NervGen Pharma Announces Expanded CONNECT SCI Study Data Demonstrating Unprecedented Durable Improvement in Function, Independence, and Quality of Life in Chronic Spinal Cord Injury

Rhea-AI Summary

NervGen (OTCQB:NGENF) reported expanded 16-week CONNECT SCI data showing durable, post-treatment improvements in function, independence, and quality of life in people with chronic spinal cord injury.

Key findings: NVG-291 participants (n=20 trial; avg. 3.5 years post-injury) had a 2.6-fold greater mean GRASSP total score improvement and 3.7-fold greater GRASSP quantitative prehension improvement versus placebo at Week 16; participant interviews up to 364 days reported sustained benefits including bladder control and reduced spasticity.

Neurophysiology: significant reductions in hyperactive reticulospinal signaling (leg 142%, p=0.0062; hand 48%, p=0.0280) and a correlation with strengthened corticospinal signaling (R=-0.794, p=0.006). FDA Type C meeting confirmed multiple regulatory pathways; an End-of-Phase 2 meeting is anticipated in early 2026.

Positive

• GRASSP Total improvement 2.6-fold vs placebo at Week 16
• GRASSP Quantitative Prehension improvement 3.7-fold vs placebo at Week 16
• Participant-reported 67% improved bladder control vs 22% placebo
• Significant reduction in reticulospinal signaling: Leg 142% (p=0.0062)
• Correlation between reduced reticulospinal and increased corticospinal signaling (R=-0.794; p=0.006)
• FDA Type C meeting: multiple regulatory pathways available; EOP2 expected early 2026

Negative

• Small trial population: 20 participants limits statistical power and generalizability
• Some outcome comparisons use very small denominators (e.g., 6–9 participants per arm in reported QoL metrics)

• Week 16 follow-up data, coupled with blinded exit interviews conducted up to 364 days after the study period, confirm durable and wide-ranging upper and lower-body improvements compared to placebo
• Participant-reported outcomes highlight substantial improvements in bladder control and muscle spasticity compared to placebo
• Statistically significant reduction of hyperactive reticulospinal signaling in upper and lower limbs (via startle MEP), together with previously reported increases in corticospinal signaling (via MEP), establish the biological basis for NVG-291's clinical efficacy
• Company completed a U.S. Food and Drug Administration (FDA) Type C meeting in September; FDA confirmed that multiple regulatory routes are available to support approval of NVG-291 as the first pharmacologic treatment for spinal cord injury

Vancouver, British Columbia--(Newsfile Corp. - November 24, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) ("NervGen" or the "Company"), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other traumatic and neurologic disorders, today announced expanded CONNECT SCI Study data demonstrating unprecedented durable improvement in function, independence, and quality of life in individuals living with chronic SCI.

"The expanded CONNECT SCI Study data builds upon our landmark topline results and represents a moment of real hope for the SCI community and a defining milestone for NervGen. NVG-291 continues to demonstrate the ability to restore clinically meaningful function and drive dramatic, real-world improvements in daily independence and quality of life. More importantly, we are observing durable clinical benefits that extend well beyond the 12-week treatment period. Taken together, these findings validate the biologic repair mechanisms first discovered by Dr. Jerry Silver and mark the successful translation of his pioneering work, challenging the long-held belief that the central nervous system cannot repair itself after neurologic trauma," said Adam Rogers, MD, Interim Chief Executive Officer at NervGen Pharma.

"We recognize that the clinical progress achieved to date and the continued advancement of NVG-291 would not be possible without the support and participation of the SCI community. We are deeply grateful to the individuals and families who placed their trust in NervGen and the Shirley Ryan AbilityLab through their participation in the CONNECT SCI Study. Their courage, commitment and determination have helped to advance the field of neurorepair, bringing us closer to a future where meaningful recovery, even years after SCI, is possible."

Week 16 and Post-Study Clinical Data from the Phase 1b/2a CONNECT SCI Study
The CONNECT SCI Study was a 16-week placebo-controlled trial in individuals with chronic SCI. Twenty participants (avg. 3.5 years post-injury) were randomized to receive daily subcutaneous NVG-291 or placebo for 12 weeks, followed by a 4-week observation period to assess durability of response at Week 16. In addition, blinded qualitative exit interviews were conducted to provide insight into participants' real-world experiences and evaluate improvements beyond Week 16.

NVG-291 Functional Gains were Durable and Continued to Improve at and After Week 16

• Functional gains continued to increase four weeks after treatment ended. NVG-291 participants demonstrated a 2.6-fold greater mean improvement in GRASSP Total Score compared to placebo at Week 16.
• Hand function improvements were durable and continued to further strengthen post-treatment, with NVG-291 participants experiencing a 3.7-fold greater mean improvement in GRASSP Quantitative Prehension compared to placebo at Week 16.
• Blinded exit interviews conducted up to 364 days after Week 16 revealed that NVG-291 participants reported more consistent, durable, and wide-ranging functional gains, particularly in upper and lower limb movement, compared to placebo.
• NVG-291 participants further reported that functional improvements often directly enabled greater daily independence and activity, compared to placebo.

Quality of Life Improvements Observed in NVG-291 Participants Following Study Completion
Blinded qualitative exit interviews were conducted by an institutional review board (IRB) approved clinical research organization (CRO). These interviews reinforced and extended the observed quantitative findings, underscoring NVG-291's potential to deliver clinically meaningful and durable improvements.

• NVG-291 participants reported greater overall improvement on the Participant Global Impression of Change scale.
  • 75% (6/8) of NVG-291 participants reported "much" or "very much" improved overall symptoms compared to 33% (3/9) on placebo.
• 67% (6/9) of NVG-291 participants reported improved bladder control compared to 22% (2/9) of placebo participants.
• 56% (5/9) of NVG-291 participants reported reduced muscle spasticity compared to 22% (2/9) of placebo participants.
• NVG-291 participants were more likely than placebo to report sustained improvements across key quality of life domains, including reduced reliance on medications or mobility aids, and greater physical activity tolerance.

Blinded Exit Interviews Highlight the Real-World Impact of NVG-291 Treatment¹
"I can now take care of myself: brush my hair, brush my teeth, cut my own food. I've even started working on art projects. I can open a can of soda, or twist open a bottle of water. All of these were impossible before the study and more importantly, I've continued to maintain my improvements."
- NVG-291 treated participant 158 days after study completion

"Before the study, I couldn't go four hours without my bladder leaking, and I'd need catheterization every two hours. I used to rely on Botox treatments, but I'm now catheterizing less and continuing to notice improvements in my bladder control."
- NVG-291 treated participant 360 days after study completion

"I started to notice that I could voluntarily hold my bladder for longer without leaking when not catheterized. I used to experience autonomic dysreflexia when attempting to hold my bladder where my heart would beat faster and I'd begin to sweat. I don't experience that anymore."
- NVG-291 treated participant 17 days after study completion

"I used to experience tightness and spasticity throughout my body multiple times a day. I can now move my arms better, my walking has improved now that I feel less tight, and the frequency and severity of the spasms has decreased. These improvements have continued since ending the study."
- NVG-291 treated participant 350 days after study completion

Statistically Significant Reduction of Hyperactive Reticulospinal Signaling Establish the Biological Basis for NVG-291's Clinical Efficacy
In SCI, damage to the corticospinal tract, the pathway responsible for fine motor control, forces the reticulospinal tract, which governs involuntary and gross motor movement, to become abnormally hyperactive in compensation. This maladaptive hyperactivity disrupts normal motor signaling and contributes to symptoms such as muscle spasticity and impaired fine motor control.

• NVG-291 treatment produced a statistically significant reduction of hyperactive reticulospinal signaling in both the upper and lower limbs, as measured by startle motor evoked potentials (startle MEPs):
  • Leg (tibialis anterior): 142% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0062)
  • Hand (first dorsal interosseus): 48% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0280)
• NVG-291 participants demonstrated a statistically significant correlation between reduced hyperactive reticulospinal signaling and strengthened corticospinal signaling in the hands (R = -0.794; p = 0.006), indicating a restored balance between voluntary and involuntary motor pathways.

Together with the previously reported statistically significant increase in upper-limb corticospinal signaling, these findings provide compelling neurophysiological evidence that NVG-291 restores normal communication between motor systems; the biological foundation for the durable improvements in function, daily independence, and quality of life.

Based on the clinical evidence of NVG-291 to reduce hyperactive reticulospinal signaling and muscle spasticity, NervGen has filed a patent application to strengthen the Company's intellectual property position and further support NVG-291's broad therapeutic potential. 

Expanded CONNECT SCI Data Strengthens NVG-291's Efficacy Profile in Chronic SCI
"The expanded clinical findings from the CONNECT SCI Study mark an exciting advancement for the field of neurorepair and reinforces NVG-291's potential to enable the nervous system to repair itself after neurologic trauma," said Randall Kaye, MD, Chief Medical Advisor at NervGen Pharma. "Importantly, the continued improvements in function, daily independence, and quality of life after NVG-291 treatment provides compelling evidence that recovery remains possible, even years after injury. With no approved pharmacologic treatments for SCI, we remain deeply committed to advancing NVG-291 as safely and expeditiously as possible, in collaboration with the SCI community and the FDA, to bring the potential of hope and recovery to this long-overlooked community."

Update on Recent and Upcoming Regulatory Agency Interactions
The Company completed a productive FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with SCI and the lack of any approved pharmacologic treatments. The Company anticipates an End-of-Phase 2 meeting in early 2026 to further align with the FDA on the development and registration pathway for NVG-291.

Videos Documenting Functional Change Following NVG-291 Treatment in the CONNECT SCI Study
The videos below present visual documentation from the CONNECT SCI Study showing two participants performing a standardized 10-meter walking assessment at baseline and after 12 weeks of NVG-291 treatment. These side-by-side recordings highlight the functional impact of NVG-291 treatment, including observable changes in gait, balance, coordination, and walking efficiency. Additional participant videos, as well as a new corporate presentation highlighting the expanded CONNECT SCI data, are available at https://nervgen.com/presentations/.

Cannot view this video? Visit:
https://www.youtube.com/watch?v=ONjypyGaIOc

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https://www.youtube.com/watch?v=G6AwHbOXvYA

About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first- and potential best-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent variant of NVG-291, in animal models of spinal cord injury. These studies implicated multiple potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA and Orphan Designation from the EMA for NVG-291 in individuals with spinal cord injury.

About NervGen
NervGen (TSXV: NGEN) (OTCQB: NGENF) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies that enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. The Company is evaluating the clinical efficacy of its first- and potential best-in-class lead candidate, NVG-291, in the Phase 1b/2a CONNECT SCI Study in spinal cord injury. For more information about NervGen, visit www.nervgen.com and follow NervGen on X and LinkedIn for the latest news on the company.

Contacts
Huitt Tracey, Investors
htracey@nervgen.com
604.537.2094

David Schull or Ignacio Guerrero-Ros, Ph.D., Media 
Russo Partners
David.Schull@russopartnersllc.com
Ignacio.Guerrero-Ros@russopartnersllc.com
858.717.2310

Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note and Forward-Looking Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation (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 anticipated Nasdaq listing; the Company's potential best-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and final results from our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; the future development plans and benefits of NVG-291; and the creation of neuro-reparative therapeutics to promote nervous system repair 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 prospectus supplement, short form base shelf prospectus, annual information form, financial statements and management discussion and analysis all of which can be found on NervGen's profile on SEDAR+ at www.sedarplus.ca. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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FAQ

What did NervGen (NGENF) announce about the CONNECT SCI study on November 24, 2025?

NervGen announced expanded CONNECT SCI data showing durable functional and quality-of-life gains after 12 weeks of NVG-291 plus four-week follow-up, with blinded interviews up to 364 days.

How much did NVG-291 improve GRASSP scores in the CONNECT SCI trial (NGENF)?

NVG-291 participants showed a 2.6-fold greater mean improvement in GRASSP Total score and 3.7-fold greater improvement in GRASSP quantitative prehension versus placebo at Week 16.

What neurophysiological effects did NervGen report for NVG-291 (NGENF)?

The study reported significant reductions in hyperactive reticulospinal signaling: Leg 142% (p=0.0062) and Hand 48% (p=0.0280), and a correlation with increased corticospinal signaling (R=-0.794; p=0.006).

What quality-of-life changes did NVG-291 participants report in the CONNECT SCI study?

Blinded exit interviews found participants reported greater overall improvement, with 67% reporting improved bladder control and 56% reporting reduced muscle spasticity among NVG-291 recipients.

What regulatory progress did NervGen (NGENF) disclose for NVG-291 on November 24, 2025?

NervGen completed an FDA Type C meeting where the agency confirmed multiple regulatory pathways could support approval; an End-of-Phase 2 meeting is anticipated in early 2026.

How durable were NVG-291 benefits reported by NervGen (NGENF)?

Functional gains persisted and in some measures increased at Week 16 (four weeks post-treatment), with blinded interviews documenting benefits up to 364 days after study end.