June 2011
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,'' ``believes,'' ``will,'' ``estimates,'' ``forecasts,'' ``projects'' or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward ‐ looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward ‐ looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Anavex Life Sciences Corp. with the Securities and Exchange Commission, which should be considered together with any forward ‐ looking statement. No forward ‐ looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Anavex Life Sciences Corp. undertakes no obligation to update publicly any forward ‐ looking statements, whether as a result of new information, future events or otherwise. Anavex Life Sciences Corp. cannot be sure when or if it will be permitted by regulatory agencies to undertake clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Anavex Life Sciences Corp. will obtain regulatory approval for any ``phase'' of clinical trials. We also cannot be sure of the clinical outcome for efficacy or safety of our compounds. Potential investors should refer to the risk factors in our reports filed on Edgar. 2
Confidential Nature Of Material This presentation contains material information about Anavex Life Sciences Corp. which has not been disseminated to the public. This document and the information contained herein is confidential and should not be communicated to any other person except as permitted in writing by Anavex Life Sciences Corp.. By viewing this presentation, the recipient hereby acknowledges that the recipient is aware that applicable securities laws prohibit any person who has material, non ‐ public information about Anavex Life Sciences Corp. from purchasing or selling securities of Anavex Life Sciences Corp. (or any public company with whom Anavex Life Sciences Corp. has agreed to be acquired) or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities. A person who violates insider trading or tipping rules is subject to severe criminal and civil penalties. 3
Company Overview • Anavex focuses on developing novel treatments for upstream causes of Alzheimer’s disease • Alzheimer’s is a huge and growing market with significant unmet medical needs • Anavex 2 ‐ 73 (lead product) shows behavioral, pharmacologic and histologic evidence with robust neuroprotection • Named “#1 most promising trial drug” by Dementia and Alzheimer’s Weekly • Phase I/IIa data this year • Recent big pharma deals for early Alzheimer drugs have been in the 100’s of millions • Strong IP portfolio with patents going to 2027 • Capital raise secures further evidence to prepare for partnership/acquisition Sources: Cell, Volume 131, Issue 3, 596 ‐ 610, November 2007, Teruo Hayashi and Tsung ‐ Ping Su, Cellular Neurobiology Research Branch, National Institutes of Health; JPsychopharmacology, September 9, 2010, Villard et al, Anti ‐ amnesic and neuroprotective potentials of the mixed muscarinic receptor/sigma1 ligand ANAVEX2 ‐ 73, a novel aminotetrahydrofuran derivative; Dementia and Alzheimer’s Weekly January 2011 4
Key Near ‐ Term Milestones Product Indication Event Timing 2-73 Alzheimer’s Initiate Enrollment for Phase 1 trial 1Q 2011 2-73 Alzheimer’s Complete Enrollment of Phase 1 Trial 1/2Q 2011 2-73 Alzheimer’s Announce Data for Phase 1 Trial 2/3Q 2011 2-73 Alzheimer’s Initiate Enrollment for Phase 2a trial 3/4Q 2011 2-73 Alzheimer’s Complete Enrollment of Phase 2a Trial 4Q 2011 2-73 Alzheimer’s Announce Data for Phase 2a Trial 1/2Q 2012 Alzheimer’s Initiate Phase 2bTrial 3Q 2012 2-73 19-144 Alzheimer’s/Epilepsy Toxicology Study Initiation FY 2012 19-144 Alzheimer’s/Epilepsy IND/CTA Submission FY 2012 1-41 Alzheimer’s/Depression Toxicology Study Initiation 3/4Q 2011 1-41 Alzheimer’s/Depression IND/CTA Submission FY 2012 5
Anavex Team Cameron Durrant, MD, MBA Harvey Lalach Executive Chairman, Acting CEO President, COO, Director • Former big pharma executive (Merck, GSK, • BMO Nesbitt, Burns, TD Bank, Assure Energy, Pharmacia, J&J) Quarry Oil & Gas • CEO specialty pharma and drug delivery/development (PediaMed, Spherics) Angelos Stergiou, MD Sean Lowry Independent Director VP, Clinical and Medical Affairs • Venture capital, portfolio manager, IR (Work • Clinical, Product Development, Pharmacovigilance, Regulatory , CMC (PAION Brain) , Striker AG, Accentia, BioVest,Genesis BioPharma) Alison Ayers, MSc Robert Chisholm Independent Director Director • Emprise Capital Corp, Savary Capital Corp., • Worldwide Commercial Head Oncology (Pfizer) Windamere Ventures Ltd. (formerly • Previously Pharmacia, BMS, Merck, Lederle Advanced Vision Systems Corp.), Brookwater Ventures, Seymour Ventures 6
Scientific Advisory Board Alexandre Vamvakides, PhD Chief Scientific Officer with 30 years in research, focusing on the therapeutic/pharmacological areas of anti ‐ neurodegenerative, anti ‐ epileptic and anti ‐ depressive molecules Tangui Maurice, PhD Institut national de la santé et de la recherche médicale at INSERM, Montpellier, France 15 years in the field of neurosciences, including sigma receptors, normal/pathological aging models for Alzheimer’s, and behavioral and molecular neuropharmacology Rachelle Doody, MD, PhD Professor of Neurology and Director of the Alzheimer's Disease and Memory Disorders Center at Baylor College of Medicine, which has conducted studies on all of the marketed Alzheimer's drugs to date Paul Aisen, MD Professor, Department of Neurosciences, University California San Diego School of Medicine, Director of the Alzheimer’s Disease Cooperative Study, Associate Editor of Alzheimer’s Research and Therapy Jeffrey Cummings, MD Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic and member of the Alzheimer’s Disease Cooperative Study Christopher Shackleton, MD Ttriple specialist credentials in both medical and surgical disciplines, an established record of success in the development and deployment of programs at the forefront of the intersection of laboratory and clinical innovation. 7
Alzheimer’s Market Overview Thousands Millions Diagnosis accelerating Aging strongest predictor • 5 million+ Americans currently diagnosed • 40 million Americans are over the age of 65 • 11 million by 2040 • First ‘Baby Boomers’ turn 65 • 1 million new cases per year by 2050 • 80 million Americans over 65 by 2040 Sources: Alzheimer’s Association, ICAD, UC Davis Alzheimer’s Disease Center, IMS 8
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 create a multibillion dollar product market opportunity • Existing Alzheimer’s disease treatments are not disease modifying, all are off patent or soon will be Donepezil Memantine Rivastigmine Galantamine Source: Alzheimer’s Association, ICAD, UC Davis Alzheimer’s Disease Center, IMS, Orange Book 9
Amyloid Plaque Not Correlated With Cognition Flurizan Monoclonals Semagacestat Vaccines IgIV Posiphen Alzamed 10
Pathophysiology of Alzheimer’s Amyloid may be a consequence rather than causative Amyloid interrupts calcium signaling, causes (or is a consequence of) inflammation and neuronal cell death Amyloid combines with caspase ‐ 3 (and EphB2) to interrupt dendritic function Stressed neurons double genetic material and more prone to apoptosis Endoplasmic reticulum, mitochondrial and oxidative stress correlates with amyloid and vice versa 11
MOA of Sigma Receptor Agonists Sigma ‐ 1 receptors regulate calcium and control gene expression of a protein which preserves cells Agonism of Sigma ‐ 1 receptors (via 2 ‐ 73) leads to: Modulation of calcium flow and ATP formation Enhanced cholinergic function Growth of nerve cells Leads to neuroprotective properties Sigma ‐ 1 Receptor Chaperones at the ER ‐ Mitochondrion Interface Regulate Ca 2+ Signaling and Cell Survival Cell, Volume 131, Issue 3, 596 ‐ 610, 2 November 2007 Hayashi and Su, Cellular Neurobiology Research Branch, National Institutes of Health (NIH) The sigma ‐ 1 receptor chaperone as an inter ‐ organelle signaling modulator Trends in Pharmacological Sciences, 2010 (1 ‐ 10), Su et al 12
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