Anavex Life Sciences Corp. · NASDAQ:AVXL
Anavex Life Sciences — BIO CEO Conference 2012
25 slides from Anavex Life Sciences's conference presentation, Feb 14, 2012
Slide 1: BIO CEO Conference
AVXL: OTCBB BIO CEO Conference February 14, 2012
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements made within the meaning of the Private Securities Litigation Reform Act of 1995 by Anavex Life Sciences Corp. and its representatives. These statements can be identified by introductory words such as ``expects,'' ``plans,'' ``intends,
Slide 3: Company Overview
Company Overview • Leader in targeting a key protein for the treatment of CNS diseases - Sigma-1 receptor plays a central role in Alzheimer’s Disease (AD), depression, seizures • Clinical-stage product candidate improves all aspects of AD in mouse models • Pipeline of compounds for depression and ep
Slide 4: Rich Calendar of Value Driving Milestones
Rich Calendar of Value Driving Milestones 4
Slide 5: Clinical Advisory Board
Clinical Advisory Board Jeffrey Cummings, MD Professor of Neurotherapeutics and Drug Development in the Neurological Institute Cleveland Clinic Member of the Alzheimer’s Disease Cooperative Study Paul Aisen, MD Professor, Department of Neurosciences, University California San Diego School of Medicin
Slide 6: Alzheimer's Market Overview
Alzheimer’s Market Overview Thousands Millions Aging strongest predictor Diagnosis accelerating •40 million Americans are over the age of 65 •5 million+ Americans currently diagnosed •First ‘Baby Boomers’ turn 65 •11 million by 2040 •80 million Americans over 65 by 2040 •1 million new cases per year
Slide 7: Huge Market Potential
Huge Market Potential • $183 billion spent caring for those suffering from Alzheimer’s disease, plus $202 billion in unpaid care • Market leading drug (Aricept) annual sales of $4 billion • Total drug sales were $8 billion – none of these drugs are disease- modifying • More effective treatments will
Slide 8: Pathophysiology of Alzheimer's
Pathophysiology of Alzheimer’s Amyloid plaque may be a consequence rather than causative Tau protein appears to be very important Insults to the neurons interrupt calcium signaling Sigma-1 receptors regulate calcium signaling between cellular organelles Organelle stress and oxidative stres
Slide 9: Anatomy of a Neuron
Anatomy of a Neuron From The Neuron by Dr. George Boeree 9
Slide 10: Mitochondria and Calcium Flux are Critical to Neuron Viability
Mitochondria and Calcium Flux are Critical to Neuron Viability Ca2+ Mitochondria control cell viability via calcium flux 10
Slide 11: Mitochondria and Calcium Flux are Critical to Neuron Viability
Mitochondria and Calcium Flux are Critical to Neuron Viability Impaired calcium Ca2+ flux causes neuron death Neuron death 11
Slide 12: Mitochondria and Calcium Flux are Critical to Neuron Viability
Mitochondria and Calcium Flux are Critical to Neuron Viability Sigma-1 receptor Sigma-1 receptors Ca2+ facilitate healthy calcium flux Viable neuron 12
Slide 13: Mitochondria and Calcium Flux are Critical to Neuron Viability
Mitochondria and Calcium Flux are Critical to Neuron Viability Insults: aging, plaque, etc AD results from injury to neurons by plaque and other Ca2+ factors. Neuron death results from reduced sigma-1 receptors and calcium flux Neuron death 13
Slide 14: Mitochondria and Calcium Flux are Critical to Neuron Viability
Mitochondria and Calcium Flux are Critical to Neuron Viability ANAVEX 2-73 ANAVEX 2-73 increases the activity Ca2+ of sigma-1 receptors leading to viable neurons Viable Neuron 14
Slide 15: Sigma Receptors: Proven Role in CNS Disease
Sigma Receptors: Proven Role in CNS Disease Sigma-1 knockout mice show memory and depression defects Female sigma-1 knockout show most severe alterations, AD significantly higher in females 15
Slide 16: Anavex 2-73: A Sigma-1 Agonist
Anavex 2-73: A Sigma-1 Agonist Selective ligand for σ-1 receptors with a nanomolar affinity (pKi=6.3) and no affinity for Me σ-2 receptors N Due to sigma-1 selectivity, there are no interactions with σ-2 agonistic action and Me therefore no related adverse effects seen to date Anti-amnesic act
Slide 17: 2-73 Protects From Induced Learning Deficits
2-73 Protects From Induced Learning Deficits Alzheimer’s Association International Conference, July 16-21, 2011, Paris, France 17
Slide 18: Clinical Development: Phase 1 Single Dose
Clinical Development: Phase 1 Single Dose Single ascending dose study in healthy human volunteers Objectives: Define maximum tolerated dose, assess pharmacokinetcs (PK), clinical and lab safety Results: Dosing from 1-60 mg Maximum tolerated dose 55 mg; above converted dose effective in ani
Slide 19: Near-term Clinical Development Plan
Near-term Clinical Development Plan Clinical Study Objective • Phase 1b Multiple Dose Determine a tolerated repeat dose and extend safety exposure; determine extended exposure pharmacokinetics • Phase 1b Assess efficacy in healthy volunteers with induced memory loss • Phase 2 First AD patient exposu
Slide 20: Anavex 2-73: An Ideal Molecule for Partners
Anavex 2-73: An Ideal Molecule for Partners • Defined molecular target • Small molecule ligand directed to target • Nanomolar binding affinity • Oral, once daily dosing projected • Behavioral, pharmacologic and histologic evidence for activity in AD animal models • Clinical data shows clean safety p
Slide 21: Alzheimer's Disease Select Deals
Alzheimer’s Disease Select Deals Upfront and total deal value Company (where known) Partner Phase Year $MM 1. EPIX 35 / 120 GSK Discovery 2006 2. Idera 30 / 366 Merck Phase I 2006 3. AC Immune 300 Genentech Preclinical 2006 4. Co-mentis 100 / 760 Astellas Phase I and 2008 Discovery 5. Myriad 100 / 2
Slide 22: Rich Calendar of Value Driving Milestones
Rich Calendar of Value Driving Milestones 22
Slide 23: Financial Summary
Financial Summary • Paid in capital $28,869,393 • Fiscal year-end Sept. 30 Most recent quarter Dec. 2011 Cash $9,079 Assets $82,593 Total liabilities $2,565,889 Net Loss $2,174,656 Net cash from financing activities $962,500 23
Slide 24: Capital Raise
Capital Raise $6-8 million provides Anavex 1 year of cash to achieve critical milestones Complete Phase 1 multiple dose study, initiate partnership discussions Complete human AD model clinical trial Complete large animal chronic tox study Complete transgenic mouse model Partnership with
Slide 25: Company Summary
Company Summary • Focusing on novel target for CNS diseases; sigma-1 receptor • Alzheimer’s is a huge and growing market with significant unmet needs • ANAVEX 2-73 shows behavioral, pharmacologic and histologic evidence for activity in AD models • ANAVEX 2-73 named “#1 most promising trial drug” by