NurExone Reports First Quarter 2024 Financial Results and Provides Corporate Update, moving forward with FDA guidelines for the Human Trials

Article content

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.

Article content

Key Business Highlights

Article content

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.

Article content

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.

Article content

Article content

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 development expenses were US$0.22 million in the first quarter of 2024, compared to US$0.37 million in the same quarter in 2023. The decrease was primarily due to the receipt of a governmental grant of US$0.02 and reductions in stock-based compensation of US$0.08, subcontractor and materials expenses of US$0.05.
• General and administrative expenses were US$0.70 million in the first quarter of 2024, compared to US$0.35 million in the same period in 2023. The increase was primarily due to costs related to public and investor relations services.
• Finance expenses were US$0.01 million in the first quarter of 2024, compared to finance income of US$0.01 million in the same period in 2023, driven by income from bank interest.
• Net loss was US$0.92 million in the first quarter of 2024, compared to a net loss of US$0.70 million in the first quarter of 2023.

Article content

As of March 31, 2024, the Company had cash and cash equivalents of US$3.25 million (December 31, 2023 – US$0.54 million) and working capital of US$3.31 million (December 31, 2023 – US$0.07 million). The increase in cash was primarily due to the completion of a private placement in January 2024 for gross proceeds of approximately US$1.49 million and the exercise of warrants in March 2024 for gross proceeds of approximately US$2.92 million.

The Company had an accumulated deficit of US$14.98 million as of March 31, 2024, (December 31, 2023 – US$14.06 million).

Eran Ovadya, NurExone’s Chief Financial Officer, added: “The Company maintains a strong cash position, ensuring sufficient funding until year-end. With strategic oversight, we navigate our business plan amidst ongoing activities, positioning ourselves for sustained growth and continued success.”

About NurExone Biologic Inc.

NurExone Biologic Inc. is a 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.

Article content

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Thesis Capital Inc.
Investment Relation – Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

Dr. Eva Reuter
Investment Relation – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

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 to in-house laboratories and offices being completed on the timelines setout herein; the in-house laboratories and offices, once construction is completed, having the intended effect on the Company and its business; the Company’s preclinical and clinical testing yielding their intended results; the Company proceeding to clinical trials on the timelines setout herein; the Company pioneering transformations in the field of regenerative medicine with new, minimally invasive therapies; the Company enhancing their ExoTherapy platform for production of nanodrugs, expanding their intellectual property, and forging strategic collaborations; the Company collaborating with biopharma companies; the Company having sufficient funding for its operations; the Company having sustained growth and continued success; and the NurExone platform technology offering novel solutions to drug companies.

Article content

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; the engagement of Dr. Petter will have its intended outcome; in-house laboratories and offices will be completed on the timelines setout herein and having their intended effects on the Company and its business; 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 pioneer transformations in the field of regenerative medicine with new, minimally invasive therapies; the Company will enhance
their ExoTherapy platform for production of nanodrugs, expand their intellectual property, and forge strategic collaborations; the Company will collaborate with biopharma companies; the Company will have sufficient funding for its operations; the Company will have sustained growth and continued success; the Company will have better liquidity and broader access for investors; the Company will enter into new partnerships and/or licensing agreement; and the NurExone platform technology will offer novel solutions to drug companies.

Article content

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; 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 complete construction of in-house laboratories and offices and/or these initiatives not having the intended effect on the Company and its business; the Company
being unable to pioneer
transformations in the field of regenerative medicine; the Company being unable to enhance
their ExoTherapy platform for production of nanodrugs,
expand
their intellectual property and/or forging strategic collaborations; the Company being unable to collaborate with biopharma companies; the Company being unable to have sustained growth and/or continued success; the NurExone platform technology being unable to offer novel solutions to drug companies; 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.

Article content