Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (October 2020)
39 slides from Vistagen Therapeutics's investor presentation, Oct 13, 2020
Slide 1: Looking beyond the standard of care for anxiety, depression and other CNS disorders
l(@) Looking beyond the standard VistaGene of care for anxiety, depression Therapeutics and other CNS disorders #- Nasdaq : VTGN Corporate Presentation
Slide 2: Forward-looking Statements
oy P VistaGene Forward-looking Statements ments € z z : 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, development efforts, collaborations, intellectu
Slide 3: Mental Health Crisis in a Pandemic
8 i - (6) 2 Mental Health Crisis “Ina Pandemic-Stressed fpVistaGen. 3 \ America, Protests Addto ! «TIME Mental Strain” THE AGE OF ‘ Forbes | ANXIETY ‘Beyond Suess + Lessons and Treatments You Are Not Alone “The Pandemic Has Caused An Increase In Anxiety, Stress, Depression And Suicides” 28 & CNN Hea
Slide 4: Social Media is Damaging Mental Health
www.vistagen.com Social Media is Damaging Mental Health K@) VistaGens Therapeutics “Why Instagram is the Worst “How ‘Keeping Up With Social Media for Mental Health” The Joneses’ On Social - : “Lots of Time on Social Media is Damaging TIME Media Linked to Anxiety, Depression in Teens” Forbes “A Rise
Slide 5: "Benzo" Epidemic
Ke) . . VistaGene “Benzo” Epidemic pean www.vistagen.com “It's not just opioids: What doctors “Benzodiazepines: Primary Care’s want you to know about benzos” New Drug Problem” EMIheatth “Anti-anxiety medication prescriptions up 34 percent since coronavirus” TIME “Use of Opioids, Benzodiazepines at S
Slide 6: Boxed Warning Update on Benzodiazepines
www.vistagen.com U.S. FOOD & DRUG om ADMINISTRATION Therapeutics Boxed Warning Update on Benzodiazepines “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, ab
Slide 7: VistaGen is committed to developing new generation medicines
VistaGen is committed to developing and commercializing new generation medicines that go beyond the standard of care for anxiety, depression and other CNS disorders. www.VistaGen.com F ci : wr = Looking beyond the sta ¢ ESS ‘other CNS disorders
Slide 8: Our CNS Pipeline
Our CNS Pipeline Product Candidate Indication Postpartum Anxiety® PTSD® Panic Disorder® Suicidal Ideation® Neuropathic Pain’® Epilepsy® Suicidal Ideation® Social Anxiety Disorder'** Generalized Anxiety Disorder® Adjustment Disorder * Perioperative Anxiety® Major Depressive Disorder* Postpartum Depre
Slide 9: Social Anxiety Disorder (SAD) in the U.S.
www.vistagen.com 4 National institutes of Health Ke) VistaGens Social Anxiety Disorder (SAD) in the U.S. Teapewse More than Just Shyness eof the most prevalent Men, O*F ealth conditions in the u,s. ntay Affects as many as 20 million’ Americans Anxiety and fear in everyday social and performance situ
Slide 10: Current Standard of Care for SAD is Inadequate
j Current Standard of Care for SAD is Inadequate Oe H ED YA Not FDA-Approved APPROVED * Prescribed Off-label * Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines, Beta Blockers * Slow onset, chronic administration x Addiction risk x May worsen anxiety initially x Significant potential side effects x
Slide 11: PH94B Neuroactive Nasal Spray for Treatment of Anxiety Disorders
Vo) er cclee PH94B Neuroactive Nasal Spray for Treatment of Anxiety Disorders www.VistaGen.com ~All other CNS disorders
Slide 12: PH94B key attributes
Ke) VistaGeno Therapeutics = Odorless, synthetic neuroactive nasal spray = Fast-acting (within 15 minutes) = Non-systemic = Exceptional safety in all clinical studies to date = Highly statistically significant Phase 2 study (p=0.002) - FDA consensus on Phase 3 studies to mirror Phase 2 FDA Fast Trac
Slide 13: PH94B's Mechanism of Action
i } g PH94B’s Mechanism of Action “Action from a Distance” = Microgram level intranasal dose (3.2 mcg) engages specific nasal chemosensory neurons (NCNs) = NCNs activate olfactory bulb neurons (OBNs) on the base of the brain = OBNs send neural connections specifically to neurons in the central limbi
Slide 14: PH94B Phase 2 SAD Study design
& 5 3, PH94B Phase 2 SAD Study Ke) 2 . . le ' Public Speaking Therapeutics Screening N=183 Piacebo Baseline Public Speaking and Social p . Interaction Challenge Visit 2 N=98 Placebo PH94B Public Speaking and Public Speaking and Visit 3 Social Interaction N=45 Social Interaction N=46 Follow- sit sate
Slide 15: PH94B Phase 2 SAD Study — Public Speaking
PH94B Phase 2 SAD Study — Public Speaking (n = 91) Ke) VistaGens Therapeutics Visit 3 atment Phase) 80 " PH94B Rapidly Reduced 6 ase Anxiety in Response to Public Speaking Challenge Subjective Units e 8 8 of Distress Score 60 (suDS) PH94B sO Active Group: Placebo Group: Mean Difference = 26.7 Mean D
Slide 16: PH94B North American Pivotal Phase 3 SAD Study Summary
Ke) PH94B North American Pivotal Phase 3 SAD Study Summary: “““2S22:.. Acute Treatment of Anxiety for Adults with Social Anxiety Disorder www.vistagen.com Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * FDA consensus that design of pivotal Phase 3 public speaking clini
Slide 17: PH94B North American Pivotal Phase 3 SAD Study design
i PH94B North American Pivotal Phase 3 SAD Study: Ke) ; Public Speaking Tenpaes LSAS<70 Lsas>70 Placebo Baseline Pub! Cha Follow-up and Open Label Safety 7
Slide 18: PH94B for Acute Treatment of SAD in the U.S.
PH94B for Acute Treatment of SAD in the U.S. ie. ‘Therapeutics www.vistagen.com SUBSTANTIAL S DIFFERENTIATED UNMET NEED ~$2.17B - SAFETY vs. BENZOS $3.1B* potential commercial opportunity for RAPID-ONSET aa ale STRONG INTENT MOA TO PRESCRIBE ‘Includes pediatric SAD indication, peak year sales; but e
Slide 19: EverInsight/CBC Group Collaboration
EverInsight/CBC Group Collaboration Development and Commercialization of PH94B in Key Asian Markets www.vistagen.com * Obligations: = Everlnsight (funded by CBC Group) will be responsible for development and commercialization of PH94B in the Territory * Territory: = Greater China =SouthKorea * South
Slide 20: Adjustment Disorder
| re) i Adjustment Disorder scaly | * Emotional or behavioral reaction considered excessive or out of proportion to a stressful event or major life change that occurred within previous 3 months Significantly impairs functioning COVID-19 pandemic and civil unrest have created many anxiety-provoking s
Slide 21: PH94B Phase 2 Program for Adjustment Disorder
www.vistagen.com Key. VistaGene 7 . ‘Therapeutics PH94B Phase 2 Program for Adjustment Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York Treatment of Adjustment Disorder with Anxiety PARTA POTENTIAL PART B * Exploratory, open-label, single-site Phase 2A * Randomiz
Slide 22: PH94B Potential Beyond SAD
www.vistagen.com Ke) VistaGens Therapeutics PH94B Potential Beyond SAD Adjustment Disorder Post- Traumatic Stress Disorder Postpartum Anxiety Preoperative & Generalized Pre-testing Anxiety (MRI) Disorder Anxiety Panic Disorder 22
Slide 23: Major Depressive Disorder (MDD) in the U.S.
i Co) 2 VistaGens i Major Depressive Disorder (MDD) in the U.S. Teapewse 17.3 million adults in Globally, 264 million the U.S. a at a one people of all ages suffer major ess ive from depression? episode? During the Pandemic “Depression Has Skyrocketed During the COVID-19 Pandemic, Study Says” TIME 1
Slide 24: Current Standard of Care for MDD is Inadequate
www.vistagen.com Ke) VistaGens ‘Therapeutics Current Standard of Care for MDD is Inadequate Oral Antidepressants Oral 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 week
Slide 25: PH10 Neuroactive Nasal Spray for Treatment of Depression Disorders
Ke) VistaGene Therapeutics PH10 Neuroactive Nasal Spray for Treatment of Depression Disorders www.VistaGen.com
Slide 26: PH10 key attributes
Ke) VistaGene Odorless synthetic neuroactive nasal spray Therapeutics Non-systemic Successful Phase 2A in MDD completed Potential rapid-onset antidepressant effects Exceptional safety in all studies to date Preparing for Phase 2B clinical development Potential rapid-onset antidepressant without side
Slide 27: PH10's Mechanism of Action
i } q i PH10’s Mechanism of Action “Action from a Distance” = Microgram level dose (6.4 mcg) engages specific nasal chemosensory neurons (NCNs) = NCNs activate olfactory bulb neurons (OBNs) on the base of the brain = OBNs send neural connections to neurons in the central limbic amygdala, the brain c
Slide 28: PH10 Published Phase 2A MDD Study (n = 30)
www.vistagen.com PH10 Published Phase 2A MDD Study (n = 30) Ie Hamilton Depression (HAM D) Score Reduction From Baseline MistaGens -5.0 i -7.5 & Microgram § -10.0 doses of PH10 z neuroactive © 7125 nasal spray s improved MDD r -15.0 symptoms with e rapid-onset -17.5 efficacy (n=30) 9 TxWkL TXWk2 TxW
Slide 29: PH10 U.S. Phase 2B Development Plan
PH10 U.S. Phase 2B Development Plan Ke) Major Depressive Disorder ‘Therapeutics www.vistagen.com 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 anti
Slide 30: PH10 Potential Beyond MDD
www.vistagen.com PH10 ”.. Potential Beyond MDD Therapeutics Suicidal Ideation PH10 Treatment- Resistant Depression Postpartum Depression
Slide 31: AV-101 for Treatment of Depression and Neurological Disorders
Ke) VistaGene Therapeutics AV-1011 for Treatment of Depression and Neurological Disorders www.VistaGen.com
Slide 32: AV-101 key attributes
Ke) VistaGeno = Oral prodrug of 7-CI-KYNA, a potent and selective Therapeutics NMDAR glycine site antagonist = Exceptional safety in all studies to date = Two positive preclinical studies show increased brain concentrations of 7-Cl-KYNA when administered in combination with FDA-approved probenecid »
Slide 33: AV-101's Mechanism of Action
www.vistagen.com AV-101’s Mechanism of Action 4-CI-KYN (prodrug) > 7-CI-KYNA (active metabolite) NMDA Receptor Pharmacology Kt fo) Classic channel-blocking antagonists: ° © mae nw 2. ‘etamine Lanicemine Phencyclidine Ke) VistaGens Therapeutics AV-101 Sere Oral Prodrug (4-Cl-KYN) L4-chlorokynurenine
Slide 34: AV-101 and Probenecid preclinical brain concentrations
Recent preclinical data demonstrate substantial increases in rodent i AV-101 and Probenecid 3 i Ke), VistaGens ‘Therapeutics brain concentrations of both AV-101 (4-CI-KYN) and 7-CI-KYNA Probenecid increases AV-101 (4-CI-KYN) brain levels by ~ 7-fold 4-Cl-Kynurenine © Vehicle + vehicle 4 Vehicle + Pr
Slide 35: AV-101/Probenecid for Multiple CNS Disorders
AV-101/Probenecid for Multiple CNS Disorders Ke) VistaGens Therapeutics www.vistagen.com Major Depressive Disorder Levodopa- Induced Dyskinesia associated with Parkinson's Therapy Neuropathic Pain Suicidal Ideation 35
Slide 36: Distinguished Clinical and Regulatory Advisors
www.vistagen.com HARVARD UNIVERSITY Couvmmia Univenstry DEPARTMENT OF PsyCHtATRY 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 37: Experienced Team
www.vistagen.com Ke) Experienced Team VistaGens 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 Research
Slide 38: Multiple Shots on Goal
Multiple Shots on Goal > PH94B for Anxiety Disorders > PH10 for Depression Disorders www.VistaGen.com > AV-101 for Depression and Neurological Disorders . other CNS disorders
Slide 39: VistaGene
Ke) VistaGene Therapeutics
VistaGen Therapeutics — Investor Presentation (October 2020) on 6ix