Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (June 2021)
34 slides from Vistagen Therapeutics's investor presentation, Jun 15, 2021
Slide 1: VistaGen Therapeutics: A Visionary Approach to Mental Health Care
oy VistaGen. THERAPEUTICS A VISIONARY APPROACH TO MENTAL HEALTH CARE oo
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: Company Highlights
COMPANY HIGHLIGHTS Three innovative CNS drug candidates advancing in clinical development * Unique mechanisms of action * Therapeutic potential in multiple anxiety, depression and neurology markets + Lead candidate in NDA-enabling Phase 3 development for acute treatment of anxiety in adults with Soc
Slide 4: Our CNS Pipeline
OUR CNS PIPELINE PRODUCT CANDIDATE POTENTIAL INDICATIONS PRECLINICAL PHASE | PHASE I PHASE i Social Anxiety Disorder? TOA ast Trac desertion gonted Adjustment Disorder” PH94B Pre-procedural Anxiety (IMR)? Nasal Spray* Prso* Postpartum Anxiety® Panic Disorder” Major Depressive Disorder* PH10 Treatmen
Slide 5: Social Anxiety Disorder
SOCIAL ANXIETY DISORDER (Social Phobia) ONE OF THE MOST PREVALENT MENTAL HEALTH CONDITIONS IN THE U.S. EFFECTING AS MANY AS MILLION AMERICANS “More than Just Shyness" - Substantially Impacts Daily Living \®@@©0@22E— Meeting new people Presenting at work or school Public speaking Interviewing for a j
Slide 6: Current Standard of Care for SAD Is Inadequate
CURRENT STANDARD OF CARE FOR SAD IS INADEQUATE There is No FDA-Approved, Fast-Acting, Acute Treatment of Anxiety for Adults Suffering from SAD © x FDA-APPROVED NOT FDA-APPROVED (Prescribed Off-label) Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines, Beta Blockers Slow onset, require chronic adminis
Slide 7: Benzodiazepines FDA Drug Safety Communication warning
Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction. WARNING FDA Drug Safety Communication | September 23, 2020 “We are taking measures and
Slide 8: PH94B for Social Anxiety Disorder
Slide 9: PH94B for Social Anxiety Disorder
PH94B FOR SOCIAL ANXIETY DISORDER Acute Treatment of Anxiety for Adults with Social Anxiety Disorder Odorless pherine nasal spray Unique MOA Microgram-level dosing Designed to be fast-acting (within 15 minutes) Non-systemic and non-sedating Well-tolerated in all clinical studies to date Met primary
Slide 10: PH94B's Potential Mechanism of Action
PH94B’S POTENTIAL MECHANISM OF ACTION “Action from a Distance” PH94B-induced anxiolytic effects appear consistent with the modulation of neural circuits involved in the pathogenesis of Social Anxiety Disorder Q Neurons in the limbic amygdala regulate fear and anxiety by modulating inhibitory neurotr
Slide 11: PH94B Phase 2B Social Anxiety Disorder Study
PH94B PHASE 2 SOCIAL ANXIETY DISORDER STUDY Public Speaking and Social Interaction Challenges * Phase 2B randomized, double-blind, placebo-controlled multi-center study (n=91) " Public speaking and social interaction challenges = Primary efficacy endpoint: Change in Subjective Units of Distress Scal
Slide 12: Subjective Units of Distress Scale (SUDS)
SUBJECTIVE UNITS OF DISTRESS SCALE (SUDS) Primary Efficacy Endpoint in Phase 2 and Phase 3 — 100 - Highest anxiety/distress that you have ever felt The SUDS measures the self-reported intensity of anxiety and/or distress in patients with SAD — 90 - Extremely anxious/distressed — 80 - Very anxious/di
Slide 13: PH94B Phase 2B SAD Study — Public Speaking (n=91)
PH94B PHASE 2 SAD STUDY — PUBLIC SPEAKING (n = 91) Minute-by-Minute SUDS Scores Visit 2 (Baseline/Placebo) Visit 3 (Treatment Phase) | PH94B Rapidly Reduced Anxiety in Response to a pt ‘m Piacebo group Public Speaking Challenge (@ PH94B group | mActive Placebo e., Ces g | Group Group 5 @ ris18 soup
Slide 14: PH94B PALISADE Phase 3 Development Program
PH94B PALISADE PHASE 3 DEVELOPMENT PROGRAM Acute Treatment of Anxiety for Adults with Social Anxiety Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York Alignment with FDA that design of Phase 3 clinical studies to substantially mirror public speaking challenge in P
Slide 15: PH94B for Acute Treatment of Anxiety in Adults with SAD
PH94B FOR ACUTE TREATMENT OF ANXIETY IN ADULTS WITH SAD VistaGen’s Initial Goal: REPLACE ANTIDEPRESSANTS, BENZOS AND BETA BLOCKERS IN THE SAD TREATMENT PARADIGM WHICH HAS LACKED EFFECTIVENESS, SAFETY AND INNOVATION SUBSTANTIAL UNMET NEED EORAGUTE THERE RENT LS DIFFERENTIATED SAFETY v BENZOS RAPID-ON
Slide 16: PH94B — Beyond SAD
PH94B — BEYOND SAD Adjustment Disorder Sa, Pre-procedural PTSD Anxiety Postpartum Anxiety Panic Disorder V ) ( Z) VistaGen
Slide 17: PH10 for Major Depressive Disorder
PH10 FOR MAJORSDEPRESSIVE DISORDER
Slide 18: Major Depressive Disorder (MDD)
MAJOR DEPRESSIVE DISORDER (MDD) PRE — PANDEMIC IN- THE US GLOBALLY 17.3 264 MILLION MILLION Adults had at Least One Major People of All Ages Suffer from Depressive Episode? Depression? DURING THE PANDEMIC “Depression Has Skyrocketed During the COVID-19 Pandemic, Study Says” Ke) VistaGen.
Slide 19: Current Standard of Care for MDD Is Inadequate
CURRENT STANDARD OF CARE FOR MDD IS INADEQUATE ANTIDEPRESSANTS * Often do not work; slow to work — Initial ADT effective in 1 of 3 patients” — May take up to 6 weeks or more for antidepressant effects + Significant potential side effects — Anxiety, sexual dysfunction, insomnia, dizziness, nausea and
Slide 20: PH10 for Major Depressive Disorder
PH10 FOR MAJOR DEPRESSIVE DISORDER Potential Stand-alone Treatment for MDD Odorless pherine nasal spray ( Unique MOA ¢@ Microgram-level dosing Designed for rapid-onset antidepressant effects without systemic uptake and distribution Successful exploratory Phase 2A clinical study Well-tolerated in all
Slide 21: PH10's Potential Mechanism of Action
PH10’S POTENTIAL MECHANISM OF ACTION “Action from a Distance” Designed to not require systemic uptake and distribution with the goal of producing rapid-onset antidepressant effects Microgram-level dose (6.4 mcg) designed to engage specific nasal chemosensory neurons (NCNs) NCNs activate olfactory bu
Slide 22: PH10 Showed Antidepressant Effects in MDD Patients
PH10 SHOWED ANTIDEPRESSANT EFFECTS IN MDD PATIENTS PUBLISHED EXPLORATORY PHASE 2A STUDY = Phase 2A randomized, double-blind, placebo-controlled, parallel design POC clinical study (n=30) = 3.2 mcg or 6.4 mcg of PH10 or placebo given intranasally 2 times per day, every day for 8 weeks = Primary effic
Slide 23: PH10 Phase 2A MDD Study (n=30)
PH10 PHASE 2A MDD STUDY (n = 30) Hamilton Depression (HAM D) Score Reduction From Baseline g 50 8g & 75 § 5 00 6.4 microgram dose produced rapid-onset = and sustained antidepressant effects in = _ ace = 125 MDD patients with minimal side effects e § = -18.0 EI 3 = 7s: T T T T T T T T Week1 Week2 Wee
Slide 24: PH10 U.S. Phase 2B Development Plan
PH10 U.S. PHASE 2B DEVELOPMENT PLAN Major Depressive Disorder Principal Investigator: Dr. Maurizio Fava, Harvard University Randomized, double-blind, placebo-controlled, multi-center monotherapy study MDD patients with zero or 1 prior failure on a standard antidepressant Twice a day administration o
Slide 25: PH10 — Beyond MDD
PH10 — BEYOND MDD Treatment-resistant Depression @) *¥ Y G) Suicidal Ideation Postpartum Depression VistaGen Therapeutics — Copyright © 2021, Al Rights Reserved VistaGen
Slide 26: AV-101 for MDD and Other CNS Disorders
FOR FOR MDD AND OTHER ENS DISORDERS “an ao) Oe
Slide 27: AV-101 for MDD and Other CNS Disorders
AV-101 FOR MDD AND OTHER CNS DISORDERS
Slide 28: AV-101's Potential MOA
AV-101’S POTENTIAL MOA NMDA Receptor Pharmacology Oral Prodrug (4-Cl-KYN) Classic channel-blocking antagonists: 7-chlorokynurenic acid oO @ - Ketamine -ciRM) Ps + low adverse evens expected) “ oe Lanicemine Phencyclidine Ie) C) lA VistaGen. THERAPEUTICS
Slide 29: AV-101 + Probenecid
AV-101 + PROBENECID Recent Preclinical Data Demonstrate Substantial Increases in Rodent and Canine Brain Concentrations of 7-CIl-KYNA PROBENECID INCREASES 7-CL-KYNA BRAIN LEVELS PROBENECID INCREASES 7-CL-KYNA BRAIN LEVELS BY > 35-FOLD BY > 3.4-FOLD” 7-Ci-Kynurenic Acid ‘Concentraton (oh) oosae S8888
Slide 30: AV-101 + Probenecid for Multiple CNS Disorders
AV-101 + PROBENECID FOR MULTIPLE CNS DISORDERS Suicidal Ideation @) lepsy Ia VistaGen VistaGon Therapeutics — Copyright © 2021, Al Rights Reserved
Slide 31: Experienced Team Leading Execution
EXPERIENCED TEAM LEADING EXECUTION Positioning VistaGen for Near-Term Shawn K. Singh Ralph Snodgrass, Ph.D. Mark A. Smith, M.D., Ph.D. Ann Cunningham, MBA Jerrold D. Dotson, CPA het execute Offer President Che Scene ffieer Chet Mec Oficr (hie Commercial Ofer Chief Financial Ofer Jo.Cato,l, Ph.D. Mar
Slide 32: Distinguished Clinical and Regulatory Advisors
DISTINGUISHED CLINICAL AND REGULATORY ADVISORS Maurizio Fava, M.D. Thomas Laughren, M.D. _ Michael Liebowitz, M.D. Sanjay Mathew, M.D. Gerard Sanacora, Mark Wallace, M.D. Ph.D., M.D. Gale University | UCSanDiego ‘SCHOOL o MEDICINE Braaro EDA Ke) VistaGen
Slide 33: Investment Highlights
INVESTMENT HIGHLIGHTS VistaGen Therapeutics (NASDAQ: VTGN) Multiple innovative clinical-stage CNS drug candidates | Increasing clinical development momentum Numerous potential catalysts 2021 — 2023 LAN) Exploring additional ex-US partnership opportunities Strong Balance Sheet and Institutional Share
Slide 34: VistaGen Therapeutics
K@) VistaGen. THERAPEUTICS NASDAQ: VTGN IR@vistagen.com
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