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 offset by a US$0.01 million decrease in insurance expenses.
Finance expenses were US$0.01 million in the second quarter of 2024, compared to finance income of US$0.02 million 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 US$1.33 million, compared to a net loss of US$1.04 million in the second quarter of 2023.
As of June 30, 2024, the Company held cash and cash equivalents totaling US$2.39 million, an increase from US$0.54 million as of December 31, 2023. The Company’s working capital also improved to US$2.24 million, up from US$0.07 million 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 US$1.49 million, as well as the exercise of warrants in March 2024, yielding an additional US$2.93 million. These inflows were partially offset by a cash outflow of US$2.57 million related to operational activities.
As of June 30, 2024, the Company had an accumulated deficit of US$16.30 million, compared to US$14.06 million as of December 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 Inc. is a TSX Venture Exchange (“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.
Dr. Lior Shaltiel Chief Executive Officer and Director Phone: +972-52-4803034 Email: [email protected]
Thesis Capital Inc. Investment Relation - Canada Phone: +1 905-347-5569 Email: [email protected]
Dr. Eva Reuter Investment Relation - Germany Phone: +49-69-1532-5857 Email: [email protected]
Allele Capital Partners Investment Relation - US Phone: +1 978-857-5075 Email: [email protected]
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements”, that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating torelating to the success of the partnership with Vivox Ltd.; the Company submitting an IND application with the FDA; the Company’s preclinical and clinical testing yielding their intended results; the Company proceeding to clinical trials on the timelines setout herein; the Company having sufficient funding for its operations; the Company having sustained growth and continued success; DTC eligibility facilitating better liquidity and broader access to investors; the Company expanding its potential market; BullVestor continuing to provide investor relations services to the Company on the timelines set out herein; the potential glaucoma market; the Company having adequate financing through the end of the year and well into 2025; the Company positioning itself for sustained growth and long-term success; and the NurExone platform technology offering novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; partnerships having their intended impact on the Company and its business; patents safeguarding NurExone’s technology; the Company’s drug products having its intended benefits and effects; the Company making progress through new partnerships and technologies to move towards commercialization of their products; the Company’s intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; exosomes becoming an ideal and natural choice for drug delivery; the Company making advancements in the manufacturing process of exosomes; exosomes holding immense promise for regenerative medicine; the Company’s preclinical and clinical testing will yield their intended results; the Company will proceed to clinical trials on the timelines setout herein; the Company will have sufficient funding for its operations; the Company will have sustained growth and continued success; the Company will enter into new partnerships and/or licensing agreement; the Vivox Ltd. partnership will be successful; the company will submit an IND application with the; DTC eligibility will facilitate better liquidity and broader access to investors; the Company will expand its potential market; BullVestor will continue to provide investor relations services to the Company on the timelines set out herein; glaucoma market will grow; the Company will have adequate financing through the end of the year and well into 2025; the Company will position itself for sustained growth and long-term success; and the NurExone platform technology will offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company’s intellectual property; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials and/or on the timelines set out herein; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the Company being unable to have sustained growth and/or continued success; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to realize upon partnerships; risk that the Vivox Ltd. partnership will be unsuccessful; risk that the Company will be unable to submit or proceed with an IND application and/or it will be denied; risk that DTC eligibility won’t facilitate better liquidity and/or broader access to investors; the Company’s inability to expand its potential market; risk that BullVestor will be unable to continue to provide investor relations services to the Company on the timelines set out herein; risks associated with the size of the glaucoma market; risks that the Company will not have adequate financing through the end of the year and/or well into 2025; risks that the Company will be unable to position itself for sustained growth and long-term success; risk that the NurExone platform technology will be unable to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 29 to 36 of the Company’s Annual Information Form dated March 30, 2023, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
