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Nurexone Biologic Inc
Symbol NRX
Shares Issued 67,489,462
Close 2024-08-28 C$ 0.63
Market Cap C$ 42,518,361
Recent Sedar Documents

Nurexone spends $510,000 (U.S.) on R&D in Q2 2024

2024-08-28 19:06 ET - News Release

Dr. Lior Shaltiel reports

NUREXONE REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Nurexone Biologic Inc. has released 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 and its profile page on SEDAR+. All dollar amounts are in United States dollars unless otherwise stated.

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, 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 10 hospitals in the world, to study ExoPTEN for its potential in the multibillion-dollar glaucoma marketi with promising preliminary results."

Second quarter fiscal 2024 financial results

  • Research and development expenses, net, were $510,000 in the second quarter of 2024, compared with $460,000 in the same quarter in 2023. The increase was primarily due to higher subcontractor and materials expenses of $70,000, partially offset by a governmental grant receipt of $20,000.
  • General and administrative expenses were $810,000 in the second quarter of 2024, compared with $600,000 in the same period in 2023. The rise was mainly attributed to an increase in professional and legal services expenses of $220,000, partially offset by a $10,000 decrease in insurance expenses.
  • Finance expenses were $10,000 in the second quarter of 2024, compared with finance income of $20,000 in the same period in 2023, primarily due to income from bank interest in the previous year.
  • The net loss for the second quarter of 2024 was $1.33-million, compared with a net loss of $1.04-million in the second quarter of 2023.

As of June 30, 2024, the company held cash and cash equivalents totalling $2.39-million, an increase from $540,000 as of Dec. 31, 2023. The company's working capital also improved to $2.24-million, up from $70,000 at the end of 2023. The increase in cash was primarily driven by the successful completion of a private placement in January, 2024, which generated gross proceeds of approximately $1.49-million, as well as the exercise of warrants in March, 2024, yielding an additional $2.93-million. These inflows were partially offset by a cash outflow of $2.57-million related to operational activities.

As of June 30, 2024, the company had an accumulated deficit of $16.30-million, compared with $14.06-million as of Dec. 31, 2023.

Eran Ovadya, Nurexone's chief financial officer, stated: "The company remains committed to advancing research and development, as well as preparing ExoPTEN for clinical trials and commercial manufacturing. Additionally, through strategic guidance, we are aligning our business plan with current operations to ensure sustained growth and long-term success."

About Nurexone Biologic Inc.

Nurexone Biologic is a TSX Venture Exchange-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 per cent 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 non-invasive targeted drug delivery for other indications.

We seek Safe Harbor.

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