NervGen Pharma Reports Second Quarter Financial Results and Provides Letter to Shareholders

Core Insights - NervGen Pharma Corp. reported significant progress in its second quarter 2025 financial results, highlighting the groundbreaking topline results from the CONNECT SCI Study, which demonstrated that NVG-291 treatment significantly improved corticospinal connectivity and restored meaningful function for individuals with chronic spinal cord injury [5][10] Financial Results - As of June 30, 2025, the company had cash and investments totaling $15.7 million, a decrease from $17.3 million as of December 31, 2024, primarily due to operating activities related to the CONNECT SCI Study [20] - Research and Development (R&D) expenses for the quarter were $2.7 million, down from $3.8 million in the same period in 2024, attributed to lower clinical and regulatory costs [21] - General and Administrative (G&A) expenses increased to $3.8 million from $2.2 million year-over-year, mainly due to higher compensation-related expenses and external legal costs [22] - The net loss for the quarter was $9.1 million, or $0.13 per share, compared to a net loss of $7.8 million, or $0.11 per share, in the same quarter of 2024 [23] Clinical Development - The CONNECT SCI Study marked a historic turning point, with NVG-291 being the first pharmacologic candidate to show statistically significant improvement in corticospinal connectivity and clinically meaningful functional gains in chronic spinal cord injury [8][15] - The study reported a 10.2-fold improvement in observed mean change from baseline in motor evoked potential (MEP) magnitude compared to placebo, indicating significant efficacy [16] - NVG-291 demonstrated a favorable safety profile, being generally safe and well tolerated without treatment-emergent adverse events leading to discontinuation [19] Pipeline Progress - The company is conducting a comprehensive analysis of NVG-291's efficacy profile, which will inform upcoming regulatory discussions with the FDA regarding potential expedited approval pathways [12][9] - Positive preclinical results were announced for NVG-291-R in models of traumatic hearing loss and peripheral nerve injury, showing significant functional recovery [13][14] Corporate Developments - In July 2025, NervGen transitioned its senior leadership, appointing Adam Rogers, MD, as Interim CEO and Randall Kaye, MD, as Chief Medical Advisor to ensure continuity in the company's mission [20][26] - The company holds exclusive worldwide rights to NVG-291, which is based on research from Case Western Reserve University and has received Fast Track designation from the FDA and Orphan Designation from the EMA for spinal cord injury [27][28]