Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Investor Presentation (July 2011)
23 slides from Neuren Pharmaceuticals's investor presentation, Jul 27, 2011
Slide 1: Neuren Pharmaceuticals July 2011
For personal use only Neuren Pharmaceuticals July 2011
Slide 2: Forward Looking Statement
Forward Looking Statement For personal use only This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Neuren can give no assurance that these expec
Slide 3: Neuren Pharmaceuticals
Neuren Pharmaceuticals For personal use only • Focused on acute and chronic indications in neurology and psychiatry • Targeting very large markets with unmet need and little or no competition • Two molecules in Phase II clinical trials under US INDs • Trial costs covered by grants from US Army and N
Slide 4: Product Pipeline
Product Pipeline For personal use only Discovery Validated Lead Formulation Phase I Phase III Pre-Clinical Manufacturing Pre-Clinical Phase II Commercialization Efficacy Toxicology Motiva® (nefiracetam) Apathy and Depression (Post-Stroke, Parkinson’s, Brain Injury) NNZ-2566 (IV) Traumatic Brain Inju
Slide 5: NNZ-2566: Innovation in the Treatment of Brain Injury and Neurodegeneration
For personal use only NNZ-2566 Innovation in the Treatment of Brain Injury and Neurodegeneration NNZ-2566, a glypromate analog, attenuates brain ischemia-induced nonconvulsive seizures in rats (Xi-Chun M Lu, Yuanzheng Si, Anthony J Williams, Jed A Hartings, Divina Gryder, Frank C Tortella (Journal o
Slide 6: NNZ-2566: Applicability across multiple indications
NNZ-2566: Applicability across multiple indications Intravenous administration For personal use only TBI (moderate to severe)* Stroke Cardiac arrest Perinatal asphyxia Penetrating brain injury Non-convulsive seizures in other CNS injuries/conditions Oral administration Mild TBI* Rett Syndrome/other
Slide 7: Annual TBI incidence and patient disposition (US)
Annual TBI incidence and patient disposition (US) Oral therapy For personal use only Oral therapy? Intravenous therapy 7
Slide 8: Dose-dependent prevention of seizures
Dose-dependent prevention of seizures For personal use only Excitoxicity Inflammation Neuronal Death • NMDA • Pro-inflammatory • Necrosis activation cytokine elevation • Apoptosis • Ca influx • Free radical production 0 hr 6 hr 24 hr 72 hr NNZ-2566 # of NCS/rat/hour Time post pMCAo (hours)
Slide 9: NNZ-2566 TBI: Therapeutic and Regulatory Strategy
NNZ-2566 TBI: Therapeutic and Regulatory Strategy For personal use only Therapeutic strategy—enhancing the brain’s response to injury • Synthetic analogue of naturally occurring peptide • Inhibits inflammatory cascade following brain injury • Prevents secondary brain injury—damage to cells adjacent
Slide 10: Why drugs fail
Why drugs fail For personal use only H. Kubinyi. Drug Research: Myths, Hype and Reality, Nature Reviews Drug Discovery (2003). 10
Slide 11: NNZ-2566: TBI profile significantly de-risked
NNZ-2566: TBI profile significantly de-risked Pharmacokinetics, animal toxicity, adverse effects in patients, For personal use only commercial and miscellaneous issues account for 60% of drug failure. Miscellaneous (5%) Pharmacokinetics (39%) • Manufacturing—fully validated; suitable for Phase III;
Slide 12: NNZ-2566: TBI commercialization strategy
NNZ-2566: TBI commercialization strategy Market potential For personal use only • 1.5 million brain injuries per year in the US alone • No approved therapies • Assuming $12,000 for IV and $3,000 for oral as price point, total potential market value is: • Moderate – severe = ~$2 billion • Mild = ~$2
Slide 13: Motiva (nefiracetam): A Novel Compound with Broad Neurobehavioral Potential
For personal use only Motiva®(nefiracetam) A Novel Compound with Broad Neurobehavioral Potential Double-Blind Treatment of Apathy in Patients with Poststroke Depression Using Nefiracetam (Robert G. Robinson, M.D., Ricardo E. Jorge, M.D., Kathleen Clarence-Smith, M.D., Ph.D., Sergio Starkstein, M.D.)
Slide 14: Apathy Syndrome: Apathy is not depression
Apathy Syndrome: Apathy is not depression For personal use only Apathy involves loss of interest and emotion and is often characterized by a flattening affect. Though distinct, apathy is often present across many disorders Post Stroke 35% Alzheimer’s Depression 20% 55% APATHY Schizophrenia Parkinson
Slide 15: Efficacy data in stroke patients—7 clinical trials
Efficacy data in stroke patients—7 clinical trials For personal use only 3 Phase IIa open-label • 165 patients; dosing up to 16 weeks studies (Japan) • Endpoint: Global Improvement Rating (GIR) • GIR results: Min = 12.5%; Max = 58.8% (450 mg/day x 16 weeks) 1 Phase IIb randomised, • 321 patients; 3
Slide 16: Market potential for apathy in selected indications
Market potential for apathy in selected indications For personal use only Stroke: $1,248,000,0001 Traumatic brain injury: $840,000,000 Parkinson’s disease: $1,056,000,000 Peak annual sales forecast2 (10% market penetration): ~$280 million 1 Assumes reimbursement at $2,400 per year 2 For stroke, trau
Slide 17: Perseis Therapeutics Ltd.
For personal use only Perseis Therapeutics Ltd. Targeting Trefoil Factors to Treat Breast and Other Cancers
Slide 18: Perseis Therapeutics: Profile
Perseis Therapeutics: Profile Developing antibodies for the treatment of breast and other cancers For personal use only • Founded in 2009 by Neuren Pharmaceuticals and the NZ Breast Cancer Research Trust • Targeting Trefoil Factors, which play a significant role in the growth and spread of solid tum
Slide 19: Corporate Highlights
For personal use only Corporate Highlights
Slide 20: Key milestones through 2012
Key milestones through 2012 For personal use only Milestone Forecast Exception from Informed Consent approved by FDA Q3 2011 Results of in vivo assessment of cancer antibodies (Perseis) Q4 2011 File IND for oral NNZ-2566 in mild TBI Q1 2012 Complete Phase I trial of oral NNZ-2566 Q1 2012 Initiate Ph
Slide 21: Financial Snapshot
Financial Snapshot For personal use only ASX ticker: NEU Outstanding Shares: 911 million Market Cap: $14.6 million Current Share Price: $0.016 Cash: ~A$7 million (after rights issue allotment) Employees: 9 21
Slide 22: Investment Summary
Investment Summary For personal use only Well positioned in the field of neurological injury and disease Growing pipeline with two dynamic clinical programs • Two drugs in Phase II clinical trials for CNS indications • Oral form of NNZ-2566 approaching clinical trials • Leveraging NNZ-2566 to pursue
Slide 23: Contact
Contact For personal use only Larry Glass, CEO +1 (301) 941 1830 lglass@neurenpharma.com New Zealand Level 2, 57 Wellington Street Freemans Bay 1011, Auckland New Zealand +64 (9) 3700 200 1 800 259 181 (Australia Freephone) USA 3 Bethesda Metro Center, Suite 700 Bethesda, Maryland 20814 USA 23
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