TORONTO and HAIFA, Israel, Aug. 28, 2024 – NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90), a leading biopharmaceutical company focusing on regenerative medicine therapies, has disclosed its financial and operational performance for the three and six months ending June 30, 2024.
Key Business Developments
On April 1, 2024, NurExone signed a contract research organization services agreement with Vivox Ltd. for conducting animal experiments as part of the preclinical evaluation for an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). This agreement aims to assess the safety and efficacy of the ExoPTEN drug before moving forward to human clinical trials, which are expected to begin in 2025. This engagement followed a pre-IND meeting with the FDA, where NurExone received feedback on the manufacturing, preclinical, and clinical development plan for ExoPTEN, the Company’s first ExoTherapy product.
On April 25, 2024, the Company’s common shares began trading on the Pink Sheets platform run by OTC Markets Group Inc. under the symbol "NRXBF". Subsequently, on May 6, 2024, the shares were approved for uplisting to the OTCQB Venture Market, retaining the same symbol. This uplisting is a significant step for NurExone, enhancing its visibility in the financial community, especially in the United States. The Company also achieved Depository Trust Company (DTC) eligibility, improving the efficiency and cost-effectiveness of trading its shares and enhancing liquidity and investor access.
On June 11, 2023, NurExone announced the expansion of its ExoPTEN patent coverage with the allowance of a patent application in Japan, widening the Company’s potential market reach to the Far East.
On June 11, 2024, NurExone amended an agreement with BullVestor Medien GmBH, extending BullVestor's investor relations services until May 15, 2025.
On June 21, 2024, the Company engaged Dr. Yona Geffen in a consulting agreement to support preclinical and clinical activities. Dr. Geffen brings over 20 years of experience in clinical and drug development in the biotechnology and pharmaceutical sectors.
Growth Prospects for 2024
Dr. Lior Shaltiel, CEO, emphasized that NurExone is progressing well on the regulatory front, including successfully transferring key manufacturing processes to a Good Manufacturing Practice (GMP)-compliant facility, which is crucial for clinical trials and commercial production. The addition of Dr. Yona Geffen is expected to bolster these efforts. Furthermore, NurExone is collaborating with the Goldschleger Eye Institute at Sheba Medical Center to explore ExoPTEN’s potential in the lucrative glaucoma market, with promising early results.
Second Quarter Fiscal 2024 Financial Results
For the second quarter of 2024, NurExone’s research and development expenses were $0.51 million, up from $0.46 million in the same period in 2023. This increase was primarily due to higher subcontractor and material costs, partially offset by a government grant. General and administrative expenses rose to $0.81 million from $0.60 million in the previous year, mainly driven by increased professional and legal services. Finance expenses were $0.01 million, compared to finance income of $0.02 million in 2023, primarily due to bank interest in the previous year.
The net loss for the second quarter of 2024 was $1.33 million, compared to $1.04 million in the same period in 2023. As of June 30, 2024, NurExone held $2.39 million in cash and cash equivalents, up from $0.54 million at the end of 2023. The increase in cash was driven by a private placement in January 2024, generating $1.49 million, and the exercise of warrants in March 2024, yielding $2.93 million. These inflows were partially offset by $2.57 million in operational expenses.
As of June 30, 2024, the Company had an accumulated deficit of $16.30 million, compared to $14.06 million as of December 31, 2023.
Eran Ovadya, Chief Financial Officer, affirmed the Company’s dedication to advancing research and development and preparing ExoPTEN for clinical trials and commercial manufacturing. Strategic guidance is aligning business plans with current operations for sustained growth and long-term success.
About NurExone Biologic Inc.
NurExone Biologic Inc. is listed on the TSX Venture Exchange and is developing a platform for biologically-guided exosome-based therapies for patients with Central Nervous System injuries. The Company’s first product, ExoPTEN, has shown promising results in preclinical trials for acute spinal cord injury and has received Orphan Drug Designation by the FDA. The NurExone platform aims to offer novel solutions for noninvasive targeted drug delivery in other medical conditions.
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