TORONTO and HAIFA, Israel, Aug. 28, 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 and six months ended June 30, 2024, the highlights of which are included in this news release. The Company's complete set of condensed interim consolidated financial statements for the three and six months ended June 30, 2024, and accompanying management's discussion and analysis for the period 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 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 is 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, the Company's common shares were quoted on the Pink Sheets platform operated by OTC Markets Group Inc. ("OTC") under the symbol "NRXBF".
On May 6, 2024, the Company's common shares were approved for uplisting from the OTC Pink Sheets to the OTCQB Venture Market, retaining the symbol "NRXBF", marking a significant milestone in the Company's growth and visibility within the financial community, including in the United States. In addition, the Company achieved Depository Trust Company ("DTC") eligibility, which enhances the efficiency and cost-effectiveness of trading the Company's shares, facilitating better liquidity and broader access for investors.
On June 11, 2023, the Company announced the expansion of its ExoPTEN patent coverage with an allowance of a patent application in Japan. This expands the Company's potential market to the far East.
On June 11, 2024, the Company entered into an amending agreement with BullVestor Medien GmBH ("BullVestor"), modifying the original agreement dated in January 2024. Under the amending agreement, BullVestor continues to provide investor relations services to the Company until May 15, 2025.
On June 21, 2024, the Company entered into a consulting agreement with Dr. Yona Geffen to support the Company's preclinical and clinical activities. Dr. Geffen brings over two decades of extensive experience in leading clinical and drug development in the biotechnology and pharmaceutical industries.
Growth Outlook for 2024
According to Chief Executive Officer Dr. Lior Shaltiel, "NurExone is making significant strides on the regulatory front, including the successful transfer of key manufacturing processes to a good manufacturing practice-compliant facility – an essential step toward clinical trials and commercial production. These efforts are being strengthened by our newly recruited consultant, Dr. Yona Geffen, a highly respected expert who has successfully guided companies through the regulatory landscape to commercialization. In parallel, the Company is collaborating with the Goldschleger Eye Institute at Sheba Medical Center, ranked by Newsweek as one of the top ten hospitals in the world, to study ExoPTEN for its potential in the multi-billion-dollar glaucoma marketi with promising preliminary results."
Second Quarter Fiscal 2024 Financial Results
Research and development expenses, net, were US$0.51 million in the second quarter of 2024, compared to US$0.46 million in the same quarter in 2023. The increase was primarily due to higher subcontractor and materials expenses of US$0.07 million, partially offset by a governmental grant receipt of US$0.02 million.
General and administrative expenses were US$0.81 million in the second quarter of 2024, compared to US$0.60 million in the same period in 2023. The rise was mainly attributed to an increase in professional and legal services expenses of US$0.22 million, partially ...
