Vancouver, Canada. November 18, 2021 – 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 third quarter ended September 30, 2021.
“Most notably, we made important progress in our Phase 1 clinical trial with NVG-291 in the third quarter of 2021,” stated Paul Brennan, NervGen’s President & CEO. “We presented blinded safety and pharmacokinetic data, including data for the highest single ascending dose (SAD) cohort, that demonstrated that NVG-291 was well tolerated and had favorable pharmacokinetic properties. We also announced that, after completing the six planned SAD cohorts, the safety review committee overseeing the study has recommended that we proceed to the multiple ascending dose (MAD) portion of the trial. All adverse events reported in the study were mild and transient and we have tested doses in the SAD portion of the study that are substantially higher than the dose equivalents used in various animal efficacy studies. 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.”
“We also announced the addition of two new Clinical Advisory Boards for 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. We were also pleased to add two experienced executives to our Board, Krista McKerracher and Glenn Ives, to help guide our development programs and governance. We also entered into two important collaborations, one for a preclinical study in Alzheimer’s disease with Massachusetts General Hospital and one with Imeka Solutions Inc. (Imeka) in which we will use their imaging technology as a sensitive pharmacodynamic biomarker for NVG-291 as part of our upcoming Phase 1b/2 clinical trials. Last week, we closed an upsized “bought deal” financing that has strengthened our balance sheet and provided important funding for the continued development of NVG-291.”
Operational Highlights for Q3 2021 and Subsequent
- In July, we announced that three additional world-class scientists and clinical researchers joined our Alzheimer’s Disease Clinical Advisory Board. In addition, we announced the formation of a Multiple Sclerosis Clinical Advisory Board comprised of six world-class scientific and clinical researchers in the field of multiple sclerosis. These Advisory Boards will work closely with us as we prepare for our upcoming Phase 1b and Phase 2 clinical trials with NVG-291 in 2022.
- In August, we completed a Non-Brokered Private Placement comprised of the sale of 1,511,636 units of the Company at a price of $1.55 per unit for aggregate gross proceeds of $2.34 million. Each unit is comprised of one common share and one-half common share purchase warrant. Each full warrant is exercisable to acquire one common share at an exercise price of $2.10 per common share, until August 4, 2023.
- Also in August, we announced that we entered into a research collaboration with Dr. Ksenia Kastanenka of Massachusetts General Hospital to study the effects of NervGen’s lead compound, NVG-291, in validated animal models of Alzheimer’s disease.
- In September, we announced the addition of Krista McKerracher and Glenn Ives to our Board of Directors. Ms. McKerracher is a biopharmaceutical leader, Board member, and strategic advisor with 35 years’ experience in both large global pharmaceutical and small biotech companies. Mr. Ives is a senior accounting professional with strong finance experience having served as the Executive Chair of Deloitte Canada and the Chair of the Deloitte Global Risk Committee.
- Also in September, we announced a partnership with Imeka. We intend to utilize Imeka’s imaging technology as a sensitive pharmacodynamic biomarker for our lead compound, NVG-291, in our Phase 1b/2 clinical trials. Additionally, we are submitting for non-dilutive grants that support combining our technologies in preclinical and clinical studies for various conditions related to central nervous system damage.
- Subsequent to the quarter end, we acknowledged the United States Senate Armed Services Committee’s release of the Fiscal Year 2022 National Defense Authorization Act (FY22 NDAA) and the accompanying report language related to traumatic brain injury (TBI). The FY22 NDAA report calls for the Department of Defense to continue investments in promising therapeutics, like NervGen’s NVG-291, for the treatment of nervous system disorders, including TBI.
- Subsequent to the quarter end, we provided a positive update on our Phase 1 program with NVG-291 in healthy volunteers at the 14th Annual Meeting of the American Neurological Association and later at the Society for Neuroscience’s Neuroscience 2021 conference. NervGen’s Chief Medical Officer, Dr. Daniel Mikol, presented blinded safety and pharmacokinetic data from the SAD cohort of the study that demonstrated that NVG-291 was well tolerated and had favorable pharmacokinetic properties.
- Subsequent to the quarter end, we announced the formation of the Spinal Cord Injury Clinical Advisory Board comprised of five world-class scientific and clinical researchers in the field of SCI. This Clinical Advisory Board will work closely with us as we prepare for our upcoming Phase 1b/2 clinical trial in SCI with NVG-291.
- Subsequent to the quarter end, we completed a financing comprised of the sale of 3,680,000 units of the Company for aggregate gross proceeds of $9,200,000, including full exercise of the underwriters’ over-allotment option of 480,000 units. Each unit is comprised of one common share and one-half common share purchase warrant. Each full warrant is exercisable to acquire one common share at an exercise price of $3.20 per common share, until November 12, 2023. 257,600 non-transferable broker warrants were also issued, exercisable to acquire one common share at the exercise price of $2.50 per common share, until November 12, 2023.
- Cash and Investments: NervGen had cash and investments of $8.2 million as of September 30, 2021, compared to $7.4 million as of September 30, 2021. The net cash burn for Q3 2021 from operating activities was approximately $2.0 million. This was offset by approximately $2.2 million in net proceeds from an equity financing and $0.6 million proceeds from the exercise of stock options and warrants during the quarter.
- R&D Expenses: Research and development expenses were $2.0 million for the three months ended September 30, 2021, compared to $0.7 million in the same period in 2020. The increase was primarily due to the initiation of additional preclinical studies required to support our clinical studies and clinical costs associated with the initiation of our Phase 1 clinical trial.
- G&A Expenses: General and administrative expenses were $1.7 million for the three months ended September 30, 2021, compared to $1.3 million in the same period in 2020. The increase was primarily due to legal, professional, financial and corporate communication services as we endeavor to increase awareness about our technology and attract investors.
- Net Loss: For the three months ended September 30, 2021, net loss, which included $1.2 million of non-cash expenses, was $3.6 million, or $0.09 per basic and diluted Common Share. For the three months ended September 30, 2020, net loss, which included $1.1 million of non-cash expenses, was $2.1 million, or $0.06 per basic and diluted Common Share.
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.
NervGen is restoring life’s potential by creating innovative solutions for the treatment of nervous system injury due to trauma or disease of the nervous system. The Company is initially developing drugs for the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease.
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
Nancy Thompson, Vorticom Public Relations
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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: 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 injury due to trauma or disease of the nervous system.
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.