NervGen Doses First Participant in Phase 3 RESTORE Study of NVG-291 for Chronic Spinal Cord Injury

NervGen Pharma Corp. (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing treatments for spinal cord injury (SCI), announced on October 12, 2026 that the first participant has been dosed in RESTORE, its Phase 3 registrational study of NVG-291. Specifically, the study is testing whether the drug can improve hand function in people living with chronic cervical SCI. As a next step, NervGen expects to complete enrollment in the second half of 2027 and report topline data in the first half of 2028.

How the RESTORE Study Is Designed

RESTORE is a multicenter, randomized, double-blind, placebo-controlled study that is expected to enroll about 150 participants across the United States and Canada. Its primary endpoint measures improvement in hand function using GRASSP Quantitative Prehension. In addition, secondary endpoints and blinded participant interviews will look at functional independence and quality of life.

To qualify, participants must be one to ten years past a traumatic SCI, with a motor level at C7 or higher on both sides and an ASIA Impairment Scale classification of C or D. Once enrolled, they will be randomized 1:1 to receive NVG-291 or placebo through a once-daily subcutaneous injection for 12 weeks, followed by a four-week observation period. After the study, NervGen plans an optional 12-week open-label extension.

Building on CONNECT SCI and FDA Alignment

The Phase 3 design also follows earlier regulatory work. First, in April 2026, NervGen reported a successful End-of-Phase 2 meeting and alignment with the U.S. Food and Drug Administration on RESTORE’s registrational design. According to the company, findings from its placebo-controlled Phase 1b/2a CONNECT SCI study informed the choice of endpoints, treatment duration and participant-reported measures.

In May, NervGen also released independent, blinded biomechanical gait analyses from CONNECT SCI. As reported, those analyses showed a statistically significant improvement in gait quality (p=0.0197) on a combined statistical test. Specifically, all 10 NVG-291 subjects were classified as responders, compared with 1 of 10 placebo subjects. The company said these results add to previously reported improvements in electrophysiological signaling, hand use and quality of life.

NVG-291 is a subcutaneously administered peptide designed to target the inhibitory CSPG-PTPσ pathway. In addition, it holds Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for SCI. “Dosing the first participant in RESTORE marks a critical milestone for NervGen and a major step toward our goal of restoring function and independence for people living with spinal cord injury,” said CEO Adam Rogers, MD.

Funding the Path to a 2028 Readout

NervGen entered the Phase 3 with cash and cash equivalents of C$86.8 million (US$61.1 million) as of June 30, 2026, up from C$22.1 million at the end of 2025. The company expects that cash to fund operations through the RESTORE topline readout in the first half of 2028. In May, NervGen completed a US$60.0 million public offering, which it said extended its expected runway through that readout. Then, in July, NervGen set up an at-the-market facility of up to US$50.0 million, with no shares sold under it as of mid-August.

Separately, NervGen announced in September that it will restate its 2025 annual and second-quarter 2026 financial statements to revise the valuation of certain warrants and options. However, the company said the adjustments are non-cash, have no impact on its cash, runway or operations, and that it remains on track to report third-quarter results.

Strategic Investment Summary

• Phase 3 Underway: NervGen Pharma Corp. (NASDAQ: NGEN) dosed the first participant in RESTORE, its Phase 3 registrational study of NVG-291 in chronic cervical SCI.
• Study Design: About 150 participants in the U.S. and Canada will be randomized 1:1 to NVG-291 or placebo for 12 weeks.
• Primary Endpoint: The study measures improvement in hand function using GRASSP Quantitative Prehension.
• Timeline: NervGen expects to complete enrollment in the second half of 2027 and report topline data in the first half of 2028.
• Regulatory Status: The company aligned with the FDA on the study design, and NVG-291 holds FDA Fast Track and EMA Orphan Drug designations.
• Cash Position: Cash and cash equivalents of US$61.1 million as of June 30, 2026, are expected to fund operations through the topline readout.

Find out more about the latest corporate developments and financial reports at the NervGen investor portal.