Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (December 2019)
47 slides from Vistagen Therapeutics's investor presentation, Dec 27, 2019
Slide 1: VistaGen Therapeutics Winter 2019
Ke) VistaGene Therapeutics j® Nasdaq: VTGN Winter 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 diseases and disorders
www.vistagen.com Looking beyond current therapies for CNS diseases and disorders with high unmet need 3 differentiated clinical-stage product candidates Rapid-onset Each candidate has potential in multiple markets Key, VistaGen ‘Therapeutics
Slide 5: Our CNS Pipeline
Our CNS Pipeline Product ie of Social Anxiety Disorder"? _TCCCTCSCSS ZZ Generstzed Ansety Deore? Peripartum Anxiety? =a 677 )> Preoperative Anxiety® rrr f 7 £5 8> Panic Disorder* Dn fF 755> PTs? : Dn PF 7Fs> Major Depressive Disorde! PG Treatment-Resistant Depression’ — UY Na» Suicidal Ideation? Ey
Slide 6: PH94B: therapy for anxiety disorders
VistaGenoe Novel, fast-acting, non-systemic therapy for: Therapeutics » Social Anxiety Disorder * Generalized Anxiety Disorder * Peripartum Anxiety * Preoperative Anxiety » Panic Disorder + PTSD
Slide 7: Social Anxiety Disorder (SAD) in the U.S.
www.vistagen.com Social Anxiety Disorder (SAD) in the U.S. h Ke) VistaGens Therapeutics More than Just Shyness the most prevalent Men, of is Om¥ alth conditions in the uy. °/ Affects as many as 20 million’ Americans anxiety and fear in everyday social and performance situations meeting new people RA
Slide 8: Current SAD Drug Treatments Fall Short
& ¢ \( } Current SAD Drug Treatments Fall Short Ie 3 Therapeutics i EDA Not FDA-Approved re * Prescribed Off-label * APPROVED Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines & Beta Blockers * Slow onset, chronic administration x Addiction risk x May worsen anxiety initially x Significant potential
Slide 9: The Benzo Epidemic
Ke) VistaGens ‘Therapeutics The “Benzo Epidemic” www.vistagen.com “It's not just opioids: What doctors want you to know about benzos” EMhealth “Benzodiazepines: Primary Care’s New Drug Problem” Psychiatry Advisor “Use of Opioids, Benzodiazepines at Same Time is Skyrocketing. Here’s Why That Matters”
Slide 10: PH94B first-in-class highlights
Ke) VistaGenoe Therapeutics First-in-class; different from all current SAD therapies Successful Phase 2 completed Initial US Phase 3 launch in 2H 2020 Fast-acting efficacy (10-15 minutes), exceptional safety Microgram dosing (3.2 ug), non-systemic Well-tolerated, non-sedating, non-addictive FDA Fast
Slide 11: PH94B Mechanism of Action
www.vistagen.com PH94B Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain that suppress fear and anxiety = Engages nasal chemosensory receptors, which activate olfactory bulb (OB) neurons that project to the limbic amygdala = Modulates activity of
Slide 12: PH94B Reduced Social Anxiety Produced by Public Speaking and Social Interaction Challenges
PH94B Reduced Social Anxiety Produced by Public Speaking ie. and Social Interaction Challenges o— www.vistagen.com Multi-center, randomized, double-blind, placebo-controlled, parallel design laboratory study 91 female patients ages 19-60 with social anxiety disorder (SAD) 1.6 pg of PH94B or placebo
Slide 13: Published PH94B Phase Study — Public Speaking (n = 91)
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 Di
Slide 14: Published PH94B Phase Study — Social Interaction (n = 91)
Published PH94B Phase 2 Study — Social Interaction (n = 91) Ke) Visit 3 (Treatment Phase) 60 55 50 Subjective Units of Distress Score 45 (SuDS) 40 PHO4B 35 30 i 2 i} oa Anticipatior Performance ‘Anxiety i Chall Challenge D t-=>| Challenge 8 eens J 15-min "| instructions Patient is told that will joi
Slide 15: PH94B Reduced Anxiety in a Pilot Phase Real World SAD Cross-over Study
www.vistagen.com a Ke) PH94B Reduced Anxiety in a Pilot Phase 3 “Real World” VistaGens SAD Cross-over Study Randomized, double-blind, 4 week (two 2-week periods), cross-over study 22 male and female patients ages 18-65 with social anxiety disorder (SAD) Before a potentially stressful social situatio
Slide 16: PH94B Pilot Phase Cross-over Study
www.vistagen.com PH94B Pilot Phase 3 Cross-over Study Peak Suds at Baseline and Weeks 1-4 P1045, MEE Placebo Ke) VistaGens ‘Therapeutics * Early suggestions of drug/placebo differences were seen in week 1 and week 2 SUDS scores: average change in SUDS at week 1 was 16.1 for PH94B vs. 3.4 for placebo
Slide 17: PH94B Pilot Phase Cross-over Study
www.vistagen.com Ke) PH94B Pilot Phase 3 Cross-over Study agate * 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 over to placebo LSAS at Baseline and Weeks 1-4 * A
Slide 18: PH94B Pilot Phase Cross-over Study
www.vistagen.com | PH94B Pilot Phase 3 Cross-over Study F z 5 £ 3 2 € & 5 = é 2 3 Predicting Change in LSAS from Change in SUDS During Week 1 0 10 20 30 ‘SUDS Change from Baseline Week 1 Ke) VistaGens ‘Therapeutics Changes in total LSAS scores were closely associated with change in SUDS peak anxiety
Slide 19: PH94B Phase 3 Development Plan for SAD
\} PH94B Phase 3 Development Plan for SAD Visage. Initial U.S. Phase 3 Study www.vistagen.com Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Randomized, double-blind, placebo-controlled, parallel design monotherapy study * 3.2 1g of PH94B or placebo for 4 weeks * Mult
Slide 20: PH94B Commercial Opportunity — U.S. SAD Market
www.vistagen.com SUBSTANTIAL UNMET NEED Though SAD is highly prevalent with a significant impact on quality of life recognition, diagnosis and treatment remain low. Few novel medications in development to address high unmet needs. UNIQUE MOA While some clinicians are skeptical that PH94B is not habi
Slide 21: PH94B Beyond SAD
Ky] PH94B Beyond SAD VistaGen. www.vistagen.com Generalized Anxiety Disorder Peripartum Anxiety Panic Disorder Potential Next Steps: Phase 2a POC studies Post- Traumatic Stress Disorder Preoperative Anxiety 21
Slide 22: PH10: therapy for depression
Ke) VistaGene Therapeutics Novel, safe, fast-acting therapy for: Major Depressive Disorder Treatment-Resistant Depression \ Peripartum Depression Suicidal Ideation
Slide 23: Major Depressive Disorder in the U.S.
www.vistagen.com Ke) VistaGens Major Depressive Disorder in the U.S. meen 1in 4 women 1in6men 1in8 ee = RAG So 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 Disorder 7
Slide 24: FDA-Approved MDD Treatments Fall Short
Ke) VistaGens Therapeutics www.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 mo
Slide 25: Ketamine Therapy for Treatment-Resistant Depression
www.vistagen.com Ky] Ketamine Therapy for Treatment-Resistant Depression Intravenous ketamine Intranasal ketamine E> 9% CNBC eons, “J&J’s new ketamine-like depression drug Spravato off to ‘very, very strong start,’ company says” “Ketamine offers lifeline for people with severe depression, suicidal t
Slide 26: Ketamine-based therapy offers new hope, but is it a safe, convenient solution?
www.vistagen.com Ke) Ketamine-based therapy offers new hope to millions, but is —_ VistaGen- it a safe, convenient and cost-effective long-term solution? “In the clinical trials, the most common side effects of SPRAVATO™ when used along with an antidepressant taken by mouth included: dissociation, d
Slide 27: PH10 first-in-class highlights
Ke) VistaGene First-in-class Therapeutics Fundamentally different MOA from all antidepressants Successful Phase 2a completed Rapid-onset antidepressant effects Microgram dosing, non-systemic Well-tolerated, minimal side effects Preparing for U.S. Phase 2b Potential stand-alone and adjunctive at-home
Slide 28: PH10 Mechanism of Action
i } 3 i PH10 Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain leading to antidepressant effects Engages nasal chemosensory receptors, which activate olfactory bulb (OB) neurons that project to the limbic amygdala OB neurons stimulate neurons in
Slide 29: PH10 Demonstrates Antidepressant Effects in MDD Patients
Ke) VistaGens PH10 Demonstrates Antidepressant Effects in MDD Patients Terpeuscs www.vistagen.com ° Randomized, double-blind, placebo-controlled, 8-week, parallel design POC study conducted in Mexico City 30 male and female patients ages 18-65 with major depressive disorder (MDD) Microgram dosing: M
Slide 30: PH10 Phase 2a MDD Monotherapy Study
www.vistagen.com PH10 Phase 2a MDD Monotherapy Study (n = 22) Hamilton Depression (HAM D) Score Reduction From Baseline -10.0 712.5 -15.0 Reduction in HAM D from Baseline -17.5 (n=30) Txwki TxwWk2 Txwk3 Txwk4 TxwWkS Txwk6 Txwk7 Txwks 3.2419 ( 6.4 41g ( Placebo rf ne fr FF f B Dose) 01 .74 Dose) 22 .
Slide 31: 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. 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 standar
Slide 32: PH10 Beyond MDD
www.vistagen.com PH10 Beyond MDD Treatment- Resistant Depression PH10 Suicidal Peripartum Ideation Depression Ke) VistaGens Therapeutics Potential Next Steps: Phase 2a studies 32
Slide 33: AV-101: oral NMDA receptor antagonist
Ke) VistaGene Novel oral NMDA receptor GlyB antagonist for: Therapeutics » Major Depressive Disorder 6 hrs » Suicidal Ideation » Neuropathic Pain -. » Epilepsy cl NH, » Levodopa-Induced Dyskinesia associated with Parkinson’s Therapy
Slide 34: AV-101 key characteristics
Ke) VistaGenoe Therapeutics « Oral prodrug of 7-CI-KYNA, a selective NMDA receptor glycine site antagonist (full antagonist) = Well-tolerated in all clinical studies to date = No dissociative side effects or treatment-related SAEs » Non-addictive, non-sedating = FDA Fast Track designations in MDD an
Slide 35: AV-101's Mechanism of Action
Ke) VistaGens AV-101’s Mechanism of Action Therapeutics 4-CI-KYN (prodrug) — 7-CI-KYNA (active metabolite) www.vistagen.com NMDA Receptor Pharmacology Kt fo) AV-101 Oral Prodrug (4-Cl-KYN) L4-chlorokynurenine (4-CHKYN) (oral delivery to CNS) Activated * Atos OH AV-101 Active Metabolite (7-Cl-KYNA) C
Slide 36: AV-101 in Published Phase 1 Clinical Trials
AV-101 in Published Phase 1 Clinical Trials VistaGen- ‘Therapeutics i Ka) 3 H AV-101 is very well-tolerated and orally bioavailable * Plasma half-life is about 2 hr Plasma levels of AV-101 in normal . volunteers following single oral dosing * Dosed up to 1440 mg daily for 2 weeks A 70000 + Adverse e
Slide 37: AV-101 and Adjunctive Probenecid
i i 2 AV-101 and Adjunctive Probenecid Ke) VistaGens Therapeutics Substantial increases in rodent brain concentrations of AV-101 and 7-CI-KYNA Probenecid increases AV-101 brain levels by ~ 7 fold 4-Cl-Kynurenine © Vehicle + vehicle 4 Vehicle + Probenecid 100 mgihg te AV-104 100 mg/kg + Vehicle -% AV
Slide 38: AV-101 with Adjunctive Probenecid for Multiple Indications
Ke) AV-101 with Adjunctive Probenecid for Multiple Indications V'st2Sen: ‘Therapeutics www.vistagen.com Suicidal Ideation Major Depressive Neuropathic Potential Next Steps: Disorder Pain Phase 2a POC studies with AV-101 adjunctive probenecid bon) Induced = Dyskinesia associated with Parkinson's Ther
Slide 39: AV-101 for Major Depressive Disorder
www.vistagen.com AV-101 for Major Depressive Disorder Therapeutics * Ketamine-like antidepressant effects, no ketamine-like side effects in = published preclinical studies? cy * No differentiation in initial Phase 2 MDD study (1440 mg with adjunctive ADT) (ala i ° Well-tolerated, no psychotomimetic
Slide 40: AV-101 for Suicidal Ideation
www.vistagen.com Ke) Medicine US. Department Baylor VistaGen. AV-101 for Suicidal Ideation 2) Us epee pylon taGen. Baylor / VA Phase 1b NMDAR Target Engagement Study (n=10) ° Double-blind, placebo-controlled, cross-over study sponsored by U.S. Department of Veterans Affairs (VA) and conducted at Bay
Slide 41: AV-101 for Neuropathic Pain in Preclinical Studies
AV-101 for Neuropathic Pain in Preclinical Studies nara Significant dose-response with similar efficacy in a rat model of a mononeuropathy as compared to gabapentin (Neurontin) and pregabalin (Lyrica)? www.vistagen.com Robust analgesic effects, similar to gabapentin and pregabalin, but fewer side ef
Slide 42: AV-101 for Seizures in Preclinical Studies
www.vistagen.com \} AV-101 for Seizures in Preclinical Studies Mees * By stimulating the NMDAR, glutamate is believed to be critical in the neuropathology and clinical symptoms of seizures * Multiple published reports demonstrate that, if delivered by injection into brain, 7-CI-KYNA substantially re
Slide 43: AV-101 for Levodopa-induced Dyskinesia in Preclinical Studies
www.vistagen.com Ke) AV-101 for Levodopa-induced Dyskinesia associated bac elm with Parkinson’s Therapy in Preclinical Studies ° Antidyskinetic effects in the MPTP primate model similar to those generally observed with amantadine therapy, but without adverse nn effects experienced with amantadine ~~
Slide 44: Distinguished Clinical and Regulatory Advisors
www.vistagen.com HARVARD UNIVERSITY Convama University GY DevartMent or Psycutatey 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 an
Slide 45: 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 46: Looking beyond current therapies for CNS diseases and disorders
www.vistagen.com Looking beyond current therapies for CNS diseases and disorders with high unmet need 3 differentiated clinical-stage product candidates Rapid-onset Each candidate has potential in multiple markets Key, VistaGen ‘Therapeutics
Slide 47: 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 ie & & £ 2 3 3 3 g® Nasdaq:vTen
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