Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Investor Presentation (November 2005)
35 slides from Neuren Pharmaceuticals's investor presentation, November 2005
Slide 1: Neuren Pharmaceuticals Institutional Placement
Neuren Pharmaceuticals Institutional Placement Raising $6.36 million November 2005
Slide 2: Important information
Important information The information contained it his document and otherwise disclosed to you by Patersons Securities Ltd or Neuren Pharmaceuticals Limited prior to a public announcement must be kept strictly confidential for the following reasons: In accordance with Section 1043A of the Corporatio
Slide 3: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 3
Slide 4: Corporate overview
Corporate overview Corporate Snapshot Register Neuren is a drug development company targeting Neuronz Ltd: 12.4% brain repair& rescue, metabolism and cancer NZ Seed Fund Management Ltd: 11.4% Neuren’s lead products protect against brain damage Macquarie Bank Tech Funds: 9.6% Glypromate® has been acc
Slide 5: Investment highlights
Investment highlights Glypromate® accelerated to Phase 3 in CY2006 Stage of Development Poised for Major Milestones – Multi-site international and domestic trials NNZ 2566 is entering Phase 1 in 1H CY2006 & Phase 2 in 2H CY2006 – Conducting in collaboration with the US Department of Defence Ma
Slide 6: Investment highlights
Investment highlights Very few Australian companies are in Phase 3 trials: Typically Uniquely positioned to fund its prohibitively expensive own Phase 3 Study Neuren in close consultation with the US FDA are structuring a very cost effective Phase 3 trial (first pivotal study = A$10m) Plus tim
Slide 7: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 7
Slide 8: Repairing brain damage from aging and injury
Repairing brain damage from aging and injury BRAIN INJURY DISEASE Brain cells die acutely Stroke – No blood supply Traumatic Brain Injury – Trauma (TBI) Brain cells die chronically Alzheimer’s Disease – Disease process Parkinson’s Disease – Aging Memory Loss Nervous tissue in the bra
Slide 9: Lead Products: Glypromate and NNZ-2566
Lead Products: Glypromate® and NNZ-2566 Neural repair agents face several challenges, including: – Blood-brain barrier prevents many molecules reaching the brain – Most brain injuries, such as stroke, are unscheduled – Several mechanisms by which cell death occurs Neuren’s two lead compounds add
Slide 10: Lead Products: Glypromate and NNZ-2566
Lead Products: Glypromate® and NNZ-2566 NNZ-2566 is a modified version of Glypromate® with additional attractive characteristics including: 1. Longer Acting: Better treatment window 2. Oral bioavailability: Critical for chronic indications including Parkinson’s Disease, Alzheimer’s Disease and age
Slide 11: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 11
Slide 12: Glypromate - Neuroprotection in CABG Surgery
Glypromate® - Neuroprotection in CABG Surgery The first indication that Glypromate® is being tested for is neuroprotection in patients undergoing Coronary Artery Bypass (CABG) Surgery – During CABG surgery the heart is stopped and bypassed using a machine – When machine is removed and heart re-sta
Slide 13: Glypromate – Accelerated into Phase 3
Glypromate® – Accelerated into Phase 3 Successfully completed the preclinical program and Phase 1 clinical study – Safe and non-toxic; Well tolerated by humans Currently in Phase-2a – Multi-centre trial for patients undergoing CABG which will complete in early CY2006 Pre-investigational new GL
Slide 14: Glypromate - Cost effective Phase 3 study
Glypromate® - Cost effective Phase 3 study Phase 3 trials are normally prohibitively expensive for Australian companies Neuren’s first pivotal Phase 3 study has been structured in close consultation with the FDA and is extremely cost effective Phase 3 study in CY2006: – 500 patient multi- site t
Slide 15: Glypromate - Development has been significantly de-risked
Glypromate® - Development has been significantly de-risked Why do drugs fail? – Safety Neuren’s development program has – Manufacturing The reasons that 70% demonstrated that these factors are not an of drugs fail issue for Glypromate® – Toxicology Phase 3 study will generate efficacy data from
Slide 16: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 16
Slide 17: Development pipeline
Development pipeline y log cy n o n ca tio ic at io ad ffi u c Tox e 1 e 2 e 3 is Le n al E od al ha s ha s ha s al ry ti o ic Pr ic ci ve ed la l in l P l P l P er o at lin ia Cl ca ca ca m sc li d rm u -C t er e- ni ni ni m Di Va Fo P re M a P r C l i C l i C l i Co • Glypromate® CY2006 • NNZ-2566
Slide 18: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 18
Slide 19: Commercialisation strategy
Commercialisation strategy Option to secure licensing deal for Lead Products (Glypromate® Excellent Commercialisation and NNZ 2566 IV) in 2008 Prospects – Lucrative deal has pivotal Phase 3 efficacy trial will have been completed independently for Glypromate® Opportunity to out-license three pro
Slide 20: Significant market opportunities
Significant market opportunities Several significant applications for both acute (short-term) and chronic (long-term) indications: Acute Indications Chronic Indications Stroke Alzheimer’s Disease Coronary Artery Bypass (CABG) Surgery Parkinson’s Disease Traumatic Brain Injury Multiple
Slide 21: Key commercial milestones
Key commercial milestones Glypromate® NNZ-2566 Other Compounds Completion of Phase Q1 Pre-clinical Phase 1 Q4 NRP in vivo Q3 2a trial report toxicology completed programme CY2006 CY2005 CY2006 completes Pre-Phase 3 CMC,Tox Q1 Third-stage contract Q1 DKP’s – Lead Q2 package Trial with US Dep’t of can
Slide 22: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 22
Slide 23: Quality Board with direct experience in commercialising drugs
Quality Board with direct experience in commercialising drugs Neuren’s Board has Board of Directors extensive experience and Dr Robin Congreve (PHD) Leading NZ international businessman expertise in drug Chairman Partner in Oceania and Eastern Group development, regulatory David Clarke (ME, MBA) S
Slide 24: Highly experienced management and scientists
Highly experienced management and scientists Management and Scientists Prof Peter Gluckman (MB, DSc, FRS) Pediatrician, endocrinologist, Director of Liggins Institute CSO Former Dean, University of Auckland Medical School World authority in neuroscience and endocrinology Dr Mike Bickerdike (Phd ) Fo
Slide 25: Executive staff experience
Executive staff experience Drugs to market in USA: 100+ years experience, 100 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, Fl
Slide 26: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 26
Slide 27: Placement
Placement Neuren Pricing Graph 30 DAY 0.8 VWAP 0.7 5 DAY 0.6 VWAP 0.5 0.4 ISSUE PRICE 0.3 0.2 0.1 0 N 05 5 Ju 05 Ju 5 Ju 5 Au 05 Ap 5 M -05 Fe 05 M 05 M 05 M 05 Ap 5 N 5 Au 05 Au 05 Se 05 Se 05 O 05 O 5 M 05 Ju 5 -0 0 l-0 r-0 -0 -0 -0 -0 - n- n- l- b- b- - - - g- g- p- g- p- ov ov r ar ar ar ay ay c
Slide 28: Use of funds
Use of funds Share Capital Structre Existing shares on issue 100,000,000 89% Placement shares 11,990,000 11% Total shares post capital raising 147,758,765 100% Market capitalisation @0.53 per share $59,254,700 Use of Funds A$000 Glypromate® pre-Phase 3 costs $2,300 Accelerated Chronic (NNZ-2566, NNZ
Slide 29: Indicative timetable
Indicative timetable Trading halt 29-30 November Dispatch of Firm Allocation Offer Letters 1 December Receipt of Firm Allocation Offer Letters 2 December Announce Placement to ASX 2 December Settlement of Placement shares 7 December Placement shares listed on ASX 8 December All queries regarding the
Slide 30: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 30
Slide 31: Investment highlights
Investment highlights Glypromate® accelerated to Phase 3 in CY2006 Stage of Development Poised for Major Milestones – Multi-site international and domestic trials NNZ 2566 is entering Phase 1 in 1H CY2006 – Conducted in collaboration with the US Department of Defence Major milestones that are
Slide 32: Investment highlights
Investment highlights Very few Australian companies are in Phase 3 trials: Typically Uniquely positioned to fund its prohibitively expensive own Phase 3 Study Neuren in close consultation with the US FDA are structuring a very cost effective Phase 3 trial (first pivotal study = A$10m) Plus tim
Slide 33: Agenda
Agenda 1. Company Overview 2. Lead Products - Glypromate® and NNZ 2566 3. Glypromate® Development 4. Development Pipeline 5. Commercialisation Strategy 6. Board and Management 7. Offer Details 8. Conclusion 9. Appendices 33
Slide 34: Pipeline offers excellent potential
Pipeline offers excellent potential Diketopiperazines • Small molecules that are both neuroprotectant and stimulate neurite growth for neurodegenerative diseases (DKPs) • Most advanced compound, NNZ-2591, is currently being tested in animals Growth Hormones • Growth hormone program is focused on fin
Slide 35: Limited competition
Limited competition No drugs currently on the market Acute Competitors are currently conducting clinical trials for CABG, Traumatic Brain Neurodegeneration Injury and Stroke Glypromate® has a superior profile to other products in development Current products offer minimal effectiveness Chron
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