Slide 1: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself Corporate Presentation August 2024
Slide 2: Financial Disclosure Statement
Financial Disclosure Statement Not an offer or solicitation: This document is provided for general information purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any security in any jurisdiction. The contents of this document have not been approved or disappr
Slide 3: NervGen Highlights
NervGen Highlights NVG-291, a novel first-in-class drug candidate with potential to repair nervous system damage and restore motor, sensory and cognitive function Demonstrated functional improvement in six different preclinical models in several independent labs NVG-291 – Phase 1b/2a proof-of-concep
Slide 4: Multiple Preclinical Studies Using NVG-291-R Report Improved CNS/PNS Repair
Multiple Preclinical Studies Using NVG-291-R* Report Improved CNS/PNS Repair Enhanced Plasticity, Repair (Axonal, Myelination), and Recovery of Function ACUTE SPINAL CHRONIC SPINAL STROKE MULTIPLE PERIPHERAL NERVE OPTIC NERVE CORD INJURY CORD INJURY (Ischemic, Hemorrhagic) SCLEROSIS (EAE) INJURY DEM
Slide 5: Product Pipeline
Product Pipeline Multiple development opportunities CANDIDATE PROGRAM DISCOVERY PRECLINICAL PHASE 1 PHASE 1b/2a Spinal Cord Injury NVG-291 Stroke Stroke Amyotrophic Lateral Sclerosis NVG-300* Alzheimer's Disease Multiple Sclerosis 5 *Internally developed
Slide 6: Nervous System Damage Markets and Opportunity
Nervous System Damage Markets and Opportunity Significant medical costs and morbidity SCI Ischemic Stroke ALS MS AD Incidence* 18,000 ~690,000 ~7,000 10,000 500,000 Prevalence* 291,000 9.4M ~25K-30K ~1M 6.7M Lifetime Cost* $1M-$4M+ $140,000+ $1.4M $4M+ $400,000 System Cost* $50B+ $57B $250M-$1.0B $8
Slide 7: SCI Demographics
SCI Demographics • Average age: ~43 • Male (78%), female (22%) • Cause: vehicle (38%); fall (33%); violence (15%); sports (8%) • Annual hospitalization (30%): UTI, pneumonia, decubitus ulcer • Duration of hospitalization and rehabilitation: 2 to 3 months • Chance of depression: 25% • Significant uri
Slide 8: SCI Facts and Figures
SCI Facts and Figures Incidence and Prevalence Economic Impact Individuals with SCI face a difficult and expensive Spinal cord injuries every journey through the healthcare system; that ~18,000 year in the US1 journey begins with 2-3 months in rehabilitation and costs $200,000 or more per patient3 P
Slide 9: NVG-291-R Promotes Recovery in Acute SCI
NVG-291-R Promotes Recovery in Acute SCI Hindlimb function (BBB Score) Overview 20 21 = Normal • T8 compression injury Treatment Period function **** **** • 500 µg/day x 7 weeks **** 15 **** • Treatment began 1 day post-injury NVG-291-R ≥14 = fine motor movements (N=10) Results 10 Occasional coordin
Slide 10: NVG-291-R Promotes Recovery in Chronic SCI
NVG-291-R Promotes Recovery in Chronic SCI Overview Forelimb function (FLS score) • C2 lateral hemisection Treatment Period • 500 µg/day x 8.5 weeks Consistent *** walking • Treatment began 12 weeks post-injury * ** Results Weight • Significant recovery of forelimb locomotor support function • Funct
Slide 11: Spinal Cord Injury: Bladder function improved
Spinal Cord Injury Bladder function improved following NVG-291-R treatment in preclinical animal studies 1.5 Bladder Dose Response1 ** * 1.0 Responders Void (2x SD of vehicle mean) 100% of animals in the Frequency (voids / hour) two highest dose groups had improved bladder 0.5 control function 1Anim
Slide 12: NVG-291 Phase 1 Clinical Trial Results
NVG-291 Phase 1 Clinical Trial Results Study Design Safety Results Single Dose • Well tolerated across all doses • 37 subjects − Maximum tolerated dose (MTD) not reached • 6 dose levels • No treatment discontinuations • Assessed through Day 8 • No serious/severe adverse events (AE) in NVG-291 Multip
Slide 13: Phase 1b/2a Trial: Study NVG-291-201
Phase 1b/2a Trial: Study NVG-291-201 No Over 16 weeks: NVG-291 intervention • Daily sub-cue injections (12 weeks) Screening • Electrophysiological assessments No Placebo intervention • Clinical assessments Wk0 Wk4 Wk8 Wk12 Wk16 • Exercise/training: ~5 days per week • Single-center study – Shirley Ry
Slide 14: Study Population
Study Population Cohorts of motor incomplete cervical SCI: 1. Chronic: 1-10 years post-injury 2. Subacute: 20-901 days post-injury Key Inclusion Criteria Key Exclusion Criteria • Age 18-75 • Non-traumatic SCI • Traumatic SCI • SCI from gunshot or penetrating/stab injury • Neurological level of injur
Slide 15: Primary Objective and Endpoint
Primary Objective and Endpoint Ten Muscle Groups Assessed • Primary Objective ‒ To evaluate the effect of NVG-291 compared to Upper extremity Lower extremity placebo on relative percentage change in corticospinal Biceps brachii Quadriceps connectivity to qualifying muscle groups Triceps brachii Hams
Slide 16: Secondary Endpoints (Clinical)
Secondary Endpoints (Clinical) 1. Change from baseline to Week 12 in 10mWT time 2. Change from baseline to Week 12 in 9-HPT time 3. Change from baseline to Week 12 in pinch dynamometry force 4. Change from baseline to Week 12 in GRASSP version 2 scores 5. Change from baseline to Week 12 in lower ext
Slide 17: Additional Data: Qualitative Review of Subject Experience
Additional Data: Qualitative Review of Subject Experience • Incorporating qualitative semi-structured subject interviews • Exploring subjects’ experiences of potential beneficial treatment • Aligns with FDA Patient-Focused Drug Development Guidance 17
Slide 18: Blinded Baseline Demographic and Clinical Characteristics
Blinded Baseline Demographic and Clinical Characteristics *Chronic cohort Age (years) Mean (SD) 45.2 (17.82) Sex N (% male) 11 (91.7%) Time since SCI (years) Mean (SD) 3.76 (2.717) Neurological level of injury N (%) C2 2 (16.7%) N (%) C3 4 (33.3%) N (%) C4 3 (25%) N (%) C5 1 (8.3%) N (%) C6 2 (16.7%
Slide 19: Advancing NVG-300
Advancing NVG-300 • A new proprietary molecule discovered at NervGen in 2022 • Demonstrated promising efficacy during initial preclinical evaluation in SCI • Severe injury model characterized by heightened spinal cord damage and impaired spontaneous recovery • Demonstrated favorable pharmaceutical p
Slide 20: NervGen Summary
NervGen Summary • NVG-291 proof-of-concept trial underway in subjects with chronic SCI • Evaluating motor connectivity, function and subject-perceived benefit • Targeting to complete chronic cohort enrollment in Q3 • Subacute cohort targeted to initiate enrollment in Q3 • NVG-300 advancing • Further
Slide 21: Upcoming Milestones
Upcoming Milestones Targeting Q3 to complete Phase 1b/2a enrollment in chronic cohort Initiating enrollment in subacute cohort NVG-300 preclinical data in stroke, ALS, SCI Phase 1b/2a proof-of-concept readout in chronic SCI 21
Slide 22: Leadership
Leadership Mike Kelly, MBA Bill Adams, CPA, CA Dan Mikol, MD, PhD Chuck Olson, DSc Liz Eberhardt, BSc Matvey Lukashev, PhD Chief Executive Officer Chief Financial Officer Chief Medical Officer Sr. VP, Technical Operations Sr. VP, Project Management VP, Research & Preclinical Mike has over 30 years o
Slide 23: Share and Capital Structure
Share and Capital Structure Exchange/Market: Ticker TSX: NGEN.V OTCQB: NGENF Recent Share Price CA $2.96 US $2.15 (August 9, 2024) Shares Outstanding 70.2 million 92.5 million Fully Diluted (~12.2 million options & retention securities, ~10.1 million warrants*) Insider Ownership 23.3% Cash & Cash Eq
Slide 24: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself www.nervgen.com Certain images in this presentation are sourced from Flaticon All trademarks are the property of their respective Company owners