Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (June 2020)
36 slides from Vistagen Therapeutics's investor presentation, Jun 1, 2020
Slide 1: VistaGen Therapeutics Summer 2020
Ke) VistaGene Therapeutics st Nasdaq: VTGN Summer 2020
Slide 2: Forward-looking Statements
Oy VistaGene« Forward-looking Statements manent € z z : 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, development efforts, collaborations, intellectu
Slide 3: COVID-19 Pandemic is Causing a Mental Health Pandemic
(oy COVID-19 Pandemic is Causing a Mental Health Pandemic tsmi~ www.vistagen.com | The Washington Post “A third of Americans now show signs of clinical anxiety or depression, Census Bureau finds amid coronavirus pandemic” —TIME- TIME ANXIETY “Anti-anxiety medication prescriptions up 34 percent since
Slide 4: Social Media is Damaging Mental Health
www.vistagen.com Social Media is Damaging Mental Health “How ‘Keeping Up With The Joneses’ On Social Media is Damaging Everyone’s Mental Health” Forbes “Why Instagram is the Worst Ke) VistaGens Therapeutics “Association between Social Media for Mental Health” Social Media Use and O “Lots of Time on
Slide 5: "Benzo Epidemic" is Upon Us
£ H Ke) i a, : e “Benzo Epidemic” is Upon Us : | The “B Epidemic” is Upon U ™ “Benzodiazepines: Primary Care’s New Drug Problem” Psychiatry Advisor E: . = “It's not just opioids: What doctors a1 2 By want you to know about benzos” Mheatth “Use of Opioids, Benzodiazepines at Same Time is Skyrocketing
Slide 6: VistaGen is committed to developing and commercializing new generation medicine
VistaGen is committed to developing and commercializing new generation medicine for large and growing anxiety, depression and neurology markets worldwide where current treatments are inadequate to meet the needs of millions of patients. www.vistagen.com st Nasdaq: VTGN LOOKING BEYOND CURRENT TREATME
Slide 7: Our CNS Pipeline
Product Candidate Our CNS Pipeline Social Anxiety Disorder’ Generalized Anxiety Disorder* Peripartum Anxiety* Perioperative Anxiety* isorder* pTsp* Major Depressive Disorder” Postpartum Depression* ‘Treatment-resistant Depression* Suicidal Ideation* Phase 2 Phase 3 1. Successfull Phase 2 program com
Slide 8: PH94B: Novel, fast-acting, non-systemic therapy
Novel, fast-acting, non-systemic therapy for: * Social Anxiety Disorder » Adjustment Disorder with Anxiety * Postpartum Anxiety * PTSD * Generalized Anxiety Disorder - Preoperative/Pre-testing Anxiety * Panic Disorder HO VistaGene Therapeutics
Slide 9: Social Anxiety Disorder (SAD) in the U.S.
www.vistagen.com 24 National institutes of Health = fo) Social Anxiety Disorder (SAD) in the U.S. Ke) VistaGens ‘Therapeutics More than Just Shyness of the most prevalent me realth conditions in the y. a Affects as many as 20 million’ Americans Anxiety and fear in everyday social and performance sit
Slide 10: Current SAD Drug Treatments Fall Short
& ¢ \( } Current SAD Drug Treatments Fall Short Ie S Therapeutics i ED \ Not FDA-Approved * i a * APPROVED Prescribed Off-label Antidepressants Benzodiazepines & Beta Blockers * Slow onset, chronic administration x Addiction risk x May worsen anxiety initially x Significant potential side effects x
Slide 11: PH94B: First-in-class for SAD
Ke) VistaGenoe Therapeutics First-in-class Successful Phase 2 completed; preparing for Phase 3 Fast acting (15 minutes), exceptional safety Non-systemic (microgram dosing) Non-sedating and non-addictive FDA Fast Track designation; first ever granted by FDA Potential to be the first FDA-approved, fas
Slide 12: PH94B's Mechanism of Action
www.vistagen.com PH94B’s Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain that suppress fear and anxiety = Nasal chemosensory receptors activate olfactory bulb (OB) neurons in nasal passages that project to the limbic amygdala = Modulates activi
Slide 13: Published PH94B Phase 2 Study — Social Interaction
Published PH94B Phase 2 Study — Social Interaction (n = 91) Key. Visit 3 (Treatment Phase) 60 55 50 Subjective Units of Distress Score 45 (SuDS) 40 PHO4B 35 30 i 2 i} oa Anticipatior Performance ‘Anxiety i Chall Challenge D t-=>| Challenge 8 eens J 15-min "| instructions Patient is told that will jo
Slide 14: Published PH94B Phase 2 Study — Public Speaking
Published PH94B Phase 2 Study — Public Speaking (n = 91) Visit 3 (Treatment Phase) 70 Placebo Subjective Units of Distress Score 60 Ke) VistaGens Therapeutics PH94B Rapidly Reduced Anxiety in Response to Public Speaking Challenge (SUDS) so Active Group: Placebo Group: Mean Difference = 26.7 Mean Dif
Slide 15: PH94B Initial Phase 3 Study for Social Anxiety Disorder
Ke) VistaGens ‘Therapeutics www.vistagen.com PH94B Initial Phase 3 Study for Social Anxiety Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Randomized, double-blind, placebo-controlled, parallel design monotherapy study ° 3.2 ug of PH94B or placebo for 4 weeks
Slide 16: PH94B Commercial Opportunity — U.S. SAD Market
www.vistagen.com ~~ SUBSTANTIAL UNMET NEED There are few novel medications in development. PH94B promotion, SAD disease education and DTC efforts will drive physician urgency to diagnose and treat. UNIQUE MOA While some clinicians are skeptical, most are cautiously optimistic that PH94B is not habit
Slide 17: Adjustment Disorder with Anxiety Related to COVID-19
Ke) www.vistagen.com VistaGens Adjustment Disorder with Anxiety Related to COVID-19 Therapeutics Adjustment Disorder Adjustment Disorder and COVID-19 * An emotional or behavioral reaction * COVID-19 pandemic has created fear, anxiety considered excessive or out of proportion to a and uncertainty abo
Slide 18: PH94B Phase 2 Program for Adjustment Disorder
www.vistagen.com Ke) VistaGens ‘Therapeutics PH94B Phase 2 Program for Adjustment Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Treatment of Adjustment Disorder with Anxiety related to the COVID-19 Pandemic PARTA * Pilot, open-label Phase 2A single site stud
Slide 19: PH94B: Additional Indications Beyond SAD & Adjustment Disorder
Slide 20: Novel, safe, fast-acting therapy for depression
Ke) VistaGene Therapeutics Novel, safe, fast-acting therapy for: Major Depressive Disorder Postpartum Depression \ Treatment-Resistant Depression Suicidal Ideation
Slide 21: Major Depressive Disorder in the U.S.
www.vistagen.com Ke) VistaGens Major Depressive Disorder in the U.S. Trespeunes 1in 4 women 1in6men 1in8 ee = RAG So He a diagnosed with depressive disorders age 12 and over takes an antidepressant’ LARGE ADDRESSABLE MARKET WITH HIGH UNMET NEED? 11.6M Drug-treated patients with Major Depressive Diso
Slide 22: FDA-Approved Oral MDD Treatments Fall Short
Ke) VistaGens ‘Therapeutics www.vistagen.com FDA-Approved Oral MDD Treatments Fall Short Oral Antidepressants Oral Atypical Antipsychotics * Often do not work; slow to work * Often do not work — Initial ADT effective in 1 of 3 patients — Only ca. 20% of patients respond to — May take 4 to 6 weeks or
Slide 23: PH10: First-in-class for MDD
Ke) VistaGene Therapeutics First-in-class Successful Phase 2A completed Rapid-onset antidepressant effects Microgram dosing, non-systemic Well-tolerated, minimal side effects Preparing for U.S. Phase 2B in 2021 Potential stand-alone and adjunctive at-home therapy with fast-acting, esketamine-like an
Slide 24: PH10 Mechanism of Action
i } 3 i PH10 Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain leading to antidepressant effects Nasal chemosensory receptors activate olfactory bulb (OB) neurons in the nasal passages that project to the limbic amygdala OB neurons stimulate neur
Slide 25: PH10 Published Phase 2A MDD Monotherapy Study
www.vistagen.com PH10 Published Phase 2A MDD Monotherapy Study (n = 30) Hamilton Depression (HAM D) Score Reduction From Baseline -10.0 712.5 -15.0 Reduction in HAM D from Baseline -17.5 (n=30) Txwki TxwWk2 Txwk3 Txwk4 TxwWkS Txwk6 Txwk7 Txwks 3.2 1g (lV Dose) 01 74, 6.4 11g ( Dose) 22 .95, Placebo
Slide 26: PH10 U.S. Phase 2B Development Plan for MDD
Ke) VistaGens ‘Therapeutics PH10 U.S. Phase 2B Development Plan for MDD www.vistagen.com Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Randomized, double-blind, placebo-controlled, multi-center monotherapy study * MDD patients with zero or 1 prior failure on a standa
Slide 27: PH10: Additional Indications Beyond MDD
Ke) PH10: Additional Indications Beyond MDD MistaGens Therapeutics Potential Next Steps: Phase 2A studies PH10 Treatment- Resistant Depression Postpartum Depression 27
Slide 28: Novel oral NMDA receptor GlyB antagonist
Ke) VistaGene Novel oral NMDA receptor GlyB antagonist for: Therapeutics » Major Depressive Disorder 6 Nit » Suicidal Ideation ri et » Neuropathic Pain -. » Epilepsy cl NH, » Levodopa-Induced Dyskinesia associated with Parkinson’s Therapy LOOKING
Slide 29: AV-101 overview
A\/J 14 f\4 AV - | a V = vw, VV a. a a WY ot = Oral prodrug of 7-CIl-KYNA » Selective NMDA receptor glycine site antagonist =» Well-tolerated in all clinical studies to date = No dissociative side effects or treatment-related SAEs » Non-addictive, non-sedating « FDA Fast Track designations in MDD an
Slide 30: AV-101's Mechanism of Action
AV-101’s Mechanism of Action Therapeutics 4-CI-KYN (prodrug) — 7-CI-KYNA (active metabolite) i } VistaGens i AV-101 NMDA Receptor Pharmacology Kt fo) Oral Prodrug (4-Cl-KYN) L4-chlorokynurenine (4-CHKYN) (oral delivery to CNS) Activated * Atos OH AV-101 Active Metabolite (7-Cl-KYNA) Classic channel-
Slide 31: AV-101 and Probenecid Synergy
é §| AV-101 and Probenecid Synergy Recent preclinical studies demonstrate substantial increases in rodent Ke), VistaGens ‘Therapeutics brain concentrations of both AV-101 (4-CI-KYN) and 7-CI-KYNA Probenecid increases AV-101 (4-CI-KYN) brain levels by ~ 7 fold 4-Cl-Kynurenine © Vehicle + vehicle 4 Ve
Slide 32: AV-101 with Probenecid for Multiple CNS Indications
Ke) AV-101 with Probenecid for Multiple CNS Indications MistaGens www.vistagen.com Major Depressive Disorder Potential Next Steps: Neuropathic Pain Phase 1B/2A POC studies with adjunctive probenecid Levodopa- Induced Dyskinesia associated with Parkinson's Therapy 32
Slide 33: Distinguished Clinical and Regulatory Advisors
www.vistagen.com HARVARD UNIVERSITY Couvmmia Univenstry DEPARTMENT OF PsyCHtATRY 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
Slide 34: Experienced Team
www.vistagen.com Ke) Experienced Team VistaGens Leading Execution Shawn K. Singh Chief Executive Officer + 25 years of experience with biopharmaceutical companies, a healthcare venture capital firm and a profitable CRO * Artemis Neuroscience; SciClone Pharmaceuticals; Cato BioVentures; Cato Research
Slide 35: Differentiated, Clinical-Stage CNS Drug Candidates
Ke) VistaGens Therapeutics www.vistagen.com 3 Differentiated, Clinical-Stage CNS Drug Candidates > Rapid-onset potential > Multiple large global markets
Slide 36: Looking Beyond Current Treatments for Anxiety, Depression and Other CNS Diseases
Ke) VistaGene Therapeutics LOOKING BEYOND,CURRENE TREATMENTS FOR ANXIETY, DEPRESSION. AND OTHER CNS DISEASES AND DISORDERS WITH HIGH UNMET NEED www.vistagen.com g® Nasdaq:vten
VistaGen Therapeutics — Investor Presentation (June 2020) on 6ix