Vancouver, British Columbia–(Newsfile Corp. – April 17, 2024) – NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF) 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, 2023.
“Recruitment in our Phase 1b/2a clinical study of NVG-291 for individuals with spinal cord injury continues and we are targeting for the chronic cohort to be fully enrolled this quarter. We also plan to initiate recruitment in the subacute cohort shortly with enrollment expected to be completed in 2025,” said Mike Kelly, NervGen’s President & CEO. “This clinical trial is an important proof-of-concept study aimed at demonstrating for the first time the potential NVG-291 may have in enabling repair of nervous system damage in individuals with spinal cord injury. We are also encouraged by the FDA’s decision to grant Fast Track designation for NVG-291 which underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers. Importantly, we expect that the net proceeds from our recently completed CA$23 million bought deal financing, coupled with our existing working capital, will fund our Phase 1b/2a clinical trial along with research and development activities to support further NVG-291 clinical studies and preclinical activities in other indications through Q3 2025.”
Operational Highlights for 2023 and Subsequent
Financial Highlights
About the NVG-291 Phase 1b/2a Trial
The double-blind, placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), 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, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments that will offset a portion of the direct costs of this clinical trial.
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 being evaluated in a Phase 1b/2a clinical trial. The company’s initial target indication is spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X, LinkedIn, and Facebook for the latest news on the company.
For further information, please contact:
Contacts
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
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, NervGen’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, rate of subject recruitment and study design of the clinical development of NVG-291, including the Phase 1b/2a clinical trial in spinal cord injury; our belief that the net proceeds from our recent financing, along with our current working capital, is sufficient to fund our planned research and development activities through Q3 2025; the expected benefits of Fast Track designation; our plans to initiate a new study to offer open-label NVG-291 for patients that received placebo in the current study subject to certain conditions being met; the receipt of the milestone-based grant payments; the belief that targeting mechanisms that interfere with nervous system repair 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 NervGen 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, we have relied on various assumptions, including, but not limited to: our ability to manage the effects of COVID-19; the accuracy of our financial projections; obtaining positive results in our clinical and other trials; NervGen 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 COVID-19, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of our Annual Information Form, Prospectus Supplement, financial statements and Management Discussion and Analysis which can be found on SEDAR+ at www.sedarplus.ca. 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.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/205823
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