NurExone Advances U.S. Growth Strategy with Acceptance into Prestigious ARMI HealthTech Hub Accelerator and Provides Corporate Update
NurExone's acceptance into the prestigious HTH Accelerator Program will support the Company's expansion into the U.S. market following the establishment of Exo-top Inc. ('Exo-TOP'), the Company's wholly owned U.S. subsidiary dedicated to GMP-compliant exosome manufacturing for clinical development and commercial scale-up.
HTH, co-led by ARMI and Mass General Brigham, is a competitive accelerator program supported by the U.S. Department of Health and Human Services and Israel's Ministry of Health. The HTH Accelerator Program selects a limited number of innovative companies each year to help them validate U.S. clinical relevance, strengthen commercialization strategies, and build meaningful collaborations with key stakeholders across the U.S. HealthTech landscape. The program is funded by HTH at no cost to participants.
Dr. Lior Shaltiel, CEO of NurExone, commented: 'The HTH Acceleration Program offers the kind of U.S.-based insight and guidance needed at this stage of our growth. As we establish Exo-TOP to manufacture clinical-grade exosomes in the U.S., the HTH will help us sharpen our regulatory and scale-up strategies and pursue meaningful commercial collaboration opportunities. This is a timely and strategic opportunity to accelerate our commercialization pathway in the world's largest healthcare market 2.'
NurExone's participation in the HTH Accelerator Program is expected to enhance its visibility within the U.S. regenerative medicine ecosystem and to support its mission to bring novel exosome-based therapeutics to patients with unmet needs.
Omnibus Plan Approval
The Company is pleased to announce that, further to its press release dated June 4, 2025, at the Company's annual general and special meeting held on June 18, 2025 (the 'Meeting'), disinterested shareholders ratified and approved the amended and restated omnibus incentive plan (the 'Omnibus Plan'), a copy of which is available under the Company's SEDAR+ profile at www.sedarplus.ca.
The Omnibus Plan is a hybrid plan that provides flexibility to grant-equity incentive awards in the form of stock options ('Options'), restricted shares ('Restricted Shares') and restricted share units ('RSUs').
The Omnibus Plan is a hybrid 10% rolling and 10% fixed share-based compensation plan that amends and restates the Company's previous equity incentive plan approved by shareholders on June 4, 2024 (the 'Previous Plan'). The Previous Plan was a 20% fixed share-based compensation plan whereby the maximum number of common shares in the capital of the Company ('Common Shares') reserved for issuance was set at 13,166,085, representing 20% of the issued and outstanding Common Shares as of the effective date.
The Omnibus Plan now includes (i) a 10% 'rolling' Option component that shall not exceed 10% of the Company's total issued and outstanding Common Shares from time to time; and (ii) a 10% fixed component permitting up to 7,800,781 RSUs and Restricted Shares in the aggregate.
Additionally, the Omnibus Plan was amended to increase the number of securities issuable to insiders of the Company. The Previous Plan provided, that unless approved by disinterested shareholders, (i) the maximum number of securities issuable to insiders collectively would not exceed 10% of the Company's securities at any time and (ii) the maximum number of securities issuable to insiders collectively in any twelve-month period would not exceed 10% of the Company's total issued and outstanding securities as at the date any award was granted to an insider. Now, the Omnibus Plan provides the following that (i) the maximum number of the Company's securities issuable to insiders collectively shall not exceed 20% of the Company's total issued and outstanding Common Shares at any point in time and (ii) the maximum number of the Company's securities issuable to insiders collectively, in any 12-month period, when combined with all of the Company's other share compensation arrangements, shall not exceed 20% of the Company's total issued and outstanding securities, calculated as at the date any award is granted or issued to any insider.
RSU Grants
In addition, the Company announced that it has granted an aggregate of 1,125,000 RSUs to certain officers and directors of the Company pursuant to the terms and conditions of the Omnibus Plan. Each RSU vests on the one-year anniversary of the grant date and may be settled, upon their vesting, into one Common Share. The RSUs and underlying Common Shares are subject to the Exchange Hold Period (as such term is defined under the policies of the TSX Venture Exchange ('TSXV')).
About NurExone
NurExone Biologic Inc. is a TSXV, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsi. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, 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
Dr. Eva ReuterInvestor Relations – GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu
Allele Capital PartnersInvestor Relations – U.S.Phone: +1 978-857-5075Email: aeriksen@allelecapital.comThis 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; the Company's acceptance into the prestigious HTH Accelerator Program will support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program is expected to enhance its visibility within the U.S. regenerative medicine ecosystem and support its mission as discussed herein; each RSU will be settled into one Common Share; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health.
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 Company's acceptance into the prestigious HTH Accelerator Program will allow it to support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program will give the Company the ability to enhance its visibility within the U.S. regenerative medicine ecosystem and support its mission as discussed herein; each RSU will be settled into one Common Share; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health
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; 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 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 inability to obtain adequate financing; the inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; 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 carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to realize on the benefits of exosomes; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company's products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the Company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the Company's inability to realize upon the stated potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company's inability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and/or cell therapy applications; the Company's inability to expand into further studies; the Company will not receive all required regulatory approvals; the Company will not have clinical and/or commercial breakthroughs in regenerative medicine; the Company will be unable to enhance its presence in key markets; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; the Company will not realize its future development plans, operational initiatives, and strategic objectives; the Company will not advance its therapeutic programs and clinical milestones; the Company will not engage with regulatory agencies; the Company's acceptance into the prestigious HTH Accelerator Program will not support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program will not enhance its visibility within the U.S. regenerative medicine ecosystem and will not support its mission as discussed herein; each RSU will not be settled into one Common Share; 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.
i Spinal cord injury, Glaucoma
1 https://www.epmscientific.com2 https://www.hbmhealthcare.com
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