Pioneering neuroscience to deliver

groundbreaking therapies

for individuals affected by

psychiatric and neurological disorders

See why now could be the best time to start your research on Vistagen (Nsdq: VTGN)

Price Targets

$7.19

$17.06

$23.12

$31.76

Potential support in the mid-$1.60 range

LATEST NEWS

Transforming Mental Health Treatment: Vistagen

Nasdaq Listings Host, Kristina Ayanian, sits down with Shawn Singh, CEO of Vistagen (NSDQ: VTGN), to discuss their mission to address mental health disorders and their recently announced positive Phase 3 results for fasedienol in treating social anxiety disorder.

4 Reasons Why Vistagen (NSDQ: VTGN) Could Be Poised For Significant Upside Potential in 2024

Deep neuroscience pipeline differentiated from current standards of care: The innovative research and medications used by Vistagen bring new, creative solutions to the market to fill massive gaps of ineffective and outdated treatment methodologies.

targeting large and diverse neuroscience markets: Targeting some of the most common conditions with groundbreaking neuroscience, Vistagen is sure to leave their mark on the market.

positive late-stage clinical studies in multiple neuroscience indications: Vistagen boasts a portfolio of unique, well-tested treatments for a number of prevalent conditions like Major Depressive Disorder and Social Anxiety Disorder.

dISTINGUISHED CLINICAL AND REGULATORY ADVISORS: The company's leadership team represents premier institutions and deep neuroscience and regulatory expertise, including experts from top institutions like Harvard Medical School, Baylor College of Medicine, and the FDA.

IDENTIFYING THE OPPORTUNITY

INSTITUTIONAL SUPPORT IS IN PLACE AND READY TO RUN

We are in a significant blast zone and are seeing sparks

This zone has massive potential, as we have seen on the recent retests of the upper local range

We are seeing aggressive volume as the RSI is overextended into this recent up-curl. We are also breaking over consolidation into new local highs

If we can reclaim the previous support zone, that provides a beautiful springboard for a potential rally into that large distribution gap above the 31-dollar range.

TARGETS

Target #1: $7.19 (+29.55%)

Target #2: $17.06 (+207.39%)

Target #3: $23.12 (+316.58%)

Target #4: $31.76 (+472.25%)

Target #5: $53.85 (+870.27%)

Target #6: $63.21 (+1,038.92%)

Support: $1.60

vISTAGEN

(NSDQ: vtgn)

Bold opportunities to change the course of mental health care

Vistagen (Nasdaq: VTGN) is a biopharmaceutical company dedicated to pioneering neuroscience to develop and commercialize groundbreaking therapies for individuals affected by psychiatric and neurological disorders. To that end, Vistagen is innovating a pipeline of candidates with the potential to establish new standards of care, safety, and effectiveness for disorders that are disrupting the lives of tens of millions of people around the world.

What Sets vistagen apart: Pherines

A novel class of neuroactive therapies

Pherines, with their innovative Mechanism of Action (MOA), represent a groundbreaking approach to pharmaceutical intervention. Administered intranasally, they offer rapid efficacy while being odorless and tasteless, enhancing patient acceptability. By activating neural circuitry linked to various brain regions crucial for addressing a spectrum of Central Nervous System (CNS) disorders, pherines demonstrate a unique therapeutic potential.

Notably, their mode of action avoids systemic uptake and direct central nervous system absorption, mitigating concerns about neuronal effects. Furthermore, their non-binding nature to receptors associated with abuse liability, coupled with favorable safety profiles observed across completed clinical trials, underscores their promise as a safe and effective treatment option.

Fasedienol Nasal Spray for the Acute Treatment of Social Anxiety Disorder (SAD)

SAD is not medicalized shyness. It is a chronic disorder characterized by a number of symptoms:

Emotional Symptoms

• Overwhelming fear

• Surges of anxiety

• Extreme self-consciousness

• Isolation leading to depression


Physical Symptoms

• Blushing / Sweating

• Trembling

• Nausea

• Fast heartbeat / Chest discomfort

• Shortness of breath / Dizziness

In everyday social or performance situations...

SAD affects ~10% of the U.S. population, and unfortunately, it has been two decades since the standard therapies were approved by the FDA. Additionally, there are currently no FDA-approved acute treatment methods available for SAD, and the options that exist often fall short of physician expectations.

This is Where The Genius Of Vistagen (Nasdaq: VTGN) Comes In

  • Registration-directed PALISADE Phase 3 program underway; positive PALISADE-2


  • Reported in August 2023; PALISADE-3 initiated in March 2024


  • Mechanism of action is differentiated from all FDA-approved products


  • Designed for patient-tailored administration, as-needed


  • No observed systemic absorption or direct activity on neurons in the brain


  • Does not potentiate GABA or bind to abuse liability receptors


  • Favorable tolerability profile, no evidence of abuse liability potential


  • Potential to build confidence and reduce fear, anxiety, and avoidance of stressors



  • FDA Fast Track Designation granted

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

Fasedienol’s Novel Proposed Mechanism of Action

Differentiated from all current therapies for anxiety disorders

PALISADE-2 Phase 3 Trial for Acute Treatment of SAD - Public speaking challenge

Study Design

Randomized, 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 in adult subjects

with SAD induced by a public speaking challenge in a clinical setting

Screening Criteria

Participants meeting inclusion criteria for the study must have a diagnosis of Social Anxiety Disorder (SAD) with a Liebowitz Social Anxiety Scale (LSAS) score exceeding 70 and a Hamilton Depression Rating Scale (HAMD) score below 18 at screening. Normal olfactory function is required, with the option for a Quick Olfactory Test if suspicion arises. Additionally, individuals with no recent history of COVID-19 are eligible. Exclusion criteria encompass significant psychiatric illness or use of psychotropic medication, history of suicidal behavior, alcohol or substance use disorder, and notable nasal pathology.

Outcome Measures

The primary endpoint measured for the study was a change in mean Subjective Units of Distress (SUDS) scores from baseline compared to placebo, with a secondary endpoint focused on responder rates for Clinical Global Impression - Improvement (CGI-I)

PALISADE-2 Phase 3 Trial Efficacy Summary

The PALISADE-2 Phase 3 trial demonstrated strong efficacy of the treatment across all measured aspects. Patients experienced significant reductions in anxiety levels, as indicated by improvements in the Subjective Units of Distress Scale (SUDS) compared to placebo (p=0.015). Additionally, a notable proportion of patients reported feeling much or very much less anxious, as assessed by the Clinical Global Impression-Improvement (CGI-I) scale (p=0.033). These results highlight the treatment's effectiveness in reducing anxiety symptoms among individuals with Social Anxiety Disorder.

VISTAGEN

(NSDQ: VTGN)

Itruvone Nasal Spray for Major Depressive Disorder

Another of the company's groundbreaking medications, IItruvone is a rapid-onset investigational pherine nasal spray designed for potential stand-alone treatment for major depressive disorder and other neuropsychiatric indications involving depression. With 19.4 million American adults experiencing at least one major depressive episode, this medication could fill a massive hole in the pharmaceutical market.

Itruvone’s Novel Proposed Mechanism of Action

  1. Microgram-level intranasal dose of itruvone is administered intranasally
  2. Itruvone engages peripheral receptors in nasal chemosensory neurons (NCNs)
  3. NCNs trigger subgroups of interneurons in the olfactory bulbs (OBs)
  4. Neurons in the OBs then stimulate GABAergic and CRH neurons in the limbic amygdala
  5. The stimulation of the limbic amygdala INCREASES the activity of the sympathetic autonomic nervous system and the release of catecholamines from the midbrain

Vistagen

(NSDQ: VTGN)

why Vistagen Is set to leave their mark on the Dynamic Neuroscience market

Neuroscience Pipeline Overview

Vistagen (NSDQ: VTGN) stands at the forefront of the global neuroscience market, with a strong portfolio of innovative, clinical-stage medications. The team's experience and deep understanding of these novel drug candidates propel clinical endeavors aimed at pioneering therapies for individuals grappling with psychiatric and neurological disorders.

The Numbers: Large Unmet Mental Health Care Needs in Anxiety and Depression

Vistagen

(NSDQ: VTGN)

Vistagen's Leadership: Experienced and Committed

Maurizio Fava, M.D.

Harvard University - Chairman

Professor of Psychiatry, Harvard Medical School; Director, Division of Clinical Research, Massachusetts General Hospital (MGH) Research Institute; and Executive Vice Chair of the Department of Psychiatry

Thomas Laughren, M.D.

Division Director for the Division of Psychiatry Products, U.S. FDA (retired)

Director (retired), U.S. Food and Drug Administration (FDA) Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER)

Michael Liebowitz, M.D.

Columbia University; The Medical Research Network

Former Columbia University psychiatrist, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute; current Managing Director of The Medical Research Network LLC

Sanjay Mathew, M.D.


Baylor College of Medicine

Vice Chair for Research and Professor of Psychiatry and Behavioral Sciences at Baylor College of Medicine; Staff Psychiatrist at the Michael E. DeBakey VA Medical Center

Gerard Sanacora, Ph.D., M.D.


Yale University

Professor of Psychiatry, YaleSchool of Medicine; Director, Yale Depression Research Program; Co-Director, Yale-New Haven Hospital Interventional Psychiatry Service

Mark Wallace, M.D.


University of California San Diego

Professor of Clinical Anesthesiology, Chair of the Division ofPain Medicine, Medical Director and Director at the University of California, San Diego

Sources

  • Source 1: https://www.vistagen.com/
  • Source 2: https://www.vistagen.com/pipeline/overview
  • Source 3: https://www.vistagen.com/investors/overview
  • Source 4: https://www.vistagen.com/static-files/b1bcf087-576a-4e58-bd6c-4f5cdd9ad907
  • Source 5: https://www.vistagen.com/news-releases/news-release-details/vistagen-initiates-palisade-3-phase-3-study-fasedienol-acute
  • Source 6: https://www.vistagen.com/news/press-releases
  • Source 7: https://www.vistagen.com/investors/overview
  • Source 8: https://www.vistagen.com/about/advisory-board
  • Source 9: https://www.vistagen.com/about/advisory-board
  • Source 10: https://www.vistagen.com/presentations

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