Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Cowen and Company 39th Annual Health Care Conference (March 2019)
36 slides from Vistagen Therapeutics's conference presentation, Mar 14, 2019
Slide 1: Looking Beyond Current Treatments for CNS Diseases and Disorders
Ke) VistaGene Therapeutics L LOOKING BEYOND CURRENT TREATMENTS FOR CENTRAL NERVOUS SYSTEM (CNS) = + DISEASES AND DISORDERS WITH ‘ 3 HIGH UNMET NEED = Cowen and Company g® Nasdaq:vten 39%" Annual Health Care Conference March 13, 2019
Slide 2: Forward-looking Statements
a Forward-looking VistaGens_ Statements
Slide 3: Looking beyond current therapies for CNS diseases and disorders with high unmet need
Looking beyond current therapies for CNS vores. diseases and disorders with high unmet need eretagenson Emphasis: at-home use, rapid-onset, exceptional safety 3 late-stage product candidates with new generation MOAs aA f 2 with Phase 2 POC efficacy and safety, 3rd with potential in 2019 “3 ‘ 3 clini
Slide 4: Pipeline
Pipeline VistaGen. Phase 3 PH94B social Anxiety Disorder | phade’3 preparation in process AV-101 Major Depressive Disorder’ ELEVATE Study, Ongoing Major Depressive Disorder /UISYNIMH Std ongoing Treatment Resistant Depression RELAY Study, preparation in process Suicidal Ideation Baylor/VA Study, ong
Slide 5: Most Advanced Clinical Program: PH94B for Social Anxiety Disorder
Most Advanced Clinical Program - Entering Pivotal Phase 3 - PH94B for Social Anxiety Disorder _——— [M nasdaq:vton
Slide 6: Social Anxiety Disorder in the U.S.
VistaGen. Social Anxiety Disorder in the U.S. | SAD is More than Just Shyness ‘of the most prevalent m, jividuals feel anxiety or fear in. one cath conditions in the yoreay | vndividuats hs performance situations? 2Y sch a. Affects as many as 22 million i Pec ask ningun f en Interviewing fora job Na
Slide 7: Current SAD Treatment Options Fall Short
Current SAD Treatment Options Fall Short VistaGen. FoA Not FDA-Approved ‘APPROVED Prescribed Off-label Antidepressants Benzodiazepines & Beta Blockers Slow onset, chronic administration x Addiction risk » May worsen anxiety initially Sedation x Significant side effects % Cognitive impairment Potenti
Slide 8: Novel PRN Treatment, Rapid-Onset Efficacy, Exceptional Safety
| Novel PRN Treatment, Rapid-Onset Efficacy, Exceptional Safety VistaGen. ‘Novel CNS neuroactive steroid nasal spray Activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety PRN treatment prior to a fear- or anxiety-producing social event Rapid-
Slide 9: PH94B Mechanism of Action
i PH94B Mechanism of Action 1) Activates Neural Circuits that Suppress Fear and Anxiety = Fundamentally different from all current treatments * Activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety Engages nasal chemosensory receptors that tr
Slide 10: PH94B Phase 2 POC Study: Public Speaking Challenge
remileogencom PH94B Phase 2 POC Study \] | Reduced Anxiety in Response to Public Speaking Challenge Visit 2, Baseline assessment: ‘Visit 3, Treatment Period: ‘Both groups treated with Each group treated with Placebo Placebo or PHSAB Vor 2 (oasetne/Piacebo) vi ot ehese) ir || |- ae Ho eee |_ 4
Slide 11: PH94B Phase 2 POC Study: Social Interaction Challenge
remileogencom PH94B Phase 2 POC Study Reduced Anxiety in Response to Social Interaction Challenge ‘Visit2, Baseline assessment: Both groups treated with Visit 3, Treatment Period: ach group treated with ether Placebo or PHOB view 3 re Phase)
Slide 12: AV-101 and PH10 for MDD and Treatment-Resistant Depression
Phase 2 Clinical Programs AV-101 and PH10 i for } Major Depressive Disorder = and — Treatment-Resistant Depression [M nasdaq:vton
Slide 13: Major Depressive Disorder in the U.S.
VistaGen. Major Depressive Disorder in the U.S. | © 1in4 women 1in6men 1in8 ae | oh RG eo ae RAR > REDD TTTT diagnosed with depressive disorders age 12 and over takes an antidepressant* LARGE ADDRI 11.6M 7.3M 5.1M Drug-treated patients with Inadequate response Treatment-resistant after Major Depress
Slide 14: Current Drug Treatments Fall Short
VistaGen- remileogencom Current Drug Treatments Fall Short 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 more for augmentation antidepressant effect
Slide 15: Ketamine-based therapies offer new hope to millions
Ketamine-based therapies offer new hope to millions, vores. | but are they long-term solutions? } Ke “Club Drug Ketamine Provides Hope in Fight Against Depression” I |ME. TheNew York Times Fast-Acting Depression Drug, Newly Approved, Could Help Millions * Safety? - * Side Effects? * Durability? * Co
Slide 16: AV-101 for MDD and TRD: Transformative Potential
Rapid-onset Potential with Exceptional Safety é H AV-101 for MDD and TRD: Transformative Potential e.. I — “ Oral prodrug of 7-CI-KYNA NMDA receptor glycine site antagonist (a full antagonist) Rapid-onset antidepressant effects and neurogenesis in preclinical studies Well-tolerated in all clinical s
Slide 17: AV-101's Mechanism of Action
remileogencom _ AV-101’s Mechanism of Action Inhibits NMDA Receptor Activity NMDA Receptor Pharmacology “o ‘asic cRanne locking antagonists
Slide 18: AV-101's Mechanism of Action
remileogencom AV-101’s Mechanism of Action Inhibits NMDA Receptor Activity ine completely blocks the ion channel of the NMDA receptor VistaGen. AV-101's active metabolite (7-CI-KYNA) does
Slide 19: AV-101 vs. Ketamine in Published Preclinical Studies
} AV-101 vs. Ketamine in Published Preclinical Studies Rapid-acting, Antidepressant-like Effects AV-101 Ketamine Forced-swim =i Toll-suspension ea Leamed-helplessness ec Novelty-suppressed feeding ge comranance Side Effects AV-101 Ketamine Psychotomimetic and rewarding No Ye Hyper movement No Ye i M
Slide 20: AV-101 Published Phase 1A and 1B Safety Studies
t } AV-101 Published Phase 1A and 1B Safety Studies te, 7 i Excellent safety profile, similar to placebo ‘ees + Two NiH-funded Phase 1 safety studies conducted in 86 normal volunteers + Phase 1A: Single ascending dose: 30 to 1440 mg administered once + Phase 18: Multiple ascending dose: 360, 1080 an
Slide 21: AV-101 NIMH Phase 2 Study for MDD
VistaGen. AV-101 NIMH Phase 2 Study for MDD Nationalists VRS, Principal Investigator: Dr. Carlos Zarate, Jr., National Institute of Mental Health + NIH-sponsored, ongoing at NIMH * Monotherapy for TRD, cross-over study, once per day for 14 days + Blinded AEs suggest AV-101 continues to be exceptiona
Slide 22: AV-101 ELEVATE Phase 2 Study for MDD
ease AV-101 ELEVATE Phase 2 Study for MDD Vee Principal Investigator: Dr. Maurizio Fava, Harvard Medical School + Company-sponsored + Adjunctive treatment for inadequate response to current SSRI/SNRI therapy * Oral dose, once per day for 14 days * Blinded AEs suggest AV-101 continues to be exception
Slide 23: Initial Regulatory and Commercial Objectives for AV-101
Initial Regulatory and Commercial Objectives for AV-101 vores. Displace Adjunctive Atypical Antipsychotics el ‘SSRI/SNRI ‘SSRI/SNRI ‘SSRI/SNRI | L//L// spa otitendss / / TTP 2
Slide 24: Next Step: The RELAY Study
Next Step: The RELAY Study VistaGene. Prevent TRD Relapse following Ketamine-based Therapy el Phase 2 study preparation in process + Relapse prevention post-ketamine-based therapy, AV-101 vs. placebo + Multi-center, double blind, placebo-controlled (ca. 200 subjects) + TRO patients who have responde
Slide 25: PH10 for MDD: Rapid-Onset, Exceptional Safety
i PH10 for MDD }| Rapid-Onset, Exceptional Safety * Novel CNS neuroactive steroid nasal spray = Activates nasal chemosensory receptors that trigger neural circuits in the brain leading to antidepressant effects = Rapid-onset antidepressant efficacy in Phase 2a = Microgram dose, no systemic exposure
Slide 26: PH10 Mechanism of Action
PH10 Mechanism of Action Activates Neural Circuits Leading to Antidepressant Effects Fundamentally different from all current treatments Activates nasal chemosensory receptors that trigger neural circuits in the brain leading to antidepressant effects = Engages nasal chemosensory receptors that trig
Slide 27: PH10 Phase 2a MDD Study (Monotherapy)
eretagenson PH10 Phase 2a MDD Study (Monotherapy) Hamilton Depression (HAM D) Score Reduction From Baseline Ultra low doses of intranasal PH10 improve MDD symptoms with rapid- onset efficacy.
Slide 28: Summary: AV-101 and PH10 for MDD and TRD
reetngenson Ke. Summary: AV-101 and PH10 for MDD and TRD VistaGen, Multiple Shots on Goal : Augmentation for inadequate response to SSRIs/SNRIs + AV-101 ELEVATE Study (ongoing) Relapse prevention after successful ketamine-based therapy + AV-101 RELAY Study (preparing for launch in 2020) First-line m
Slide 29: AV-101 for Suicidal Ideation
Phase 1 Clinical Program Ke) § AV-101 || VistaGene for I Therapeutics Suicidal Ideation a PM nasdaq:vten
Slide 30: AV-101 for Suicidal Ideation: Baylor / VA Phase 1b Study
US. Department i AV-101 for Suicidal Ideation == Baylor / VA Phase 1b Clinical Study + Sponsored by U.S. Department of Veteran’s Affairs (VA) * Ongoing at Baylor University + First-step study testing for potential anti-suicidal effects of AV-101 * Double-blind, placebo-controlled, crossover design +
Slide 31: Additional Programs
Additional Programs Ke) AV-101 _——— for VistaGene Neuropathic Pain Ee eer and Parkinson’s LID [M nasdaq:vton
Slide 32: AV-101 for Neuropathic Pain and Parkinson's LID
emiteagenstn Ke, VistaGen. AV-101 for Neuropathic Pain AV-101 for Parkinson’s LID Potential oral non-opioid treatment option * Non-addictive and non-sedating in published preclinical studies *+ FDA Fast Track designation “{Whe've undertaken .. steps to ‘advance the development of non- ‘addictive tre
Slide 33: Experienced Team
2 Experienced Team i} Leading Execution Tonite Chief Executive Officer + 25 years of experience with blopharmaceutical companies, 2 hnealtncare venture capital fm and a profitable CRO ‘Artemis Neuroscence; Scone Pharmaceuticals; Cato BlVentures: (ato Research: Mortson& Foerster + 23 yearsof experien
Slide 34: Distinguished Clinical and Regulatory Advisors
HARVARD. FDA Maurizio Fava, M.O. Professrof Psychiatry, Harvard Medal School, Decor, Orion of Cea Research, Massachusetts General Hoxptal GH) Reseach inte xeeutve Decor, MGM Clint re etwork a nstte Michael Liebowitz, M.D. Profesor of Clea Payee, Columba Univers: Managing ecto and Founder, The Medial
Slide 35: Looking beyond current therapies for CNS diseases and disorders with high unmet need
Looking beyond current therapies for CNS vores. diseases and disorders with high unmet need eretagenson Emphasis: at-home use, rapid-onset, exceptional safety 3 late-stage product candidates with new generation MOAs = 2 with Phase 2 POC efficacy and safety, 3rd with potential in 2019 “3 ‘ 3 clinical
Slide 36: Thank You
Ke) VistaGene Therapeutics L LOOKING BEYOND CURRENT TREATMENTS FOR CENTRAL NERVOUS SYSTEM (CNS) + DISEASES AND DISORDERS WITH , . 3 HIGH UNMET NEED (j® Nasdaq-vten Thank You
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