Nervgen Pharma Corp. · NASDAQ:NGEN
Nervgen Pharma — Investor Day (September 2026)
99 slides from Nervgen Pharma's investor day presentation, Sep 30, 2026
Slide 1: Research & Development (R&D) Day: Enabling the Nervous System to Repair Itself
Research & Development (R&D) Day Enabling the Nervous System to Repair Itself September 30, 2026 • NASDAQ: NGEN
Slide 2: Cautionary Note Regarding Forward-looking Statements
Cautionary Note Regarding Forward-looking Statements This presentation may contain “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities laws (collectively, “forward-looking statements”). Forward-looking statements inclu
Slide 3: Management Attendees
Management Attendees Adam Rogers, MD Marc DePaul, PhD Christine McSherry, RN Chairman & Senior Director, Senior Vice President, Chief Executive Officer Research Patient Advocacy & Clinical Affairs 3
Slide 4: Guest Presenters
Guest Presenters Benjamin Abramoff, MD, MS Sukhvinder Kalsi-Ryan, PhD, PT Director, SCI Services & Associate Clinician Scientist and Professor of Clinical PM&R Lead Developer of GRASSP University of Pennsylvania KITE Research Institute, UHN Philippa Warren, PhD Barry Munro Sir Henry Dale Fellow, Chi
Slide 5: Today's Agenda
Today’s Agenda 01 Introduction Adam Rogers, MD · Chairman & CEO 02 NVG-291 Program deep dive 01 01 THE UNMET NEED IN SPINAL CORD INJURY 04 PHASE 1B/2A CONNECT SCI STUDY 03 02 SCIENTIFIC RATIONALE 05 PHASE 3 RESTORE STUDY 03 PHASE 1 HEALTHY VOLUNTEER STUDY 06 COMMUNITY PERSPECTIVES & ADVOCACY 03 Clos
Slide 6: NVG-291: The potential to redefine recovery after spinal cord injury
Significant Unmet Need 01 No approved drug to restore lost function or quality of life in chronic spinal cord injury (SCI); ~312,000 living with traumatic SCI in the United States alone1 Clinical Proof-of-Concept NVG-291 02 Converging efficacy across functional, electrophysiological, and patient-rep
Slide 7: NervGen Has Delivered Key Milestones Ahead of Phase 3 RESTORE
NervGen Has Delivered Key Milestones Ahead of Phase 3 RESTORE JUNE SEPTEMBER NOVEMBER 2025 Phase 1b/2a CONNECT SCI FDA Type C Phase 1b/2a CONNECT SCI topline data meeting expanded data JANUARY FEBRUARY/ MARCH MAY 2026 Nasdaq • FDA End - of - Phase 2 alignment • Positive blinded gait analyses listing
Slide 8: NervGen Has Built an Experienced Leadership Team to Advance NVG-291
NervGen Has Built an Experienced Leadership Team to Advance NVG-291 Adam Rogers, MD Keith Vendola, MD, MBA Shamim Ruff Chairman, Chief Chief Financial Chief Regulatory Executive Officer Officer Affairs Officer 15+ years advancing 25+ years across 30+ years leading global novel therapies in areas fin
Slide 9: The Unmet Need in Spinal Cord Injury
The Unmet Need in NVG-291 Spinal Cord Injury No FDA-approved drug to restore lost function THE UNMET NEED IN SPINAL CORD INJURY after spinal cord injury SCIENTIFIC RATIONALE PHASE 1 HEALTHY VOLUNTEER Adam Rogers, MD Chairman & Chief Executive Officer, NervGen PHASE 1B/2A CONNECT SCI RESULTS PHASE 3
Slide 10: Spinal Cord Injury Has a Profound Global Impact With a Substantial United States Footprint
Spinal Cord Injury (SCI) Has a Profound Global Impact With a Substantial United States Footprint U.S. PREVALENCE ~312,000 people living with traumatic spinal cord injury2 GLOBAL PREVALENCE ANNUAL INCIDENCE INJURY SEVERITY 15M+ ~18,500 ~48% people living with SCI1 new tSCI cases each year2 incomplete
Slide 11: Cervical Spinal Cord Injury Carries a Severe Lifelong Economic Burden
Cervical Spinal Cord Injury Carries a Severe Lifelong Economic Burden THE U.S. ECONOMIC BURDEN THE U.S. SCI COMMUNITY AT A GLANCE 3 Traumatic spinal cord injury across all injury levels AGE AT INJURY SEX ~$61B ~44 78% 22% Estimated annual U.S. healthcare cost of SCI across all injury levels1 years o
Slide 12: Restoring Lost Function and Increasing Daily Independence Has the Potential to Transform Lives
Restoring Lost Function and Increasing Daily Independence After Spinal Cord Injury Has the Potential to Transform Lives HAND FUNCTION IS A LEADING PRIORITY IN CERVICAL SCI ~77% of individuals with cervical SCI expect recovery of hand function to meaningfully improve quality of life1 RECENT STRUCTURE
Slide 13: Scientific Rationale
NVG-291 Scientific Rationale More than a decade of peer-reviewed validation supporting NVG-291 THE UNMET NEED IN SPINAL CORD INJURY SCIENTIFIC RATIONALE Philippa Warren, PhD Sir Henry Dale Fellow, School of Neuroscience PHASE 1 HEALTHY VOLUNTEER King's College London PHASE 1B/2A CONNECT SCI RESULTS
Slide 14: The Science Behind Intracellular Sigma Peptide (ISP)
Unlocking the Body's Capacity to Restore the Spinal Cord: The Science Behind Intracellular Sigma Peptide (ISP) Dr. Philippa Warren Wolfson Sensory, Pain and Regeneration Centre, King’s College London
Slide 15: Axons reach the injury and stop
Axons reach the injury and stop. Regeneration does not fail for want of effort. It fails because the injured cord builds an environment that actively forbids it. Injury site Silver and Miller (2004) Nature Reviews Neuroscience, 5, 146-156
Slide 16: CSPGs in Pathfinding and Architecture
CSPGs in Pathfinding and Architecture Chondroitin sulfate proteoglycans Guidance and pathfinding: Cellular architecture: (CSPGs) are macromolecules CSPGs in eye development CSPGs as a stabilizing force consisting of a protein core with sulphated sugar sidechains Core Protein Glycosaminoglycan (GAG)
Slide 17: CSPGs Inhibit Nervous System Repair
CSPGs Inhibit Nervous System Repair Chondroitin sulfate proteoglycans Preventing growth: CSPGs increase around the injury site (CSPGs) are macromolecules consisting of a protein core with sulphated sugar sidechains Core Protein Glycosaminoglycan (GAG) Injured spinal cord Injured spinal cord showing
Slide 18: CSPGs Inhibit Nervous System Repair (Cont.)
CSPGs Inhibit Nervous System Repair (Cont.) Three decades of CSPG research across dozens of independent labs 1990 - 2022 73 66 5 publications compiled distinct publication independent lines for this talk first authors span of evidence Five separate lines of evidence, each replicated: • CSPGs block n
Slide 19: CSPGs Inhibit Repair Through Multiple Mechanisms
CSPGs Inhibit Repair Through Multiple Mechanisms CSPG: a Chemical barrier CSPGs: Physical barrier Tang et al. (2003) J. Neurosci . Res., 71, 427 –444; Sorg, B.A. et al. (2016) J. Neurosci ., 36, 11459 –11468; Schwab,M.E . et al. Current Opinion in Neurobiology, 27, 53 –60. (2014); Lang,B.T. et al. N
Slide 20: ISP: Modulating the CSPG Signaling Cascade
ISP: Modulating the CSPG Signaling Cascade Knocking out PTP σ promotes axonal growth on CSPGs Dimer Monomeric Inactive Active PTPσ PTPσ CSPG IgG domain wedge domain ISP prevents growth cone collapse Fibronectin domain Phosphatase domain Regulatory wedge Phosphatase pocket RhoA Erk ISP enables gr
Slide 21: ISP: Chronic Recovery of Function
ISP: Chronic Recovery of Function Uninjured spinal cord Contused spinal cord Warren, P.M. (2018); Warren, P.M. unpublished data (2026)
Slide 22: Increasing Spinal Plasticity Restores Diaphragm Function
Increasing Spinal Plasticity Restores Diaphragm Function Injured Treated Videos slowed x2; Warren et al. (2018) Nature Communications 9, 4843 Click here to watch
Slide 23: ISP: Chronic Recovery of Function
ISP: Chronic Recovery of Function • Severe unilateral cervical (C3) contusion in adult rat. Treatment Groups • Daily subcutaneous treatment began 4 weeks after injury for 8 weeks, then animals were followed a further 8 weeks off treatment. Uni njured Injured with vehicle METHOD • Adult female rats,
Slide 24: ISP: Chronic Recovery of Respiratory Function
ISP: Chronic Recovery of Respiratory Function Uninjured Uninjured Uninjured ISP decreases relative effort of breathing The amplitude is measured relative to the maximum output that the same half of the diaphragm can produce when the airway is blocked during the same test After an incomplete injury,
Slide 25: ISP: Chronic Recovery of Forelimb Function
ISP: Chronic Recovery of Forelimb Function Open Field Locomotion Assessment FLS · GROSS FORELIMB MOVEMENT Treatment window Forelimb Locomotor Score ISP significantly improves forelimb function compared to control . Significance first observed 2 weeks after dosing began, and continued after treatment
Slide 26: Thank You
Thank You Warren lab: Zahra Laouby Ph.D. Felicia Michael Ph.D. Sally McPherson M.Sc. Charlotte Day M.Sc. Natasha Hill M.Sc. Jekaterina Jegorova B.Sc. (alumni) Rosa Laura Depau M.Sc. (alumni) Heidi Green M.Sc. (alumni) Margarida Baptista M.Sc. (alumni) Alice Koltchev M.Sc. (alumni) Collaborators: Gra
Slide 27: Peer-Reviewed Literature Supports NVG-291's Broad Therapeutic Potential as a Pipeline in a Product
Published, Peer-Reviewed Literature Supports NVG-291’s Broad Therapeutic Potential as a Pipeline in a Product Stroke & brain injury Peripheral nerve injury Demyelinating disease Ischemic stroke; hemorrhagic stroke; Spinal root avulsion; sciatic nerve injury Autoimmune and chemically induced hypoxic
Slide 28: Phase 1 Healthy Volunteer Results
Phase 1 Healthy Volunteer NVG-291 Results Safety, tolerability and pharmacokinetics of THE UNMET NEED IN SPINAL CORD INJURY NVG-291 in healthy adults SCIENTIFIC RATIONALE Adam Rogers, MD Chairman & Chief Executive Officer, PHASE 1 HEALTHY VOLUNTEER NervGen PHASE 1B/2A CONNECT SCI RESULTS PHASE 3 RES
Slide 29: Phase 1 Established the Clinical Foundation for NVG-291
Phase 1 Established the Clinical Foundation for NVG-291 A three-part, placebo-controlled study conducted in Australia in 70 randomized healthy volunteers evaluated safety, tolerability and pharmacokinetics across single- and repeat-dose cohorts. PART 1 PART 2 PART 3 (n=37; ~2:1 randomization) (n=17;
Slide 30: Phase 1 Safety and Tolerability in Healthy Volunteers
Phase 1 Safety and Tolerability in Healthy Volunteers SINGLE ASCENDING DOSE MULTIPLE-ASCENDING/REPEAT DOSE PREFERRED TERM NVG-291 N=24 PLACEBO N=13 NVG-291 N=23 PLACEBO N=10 OVERALL SAFETY Any treatment-emergent adverse event (TEAE) 24/24 (100.0%) 7/13 (53.8%) 23/23 (100.0%) 9/10 (90.0%) Severe TEAE
Slide 31: NVG-291 Showed Predictable Plasma Pharmacokinetics
NVG-291 Showed Predictable Plasma Pharmacokinetics Following Single and Multiple-Ascending Dosing DAY 1: SINGLE ASCENDING DOSE DAY 14: MULTIPLE-ASCENDING DOSE 1000 1000 Plasma Concentration (ng/mL) Plasma Concentration (ng/mL) 100 100 10 10 1 1 0 6 12 18 24 0 6 12 18 24 Time (h) Time (h) Cohort 1: 0
Slide 32: Phase 1b/2a CONNECT SCI Study
Phase 1b/2a CONNECT SCI Study NVG-291 Proof-of-concept clinical efficacy of NVG-291 in chronic spinal cord injury THE UNMET NEED IN SPINAL CORD INJURY SCIENTIFIC RATIONALE PHASE 1 HEALTHY VOLUNTEER Adam Rogers, MD Sukhvinder Kalsi-Ryan, PhD, PT Chairman & CEO, Clinician Scientist & Lead Developer of
Slide 33: Living with Chronic Cervical Spinal Cord Injury
LIVING WITH CHRONIC CERVICAL SPINAL CORD INJURY Benjamin Abramoff MD MS Director of Spinal Cord Injury Services Department of Physical Medicine and Rehabilitation University of Pennsylvania - Perelman School of Medicine
Slide 34: Anatomy of the Central Nervous System
Anatomy of the Central Nervous System 34 Injury Outcome Treatment Location Area Injured = Clinical Deficit Can be looked at in two dimensions
Slide 35: Spinal Cord Anatomy
Spinal Cord Anatomy 35 Longitudinal (Level) Cross Sectional (Syndrome)
Slide 36: Cervical Cord
Cervical Cord 36 7 cervical vertebrae 8 pairs of cervical spinal nerves Bulge in spinal cord Sensation (dermatome) through arm Motor: C3 - C5 - Diaphragm (phrenic nerve, inspiration) C4 - C7 - Shoulder and arm musculature C6 - C8 - Forearm extensors and flexors C8 - T1 - Hand muscl
Slide 37: Pathogenesis of Spinal Cord Injury
Pathogenesis of Spinal Cord Injury 37 2 stages Primary Injuries Directly From Trauma Secondary Injuries From Cascade of Effects from Primary Injury
Slide 38: Recovery Changes Over Time
Recovery Changes Over Time 38 Early After Injury Chronic Phase Neurologic Changes Neurologic Baseline Most spontaneous motor Motor function stabilizes and recovery occurs early with spontaneous gains are slowing over time. uncommon. Clinical Focus Clinical Focus Medical stabilization, Preserve healt
Slide 39: Level of Spinal Cord Injury
Level of Spinal Cord Injury 39 • Neurologic level is defined by the most caudal (lowest) neurologic segment that retains normal motor and sensory function on both sides. • Neurologic level defines remaining biomechanical joint motion and muscle strength available • Neurologic level is used to determ
Slide 40: Complete vs. Incomplete Injuries
Complete vs. Incomplete Injuries 40 Complete spinal cord injury No motor or sensory function below the neurologic level Less common Incomplete spinal cord injury Some motor or sensory function below the neurologic level More common
Slide 41: Injury Severity Determines Function
Injury Severity Determines Function 41 American Spinal Injury Association (ASIA) Impairment Scale (AIS) ASIA A “Complete” No motor or sensory in sacral segments Severe impairment below level of injury ASIA B “Sensory Incomplete” Sensation in sacral segments but no motor function Ca
Slide 42: Injury Severity Determines Function
Injury Severity Determines Function 42 American Spinal Injury Association (ASIA) Impairment Scale (AIS) ASIA C “Motor Incomplete” Less than half of key muscles below the neurological level are antigravity (grade ≥3) Some purposeful movement is present but weakness still often requires help
Slide 43: Complications
Complications 43 Skeletal changes Heterotopic ossification Osteoporosis/Fractures Pain Dysesthesias: pain, burning, tingling Overuse injuries (rotator cuff tears from wheelchair use) Fatigue Spasticity
Slide 44: Complications (Cont.)
Complications (Cont.) 44 Respiratory complications Cardiovascular complications Autonomic dysreflexia, deep vein thrombosis / pulmonary embolism, myocardial infarction (heart attack), obstructive sleep apnea, etc … Metabolic disorders Pressure ulcers Bladder and bowel dysfunction Sexua
Slide 45: Level and Preserved Function
Level and Preserved Function 45 C2 –4 AIS C or D Motor function remains below the injury Arm and hand strength can vary widely Eating, dressing and transfers may require substantial help Power mobility or adapted controls may be needed Breathing may require support Better reach or gras
Slide 46: Level and Preserved Function (Cont.)
Level and Preserved Function (Cont.) 46 C5 AIS C or D Shoulder movement and elbow flexion support reaching Wrist and hand weakness may limit grasp and release Source: ROSE Ergotherapie Adaptive utensils or arm supports may assist with eating Dressing and transfers may still require help
Slide 47: Level and Preserved Function (Cont.)
Level and Preserved Function (Cont.) 47 C6 AIS C or D Wrist extension can support grasp through tenodesis Finger strength and sensation may remain impaired Buttons, utensils and catheterization can remain difficult Transfers may require a board or assistance Mobility may include a wheelc
Slide 48: Level and Preserved Function (Cont.)
Level and Preserved Function (Cont.) 48 C7 AIS C or D Elbow extension supports pushing and transfers Finger weakness can still limit grip and fine motor control Some daily tasks may be independent while others need help Walking ability can coexist with substantial hand impairment Cathete
Slide 49: Upper Extremity Function Leads to Independence
Upper Extremity Function Leads to Independence 49 1 Bring the hand to the face Eating, grooming, communication devices 2 Extend the wrist Tenodesis grasp for cups, utensils and phones 3 Extend the elbow Transfers, pressure relief and wheelchair control Catheterization, buttons, medication, 4 Control
Slide 50: Arm and Hand Function is a Leading Priority for Individuals with Tetraplegia
Arm and Hand Function is a Leading Priority for Individuals with Tetraplegia 50 Of 565 respondents with tetraplegia expected an important or very important improvement in quality of life if their hand function improved. Snoek GJ et al. Spinal Cord. 2004;42:526 –532.
Slide 51: Measuring this Patient Priority
Measuring this Patient Priority 51 Critical to use an outcome measure that reliably tracks this function which is so important to patients Strength Sensation Prehension Complementary elements to allow for function GRASSP serves this function
Slide 52: Phase 1b/2a CONNECT SCI Was Designed to Establish Biological & Functional Proof of Concept
Phase 1b/2a CONNECT SCI Was Designed to Establish Biological & Functional Proof of Concept in Chronic SCI Co-Primary Endpoints Key Inclusion Criteria Enrollment Statistical Power MEP Amplitude in the Hand (FDI) or Leg (TA) Traumatic cervical SCI at C7 or higher • AIS C or AIS D • 20 ~80% 1–10 years
Slide 53: CONNECT SCI Baseline Characteristics
CONNECT SCI Baseline Characteristics PARTICIPANT AND INJURY CHARACTERISTICS BASELINE CLINICAL CHARACTERISTICS NVG-291 Placebo NVG-291 Placebo Characteristic Endpoint (n=10) (n=10) (n=10) (n=10) ES-MEP First Dorsal Interosseous (FDI) 6.21 6.53 Age, years 43.0 (19.7) 50.3 (15.0) (% maximum motor respo
Slide 54: NVG-291 Was Generally Safe and Well Tolerated
NVG-291 Was Generally Safe and Well Tolerated, With 100% Treatment Completion of Once-Daily Subcutaneous Dosing for 12 Weeks Participants with ≥1 event, n (%) Mild-to-moderate injection site reaction NVG-291 (n=10) 9 (90.0%) Placebo (n=10) 3 (30.0%) 100% Of participants completed 12 weeks Fatigue 1
Slide 55: Electrically Stimulated MEPs Assess Function of the Damaged Corticospinal Pathway
Electrically Stimulated Motor Evoked Potentials (MEPs) Assess Function of the Damaged Corticospinal Pathway After Spinal Cord Injury 1. HOW ELECTRICAL MEPs ARE MEASURED 2. WHAT THE RESPONSE CAN MEAN Participant with cervical SCI Descending corticospinal pathway After spinal cord injury (SCI), damage
Slide 56: NVG-291 Met the Hand Co-Primary Endpoint
NVG-291 Met the Hand Co-Primary Endpoint, Increasing Motor Evoked Potential Amplitude and Supporting Increased Corticospinal Connectivity HAND (FIRST DORSAL INTEROSSEOUS) LEG (TIBIALIS ANTERIOR) NVG-291 Placebo NVG-291 Placebo (% points of max. motor response) (% points of max. motor response) 20 10
Slide 57: Startle-React MEPs Assess Reticulospinal Hyperexcitability
Startle - React Motor Evoked Potentials (MEPs) Assess Reticulospinal Hyperexcitability after Spinal Cord Injury 1. HOW STARTLE - REACT MEPs ARE MEASURED 2. WHAT THE RESPONSE CAN MEAN A startling sound precedes electrical stimulation. After spinal cord injury (SCI), the reticulospinal pathway becomes
Slide 58: NVG-291 Reduced Startle-React MEP Amplitude in the Hand and Leg
NVG-291 Reduced Startle-React Motor Evoked Potential Amplitude in the Hand and Leg, Supporting Reduced Reticulospinal Hyperexcitability HAND (FIRST DORSAL INTEROSSEOUS) LEG (TIBIALIS ANTERIOR) NVG-291 Placebo NVG-291 Placebo 15 0 (% points of test MEPs) (% points of test MEPs) Change from baseline C
Slide 59: Bridging the GAP: the hand and function for the RESTORE study
Bridging the GAP, defining the connection between the hand and function for the RESTORE study.
Slide 60: About Me
About Me • Clinician Scientist KITE Research Institute • PI - Upper Extremity NeuroRestorative and Innovations Lab - Lyndhurst Site/University Health Network • University of Toronto o Assistant Professor, Department of Physical Therapy o Faculty - Rehabilitation Sciences Institute o Faculty - Spine
Slide 61: Why is the Hand so Important?
Why is the Hand so Important? Restoring hand function is one of the most important priorities for people with chronic tetraplegia. Anderson KD. J Neurotrauma. 2004;21(10):1371 –1383.
Slide 62: Why Could NVG-291 Potentially be so Important?
Why Could NVG-291 Potentially be so Important? 1. Prevalence vs. Incidence Months and 0-28 days 2. Window to treat is broader years Traumatic Non-traumatic 3. Potential application in non - traumatic SCI cervical SCI all levels of SCI 62
Slide 63: The GAP > Why the HAND > GRASSP
The GAP > Why the HAND > GRASSP Endpoint 2005/2006 Exploratory > Secondary > First in human acute Primary cervical SCI trial 2016 Inclusive Study Design 2006 - 2009 • Clinically Feasible • Sensitive • Acute/Chronic GAP - No upper “Even just being able extremity measure to pick up food and sensitive
Slide 64: GRASSP Research and Design Team
GRASSP Research and Design Team CANADA (U of T/UHN) SWITZERLAND ( Balgrist /Nottwil ) Dr. Sukhvinder Kalsi - Ryan BScPT , MSc, PhD Dr. Inge - Marie Velstra BScOT , MSc, PhD Professor Mary Verrier Dip(P&OT) Professor Armin Curt, MD Dr. Michael Fehlings MD, PhD
Slide 65: The Hand is Complex – GRASSP V2
The Hand is Complex – GRASSP V2 Specific to Upper Limb for Tetraplegia GRASSP Construct and Domains Items Subtest/Scores Sensorimotor /12 /24 Hand Function Sensation GR Sen /50 /100 Strength GR - Str /12 /24 Prehension GR - PA, GR - QtP /20 /40 65
Slide 66: Prehension Restoration & Function
Prehension Restoration & Function Prehension = GR-QtP Act of taking hold or grasping an object C. Sollerman = Eight core grasping patterns that account for 100% of daily function GRASSP V2 – Selected 4/8 that represent 75% of one’s daily functioning 20% 20% 20% 15% 66
Slide 67: What does a score on Quantitative Prehension mean?
What does a score on Quantitative Prehension mean? 0 No Activity One Both Hand Hands 1 Activity but no task 0/20 0/40 Potential score range execution Hands are moving, but no 2 4/20 0-9/40 function Partial task completion 3 Partial function, tasks 8/20 10-19/40 Task completed with incomplete abnorma
Slide 68: Rationale for Using Quantitative Prehension
Rationale for Using Quantitative Prehension 1. Relatable to everyday function • Approximately 75% of daily tasks are covered 2. Evaluates quality and completion of tasks 3. How the task is completed: • Which neurological elements of hand function are improving • This is how we will target whether it
Slide 69: Measurement Properties Quantitative Prehension V2
Measurement Properties V2 Quantitative Prehension Reliability: Highly Inter - rater reliability 0.96 – 0.97 reproducible Test - retest reliability 0.96 – 0.97 Concurrent Validity: Associated SCIM: 0.71 | SCIM Self - Care: 0.82 with function & independence CUE - Q: 0.83 Responsiveness/Sensitivity to
Slide 70: Standardization of the GRASSP Assessment
Standardization of the GRASSP Assessment Standardized education 1 Shared reference materials and e - learning Standardized e - learning materials Expert - led training 2 Trainer demonstrations and practical instruction or video examples Competency confirmation 3 Skills demonstration with trainer rev
Slide 71: To Summarize
To Summarize • Significance of the RESTORE Study o Upper extremity o Chronic spinal cord injury o Inclusive • Understand the importance of using the GRASSP assessment • Robust measurement properties make it a well - suited assessment • Sensitive to subtle change in people living with tetraplegia 71
Slide 72: NVG-291 Showed Greater Observed Improvement in GRASSP Quantitative Prehension at Week 12
NVG-291 Showed Greater Observed Improvement in GRASSP Quantitative Prehension Than Placebo at Week 12 OBSERVED MEAN CHANGE AT WEEK 12 INDIVIDUAL WEEK 12 WATERFALL PLOT ( Δ from baseline) 6 NVG - 291 (n=10) 5 +12 +11 Change from Baseline (points) +9 +8 4 +8 +4 +4 3 Minimally +4 +2 Important +1 0 0 Di
Slide 73: Observed Prehension Improvement Maintained at Week 16
Observed Improvement in GRASSP Quantitative Prehension With NVG-291 Were Maintained Four Weeks After Treatment Cessation at Week 16 OBSERVED MEAN CHANGE AT WEEK 16 INDIVIDUAL WEEK 16 WATERFALL PLOT ( Δ from baseline) 6 NVG - 291 (n=10) 5 +11 +10 +10 Change from Baseline (points) +10 +7 4 +6 +3 +2 +2
Slide 74: Greater Observed Improvement in GRASSP Total at Week 12
NVG-291 Showed Greater Observed Improvement in GRASSP Total at Week 12, a Composite of Strength, Sensation and Prehension OBSERVED MEAN CHANGE AT WEEK 12 INDIVIDUAL WEEK 12 WATERFALL PLOT ( Δ from baseline) 12 NVG - 291 (n=10) 10 +23 +22 +24 Change from Baseline (points) +18 +13 8 +10 +10 +10 +12 +6
Slide 75: Continued Observed Improvement in GRASSP Total at Week 16
NVG-291 Showed Continued Observed Improvement in GRASSP Total at Week 16, a Composite of Strength, Sensation and Prehension OBSERVED MEAN CHANGE AT WEEK 16 INDIVIDUAL WEEK 16 WATERFALL PLOT ( Δ from baseline) 16 NVG - 291 (n=10) 14 +32 +25 Change from Baseline (points) +24 +22 12 +24 +18 +16 10 +16
Slide 76: Greater Overall Improvement on Patient Global Impression of Change
NVG-291-Treated Participants Reported Greater Overall Improvement on Patient Global Impression of Change (PGIC) Assessed during blinded exit interviews conducted a median of 296 days after study completion NVG - 291 Placebo n=8 n=9 REPORTED OVERALL CONDITION 7 Very much improved “Much improved” or “
Slide 77: Blinded Interviews Contextualized Improvements in Everyday Life
Blinded Interviews Supported the Contextualization of Clinically Meaningful Improvements in Everyday Life after NVG-291 Treatment Blinded, IRB - Approved Qualitative Exit Interviews · Participants Blinded To Treatment Assignment · Median: 296 Days post - study 1 SELECT PARTICIPANT - REPORTED CHANGES
Slide 78: Three Biomechanical Hallmarks Distinguish Recovery from Compensation
Three Biomechanical Hallmarks Distinguish Recovery from Compensation1 Independent, blinded video - based analysis of standardized walking assessments from Phase 1b/2a CONNECT SCI ILLUSTRATIVE PARTICIPANT EXAMPLE Participant ~3 years post transportation - related C3 spinal cord injury BASELINE Unable
Slide 79: All Three Hallmarks of Gait Recovery Favored NVG-291
All Three Hallmarks of Gait Recovery Favored NVG-291 Coordination, mechanical effort and postural stability each showed a statistically significant difference favoring NVG - 291 over placebo Change from Baseline to Week 12 P - value: 0.007 P - value: 0.038 P - value: 0.044 40 800 20 °) °) ° /s) 20 6
Slide 80: Significant Improvement in the Composite Gait Recovery Score
NVG-291 Showed Significant Improvement in the Composite Gait Recovery Score Compared with Placebo The global statistical test (GST) integrates the three hallmarks of recovery – coordination, mechanical effort, and postural stability – into a single recovery outcome score to quantify the magnitude of
Slide 81: All NVG-291 Participants Met the Composite Gait Responder Criterion
All NVG-291 Participants Met the Composite Gait Responder Criterion Each participant was compared with every participant in the opposite treatment arm across the three hallmarks; a composite score above zero defined a responder. PAIRWISE SCORES ACROSS GAIT RECOVERY METRICS1 PAIRWISE COMPOSITE RESPON
Slide 82: Converging Evidence Supports NVG-291's Phase 3 Path
Converging Evidence Supports NVG-291’s Phase 3 Path 01 A mechanism designed to rescue endogenous repair NVG-291 addresses CSPG-driven inhibition, supported by preclinical evidence in acute and chronic SCI. 02 Neurophysiologic evidence supports improved motor pathway function CONNECT SCI met the hand
Slide 83: Phase 3 RESTORE Study
NVG-291 Phase 3 RESTORE Study THE UNMET NEED IN SPINAL CORD INJURY Pivotal evaluation of NVG-291 in chronic cervical motor incomplete spinal cord injury SCIENTIFIC RATIONALE PHASE 1 HEALTHY VOLUNTEER Adam Rogers, MD Chairman & Chief Executive Officer, NervGen PHASE 1B/2A CONNECT SCI RESULTS PHASE 3
Slide 84: FDA Feedback Guided RESTORE's Focus on Clinical Benefit
FDA Feedback Guided RESTORE’s Focus on Clinical Benefit Type C End-of-Phase 2 Meeting Alignment 3Q 2025 1Q 2026 CLINICAL FOCUS R E S T O R E A S S E SS M E NT F R A M E WO R K Measure clinically PRIMARY ENDPOINT 01 meaningful benefit GRASSP Quantitative Prehension Change from baseline to Week 12 Ass
Slide 85: RESTORE is an FDA-Aligned Phase 3 Registrational Study
RESTORE is an FDA-Aligned Phase 3 Registrational Study RESTORE retains core design elements from the Phase 1b/2a CONNECT SCI study Primary Endpoint Key Inclusion Criteria Enrollment Statistical Power GRASSP Quantitative Prehension Traumatic cervical SCI at C7 or higher • AIS C or AIS D • ~150 ~90% 1
Slide 86: Rigorous Oversight of RESTORE's GRASSP QtP Primary Outcome Measure
Rigorous Oversight of RESTORE’s GRASSP Quantitative Prehension (QtP) Primary Outcome Measure Specialist training and blinded video review support consistent assessment in multi - center use SPECIALIST-LED RATER INDEPENDENT, BLINDED VIDEO TRAINING AND CERTIFICATION OVERSIGHT OF GRASSP QTP Dedicated G
Slide 87: RESTORE is Designed to Support At-Home Administration
RESTORE is Designed to Support At-Home Administration Structured participant and caregiver training, with follow - up during the first three weeks TRAINING AND COMPETENCY ASSESSMENT DAY 1 DAY 2 DAY 3 First dose at study center Nurse demonstration at home Competency assessment Study - site administra
Slide 88: RESTORE is Well Powered to Show a Difference in GRASSP Quantitative Prehension
RESTORE is Well Powered to Show a Difference Between Treatment Groups in GRASSP Quantitative Prehension 100% 90% Illustrative Statistical Power Observed Planned 80% Treatment difference (points) +3.3 +2.5 70% Standard deviation (points) 3.42 4.50 Pooled within arms Evaluable participants 60% (total)
Slide 89: Community Perspectives & Advocacy
NVG-291 COMMUNITY PERSPECTIVES & ADVOCACY THE UNMET NEED IN SPINAL CORD INJURY SCIENTIFIC RATIONALE Christine McSherry, RN SVP, Patient Advocacy & Clinical Affairs, NervGen PHASE 1 HEALTHY VOLUNTEER PHASE 1B/2A CONNECT SCI RESULTS PHASE 3 RESTORE STUDY Barry Munro Chief Development Officer & SCI Adv
Slide 90: Bringing the Community and Participant Voice into Clinical Development
Bringing the Community and Participant Voice into Clinical Development Christine McSherry Senior Vice President, Patient Advocacy & Clinical Affairs Founder, Jett Foundation Established following her son Jett’s diagnosis with Duchenne muscular dystrophy Co-founder, Casimir Advanced outcome measures
Slide 91: Where My Advocacy Began
Where My Advocacy Began YEARS OF 91 i (—_—
Slide 92: Changing How Potential Benefit Is Defined
Changing How Potential Benefit Is Defined Addressing what participants and caregivers find meaningful 92 Data adapted from McDonald CM et al. Muscle Nerve. 2013;48(3):343–356, Figure 4A.
Slide 93: Turning Experience Into Action
Turning Experience Into Action Bringing patient and caregiver priorities into research 93
Slide 94: Elevating the Participant Voice
Elevating the Participant Voice Bringing patient and caregiver priorities into research 94 Source: FDA. Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. February 2022.
Slide 95: From Lived Experience to Advocacy
From Lived Experience to Advocacy 95
Slide 96: The First Externally Led SCI Patient-Focused Drug Development Meeting
The First Externally Led Spinal Cord Injury Patient-Focused Drug Development (PFDD) Meeting Held on September 29, 2026 1,000+ Individuals registered 10 SCI coalition member organizations 1st Externally led PFDD meeting for spinal cord injury Patient perspectives will inform a Voice of the Patient re
Slide 97: With Gratitude to Dr. Jerry Silver
With Gratitude to Dr. Jerry Silver Recognizing the scientific vision and persistence that continue to shape our work today A Scientific Foundation 01 Pioneering the biology underlying neural repair. A Vision for Translation 02 Championing the belief that CSPG modulation could be translated into a po
Slide 98: Converging Evidence Supports NVG-291's Phase 3 Path; RESTORE Key Milestones
Converging Evidence Supports NVG-291’s Phase 3 Path 01 A mechanism designed to rescue endogenous repair NVG-291 addresses CSPG-driven inhibition, supported by preclinical evidence in acute and chronic SCI. 02 Converging clinical evidence supports NVG-291’s potential in chronic SCI CONNECT SCI met th
Slide 99: Transforming the Lives of Individuals with Spinal Cord Injury
Transforming the Lives of Individuals with Spinal Cord Injury