Nervgen Pharma Corp. · NASDAQ:NGEN
Nervgen Pharma — Investor Presentation (February 2023)
34 slides from Nervgen Pharma's investor presentation, Feb 14, 2023
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 February 14, 2023
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, BASc Adam Rogers, MD Dan Mikol, MD, PhD Executive Chairman Interim President Chief Medical Officer & Interim CEO & Board Member • Co-founder of NervGen • Co-founded Hemera Biosciences in 2010, a • 25+ years pharma experien
Slide 4: NervGen Highlights
NervGen Highlights NVG-291, a first-in-class neuroreparative drug candidate administered by subcutaneous injection, has the potential to redefine treatment paradigms by repairing nervous system damage Improvement demonstrated across 6 different animal models in fine and gross motor control, sensory
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 Foundation of Our Technology
The Foundation of Our Technology Pre 1990 1990s 2009 2015 It was demonstrated Dr. Silver identified a class of Dr. Silver and collaborators from Dr. Silver's team designed a that glial scars form at the molecules called CSPGs, Harvard co-discovered that peptide derived from PTPσ site of injury to th
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 February 2023 Dosing of All Subjects - COMPLETED SAD - 37 subjects, MAD* - 33 subjects *Subjects dosed subcutaneously once a day for 14 days • NVG-291 was well tolerated at a high dose - 170% higher than the equivalent highest dose in preclinical efficacy
Slide 15: Spinal Cord Injury
Spinal Cord Injury Acute and Chronic patients • No FDA Approved Drug that Improves Function • NervGen’s goal is to improve motor, bladder/bowel/sexual and/or sensory function in High unmet need coupled with potential key clinical outcomes may provide opportunity for expedited regulatory approval • U
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: NVG-291-R Promotes Functional Recovery (BBB Score)
Spinal Cord Injury – NVG-291-R Promotes Functional Recovery BBB Scale = Standard measure of mobility 21 = Normal NVG-291-R function 20 Vehicle Treatment period UNPRECEDENTED **** **** RESULTS ≥14 = fine motor **** NVG-291-R movements 15 500ug BBB Score **** (N=10) Extremely high ≤13 = Occasional coo
Slide 18: 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 19: 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 20: NVG-291 Spinal Cord Injury Clinical Trial
NVG-291 Spinal Cord Injury Clinical Trial Spinal Cord Injury Phase 1b/2a • Single center trial at Shirley Ryan AbilityLab, Chicago US News & World Report #1 Ranked Hospital for ~$10 million estimated cost Physical Medicine & Injury Rehabilitation for 32 Consecutive Years Chronic arm: 20 individuals
Slide 21: Spinal Cord Injury Financial Case
Spinal Cord Injury Financial Case R A R E D I S EA S E P R I C I N G I N A S U B STA N T I A L A D D R ES SA B L E M A R K E T REVENUE PROJECTIONS US MARKET Target pricing per course $200,000 Acute patients annually ~18,000 Acute: US peak annual revenue $500M++ Chronic patients total ~300,000 Chroni
Slide 22: 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 23: 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 24: 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 ~80 patients, ~$20 million estimated cost structural imaging, cognitive assessments and fluid biomarkers
Slide 25: 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 after stroke 25 Luo et al., Cell Reports Volume 40, Issue 4, 111137, July 26, 2022 (https://doi.org/10.1016/j.celrep.2022.111137)
Slide 26: NVG-291-R in Stroke – Breakthrough Results in a New Indication
NVG-291-R in Stroke – Breakthrough Results in a New Indication C E L L R E P O RT S – P E E R - R E V I E W E D P U B L I C AT I O N Pioneering preclinical study in the peer-reviewed “… Small Canadian scientific journal Cell Reports demonstrating Biotech Could Challenge NVG-291-R promotes nervous sy
Slide 27: 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 28: 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 29: 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 29 1Luo, F. et
Slide 30: 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 31: NVG-291 Safety/Efficacy Studies in Multiple Sclerosis Patients
NVG-291 Safety/Efficacy Studies in Multiple Sclerosis Patients • Multicenter, placebo controlled Multiple Sclerosis Phase 2 • 3 months treatment duration • Efficacy analysis includes clinical assessments, ~80 patients, ~$20 million estimated costs advanced structural imaging and fluid biomarkers Wor
Slide 32: Share and Capital Structure
Share and Capital Structure Exchange/Market: Ticker TSX: NGEN.V OTCQX: NGENF Recent Share Price CA $1.96 US $1.50 (February 10, 2023) Shares Outstanding 59.0 million 76.2 million Fully Diluted (~7.3 million options, ~9.9 million warrants) Insider Ownership 24.4% ~Cash & Cash Equivalents CA $27.7 mil
Slide 33: Key Upcoming Value Drivers
Key Upcoming Value Drivers Phase 1b/2a spinal cord injury clinical trial to be initiated Preclinical study results in an Alzheimer's model Awarding of US Department of Defense and privately funded grants New CEO 33
Slide 34: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself www.nervgen.com @NervgenP NervGen Pharma Corp. NervGen
NervGen Pharma — Investor Presentation (February 2023) on 6ix