NervGen Pharma Reports Third Quarter Financial Results and Provides Business Updates

Executive Summary

• NervGen reported Q3 2025 financial results and announced expanded CONNECT SCI Study data showing durable functional improvements in spinal cord injury patients treated with NVG‑291.
• Completed a US$10.05 M non‑brokered private placement (4,785,674 units at $2.10 per unit) to fund continued development and an anticipated Nasdaq listing.
• FDA Type C meeting confirmed multiple regulatory pathways for NVG‑291; an End‑of‑Phase 2 meeting is planned for early 2026.

Key Details

• Clinical Trial Results – At Week 16 (four weeks post‑treatment) NVG‑291 participants showed a 2.6× greater mean improvement in GRASSP Total Score and a 3.7× greater mean improvement in GRASSP Quantitative Prehension versus placebo.
• Long‑Term Follow‑Up – Up to 364 days after study end, 75% of NVG‑291 participants reported “much” or “very much” improved symptoms (vs 33% on placebo). Improvements included bladder control (67% vs 22%) and reduced muscle spasticity (56% vs 22%).
• Neurophysiology – Statistically significant reductions in hyperactive reticulospinal signaling (MEP) and improvements in upper‑body corticospinal signaling were observed.
• Regulatory Update – FDA Type C meeting confirmed multiple pathways for accelerated approval of NVG‑291; End‑of‑Phase 2 meeting targeted for early 2026.
• Financing – Private placement closed 19 Nov 2025: 4,785,674 units @ US$2.10/unit → gross proceeds US$10,049,915. Each unit = 1 common share + ½ warrant; warrants exercisable at US$2.65 for 36 months. Investors included SCI Ventures and the Paul & Phyllis Fireman Charitable Foundation.
• Cash Position – Cash & investments of $11.4 M as of 30 Sep 2025 (excluding recent private‑placement proceeds), down from $17.3 M at year‑end 2024 due to operating outflows for the CONNECT SCI Study.
• R&D Expenses – $4.4 M for Q3 2025, flat YoY; driven by drug‑supply procurement, expanded access program, and regulatory activities.
• G&A Expenses – $1.7 M for Q3 2025, down from $2.8 M YoY, reflecting lower stock‑based compensation and professional fees.
• Net Loss – $4.2 M ($0.06 per share) for the quarter; includes $1.2 M non‑cash expenses and a $2.0 M non‑cash gain from warrant derivative fair‑value adjustment.
• Leadership Changes – Adam Rogers, MD appointed Interim CEO; Randall Kaye, MD named Chief Medical Advisor (both effective July 2025).

Notable Quotes

“The expanded CONNECT SCI Study data we reported today further strengthens and reinforces our conviction in NVG‑291… individuals regaining function and independence years after SCI is increasingly becoming a potential reality.” – Adam Rogers, MD, Interim CEO

All forward‑looking statements are subject to risks and uncertainties detailed in the full release.