Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (June 2022)
40 slides from Vistagen Therapeutics's investor presentation, Jun 9, 2022
Slide 1: A Visionary Approach to Mental Health Care
Ke, VistaGen. Therapeutics A Visionary Approach to Mental Health Care Corporate Presentation June 2022 wwwvistagen.com
Slide 2: Forward-Looking Statements
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 involve known and unknown risks that are difficult to predict and include all matters that are not historica
Slide 3: Our Vision: Radically Improve Mental Health Care - One Mind at a Time
Our Vision: Radically Improve Mental Health Care - One Mind at a Time™ o Differentiated clinical-stage Targeting large anxiety, depression Numerous potential catalysts CNS drug candidates and neurology markets in 2022 and beyond & New MOAs bringing value to patients, Strong balance sheet and institu
Slide 4: Our Pipeline
Our Pipeline PALISADE-1 PALISADE-2 PALISADE Phase 3 Program Social Anxiety Disorder =I PH94B Nasal Spray” Exploratory Phase 2A Program Major Depressive Disorder Potential CNS Indications HM ongoing =). Planned “The commencement fal potential studies is subject to US. FDA regulatory authorization FP
Slide 5: PH94B vs. PH10 — Similar but Different
PH94B vs. PH10 — Similar but Different PH94B and PH10 are chemically distinct but physiologically similar. Both bind to nasal chemosensory receptors, but each activates different nasal chemosensory neurons and interneurons resulting in different pharmacological effects. Primary target Nasal Chemosen
Slide 6: PH94B for Social Anxiety Disorder
PH94B for Social Anxiety Disorder wwwvistagen.com
Slide 7: Social Anxiety Disorder is a debilitating mental health condition
Social Anxiety Disorder is a debilitating mental health condition SAD is more than just shyness. It is a serious and disabling disorder characterized by ... Debilitating emotional and physical symptoms In everyday social or performance situations oe Emotional symptoms: i Surges of intense and overwh
Slide 8: Social Anxiety Disorder impacts multiple facets of patient lives
Social Anxiety Disorder impacts multiple facets of patient lives Leading to occupational, social and academic impairment eS) Leading a limited, isolated & aa “== discouraging life “Making a phone call would send me into A ; ~— a hot sweat.” oe i.) Missing out on moments with 00 i -_ family & friends
Slide 9: Social Anxiety Disorder affects ~10% of the US population
Social Anxiety Disorder affects ~10% of the US population, with only ~20% of patients helped by current pharmacotherapy 25M Overall SAD Prevalence Patients Treated SAD Patients SSouroes: Kantar Health. Nav 2021, National Heath and Wellness Survey (NHWS), 2021. [US]. Malvern, PA. tune! vi A Future Pa
Slide 10: It has been ~2 decades since a new therapy was approved for SAD
It has been ~2 decades since a new/novel therapy was approved for treatment of Social Anxiety Disorder ‘a US Adult SAD Prevalence (in Millions)‘ ) SAD is a highly prevalent condition which continues to affect increasing numbers of people in the US each year e SAD disease burden continues to C4 grow
Slide 11: Current Standard of Care for Social Anxiety Disorder is Inadequate
Current Standard of Care for Social Anxiety Disorder is Inadequate TREATMENTS For SociaAL ANXIETY ORDER No Long-Term Norcagaitl | \gnitivel Drug Fast Acting No Systemic Side Effects Non-Sedating Fis No Withdrawal No Abuse Absorption (Sexual dysfunction Impairment Syndrome Potential etc.) FDA Approve
Slide 12: Physician satisfaction with current therapies is modest
Physician satisfaction with current therapies is modest, leaving significant opportunity for new, differentiated therapies Satisfaction with current treatments for ACUTE episodes of SAD from a large online survey Primary Care (n=126) SSRIS / SNRIS SSRIS / SNRIS BETA BLOCKERS BETA BLOCKERS BENZOS BEN
Slide 13: SAD patients desire new treatment options to fill unmet needs
SAD patients desire new treatment options to fill unmet needs The Ideal SAD Medication is Safe & Works Quickly — patient survey Fast onset for acute situations Efficacy against Ability to take symptoms of with other drugs SAD Safe with few side effects Ke. n Propristary Market Research October 2021
Slide 14: PH94B has potential to be 1st FDA-approved fast-acting acute treatment of SAD
PH94B has potential to be 1st FDA-approved fast-acting, acute treatment of SAD &) Odorless & Tasteless -¥. Differentiated MoA Specific for SAD Used on as-needed basis Designed to be fast-acting (within 15 mins) Designed to be non-systemic, non-sedating Designed to be non-addictive Well-tolerated in
Slide 15: PH94B is rated highly by physicians
PH94B is rated highly by physicians and recognized as a potentially valuable and differentiated approach to treating acute episodes of SAD Physician assessment of a blinded PH94B product profile from a large online survey of 251 respondents FULFILLS UNMET NEED OVERALL RATING IS UNIQUE IS AN ADDED BE
Slide 16: Physicians indicate very high intent to prescribe PH94B for SAD
Physicians indicate very high intent to prescribe PH94B for SAD After reviewing a blinded PH94B product profile... 90% of Psychiatrists indicated they 79% of Primary Care Physicians indicated would likely prescribe PH94B they would likely prescribe PH94B (N=125) (N=126) LIKELY TO PRESCRIBE LIKELY TO
Slide 17: Physicians believe PH94B would be appropriate for the majority of SAD patients
Physicians believe that PH94B would be appropriate for the majority of their SAD patients After reviewing a blinded PH94B product profile... Psychiatrists believe 56% of their patients Primary Care Physicians believe 51% of could use PH94B their patients could use PH94B (N=125) (N=126) % OF YOUR SAD
Slide 18: PH94B: Novel MOA via olfactory-amygdala circuit
PH94B Novel MOA via olfactory-amygdala circuit vocus COERULEUS ©0080 86 Microgram-level intranasal dose of PH94B (3.2 mcg) is administered PH94B engages peripheral receptors in nasal chemosensory neurons (NCNs) Once stimulated with PH94B, NCNs then trigger subsets of interneurons in the olfactory bu
Slide 19: PH94B Positive Phase 1 Data
PH94B Positive Phase 1 Data Sympatholytic effects observed in healthy volunteers after PH94B administration Design: Three similarly designed Phase 1 studies in healthy volunteers Physiologic biomarkers showed aioe Target Enrollment: N = 64, 32 male & 32 female transiently reduced autonomic nervous s
Slide 20: PH94B Highly Significant Phase 2B Data in SAD
PH94B Highly Significant Phase 2 Data in Social Anxiety Disorder * Phase 2B randomized, double-blind, placebo- controlled multi-center study (n=91) * Study uniquely designed to assess the efficacy of a fast-acting drug for social anxiety disorder in an acute anxiety setting + Stressors included both
Slide 21: SUDS is the ideal scale to measure acute anxiety
Subjective Units of Distress Scale (SUDS) is the ideal scale to measure acute anxiety in the moment of a stressful event The SUDS scale measures the patient’s self-reported intensity of query and/or distress at a point in ime + Patients are asked to rate their current level of anxiety/distress on a
Slide 22: PH94B Phase 2B Public Speaking Challenge
PH94B Phase 2 SAD Study — Public Speaking Challenge (n = 91) Minute-by-Minute SUDS Scores Visit 2 (Baseline/Placebo) 20 1 Placebo group @ PHO4B group 70 80 All patients: received placebo at visit 2 to establish baseline SUDS scores ‘Subjective Units of Distress Score 50 40 Rt 1 240 1 2 3 4 Anticipat
Slide 23: PH94B Phase 2B Social Interaction Challenge
PH94B Phase 2 SAD Study — Social Interaction Challenge (n = 91) Minute-by-Minute SUDS Scores Visit 2 (Baseline/Placebo) Visit 3 (Treatment Phase) 60 2) @ Placebo group. to a Social Interaction Challenge @ PH94B group @ Active Group Ill Placebo Group 2 5 » 3 3 8 ° | 3 Mean Difference 183 66 B so a 8
Slide 24: PALISADE-1 and PALISADE-2 Phase 3 SAD Studies
PH94B PALISADE-1 and PALISADE-2 Phase 3 SAD Studies Acute Treatment of Anxiety for Adults with Social Anxiety Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University QW pai Evaluate ae ata: paar of oe ka If successful, the acute treatment of anxiety in adults with social anxiety
Slide 25: PH94B - Potential Opportunities Beyond Social Anxiety Disorder
PH94B - Potential Opportunities Beyond Social Anxiety Disorder Adjustment Disorder Post Traumatic Stress Disorder 0) ‘o) Post-partum Anxiety Panic Disorder Prevalence: ~18M Prevalence: ~9M Prevalence: Prevalence: ~0.6M Prevalence: ~7M Current treatment paradigm lacks major studies to support pharmac
Slide 26: PH10 for Major Depressive Disorder
Ke, VistaGen» Therapeutics PH10 for Major Depressive Disorder wwwvistagen.com
Slide 27: Significant Unmet Need in Major Depressive Disorder
Significant Unmet Need in Major Depressive Disorder (MDD) 21m Untreated Pts: A large percentage of patients remain untreated as a result of lack of options and discontinuations due to severe side effects First Line Treated Pts: Only 1 in 3 patients respond to first anti- depressant. May take 4 to 6
Slide 28: PH10 is a potential stand-alone treatment for MDD
PH10 is a potential stand-alone treatment for Major Depressive Disorder PH10 is an odorless & tasteless novel synthetic neuroactive steroid nasal spray 2) Designed to be non-systemic, Differentiated MoA non-sedating (doesn’t potentiate GABA-A) aS G) Designed to be non-addictive Designed to be used a
Slide 29: PH10 Novel MOA via olfactory-amygdala circuit
PH10 Novel MOA via olfactory-amygdala circuit i) Microgram-level intranasal dose of PH10 engages peripheral receptors in nasal chemosensory neurons (NCNs) e Chemosensory receptors in nose Trigger subsets of neurons in the olfactory bulbs OLFACTORY: (+) Which stimulate neurons in the limbic amygdala
Slide 30: Antidepressant Effects in Exploratory Phase 2A Study
PH10 Antidepressant Effects in Exploratory Phase 2A Study Study design: Phase 2A randomized, double-blind, placebo-controlled, parallel design POC clinical study W Dose administered: 3.2 mcg or 6.4 mcg of PH10 or placebo given Y intranasally 2 times per day, every day for 8 weeks Rapid-onset ater Ta
Slide 31: Phase 2A MDD Study (n = 30)
PH10 Phase 2A MDD Study (n = 30) HAMILTON DEPRESSION (HAM D) SCORE REDUCTION FROM BASELINE ion in HAM D from Baseline 1 ~ | T T T T T T T T Week1 Week2 Week3 Week4 Week Week6 Week7 Week8 HAM D Score (PH10vs Placebo) Cohen's D (Effect 3.2 mg (Low Dose) 16.3 104 0.74 @ 641mg (High Dose) 178 022 0.95 P
Slide 32: PH10 - Potential Opportunities Beyond Major Depressive Disorder
PH10 - Potential Opportunities Beyond Major Depressive Disorder Treatment Prevalence: Treatment lacks consistent symptom control, bother-some side Resistant ~7M effects and tolerance, and risk of abuse. Options do not provide Depression acute symptomatic relief Pest Partum Prevalence: Concem of PPD
Slide 33: AV-101 for Multiple CNS Disorders
AV-101 for Multiple CNS Disorders www.vistagen.com
Slide 34: AV-101 For Multiple CNS Disorders
AV-101 For Multiple CNS Disorders Designed to Inhibit (but not block) NMDA Receptor Activity * Oral prodrug of 7-CI-KYNA, a potent and selective full antagonist at the glycine site of the NMDA receptor + Well-tolerated in all clinical studies to date * Two positive preclinical studies show increased
Slide 35: Ketamine Therapy
Ketamine Therapy Ketamine completely blocks the ion channel of NMDAR, causing undesirable safety concerns Extracellular side \ Glycine binding site Glutamate ) = binding site Pn an PS Classic channel-blocking antagonists: ® Ketamine ‘Cytoplasmic ° Lanicemine side d Phencyciidine CAe@ @/. @ “© @NAt K
Slide 36: AV-101's Potential MOA
AV-101’s Potential MOA Extracellular | Glutamate : even, aa . binding site binding site CAt @ June 2022 \VistaGen: A VISIONARY APPROACH TO MENTAL HEALTH CARE AV-401 - Oral Prodrug (4-CL-KYN) Ky VistaGen
Slide 37: AV-101 + Probenecid
AV-101 + Probenecid Recent Preclinical Data Demonstrate Substantial Increases in Brain Concentrations of 7-CIl-KYNA PROBENECID INCREASES A PROBENECID INCREASES - 7-CLKYNA BRAIN LEVELS BY > 35-FOLD 7-CL-KYNA BRAIN LEVELS BY > 3.4-FOLD” 7-Cl-Kynurenic Acid 00 00 450 400 400 30 © AH101 Comore) = %0 > V
Slide 38: Dynamic Leaders Driving Innovative Treatments for Mental Health
Dynamic Leaders Driving Innovative Treatments for Mental Health © @ Positioning VistaGen for Near-Term Success Shawn K. Singh Ralph Snodgrass, Ph.D. Mark A. Smith, M.D.,Ph.D. Ann Cunningham,MBA Jerrold D. Dotson, CPA Reid Adler, J.D. Chief Executive Officer prosident, Chief Scientific Officer Chief
Slide 39: Distinguished Clinical and Regulatory Advisors
Distinguished Clinical and Regulatory Advisors HARVARD 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 institute Baylor Medicin S
Slide 40: Healthy minds create healthy communities
Healthy minds create healthy communities, and we are innovating to change the trajectory of global mental health care... One Mind at a Time™
VistaGen Therapeutics — Investor Presentation (June 2022) on 6ix