NervGen Announces Appointment of Randall Kaye, MD to Chief Medical Advisor Role

Rhea-AI Summary

NervGen Pharma has appointed Dr. Randall Kaye as Chief Medical Advisor, expanding his role beyond his current positions as Board Member and Science Committee Chair since 2020. This appointment follows positive topline results in the chronic cohort of NVG-291's Phase 1b/2a trial for cervical spinal cord injury. Dr. Kaye brings extensive experience in CNS therapeutic development, regulatory strategy, and medical affairs. His most recent role was as Chief Medical Officer at Longboard Pharmaceuticals, where he contributed to CNS development programs leading to a $2.6 billion acquisition by H. Lundbeck A/S. Dr. Kaye will assist in analyzing chronic cohort data and help prepare for an upcoming FDA meeting in late 2025.

Positive

• Appointment of experienced CNS development expert Dr. Kaye who is already familiar with NVG-291 program
• Recent positive topline results in Phase 1b/2a trial for spinal cord injury treatment
• Dr. Kaye's proven track record includes involvement in programs leading to a $2.6B acquisition

Negative

• None.

Vancouver, British Columbia--(Newsfile Corp. - June 18, 2025) - NervGen Pharma Corp. (TSXV: 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

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

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.

Forward-looking statements are based on estimates and assumptions made by the company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, we have relied on various assumptions, including, but not limited to: our ability to obtain future funding on favourable terms or at all; the accuracy of our financial projections; obtaining positive results in our clinical and other trials; our ability to obtain necessary regulatory approvals; our ability to arrange for the manufacturing of our product candidates and technologies; and general business, market and economic conditions.

Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the company's most recently filed prospectus supplement, short form base shelf prospectus, annual information form, financial statements and management discussion and analysis all of which can be found on NervGen's profile on SEDAR+ at www.sedarplus.ca. All clinical development plans are subject to additional funding.

Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/255973

FAQ

Who is Dr. Randall Kaye and what is his new role at NervGen Pharma (NGENF)?

Dr. Randall Kaye is NervGen's newly appointed Chief Medical Advisor, previously serving as Board Member and Science Committee Chair since 2020. He brings extensive experience in CNS therapeutic development and regulatory strategy.

What are Dr. Kaye's responsibilities at NervGen Pharma (NGENF)?

Dr. Kaye will help analyze the complete chronic cohort data from the NVG-291 trial and assist in preparing for the FDA meeting in late 2025, while providing expertise in clinical and regulatory strategy.

What is NervGen's (NGENF) main drug candidate and its current development stage?

NervGen's main drug candidate is NVG-291, which is currently in Phase 1b/2a clinical trials for cervical spinal cord injury and has recently reported positive topline results in the chronic cohort.

What is Dr. Kaye's previous experience in the pharmaceutical industry?

Dr. Kaye previously served as Chief Medical Officer at several biopharmaceutical companies, most recently at Longboard Pharmaceuticals, where he helped guide CNS development programs through a $2.6 billion acquisition by H. Lundbeck A/S.