Mr. Bill Adams reports

NERVGEN INITIATES EXPANDED ACCESS POLICY

Nervgen Pharma Corp. has initiated an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with spinal cord injury (SCI) who have participated in Nervgen clinical trials and meet specific eligibility criteria. The company received a request from a physician for expanded access to NVG-291 for a subject who participated in the chronic cohort of the phase 1b/2a clinical trial. After the company submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed the company that the study could proceed.

• The United States Food and Drug Administration (FDA) informed the company that an expanded access protocol for NVG-291 may proceed.

NVG-291 is an investigational drug in clinical development that has not been approved by regulatory authorities for marketed use. It is unknown whether it is effective for the treatment of individuals with SCI, and there may be unknown risks associated with its use. Expanded access programs allow patients who have unmet medical needs with serious or life-threatening conditions to access investigational products that are not yet approved by the FDA outside of a clinical trial.

"Nervgen is committed to the continued clinical development and evaluation of NVG-291 as a potential novel treatment approach in spinal cord injury," said Daniel Mikol, MD, PhD, Nervgen's chief medical officer. "As we announce this expanded access policy for specific participants, we continue to enroll the subacute cohort of the phase 1b/2a study in SCI as we prepare to unblind the efficacy and safety results from the chronic cohort of this study in early June, 2025."

The company's expanded access policy provides a potential opportunity for individuals living with SCI who have participated in Nervgen clinical trials to continue access to NVG-291 for treatment. The company's decision to change its expanded access policy was based, in part, upon a special circumstance related to a physician request for access to NVG-291.

For information about Nervgen's expanded access policy for NVG-291 and the process to submit a request, please refer to the company's policy.

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 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 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 becomes available. The trial is being partially financed 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 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 (ALS) and spinal cord injury.

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