NGEN

Completed successful FDA End-of-Phase 2 meeting, reaching alignment on the study parameters of RESTORE, a registrational study of NVG-291 in chronic tetraplegia, with site activation underway and study initiation on track for mid-2026. Independent, blinded biomechanical gait analyses of the CONNECT SCI study designed to differentiate genuine neural recovery from compensatory movement remain ongoing, with results anticipated in 2Q 2026. Successfully listed on Nasdaq under the symbol 'NGEN' on January 8, 2026, and voluntarily delisted from the TSX Venture Exchange. Strengthened leadership team with three senior appointments to support late-stage clinical development and Nasdaq listing. VANCOUVER, British Columbia, May 18, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. "With the achievement of FDA alignment on the study parameters of RESTORE, our registrational study of NVG-291 in chronic tetraplegia, NervGen is now firmly in execution mode," said Adam Rogers, MD, President and Chief Executive Officer of NervGen. "Our focus is on initiating the registrational study in mid-2026, advancing forward on behalf of the individuals living with SCI who today have no pharmacologic options capable of enabling meaningful recovery of function, independence, or quality of life. The progress we are making, including activating study sites and expanding our senior leadership team, reflect the necessary steps to advance a therapy of this magnitude toward potential approval." Business HighlightsNVG-291 in Chronic Tetraplegia RESTORE Registrational Study Progress NervGen completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), reaching alignment on the study parameters of RESTORE, a registrational study evaluating NVG-291 in chronic tetraplegia. The RESTORE study is on track for initiation in mid-2026, with site activation underway. CONNECT SCI Biomechanical Gait Analyses Independent, blinded biomechanical gait analyses of the Phase 1b/2a CONNECT SCI study remain ongoing, conducted by a specialized movement intellige...

Completed End-of-Phase 2 meeting with the FDA; Company expects to provide a regulatory update in early 2Q 2026 and remains on track to initiate a Phase 3 study in chronic tetraplegia in mid-2026. Company expects to present clinical data from independent, blinded biomechanical gait analyses of the CONNECT SCI study in 2Q 2026, providing additional evidence with the potential to further support the systemic biological effect of NVG-291, differentiating genuine neural recovery from compensatory movement. Company expects to expand NVG-291 into complementary clinical indications, as informed by established preclinical efficacy, with prioritization expected to be announced by mid-2026. Successful Nasdaq listing and continued growth of leadership team supports the Company’s emergence as a leader in the development of neuroreparative therapeutics. VANCOUVER, British Columbia, March 31, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported its full year 2025 financial results and provided business updates. “2025 was a transformative year for NervGen, but more importantly the SCI community,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “We’ve demonstrated the potential best-in-class profile of NVG-291 and its ability to meaningfully improve the lives of those with chronic tetraplegia in the CONNECT SCI study, and we continue to strengthen our understanding of the breadth and quality of that recovery.” “It is our responsibility now to make the promise of NVG-291 a reality and execute on both its increasingly de-risked late-stage clinical development and commercial potential,” continued Dr. Rogers. “We are now more confident than ever that we are positioned to carry forward our significant momentum through the rest of 2026. We look forward to providing a regulatory update and delivering on a series of meaningful catalysts throughout the year, including NVG-291’s expansion into complementary clinical indications and the initiation of our Phase 3 study in chronic tetraplegia in mid-2026.” Business Highlights NVG-291 Chronic Tetraplegia Clinical Development In June 2025, NervGen reported positive topline results from th...