NervGen Advances Phase 3 RESTORE Study with FDA Alignment and Leadership Hires
Event summary
- Phase 3 RESTORE study site activation and screening to begin in September 2026, with first participant dosing expected shortly thereafter.
- Strengthened leadership team with appointments of Keith Vendola as CFO and Marissa Volpe as SVP, Clinical Development.
- C$86.8 million (US$61.1 million) in cash reserves as of June 30, 2026, expected to fund operations through topline data readout from RESTORE in 1H 2028.
- Completed US$60.0 million underwritten public offering with participation from leading institutional healthcare investors.
The big picture
NervGen's progress in advancing the Phase 3 RESTORE study marks a significant step forward in the development of neuroreparative therapeutics for spinal cord injury (SCI). The company's strategic alignment with the FDA and strengthened leadership team position it to navigate the operational demands of late-stage clinical development. With C$86.8 million in cash reserves, NervGen is well-funded to pursue its mission of transforming the lives of individuals living with SCI.
What we're watching
- Clinical Execution
- The pace at which NervGen can enroll participants and maintain study momentum will be critical to meeting the anticipated topline data readout in 1H 2028.
- Regulatory Dynamics
- How FDA alignment on the RESTORE trial design translates into smoother regulatory pathways for future studies of NVG-291 and other neuroreparative therapeutics.
- Financial Strategy
- Whether NervGen’s current cash reserves and potential ATM facility will be sufficient to support operations through the RESTORE data readout, or if additional funding rounds will be necessary.