Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (August 2021)
34 slides from Vistagen Therapeutics's investor presentation, Aug 12, 2021
Slide 1: A Visionary Approach to Mental Health Care
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 S
Slide 4: Our CNS Pipeline
OUR CNS PIPELINE PRODUCT CANDIDATE POTENTIAL INDICATIONS PRECLINICAL PHASE! PHASE PHASE I Social Ansiety Disorder! Adjustment Disorder PHO4B Pre procedural Anety (Mm? Nasal Spray PTSD? Postpartum Anxiety? Panic Disorder* Major Depressive Disorder” PH10 Treatment-esistant Depression* Nasal Spray Post
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 23.7 | MILLION AMERICANS “More than Just Shyness” - Substantially Impacts Daily Living 2 amar ation eh ae Wes Seve 2020 ‘VistaGen Therapeutics — Copyright © 2021, All Rights Re
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 FDA-APPROVED NOT FDA-APPROVED (Prescribed Off-label) Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines, Beta Blockers Slow onset, require chronic administrat
Slide 7: Benzodiazepines FDA Drug Safety Communication
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 |.S. FOOD & DRUG FDA Drug Safety Communication | September 23, 2020 “We are ta
Slide 8: x Zz < ar < ) fe) n [4 ‘e) x
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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
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 typothalamu O Neurons in the limbic amygdala regulate fear and anxiety by in other m region
Slide 11: PH94B Phase 2 Social Anxiety Study
PH94B PHASE 2 SOCIAL ANXI Public Speaking and Social Interaction = Phase 2B randomized, double-blind, placebo-controlled multi center * Public speaking and social:interaction challenges _ + = Primary efficacy endpoint: Change in Subjective Units of Distress Scale (SUDS from baseline compared to plac
Slide 12: Subjective Units of Distress Scale (SUDS)
SUBJECTIVE UNITS OF DISTRESS SCALE (SUDS) Primary Efficacy Endpoint in Phase 2 and Phase 3 The SUDS measures the self-reported intensity of anxiety and/or distress in patients with SAD * Patients are asked to rate their level of anxiety/distress on a scale of 0-100 + Physiological signs of distress
Slide 13: PH94B Phase 2 SAD Study — Public Speaking (n = 91)
PH94B PHASE 2 SAD STUDY — PUBLIC SPEAKING (n = 91) Minute-by-Minute SUDS Scores Visit 2 (Baseline/Ptacebo} Vist 3 crreatment Phase) so aa se © PHo4s group § Placebo group H 3 © Piss pup ao 5 é 5 3 Bo 3 5 5 3 z | z Al patents esd i ae Placebo at vis 2 to 2” establish baseline 7° ‘SUDS scores. ° “RH1
Slide 14: PH94B PALISADE Phase 3 Program
PH94B PALISADE PHASE 3 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 Phase 2 study
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 CURRENT SAD TREATMENT PARADIGM WHICH HAS LACKED EFFECTIVENESS, SAFETY AND INNOVATION SUBSTANTIAL UNMET NEED FOR ACUTE TREATMENT ( DIFFERENTIATED SAFETY v BENZOS R
Slide 16: PH94B — Beyond SAD
Vistasen PH94B — BEYOND SAD oe Adjustment Disorder Pre. ®) ® @ Anxiety Panic G) \ ) (O A VistaGen
Slide 17: PH10 for Major Depressive Disorder
Slide 18: Major Depressive Disorder (MDD)
MAJOR DEPRESSIVE DISORDER (MDD) PRE — PANDEMIC IN. THE US GLOBALLY 19.4 264 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” TIME Ke) VistaGen. 1. Sub
Slide 19: Current Standard of Care for MDD Is Inadequate
CURRENT STANDARD OF CARE FOR MDD IS INADEQUATE ORAL 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, nause
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” Innovative Mechanism of Action, differentiated from all known antidepressants © Microgram-level dose (6.4 meg) designed to engage specific peripheral nasal chemosensory neurons (NCNs) Q NCNs activate olfactory bulb neurons (OBNs) on the b
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 2 50 5 3 75 6 = a 6.4 microgram dose produced rapid-onset 2 and sustained antidepressant effects in = aps. MDD patients with minimal side effects § £150 Ey 3 = ans. T T T T T T T T Week1 Week2 Week3 Week4 Week
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 U.S. multi-center, randomized, double-blind, placebo-controlled, monotherapy clinical trial MDD patients with zero or 1 prior failure on a standard oral antidepressant Twice a
Slide 25: PH10 — Beyond MDD
PH10 —- BEYOND MDD tr S) it Depre sal su ©) ideation @) @) Depression VistaGen. ‘VistaGen Therapeutics — Copyright © 2021, All Rights Reserved. Fs}
Slide 26: AV-101 for Multiple CNS Disorders
Slide 27: 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 28: AV-101's Potential MOA
AV-101’S POTENTIAL MOA NMDA Receptor Pharmacology | AV-10: oO, fz ¢ ‘coon Active Metabolite | (7-C-KYNA Classic channel-blocking antagonists: | 7-chlorokynurenic acid ¥ o °o * Ketamine vor Nat cart Lanicemine ee Phencyclidine (@) Ke) VistaGen. THERAPEUTICS
Slide 29: AV-101 + Probenecid
AV-101 + PROBENECID Recent Preclinical Data Demonstrate Substantial Increases in Rodent and Canine Brain Concentrations of 7-CI-KYNA PROBENECID INCREASES 7-CL-KYNA BRAIN LEVELS PROBENECID INCREASES 7-CL-KYNA BRAIN LEVELS BY > 35-FOLD BY > 3.4-FOLD” 7-Cl-Kynurenic Acid oe Veni venice “© avi01 10m) A
Slide 30: AV-101 + Probenecid for Multiple CNS Disorders
AV-101 + PROBENECID FOR MULTIPLE CNS DISORDERS e) op IS @ vodopa- Induced Dyskine ® @) Pain ® Depres Disorder oO Suicidal Ideation Epilepsy \C ) (O A VistaGen. \VisiaGen Therapevics — 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 Chief Executive Officer President, Chief Scientific Oficer Chief Medical Officer ‘Chief Commercial Officer (Chief Financia
Slide 32: Distinguished Clinical and Regulatory Advisors
DISTINGUISHED CLINICAL AND REGULATORY ADVISORS ay Maurizio Fava, M.D. Thomas Laughren, M.D, Michael Liebowitz, M.D. Sanjay Mathew, M.D. Gerard Sanacora, Mark Wallace, M.D. Ph.0., M.D. G vale University | UCSanDiego SCHOOL cw MEDICINE Q® HARVARD B Hagar FDA Ke) VistaGen
Slide 33: Investment Highlights
INVESTMENT HIGHLIGHTS VistaGen Therapeutics (NASDAQ: VTGN) Exploring additional ex-US partnership opportunities Ke) VistaGen. THERAPEUTICS
Slide 34: VistaGen Therapeutics
K@) VistaGen. THERAIWEUTICS NASDAQ: VTGN IR@vistagen.com VistaGen Therapewtes — Copyright © 2021, Al Rights Resewed
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