Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (October 2016)
36 slides from Vistagen Therapeutics's investor presentation, Oct 21, 2016
Slide 1: VistaGen Therapeutics Corporate Presentation
Ke) VistaGene Therapeutics Developing Novel Medicines for CNS Disorders Corporate Presentation Nasdaq VTGN www.vistagen.com
Slide 2: Forward-Looking Statements
VistaGen» Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements concern our product candidates, our development efforts, our collaborations, our intellectual prop
Slide 3: VistaGen Overview
VistaGen Overview * AV-101 (4-Cl-KYN), flagship clinical-stage oral CNS prodrug candidate New generation antidepressant with potential to displace atypical antipsychotics as primary adjunctive treatment for major depressive disorder (MOD); currently in Phase 2 development ~ Results from ongoing NIH-
Slide 4: Major Depressive Disorder: Substantial Market with Growing Unmet Need
Major Depressive Disorder: Substantial Market with Growing Unmet Need 350 Million People Lin 10 in U.S. Over Age 12 Major Global Depression Markets are Worldwide Takes an Antidepressant Medication? Expected to Grow at Staggering Rates! Suffer Feouamgpresion! $128 q 40 14 Ng, $758 $ ft aa i as on USS
Slide 5: Current Depression Medications
Current Depression Medications Standard Antidepressants Adjunctive Treatments (SSRIs and SNRIs) (Atypical Antipsychotics) Zeef Bee Seleoeih Lexcere | W canvas Titel & —> omen (Mb
Slide 6: Atypical Antipsychotics
Atypical Antipsychotics VistaGen»
Slide 7: Problems with Standard Antidepressants
Problems with Standard Antidepressants * Initial treatment effective in only Often do not work 1 of 3 patients * Weeks to months to experience antidepressant benefits Slow to work * Decreased libido, nausea, sleep Side-effects disturbances OI VistaGen,
Slide 8: Problems with Atypical Antipsychotics as Adjunctive Treatment for MDD
Problems with Atypical Antipsychotics as Adjunctive Treatment for MDD Limited efficacy Side-effects Safety concerns OI VistaGen, * Only 10-15% of patients respond * Weight gain and metabolic syndrome * Movement disorders and tardive dyskinesia * Sedation and cognitive impairment * “Black Box” warnin
Slide 9: Where AV-101 Might Fit as an Adjunctive Therapy in the Depression Treatment Algorithm
Where AV-101 Might Fit as an Adjunctive Therapy in the Depression Treatment Algorithm Second Line: SNR AV-101 has Potential to Di Antipsychotics and Not place Atypical ug Interventions
Slide 10: Ketamine Hydrochloride
Ketamine Hydrochloride FDA-approved anesthetic On WHO's Model List of Essential Medicines Administered IV or IM NMDA receptor antagonist (ion channel blocker) Schedule III Controlled Substance: risk of abuse Safety concerns include - anxiety, disorientation, hallucinations, hypertension and psychoti
Slide 11: Ketamine: Potential Treatment for MDD
Ketamine: Potential Treatment for MDD TIME civ oruz’ Ketamine Provides Hope in Fight Against Depression Then Fost Special K, a Hallucinogen, Raises Hopes and G 8 G The New York Eimes Concerns as a Treatment for Depression THE WALL STREET JOURNAL. drugs to Lift Depression in Hours Rather Than Weeks S
Slide 12: NIH Paradigm Shift in Treatment of Depression
= NIH Paradigm Shift in Treatment of Depression National institute Dr. Carlos Zarate Jr. INIHY) of Mental Health * Chief, Section on Neurobiology and Treatment of Mood Disorders at NIMH * Principal Investigator, NIMH paradigm-shifting clinical studies of ketamine in MDD NIH paradigm-shifting clinica
Slide 13: Rapid Antidepressant Effects of Ketamine in Dr. Zarate's NIH Study in MDD
Rapid Antidepressant Effects of Ketamine in Dr. Zarate’s NIH Study in MDD Responder' Rates at 1 Day with Ketamine in Treatment-Resistant MDD "Proportion of patients with treatment resistant MOD with atleast SO%improvementin depression rating [HX Response Ketamine fl % Response Placebo
Slide 14: AV-101: A New Generation Oral Antidepressant
AV-101: A New Generation Oral Antidepressant Ketamine-like Antidepressant Effects without Ketamine’s Serious Side-Effects Ke, rapidly absorbed through the gut, actively transported into the brain, converted into its active metabolite, 7-CI-KYNA, and binds to NMDAR Gly site ‘Similar to ketamine: acts
Slide 15: AV-101 Indirectly Blocks NMDA Receptor Activity Through Glycine Antagonism
bk Py AV-101 Indirectly Blocks NMDA Receptor Activity 4 Through its Mechanism as a Glycine Antagonist NMDA Receptor Pharmacology
Slide 16: AV-101 Advantages Over NR2B Specific NMDA Receptor Antagonists
AV-101 Advantages Over NR2B Specific NMDA Receptor Antagonists 8 AV-101 Gly, NMDA receptor antagonist regulates + + NR2B specific NMDA receptor antagonist regulates - + There are 9 different variants of the NMDAR § Dicheteromeric NMDARs Tei-heteromeric NMDARS 900 oo00 tat ne a + In addition to neuro
Slide 17: AV-101 Has Similar Efficacy to Ketamine in Published Preclinical Studies
AV-101 has Similar Efficacy to Ketamine in Published Preclinical Studies ‘A single dose of AV-101 demonstrated acute (24h) and NBQX (AMPA antagonist) blocks AV-101 effects which supports chronic (7 d) antidepressant effects similar to ketamine AMPA receptor activation as necessary for rapid-onset, N
Slide 18: Compared to Ketamine, AV-101 Does Not Impair Rodent Behavior
Compared to Ketamine, AV-101 Does Not Impair Rodent Behavior in Published Preclinical Studies AVAO1 | Ketamine
Slide 19: NIH Support for AV-101 Development
NIH Support for AV-101 Pepreleheior * Received $8.8 million from NIH for AV-101 preclinical development and two AV-101 Phase 1 clinical safety studies + NIH Cooperative Research and Development Agreement (CRADA) signed in 2015 * NIH funding and conducting AV-101 Phase 2a study in MDD; results curren
Slide 20: NIH-Funded AV-101 Phase 1a and Phase 1b Clinical Safety Studies
NIH-Funded AV-101 Phase 1a and Phase 1b Clinical Safety Studies Randomized, double-blind, placebo-contrlled Single oral dose with sequential dose-escaation Six single dose levels: 30,120, 360,720, 1,080 and 1,440 mg 36 subjects: 18 treatment and 18 placebo; 6 per cohort Results + Welktolerated even
Slide 21: AV-101 Phase 1 Clinical Safety Studies: Reports of Feelings of Well-Being
AV-101 Phase 1 Clinical Safety Studies: Reports of Feelings of Well-Being SS TT oe z doe Steen eee x isi 2 2 epee s 2 2 20 3 ° moos “ 5 ™ 70 3 ° acto % ° ~ i 6 2 ux + Phase 1 safety studies -no direct measures of mood «279s of well-being were voluntarily expressed by certain subjects on AV-101 durin
Slide 22: NIH-Sponsored AV-101 Phase 2a Study in MDD
Ke. VistaGer NIH-Sponsored AV-101 Phase 2a Study in MDD Primary Endpoint: Secondary Endpoints: Safety and efficacy using standard ‘Change from baseline in other widely-accepted. Hamilton Rating Scale (HDRS) ‘measures of mood, depression and cognition Principal Investigator: Dr. Carlos Zarate, NIMH D
Slide 23: VistaGen's AV-101 Phase 2b Study in MDD
. ii VistaGen’s AV-101 Phase 2b Study in MDD 9) Projected to Launch in Q1 2017 * Principal investigator: Dr. Maurizio Fava, Harvard + Projected enrollment: ca. 280 patients at 20 - 25 U.S. sites * Double-blind, placebo-controlled efficacy and safety study of AV-101 as adjunctive treatment for MDD pa
Slide 24: AV-101 Phase 2b Study in MDD: Sequential Parallel Comparison Design (SPCD)
: AV-101 Phase 2b Study in MDD: Ra Sequential Parallel Comparison Design (SPCD) I trial methodology to overcor the challenges of placebo eff in psy tric clinical trials Two doses of AV-101 will be evaluated Cnly the groups within grey highlight are analyzed for efficacy L IL 5 Stage 1 Stage 2 + Comp
Slide 25: Preeminent CNS Clinical and Regulatory Advisors
Preeminent CNS Clinical and Regulatory Advisors HARVARD UNIVERSITY FDA Maurizio Fava, M.D. + Professor of Psychiatry, Harvard Medical School; Director, Division of Clinical Research, Massachusetts General Hospital (MGH) Research Institute; Executive Director, MGH Clinical Trials Network and Institut
Slide 26: Leading CROs Supporting Phase 2b Execution
Leading CROs Supporting Phase 2b Execution }? Leading full-service global CRO, with extensive CNS drug development, clinical trial design and execution, and regulatory services CAT CE siraicro novia esrnce co and ted replay services 6
Slide 27: High Value AV-101 CNS Expansion Opportunities
© High Value AV-101 CNS Expansion Opportunities ¥ ¥ ¥ Neuropsychiatric Disorders Neurological Disorders Neurodegenerative * Depression * Chronic neuropathic pain Diseases * Bipolar disorder + Epilepsy + Huntington's disease * Parkinson's disease OI VistaGen, »
Slide 28: Recent Pharma/Peer M&A Indicates Potential for Significant Upside
Significant Upside Recent Pharma/Peer M&A Indicates Potential for (DP naurex- Rapastinel (GLYX-13) * Developed for treatment of MDD + Similar to AV-101 (blocks NMDAR at Gly, Allergan. + Allergan acquired Naurex in Sept 2015 after ‘one Phase 2b study of rapastinel in MDD (ca. 360 patients) + Allergan
Slide 29: Business Development Strategy
Business Development Strategy “Allergan’s acquisition of Naurex is a key positive for VistaGen as it is Forbes ‘Naurex’s closest competitor...” = Gbola Amusa, Head of Healthcare Research, Chardan Capital Markets, NY + Advance Phase 2 clinical development of AV-101 for adjunctive treatment of MDD and
Slide 30: CNS-Related Value Indicators Suggest Significant Upside Potential
CNS-Related Value Indicators Suggest Significant Upside Potential = a = a ‘company Prawes —-epAllergan esteem) ‘company Tike Development Stge Marat Cn ACADIA ACAD Newly Approved Product 9328 Pharmac (Alkermes: us utile Approved Products sere > i nase I CS Intra-Cellular Therapies rat Phase 3 $625M 1
Slide 31: Capitalization
Capitalization - NASDAQ: VTGN Closed $10 Million Public Offering and Listed on NASDAQ in May 2016 ‘Common Stock 326988 Preferred Stock! Series A 780,000 Series 8 4,160,240 Series € 2318012 ‘Tota Preferred Stock 228,252 ‘Total Common and Preferred 32,497,715 ‘Stock Plan Options 1,100,643, ‘Common Sto
Slide 32: Management Team
Management Team ‘Shawn Singh - Chief Executive Officer *'25 years of experience working with blopharmaceutical companies, a healthcare venture capital firm and a profitable CRO + Artemis Neuroscience; SciClone Pharmaceuticals; cho Therapeutics; Cato BioVentures; Cato Research Ralph Snodgrass, Ph.0.
Slide 33: Board of Directors
Board of Directors Jon $. Saxe - Chairman * 35 years of biopharmaceutical experience, director of multiple public and private healthcare companies + Former President and director, POL BioPharma; CEO, Synergen (acquired by Amgen for $262M); VP, Licensing and Corporate Development, Head of Patent Law,
Slide 34: Using on aso4@ 7,
Using on aso4@ 7, meg 01 yD * are eat * Ae testo er * Sasser * OI VistaGen» tt
Slide 35: VTGN: A Compelling Investment Opportunity
VTGN: A Compelling Investment Opportunity Developing a new generation fast-acting oral antidepressant with strong safety and emerging efficacy profile addressing significant gap in global depression market Large, established global depression market with anticipated exponential growth Pipeline expan
Slide 36: VistaGen Therapeutics
Ke) VistaGene Therapeutics Developing Novel Medicines for CNS Disorders Nasdaq VTGN www.vistagen.com
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