Mr. Mike Kelly reports

NERVGEN COMPLETES ENROLLMENT IN CHRONIC COHORT OF ITS PHASE 1B/2A CLINICAL TRIAL OF NVG-291 IN SPINAL CORD INJURY

Nervgen Pharma Corp. has enrolled the 20th and final subject in the chronic cohort of its 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 (SCI). Furthermore, the company has received institutional review board (IRB) approval for an amendment to its phase 1b/2a clinical trial and has initiated the screening of subjects for the subacute cohort of the study.

"We are pleased to share that enrolment is complete in the chronic cohort of our phase 1b/2a clinical trial in traumatic spinal cord injury," said Dr. Daniel Mikol, MD, PhD, Nervgen's chief medical officer. "Following the conclusion of the 16-week trial for the last enrolled patient, we can proceed with the next step, which is to ensure all data are thoroughly collected and reviewed, including database lock, unblinding and in-depth analysis of the results. When these critical steps are completed, we anticipate announcing top-line results in the second quarter of this year."

"Completing enrolment for the chronic cohort is an exciting and critical milestone for Nervgen," said Mike Kelly, Nervgen's president and chief executive officer. "The team will now shift its focus to enrolling subjects in the subacute cohort. We believe our experience over the past year in recruiting for the chronic cohort together with the recently approved protocol amendment for the subacute cohort should help improve the recruitment process for this second cohort in addition to making the study less burdensome for participants."

Mr. Kelly added: "This milestone is a great way to start the year as we continue to advance our clinical development efforts. We've made significant progress in 2024 and 2025 is poised to be a pivotal year for both Nervgen and the SCI community. We remain fully committed to advancing NVG-291 through the clinical and regulatory process with a goal to eventually make it widely available to individuals living with SCI, the vast majority of whom remain without any therapeutic options."

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 (magnetic resonance 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-extremity and lower-extremity muscle groups following treatment based on changes in motor-evoked potential amplitudes. Secondary 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 comprise 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 biotechnology 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.

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