Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2009)
20 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 28, 2009
Slide 1: Neuren Pharmaceuticals AGM 28 May 2009
For personal use only Neuren Pharmaceuticals AGM 28 May 2009 0
Slide 2: Agenda
Agenda For personal use only 1. Chairman’s introduction 2. Key achievements in 2008/2009 3. Perseis Therapeutics 4. Glypromate® trial results 5. NNZ-2566 6. Corporate strategy 1
Slide 3: Key achievements in 2008/09
Key achievements in 2008/09 For personal use only • Early completion of Glypromate® trial – Glypromate® trial was completed with 325 patients in December 2009 – Glypromate® had no observable effect in patients undergoing cardiopulmonary bypass surgery and development has been discontinued • NNZ-2566
Slide 4: Perseis Therapeutics: Toward A Cure For Breast Cancer
ft Ne Perseis Therapeutics Toward A Cure For Breast Cancer
Slide 5: Company Shareholders and Management
Company Shareholders and Management For personal use only • 2 Founding Shareholders – Neuren Pharmaceuticals contribution of the TFF 1, TFF 3 and Growth Hormone IP – BCRT providing NZD$1.18M year 1 seed funding • CEO Dr Parmjot Bains
Slide 6: Therapeutic Targets
Therapeutic Targets For personal use only • Antibody Therapeutics – Trefoil Factors (TFF 1 and 3) and Growth Hormone are critical regulators of cell functions leading to breast cancer progression – Clinically validated targets, expression correlated with disease/outcome – Polyclonal antibody proof o
Slide 7: Trefoil Factors 1,3
Trefoil Factors 1,3 For personal use only • Members of the trefoil factor family • Produced as estrogen regulated local growth factors • Local increased expression in mammary, prostate, gastric, liver and pancreatic carcinoma • Independent predictive/prognostic factors in carcinoma
Slide 8: Antibody neutralisation of TFF-3 reduces xenograft tumour volume
Antibody neutralisation of TFF-3 reduces xenograft tumour volume For personal use only 150 130 TUMOR VOLUME (mm3) 110 90 70 50 30 10 -10 0 15 20 25 30 35 Mab TFF3 or mouse IgG DAYS
Slide 9: Anti-hGH IgY decreases cell viability of cancer cells
Presence of anti-hGH IgY (polyclonal antibody) in media significantly decrease cell viability of cancer cells For personal use only 140 anti-hGH antibody Control 120 PBS 100 Cell viability (%) 80 * 60 40 * 20 * 0 Affinity purified Dialyzed Dialyzed antisera anti-hGH IgY anti-hGH IgY (Rabbit) p-value
Slide 10: Development Objectives
Development Objectives For personal use only Milestone • Monoclonal antibody in-vivo Seed Funding (Yr 1) proof of concept at the end of year 1 in the three targets Outlicensing/ co-development/ • Phase I/II Human Clinical external Signal capital
Slide 11: Market Potential
Market Potential For personal use only • Promising candidates for molecularly targeted cancer therapeutics – Oncology third largest pharmaceutical market expected to grow to $60bn in 2010 – Molecularly targeted drugs (mAbs) are a validated approach (e.g Biogen-Idec/Roche's MabThera, OSI/Genentech/ R
Slide 12: Early Stage Deal Potential
Early Stage Deal Potential For personal use only Early Stage Deal Potential USD Source: Recap; Genentec; http://www.bioportfolio.com/news/DailyUpdates_74.htm
Slide 13: Glypromate trial results
Glypromate® trial results For personal use only • Trial was completed early and on budget in December 2008 with 325 patients recruited • Only a small proportion of patients (approximately 20%) showed cognitive decline at 12 weeks compared to before surgery and virtually all decline observed was mini
Slide 14: NNZ-2566
NNZ-2566 • NNZ-2566 Phase II trial in Moderate-Severe TBI For personal use only – Phase II trial (260 moderate to severe TBI patients) to be initiated Q3 2009 – Interim analysis after 100 patients completed expected Q2 2010 – Top-line results expected by Q2 2011 – With strong positive results, singl
Slide 15: NNZ-2566 TBI protocol overview
NNZ-2566 TBI protocol overview For personal use only • 260 acute TBI patients (Glasgow Coma Scale 4-12) • Stratified 2:1 moderate (GCS 9-12) to severe (GCS 4-8) • Randomized 2:1 drug to placebo • Administration of drug within 8 hours of injury • 3 cohorts - 20 mg/kg bolus followed by 1, 3 or 6 mg/kg
Slide 16: Opportunity in TBI
Opportunity in TBI For personal use only • 1.5 million head injuries per year in the US • 850,000 mild-moderate, 155,000 severe • $50b in direct and indirect costs • No approved therapy • Few drugs in development, none for mild-moderate 15
Slide 17: Corporate Strategy
Corporate Strategy For personal use only • Focus on NNZ-2566 program, leveraging US Army funding to accelerate development • Aggressively seek project-specific funding (e.g. Perseis, US Army) to enhance shareholder value • Progress other programs only with access to non-dilutive grants and partnersh
Slide 18: Update on Army Funding
Update on Army Funding • Neuren was invited to submit a proposal to the US Army Medical Research & For personal use only Materiel Command (USAMRMC) including: – Phase II trial in patients with moderate to severe traumatic brain injury (TBI) – Proof of concept study in patients with mild TBI – Additi
Slide 19: Anticipated Milestones: 2009 - 2011
Anticipated Milestones: 2009 - 2011 For personal use only • NNZ-2566 – Initiation of Phase II trial Q3 2009 – Interim analysis after 100 patients completed expected Q2 2010 – Top-line results expected by Q2 2011 • Perseis – Proof of principle for monoclonal antibodies by mid 2010 – Licensing/develop
Slide 20: Neuren Contact Information
Neuren Contact Information For personal use only Larry Glass, CEO Dr Parmjot Bains, CEO Tel: +1 (301) 941 1830 Tel: +61 (2) 9880 8630 Fax: +1 (301) 920 1915 Fax: +64 (9) 361 7981 Neuren Pharmaceuticals Inc and Perseis Therapeutics Limited Hamilton Pharmaceuticals Inc USA 3 Bethesda Metro Center, Sui
Neuren Pharmaceuticals — Shareholder Meeting (May 2009) on 6ix