NEW YORK, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series, in partnership with KCSA Strategic Communications (“KCSA”), today announced the presentations from its KCSA Mental Health Virtual Investor Conference held on December 15 ^th are now available for online viewing.

REGISTER NOW AT : https://bit.ly/3FPSRgW

The company presentations will be available 24/7 for 90 days. Investors, advisors, and analysts may download
investor materials from the company’s resource section.

Select companies are accepting 1x1 management meeting requests through December 20 ^th .

December 15 ^th

To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com .

About Virtual Investor Conferences ^®

Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.

Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.

Media Contact:
OTC Markets Group Inc. +1 (212) 896-4428, [email protected]

Virtual Investor Conferences Contact:
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
[email protected]

NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series, in partnership with KCSA Strategic Communications (“KCSA”), today announced the agenda for the upcoming KCSA Mental Health Virtual Investor Conference to be held on Thursday, December 15, 2022. Individual investors, institutional investors, advisors, and analysts are invited to attend.

“The mental healthcare crisis is debilitating for our society, economy and individual well-being. There are hundreds of companies committed to finding novel solutions to bring ease to that suffering. The KCSA Mental Health Virtual Investor Conference highlights some of the most innovative public and private companies in the sector. We believe these companies are on the cusp of changing the world,” said Lewis Goldberg, Managing Partner.

REGISTER NOW AT: https://bit.ly/3Y8vKoT

It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend live presentations and schedule 1x1 meetings with select management.

December 15 ^th

To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com .

About Virtual Investor Conferences ^®

Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.

Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.

About KCSA Strategic Communications

KCSA is a fully integrated communications agency specializing in public relations, investor relations and social media, with expertise in financial and professional services, technology, healthcare, digital media and cannabis. Since 1969, the firm has demonstrated strategic thinking and program execution that drives results for its clients in the ever-changing communications and digital landscape. The firm's clients are its best references. For more information, please visit www.kcsa.com .

Media Contact:
OTC Markets Group Inc. +1 (212) 896-4428, [email protected]

Virtual Investor Conferences Contact:
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
[email protected]

KCSA Contact:
Allison Soss
KCSA Strategic Communications
[email protected]

LOS ANGELES, CA / ACCESSWIRE / August 31, 2020 / LD Micro today announced the final list of companies slated to present at the upcoming LD 500, taking place September 1st-4th, 2020, exclusively online.

Registration details and the company schedule can be seen here: https://ld500.ldmicro.com

"I have slept well since March," said Chris Lahiji, Founder of LD Micro.

The list of presenters in below:

About LD Micro:

LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space.

What started out as a newsletter highlighting unique companies has transformed into several influential events annually (Invitational, Summit, and Main Event).

In 2015, LD Micro launched ldmicro.com as a portal to provide exclusive intraday information on the entire sector, including the first pure micro-cap index (LDMi) which covers stocks in North America with market capitalizations between $50 million to $300 million.

SOURCE: LD Micro

LOS ANGELES, CA / ACCESSWIRE / August 5, 2020 / LD Micro today announced the initial list of companies slated to present at the upcoming LD 500, taking place September 1st-4th, 2020, exclusively online.

"For the first time in ten years, we were unable to host our mid-year conference, which caused us to dream up the LD 500," stated Chris Lahiji, President of LD Micro. "This will be our most ambitious event to date, expected to feature over 300 companies to more than 20,000 attendees. While the economy and financial world have been turned upside down, investor interest is as high as we have ever seen, and we will have something for everyone. Our "Zooming with LD" series has created some significant momentum that we plan to ride out till the big week."

REGISTER HERE

The preliminary list of presenting companies:

About LD Micro

SOUTH SAN FRANCISCO, CA / ACCESSWIRE / August 13, 2019 / VistaGen Therapeutics (NASDAQ:VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced financial results for its fiscal year 2020 first quarter ended June 30, 2019.

“The next few months are potentially transformative for VistaGen, as we look forward to several clinical and regulatory milestones before year-end,” stated Shawn Singh, Chief Executive Officer of VistaGen. “We have three differentiated clinical-stage drug candidates, each of which has an exceptional safety profile in studies to date and significant therapeutic and commercial potential in multiple large and growing CNS markets where current treatments are inadequate to meet the needs of millions of patients. Our team is focused on driving continued progress across our pipeline, and we are confident in our efforts to achieve our core goals - to deliver both safe and effective new generation treatments in neuropsychiatry and neurology for patients and extraordinary value to our loyal shareholders.”

Financial Results for the Fiscal Quarter Ended June 30, 2019:

Net loss attributable to common stockholders for the fiscal quarter ended June 30, 2019 was approximately $6.2 million, including approximately $1.2 million of noncash charges, compared to $4.2 million for the fiscal quarter ended June 30, 2018, primarily attributable to increased research and development activities relating to the Company’s CNS drug development programs.

Research and development expense totaled $4.3 million for the fiscal quarter ended June 30, 2019, compared with $2.7 million for the fiscal quarter ended June 30, 2018. The increase in research and development expense is primarily related to the continued progress of ELEVATE, the Company’s Phase 2 clinical study evaluating efficacy and safety of AV-101, its novel oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an add-on treatment (together with an FDA-approved oral antidepressant) for adults with major depressive disorder (MDD), several preclinical studies, including studies supporting AV-101’s potential for treating neuropathic pain (NP) and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease, and manufacturing activities involving AV-101 and the Company’s two novel, clinical-stage neuroactive nasal spray candidates, PH94B for social anxiety disorder (SAD) and PH10 for MDD.

General and administrative expense was approximately $1.9 million in the fiscal quarter ended June 30, 2019, compared to approximately $1.5 million in the fiscal quarter ended June 30, 2018. The increase was primarily attributable to noncash stock compensation expense.

At June 30, 2019, VistaGen had cash and cash equivalents of $8.3 million, compared to $13.1 million at March 31, 2019.

As of August 13, 2019, there were 42,622,965 shares of common stock outstanding.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders where current treatments are inadequate, resulting in high unmet need. VistaGen’s pipeline includes three differentiated, clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each with an exceptional safety profile in all clinical studies to date and therapeutic potential in multiple large and growing CNS markets. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This release contains various statements concerning VistaGen's future expectations, plans and prospects, including without limitation, our expectations regarding development and commercialization of our three drug candidates: (i) AV-101 for MDD, NP, LID and suicidal ideation; (ii) PH94B for SAD; and (iii) PH10 for MDD. In addition, statements concerning the Company’s future expectations may include statements regarding intellectual property and commercial protection of our drug candidates. Each of these statements constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and may cause actual results to differ materially from those contemplated in these forward-looking statements. Those risks include the following: (i) we may encounter unexpected adverse events in patients during our clinical development of any product candidate that cause us to discontinue further development; (ii) we may not be able to successfully demonstrate the safety and efficacy of our product candidates at each stage of clinical development; (iii) success in preclinical studies or in early-stage clinical trials may not be repeated or observed in ongoing or future studies, and ongoing or future preclinical and clinical results may not support further development of, or be sufficient to gain regulatory approval to market AV-101, PH94B, and/or PH10; (iv) decisions or actions of regulatory agencies may negatively affect the progress of, and our ability to proceed with, further clinical studies or to obtain marketing approval for our drug candidates; (v) we may not be able to obtain or maintain adequate intellectual property protection and other forms of marketing and data exclusivity for our product candidates; (vi) we may not have access to or be able to secure substantial additional capital to support our operations, including our ongoing clinical development activities; and (vii) we may encounter technical and other unexpected hurdles in the manufacturing and development of any of our product candidates. Certain other risks are more fully discussed in the section entitled "Risk Factors" in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC's website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

VISTAGEN THERAPEUTICS
Consolidated Balance Sheets
Amounts in Dollars, except share amounts)

VISTAGEN THERAPEUTICS
STATEMENT OF OPERATIONS
Amounts in Dollars, except share amounts
(Unaudited)

Company Contact

Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]

Investor Contact

Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: [email protected]

Media Contact

Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications
Phone: +1 (212) 896-1241/+1 (508) 843-6428
Email: [email protected]

SOURCE: VistaGen Therapeutics

Previously completed Phase 2a clinical study of PH10 demonstrated significant antidepressant effects without psychological side effects or safety concerns after only one week of administration

Phase 2b clinical trial for treatment of Major Depressive Disorder (MDD) planned for second half 2020

SOUTH SAN FRANCISCO, CA / ACCESSWIRE / July 23, 2019 / VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 10,322,138 related to methods of treating major depressive disorder (MDD) with VistaGen’s PH10 neuroactive nasal spray, a potential first-in-class, neurosteroid administered in microgram doses for treatment of MDD. The newly granted patent will not expire until at least 2034. Counterpart foreign patents have already been issued in China, Europe, Japan and several other countries.

“We continue to assemble a strong portfolio of patents related to our CNS drug pipeline. This newly granted patent is a key component of our commercial protection strategy for PH10 in the U.S.,” stated Shawn Singh, Chief Executive Officer of VistaGen. “Based on positive results of an exploratory Phase 2a study of PH10 as a stand-alone therapy for MDD, during which rapid-onset antidepressant effects were observed at microgram doses, without systemic exposure, psychological side effects or safety concerns, we are preparing for Phase 2b clinical development of PH10 in 2020, initially as a novel, fast-acting, at-home stand-alone treatment for MDD.”

“MDD affects approximately 16 million adults in the U.S. and is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer from the disorder and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments currently available. With both PH10 and AV-101, our novel oral NMDA receptor antagonist currently in Phase 2 development as an add-on treatment for MDD, our goal is to help fill the void of inadequate current therapies for MDD and transform the treatment landscape for individuals with MDD. Unfortunately, there is no ‘one size fits all’ solution for depression. With their unique mechanisms of action, we believe both AV-101 and PH10 have potential for multiple applications in global depression markets, as stand-alone therapies, or as add-on therapies to augment current FDA-approved antidepressants, and to prevent relapse following successful treatment with ketamine-based therapies,” continued Mr. Singh.

PH10 for MDD, Phase 2a Study and Next Steps:

In an exploratory 30-patient Phase 2a clinical study, PH10 was well-tolerated and, at microgram doses, demonstrated rapid-onset antidepressant effects, as measured by the Hamilton Depression Rating Scale (HAM-D), without psychological side effects or safety concerns. VistaGen is planning Phase 2b clinical development of PH10 in 2020 initially as a new stand-alone treatment for MDD. With its exceptional safety profile during clinical development to date, PH10 also has potential to change the current paradigm for treatment of treatment-resistant depression (TRD) with ketamine-based therapy (intravenous ketamine or esketamine nasal spray, both of which must be administered in a clinical setting), by enabling those who respond to such therapy to transition to more convenient at-home administration of PH10 to maintain the therapeutic benefits of ketamine or esketamine.

About PH10

PH10 is a novel, rapid-acting CNS neuroactive nasal spray administered in microgram doses. PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current antidepressants and ketamine-based therapy (intravenous ketamine or esketamine nasal spray). Based on positive results of an exploratory 30-patient Phase 2a clinical study in MDD in which rapid-onset antidepressant effects were observed without psychological side effects or systemic exposure, VistaGen is preparing for planned Phase 2b clinical development of PH10 in 2020, initially as a new stand-alone treatment for MDD.

About Major Depressive Disorder (MDD)

MDD is a serious neurobiologically-based mood disorder, affecting approximately 16 million adults in the U.S., according to the NIMH. Individuals diagnosed with MDD exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities, for more than a two-week period, as well as impaired social, occupational, educational or other important functioning which has a negative impact on their quality of life. Globally, MDD affects nearly 300 million people of all ages and is the leading cause of disability worldwide.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders with high unmet need. VistaGen’s pipeline includes three CNS drug candidates, AV-101, PH10 and PH94B. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This release contains various statements concerning VistaGen's future expectations, plans and prospects, including without limitation, our expectations regarding development and commercialization of our drug candidates, including PH10 and AV-101 for MDD, all of which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and may cause actual results to differ materially from those contemplated in these forward-looking statements. Among these risks is the possibility that (i) we may encounter unexpected adverse events in patients during our clinical development of any product candidate that cause us to discontinue further development, (ii) we may not be able to successfully demonstrate the safety and efficacy of our product candidates at each stage of clinical development, (iii) success in preclinical studies or in early-stage clinical trials may not be repeated or observed in ongoing or future studies, and ongoing or future preclinical and clinical results may not support further development of, or be sufficient to gain regulatory approval to market PH10, AV-101 or our other drug candidates, (iv) decisions or actions of regulatory agencies may negatively affect the progress of, and our ability to proceed with, further clinical studies or to obtain marketing approval for our drug candidates, (v) we may not be able to obtain or maintain adequate intellectual property protection and other forms of marketing and data exclusivity for our product candidates, (vi) we may not have access to or be able to secure substantial additional capital to support our operations, including our ongoing clinical development activities, and (vii) we may encounter technical and other unexpected hurdles in the manufacturing and development of any of our product candidates. Certain other risks are more fully discussed in the section entitled "Risk Factors" in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC's website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]

Investor Contact
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: [email protected]

Media Contact
Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications
Phone: +1 (212) 896-1241/+1 (508) 843-6428
Email: [email protected]

SOURCE: VistaGen Therapeutics, Inc.

SOUTH SAN FRANCISCO, CA / ACCESSWIRE / June 25, 2019 / VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today reported financial results for its fiscal year ended March 31, 2019 and provided an overview of operational highlights on its CNS pipeline.

"We are excited about our progress and recent developments involving AV-101, our novel, oral NMDA receptor glycine site antagonist. VistaGen is on track to reach target enrollment in ELEVATE, our Phase 2 study of AV-101 as a new generation treatment of major depressive disorder, during next quarter, with topline results expected in the second half of 2019. In addition, we are delighted with recently reported preclinical data supporting AV-101's potential in two additional large CNS markets with high unmet need, neuropathic pain and levodopa-induced dyskinesia affecting individuals with Parkinson's disease," said Shawn Singh, Chief Executive Officer of VistaGen.

"We are also pleased with FDA feedback regarding our plans for pivotal Phase 3 development of PH94B, our novel, rapid-acting neuroactive nasal spray for treatment of social anxiety disorder. With the growing misuse of benzodiazepines already at epidemic levels, we are very optimistic about PH94B's potential to transform the treatment paradigm for social anxiety disorder and reduce significantly or, ideally, eliminate current off-label use and misuse of benzodiazepines to treat this widespread and debilitating disorder. In addition, we believe successful Phase 2a study results support the potential of PH94B as a new treatment for generalized anxiety disorder and PH10, our second novel, rapid-acting, neuroactive nasal spray, as a novel first-line treatment for major depressive disorder. The multiple late-stage opportunities for VistaGen's pipeline to address large CNS market needs are robust, and we look forward to keeping our shareholders informed of our continued progress," added Mr. Singh.

CNS Pipeline Update:

VistaGen's CNS investigational pipeline currently contains three late-stage (in Phase 2 or entering Phase 3) product candidates, AV-101, PH94B, and PH10.

• AV-101 (4-Cl-KYN): One of VistaGen's two CNS product candidates in Phase 2 clinical development for major depressive disorder MDD belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with multiple CNS diseases and disorders, including MDD, neuropathic pain (NP), epilepsy, and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD). AV-101 is a novel, oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), a potent and selective full antagonist of the glycine site of the NMDA receptor, although it does not block the ion channel of the NMDA receptor. Instead, 7-Cl-KYNA is an allosteric antagonist and down-regulates the NMDA receptor which, in part, accounts for AV-101's exceptional safety profile and lack of psychological side effects and safety concerns compared to classic ion-channel blocking NMDA receptor antagonists such as ketamine. AV-101 has potential to be a new generation, oral, at-home treatment for MDD and several other CNS diseases and disorders.

• AV-101 for MDD, the ELEVATE Study: VistaGen's ELEVATE study is a Phase 2 multi-center, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of AV-101 as an add-on treatment (together with an FDA-approved oral antidepressant (AD)) for adult MDD patients with an inadequate therapeutic response to their current AD. VistaGen is also planning a Phase 2a study of AV-101 as an add-on treatment (together with standard ADs) to prevent relapse of MDD following successful ketamine-based therapy. The FDA has granted Fast Track designation for development of AV-101 as a potential add-on treatment of MDD.

• AV-101 for Suicidal Ideation, the Baylor/VA Study: VistaGen is collaborating with Baylor College of Medicine (Baylor) and the U.S. Department of Veterans Affairs (VA) on a small Phase 1b clinical trial of AV-101 in healthy volunteer U.S. military veterans. The Baylor/VA study is a randomized, double-blind, placebo-controlled crossover study designed as a first-step in VistaGen's plans to test potential anti-suicidal effects of AV-101 in U.S. military veterans who respond to ketamine-based therapy. Government funding from the VA is being provided for substantially all study costs.

• AV-101 for NP and LID: VistaGen is planning exploratory Phase 2a studies to assess the efficacy and safety of AV-101 for treatment of chronic NP and LID affecting PD patients.

• NP: In a recently reported preclinical study examining AV-101's analgesic and behavioral profile compared to pregabalin (Lyrica®), AV-101 demonstrated robust analgesic effects, similar to pregabalin, but fewer side effects as measured in the rotarod assay. The FDA has granted Fast Track designation for development of AV-101 as a non-opioid treatment for NP.

• LID: In a recently reported preclinical study in the "gold standard" MPTP monkey model of LID, AV-101 significantly (p = 0.01) reduced LID, without affecting the timing, extent or duration of the therapeutic benefits of levodopa therapy for PD, and without adverse events associated with amantadine therapy for LID.

• PH94B: VistaGen's PH94B neuroactive nasal spray is fundamentally different from all current treatments for social anxiety disorder SAD and generalized anxiety disorder (GAD). Administered at microgram doses as an odorless, rapid-onset (10 to 15 minutes) nasal spray, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations.

• PH94B for SAD, Published Phase 2 Clinical Trial: In a 91-patient published, peer-reviewed, randomized, double-blind, placebo-controlled Phase 2 clinical trial, which included both laboratory-based public speaking and social situation challenges, PH94B significantly improved the primary efficacy endpoint, as assessed using the Subjective Units of Distress (SUDS) scale, within 10 to 15 minutes of self-administration. It was not observed to be addictive, sedative or have other adverse events. VistaGen believes that PH94B neuroactive nasal spray is a novel product candidate with potential to become the first FDA-approved on-demand, as-needed treatment for SAD.

• PH94B for SAD, Pilot Phase 3 Crossover Study: In a 22-patient, four-week, randomized, double blind, placebo-controlled pilot Phase 3 crossover study, subjects receiving PH94B had a significantly greater decrease in average peak SUDS scores compared to placebo within one week of treatment. There was also a significantly greater decrease in the Liebowitz Social Anxiety Scale avoidance scores for subjects who received PH94B first, before crossing over to placebo. The data were presented in a poster session at Anxiety and Depression Association of America's 2019 Annual Conference.

• PH94B for GAD, Phase 2a Study: PH94B demonstrated efficacy in an exploratory placebo-controlled Phase 2a study in patients with GAD. Twenty-one patients were randomized to receive PH94B or placebo. Thirty minutes after treatment there was mean reduction of 32.0% for the PH94B group and 19.6% for the placebo group in the total Hamilton Anxiety Rating Scale (HAM-A) score. Electrophysiological changes (respiratory, cardiac, and electrodermal frequency), concordant with the reduction in anxiety, were significantly greater for the PH94B group. We believe these transient anti-anxiety effects of PH94B may warrant further investigation in a Phase 2b GAD trial.

• PH10 for MDD: VistaGen's second product candidate for MDD in Phase 2 development is PH10 a novel, rapid-acting CNS neuroactive nasal spray administered in microgram doses. PH10 nasal spray activates nasal chemosensory receptors that, in turn, engage GABA (gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone) neurons in the limbic amygdala system. The activation of these neural circuits is believed to have the potential to lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current ADs and ketamine-based therapy.

• PH10 for MDD, Phase 2a Study: In an exploratory 30-patient Phase 2a clinical study, PH10 was well-tolerated and, at microgram doses, demonstrated rapid-onset antidepressant effects, as measured by the Hamilton Depression Rating Scale (HAM-D), without psychological side effects or safety concerns. VistaGen is planning Phase 2b clinical development of PH10 as a first-line treatment for MDD.

Upcoming Clinical Milestones:

• Complete patient enrollment and obtain topline results from the ELEVATE study in the second half of 2019.

• Complete patient enrollment and obtain top line results from the Phase 1b Baylor/VA Study in the second half of 2019.

• Advance preparations for pivotal Phase 3 clinical development of PH94B for treatment of SAD, to begin first half 2020.

Fiscal Year Ended March 31, 2019 Financial Highlights:

Net loss attributable to common stockholders for the fiscal year ended March 31, 2019 was $25.7 million compared to $15.6 million for the fiscal year ended March 31, 2018. Net loss in fiscal 2019 included aggregate noncash expense of approximately $8.2 million, including $4.25 million for the acquisition of exclusive worldwide licenses to develop and commercialize our two novel, late-stage, neuroactive nasal spray product candidates, PH94B and PH10, through the issuance of unregistered shares of VistaGen's common stock.

Research and development expense totaled approximately $17.1 million in fiscal 2019, compared with approximately $7.8 million in fiscal 2018. The increase in fiscal 2019 is primarily attributable to (i) expense related to conducting the ELEVATE study throughout fiscal 2019, (ii) noncash expense of $4.25 million related to acquisition of our licenses to PH94B and PH10 through the issuance of unregistered shares of VistaGen common stock, and (iii) nonclinical activities, including manufacturing expense associated with the production of AV-101 for preclinical and clinical studies.

General and administrative expense was approximately $7.5 million in fiscal 2019, compared to approximately $6.4 million in fiscal 2018, primarily as a result of increased noncash stock-based compensation expense in fiscal 2019.

At March 31, 2019, VistaGen had cash and cash equivalents of approximately $13.1 million.

As of June 24, 2019, there were 42,622,965 shares of common stock outstanding.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders with high unmet need. VistaGen's pipeline includes three CNS drug candidates, AV-101, PH10 and PH94B. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This release contains various statements concerning VistaGen's future expectations, plans and prospects, including without limitation, our expectations regarding development and commercialization of our drug candidates, including AV-101 for MDD, NP, LID and suicidal ideation, PH94B for SAD, and PH10 for MDD, as well as our intellectual property and commercial protection of our drug candidates, all of which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and may cause actual results to differ materially from those contemplated in these forward-looking statements. Those risks include the following: (i) we may encounter unexpected adverse events in patients during our clinical development of any product candidate that cause us to discontinue further development; (ii) we may not be able to successfully demonstrate the safety and efficacy of our product candidates at each stage of clinical development; (iii) success in preclinical studies or in early-stage clinical trials may not be repeated or observed in ongoing or future studies, and ongoing or future preclinical and clinical results may not support further development of, or be sufficient to gain regulatory approval to market AV-101, PH94B, and/or PH10; (iv) decisions or actions of regulatory agencies may negatively affect the progress of, and our ability to proceed with, further clinical studies or to obtain marketing approval for our drug candidates; (v) we may not be able to obtain or maintain adequate intellectual property protection and other forms of marketing and data exclusivity for our product candidates; (vi) we may not have access to or be able to secure substantial additional capital to support our operations, including our ongoing clinical development activities; and (vii) we may encounter technical and other unexpected hurdles in the manufacturing and development of any of our product candidates. Certain other risks are more fully discussed in the section entitled "Risk Factors" in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC's website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]

Investor Contact
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: [email protected]

Media Contact
Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications
Phone: +1 (212) 896-1241/+1 (508) 843-6428
Email: [email protected]

VISTAGEN THERAPEUTICS
Consolidated Balance Sheets
(Amounts in dollars, except share amounts)

VISTAGEN THERAPEUTICS
STATEMENT OF OPERATIONS
Amounts in Dollars, except share amounts

SOURCE: VistaGen Therapeutics

Significant reduction of levodopa-induced dyskinesia by AV-101 observed in "gold standard" MPTP non-human primate model of Parkinson's disease, while maintaining antiparkinsonian activity of levodopa and without causing amantadine-like adverse effects

SOUTH SAN FRANCISCO, CA / ACCESSWIRE / June 20, 2019 / VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company committed to developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced positive results of recent preclinical studies of the effects of AV-101, its oral NMDA receptor glycine site antagonist, in a widely-used MPTP non-human primate model for reproducing motor complications of Parkinson's disease (PD), including dyskinesia (sudden uncontrolled movements) observed in PD patients treated with levodopa. In the MPTP primate model, AV-101's antidyskinetic effects were similar to those generally observed with amantadine therapy, but AV-101 did not cause adverse effects experienced with amantadine.

The MPTP primate model used in this study is the "gold standard" for animal modeling of PD and has been used extensively to study both antiparkinsonian therapies and levodopa-induced dyskinesia (LID). MPTP is a neurotoxin that kills dopaminergic neurons in the striatum, producing motor symptoms similar to those of PD. In this study, AV-101's efficacy against LID was measured through behavioral scores on a dyskinesia scale, and a Parkinsonian disability scale was used to measure levodopa antiparkinsonian efficacy. This study demonstrated that AV-101 significantly (p = 0.01) reduced LID without affecting the timing, extent, or duration of the therapeutic benefits of levodopa. This new preclinical study was conducted by Dr. Thérèse Di Paolo, Professor in the Faculty of Pharmacy at Laval University and among the world's leading researchers focused on Parkinson's disease and LID, pursuant to VistaGen's research agreement with CHU de Québec – Université Laval Research Center in Québec, Canada. Summary results of the study will be presented at an upcoming scientific conference.

"The antidyskinetic activity of AV-101 that we measured compares favorably with our observation with amantadine in parkinsonian monkeys," said Dr. Di Paolo. "Better than amantadine, with its known side effects (in humans with Parkinson's disease and in parkinsonian monkeys), we observed no adverse effects with AV-101."

A pivotal pathological hallmark of PD is a loss of dopamine neurons in the substantia nigra. Loss of dopamine neurons is thought to be due to neurotoxicity associated with misfolding of proteins and is associated with increased signaling of glutamate, the most abundant excitatory neurotransmitter in the brain. Increased glutamate activity is involved with aberrant neuronal signaling and excitotoxic death of neurons.

"The NMDA receptor plays a major role in glutamatergic signaling and has been shown to be a therapeutic target for LID," said H. Ralph Snodgrass, Ph.D., VistaGen's Chief Scientific Officer. "AV-101's active metabolite, 7-Cl-KYNA, is a potent and selective NMDA receptor glycine site antagonist with neuroprotective properties. These recent results confirm our prior antidyskinesia study in this MPTP monkey model. We believe these preclinical data and AV-101's positive safety profile in all clinical studies to date support AV-101's potential to treat LID, while both maintaining the antiparkinsonian benefits of levodopa and without causing hallucinations or other serious side effects that may be associated with current amantadine-based therapy for LID," added Dr. Snodgrass.

About Parkinson's Disease

PD is the second most common neurodegenerative disease worldwide, affecting approximately one million people in the U.S. and ten million people worldwide, according to the Parkinson's Foundation. Although there is no "one-size-fits-all" description of PD, PD is a complex neurodegenerative disorder that occurs when brain cells that make dopamine, a chemical that coordinates movement, stop working or die, resulting in progressive deterioration of voluntary motor control. Classic PD motor symptoms include muscular rigidity, resting tremor, and postural and gait impairment. Typically, PD patients present with a combination of motor and non-motor symptoms. Non-motor symptoms may include cognitive impairment, sleep disorders, pain and fatigue. There is currently no medication to slow, delay, stop or cure PD, and currently available treatments are symptomatic. Treatment of motor symptoms with oral levodopa, introduced about 50 years ago, remains the gold standard treatment.

About Levodopa-Induced Dyskinesia

LID is a disorder that affects people with PD who are treated with the current standard of care, oral levodopa, for an extended period of time. Oral levodopa remains the most effective therapy for motor symptoms of PD. However, after continuous long-term use (longer than five years), many PD patients experience LID. Although clinical manifestations of LID are heterogenous, LID is commonly associated with abnormal involuntary movements, including chorea and dystonia. These motor complications tend to become more severe as PD progresses and as the duration of levodopa treatment is extended, until the impact of LID may compromise the advantage of treatment with levodopa. PD treatment with levodopa is routinely delayed due to concerns over LID. Once LID develops, levodopa-treated PD patients may be faced with a choice between immobility due to untreated and uncontrolled PD, or mobility with the associated LID.

About AV-101

AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with multiple CNS diseases and disorders, including chronic neuropathic pain, epilepsy, major depressive disorder, LID and many others. AV-101 is an oral prodrug of 7-Cl-KYNA which binds uniquely at the glycine site of the NMDA receptor and has potential to be a new at-home treatment for multiple CNS indications with high unmet need. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company committed to developing new generation medicines for CNS diseases and disorders with high unmet need. VistaGen's pipeline includes three clinical-stage CNS drug candidates, AV-101, PH10 and PH94B. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This release contains various statements concerning VistaGen's future expectations, plans and prospects, including without limitation, our expectations regarding development and commercialization of our drug candidates, including AV-101 for treatment of LID in patients with PD receiving levodopa therapy, all of which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and may cause actual results to differ materially from those contemplated in these forward-looking statements. Among these risks is the possibility that (i) we may encounter unexpected adverse events in patients during our clinical development of any product candidate, including AV-101, that cause us to discontinue further development, (ii) we may not be able to successfully demonstrate the safety and efficacy of AV-101 or any of our other product candidates at each stage of clinical development, (iii) success in preclinical studies or in early-stage clinical trials may not be repeated or observed in ongoing or future studies, and ongoing or future preclinical and clinical results may not support further development of, or be sufficient to gain regulatory approval to market our drug candidates, including AV-101, (iv) decisions or actions of regulatory agencies may negatively affect the progress of, and our ability to proceed with, further clinical studies or to obtain marketing approval for our drug candidates, (v) we may not be able to obtain or maintain adequate intellectual property protection and other forms of marketing and data exclusivity for our product candidates, (vi) we may not have access to or be able to secure substantial additional capital to support our operations, including our ongoing clinical development activities, and (vii) we may encounter technical and other unexpected hurdles in the manufacturing and development of any of our product candidates. Certain other risks are more fully discussed in the section entitled "Risk Factors" in our most recent annual report on Form 10-K, and subsequent quarterly reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC's website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Company Contact

Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]

Investor Contact

Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: [email protected]

Media Contact

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SOURCE: VistaGen Therapeutics, Inc.