Mr. Mike Kelly reports

NERVGEN PHARMA TO RECEIVE MORE THAN US$3 MILLION FROM WINGS FOR LIFE TO SUPPORT UPCOMING CLINICAL STUDY IN SPINAL CORD INJURY

Nervgen Pharma Corp. has been awarded a grant of up to $3.18-million (U.S.) from Wings for Life, a not-for-profit spinal cord injury research foundation, under the foundation's Accelerated Translational Program. The financing will support the coming phase 1b/2a proof-of-concept clinical trial for the company's proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Additionally, the U.S. Food and Drug Administration (FDA) has completed its review of the company's clinical trial protocol and has determined that the study may proceed. The company will continue to work to resolve the continuing partial clinical hold from the FDA, but the hold does not impact the conduct of this trial.

"We are very grateful to have the support of Wings for Life for this important clinical study of NVG-291 in individuals with spinal cord injury," stated Mike Kelly, Nervgen's president and chief executive officer. "Our goal is to begin enrolling subjects in this trial in the third quarter of this year. Wings for Life's grant support for our SCI clinical program comes at an important inflection point for Nervgen as we transition from our recently completed phase 1 study in healthy volunteers to this phase 1b/2a proof-of-concept study."

"Wings for Life USA is thrilled to partner with Nervgen, Dr. Monica Perez and Shirley Ryan AbilityLab to translate this promising intervention from laboratory research to human clinical trial," said Andrew Wagner, CEO of Wings for Life USA. "Bridging this gap is critical to accelerating progress. We are more excited than ever about driving our mission to find a cure for spinal cord injuries, and we thank our generous donors who make it possible to fund this progress."

"One of the novel aspects of this clinical trial is the use of advanced quantitative electrophysiology to assess recovery of motor connectivity following treatment with NVG-291, in addition to clinical assessments to measure recovery of motor function," stated Dr. Perez, PT, PhD, scientific chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; professor of physical medicine and rehabilitation at Northwestern University; research scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. "At Shirley Ryan AbilityLab, we have leveraged electrophysiology extensively to strengthen neuronal connectivity using non-invasive spike-timing-dependent plasticity protocols, but this approach has been sparsely used in clinical trials of investigational pharmacologic therapies for individuals with spinal cord injury. We are excited that Shirley Ryan AbilityLab will be the single centre working with Nervgen on this important clinical trial."

The placebo-controlled proof-of-concept trial will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (one to 10 years postinjury) and subacute (10 to 49 days postinjury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI (magnetic resonance imaging) 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 objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity, and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data become available. The grant financing from Wings for Life, which is to be provided in several milestone-based payments, 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 mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular domain of the receptor-type protein tyrosine phosphatase sigma (PTPsigma). NVG-291-R, a rodent analogue of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration and remyelination.

About Nervgen Pharma Corp.

Nervgen is a clinical-stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. Nervgen's lead drug candidate, NVG-291, is currently planned to be evaluated in a phase 1b/2a clinical trial. The company's initial target indication is spinal cord injury.

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