- 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.
“2025 was a transformative year for NervGen, but more importantly the SCI community,” said
“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
Business Highlights
- In
June 2025 , NervGen reported positive topline results from the Phase 1b/2a CONNECT SCI study in chronic tetraplegia (1-10 years post-injury). NVG-291 met its primary endpoint, demonstrating statistically significant improvement in upper-limb corticospinal connectivity (p=0.0155), with an 825% improvement versus placebo in functional hand use, as measured by GRASSP Quantitative Prehension. - Additional analyses reported in
November 2025 further support the biological basis for NVG-291’s observed clinical effects, including statistically significant improvement in the normalization of maladaptive hyperexcitable reticulospinal activity in the upper (p=0.0280) and lower limbs (p=0.0062). - Functional improvements were durable, both persisting and continuing to improve beyond the 12-week treatment period, as reported at Week 16 and via blinded qualitative exit interviews conducted up to 364 days after the study period.
- Independent, blinded biomechanical gait analyses of the CONNECT SCI study are ongoing, conducted by a specialized third-party motion analysis group to provide additional evidence with the potential to further support the systemic biological effect of NVG-291, differentiating genuine neural recovery from compensatory movement. These analyses assess joint kinematics, inter-joint coordination, and postural stability across treatment groups. The Company expects to present these data in 2Q 2026.
- NervGen completed its End-of-Phase 2 meeting with the FDA in 1Q 2026 and expects to provide a regulatory update in early 2Q 2026. The Company previously completed a Type C Meeting in
September 2025 , in which FDA indicated that multiple regulatory pathways may be available to support approval, given the significant unmet need among the SCI community and the lack of approved pharmacologic treatments. The Company remains on track to initiate its Phase 3 study in chronic tetraplegia in mid-2026.
- NervGen expects to provide an update on the status of the Phase 1b/2a CONNECT SCI study in subacute tetraplegia in 2Q 2026.
NVG-291 Clinical Indication Expansion
- NervGen expects to expand NVG-291 into complementary clinical indications, as informed by established preclinical efficacy, with prioritization expected to be announced by mid-2026.
- NVG-291 has demonstrated preclinical efficacy across more than 15 unique models of neurotraumatic and neurologic conditions, including in collaboration with the
U.S. Department of Defense and leading independent academic institutions.
Growth of Senior Leadership
- In 2025 and early 2026, NervGen strengthened its leadership team with the appointments of Dr.
Adam Rogers as Chairman, President and Chief Executive Officer and Dr.Randall Kaye as Chief Medical Advisor. - In
March 2026 , NervGen appointedShamim Ruff as Chief Regulatory Affairs Officer, bringing more than 30 years of regulatory leadership experience, andChristine McSherry as SVP, Patient Advocacy and Clinical Affairs, adding deep expertise in patient-focused drug development. - In
March 2026 , NervGen announced the retirement ofBill Adams as Chief Financial Officer and engaged a leading executive search firm to identify a successor.Mr. Adams has remained in an advisory capacity to support the transition.
Full Year 2025 Financial Results
Cash and Investments. As of
Research & Development (R&D). R&D expenses were
General and Administrative (G&A). G&A expenses were
Net Loss. Net loss was
About
Contacts
htracey@nervgen.com
604.537.2094
David.Schull@russopartnersllc.com
Ignacio.Guerrero-Ros@russopartnersllc.com
858.717.2310
Cautionary Note and Forward Looking-Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Such forward-looking statements herein include but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the Company's potentially best-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; the regulatory pathways available to the Company for NVG-291; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and results from the Company's Phase 1b/2a clinical trial of NVG-291 in individuals with subacute spinal cord injury; the anticipated time of initiating a Phase 3 clinical trial in chronic tetraplegia; the potential of NVG-291 to address the unmet medical need for patients with SCI; ; the anticipated timing of additional data and analyses relating to NVG-291 for SCI; the procurement of drug supply for future NVG-291 clinical trials; the sufficiency of the Company's cash and investments to fund its operations and clinical development plans; and the creation of neuroreparative therapeutics to enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: its ability to obtain future funding on favorable terms, if at all; the accuracy of its financial projections; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Many factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's most recently filed Annual Information, which is available under the Company’s profile on SEDAR+ at www.sedarplus.ca (which are also available on the website of the
