NervGen Pharma to Host Virtual Investor Event

Rhea-AI Summary

NervGen Pharma (OTCQB: NGENF) has announced a virtual investor event scheduled for April 9, 2025, at 10:00 a.m. ET, focusing on their spinal cord injury treatment developments. The event will feature key opinion leaders Dr. Monica Perez from Shirley Ryan AbilityLab and Dr. Steven Kirshblum from Rutgers New Jersey Medical School.

The presentation will cover:

• Current treatment landscape for spinal cord injury patients
• Overview of NervGen's Phase 1b/2a proof-of-concept clinical trial
• Discussion of study endpoints, including electrophysiology
• Review of preclinical data for NVG-291-R
• Phase 1 safety trial results for NVG-291, their first-in-class therapeutic peptide

Clinical data from the Phase 1b/2a trial is expected in the second quarter. The event will conclude with a live Q&A session.

Key opinion leaders and company management will discuss the current spinal cord injury treatment landscape and NervGen's Phase 1b/2a clinical trial evaluating NVG-291 in individuals with spinal cord injury

VANCOUVER, British Columbia, March 25, 2025 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (TSX-V: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced that it will host a virtual investor event on Wednesday, April 9, 2025, at 10:00 a.m. ET. To register for the event, click here.

The event will feature key opinion leaders, Monica Perez, PT, Ph.D. (Shirley Ryan AbilityLab) and Steven Kirshblum, MD (Rutgers New Jersey Medical School), who will join company management to discuss the unmet medical need and current treatment landscape for individuals with spinal cord injury.

Ahead of clinical data expected in the second quarter for the company’s Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial, the event will highlight the study design and provide an overview of endpoints being measured, including electrophysiology. NervGen will also review data from preclinical trials evaluating NVG-291-R and the Phase 1 trial evaluating safety of NVG-291, NervGen's first-in-class therapeutic peptide targeting nervous system repair, in chronic and subacute SCI.

A live question and answer session will follow the formal presentations.

About Monica A. Perez, PT, PhD
Monica A. Perez, PT, PhD, is the Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab, a Professor in the Department of Physical Medicine and Rehabilitation at Northwestern University, and a Research Scientist at the Edward Jr. Hines VA Hospital. Dr. Perez has studied neural mechanisms contributing to the control of voluntary movement in healthy humans and in people with spinal cord injury for more than 15 years. Her research aims to understand how the brain and spinal cord contribute to the control of movement with the ultimate goal of using this mechanistic information to develop more effective rehabilitation therapies for people with spinal cord injury. This theme is mainly investigated from a neurophysiological point of view, using a combination of transcranial magnetic stimulation, magnetic resonance imaging, electrical stimulation, and behavioral techniques.

About Steven Kirshblum, MD
Steven Kirshblum, MD, is a Professor and Chair of the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School and the program director for the Spinal Cord Injury Medicine Fellowship. He also serves as the chief medical officer for the Kessler Foundation and the co-director of the Foundation’s Tim and Caroline Reynolds Center for Spinal Stimulation. Dr. Kirshblum is the project co-director of the Northern New Jersey Spinal Cord Injury Model System, one of only 18 federally designated centers in the country. Dr. Kirshblum also serves as chief medical officer for Kessler Institute for Rehabilitation.

About Phase 1b/2a Trial
The double-blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary and exploratory objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. The cohorts will be comprised of approximately 20 subjects each and will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.

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 was licensed from Case Western Reserve University and is based on academic studies demonstrating the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. Effects of NVG-291-R reported in multiple independent academic studies include the promotion of neuroplasticity, remyelination, anti-inflammatory polarization of microglia, and functional improvement in preclinical models of spinal cord injury, stroke, and peripheral nervous system injury. NVG-291 has received Fast Track designation in spinal cord injury from the U.S. Food and Drug Administration.

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 molecule, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury and has initiated preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS) and spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X, LinkedIn, and Facebook for the latest news on the company.

Contacts

Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711

Mike Moyer
Managing Director, LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
617.308.4306

David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners
david.schull@russopartnersllc.com
ignacio.guerrero-ros@russopartnersllc.com
858.717.2310
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 subject matter to be presented at the virtual investor event; 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 development plans, timelines, expected benefits, and prospective target indications for NVG-300; the receipt of the milestone-based grant payments; and the creation of neurorestorative 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.

FAQ

When will NervGen Pharma (NGENF) release clinical data for their spinal cord injury treatment?

NervGen expects to release clinical data from their Phase 1b/2a trial in the second quarter of 2025.

What is NVG-291 and how is it being tested for spinal cord injury?

NVG-291 is a first-in-class therapeutic peptide targeting nervous system repair, currently being evaluated in a Phase 1b/2a double-blind, randomized placebo-controlled trial for spinal cord injury treatment.

Who are the key opinion leaders presenting at NervGen's April 2025 investor event?

Dr. Monica Perez from Shirley Ryan AbilityLab and Dr. Steven Kirshblum from Rutgers New Jersey Medical School will be presenting.

What will be discussed at NervGen's (NGENF) April 9 virtual investor event?

The event will cover spinal cord injury treatment landscape, Phase 1b/2a trial design, study endpoints, preclinical data for NVG-291-R, and Phase 1 safety trial results.