Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2008)
18 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 29, 2008
Slide 1: Annual Shareholders' Meeting 29 May 2008
For personal use only Neuren Pharmaceuticals (ASX: NEU) Dr Parmjot Bains and Dr Robin Congreve Presentation Annual Shareholders’ Meeting 29 May 2008 0
Slide 2: Neuren: emerging global leader in CNS disorders and brain injury
Neuren For personal use only An emerging global leader in the treatment for central nervous system disorders and brain injury 1
Slide 3: Agenda
Agenda For personal use only • Neuren Today • Year in Review • Opportunity Update • The Year Ahead 2
Slide 4: Neuren Today
Neuren Today For personal use only • Focus on three very promising late stage clinical candidates • Grant funded development of preclinical candidates with the view to partnering • Management focus on creating shareholder wealth through the fast and efficient progress of our clinical trial programs
Slide 5: The Year in Review
The Year in Review Achieved: For personal use only Capital Raising and Business Development • Raised AU$7.1M in January 2008 • Secured US$4M US Department of Defense funding for NNZ-2566 Phase II • Acquisition of Hamilton and MotivaTM • Leading US life science investors join share register Team Chan
Slide 6: The Year in Review, continued
The Year in Review, continued For personal use only Trial Progress • Glypromate® trial under US IND enrolment on target with 272 patients and positive DSMC safety review • NNZ-2566 successful Pre-IND meeting with an IND filing pending in Q3 2008 • NNZ-2566 Phase II sites and world-class investigator
Slide 7: Product Development Status
Product Development Status Current stage of program For personal use only Lead Programs – central nervous system and brain injury Preclinical Phase I Phase II Phase III Glypromate® – Cognitive impairment post cardiac bypass surgery Pivotal results expects Q2 2009 PIIIb in 2010 MotivaTM – Post Stroke
Slide 8: Motiva
MotivaTM For personal use only • Dysmotivational syndrome common to many acute and chronic CNS disorders – Results from damage or neurodegeneration, particularly in the frontal lobe – A primary obstacle to rehabilitation and improved functional performance • Large and unmet need – Recognized need bu
Slide 9: NNZ-2566
NNZ-2566 For personal use only • Traumatic brain injury (TBI) is a major problem • 1.5 million head injuries per year in the US • 850,000 mild-moderate, 155,000 severe • US$50 billion in direct and indirect costs to healthcare system • No approved therapy and few drugs in development 8
Slide 10: Pre-IND Meeting: May 2008
Pre-IND Meeting: 21 May 2008 For personal use only • Met with Russell Katz, MD (Director) and medical, pharmacology/toxicology, Chemistry reviewers from Neurology Products Division • Chemistry Manufacturing and Controls (CMC) – no concerns expressed • Regulatory – Fast Track status likely to be gran
Slide 11: World-Class NNZ-2566 Advisory Team
World-Class NNZ-2566 Advisory Team For personal use only • Ross Bullock, MD, PhD • Frank Tortella, PhD – Professor and Director of Neuroscience Intensive – Chief, Dept of Applied Neurobiology, Walter Care, Division of Neurosurgery, University of Reed Army Institute of Research; leading Miami; leadin
Slide 12: Glypromate
Glypromate® For personal use only • CABG and CPB result in over 350,000 patients with persistent cognitive impairment – Equivalent to the difference in function between a 40-year old and a 60-year old – >50% impaired at discharge, >20% at 6 months, >40% at 5 years(1) – Primary factor diminishing qua
Slide 13: The Market Opportunity
The Market Opportunity For personal use only • Three compounds with few or no competitors • Indications with a large, unmet need (Coronary Artery Bypass Grafts, Traumatic Brain Injury, Apathy) • Cumulative conservative $US3bn estimated market • Compounds in late stage clinical development – Proven h
Slide 14: The Year Ahead
The Year Ahead For personal use only • Resolve long-term capital needs to the benefit of all shareholders • Promising lead compounds Glypromate® , MotivaTM and NNZ-2566 on track for major valuation milestones • Confirmed efficacy of Glypromate® in Phase III / major efficacy trial • Confirmed efficac
Slide 15: Future Milestones
Future Milestones For personal use only • Glypromate® Timing Status – 100 patients data safety review Q2 2008 3 – 300 patient data safety and sample size review Q4 2008 on track – Completed recruitment Q4 2008 on track – Announce results Q2 2009 on track • MotivaTM – Form committee around clinical s
Slide 16: Financial Snapshot
Financial Snapshot For personal use only ASX code: NEU Shares on issue: 219.96 million Market Cap: ~ $24M Cash on hand: A$4.2M (31 March) Number of employees: 16 Top 20 shareholders: > 67 % of shares 15
Slide 17: Summary
Summary For personal use only • An emerging global leader in treatments for central nervous system disorders and brain injury • Three very promising late stage clinical candidates moving closer to registration • Confident we have a very promising year ahead of us 16
Slide 18: Contact Us
Contact Us For personal use only Neuren Pharmaceuticals Inc and Neuren Pharmaceuticals Limited Hamilton Pharmaceuticals Inc USA Level 1, 103 Carlton Gore Road 3 Bethesda Metro Center, Suite 700 Newmarket, Auckland Bethesda, Maryland 20814 USA New Zealand PO Box 9923 Newmarket, Auckland Larry Glass,
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