Mr. Mike Kelly reports

NERVGEN PHARMA TO PROCEED WITH LANDMARK PHASE 1B/2A CLINICAL TRIAL FOR NVG-291 IN SPINAL CORD INJURY HAVING COMPLETED FDA REVIEW AND RECEIVED IRB APPROVAL

Nervgen Pharma Corp. has received Institutional Review Board (IRB) approval for its landmark phase 1b/2a proof-of-concept clinical trial protocol of its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Nervgen is now actively recruiting potential subjects. As previously announced, the United States Food and Drug Administration (FDA) completed its review of the clinical trial protocol and determined that the study may proceed. This first-in-kind trial is sponsored in part by a grant of up to $3.18-million (U.S.) from Wings for Life, a not-for-profit spinal cord injury research foundation. Preclinical studies of NVG-291 demonstrated unprecedented functional improvement in both acute and chronic spinal cord injury models, as well as in five other models of nervous system damage.

"We are very excited to advance this unique and important clinical study in individuals with spinal cord injury and to soon administer our lead drug candidate, NVG-291, which we believe has the potential to repair nervous system damage," said Mike Kelly, Nervgen's president and chief executive officer. "This study is essentially two studies in one as it will inform about NVG-291's efficacy in individuals with both subacute and chronic SCI. We are optimistic that the results of this study may be a key enabling step in advancing NVG-291 through the clinical development process toward approval. Most importantly, we are thrilled that we can offer hope to individuals with spinal cord injury, as well as to their families and caregivers, as there are no FDA-approved drugs to promote sustained functional recovery."

Recruitment of the chronic cohort (one to 10 years postinjury) is now open. Given the significant number of individuals suffering with chronic SCI and the tremendous anticipation of the trial within the SCI community, recruitment is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10 to 49 days postinjury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions.

"Our team at Shirley Ryan AbilityLab is ready and excited to start this state-of-the-art clinical trial after extensive planning," stated Monica A. 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. "This trial uses an innovative design that incorporates electrophysiology, not only as part of the outcome measures to monitor motor recovery, but also as part of the inclusion criteria of participants. Together, results from electrophyisiological measures, combined with clinical measures, will help us to enhance our knowledge about the efficacy of NVG-291 and could result in a paradigm shift in the treatment of spinal cord injury."

About the NVG-291 phase 1b/2a trial

The placebo-controlled proof-of-concept trial (NCT05965700) 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 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 becomes 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 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.

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