Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (January 2026)
45 slides from Vistagen Therapeutics's investor presentation, Jan 9, 2026
Slide 1: Corporate Presentation: Pioneering neuroscience with nose-to-brain neurocircuitry
1 Nasdaq: VTGN Corporate Presentation Pioneering neuroscience with nose-to-brain neurocircuitry January 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 candidates that are not absorbed systemically and don’t act directly on neurons in the brain Clinical-stage pipeline with five pherine product candidates that have been well tolerated in all studies completed to-date T
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 drug candidates Based on naturally- occurring compounds Phe
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: distinct neurocircuits in the brain
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 Pherine Pipeline in Multiple Therapeutic Areas
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 Vasomotor symptoms (hot flashes) due
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 mental health 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: Onset of social anxiety disorder most commonly manifests during adolescence
12 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 13: No FDA-Approved Acute Treatment for Social Anxiety Disorder
13 No 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 (prescribing informat
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 among HCPs
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 Program Design
17 PALISADE Phase 3 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 psychiatric conditions, suicidal
Slide 18: PALISADE-2 Phase 3 Study 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 Long-term Safety Study (Open Label)
20 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 21: Fasedienol's Treatment Effect Across Public Speaking Challenge Studies
21 18.3 6.6 PHASE 2 PH94B Placebo Fasedienol’s Treatment Effect Across Public Speaking Challenge Studies were Similar; the 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=12
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: Crossover study SUDS and LSAS 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 (OLSS)
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: PALISADE Real-World OLSS Results
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Slide 28: 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 29: 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 30: Fasedienol U.S. Market Opportunity, if Approved
30 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 31: Major Depressive Disorder: Itruvone
31 Major Depressive Disorder Itruvone
Slide 32: MDD is a Highly Prevalent & Underserved Market
32 MDD is a Highly Prevalent & Underserved Market (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 dysfunction, insomnia
Slide 33: Itruvone Has Transformative Potential for MDD Patients
33 Itruvone Has Transformative Potential for MDD Patients 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 h
Slide 34: Itruvone Positive Phase 2a MDD Study
34 Itruvone Positive Phase 2a MDD Study • 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 Results Itruvone 6.4 µg delivered
Slide 35: Itruvone 6-Week Double-blind Phase 2b Study Plan
35 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 36: Vasomotor Symptoms (Hot Flashes) due to Menopause: Refisolone (PH80)
36 Vasomotor Symptoms (Hot Flashes) due to Menopause Refisolone (PH80)
Slide 37: Menopausal Women Experience Vasomotor Symptoms (Hot Flashes)
37 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 38: Refisolone: on-demand, non-hormonal, non-systemic candidate for hot flashes
38 Refisolone: A novel, on-demand, non-hormonal, non-systemic product candidate designed for the treatment of hot flashes due to menopause Designed as a potential on-demand, fast-acting, non-hormonal, non- systemic treatment for menopausal hot flashes, without the potential of serious adverse events
Slide 39: Refisolone Positive Phase 2a Study: Menopausal Hot Flashes
39 Refisolone Positive 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 3.4 µg up to 5 times daily. •
Slide 40: Refisolone Positive Phase 2a Study: PMDD
40 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 administere
Slide 41: Psychomotor / Cognitive Impairment due to Mental Fatigue: PH15
41 Psychomotor / Cognitive Impairment due to Mental Fatigue PH15
Slide 42: PH15: fast-acting, non-systemic candidate for mental fatigue impairment
42 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 43: Cancer Cachexia (Cancer Supportive Care): PH284
43 Cancer Cachexia (Cancer Supportive Care) PH284
Slide 44: PH284: non-systemic candidate for cancer cachexia
44 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 45: Contact us
45 Contact us: Investors: IR@vistagen.com Media: media@vistagen.com Business Development: busdev@vistagen.com
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