Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2007)
20 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 22, 2007
Slide 1: Neuren Pharmaceuticals CEO Presentation AGM May 2007
-(meuren. pharmac Neuren Pharmaceuticals CEO Presentation AGM May 2007
Slide 2: Summary - progress
Summary - progress Major progress has been made... « Phase 3 Glypromate® US FDA trial underway « Major focus for the Company over the last year « FDA validation... highest hurdle « Very cost effective trial « First to market « Phase 1a NNZ-2566 complete « Safe and well tolerated « Phase 1b NNZ-2566
Slide 3: More...
More... = Cancer technology significantly progressed ~ Significant interest =" Partnering programme developed - Under Due Diligence - Multiple CDA and MTA agreements signed = Strong Trial infrastructure built - COO appointed... Dr Parmjot Bains - Other CD Staff appointed... 36 years experience in US
Slide 4: Our strategy
Our strategy » The Glypromate® Phase 3 trial is on target to complete in 18 months - Examining other potential applications - Created significant US interest =» The NNZ-2566 TBI trials (2) planned to commence near term - Efficiency signals in next 18 months - US army support and Fast track/Orphan St
Slide 5: Development pipeline
Development pipeline Glypromate® - MCI Glypromate® - TBC i 032007 NNZ-2566 (IV) — TBI mild-mod NNZ-2566 (IV)~TBi severe CNS Product ~~" Jd sHev2008 Portfolio _ y MCs Cancer - BC Growth Hormone Portfolio
Slide 6: Multiple out-licensing opportunities
Multiple out-licensing opportunities « NEU has an extensive pipeline as a result of its “Right to Own” agreement with the University of Auckland « NEU has focused on developing four + product lines such that they are attractive out-licensing or further investment opportunities NNZ-2566 / : _ Cancer:
Slide 7: Glypromate®
(meuren Glypromate® Safe, non-toxic and in Phase 3
Slide 8: Glypromate® Phase 3 - Why is this important?
Glypromate® Phase 3 - Why is this important? =» Excellent drug design... pharmacology, safety profile, long therapeutic time window - Typical of naturally occurring compounds; evolution as an effective drug discovery strategy - Multiple modes of action = multiple opportunities for effect - Single ac
Slide 9: Glypromate® Phase 3 - Why this trial?
Glypromate® Phase 3 - Why this trial? = Adequately powered to detect an effect - Many trials have been underpowered (e.g., Pharmos dexanabinol) - FDA have agreed to ADAPTIVE DESIGN... at 300 patients it will be opened and patient numbers increased to ensure adequate trial power if needed = Resources
Slide 10: Commercial strength
Commercial strength We believe this combination of - Drug properties and - Trial design has a better combination than all others we know in this space and is very well matched to the endpoint... And we have FDA validation... — everyone has to go to the FDA eventually!!! Affordable trial, A$10 millio
Slide 11: Phase 3 Executive Committee
Phase 3 Executive Committee Comprising a number of global leading clinicians and researchers in neurology, cardiology, cardiothoracic surgery and anaesthesiology. The members of the Executive Committee are: « Professor Harvey White (Auckland Hospital, Professor of Cardiology, Chair), « Professor Ala
Slide 12: NNZ-2566
NNZ-2566 About to enter Phase 2 for TBI
Slide 13: NNZ-2566 TBI Program
NNZ-2566 TBI Program = Completed - Complex pharmacology - multiple modes of action in multiple pathways ~ Obtained Consistent effects in multiple models - stroke, closed-head injury, penetrating head injury - Drug CMC logistics completed = Flexible clinical trial strategy -— Separate moderate from s
Slide 14: NNZ-2591
NNZ-2591 Oral treatment for Chronic CNS
Slide 15: NNZ-2591 — Oral treatment for multiple diseases
NNZ-2591 — Oral treatment for multiple diseases " Meets all requirements for a CNS drug candidate - 100% oral bioavailability ~- Safe, non-toxic, crosses into brain, therapeutic window ~- Stable, low cost of goods " Key Results ~- Parkinson's disease: long-term disease modifying effects as well as s
Slide 16: NNZ-8000
NNZ-8000 A treatment for solid tumours
Slide 17: Cancer programme
Cancer programme " _Neuren has developed unique IP in a set key molecules involved in many cancers «The presence of these factors , called TFF’s , lead to tumor growth and spread « We have strong laboratory evidence reinforced by strong clinical evidence « — In vitro and in vivo proof of principle e
Slide 18: Tumor volume in xenograft model of human breast cancer
Tumor volume in xenograft model of human breast cancer (polyclonal antibody; MCF-7 cell line) 1350 Tumour volume mm3
Slide 19: Our strategy
Our strategy Hasn’t changed.... ~ Well developed clinical trial programme and out-licensing strategy ~ Agreat deal of effort over the last year in preparing for Phase 3 US FDA trial A leader in the area of reducing acute brain damage ~ Large markets, high unmet need and limited competition ~ Well-de
Slide 20: Thank you for your continued support...
Thank you for your continued support...
Neuren Pharmaceuticals — Shareholder Meeting (May 2007) on 6ix