NRX Nurexone Biologic Inc

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 nine months ended September 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 nine months ended September 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

• In July 2024 and September 2024, the Company generated gross proceeds of C$143,172.05 through the issuance of 409,063 common shares upon the exercise of warrants at price of C$0.35 per common share which were issued in the Company’s January 2024 private placement.
• On August 1, 2024, the Company engaged Allele Capital Partners, LLC, an independently owned capital markets advisory firm based in the United States, for investor relations services.
• On September 26, 2024, the Company closed the first tranche of its non-brokered private placement through the issuance of 2,927,541 units at a price of C$0.55 per unit, resulting in aggregate gross proceeds of C$1,610,147.55. Each unit consisted of one common share and one common share purchase warrant, with each warrant entitling the holder thereof to purchase one additional common share at a price of C$0.70 per common share for a period of 36 months, subject to acceleration, as more particularly set out in the Company’s September 26, 2024 press release.
• On November 1, 2024, the Company closed the final tranche of its non-brokered private placement through the issuance of 231,818 units at a price of C$0.55 per unit, resulting in aggregate gross proceeds of C$127,499.90.
• On November 1, 2024, the Company engaged Independent Trading Group and Oak Hill Financial Inc. to provide market-making, business, and capital markets advisory services.
• On November 13, 2024, the Company announced that the European Medicines Agency granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this potential treatment available for acute spinal cord injury patients across Europe.

Third Quarter Fiscal 2024 Financial Results

• Research and development expenses, net, were US$0.50 million in the third quarter of 2024, compared to US$0.40 million in the same quarter in 2023. The increase was primarily due to higher subcontractor and materials expenses of US$0.15 million, partially offset by a governmental grant receipt of US$0.05 million.
• General and administrative expenses were US$0.78 million in the third quarter of 2024, compared to US$0.76 million in the same period in 2023. The rise was mainly attributed to an increase in non-cash costs associated with granted stock options of US$0.17, partially offset by professional and legal services expenses of US$0.15 million.
• Finance income was US$0.04 million in the third quarter of 2024, compared to finance income of US$0.01 million in the same period in 2023, primarily due to income from bank interest and financing exchange rate adjustments.
• The net loss for the third quarter of 2024 was US$1.25 million, compared to a net loss of US$1.16 million in the same quarter of 2023.

As of September 30, 2024, the Company held cash and cash equivalents totaling US$2.52 million, an increase from US$0.54 million as of December 31, 2023. The Company’s working capital also improved to US$2.39 million, up from US$0.07 million at the end of 2023. The increase in cash was primarily driven by the successful completion of private placements in January and September 2024, which generated gross proceeds of approximately US$2.68 million, as well as the exercise of warrants during 2024, yielding an additional US$3.30 million. These inflows were partially offset by a cash outflow of US$3.61 million related to operational activities.

As of September 30, 2024, the Company had an accumulated deficit of US$17.55 million, compared to US$14.06 million as of December 31, 2023.

Eran Ovadya, NurExone’s Chief Financial Officer, stated: “Our latest financial performance reflects our commitment to advancing ExoPTEN to clinical trials, while streamlining operations and optimizing our business strategy to drive sustainable growth and secure long-term success.”

Growth Outlook for 2024-2025

According to Chief Executive Officer Dr. Lior Shaltiel, “NurExone is making significant strides on the path towards human trials, including the receipt of Orphan Drug Status for ExoPTEN in Europe, 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 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 a second commercial market, the multi-billion-dollar glaucoma market(1), with promising preliminary results.”

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.

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

For more information, please contact:

Dr. Lior ShaltielChief Executive Officer and DirectorPhone: +972-52-4803034Email: info@nurexone.com

Oak Hill Financial Inc.2 Bloor Street, Suite 2900Toronto, Ontario M4W 3E2Investor Relations - CanadaPhone: +1-647-479-5803Email: info@oakhillfinancial.ca

Dr. Eva ReuterInvestment Relation - GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu

Allele Capital PartnersInvestment Relation - USPhone: +1 978-857-5075Email: aeriksen@allelecapital.com

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 the receipt of the Orphan Medicinal Product Designation having the intended benefits and incentives on the Company and its business as set out herein; the potential glaucoma market; the Company having adequate financing through the end of the year and well into 2025; the Company entering the European market and bringing its products to patients across Europe; the Company’s latest financial performance positioning it for sustained growth and long-term success; the Company making significant strides on the path towards human trials with assistance from Dr. Yona Geffen; the Company collaborating with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results; 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 enter into new partnerships and/or licensing agreements; the receipt of the Orphan Medicinal Product Designation having the intended benefits and incentives on the Company and its business as set out herein; the Company will enter the European market and bring its products to patients across Europe; the Company being able to make significant strides on the path towards human trials with assistance from Dr. Yona Geffen; the Company being able to collaborate with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results; the 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 being able to 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; 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; the receipt of the Orphan Medicinal Product Designation not having the intended benefits and incentives on the Company and its business as set out herein; the Company not entering the European market and bringing its products to patients across Europe; risk that the Company will not make significant strides on the path towards human trials with assistance from Dr. Yona Geffen; risk that the Company will not collaborate with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results already available; 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 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, 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.

___________________________(1) Global Glaucoma Treatment Market Analysis by Spherical Insights LLP