Quarterly report pursuant to Section 13 or 15(d)

History and Organization

v2.4.0.8
History and Organization
6 Months Ended
Sep. 30, 2014
Notes to Financial Statements  
NOTE 1 - History and Organization

Overview

 

VistaGen Therapeutics, Inc. (formerly Excaliber Enterprises, Ltd.), a Nevada corporation, is a clinical-stage biopharmaceutical company developing novel medicine to treat depression, cancer and diseases and disorders involving the central nervous system. Our principal executive offices are located at 343 Allerton Avenue, South San Francisco, California 94080, and our telephone number is (650) 577-3600. Our website address is www.vistagen.com. Unless the context otherwise requires, the words “VistaGen Therapeutics, Inc.” “VistaGen,” “we,” “the Company,” “us” and “our” refer to VistaGen Therapeutics, Inc., a Nevada corporation.

 

VistaGen Therapeutics, Inc., a California corporation incorporated on May 26, 1998 (VistaGen California), is our wholly-owned subsidiary. Pursuant to a strategic merger transaction on May 11, 2011, we acquired all outstanding shares of VistaGen California in exchange for 341,823 shares of our common stock (Merger), and assumed all of VistaGen California’s pre-Merger obligations. Our Condensed Consolidated Financial Statements in this report also include the accounts of VistaGen California’s two wholly-owned subsidiaries, Artemis Neuroscience, Inc., a Maryland corporation, and VistaStem Canada, Inc., a corporation organized under the laws of Ontario, Canada.

 

AV-101

 

Our initial product candidate is AV-101, an orally-available, non-sedating prodrug (precursor chemical compound) that is rapidly converted in vivo to its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized, potent and selective blocker of the required glycine-B (GlyB) site of the N-methyl-D-aspartate receptors (NMDAR). However, 7-Cl-KYNA does not cross the blood-brain barrier, making it a poor drug candidate. AV-101, the prodrug of 7-C1-KYNA, readily gains access to the central nervous system (CNS) after oral administration and is converted to 7-Cl-KYNA by astrocytes that are preferentially activated at sites of neuronal injury or excitotoxic insult. AV-101 is a novel potential treatment for multiple diseases and disorders involving the CNS, including Major Depressive Disorder, epilepsy, neuropathic pain and neurodegenerative diseases such as Parkinson’s disease.

 

AV-101 for Depression

 

Depression is a global public health concern. The World Health Organization estimates that “depression is the leading cause of disability worldwide, and is a major contributor to the global burden of disease,” affecting 350 million people globally, including nearly 7% of adults in the United States.

 

Although antidepressant drugs are available, millions of depression patients are poorly served by current antidepressant therapies, many of which require several weeks before therapeutic benefits are achieved. In addition to the high percentage of depressed patients who are not effectively treated by current antidepressant drugs, the several week lag period in onset of action of traditional antidepressants is recognized as a major limitation, resulting in substantial morbidity and high risk of suicidal behavior, especially during the first two weeks after starting treatment. Therefore, safe, novel depression medicine with rapid onset of antidepressant effects could have a major impact on public health in the U.S. and worldwide.  

 

In randomized, placebo-controlled, double-blind clinical trials conducted by Dr. Carlos Zarate and others at the National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), ketamine, a classic NMDAR channel blocker, produced robust and rapid antidepressant effects in treatment-resistant patients suffering with Major Depressive Disorder. However, the clinical utility of ketamine, which is administered intravenously, and other NMDAR channel blockers has been severely limited by their potential for abuse and dissociative side effects, including hallucinations and schizophrenia-like effects.

 

By regulating the NMDAR rather than blocking it, AV-101 has the potential to achieve the rapid-onset antidepressant effects of ketamine and many other classic NMDAR channel blockers, without causing their serious side effects.

 

On November 6, 2014, we signed a Letter of Intent to enter into a Cooperative Research and Development Agreement (CRADA) with the NIMH to collaborate on a NIMH-sponsored Phase 2 clinical study of AV-101 in Major Depressive Disorder. Dr. Carlos Zarate, Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be the Principal Investigator for our AV-101 Phase 2 depression study under the proposed CRADA. We anticipate both commencing and completing the study in 2015.

 

The NIH previously awarded us $8.8 million for our AV-101 preclinical and Phase 1 clinical development programs. In two randomized, double-bind, placebo-controlled Phase 1 safety studies, AV-101 was well tolerated and not associated with any severe adverse events. There were no signs of sedation, hallucinations or schizophrenia-like side effects often associated with ketamine and many of the NMDAR channel blockers. 

 

Stem Cell Technology-based Drug Rescue

 

With mature, adult human heart cells and liver cells produced using our proprietary pluripotent stem cell technology, we have developed two customized human cellular bioassay systems, CardioSafe 3D and LiverSafe 3D, for predicting heart toxicity and liver toxicity of new drug candidates long before they are ever tested in animal or human studies. We are leveraging CardioSafe 3D and LiverSafe 3D for drug rescue focused on producing new, safer variants of drug candidates previously optimized and tested for efficacy by pharmaceutical companies but terminated before FDA approval due to heart or liver toxicity concerns. Our initial drug rescue programs are focused on novel therapies for cancer.