Vancouver, British Columbia–(Newsfile Corp. – March 30, 2023) – NervGen Pharma Corp. (TSXV: 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 results for the year ended December 31, 2022 and provided an operational update, including details related to the Company’s enhanced cash position, research funding, and the ongoing development of NervGen’s proprietary compound, NVG-291. In preclinical studies, NVG-291 has been demonstrated to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination and enhanced plasticity.
“We reached an important milestone when we recently completed the dosing of all subjects in our Phase 1 clinical trial,” stated Bill Radvak, NervGen’s Executive Chairman & Interim CEO. “Now we are analyzing the remaining data and closing the Phase 1 trial while also working toward starting our Phase 1b/2a clinical trial for individuals with spinal cord injury as soon as possible. Last year, we added Dr. Matvey Lukashev as our VP, Research & Preclinical Development, who brings 20+ years of experience in drug discovery and translational research with a focus on neuroinflammation and neurodegenerative diseases. Dr. Lukashev provides us two significant benefits: (1) expertise to expand our research program by leveraging our current knowledge of NVG-291 into new formulations and molecules, and (2) the ability to further strengthen and add to our intellectual property position.” Mr. Radvak added, “As we near the initiation of our Phase 1b/2a clinical trial in individuals with spinal cord injury, we also remain committed to advancing our other priority indications that include Alzheimer’s disease and multiple sclerosis.”
Dr. Daniel Mikol, NervGen’s Chief Medical Officer, commented, “We are currently in the process of reviewing safety and pharmacokinetic data from our Phase 1 trial. Although data from the final cohorts of males and premenopausal females are still blinded, we are pleased to report there have been no serious adverse events reported in subjects receiving NVG-291 in the Phase 1 trial. Based on these encouraging results, we plan to evaluate the efficacy of NVG-291 versus placebo in two cohorts of individuals with spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury). We have engaged Shirley Ryan AbilityLab of Chicago, IL to conduct this single site Phase 1b/2a trial.”
Operational Highlights for 2022 and Subsequent
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 that mimics the intracellular domain of the receptor protein tyrosine phosphatase sigma (PTPσ), a cell surface receptor known to interact with chondroitin sulfate proteoglycans (CSPGs). Both PTPσ and CSPGs have been shown to inhibit neural repair mechanisms following nervous system damage. NVG-291-R, the rodent form of NVG-291, has been shown to promote functional recovery and enable nervous system repair in a range of animal models, including models of spinal cord injury, peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination.
About NervGen
NervGen (TSXV: NGEN) (OTCQX: NGENF) 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 currently planned for a Phase 1b/2a clinical trial. The Company’s initial target indications include spinal cord injury, Alzheimer’s disease and multiple sclerosis. For more information, go to www.nervgen.com.
For further information, please contact:
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
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 objectives, timing and study design of the clinical development of NVG-291 including our planned Phase 1b/2a clinical trials; the anticipated contributions of our VP, Research & Preclinical Development; our commitment to advancing our other priority indications that include Alzheimer’s disease and multiple sclerosis; the use of proceeds from equity and grant funding; our belief that the preclinical result in stroke is novel and unprecedented providing continuing evidence of the unique capabilities of NVG-291; our belief that a reproducible pharmacokinetic profile is a highly desirable property for any drug being developed for human use; 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, Short Form Base Shelf Prospectus, 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.
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