Vancouver, Canada, June 18, 2025 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neuroreparative therapeutics, today announced the appointment of Randall Kaye, MD, to the role of Chief Medical Advisor. Dr. Kaye, a current member of NervGen’s Board of Directors and Chair of the Science Committee since 2020, brings highly relevant and extensive experience in central nervous system (CNS) therapeutic development, regulatory strategy, and medical affairs to the NervGen team. The expanded engagement follows the company’s announcement of positive topline results in the chronic cohort of the Phase 1b/2a clinical trial evaluating NVG-291 in individuals with cervical spinal cord injury.
“We are very pleased to welcome Dr. Kaye in his expanded capacity as a medical advisor to the company,” said Mike Kelly, NervGen’s President & CEO. “In addition to his close history and contributions to the NVG-291 program, he brings extensive industry and CNS development expertise focused on clinical and regulatory strategy. Dr. Kaye has highly relevant experience and is well positioned to assist the team in analyzing the complete chronic cohort data and help chart the next phase of NVG-291’s clinical and regulatory pathway, which includes assisting in preparations for our anticipated meeting with the U.S. Food and Drug Administration (FDA) in the second half of this year.”
As a NervGen Board member and Science Committee Chair, Dr. Kaye has served as an advisor to the NVG-291 program since its early clinical development. He previously served as chief medical officer of multiple biopharmaceutical companies, including most recently at Longboard Pharmaceuticals Inc., where he helped guide CNS development programs through a $2.6 billion acquisition by H. Lundbeck A/S. His expertise spans the areas of neurology, psychiatry, immunology, and infectious disease, and includes oversight of clinical operations, regulatory affairs, and medical strategy. Dr. Kaye earned his MD, MPH, and BS degrees from George Washington University and completed a Research Fellowship at Harvard Medical School.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291’s technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury.
About NervGen
NervGen (TSXV: NGEN, OTCQB: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease. The company is testing the clinical efficacy of its lead candidate, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury. Topline data from the chronic cohort (1-10 years post-injury) of this trial showed that NVG-291 met its primary endpoint and demonstrated promising changes in a secondary endpoint assessing hand function. Enrollment in the subacute cohort (20-90 days post-injury) of the trial continues, and more information about participation in the subacute study is available at www.connectscistudy.com. In addition, the company has initiated preclinical test of concept evaluation of its pipeline candidate, NVG-300, in models of ischemic stroke and spinal cord injury.
For more information about NervGen, visit www.nervgen.com and follow NervGen on X and LinkedIn for the latest news on the company.
Contacts
Huitt Tracey, Investor Relations
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
Christy Curran
Sam Brown Healthcare Communications
christycurran@sambrown.com
615.414.8668
646.942.5604
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This news release may contain “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation (collectively, “forward-looking statements”). Such forward-looking statements herein include but are not limited to, the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “trend”, “indication”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the strategic guidance to be provided by the chief medical advisor; the anticipated meeting with the FDA; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and timing of data readout and study design of our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; the future development plans and benefits of NVG-291; the development plans and prospective target indications for NVG-300; and the creation of neuroreparative therapeutics to promote nervous system repair in settings of neurotrauma and neurologic disease.
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