Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (March 2026)
47 slides from Vistagen Therapeutics's investor presentation, Mar 16, 2026
Slide 1: Corporate Presentation: Pioneering neuroscience with nose-to-brain neurocircuitry
1 Nasdaq: VTGN Corporate Presentation Pioneering neuroscience with nose-to-brain neurocircuitry March 2026
Slide 2: Forward-looking Statements
2 Forward-looking Statements This presentation contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are within the meaning of federal securities laws. These forward-looking statements involve known and unknown risks that are diff
Slide 3: Vision and Mission
3 Vision Mission Pioneer breakthroughs in neuroscience by harnessing the potential of brain regulation Leverage nose-to-brain neurocircuitry to deliver transformative treatments and improve lives
Slide 4: Company Highlights
4 Company Highlights Pherines are a potential new class of rapid-onset intranasal product candidates Pherines are not absorbed systemically and do not act directly on neurons in the brain Diverse pipeline with five clinical-stage product candidates U.S. Phase 3 program for acute treatment of social
Slide 5: Pherines: Chemically and biologically distinct synthetic steroid-like structures
5 Pherines: Chemically and biologically distinct synthetic steroid-like structures from an advanced discovery platform Louis Monti, MD, PhD, Vistagen SVP, Translational Medicine, a pioneer in the discovery and ongoing development of pherine product candidates Based on naturally- occurring compounds
Slide 6: Novel class of non-systemic neurocircuit-modulators
6 Favorable safety and tolerability reported in all clinical trials to date Bind to & rapidly activate receptors in nasal chemosensory neurons, inducing autonomic nervous system and behavioral changes Successfully administered intranasally by subjects in certain studies, including extended self-admi
Slide 7: Novel MOAs: each pherine modulates distinct neurocircuits
7 Novel MOAs: Pherines have similar proposed MOAs; each is designed to modulate distinct neurocircuits in the brain 1 Monti L & Liebowitz MR, Neural circuits of anxiolytic and antidepressant pherine molecules (2022) and Other Internal Vistagen research 2 Previously known as PH80 1 Olfactory Bulb Nas
Slide 8: Clinical-Stage Intranasal Pherine Product Candidates
8 Product Candidate Indication(s) Preclinical Phase 1 Phase 2 Phase 3 Neuropsychiatry Fasedienol Acute Treatment of Social Anxiety Disorder Itruvone Major Depressive Disorder PH15 Psychomotor / cognitive impairment due to mental fatigue1 Women’s Health Refisolone VMS (hot flashes) due to menopause P
Slide 9: Lead Pherine Product Candidates Have Significant Market Potential
9 Lead Pherine Product Candidates Have Significant Market Potential Fasedienol Acute Treatment of Social Anxiety Disorder ~30 million people with social anxiety disorder in the U.S.1 • Potential to be the first FDA-approved product for the acute treatment of social anxiety disorder • Positive result
Slide 10: Acute Treatment of Social Anxiety Disorder: Fasedienol
10 Acute Treatment of Social Anxiety Disorder Fasedienol
Slide 11: Social Anxiety Disorder: A serious and debilitating condition
11 Social Anxiety Disorder: A serious and debilitating mental health condition characterized by intense fear of being judged & embarrassed Social anxiety disorder is typically characterized by a combination of symptoms stemming from fear, avoidance, and worry Emotional Symptoms • Overwhelming fear •
Slide 12: No U.S. FDA-Approved Acute Treatment for Social Anxiety Disorder
12 There is No U.S. FDA-Approved Acute Treatment for Social Anxiety Disorder Current Rx therapies fall short of addressing the acute, in-the-moment needs of patients in anxiety-provoking social and performance situations. 1 Blackbox warning for increased risk of suicide and suicidal ideation (prescr
Slide 13: High Unmet Need for a Novel Acute Treatment
13 Onset of social anxiety disorder can occur at any age but most commonly manifests during adolescence2 ~30M adults, or ~12% of the U.S. adult population, suffer from Social Anxiety Disorder1 U.S. Social Anxiety Disorder Prevalence* = ~30 million adults <50% of social anxiety disorder patients are
Slide 14: Fasedienol May Bring New Optimism for Patients
14 Fasedienol May Bring New Optimism for Patients with Social Anxiety Disorder Fasedienol is designed to trigger neural signals in the olfactory bulb, which travel to the “fear centers” of the limbic amygdala, and other brain regions involved in emotion and behavior.1 Fasedienol Design Traits Rapid
Slide 15: Physician Adoption: High intent to prescribe
15 Physician Adoption: Fasedienol’s target product profile elicited a high intent to prescribe among Health Care Providers (HCPs) Psychiatrists and Primary Care Physicians (PCPs) Evaluation1 (top 2-box of 5 pt scale) Likely to prescribe Product X % of your social anxiety disorder patients who would
Slide 16: Phase 3 PALISADE Program: Fasedienol
16 Phase 3 PALISADE Program Fasedienol
Slide 17: PALISADE Phase 3 Public Speaking Challenge Program Design
17 PALISADE Phase 3 Public Speaking Challenge Program Design ØKey Inclusions • 18-65 years of age • Social anxiety disorder as defined by DSM-5 • LSAS score≥ 70 at screening • Clinician-rated 17-item Hamilton Depression Rating Scale (HAMD-17) < 16 at screening ØKey Exclusions • No history of psychia
Slide 18: PALISADE-2 Phase 3 Primary Efficacy
18 PALISADE-2 Phase 3 Study Primary Efficacy: Statistically significant relief of acute anxiety as measured by the Subjective Units of Distress Scale (SUDS) 13.8 8.0 0 5 10 15 20 (p=0.015) Absolute Change in Least-squares Mean SUDS (Visit 2 to 3) Fasedienol Placebo • The LS1 mean SUDS change from ba
Slide 19: PALISADE-2 Secondary & Exploratory Endpoints
19 PALISADE-2 Secondary & Exploratory Endpoints: Statistically significant and supportive of primary results • CGI-I proportion of responders vs placebo, rating of 1 (very much less anxious) or rating of 2 (much less anxious) from Baseline Speech #1 to Randomized Speech #2 • Fasedienol responders we
Slide 20: PALISADE-4 Phase 3 Study with Open Label Extension
20 PALISADE-4 Phase 3 Study with Open Label Extension PALISADE-4 • Design: Phase 3 Acute Treatment Public Speaking Challenge, similar to PALISADE-2 • Potential OLE: Up to 12 months • Target enrollment: Approximately 236 randomized subjects • Estimated top-line data readout: 1H 2026 Vistagen believes
Slide 21: Treatment Effect Across Public Speaking Challenge Studies
21 26.7 14.0 PHASE 2 PH94B Placebo Fasedienol’s Treatment Effect Across Public Speaking Challenge Studies was Similar; Placebo Results were Variable 13.6 14.0 PALISADE-3 PH94B Placebo 13.8 8.0 PALISADE-2 PH94B Placebo 15.6 17.3 PALISADE-1 PH94B Placebo (n=111) (n=111) (n=70) (n=71) (n=115) (n=123) 2
Slide 22: Clinical Development Summary: Fasedienol
22 Clinical Development Summary Fasedienol
Slide 23: Fasedienol Clinical Trials in Social Anxiety Disorder
Fasedienol Clinical Trials in Social Anxiety Disorder 2008-2014 2020 2021 2022 2023 2024 2025 2026 SUDS – continued protocol CL 016, pooled data from 91 patients (positive) Mean peak SUDS on active to average on placebo as needed in distressing social and performance anxiety situations (positive) Ph
Slide 24: Fasedienol Phase 2 Real-World Crossover Study
Fasedienol Phase 2 Real-World Crossover Study in Social Anxiety Disorder Sources: Liebowitz MR et al (2016) Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety 33: 1081-1089 Used as-needed in daily life, fasedieno
Slide 25: Phase 2 crossover study results
• On the primary endpoint, mean change from baseline in peak SUDS score, fasedienol (–15.60) was superior vs placebo (-8.34, p=.006, ES=0.83) • At W2, -15.9 vs -6.9, fasedienol vs placebo, respectively (p=0.192, ES=0.576) • Peak SUDS scores in fasedienol group increased after crossover to placebo bu
Slide 26: PALISADE Real-World Open Label Safety Study
PALISADE Real-World Open Label Safety Study (OLSS) Exploratory Efficacy Objective Evaluate fasedienol's effectiveness in real-world social anxiety Study Duration 4 months, max 10 months study duration Administration 3.2 ug PRN up to 4x/day for anxiety 30K Doses 500 Patients LSAS reduction observed f
Slide 27: TEAE by Preferred Term
27 TEAE by Preferred Term n=481, n (%) Headache 82 (17.0) COVID-19 infection 55 (11.4) Dizziness 22 (4.6) Epistaxis 18 (3.7) Nausea 15 (3.1) Oropharyngeal pain 15 (3.1) Nasopharyngitis 13 (2.7) Urinary tract infection 13 (2.7) Nasal congestion 12 (2.5) Upper respiratory tract infection 12 (2.5) 1. S
Slide 28: PALISADE Real-World Open Label Safety Study Results
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Slide 29: Fasedienol LSAS Results
Fasedienol LSAS Results: Demonstrated rapid-onset and meaningful improvement of LSAS Scores 60 70 80 90 100 110 Baseline Week 1 Week 2 LS AS PH94B Placebo 60 70 80 90 100 110 Baseline Month 1 Month 2 Month 3 LS AS Mean LSAS reduction of 16 points at Month 1 and 24 points at Month 3 Mean LSAS change
Slide 30: Fasedienol clinical study summary
P2 Design: Double-blind randomized N=51, 18-65Y Status: Completed PE: SUDS (pooled data from 91 patients) (positive) Design: Double-blind randomized, 4-wk crossover N=22, 18-65Y Status: Completed PE: Mean peak SUDS in distressing social & performance anxiety situations P2 P3 Design: Repeat Dose stud
Slide 31: FDA One Pivotal Trial Policy Update
31 "Going forward, the FDA’s default position is that one adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel products." 1 1 The NEJM article also states that there will be instances when the Agency will still require t
Slide 32: Fasedienol U.S. Market Opportunity, if Approved
32 Fasedienol U.S. Market Opportunity, if Approved Market Size & Growth Commercial Leadership Potential for Tailored Commercial Model Value Proposition • Social anxiety disorder offers large U.S. market opportunity • Underserved market with no FDA approved Rx therapy for acute treatment of social an
Slide 33: Vasomotor Symptoms (Hot Flashes) due to Menopause: Refisolone
33 Vasomotor Symptoms (Hot Flashes) due to Menopause Refisolone
Slide 34: Menopausal Women Experience Vasomotor Symptoms
34 A Significant Portion of Menopausal Women Experience Vasomotor Symptoms (Hot Flashes) ~27M women in the U.S.1,2,3 ~9M suffering with severe form of hot flashes1,2,3,4 Symptoms persist for a median of 7.4 years6 Hot flashes are the most common symptoms of menopause for which women seek treatment5
Slide 35: Refisolone: novel on-demand non-hormonal product candidate
35 Refisolone: A novel, on-demand, non-hormonal, non-systemic product candidate designed for the treatment of Menopausal Hot Flashes Designed as a potential on-demand, fast-acting, non-hormonal, non- systemic treatment for menopausal hot flashes, without the potential of serious adverse events or sa
Slide 36: Refisolone Positive Phase 2a Study: Menopausal Hot Flashes
36 Refisolone Positive Exploratory Phase 2a Study Menopausal Hot Flashes The Phase 2a study demonstrated statistically and clinically significant improvement vs placebo in the frequency and severity of menopausal hot flashes Phase 2a Study Results1 • Refisolone was administered at 3.2 µg up to 5 tim
Slide 37: Refisolone Positive Phase 2a Study: PMDD
37 Refisolone Positive Phase 2a Study Premenstrual Dysphoric Disorder (PMDD) Refisolone showed statistically & clinically significant improvement vs placebo in symptoms of PMDD at study endpoint after 6 days of treatment (n=52) in a Phase 2a study Phase 2a Study Results • Refisolone was administered
Slide 38: Major Depressive Disorder: Itruvone
38 Major Depressive Disorder Itruvone
Slide 39: Major Depressive Disorder Market is Large and Underserved
39 Major Depressive Disorder Market is Large and Underserved (Drug classes: SSRIs, SNRIs, NDRI, 5-HT1A, TCAs, MAOIs) • Often do not work or are slow to work • STAR*D showed ADT# effective in 1 of 3 patients3 • Significant and persistent side effects reported • Anxiety, weight gain, sexual dysfunctio
Slide 40: Itruvone: novel non-systemic product candidate for MDD
40 Itruvone is designed to modulate olfactory- amygdala circuits and activate local GABAergic inhibitory pathways, which help improve anhedonia and restore balanced autonomic response.1 Itruvone Design Traits Rapid-onset antidepressant effects have been observed No evidence of systemic absorption or
Slide 41: Itruvone Exploratory Positive Phase 2a Study
41 Itruvone Exploratory Positive Phase 2a Study Major Depressive Disorder • 6.4 µg dose significantly reduced depressive symptoms as early as Week 1 and sustained through Week 8 compared to placebo (p=0.022) • Rapid onset improvements observed for 3.2 µg and 6.4 µg vs placebo at Week 1 Phase2a Study
Slide 42: Itruvone 6-Week Double-blind Phase 2b Study Plan
42 Itruvone 6-Week Double-blind Phase 2b Study Plan ØKey Inclusions • Male or female, 18-65 years of age • Major Depressive Disorder, as defined by DSM-5 • HAMD-17 > 21 at screening & randomization • MacLean screen for BPD < 6 ØKey Exclusions • No history of other significant psychiatric disorders •
Slide 43: Psychomotor / Cognitive Impairment due to Mental Fatigue: PH15
43 Psychomotor / Cognitive Impairment due to Mental Fatigue PH15
Slide 44: PH15: novel fast-acting non-systemic product candidate
44 PH15: A novel, fast-acting, non-systemic clinical-stage product candidate designed for the acute treatment of cognitive/psychomotor impairment due to mental fatigue PH15 is designed to modulate hippocampal activity and related limbic circuitry, which may support improvements in cognitive and psyc
Slide 45: Cancer Cachexia (Cancer Supportive Care): PH284
45 Cancer Cachexia (Cancer Supportive Care) PH284
Slide 46: PH284: non-systemic product candidate for cancer cachexia
46 PH284: An innovative non-systemic clinical stage product candidate designed for the acute treatment of cancer cachexia Potential to non-systemically modulate hypothalamic pathways that regulate appetite and energy balance. PH284 Design Traits Novel neurocircuitry-focused proposed MOA differentiat
Slide 47: Contact us
47 Contact us: Investors: IR@vistagen.com Media: media@vistagen.com Business Development: busdev@vistagen.com
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