Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Investor Presentation (October 2005)
33 slides from Neuren Pharmaceuticals's investor presentation, Oct 14, 2005
Slide 1: Neuren Pharmaceuticals Market Update October 2005
steiner, pharmaceutical Neuren Pharmaceuticals Market Update October 2005
Slide 2: Corporate Overview
1 Corporate Overview
Slide 3: Corporate Snapshot
Corporate Snapshot Neuren is a biotech development company targeting neuroprotection, metabolism and cancer Neuren’s lead products protect against brain damage Glypromate® has been accelerated into Phase-3 clinical trials following a productive meeting with FDA ASX code: NEU Share price: $0.75 (as a
Slide 4: Value Proposition: Why Invest in Neuren?
Value Proposition: Why Invest in Neuren? News flow over next 6 — 12 months should lead to a significant re-rating in stock - Glypromate® enters Phase-3 trials in CY2006: Only a very small number of Australian Biotechs are testing Phase-3 products - NNZ-2566 currently being tested by the US in the US
Slide 5: Recent Events
Recent Events: Initiated Phase 2a trial with Glypromate® Accelerated Glypromate® to Phase 3 following productive meeting with FDA: Expected to enter Phase 3 in CY2006 NNZ-2566 (follow up compound to Glypromate®) delivered positive results in testing with WRAIR: Expected to enter Phase 1 in early CY2
Slide 6: Product Development
pharmaceuticals 2 Product Development
Slide 7: Glypromate and NNZ-2566
Glypromate® : NNZ-2566 Naturally occurring compound that protects against neuronal damage Many medical conditions result from damage to nervous tissue in the brain Key Features: Exhibited potent neuroprotective activity; Small enough to cross blood-brain barrier, long therapeutic window (11 hours) A
Slide 8: Diketopiperazines and Growth Hormones
Di etopiperazines | (OKPs) Growth Hormones (GH Liggins institute Small molecules that are both neuroprotectant and stimulate neurite growth for neurodegenerative diseases Most advanced compound, NNZ-2591, is currently being tested in animals Growth hormone program is focused on finding molecules for
Slide 9: CNS Product Portfolio
Glypromate® NNZ-2566 (acute/sub-acute) NNZ-2566 (oral) DKP’s MC’s NRP’s Growth Hormone Portfolio + Collaborations with Pfizer and Metabolic GH Antagonists GH Variants CNS Product Portfolio + 6 Compound Families + Lead compound in Phase II and entering Phase lil in CY2006
Slide 10: Glypromate and Clinical Development
aa pharma 3 Glypromatee and Clinical Development
Slide 11: Glypromate - Lead compound
Glypromate® - Lead compound Molecule derived from the IGF-1 growth factor, but with distinct properties Naturally occurring Exceptional neuroprotection characteristics
Slide 12: Glypromate and the FDA
Glypromate® and the FDA Pre-investigational new drug meeting with the US FDA Poised to commence Phase 3 clinical trial in 2006 (originally planned for 2008) - directly from Phase 2a 400-500 patient multi site trial Approximate cost <AUD$10 million Completion within 18 months Commercial Benefits Sign
Slide 13: Clinical Strategy
Clinical Strategy Elective procedure : 1 Recruitment and Pre-selection Simpie clinical signal Administer drug at time of injury Large potential market with no current “treatment .. Significant market a4 No current treatment — US Army Funding . Multiple variables : 3 Varying degrees of injury Varying
Slide 14: In-vivo efficacy results
In-vivo efficacy results Q3 CY2005 Oral development results Q4 CY2005 Pre-clinical toxicology completed Q4 CY2005 14
Slide 15: Upcoming clinical milestones
Results of Phase Third-stage contract Qi NRP in vivo Q3 |Tral with US Dep't of cy2006 programme CY2006 : Defence completes Commence Phase 3 Commence Phase 1 Qi DKP’s - Lead Q2 Trial Trial cyY2006 candidate selection cy2006 Phase 1 results Q2/3 cY2006 Major value driver — One of only a very small gro
Slide 16: Why Do Drugs Fail?
Wh y Do Why The Drugs Fail? do drugs fail? Safety . Neuren’s Glypromate®and 2566 Manufacturing, The reason that 2/3 of Development Program has Toxicology drugs fail effectively mitigated against these development risks Efficacy Glypromate® Development Program: Look at competitive space and why other
Slide 17: Jain Report Criteria
Jain Report* Criteria Why have other neuroprotection drugs failed? (analogue) aati te eee etait
Slide 18: Commercialisation and Market Metrics
a = pharmaceu! 4 Commercialisation and Market Metrics
Slide 19: Commercialisation Strategy
Commercialisation Strategy 1. Build World-Class Partnerships Early - Joint development (e.g. Pfizer, WRAIR, Metabolic Pharmaceuticals) - External verification (FDA IND) 2. Move Quickly into Clinical Trials - Acute CNS (CABG, TBI...) followed by chronic CNS diseases 3. Maintain Multiple Products and
Slide 20: Market Size by Indication
_Cases per Year (USA) Market Size oo _ Effective Treatment Bypass Surgery 400,000 $2.0b Traumatic Brain Injury 1,000,000 $1.0b N Stroke 800,000 $3.5b N Parkinson’s Disease 3,000,000 $2.0b Y/N Alzheimer’s Disease 4,500,000 $2.5b Y/N Multiple Sclerosis 800,000 $2.5b Y/N 20
Slide 21: Chronic Neuroprotection and Neuroregeneration
| Chronic Neuroprotection —_ | and Neuroregeneration No drug currently on the market Trials ongoing for CABG (Medicure, Alexion, NIH) Trials ongoing for stroke, TBI Neuren’s products have superior profile Limited effectiveness of current offerings Neuren’s NP’s animal model results Oral NNZ-2566 in
Slide 22: Board and Senior Management
a = pharmaceu! 5 Board and Senior Management
Slide 23: Neuren's Board
Neuren’s Board has extensive experience and expertise in drug development, regulatory approval and commercialisation Two of Neuren’s Board have major multinational pharmaceutical experience with direct expertise in successfully taking drugs to global markets Leading NZ internationai businessman Part
Slide 24: Management and scientific team
Pediatrician, endocrinologist, Director of Liggins Institute Former Dean, University of Auckland Medical School World authority in neuroscience and endocrinology Formerly private UK biotech Clinical and Collaboration/JV experience (Roche) 25+ years experience in biomedical research and product devel
Slide 25: Conclusion
6 Conclusion
Slide 26: Investment Highlights
~ (meuren = pharmac investment Highlights e Stage of Development: Glypromate® enter Phase 3 in CY2006 - FDA verification...Safety and need — Further CY2006 milestones focused on increasing investor value Breadth and quality of portfolio - World class partners: Pfizer, US Department of Defence, Metab
Slide 27: David Clarke
David Clarke Neuren Pharmaceuticals 1800 259 181 [email protected]
Slide 28: Appendices
pharmaceutical Appendices
Slide 29: Neuren's Core CNS Biology
Neuren’s Core CNS Biology Inflammation Cause of Cell Death Opportunity for Rescue Therapy Cell Damage Event 4 Hour 24 Hours 5 Days 29
Slide 30: Promoting neurite and axonal growth
thalarriy * Promote neurite and axonal growth visual cortex ® < \N dorsa Kwon \ habenul * Promote neural stem cell proliferation, migration and differentiation * Optimal Attributes for a Neural Recovery Drug 30
Slide 31: GH Implication in Breast Cancer
GH ~ Implication in Breast Cancer Without Growth Hormone * Cells that do not express GH remain non aggressive and non invasive * Cells made to express GH become aggressive, proliferative and invasive 31
Slide 32: Collaborations with WRAIR and Metabolic
_ meuren) Collaborations with WRAIR and Metabolic US Army Stage 2 ; WRAIR Metabolic Deal + TBI Stage 1 results confirmed » Faster Development + US Army confirmed 2nd Stage + Move to Pre-Clinical — Share Costs — MBP 2:1 « Less Costs - Save 50% * Government Grant A$585,000 + “Goal... advanced drug for
Slide 33: Executive Staff Experience
Executive Staff Experience Drugs to market in USA: 100+ years experience, Multiple IND’s Atrovent for common cold, Atrovent nasal for allergic rhinitis, Combivent for COPD, Asasantin for TIAs, pameprexole for Parkinson’s, Meloxicam as a NSAID for osteoarthritis, Spiriva for COPD, Nevirapine for HIV,
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