Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (August 2019)
42 slides from Vistagen Therapeutics's investor presentation, Aug 16, 2019
Slide 1: VistaGen Therapeutics Corporate Presentation August 2019
Ke) VistaGene Therapeutics j® Nasdaq: VTGN August 2019
Slide 2: Forward-looking Statements
www.vistagen.com 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 concern our product candidates, our development efforts, our collaborations, our intellectu
Slide 3: Looking Beyond Current Treatments for CNS Diseases and Disorders with High Unmet Need
Looking Beyond Current Treatments for CNS Diseases and Disorders with High Unmet Need VistaGen is developing differentiated’new generation medications for large and growing mental health and neurology markets where current treatments are inadequate to meet the needs of millions of patients worldwide
Slide 4: Looking beyond current therapies for CNS disorders with high unmet need
Ko] Looking beyond current therapies for CNS ees disorders with high unmet need www.vistagen.com New generation MOAs Fast-acting, exceptional safety Potentially transformative milestones in 2H 2019
Slide 5: Our Pipeline
www.vistagen.com Our Pipeline Product Candidate Indication Social Anxiety Disorder’ Generalized Anxiety Disorder’ PTSD, Postpartum Anxiety, Panic’ Major Depressive Disorder" (inadequate response to ADT) Major Depressive Disorder’ (ketamine therapy relapse prevention) Neuropathic Pain" Parkinson’s LI
Slide 6: PH94B
VistaGene Pherine, synthetic neuroactive steroid Therapeutics (3B)-androsta-4,16-dien-3-ol Novel, safe, fast-acting, on-demand therapy for: * Social Anxiety Disorder * Generalized Anxiety Disorder Postpartum Anxiety » Panic Disorder » Post-Traumatic Stress Disorder
Slide 7: Social Anxiety Disorder (SAD) in the U.S.
5 A 3 : Ke) VistaGens Social Anxiety Disorder (SAD) in the U.S. “ns More than Just Shyness eof the most prevalent Meng. * ealth conditions in the y, s. Otay Affects as many as 20 million’ Americans Anxiety/fear in everyday social and performance situations T making a work presentation giving a speec
Slide 8: Current SAD Drug Treatments Fall Short
Current SAD Drug Treatments Fall Short Oa ‘Therapeutics Not FDA-Approved EDA : ABPROVED * Prescribed Off-label * wwnw.vistagen.com Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines & Beta Blockers x Slow onset, chronic administration x Addiction risk * May worsen anxiety initially x Sedation x Signi
Slide 9: Novel, safe, fast-acting, on-demand therapy
VistaGene Novel, safe, fast-acting, on-demand therapy Therapeutics * Fundamentally differentiated from all current treatments » Successful Phase 2 completed - Fast-acting efficacy (10-15 minutes), exceptional safety + Microgram dose, no systemic exposure » Well-tolerated, non-sedating, non-addictive
Slide 10: Mechanism of Action
Ke) VistaGens Therapeutics Mechanism of Action www.vistagen.com = Activates nasal chemosensory neurons that trigger neural circuits in the brain that suppress fear and anxiety = Engages nasal chemosensory neurons that trigger a subset of neurons in the main olfactory bulbs (OB) = OB neurons stimulat
Slide 11: PH94B Phase 2 Study - Social Interaction
PH94B Phase 2 Study - Social Interaction (n = 91) Ko} wwnw.vistagen.com Visit 3 (Treatment Phase) 60 55 ce Placebo, Subjective Units of Distress Score 45 (SUDS) 40 PH94B 35 30° Rf?1 270 12 2 3 4 5(min) Anticipatior Performance ‘Anxiety Anxiety + + Chall Patient is told that will join 3 role-players
Slide 12: PH94B Phase 2 Study - Public Speaking
PH94B Phase 2 Study - Public Speaking (n = 91) K@) VistaGen« ‘Therapeutics Visit 3 (Treatment Phase) eS PH94B Rapidly Reduced Anxiety in Response to Public wwnw.vistagen.com 70 Placebo Subjective Units f Distress S : Se ene ee ee Speaking Challenge PH94B sO Active Group: Placebo Group: Mean Differen
Slide 13: PH94B Pilot Phase 3 Crossover Study
www.vistagen.com ‘Anxiety Disorder. 2019 Anxiety and Depression Assocation of America (ADAA) Annual Conference Poster Session, Ke) VistaGens PH94B Pilot Phase 3 Crossover Study (n= 22) Tet )ss-over Phase 1 Phase 2 Screening Safety Period Follow-up 14-45 Period da 2 weeks: Visit 1 v2 v3 v4 V5 vé Visi
Slide 14: PH94B Pilot Phase 3 Crossover Study: Peak SUDS
| wwnw.vistagen.com Peak Suds at Baseline and Weeks 1-4 P1045, EEE Placebo Ke) PH94B Pilot Phase 3 Crossover Study VistaGen Therapeutics * Early suggestions of drug/placebo differences were seen in Week 1 and 2 SUDS scores: average change in SUDS at week 1 was 16.1 for PH94B versus 3.4 for placebo (
Slide 15: PH94B Pilot Phase 3 Crossover Study: LSAS
wwnw.vistagen.com Ke) PH94B Pilot Phase 3 Crossover Study VistaGens LSAS at Baseline and Weeks 1-4 Therapeutics * In the sample as a whole, drop in LSAS scores after treatment did not differ between groups because subjects receiving PH94B before receiving placebo continued to improve when crossed ov
Slide 16: PH94B Pilot Phase 3 Crossover Study: LSAS and SUDS changes
wwnw.vistagen.com | , Ko] | PH94B Pilot Phase 3 Crossover Study wns Changes in total LSAS scores were closely associated with change in SUDS peak anxiety scores at Week 1 (R- sq (adj) 45.2%) and at Week 2 (R-sq (adj) 34.95%). Looking at LSAS subscales, the strongest associations for SUDS peak anxiet
Slide 17: Planned Pivotal Phase 3 Development Plan for SAD
Ke) Planned Pivotal Phase 3 Development Plan for SAD “===: First Phase 3 Study wwnw.vistagen.com Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Randomized, double-blind, placebo-controlled, monotherapy study ° 3.2 ug of PH94B or placebo for 4 Weeks * Multi-center, ca.
Slide 18: AV-101
101 K@) VistaGene Synthetic NMDA receptor GlyB antagonist Therapeutics L-4-chlorokynurenine; 7-chlorokynurenic acid Novel oral prodrug therapy for: » Major Depressive Disorder + Suicidal Ideation » Neuropathic Pain + Levodopa-Induced Dyskinesia + Epilepsy
Slide 19: Major Depressive Disorder in the U.S.
wwnw.vistagen.com Ke) VistaGens Major Depressive Disorder in the U.S. “ns 1 in 4women 1in6men 1in8 ee ARS re hh Oa RRR diagnosed with depressive disorders age 12 and over takes an antidepressant’ LARGE ADDRESSABLE MARKET WITH HIGH UNMET NEED? 11.6M 7.3M 5.1M Drug-treated patients with Inadequate res
Slide 20: FDA-Approved MDD Treatments Fall Short
Ke) VistaGens ‘Therapeutics wwnw.vistagen.com FDA-Approved MDD Treatments Fall Short Current Oral Antidepressants 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 21: Ketamine Therapy for Treatment-Resistant Depression
wwnw.vistagen.com Ke) VistaGens ‘Therapeutics Ketamine Therapy for Treatment-Resistant Depression Intravenous ketamine Intranasal ketamine @ The New York Cimes \ “Fast-Acting Depression etamine HCl Drug, Newly Approved, Eta Could Help Millions” ceo. 26mg ~~ 9% CNBC “J8J’s new ketamine-like “Ketamine
Slide 22: Ketamine therapy offers new hope to millions, but are they long-term solutions?
_ Ketamine therapy offers new hope to millions, Ke | but are they long-term solutions? Tempe www.vistagen.com “In the clinical trials, the most common side effects of SPRAVATO™ when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensati
Slide 23: AV-101 for MDD: Transformative Potential
; AV-101 for MDD: Transformative Potential Ie. } a ‘Therapeutics Rapid-onset Potential, Exceptional Safety = Oral prodrug of 7-CIl-KYNA = NMDA receptor glycine site antagonist (a full antagonist) = Rapid-onset antidepressant effects and neurogenesis in preclinical studies = Well-tolerated in all cli
Slide 24: AV-101's Mechanism of Action
wwnw.vistagen.com AV-101’s Mechanism of Action Inhibits NMDA Receptor Activity NMDA Receptor Pharmacology Kt ° ° 6 = ic channel-blocking antagonists: Pers cart Ketamine Lanicemi Phencyclidine Ke) VistaGens ‘Therapeutics ° nM, ! | AV-101 fe ( Oral Prodrug A. (4-Cl-KYN) iH, L4-chlorokynurenine (@cuKyn
Slide 25: AV-101's Mechanism of Action
wwnw.vistagen.com AV-101’s Mechanism of Action Inhibits NMDA Receptor Activity Ketamine completely blocks the ion channel of the NMDA receptor
Slide 26: AV-101 vs. Ketamine in Published Preclinical Studies
www.vistagen.com Ke) AV-101 vs. Ketamine in Published Preclinical Studies “Se. ”The Prodrug 4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but Not Side Effects, by NMDA/GlycineB-Site Inhibition.” Zanos, P, et al. (2015). J Pharmacol Exp Ther 355(1): 76-85. Antidepressant-like Effect
Slide 27: Phase 1 trials demonstrate AV-101 is very well tolerated and orally bioavailable
wwnw.vistagen.com Phase 1 trials demonstrate that AV-101 is very well K@) tolerated and orally bioavailable Plasma half-life is about 2 hr Dosed up to 1440 mg daily for 2 weeks Adverse events were placebo-like except for some feelings of euphoria or “well-being” especially at the higher doses No ket
Slide 28: Initial Objective for AV-101 in MDD
www.vistagen.com Ko # Initial Objective for AV-101 in MDD veneer Displace atypical antipsychotics in current MDD treatment paradigm SSRI/SNRI SSRI/SNRI SSRI/SNRI 4-6 Weeks or more 4-6 Weeks or more 4-6 Weeks or more LLL papel seiosynatis 1 /
Slide 29: ELEVATE: Ongoing Phase 2 Clinical Study
_ Ka ELEVATE: Ongoing Phase 2 Clinical Study veneer Investigating AV-101 as a potential add-on oral treatment for MDD wwnw.vistagen.com Principal Investigator: Dr. Maurizio Fava, Harvard Medical School * Multi-center U.S. study * Evaluation of AV-101 as add-on MDD treatment for patients with inadequ
Slide 30: PH10
Ke) VistaGene Pherine, synthetic neuroactive steroid Therapeutics Pregn-4-en-20-yne-3-one Novel, safe, fast-acting therapy for Major Depressive Disorder
Slide 31: PH10 Neuroactive Nasal Spray
5 FH g : Ke) PH10 Neuroactive Nasal Spray VistaGen: + | Rapid- -Onset, Exceptional Safety Therapeutics Fundamentally differentiated from all current depression therapies Successful Phase 2a completed Rapid-onset antidepressant efficacy demonstrated in Phase 2a Microgram dose, no systemic exposure We
Slide 32: Mechanism of Action
Ke) VistaGens Mechanism of Action Tepeues www.vistagen.com = Activates nasal chemosensory neurons that trigger neural circuits in the brain leading to antidepressant effects = Engages nasal chemosensory neurons that trigger a subset of neurons in the main olfactory bulbs (OB) = OB neurons stimulate
Slide 33: PH10 Phase 1 Safety and Tolerability Study
www.vistagen.com Ke) VistaGens PH10 Phase 1 Safety and Tolerability Study Theropetls PH10 found to be safe to use in clinical studies Study Design * Open, prospective, multiple flexible doses, controlled with placebo in 12 healthy volunteers + Dose range: 0.8 1g to 6.4 yg * Self-administered intrana
Slide 34: PH10 Phase 2a MDD Study - Monotherapy
wwnw.vistagen.com PH10 Phase 2a MDD Study — Monotherapy (n = 22) Hamilton Depression (HAM D) Score Reduction From Baseline -5.0 i “7.5 E -10.0 = 3 -12.5 s 3 -15.0 4 -17.5 (n= 30) Txwki Txwk2 Txwk3 TxWk4# =TxwkS Txwk6@ 9 TxWk7 Txwks PH10 Dose HAM D Score P(PH10 vs Placebo) | Cohen's D (Effect Size) 3
Slide 35: Planned Phase 2b Development Plan for MDD
Ke) VistaGens Planned Phase 2b Development Plan for MDD Therapie wwnw.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 standard ant
Slide 36: AV-101 for Suicidal Ideation
wwnw.vistagen.com Ke) Medicine AV-101 for Suicidal Ideation US. Department BRAM VistaGen. of Veterans Affairs [URSA Baylor / VA Phase 1b Clinical Study Sponsored by U.S. Department of Veteran’s Affairs (VA) Ongoing at Baylor University First-step target engagement study Double-blind, placebo-control
Slide 37: AV-101 for Neuropathic Pain and Parkinson's LID
Ke) wwnw.vistagen.com VistaGen» Therapeutics AV-101 for Neuropathic Pain * FDA Fast Track designation * Potential FDA Fast Track designation * Potential oral non-opioid treatment option * Parkinson’s disease (PD) 0 * Non-addictive and non-sedating in levodopa-induced dyskinesia (LID) published precl
Slide 38: Distinguished Clinical and Regulatory Advisors
wwnw.vistagen.com HARVARD UNIVERSITY Couusaia Uxivenstry DEPARTMENT OF PsycuIATRY 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 39: Experienced Team Leading Execution
www.vistagen.com Ke) Experienced Team VistaGen. | 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 Resear
Slide 40: Board of Directors
www.vistagen.com Board of Directors Ke) VistaGens ‘Therapeutics Jerry Gin, Ph.D., MBA * 45 years of healthcare industry experience; Co-Founder of Oculex (acquired by Allergan for $230M) * Co-Founder, President and CEO of Nuvora Shawn Singh, JD, CEO + 25 years of experience with biopharmaceutical com
Slide 41: Looking beyond current therapies for CNS disorders with high unmet need
Ko] Looking beyond current therapies for CNS ees disorders with high unmet need www.vistagen.com New generation MOAs Fast-acting, exceptional safety Potentially transformative milestones in 2H 2019
Slide 42: Looking Beyond Current Treatments for CNS Diseases and Disorders
Ke) VistaGene Therapeutics LOOKING BEYOND CURRENT TREATMENTS FOR CNS DISEASES AND DISORDERS WITH HIGH UNMET NEED g® Nasdaq:vten
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