NervGen narrows Q1 loss and achieves FDA alignment for Phase 3 trial

NervGen Pharma (NASDAQ:NGEN) reported its financial results and operational updates for the first quarter ended March 31, 2026, highlighting clinical milestones for its lead compound and its recent successful transition to a major U.S. exchange.

The clinical-stage biotechnology company, which focuses on developing neuroreparative therapeutics to repair nervous system damage, posted a net loss of $1.7 million ($0.02 per basic share) for the three-month period.

This represents a substantial decrease from the $3.9 million net loss reported in the first quarter of 2025, a narrowing primarily driven by a $5.7 million non-cash, unrealized gain related to the fair-value revaluation of a warrant derivative liability.

Operational costs rose as the company prepared its primary clinical program for late-stage development.

First-quarter research and development (R&D) expenses increased to $4.9 million, up from $3.1 million in the prior-year period, due to scaled-up chemistry, manufacturing, and controls (CMC) work and preclinical toxicology studies.

General and administrative (G&A) expenses fell slightly to $2.7 million from $2.9 million, with reduced stock-based compensation balancing out elevated legal and compliance fees connected to the company's January 2026 listing on the Nasdaq Capital Market.

The firm concluded the quarter with $16.6 million in cash and short-term investments.

On the clinical front, NervGen completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

The regulatory agency aligned on the clinical parameters and structural design for RESTORE, a Phase 3 registrational study evaluating the company's lead drug candidate, NVG-291, in patients with chronic tetraplegia resulting from spinal cord injury (SCI).

With clinical site activation currently underway, NervGen remains on track to initiate patient dosing for the pivotal trial by mid-2026.

Concurrently, the company is advancing blinded, independent biomechanical gait analyses from its completed chronic cohort in the Phase 1b/2a CONNECT SCI trial, with data presentation expected later this quarter to help differentiate functional neural recovery from compensatory patient movement.