NervGen Pharma Q1 2024 Financial Results and Updates

NervGen Pharma Corp., a clinical-stage biotechnology firm based in Vancouver, British Columbia, released its financial and operational results for the first quarter ending March 31, 2024. The company, known for its work on innovative treatments for nervous system damage, provided updates on its ongoing clinical developments, specifically the Phase 1b/2a study of its investigational drug, NVG-291, which targets spinal cord injury (SCI).

Despite some challenges in the recruitment process, NervGen remains optimistic about the progress of its clinical study. "Recruitment in our Phase 1b/2a clinical study of NVG-291 for individuals with spinal cord injury (SCI) has gone well, however, it has been slower than originally anticipated during Q2 due to challenges in finding, screening, and onboarding individuals that meet our very specific and rigorous inclusion and exclusion study criteria," said Mike Kelly, President & CEO. The company has faced difficulties due to the heterogeneous nature of spinal cord injuries and the need to recruit a homogeneous population for their study, which is being conducted at a single site in Chicago. As a result, the target for completing enrollment of the chronic cohort has been moved to Q3 2024.

The trial itself is distinctive in that it uses both clinical assessments and electrophysiological measures to evaluate the efficacy of NVG-291 in enhancing motor recovery. To improve participant recruitment and retention, NervGen has introduced initiatives to cover travel and accommodation expenses and is working on a comprehensive communication plan to increase trial awareness within the SCI community.

Dr. Daniel Mikol, Chief Medical Officer, elaborated on the adjustments being made to the study protocol to facilitate the enrollment process. "We have modified eligibility criteria and testing requirements for the subacute cohort to make participation less burdensome," he said. These amendments will be submitted for approval to the Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA).

Financially, NervGen is in a stronger position following a bought deal financing completed in March 2024, which raised CA$23 million. This funding is expected to support the company’s cash needs through the third quarter of 2025. The public offering involved the sale of 9,792,250 units at CA$2.35 per unit, with each unit comprising one common share and a warrant for additional shares.

For the quarter ending March 31, 2024, NervGen reported cash and investments totaling $30.3 million, up from $11.7 million at the end of 2023. The net cash burn for the quarter was approximately $3.3 million. Research and development expenses were consistent with the previous year, amounting to $3.0 million, primarily due to ongoing clinical trials and related consulting costs. General and administrative expenses rose slightly to $2.0 million, mainly because of stock-based compensation and increased salary costs.

Net loss for the quarter was reported at $2.3 million, or $0.04 per share, which included a mix of non-cash expenses and gains. This represents an improvement from the same period in 2023, where the net loss was $4.7 million.

The Phase 1b/2a trial of NVG-291, registered under NCT05965700, aims to assess the drug's efficacy in individuals with cervical spinal cord injuries in both chronic and subacute stages. The trial involves comprehensive clinical and electrophysiological evaluations to measure improvements in motor function. The project is partially funded by a grant from Wings for Life, which is provided in milestone-based payments.

NervGen continues to position itself as a leader in developing treatment for nervous system repair, with NVG-291 being its flagship candidate. The company's commitment to advancing clinical research and securing necessary funding showcases its dedication to making significant strides in this challenging field.