Nervgen Pharma Corp. · NASDAQ:NGEN
Nervgen Pharma — Investor Presentation (November 2022)
33 slides from Nervgen Pharma's investor presentation, Nov 15, 2022
Slide 1: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself C O R P O R AT E P R E S E N TAT I O N November 15, 2022
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's Clinical Trials are Led by Experienced Drug Developers
NervGen’s Clinical Trials are Led by Experienced Drug Developers Bill Radvak Adam Rogers, MD Dan Mikol, MD, PhD Executive Chairman Interim President Chief Medical Officer & Interim CEO & Board Member • Co-founder of NervGen • Principal of Boston based PFP Biosciences • 25+ years pharma experience an
Slide 4: NVG-291: A Pipeline in a Product
NVG-291: A Pipeline in a Product STAGE OF DEVELOPMENT Next clinical INDICATION Phase 1 ESTIMATED COST MARKET OPPORTUNITY trial • ~18,000 new patients per year in the US Spinal Cord Injury 1b/2a $10 M • ~300,000 chronic patients • Lifetime costs range from $1 to >$5 million • ~6,000,000 patients in t
Slide 5: Revolutionizing the Treatment of Nervous System Damage
Revolutionizing the Treatment of Nervous System Damage Everyone KNOWS… Everyone BELIEVES… The nervous system is a The nervous system complex system that cannot repair itself controls thought, movement, senses, etc. 5
Slide 6: NVG-291 – First-in-Class Neuroreparative Drug
NVG-291 – First-in-Class Neuroreparative Drug Representative of Placebo Group Representative of NVG-291 Group (Back Legs and Tail Dragging) (Back Legs and Tail Active) Remarkable and robust repair across multiple models 6 Rink et al., 2018 SEVERE SPINAL CORD INJURY MODEL
Slide 7: NervGen's Technology Was Invented by Dr. Jerry Silver
NervGen’s Technology Was Invented by Dr. Jerry Silver Known in the Spinal Cord Injury Field as the “Oracle” Dr. Silver’s Spinal Cord Research • Discovered why the nervous system does not repair itself STRONG IP PORTFOLIO • Identified the surprising molecules responsible NervGen licensed the technolo
Slide 8: The Evolution of Our Proprietary Science
The Evolution of Our Proprietary Science Pre 1990 1990s 2009 2015 It was demonstrated Dr. Silver identified a class of Dr. Silver and collaborators from Dr. Silver's team then that glial scars form at the molecules called CSPGs, Harvard co-discovered that identified NVG-291, a drug site of injury to
Slide 9: NVG-291 Allows Neurons to Grow in the Scar
NVG-291 Allows Neurons to Grow in the Scar NVG-291 frees Neuron bound to neuron from CSPGs and unable CSPGs and allows to grow it to grow NVG-291, a 35 amino acid peptide, produced dramatic recovery in a spinal cord injury animal study: the results published in Nature1 are now cited in over 327 publ
Slide 10: The Body's Powerful Innate Repair Mechanisms
The Body’s Powerful Innate Repair Mechanisms Disrupted by CSPGs Repair Mechanisms: Injury Scar Formation Plasticity The creation of new neuronal connections and rewiring of existing ones Injury Brain Upregulation of CSPGs Axonal Regeneration The ability of a severed axon to reestablish connectivity
Slide 11: NVG-291 Takes the Brakes off Natural Repair Mechanisms
NVG-291 Takes the Brakes off Natural Repair Mechanisms Repair Mechanisms: Plasticity Injury Scar Formation The creation of new neuronal connections and rewiring of existing ones Injury Brain Upregulation of CSPGs Axonal Regeneration The ability of a severed axon to reestablish connectivity with othe
Slide 12: NVG-291 Broadly Restores Function
NVG-291 Broadly Restores Function NVG-291 Has Demonstrated Dramatic Repair in multiple animal models of neurological injury/disease, as documented in 15+ peer-reviewed papers ACUTE SPINAL CHRONIC SPINAL PERIPHERAL MULTIPLE OPTIC STROKE CORD INJURY CORD INJURY NERVE INJURY SCLEROSIS NEURITIS • Motor
Slide 13: NVG-291: Potential to Treat All Types of Nervous System Damage
NVG-291: Potential to Treat All Types of Nervous System Damage TRAUMA DISEASE Acute Spinal Cord Injury Multiple Sclerosis Alzheimer’s Disease Chronic Spinal Cord Injury Stroke NVG-291 ALS Traumatic Brain Injury Frontotemporal Dementia Parkinson’s Disease NervGen Priorities 13
Slide 14: NVG-291 - Phase 1 Clinical Trial in Progress
NVG-291 - Phase 1 Clinical Trial in Progress Postmenopausal females - COMPLETED • NVG-291 was well tolerated at a high dose • NVG-291 was rapidly distributed in the blood - 170% higher than the equivalent highest dose in preclinical • The calculated half-life was longer in humans than animals effica
Slide 15: Spinal Cord Injury: No FDA Approved Drug that Improves Function
Spinal Cord Injury No FDA Approved Drug that Improves Function • NervGen’s goal is to improve motor, bladder/bowel/sexual and/or sensory function 15
Slide 16: NVG-291 – Dramatically Repairs Spinal Cord Injury
NVG-291 – Dramatically Repairs Spinal Cord Injury S E V E R E S P I N A L C O R D I N J U RY M O D E L Representative of Placebo Group Representative of NVG-291 Group Hind legs are immobile Significant motor recovery: consistent coordination, toe clearance, tail held high consistently 16 Rink, S. et
Slide 17: Spinal Cord Injury – NVG-291 Promotes Functional Recovery
Spinal Cord Injury – NVG-291 Promotes Functional Recovery BBB Scale = Standard measure of mobility 21 = Normal function 20 # NVG-291 500ug UNPRECEDENTED ≥14 = fine motor # (N=5) RESULTS movements # 15 # Extremely high ≤13 = Occasional response rate coordination 10 50% Placebo Almost complete (N=20)
Slide 18: NVG-291 Improves Bladder Function
NVG-291 Improves Bladder Function BLADDER DOSE RESPONSE 1.5 Void Frequency ** 100% of animals in the * two highest dose groups 1.0 had improved bladder Responders (2x SD of vehicle mean) control function NVG-291 treatment resulted 0.5 in a dose dependent improvement in bladder function 0.0 Vehicle 3
Slide 19: Chronic Spinal Cord Injury – NVG-291-R Promotes Functional Recovery
Chronic Spinal Cord Injury – NVG-291-R Promotes Functional Recovery Forelimb Locomotor Scale Treatment beginning 3 months post spinal cord injury Animals treated with once daily systemic injection *** *** *** starting 3 months post injury for 60 days ** * Animals treated with NVG-291-R show signific
Slide 20: NVG-291 Safety/Efficacy Studies in Spinal Cord Injury Patients
NVG-291 Safety/Efficacy Studies in Spinal Cord Injury Patients • Single center, placebo controlled Spinal Cord Injury Phase 1b/2a • 3 months treatment duration • Efficacy analysis includes electrophysiology, ~20 patients per arm, minimum 40 patients clinical assessments of upper and lower ~$10 milli
Slide 21: Alzheimer's Disease: No FDA Approved Drug for Sustained Cognitive Improvement
Alzheimer’s Disease No FDA Approved Drug that Results in Sustained Improvement in Cognitive Function • Symptomatic treatments to improve cognition in Alzheimer's disease are unsatisfactory • A disease–modifying therapy approved in 2021 has questionable benefit in slowing cognitive decline • NervGen
Slide 22: NVG-291-R – Improved Spatial Learning and Memory
NVG-291-R – Improved Spatial Learning and Memory ST RO K E M O D E L Significant improvement in cognitive function when treated 24 hours - and even 7 days 22 Luo et al., Cell Reports Volume 40, Issue 4, 111137, July 26, 2022 (https://doi.org/10.1016/j.celrep.2022.111137)
Slide 23: Improved Spatial Learning and Memory
Improved Spatial Learning and Memory Barnes Maze Test Treatment beginning 7 days post stroke Animals treated with NVG-291-R made fewer errors and identified the target hole in a faster time compared to placebo treated animals Significant improvements observed when NVG-291-R was administered up to 7
Slide 24: NVG-291 Pathway to Treat Alzheimer's Disease
NVG-291 Pathway to Treat Alzheimer’s Disease CSPG ACCUMULATION IN AD PATIENT BRAINS1 Preclinical studies have demonstrated (CSPGs) Brevican/GAPDH that breaking down CSPGs 2.5 improves Alzheimer's symptoms2,3 * 2.0 1.5 Removing PTPσ improves cognitive function in Alzheimer’s models4 1.0 0.5 NVG-291’s
Slide 25: NVG-291 Safety/Efficacy Studies in Alzheimer's Disease Patients
NVG-291 Safety/Efficacy Studies in Alzheimer's Disease Patients • Multicenter, placebo controlled Alzheimer’s Phase 1b/2a • 3 months treatment duration • Efficacy analysis includes functional and structural imaging, cognitive assessments and ~80 patients, ~$20 million estimated cost fluid biomarkers
Slide 26: Multiple Sclerosis Repair: No FDA Approved Drug that Improves Function
Multiple Sclerosis Repair No FDA Approved Drug that Improves Function • MS is an autoimmune disease where the immune system attacks myelin in the central nervous system, and over time this results in increasing disability • Approved disease-modifying drugs modulate the immune system, which can reduc
Slide 27: NVG-291 Restores Motor Function in Multiple Sclerosis
NVG-291 Restores Motor Function in Multiple Sclerosis Representative of Placebo Group Representative of NVG-291 Group Score never improves from 3.5 Score improves to 0.5 in 20 days NVG-291 restored motor function in MS model1, even when administered after symptoms were fully developed 27 1Luo, F. et
Slide 28: NVG-291 Remyelinates in Multiple Sclerosis
NVG-291 Remyelinates in Multiple Sclerosis POSITIVE PLACEBO NVG-291 PRECLINICAL RESULTS1 Animals treated with NVG-291 had substantially greater remyelination 3 days compared to placebo treated animals after 21 days post-lesion Histological evidence showed that the desired types of cells were migrati
Slide 29: NVG-291 Safety/Efficacy Studies in Multiple Sclerosis Patients
NVG-291 Safety/Efficacy Studies in Multiple Sclerosis Patients • Multicenter, placebo controlled • 3 months treatment duration Multiple Sclerosis Phase 2 • Efficacy analysis includes clinical assessments, advanced structural imaging ~80 patients, ~$20 million estimated costs and fluid biomarkers Wor
Slide 30: Share and Capital Structure
Share and Capital Structure Exchange/Market: Ticker TSX: NGEN.V OTCQX: NGENF Recent Share Price CA $1.72 US $1.30 (November 15, 2022) Shares Outstanding 58.7 million 76.5 million Fully Diluted (~7.9 million options, ~9.9 million warrants) Insider Ownership 24.5% ~Cash & Cash Equivalents CA $27.7 mil
Slide 31: Upcoming Value Drivers
Upcoming Value Drivers • Phase 1 study topline MAD data (2023) • Phase 1b/2a trial planned in spinal cord injury (2023) • Preclinical study results in chronic spinal cord injury and Alzheimer's disease models which could transform treatment paradigms • Awarding of privately funded and US Department
Slide 32: Investment Highlights
Investment Highlights NVG-291 has the potential to redefine treatment paradigms for neurological disorders Improvement demonstrated across 6 different animal models in fine and gross motor control, sensory function, autonomic functions, visual acuity, memory & learning, in many cases unprecedented P
Slide 33: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself www.nervgen.com @NervgenP NervGen Pharma Corp. NervGen
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