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NurExone Biologic Inc. (TSXV: NRX,OTC:NRXBF) (OTCQB: NRXBF) (FSE: J90) ("NurExone" or the "Company") a biopharmaceutical company developing exosome-based regenerative therapies, announced that Dr. Ina Sarel, Director of Clinical and Regulatory Affairs, has been invited to speak at the Precision EV Forum 2025 being held October 27–28 in Cambridge, UK. Her participation underscores growing global recognition of NurExone's leadership in developing exosome therapies and in helping define the regulatory path for this emerging field.
Dr. Sarel will present "Regulatory Challenges in the Clinical Development of ExoPTEN: MSC EVs Loaded with PTEN-siRNA" on October 28, followed by a panel discussion on how developers of exosome therapeutics can better approach regulatory approval. The invitation reflects strong international interest in NurExone's lead program, ExoPTEN, a drug under development that combines regenerative and anti-inflammatory mechanisms to repair Central Nervous System damage.
"The Orphan Drug Designation granted to ExoPTEN in acute spinal cord injury opened the door to early and constructive discussions with the FDA, where we have built an open, data-driven relationship focused on both innovation and patient safety," said Dr. Ina Sarel, Director of Clinical and Regulatory Affairs at NurExone.
ExoPTEN is designed to address significant unmet needs and critical indications in central nervous system repair, including acute spinal cord injury and optic nerve damage associated with glaucoma. In both indications, ExoPTEN has demonstrated the ability to restore nerve function and reduce inflammation in preclinical models.
"Leading industry and regulatory stakeholders are following NurExone's progress closely, and we are glad to present our work in Cambridge," said Dr. Lior Shaltiel, CEO of NurExone. "Our strategy combines scientific innovation with regulatory leadership, paving the way for exosome-based therapies to reach clinical and commercial realization."
The Precision EV Forum 2025, focused on removing barriers to the clinic, will feature global leaders advancing the therapeutic potential of exosomes, including Marcin Jurga, PhD, Chief Scientific Officer of EXO Biologics; Heena Sharma, Associate Research Director at Evox Therapeutics; Julien Branchu, Head of R&D at EverZom; and Gloria Matthews, DVM, PhD, formerly Chief Medical Officer at multiple regenerative medicine companies.
About NurExone
Nurexone Biologic Inc. is a TSX Venture Exchange (" 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 markets i . 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 Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: 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: Dr. Ina Sarel presenting and participation in a panel discussion at the Precision EV Forum 2025 and the subject and benefits of her presentation and panel; the featured presenters and panellists; the benefits and design specifications of ExoPTEN; the Company's collaboration with the FDA; the Company advancing towards clinical and commercial realization; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive 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: Dr. Ina Sarel will present and participate in a panel discussion at the Precision EV Forum 2025 and the subject and benefits of her presentation and panel will be as outlined herein; the featured presenters and panellists will be as outlined herein; ExoPTEN will yield the benefits and have the design specifications as outlined herein; the Company will continue to collaborate with the FDA; the Company will advance towards clinical and commercial realization; and the NurExone platform technology has the ability to offer novel solutions to drug companies interested in minimally invasive 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; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company's products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company's technologies; the Company's dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company's ability to protect its intellectual property; the possibility that the Company's technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs;
Dr. Ina Sarel will be unable to present and/or participate in a panel discussion at the Precision EV Forum 2025 and/or the subject and/or benefits of her presentation and panel will not be as outlined herein; the featured presenters and panellists will not be as outlined herein; ExoPTEN will be unable to yield the benefits and/or have the design specifications as outlined herein; the Company will be unable to continue to collaborate with the FDA; the Company will not advance towards clinical and/or commercial realization; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive 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.
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i Spinal cord injury , Glaucoma
