Mr. Mike Kelly reports

NERVGEN COMPLETES DOSING OF FIRST SUBJECT IN SUBACUTE COHORT OF ITS PHASE 1B/2A CLINICAL TRIAL OF NVG-291 IN SPINAL CORD INJURY

The first subject has been enrolled and dosed in the subacute cohort of Nervgen Pharma Corp.'s phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury. The company previously reported the completion of enrolment of the chronic cohort and announced that results for the chronic cohort are expected in second quarter 2025.

Recently, the company received IRB approval for an amendment focused on the subacute cohort of its phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrolment, for example, revising the timing of subacute SCI to 20 to 90 days postinjury, and to decrease the burden on study participants by reducing the number of visits and assessments.

"The efficacy of NVG-291 is being evaluated in two separate cohorts of individuals with cervical spinal cord injury, chronic and subacute, given the demonstrated efficacy in preclinical models of both chronic and acute SCI," said Dr. Daniel Mikol, MD, PhD, Nervgen's chief medical officer. "We are pleased to report that the first subject in the subacute cohort of our phase 1b/2a clinical trial in traumatic SCI has been enrolled and dosed. We believe that the protocol amendment will enhance enrolment and result in a better overall experience for participants, particularly by reducing burden as individuals enrolled in this cohort are close to the time of their injury and will still be receiving standard of care rehabilitation."

"As we begin the year, our team is on track to report data on the chronic cohort in the second quarter and to advance the enrolment in the subacute cohort throughout 2025," said Mike Kelly, Nervgen's president and chief executive officer. "We truly believe that this will be a pivotal year for Nervgen, and we look forward to further advancing NVG-291 towards our end goal of helping individuals with SCI."

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 (one to 10 years postinjury) and subacute (20 to 90 days postinjury), 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 composed of approximately 20 subjects each and will be evaluated independently as the data become 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 Pharma Corp.

Nervgen 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 and spinal cord injury.

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