Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (August 2020)
37 slides from Vistagen Therapeutics's investor presentation, Aug 14, 2020
Slide 1: VistaGen Therapeutics Summer 2020
Ke) VistaGene Therapeutics ste Nasdaq: VTGN Summer 2020
Slide 2: Forward-looking Statements
oy 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, intellectual
Slide 3: A Growing Mental Health Pandemic
wvistagen.com ~~ D) A Growing Mental Health Pandemic VistaGens 3 \ “In a Pandemic-Stressed ! America, Protests Add to The Washington Post —TIME~ Mental Strain” THE AGE OF “A third of Americans now ANXIETY ‘or Soe em Par A Ae show signs of clinical anxiety or depression, Census Bureau finds amid coro
Slide 4: A Growing Benzo Epidemic
www.vistagen.com A Growing “Benzo Epidemic” Ke) VistaGens Therapeutics Psychiatry Advisor “Anti-anxiety medication prescriptions up 34 percent since coronavirus” TIME * a Mi — er: whe we: AY Pe —-- L 1 oe = “Benzodiazepines: Primary Care’s New Drug Problem” “It's not just opioids: What doctors want
Slide 5: Committed to developing innovative medicine for anxiety, depression and neurology disorders
VistaGen is committed to developing and commercializing innovative medicine for treatment of anxiety, depression and neurology disorders we believe are not adequately addressed by current therapies. www.vistagen.com ste Nasdaq: VTGN LOOKING BEYOND CURRENT TREATMENTS FOR CNS DISEASES AND DISORDERS WI
Slide 6: Our CNS Pipeline
Product Candidate Phase 2 Phase 3 K@). istaGens Social Anxiety Disorder’** Therapeutics Generalized Anxiety Disorder® Adjustment Disorder with Anxiety* Postpartum Anxiety® Perioperative Anxiety® Panic Disorder® PTsp® Major Depressive Disorder® Postpartum Depression® ‘Treatment-resistant Depression®
Slide 7: Anxiety indications (PH94B)
VistaGene Therapeutics * Social Anxiety Disorder » Adjustment Disorder * Postpartum Anxiety + PTSD * Generalized Anxiety Disorder HO » Preoperative/Pre-testing Anxiety » Panic Disorder
Slide 8: Social Anxiety Disorder (SAD) in the U.S.
www.vistagen.com 4 National institutes of Health Social Anxiety Disorder (SAD) in the U.S. Ke) VistaGens ‘Therapeutics More than Just Shyness of the most prevalen t me, O*F ealth conditions in the y, “tay Affects as many as 20 million’ Americans Anxiety and fear in everyday social and performance si
Slide 9: Current SAD Drug Treatments Fall Short
& : \( H Current SAD Drug Treatments Fall Short Ke) S ‘Therapeutics i ED As Not FDA-Approved * i 3. * APPROVED Prescribed Off-label Antidepressants Benzodiazepines & Beta Blockers * Slow onset, chronic administration x Addiction risk x May worsen anxiety initially x Significant potential side effect
Slide 10: PH94B: Odorless, synthetic neurosteroid nasal spray
Odorless, synthetic neurosteroid nasal spray Successful Phase 2 completed Recent FDA consensus on pivotal Phase 3 study Rapid-onset (10-15 minutes) Exceptional safety FDA Fast Track designation, first ever granted for SAD Potential to be the first FDA-approved rapid-onset acute treatment of anxiety
Slide 11: PH94B Mechanism of Action
i } g PH94B Mechanism of Action = Microgram level 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 to neurons in the central limbic amygdala, the brain center where fear and anxiety
Slide 12: Completed PH94B Phase 2 Study - Public Speaking Challenge
Ke) VistaGens ‘Therapeutics Completed PH94B Phase 2 Study - Public Speaking Challenge www.vistagen.com Screening 2 23 hoes Visit 1 B Public Speaking’ J and Social Interaction Visit 2 Challenge Public Speaking and Public Speaking and Visit 3 Social Interaction HM social interaction Ze: N=45 Liebowits
Slide 13: Published PH94B Phase 2 Study — Public Speaking
Published PH94B Phase 2 Study — Public Speaking (n = 91) Visit 3 (Treatment Phase) 70 Placebo Subjective Units of Distress Score 60 Ke) VistaGens Therapeutics PH94B Rapidly Reduced Anxiety in Response to Public Speaking Challenge (SUDS) so Active Group: Placebo Group: Mean Difference = 26.7 Mean Dif
Slide 14: PH94B Initial Pivotal Phase 3 Study
www.vistagen.com Ke) PH94B Initial Pivotal Phase 3 Study: Vise. Acute Treatment of Anxiety for Adults with Social Anxiety Disorder Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York Recent FDA agreement will substantially reduce cost (50%), time and variability Design same
Slide 15: PH94B Initial Pivotal Phase 3 Study - Public Speaking Challenge
(©) PH94B Initial Pivotal Phase 3 Study - Public Speaking Challenge ie. ‘Therapeutics www.vistagen.com Visit 1 Visit 2 f- SUDS«<75 Follow-up and Open Label Safety 15
Slide 16: PH94B Commercial Opportunity — U.S. SAD Market
www.vistagen.com Ke) PH94B Commercial Opportunity — U.S. SAD Market VistaGen. ~~ SUBSTANTIAL UNMET NEED There are few novel anti-anxiety medications in late-stage clinical development. PH94B promotion, SAD disease education and U.S. DTC advertising efforts will drive physician urgency to diagnose an
Slide 17: Everlnsight/CBC Group Collaboration June 2020
Everlnsight/CBC Group Collaboration June 2020 Phase 3 Development and Commercialization of PH94B for Acute Treatment of Anxiety in Adults with SAD in Key Asian Markets www.vistagen.com * Obligations: = Everlnsight (currently funded by CBC Group) will be responsible for Phase 3 clinical development,
Slide 18: Adjustment Disorder with Anxiety
www.vistagen.com Ke) . . . . VistaGen» Adjustment Disorder with Anxiety Therapeutics Emotional or behavioral reaction considered excessive or out of proportion to a stressful event or major life change occurring within 3 months of the anxiety-provoking stressor Significantly impairs social, occupati
Slide 19: PH94B Phase 2 Program for Adjustment Disorder
www.vistagen.com Key. VistaGene . . ‘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 20: Additional Anxiety-related Indications
& i i) 2 Additional Anxiety-related Indications peat } Postpartum Anxiety Panic Disorder Generalized Anxiety Disorder Potential Next Step: PH94B Exploratory Phase 2A studies Preoperative Post- & Traumatic Pre-testing Stress (MRI) Disorder Anxiety 20
Slide 21: Depression indications (PH10)
Ke) VistaGene Therapeutics Novel, safe, fast-acting therapy for: Major Depressive Disorder Postpartum Depression \ Treatment-Resistant Depression Suicidal Ideation
Slide 22: Major Depressive Disorder in the U.S.
www.vistagen.com Ke) VistaGens Major Depressive Disorder in the U.S. Trespeunes 1in 4 women 1in6men 1in8 ee = RAG oe He a diagnosed with depressive disorders age 12 and over takes an antidepressant’ LARGE ADDRESSABLE MARKET WITH HIGH UNMET NEED? 11.6M Drug-treated patients with Major Depressive Diso
Slide 23: FDA-Approved Oral MDD Treatments Fall Short
Ke) VistaGens ‘Therapeutics www.vistagen.com FDA-Approved Oral MDD Treatments Fall Short 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 weeks or
Slide 24: PH10: Odorless synthetic neurosteroid nasal spray
Ke) VistaGene Therapeutics Odorless synthetic neurosteroid nasal spray Successful Phase 2A completed Potential rapid-onset antidepressant effects Exceptional safety Preparing for Phase 2B Potential stand-alone rapid-onset antidepressant without side effects and safety concerns of ketamine-based ther
Slide 25: PH10 Mechanism of Action
PH10 Mechanism of Action www.vistagen.com = 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 center where mood i
Slide 26: PH10 Published Phase 2A MDD Monotherapy Study
PH10 Published Phase 2A MDD Monotherapy Study (n = 30) Ke) www.vistagen.com 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 Tx
Slide 27: PH10 U.S. Phase 2B Development Plan for MDD
Ke) VistaGens ‘Therapeutics PH10 U.S. Phase 2B Development Plan for MDD 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 antidepressa
Slide 28: Additional Indications
www.vistagen.com Additional Indications Postpartum Depression PH10 Treatment- Resistant Depression Ke) VistaGens Therapeutics Potential Next Steps: Exploratory Phase 2A studies 28
Slide 29: AV-101 indications
Ke) VistaGeno » Major Depressive Disorder Therapeutics * Suicidal Ideation » Neuropathic Pain » Levodopa-Induced Dyskinesia associated with Parkinson’s Therapy fe} NH * Epilepsy pH LOOKING H UNMET NEED
Slide 30: AV-101: Oral NMDAR glycine site antagonist
Ke) VistaGeno Therapeutics = Oral NMDAR glycine site antagonist = Prodrug of 7-Cl-KYNA » Exceptional safety = FDA Fast Track designations in MDD and pain * Go forward plan with adjunctive probenecid
Slide 31: AV-101's Mechanism of Action
AV-101’s Mechanism of Action Therapeutics 4-CI-KYN (prodrug) — 7-CI-KYNA (active metabolite) i } VistaGens i AV-101 NMDA Receptor Pharmacology Kt fo) Oral Prodrug (4-Cl-KYN) L4-chlorokynurenine (4-CHKYN) (oral delivery to CNS) Activated * Astyoetes OH AV-101 Active Metabolite (7-Cl-KYNA) Classic cha
Slide 32: AV-101 and Adjunctive Probenecid
i § | AV-101 and Adjunctive Probenecid Recent preclinical data demonstrate substantial increases in rodent brain Ke), VistaGens ‘Therapeutics concentrations of both AV-101 (4-Cl-KYN) and 7-CI-KYNA Probenecid increases AV-101 (4-CI-KYN) brain levels by ~ 7-fold 4-Cl-Kynurenine © Vehicle + vehicle 4 V
Slide 33: AV-101 with Adjunctive Probenecid for Multiple CNS Indications
Ke) AV-101 with Adjunctive Probenecid for Multiple CNS Indications Mieteoer www.vistagen.com Major Depressive Disorder Next Step: Neuropathic Pain Acute Canine Preclinical (PK) Study Levodopa- Induced Dyskinesia associated with Parkinson's Therapy 33
Slide 34: 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 35: 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 36: Differentiated, Clinical-Stage CNS Drug Candidates
Ke) VistaGens Therapeutics www.vistagen.com 3 Differentiated, Clinical-Stage CNS Drug Candidates > Rapid-onset potential > Multiple accessible global markets
Slide 37: Looking Beyond Current Treatments for Anxiety, Depression and Other CNS Diseases
Ke) VistaGene Therapeutics LOOKING BEYOND,CURRENE TREATMENTS FOR ANXIETY, DEPRESSION. AND OTHER CNS DISEASES AND DISORDERS WITH HIGH UNMET NEED www.vistagen.com g® Nasdaq:vTen
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