Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (March 2015)
18 slides from Vistagen Therapeutics's investor presentation, Mar 16, 2015
Slide 1: VistaGen
VistaGen™ OTCQB: VSTA
Slide 2: Forward-looking Statements
rward-looking Statements ‘This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future re
Slide 3: Company Overview
Company Overview + Clinical-stage biopharmaceutical company based in South San Francisco + Products - AV-101 (L-4-chlorokynurenine) New generation, orally-active Central Nervous System drug candidate + Phase 2a depression study in 2015 sponsored by National Institutes of Health Potential to transfor
Slide 4: Recent Developments
Recent Developments + NIH Phase 2a Cooperative Research and Development Agreement - NIH to conduct and fully-fund Phase 2a efficacy and safety study of AV- 101 in Major Depressive Disorder (~ $10mm) - NIH previously awarded ~$9mm for AV-101 preclinical and Phase 1 development + Appointment of key op
Slide 5: AV-101 Pipeline
AY-101 Pipeline Major Depressive Disorder Parkinson’s Disease Neuropathic pain Epilepsy VistaGen
Slide 6: Founders and Management
Founders and Management Cato Bio Ventures, Cato Research; SciClone; Echo; Artemis Progenitor; Lineberger Comprehensive Cancer Center; Basel Institute for Immunology Director, McEwen Centre for Co-founder, Head, Stem Cell Research Regenerative Medicine, University (pt), Chair, SAB Health Network Ret.
Slide 7: Depression: Global Problem & Multi-Billion Dollar Market
Depression: Global Problem & Multi-Billion Dollar Market + 350 million worldwide suffer from depression (WHO) + 1-in-10 in US. aged 12+ takes antidepressant medication (CDC) + Medical need has remained high over the past several decades, but total market value has declined due to generic pricing + A
Slide 8: Up to weeks before patients experience significant therapeutic benefit
Up to 10 weeks before patients experience significant therapeutic benefit Only ~33% of depression sufferers benefit from initial treatment Likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt Effects of multiple treatments increase risk of serious
Slide 9: NIH Ketamine Study Revolutionizes Depression Treatment Paradigm
NIH Ketamine Study Revolutionizes Depression Treatment Paradigm * In 2006, NIH single-dose ketamine studies demonstrated robust, rapid-onset antidepressant effects in patients with treatment-resistant Major Depressive Disorder Ketamine is an NMDA antagonist used widely as an anesthetic in surgical s
Slide 10: VistaGen's Solution: AV-101
VistaGen’s Solution: AV-101 NMDA receptor glycine-binding site antagonist Fundamentally novel mechanism of action versus-all current FDA-approved antidepressants Modulates (down-regulates) NMDA receptor channel activity Similar, and potentially superior, to Naurex’s GLYX-13 (.v.) and NRX-1074 Orally
Slide 11: AV-101 vs. Ketamine Preclinical Studies
AV-101 vs. Ketamine Preclinical Studies oe Preebnicelimostlsiet VistaGen’s AV-101 Ketamine Forced-swim equivalent Tail-suspension ania Learned-helplessness equivalent Novelty- suppressed feeding, oc Negative effects in preclinical models __-VistaGen’s AV-101 Ketamine ‘Hyper movement = v ‘movement se
Slide 12: AV-101 is positioned to become a transformative advancement in the treatment of depression
AV-101 is positioned to become a transformative advancement in the treatment of depression Negative Clinical Atteibutes Requires IV delivery a a Narrow therapeutic range not anticipated a Hallucinogenic o a Schizophrenia-like effects a Positive Clinical Attributes Ketamine Positive effects on mood a
Slide 13: AV-101 Phase 1a Safety Study
AV-101 Phase 1a Safety Study Results and Observations NIH-funded Single-site (University of California, San Diego), randomized, double-blind, placebo controlled Single oral dose (capsule) with sequential dose-escalation Six single dose levels: 30, 120, 360, 720, 1,080, and 1,440 mg 36 subjects: 18 t
Slide 14: AV-101 Phase 1b Safety Study
AYV-101 Phase 1b Safety Stu Results and Observations NIH-funded Single-site (University of California, San Diego), randomized, double-blind, placebo controlled Daily oral dose for 14 days, with sequential dose-escalation Three dose levels: 360, 1,080 and 1,440 mg 48 subjects: 36 treatment and 12 pla
Slide 15: AV-101 Phase 2a Study
AV-101 Phase 2a Study Major Depressive Disorder NIH-sponsored, beginning in 2Q concluding in Q4 2015 Principal Investigator - Carlos Zarate, MD, Chief of Experimental Therapeutics and Pathophysiology at the NIH’s National Institute of Mental Health - Principal investigator on NTH studies of ketamine
Slide 16: AV-101: Broad Opportunity to Expand into Range of Neurological Indications
AY-101; Broad Opportunity to Expand into Range of Neurological Indications * Parkinson’s disease - Monkey studies support potential to reduce L-DOPA dosing, thereby reducing dyskinesias associated with L-DOPA therapy ° Epilepsy - Reduced frequency of seizures and neuronal damage in well-established
Slide 17: Drug Rescue Opportunities
Drug Rescue Opportunities * One-third of new drug candidates fail due to unexpected heart or liver toxicity * CardioSafe 3D™ and LiverSafe 3D™ - Customized human cell-based bioassay systems to predict potential heart and liver toxicity of new chemical entities (NCEs) and optimized drug rescue candid
Slide 18: VistaGen Summary
VistaGen Summary + AYV-101 has the potential to be a transformative advancement in the treatment of depression + Secured NIH sponsorship funding and management for AV-101 Phase 2a clinical efficacy study to be conducted by a leading investigator at the NIH’s National Institute of Mental Health + Wor
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