Vancouver, Canada. October 27, 2021 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to creating innovative treatments for nervous system damage, today announced the formation of its Spinal Cord Injury (SCI) Clinical Advisory Board comprised of five world-class scientific and clinical researchers in the field of spinal cord injury: Drs. James Guest, Steven Kirshblum, Brian Kwon, Linda Jones and Daniel Lammertse. This Clinical Advisory Board will work closely with NervGen as the Company prepares for its upcoming Phase 1b/2 clinical trial for spinal cord injury with its lead compound, NVG-291.

“We have a tremendous opportunity to provide the first pharmacologic neurorestorative therapy for patients who have suffered a spinal cord injury,” stated Dr. Daniel Mikol, NervGen’s Chief Medical Officer. “With its multimodal mechanism of action resulting in enhanced axonal regeneration, plasticity, and remyelination, NVG-291 has the potential to repair nervous system damage and would represent a completely new treatment paradigm for spinal cord injury patients.”

Dr. James Guest, Professor of Neurological Surgery at the University of Miami and a member of the scientific faculty at The Miami Project to Cure Paralysis, added, “I have been following the tremendous advances made by Dr. Jerry Silver, the scientific founder of NervGen’s technology, for several years. I was delighted to hear that NervGen started Phase 1 clinical trials in 2021 with NVG-291, the culmination of Dr. Silver’s efforts, and I am honored to be included as an advisor in this important program for spinal cord injury patients. NervGen has established an impressive group of spinal cord injury specialists and, as a member of the advisory board, I look forward to playing a role in the development of NVG-291.”

NervGen’s President & CEO, Paul Brennan, added, “We are excited and proud to be moving a potentially game-changing therapy into clinical trials next year, not only for SCI, but also for multiple sclerosis and Alzheimer’s disease. We are grateful that such an esteemed and dedicated group of experts are eager and willing to share their wealth of experience to advise us on our upcoming Phase 1b/2 study and overall spinal cord injury development program. Our ability to attract these top tier scientific and clinical experts says volumes about the underlying science as well as the significant potential of our therapeutic platform in treating damage to the central nervous system.” Brennan concluded, “We recently announced our interim data from our Phase 1 study in healthy subjects and are very encouraged by the safety and pharmacokinetic data we received in the single ascending dose portion of the trial. The results to date have further increased our confidence that we can translate the unprecedented outcomes in animal studies to humans in our upcoming clinical trials.”

 

About NVG-291
NVG-291, a protein tyrosine phosphatase (PTPσ) modulator, has demonstrated the potential to promote repair mechanisms in the central nervous system such as axonal regeneration; remyelination; plasticity; autophagy (a cellular self-cleaning mechanism that removes unnecessary or dysfunctional components); and a non-inflammatory phenotype in microglia cells, the innate immune cells of the brain. PTPσ is a protein which has been shown to impede repair following injury to the nervous system. Nervous system injury can occur because of trauma, such as in the case of spinal cord injury or traumatic brain injury, or as a result of disease-specific mechanisms, such as multiple sclerosis or Alzheimer’s disease.

A Phase 1 trial of NVG-291 in heathy subjects is ongoing. Following completion of the multiple ascending dose portion of the study and ongoing toxicology studies requested by the FDA, NervGen will seek removal of the partial clinical trial hold initiated by the FDA and perform bridging studies in healthy males and in healthy pre-menopausal females. Following completion of the bridging studies, NervGen intends to initiate a Phase 1b/2a trial in Alzheimer’s disease patients. Concurrently, the Company also plans to initiate Phase 1b/2 trials in spinal cord injury and multiple sclerosis with each of these trials planned to start in 2022.

About NervGen
NervGen is restoring life’s potential by creating innovative treatments of nervous system injury due to trauma or disease of the nervous system. The Company is initially developing treatments for multiple sclerosis, spinal cord injury and Alzheimer’s disease.

For further information, please contact:

Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.362.6209

Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208

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Cautionary Note Regarding Forward-Looking Statements
This news release may contain “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “trend”, “indication”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: our belief in the opportunity to provide the first pharmacologic, neurorestorative therapy and new treatment paradigm for patients who have suffered an SCI; the ability of our SCI Clinical Advisory Board to advise us on our upcoming Phase 1b/2 study and overall spinal cord injury development program; our belief in the significant potential of our therapeutic platform in treating damage to the central nervous system; the favorable pharmacokinetic profile and the preclinical and clinical development of NVG-291; our conviction that the unprecedented efficacy achieved in multiple preclinical disease and injury models will translate in our upcoming clinical trials with patients; the timing and requirements to proceed to the MAD portion of the Phase 1 clinical trial and to remove the partial clinical hold initiated by the FDA; the clinical development of NVG-291 for Alzheimer’s disease, multiple sclerosis and spinal cord injuries; the belief that inhibiting the activity of PTPσ is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments of nervous system injury due to trauma or disease-specific mechanisms.

Forward-looking statements are based on estimates and assumptions made by the Company in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company’s ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company’s financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions.

Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of the Company’s Annual Information Form, Prospectus Supplement, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. All clinical development plans are subject to additional funding.

Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.