NervGen Pharma Reports 2022 Year End Results and Provides Operational Update Including Plans to Initiate Phase 1b/2a Clinical Trial of Proprietary NVG-291 in Q3 2023
- Equity proceeds of CA$22M+ raised during 2022 fiscal year
- Phase 1 clinical trial dosing of proprietary compound, NVG-291, is complete and data analysis is ongoing
- Phase 1b/2a clinical trial of NVG-291 to include individuals with chronic and subacute spinal cord injuries
VANCOUVER, BC — 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 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
- We continued to advance our Phase 1 clinical trial for NVG-291:
- In October, the U.S. Food and Drug Administration amended the partial clinical hold to permit the inclusion of males and premenopausal females at certain dose levels.
- During the year, we completed dosing in both the single ascending dose (SAD) and multiple ascending dose (MAD) cohorts of our Phase 1 clinical trial for NVG-291 in postmenopausal females.
- Subsequent to year end, on February 14, 2023, we announced that we had completed dosing of all subjects in the NVG-291 Phase 1 clinical trial including males and premenopausal females. We also announced that we plan to initiate a Phase 1b/2a clinical trial of NVG-291 in individuals with chronic or subacute spinal cord injury in Q3 2023.
- We improved our cash position with equity proceeds of over CA$22 million and were awarded a grant of up to US$1.5 million to fund ongoing clinical and preclinical activities:
- On July 13, 2022, we closed a non-brokered private placement of 10,150,000 units of the Company at a price of US$1.50 per unit, for aggregate gross proceeds of US$15,225,000. Each unit consisted of one common share and one-half of one common share purchase warrant. Each whole warrant is exercisable into one common share at a price of US$1.75 per common share until July 13, 2027.
- In October, we were awarded up to US$1.5 million in US Department of Defense funding from the Military Operational Medicine Research Program to conduct preclinical studies, starting in 2023, to evaluate NVG-291 as a therapeutic that restores function following peripheral nerve injury.
- During the 2022 fiscal year and 2023 to date, we have received proceeds of approximately CA$3.5 million from the exercise of stock options and common share purchase warrants.
- We announced pioneering research in a preclinical study of our lead drug, NVG-291, in a stroke model:
- In July, we announced that the University of Cincinnati and Case Western Reserve University had published a pioneering preclinical study in a peer-reviewed scientific journal demonstrating that our therapeutic approach promotes nervous system repair and significant improvement in motor function, sensory function, spatial learning, and memory in a mouse model of severe ischemic stroke, even when treatment was initiated up to seven days after onset. We believe this preclinical result to be both novel and unprecedented, providing continuing evidence of the unique capabilities of NVG-291.
- During the year, we continued to add expertise to our team with the following additions and appointments:
- In April, we announced the appointment of Mr. Craig Thompson to our Board of Directors, and in July, in connection with the private placement, Dr. Adam Rogers, Manager of PFP Biosciences Holdings, was appointed to our Board of Directors.
- Concurrently with Mr. Thompson joining the Board, Dr. Michael Abrams resigned from the Board.
- In September, Dr. Matvey Lukashev joined as our Vice President, Research and Preclinical Development. Dr. Lukashev has over 30 years of research experience in academia, industry, and non-profit biotech settings and will lead the development of NVG-291 beyond its initial formulation and core indications, and build a pipeline of additional proprietary compounds and intellectual property that address nervous system repair.
- On September 22, 2022, we announced the appointment of our current Executive Chairman of the Board, Mr. Radvak, as Interim CEO and Dr. Rogers as Interim President replacing Mr. Paul Brennan who is serving as a strategic advisor to management and the Board during the transition period. The Board also initiated a search for a permanent CEO that is active and ongoing.
- In November, Mr. Glenn Ives was appointed by our Board to serve as Lead Independent Director to lead and facilitate governance oversight and deliberations of the Board during the transition period in selecting a new CEO.
- We presented at several scientific conferences:
- In April, Dr. Mikol presented unblinded data from the SAD cohort of the Phase 1 clinical trial and interim blinded data from the MAD portion of the study at the 2022 American Academy of Neurology Annual Meeting. Dr. Mikol reported that the NVG-291 dose administered in the first MAD cohort is already above the highest corresponding dose found to be efficacious in animal models of nervous system injury and is substantially higher than the lower effective doses where dramatic functional improvements were observed. Additionally, the day 1 and day 14 pharmacokinetic characteristics for NVG-291 at the tested dose level were very similar to each other and to those for the same dose level in the SAD portion of the Phase 1 study. A reproducible pharmacokinetic profile is a highly desirable property for any drug being developed for human use.
- In May, we hosted a 1-hour panel discussion at the American Spinal Cord Injury Association 2022 Annual Scientific Meeting. In the translational research session entitled “Translating Positive results with NVG-291 from Animals to Patients”, Dr. Mikol provided an update on the Phase 1 clinical trial in healthy subjects. He also provided an overview of the Phase 1b/2a placebo-controlled clinical trial in spinal cord injury, which is currently designed to be conducted at a single center with both clinical and electrophysiological assessments. A single site was selected to leverage electrophysiological assessments to monitor motor recovery (in addition to clinical assessments), and a single site with extensive expertise limits variability of measurements. Subjects within each cohort of approximately 20 subjects will have similar baseline characteristics.
- In August, Dr. Mikol presented unblinded data from the SAD cohort of the Phase 1 clinical trial and interim blinded data from the MAD portion of the study at the 2022 Alzheimer’s Association International Conference and for the first time introduced the study design for a Phase 1b/2a trial of NVG-291 in subjects with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
- Our Director of Research, Dr. Marc DePaul, presented posters outlining some of the preclinical data related to NVG-291 at the Military Health System Research Symposium and at the 147th American Neurological Association Annual Meeting.
- In September, Dr. Mikol gave a presentation providing an overview of the ongoing Phase 1 study, as well as presented the study design for the upcoming Phase 1b/2a clinical trial in spinal cord injury at the 61st International Spinal Cord Society Annual Scientific Meeting.
- Dr. Mikol also provided an overview of the ongoing Phase 1 study, as well as presented the study design for a Phase 1b/2a clinical trial of NVG-291 in multiple sclerosis at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
- We continued to build our patent portfolio to strengthen our intellectual property position:
- In November, we announced that the US Patent and Trade Office had issued US Patent No. 11,497,812 B2 Compositions and Methods for Inhibiting the Activity of LAR Family Phosphatases to Case Western Reserve University. NervGen has an exclusive worldwide license to this patent and related proprietary technology, which forms the technological foundation of our NVG-291 drug development program.
- Cash and Investments: NervGen had cash and investments of $22.5 million as of December 31, 2022, compared to $16.9 million as of December 31, 2021. The net cash burn for the year ended December 31, 2022, from operating activities was approximately $17.8 million. This was offset by approximately $3.1 million in proceeds from the exercise of stock options and warrants during the year and a non-brokered private placement for gross proceeds of US$15.2 million in July.
- R&D Expenses: Research and development expenses were $16.6 million for the year ended December 31, 2022, compared to $6.9 million for the year ended December 31, 2021. The increase in the year ended December 31, 2022 is primarily related to the ongoing Phase 1 clinical trial, toxicity preclinical studies and associated drug product manufacturing.
- G&A Expenses: General and administrative expenses were $6.4 million for the year ended December 31, 2022, compared to $5.9 million for the year ended December 31, 2021. The increase was primarily due to accrued termination payments owing to our former President and CEO and for increased corporate communication services directed to increasing awareness about our technology and attracting investors.
- Net Loss: For the year ended December 31, 2022, net loss was $20.7 million, or $0.39 per basic and diluted common share. The net loss for the year included $2.9 million of non-cash expenses offset by $2.6 million of non-cash gains pertaining to unrealized foreign exchange and the fair value adjustment of the warrant derivative. For the year ended December 31, 2021, net loss, which included $4.1 million of non-cash expenses, was $12.7 million, or $0.32 per basic and diluted common share.
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.
NervGen (TSX-V: 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
Nancy Thompson, Vorticom Public Relations
Follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
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.
Original source here.