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NurExone Reports First Quarter 2024 Financial Results and Provides Corporate Update, moving forward with FDA guidelines for the Human Trials
TORONTO and HAIFA, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV:NRX) (OTCQB:NRXBF) (Germany: J90) (the "Company" or "NurExone"), a pioneering biopharmaceutical company developing regenerative medicine therapies, is pleased to announce its financial and operational results for the three months ended March 31, 2024, the highlights of which are included in this news release. The Company's full set of consolidated financial statements for the three months ended March 31, 2024, and accompanying management's discussion and analysis can be accessed by visiting the Company's website at www.nurexone.com and its profile page on SEDAR+ at www.sedarplus.ca.
Key Business Highlights
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.
On March 22, 2024, the Company completed the acceleration of 12,682,340 warrants issued pursuant to a private placement of units that closed on June 15, 2022. Following the acceleration event, the Company received gross proceeds of US$2.92 million (approximately C$4.0 million) from the exercise of 10,423,629 common share purchase warrants, which represented accelerated and non-accelerated warrants of which 9,684,993 warrants were exercised at a 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. The Company exercised its right to accelerate the expiry date of certain warrants to thirty days upon the Company's common shares exceeded C$0.475 for ten consecutive trading days on the TSX Venture Exchange ("TSXV"). "We appreciate the confidence of the investors who exercise their warrants, and the ongoing support of NurExone's journey," stated Eran Ovadya, NurExone Chief Financial Officer.
On April 1, 2024, the Company entered into a Contract Research Organization services agreement with Vivox Ltd. for animal experiments as part of the preclinical testing phase for the submission of an Investigational New Drug ("IND") application to the United States Food and Drug Administration (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-IND meeting with the FDA regarding the manufacturing, preclinical, and clinical development plan of ExoPTEN, NurExone's inaugural ExoTherapy product, and the subsequent receipt of a written response from the FDA.
On April 25, 2024, NurExone successfully secured approval for listing on the OTCQB Venture Market, marking a significant milestone in the Company's growth and visibility within the financial community, including in the USA. In addition, the Company achieved Depository Trust Company eligibility, which enhances the efficiency and cost-effectiveness of trading NurExone shares, facilitating better liquidity and broader access for investors.
Growth Outlook for 2024
According to Chief Executive Officer Dr. Lior Shaltiel, "NurExone is committed to pioneering transformations in the field of regenerative medicine with new, minimally invasive therapies and we are moving along the regulatory path towards human trials for our first product, ExoPTEN. Our focus remains on enhancing our ExoTherapy platform for the production of nanodrugs, expanding our intellectual property, and forging strategic collaborations. Towards this end, we have recently engaged Dr. Ram Petter, Vice President and head of Bio Strategy at Teva Pharmaceutical, to support our efforts in collaborating with biopharma companies."
First Quarter Fiscal 2024 Financial Results
Research and ...