Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (January 2024)
62 slides from Vistagen Therapeutics's investor presentation, Jan 9, 2024
Slide 1: Vistagen
Vistagen Innovating neurosci to change the global mental
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains "forward looking statements withinthe meaningof the Private Secures tation Reform Act of 1985. These fonward-lokingstatementsinvoleknown and unknown iss that areditficultt predictand includeall matersthat are nothistorial facts. These forward-loo
Slide 3: Our Mission
Our Mission Pioneering neuroscience to deliver first-in- class therapies for psychiatric and neurological disorders Vistagen
Slide 4: Investment Highlights
Investment Highlights os t ARR Deep clinical-stage pipeline with six drug candidates targeting large markets Differentiated MOAs to move beyond currently approved therapies Lead candidate with positive Phase 3 data for acute treatment of social anxiety disorder Potential NDA-enabling program in soci
Slide 5: Clinical-stage Pipeline
Clinical-stage Pipeline Product Candidate Lead Indication(s) Prectinical Phase Phase Phase Fasedienol ‘Social Anxiety Disorder Caan UEEEEE UTE UTERUS REEREREERUET SERENE (ese) Festive Pave San 212025 potent NOM enabling Pose 3 lst be htcaln 2028 FA as Trackdesignaton ttruvone Major Depressive Disord
Slide 6: Pherines
Vistagen Pherines — A novel clas:
Slide 7: Pherines
Pherines First-in-class neuroscience therapies for psychiatric and neurological ly \ \ ) + Rapidly active in minutes rather than hours or days + Odorless and tasteless + Favorable safety profiles observed in all clinical trials to date - do not bind to abuse-related receptors + Locally metabolized —
Slide 8: Setting a new standard of care for anxiety disorders
i Setting a eWistandard of care fPanxiet [disorders
Slide 9: Social Anxiety Disorder Is a Serious Mental Health Condition
Social Anxiety Disorder Is a Serious Mental Health Condition SAD is not medicalized shyness. It is a chronic disorder characterized by ... Debilitatingemotional and physical symptoms In everyday socialor performance situations © Emotional symptoms = O= * Overwhelming fear 000 + Surgesofanxiety — Mee
Slide 10: SAD Affects ~10% of the U.S. Population, with only ~20% Helped
SAD Affects ~10% of the U.S. Population, with only ~20% of SAD Patients Helped by Current Pharmacotherapy It has been over 2 decades since the current SAD therapies were approved by the FDA TreatablePatients © Patients suffering but unaware they may have SAD or not yet motivatedto seek professional
Slide 11: Current SAD Treatments Fall Short of Physicians' Preferred Product Profile
Current SAD Treatments Fall Short of Physicians’ Preferred Product Profile There is no FDA-approved acute treatment for SAD Desired Product Profile of Treatments for Social Anxiety Disorder No Long-termSide | Non: No Cognitive/ | 6 withdrawal | No Abuse org vanessing | Semmens | Mletemmside | om | M
Slide 12: Physician Satisfaction with Therapies Currently Prescribed for Acute Episodes of SAD
Physician Satisfaction with Therapies Currently Prescribed for Acute Episodes of SAD Is Modest Psychiatrists (n=125) SSRs /SNRS eta lockers Bemos mao. og een Therpy breathing Ce ee ee ee) 1% Extremely or Very Satisfied 1% PartalySaisied/Unsatisied 2 Primary Care Physicians (n=126) SSRs / SNRs eta lo
Slide 13: Fasedienol Brings New Optimism for the Acute Treatment of SAD
Fasedienol Brings New Optimism for the Acute Treatment of SAD YY De-risked potential NDA*-enabling pathway with positive results of PALISADE-2 Phase 3 trial for the acute treatment of SAD reported in 2H 2023 Novel mechanism of action (MOA) differentiated from all approved products Designed for patie
Slide 14: Blinded Fasedienol Target Product Profile Rated Highly by Physicians
Blinded Fasedienol Target Product Profile Rated Highly by Psychiatrists and Primary Care Physicians Overall Rating om 20% KKK 100K m Psychiatrists (n=125) _ mt Primary Care Physicians (n=126) [top 2-box of 5 pt scale) Source vengn Prepay ae eee Conan, m0 223253) a“ Falflls unmet need Is unique Is an
Slide 15: Physicians Indicate High Intent to Prescribe a Product with Fasedienol's Profile
Psychiatrists and Primary Care Physicians Indicate High Intent to Prescribe a Product with Fasedienol’s Profile and Note it Would Be Appropriate for the Majority of their SAD Patients Likely to prescribe Product X ee ee ee ee ed ‘= Psychiatrists (n=125) _ m Primary Care Physicians (n=126) (top 2-box
Slide 16: Fasedienol's Novel Proposed Mechanism of Action
Fasedienol’s Novel Proposed Mechanism of Action Differentiated from all current therapies for anxiety disorders © Olfactory Bulb v 2 ) © Arvedeta © Locus Coeruleus o) © ® Microgram-level intranasal dose of fasedienol is administered Fasedienol engages specific peripheral receptors in nasal chemosens
Slide 17: PALISADE-2 Phase 3 Trial for Acute Treatment of SAD
PALISADE-2 Phase 3 Trial for Acute Treatment of SAD pais Public speaking challenge to evaluate the efficacy, safety, and tolerability of fasedienol for the acute treatment of anxiety in adult fegege] (itilp AUS. randomized, multi-center, double-blind, placebo-controlled, single-dose administration P
Slide 18: Positive PALISADE-2 Phase 3 SAD Trial Top-line Results
Positive PALISADE-2 Phase 3 SAD Trial Top-line Results PALISADE-2 Endpoints 18 P Value
Slide 19: PALISADE-2 Primary Efficacy Endpoint
Y) PALISADE-2 Primary Efficacy Endpoint: PALISADE 2 Change in Least-squares Mean SUDS Scores from V2 to V3 vs. Placebo Met primary efficacy endpoint with a change from Baseline of 5.8 points better than placebo Absolute Change in Least-squares Mean ia SUDS (V2-V3) 15 10 (p=0.015) » mFasedienol m= Pl
Slide 20: PALISADE-2 Secondary Efficacy Endpoint
PALISADE-2 Secondary Efficacy Endpoint: PALISADE-2 CGI-I Responders vs. Placebo at V3 Met secondary efficacy endpoint with fasedienol responders 1.8 times greater than placebo CGI-I % Responders* (Rating of 1 or 2) 40% 37.7% a CGI Score 30% 1 = Very Much Less Anxious 2.= Much Less Anxious iad 21.4%
Slide 21: PALISADE-2 Exploratory Endpoint: PGI-C Responders
PALISADE-2 Exploratory Endpoint: PALISROE-2 PGI-C Responders vs. Placebo at V3 Met exploratory endpoint with fasedienol responders 2.2 times greater than placebo PGI-C % Responders* (Rating of 1 or 2) 45% 40.6% 40% PGI-C Score 35% T= Very Much Less Anxious ae 2.= Much Less Anxious 3 =A Little Less A
Slide 22: PALISADE-2 Exploratory Endpoint: SUDS Responders
PALISADE-2 Exploratory Endpoint: PALISADE-2 SUDS Responders vs. Placebo at V3 Met exploratory endpoint with fasedienol responders 1.9 times greater than placebo SUDS % Responders* 40% 35.7% 35% 30% SUDS Responders 25% 2 20-point improvement from one 18.6% Visit 2 baseline to Visit 3 15% 10% 9% % (p=
Slide 23: PALISADE-2 Tolerability Profile
PALISADE-2 Tolerability Profile > IgE 2 The tolerability profile of fasedienol was favorable and consistent with results from all fasedienol trials completed to date * No severe or serious adverse events were reported in this trial * There were no discontinuations due to adverse events following the
Slide 24: PALISADE Open Label Safety Study
PALISADE Open Label Safety Study PALISDE-LTSS Over 30,000 doses self-administered in daily life by 481 SAD patients | Design Long-term self-administration of 3.2 ug of fasedienol as-needed, up to 4x/day prior to anxiety-provokingsocial and performance stressors in daily life, with a mean study durat
Slide 25: Fasedienol Potential U.S. NDA-enabling Phase 3 Clinical Plan
Fasedienol Potential U.S. NDA-enabling Phase 3 Clinical Plan* To complement the positive results from PALISADE-2, Vistagen is preparing to initiate two additional Phase 3 clinical studies of fasedienol for the acute treatment of SAD in 2024 PALISADE-3 and PALISADE-4 Phase 3 Trials with Open-label Ex
Slide 26: PALISADE-3 and PALISADE-4 Phase 3 SAD Trials with OLE
PALISADE-3 and PALISADE-4 Phase 3 SAD Trials with OLE* Stuty Deion Grteri 26 W, PALISADE Randomized, multi-center, double-blind, placebo-controlled, single-dose administration Phase 3 trial to evaluate the efficacy, safety, and tolerability of fasedienol for the acute treatment of anxiety induced by
Slide 27: Fasedienol Phase 2B Repeat Dose Study with OLE
Fasedienol Phase 2 Repeat Dose Study with OLE* nan Randomized, multi-center, double-blind, placebo-controlled, repeat-dose administration Phase 28 trial to ll ll ll evaluate the efficacy, safety, and tolerability of a repeat dose of fasedienol for the acute treatment of anxiety induced by a public s
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Slide 29: Itruvone is a Novel Potential Monotherapy for Major Depressive Disorder
Itruvone is a Novel Potential Monotherapy for Major Depressive Disorder (MDD) A Innovative odorless, tasteless synthetic neuroactive nasal spray (A Designed for rapid-onset antidepressant effects ~ Novel and differentiated MOA from all approved antidepressants Observed to be non-systemic, non-sedati
Slide 30: Itruvone's Novel Proposed Mechanism of Action
Itruvone’s Novel Proposed Mechanism of Action Differentiated from all current therapies for depression disorders © Microgram-tevel intranasal dose of itruvone is administered © Mewvone engages spectc peripheral receptors in nasa chemosensory neurons (NCNs) @ Doree stimulated with Itruvone, NCNS tlgg
Slide 31: Itruvone Antidepressant Effects in Phase 2A MDD Study
Itruvone Antidepressant Effects in Phase 2A MDD Study Design: Phase 2A randomized, double-blind, placebo-controlled, parallel design POC clinical study (n=30) 4 Dosing:3.21g or 6.4 11g of itruvoneor placeboi.n., 2times per day for 8 weeks Primary Endpoint: Change in HAMD-17 scores from baseline comp
Slide 32: Itruvone Phase 2A MDD Study
Itruvone Phase 2A MDD Study Reduction in HAMD-17 from Baseline as as Hamilton Depression (HAMD-17) Score Reduction From Baseline 6.4 1g dose produced rapid-onset and sustained antidepressant effects in MDD study participants with minimal side effects HamDa7 @22ueKowdoe) | 163 © sayeQighooe) [a7 a Pa
Slide 33: Itruvone Phase 2B Clinical Plan
Itruvone Phase 2B Clinical Plan* Planning for potential Phase 2B development of itruvone as an innovative, non-systemic monotherapy for MDD is underway In 2 Potential Design: Double-blind, randomized, placebo-controlled, parallel study in approximately 200 total male and female subjects (18 to 65 ye
Slide 34: PH80 Nasal Spray for Vasomotor Symptoms (Hot Flashes)
Vistagen PH80 Nasal Spray for Vasomotor Sym (Hot Flashes}
Slide 35: PH80 Nasal Spray
PH80 Nasal Spray Potential treatment for vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder ®) 35 Innovative, rapid-onset product candidate Novel and differentiated MOA from all approved products Taken as-needed for treatment of multiple menopausal hot flashes dail
Slide 36: PH80's Novel Proposed Mechanism of Action
PH80’s Novel Proposed Mechanism of Action Differentiated from all currently approved VMS therapies Microgram-level intranasal dose of PH80 is administered PH80 engages specific peripheral receptors in nasal chemosensory neurons (NCNs) Once stimulated with PH80, NCNs then trigger subgroups of neurons
Slide 37: PH80 Phase 2A Study in Hot Flashes
a PH80 Phase 2A Study in Hot Flashes Objective: Proof-of-principle evaluation of PH80 efficacy and tolerability for the acute management of VMS (hot flashes) due to menopause Study Details: Randomized, double-blind, placebo-controlled, Phase 2A study. Participants self- administered PH80 (3.2 ug/dos
Slide 38: PH80 Phase 2A Study in Hot Flashes: Met Primary Efficacy Endpoint
PH80 Phase 2A Study in Hot Flashes: Met Primary Efficacy Endpoint Statistically and clinically significant improvement vs. placebo in the number of hot flashes at 1 week and maintained through 4 weeks of treatment (p<.001) 28 10 Daily Mean Number of Hot Flashes pt folwse +9180 (n=18) + Placebo (n=18
Slide 39: PH80 Phase 2A Study in Hot Flashes: Met Secondary Efficacy Endpoints
PH80 Phase 2A Study in Hot Flashes: Met Secondary Efficacy Endpoints PH80 also significantly reduced participant-reported severity, disruption in function (Bother), and sweating associated with hot flashes during the treatment period as compared with placebo Severity Bother Hot Flashes » 2
Slide 40: PH80 Phase 2A Study in Premenstrual Dysphoric Disorder (PMDD)
PH80 Phase 2A Study in Premenstrual Dysphoric Disorder (PMDD) Y S 10 Do eS @ [F «0 Objective: Proof-of-principle evaluation of PH80 efficacy and tolerability for the acute management of the symptoms of PMDD Study Details: Randomized, double-blind, placebo-controlled, exploratory Phase 2A study. Subj
Slide 41: PH80 Phase 2A Study in PMDD: Met Primary Efficacy Endpoint
PH80 Phase 2A Study in PMDD: Met Primary Efficacy Endpoint PH80 treatment resulted in significant separation in PMDD DSR scores vs placebo from Day 4 through Day 6 (p=.008) 2] == Placebo —o= PHEO Days Daya Days Day 4 Days Days (e027) (90.35) (90.21) (9=0.03") (p=0.005*) (90.008) re a Vistagen * Deno
Slide 42: PH80 Phase 2A Study in PMDD: Met Primary Efficacy Endpoint
PH80 Phase 2A Study in PMDD: Met Primary Efficacy Endpoint PH80 resulted in clinically significant reduction in PMTS from baseline vs Placebo (p=.006) PMTS Mean Diff. between Baseline and Treatment at Day 6 MliPlacebo Ml PH80 Total Score (e=.006+) * Denotes Statistical significance Vistagen
Slide 43: PH15 Nasal Spray for Acute Treatment of Cognitive Impairment
Vistagen PH15 Nasal Spray for Acute Treatme: Cognitive Imp caused by N
Slide 44: PH15 Nasal Spray
PH15 Nasal Spray Potential for improvement of cognitive impairment caused by mental fatigue Novel and differentiated MOA provides potential new treatment for acute improvement of cognition and disorders that cause sleep ~~ deprivation and ensuing fatigue and cognitive impairment (e.g., Shift Work Di
Slide 45: PH15 Novel Proposed Mechanism of Action
PH15 Novel Proposed Mechanism of Action Differentiated from all currently approved therapies ©) Microgram-tevel intranasal dose of PH15 is administered PH15 engages specific peripheral receptors in nasal chemosensory neurons (NCNs) f . Once stimulated with PH15, NCNs then trigger subgroups of neuron
Slide 46: PH284 Nasal Spray
Vistagen PH284 Nasal Sp
Slide 47: PH284 Nasal Spray
PH284 Nasal Spray Potential acute treatment for wasting syndrome (cachexia) i Innovative, fast-acting therapy for appetite enhancement ©: Intranasal administration, taken before meals Potential to increase subjective feelings of hunger and caloric intake in » patients diagnosed with wasting syndrome
Slide 48: PH284 Novel Proposed Mechanism of Action
PH284 Novel Proposed Mechanism of Action Differentiated from current treatment options © Amygdala y ), © ovector am locus @ . Coeruleus © Hypothalamus Nasal Chemosensor e ©) Microgram-tevel intranasal dose of PH284 is administered ©) P24 engages specific peripheral receptors in nasal chemosensory ne
Slide 49: AV-101 for Potential Multiple Disorders
Vistagen AV-101 for Potential
Slide 50: AV-101 for Multiple Disorders
AV-101 for Multiple Disorders Designed to inhibit (but not block) NMDA receptor activity * Oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist at the glycine site of the NMDAreceptor * Inhibition of the NMDA receptor, without fully blocking the receptor like ketamine and other NMDAR an
Slide 51: AV-101's Proposed Mechanism of Action
AV-101’s Proposed | Mechanism of Action Vistagen
Slide 52: Distinguished Clinical and Regulatory Advisors
Distinguished Clinical and Regulatory Advisors Representing Premier Institutions and Deep CNS and Regulatory Expertise HARVARD, ‘Maurizio Fava, M.D. Prolessor of Psychiat, Harvard Mediasthoo: Dieter OWson of CineaiReearch, Massahusets Genera Mosptal(MGH) Reser Instte and tacctve Vie Chair ofthe Depa
Slide 53: : seal om com
: seal om com
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Slide 55: Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) Primary efficacy endpoint in PALISADE Phase 3 trials for acute measurement The SUDS measures the self-reported intensity of anxiety and/or distress in patients with SAD Patients are asked to rate their level of anxiety/distress ona scale of 0-100 Physiologic
Slide 56: Fasedienol Efficacy in Phase 2 Public Speaking Challenge Trial
Fasedienol Efficacy in Phase 2 Public Speaking Challenge Trial Minute-by-minute SUDS scores ist 2(Baseine/tacebo) vist 3 (Treatment Phase) 1m Placebo group (© Fasedienol group in response to tm rlacebo group 7 el : sates | os i Aomioumont| # °| (I g pleats Z 3 tstblan basse SUS Hae acon . = 2 z 2 L4
Slide 57: Liebowitz Social Anxiety Scale (LSAS)
Liebowitz Social Anxiety Scale (LSAS) Primary Efficacy Endpoint for Over Time Measurement The LSAS is a 24-item clinician-rated scale used to assess how SAD impacts a patient's life across a variety of situations 13 situations pertain to performance (P) and 11 pertain to social situations (S) + Asse
Slide 58: Fasedienol Efficacy Over Time as Measured by the LSAS
Fasedienol Efficacy Over Time as Measured by the LSAS Fasedienol used as-needed over time has demonstrated reduction of LSAS scores in two trials Phase 2 Crossover Study PALISADE Open-label Safety Study Mean LSAS change from baseline vs Mean LSAS reduction of 16 points at one 110 placebo of 15 point
Slide 59: Fasedienol Phase 1/1b Data
Fasedienol Phase 1/1b Data Well tolerated with reduction in autonomic biomarkers, increased electrical activity, and anxiety effects Observed Reduction in Autonomic Biomarkers. Statistically significant reduction in heart rate, respiratory rate, and electrodermal activity was observed in both men an
Slide 60: Fasedienol Reduction in Autonomic Biomarkers: Study Results
Fasedienol Reduction in Autonomic Biomarkers: Study Results + Three similarly designed Phase 1 studies were conducted in healthy volunteers (n=64; 32 male, 32 female) in a placebo-controlled crossover study design + Doses ranging from 0.2 1g to 0.4 jig were administered across these studies using an
Slide 61: Fasedienol Electrogram of Nasal Receptors (EGNR): Study Results
Fasedienol Electrogram of Nasal Receptors (EGNR): Study Results Dose response led to selection of the effective dose to use in clinical trials Dose-dependent electrical depolarization of human nasal Fasedienol (ug) l ; chemosensory receptor cells in response to fasedienol 0.0 (Ye 5 ee CTs The traces
Slide 62: Fasedienol Dose-dependently Activates Cortical Brain Regions
Fasedienol Dose-dependently Activates Cortical Brain Regions Selective and dose-dependentbrain activation induced by odorless pherine fasedienol (A) is different from control (SHAM) and brain activation induced by primary odors shown in (B). The results are averaged functional MRI images from human
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