Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (July 2020)
35 slides from Vistagen Therapeutics's investor presentation, Jul 24, 2020
Slide 1: VistaGen Therapeutics Summer 2020
Ke) VistaGene Therapeutics ste Nasdaq: VTGN Summer 2020
Slide 2: Forward-looking Statements
oy VistaGene Forward-looking Statements ments € 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, intellectual
Slide 3: A Growing Mental Health Pandemic
wvistagen.com ~~ D) A Growing Mental Health Pandemic VistaGens 3 \ “In a Pandemic-Stressed ! America, Protests Add to The Washington Post —TIME~ Mental Strain” THE AGE OF “A third of Americans now ANXIETY ‘or Soe em Par A Ae show signs of clinical anxiety or depression, Census Bureau finds amid coro
Slide 4: A Growing Benzo Epidemic is Upon Us
12. ; A Growing “Benzo Epidemic” is Upon Us ; mens Psychiatry Advisor “Anti-anxiety medication Tl ME “Benzodiazepines: Primary Care’s prescriptions up 34 percent New Drug Problem” since coronavirus” “It's not just opioids: What doctors want you to know about benzos” EM health ¢ “Use of Opioids, Benz
Slide 5: VistaGen is committed to developing new generation medicine
VistaGen is committed to developing and commercializing new generation medicine for large global anxiety, depression and neurology markets where current treatments are inadequate to meet the needs of millions of patients. www.vistagen.com y® Nasdaq: VTGN LOOKING BEYOND CURRENT TREATMENTS FOR CNS DIS
Slide 6: Our CNS Pipeline
Our CNS Pipeline Product Candidate Phase 2 Phase 3 Social Anxiety Disorder" Generalized Anxiety Disorder® Adjustment Disorder with Anxiety* Postpartum Anxiety® Perioperative Anxiety® Panic Disorder® PTsp® Major Depressive Disorder® Postpartum Depression® ‘Treatment-resistant Depression® Suicidal Ide
Slide 7: PH94B indications
VistaGene Therapeutics * Social Anxiety Disorder + Adjustment Disorder > Postpartum Anxiety » PTSD * Generalized Anxiety Disorder HO » Preoperative/Pre-testing Anxiety » Panic Disorder
Slide 8: Social Anxiety Disorder (SAD) in the U.S.
www.vistagen.com 4 National institutes of Health Social Anxiety Disorder (SAD) in the U.S. Ke) VistaGens ‘Therapeutics More than Just Shyness of the most prevalen t me, O*F ealth conditions in the y, “tay Affects as many as 20 million’ Americans Anxiety and fear in everyday social and performance si
Slide 9: Current SAD Drug Treatments Fall Short
& : \( H Current SAD Drug Treatments Fall Short Ke) S ‘Therapeutics i ED As Not FDA-Approved * i 3. * APPROVED Prescribed Off-label Antidepressants Benzodiazepines & Beta Blockers * Slow onset, chronic administration x Addiction risk x May worsen anxiety initially x Significant potential side effect
Slide 10: PH94B: odorless synthetic neurosteroid nasal spray
Ke) VistaGene Therapeutics Odorless, synthetic neurosteroid nasal spray Successful Phase 2 completed Recent FDA consensus on unique Phase 3 program Rapid-onset (ca. 10-15 minutes), exceptional safety Non-systemic, non-sedating and non-addictive FDA Fast Track designation; first ever granted for SAD
Slide 11: PH94B Mechanism of Action
wvistagen.com PH94B Mechanism of Action = Microgram level dose (3.2 mcg) engages specific nasal chemosensory neurons (NCNs) = NCNs activate olfactory bulb neurons (OBNs) on the base of the brain = OBNs send neural connections to neurons in the central limbic amygdala, the brain center where fear and
Slide 12: Published PH94B Phase 2 Study — Public Speaking (n = 91)
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 13: PH94B Phase 3 Study: Acute Treatment of Anxiety in SAD
(©) PH94B Phase 3 Study: Acute Treatment of Anxiety in Ie Adult Patients with Social Anxiety Disorder om www.vistagen.com Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Recent FDA agreement on study design will substantially reduce cost (50%+), time and variability *
Slide 14: 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. ~$2.17B - $3.1B* potential commercial opportunity for PH94B in U.S. SAD market ie} oo UNIQUE MOA Most
Slide 15: EverInsight/CBC Group Collaboration June 2020
Everlnsight/CBC Group Collaboration June 2020 Phase 3 Development and Commercialization of PH94B in Key Asian Markets www.vistagen.com * Obligations: = Everlnsight (funded by CBC Group) will be responsible for clinical development, regulatory submissions and commercialization of PH94B in the Territo
Slide 16: Adjustment Disorder Related to COVID-19
Ke) www.vistagen.com VistaGens Adjustment Disorder 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 about health, ec
Slide 17: PH94B Phase 2A/3 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 related to the COVID-19 Pandemic PARTA * Pilot, open-label Phase 2A single site study in NYC * 3.
Slide 18: PH94B: Additional Indications Beyond SAD & Adjustment Disorder
Slide 19: PH10 indications
Ke) VistaGene Therapeutics Novel, safe, fast-acting therapy for: Major Depressive Disorder Postpartum Depression \ Treatment-Resistant Depression Suicidal Ideation
Slide 20: 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 oe 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 21: 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 22: PH10 odorless synthetic neurosteroid nasal spray
Ke) VistaGene Odorless synthetic neurosteroid nasal spray Therapeutics Successful Phase 2A completed Potential rapid-onset antidepressant effects Microgram-level dosing, non-systemic Well-tolerated, minimal side effects Preparing for Phase 2B Potential stand-alone and adjunctive depression therapy w
Slide 23: PH10 Mechanism of Action
www.vistagen.com PH10 Mechanism of Action = Microgram level dose (6.4 mcg) engages specific nasal chemosensory neurons (NCNs) = NCNs activate olfactory bulb neurons (OBNs) on the base of the brain = OBNs send neural connections to neurons in the central limbic amygdala, the brain center where mood i
Slide 24: PH10 Published Phase 2A MDD Monotherapy Study (n = 30)
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 25: 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 26: 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 26
Slide 27: AV-101 indications
Ke) VistaGeno » Major Depressive Disorder Therapeutics * Suicidal Ideation » Neuropathic Pain » Levodopa-Induced Dyskinesia associated with Parkinson’s Therapy fe} NH * Epilepsy pH LOOKING H UNMET NEED
Slide 28: AV-101
m™ AV-101 Ke) VistaGene Therapeutics » Oral NMDA receptor glycine site antagonist = Prodrug of 7-CI-KYNA « 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 and pain « Go forward
Slide 29: 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 * Astyoetes OH AV-101 Active Metabolite (7-Cl-KYNA) Classic cha
Slide 30: 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 31: 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 study with adjunctive probenecid Levodopa- Induced Dyskinesia associated with Parkinson's Therapy 31
Slide 32: 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 33: 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 34: 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 35: Looking Beyond Current Treatments
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
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