becoming a listed public Company in 2022.
  • Listing expenses were zero in 2023, compared to US$2.08 million in 2022. These expenses were associated with the closing of the reverse takeover transaction on June 15, 2022.
  • Financial income/expenses, net, were US$0.02 million of income in 2023, compared to US$0.55 million of expense in 2022. For the fourth quarter of 2023, expenses were US$0.02 million, compared to US$0.17 million in the previous year.The change in financial income of US$0.57 million in 2023, compared to 2022, was primarily due to US$0.50 million of non-cash expenses in 2022, related to the valuation of warrants and royalty liability.
  • Net loss was US$3.64 million in 2023, compared to a net loss of US$8.17 million in 2022. The decrease of US$4.53 million in 2023, compared to 2022, was primarily driven by a decrease in general and administrative expenses of US$2.03 million and a decrease in listing expenses US$2.08 million incurred in 2022, both associated with the closing of the reverse takeover transaction in 2022, contributed to the lower net loss.
  • Cash position: As of December 31, 2023, the Company had total cash and equivalents of US$0.54 million, compared to US$2.46 million as of December 31, 2022. The decrease of US$1.92 million is due primarily to US$1.09 million in net cash proceeds from completed non-brokered private placement and US$0.1 million from a received grant from the Israeli Innovation Authority, offset by US$3.11 million of net cash used in operating activities.Additionally, the Company had secured US$1.20 million as restricted cash, as of December 31, 2023, associated with a non-brokered private placement completed in January 2024 for total gross proceeds of US$1.50 million from the issuance of 7,091,993 common shares and warrants.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical Company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

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

For more information, please contact:

Dr. Lior ShaltielChief Executive Officer and DirectorPhone: +972-52-4803034Email: info@nurexone.com

Thesis Capital Inc.Investment Relation - CanadaPhone: +1 905-347-5569Email: IR@nurexone.com  

Dr. Eva ReuterInvestment Relation - GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu

Cautionary Statement Regarding Forward-Looking Statements 

This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved.

Forward-looking statements in this news release include statements relating to: the advancement of the Company’s business following the receipt of proceeds from exercised warrants; the anticipated positive results to flow from the setup of inhouse laboratories and offices; and the completion of lease and office construction by June, 2024.

Forward-looking information in this press release are based on certain assumptions and expected future events, namely; the Company’s ability to keep its ongoing commitment of the Company to further therapies for SCI; that an independent and detailed analysis will corroborate and expand upon the encouraging results observed in numerous laboratory experiments; the ExoPTEN therapy has the ability to be a significant promise as a potential treatment for SCI; the Company’s ability to realize upon the stated goals for accelerating the development and regulatory path of ExoPTEN; and the Company’s ability to realize upon its expectation of the NurExone platform technology to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company’s inability to realize upon the benefits, terms, and scope of the strategic agreement; the Company’s inability to keep its ongoing commitment of the Company to further therapies for SCI; that an independent and detailed analysis will not corroborate and expand upon the encouraging results observed in numerous laboratory experiments; the ExoPTEN therapy will not be a significant promise as a potential treatment for SCI; the Company’s inability to realize upon the stated goals for accelerating the development and regulatory path of ExoPTEN; and the Company’s inability to realize upon its expectation of the NurExone platform technology to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements.

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. 

Neither TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.

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