Mr. Mike Kelly reports

NERVGEN PHARMA RECEIVES FAST TRACK DESIGNATION FOR NVG-291 FOR THE TREATMENT OF INDIVIDUALS WITH SPINAL CORD INJURY

The U.S. Food and Drug Administration (FDA) has granted fast-track designation for Nervgen Pharma Corp.'s proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). The FDA's fast-track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast-track also provides eligibility for both priority review, which can shorten the new drug development (NDA) review process, and for accelerated approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical end point.

"The FDA's decision to grant fast-track designation for NVG-291 underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers," said Mike Kelly, Nervgen's president and chief executive officer. "We believe that NVG-291 has the potential to be the first approved treatment indicated to enable neurological/functional recovery following spinal cord injury, and we look forward to working closely with the FDA in the clinical development process with the goal of obtaining approval to market NVG-291 as soon as possible."

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 wedge domain of the receptor-type protein tyrosine phosphatase sigma (PTPsigma). NVG-291-R, a rodent analog 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. Nervgen has initiated a phase 1b/2a placebo-controlled proof-of-concept trial (NCT05965700) to 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. Initial results are expected in mid-2024.

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 being evaluated in a phase 1b/2a clinical trial. The company's initial target indication is spinal cord injury.

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