Vancouver, Canada. February 28, 2022 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today reported its financial and operational results for the year ended December 31, 2021.

“We have continued to make important progress in our Phase 1 clinical trial with NVG-291 in the fourth quarter of 2021 and early 2022,” stated Paul Brennan, NervGen’s President & CEO. “We have recently completed dosing for five subjects in the first cohort of the multiple ascending dose (MAD) portion of the study. In this cohort, subjects were treated with either placebo or NVG-291 for 14 days at a dose of 0.384 mg/kg. We have now dosed enough subjects for NervGen to proceed to the second dose cohort on the study, pending approval by the safety review committee which is scheduled to occur in the coming weeks. We are very encouraged by the fact that there have been no serious adverse events reported to date in the MAD cohort.”

Mr. Brennan added, “It is also important to note that in our animal models, the effective equivalent dose range in animals was 0.01 – 0.32 mg/kg. The dose that was used in the first cohort of the MAD has already exceeded the highest dose equivalent (0.32 mg/kg) used in the various animal models of nervous system injury and is over 35 times higher than the lowest effective dose (0.01mg/kg). The fact that we have now dosed subjects for 14 days at dose levels that have already exceeded the efficacious dose levels in animal models is very encouraging for our plans to progress to Phase 1b/2 studies by the end of this year and further increases our confidence that we can translate the unprecedented outcomes in animal studies to humans in our upcoming clinical trials.”

“We also continue to benefit from the expertise of our Clinical Advisory Boards for Alzheimer’s disease, multiple sclerosis and spinal cord injury (SCI),” Brennan continued. “Our ability to attract such 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. Additionally, the two financings that we closed during the fourth quarter have strengthened our balance sheet and provided important funding for the continued development of NVG-291.”

Operational Highlights for 2021

 

Financial Highlights

 

About NVG-291

NervGen holds the exclusive worldwide rights to NVG-291 and is developing a unique new class of drugs around the technology. NVG-291 is a therapeutic peptide which is a mimetic of the intracellular domain of protein tyrosine phosphatase (PTPσ), a cell surface receptor known to interact with chondroitin sulfate proteoglycans (CSPGs) and to be involved in the regulation of neuroplasticity and central nervous system repair. In preclinical studies, NVG-291 has demonstrated the potential to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination, and enhanced plasticity. The demonstration of repair via these mechanisms in animal models of nervous system injury has been accompanied by recovery of multiple neurological functions, including motor, sensory, autonomic and cognitive functions. NVG-291 has shown efficacy in a range of animal models, including models of nervous system trauma (e.g. spinal cord injury, peripheral nerve injury) and disease (multiple sclerosis, stroke).

About NervGen

NervGen is restoring life’s potential by creating innovative treatments for nervous system damage due to injury or disease. The Company is initially developing treatments for Alzheimer’s disease, multiple sclerosis and spinal cord injury. For more information, go to www.nervgen.com.

NervGen is currently conducting a Phase 1 trial with its lead product, NVG-291, in heathy subjects. Following completion of the MAD portion of the study and ongoing toxicology studies requested by the United States Food and Drug Administration (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 premenopausal females. Once the bridging studies are complete, NervGen intends to initiate Phase 1b/2 trials in Alzheimer’s disease, spinal cord injury and multiple sclerosis with each of these trials planned to start in 2022.

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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Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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: the timing of the clinical development of NVG-291; the objectives, timing and study design of the Phase 1 study in healthy volunteers; our confidence that we can translate the unprecedented outcomes in animal studies to humans in our upcoming clinical trials; the expected contributions of the new members of our Clinical Advisory Boards and Board of Directors; our plans to use Imeka’s imaging technology as a sensitive pharmacodynamic biomarker for NVG-291 in our Phase 1b/2 clinical trials; 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; our clinical trial designs and timing to evaluate the therapeutic potential of NVG-291 in patients in Phase 1b/2 clinical trials in Alzheimer’s disease, multiple sclerosis and spinal cord injury upon successful completion of the Phase 1 trial and bridging studies; the belief that modulating 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 damage due to trauma or disease.

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.