(Exact name of small business issuer as specified in its charter)
(State or other jurisdiction of incorporation or organization)
(IRS Employer Identification No.)
(Address of principal executive offices)
(Registrant's Telephone number)
(Former Name or Former Address, if Changed Since Last Report)
On March 12, 2013, VistaGen Therapeutics, Inc., a Nevada corporation (the "Company"), issued to Platinum Long Term Growth VII, LLC ("Platinum") a senior secured convertible promissory note in the principal amount of $750,000 (the "Investment Note"), and a warrant to purchase 750,000 shares of the Company's common stock at a price of $1.50 per share over a five year term (the "Investment Warrant"), each in accordance with the Note Exchange and Purchase Agreement, as amended (the "Agreement"), entered into by the Company and Platinum on October 11, 2012, and previously reported in the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 16, 2012. The issuance to Platinum represents the final issuance of Investment Notes and Investment Warrants under the amended terms of the Agreement.
The Investment Note matures three years from the date of issuance (the "Maturity Date"). Subject to certain conditions set forth in the Investment Note, upon the Maturity Date, all principal and accrued interest under the Investment Note shall be payable by the Company through the issuance of restricted shares of common stock to Platinum.
The Investment Note and the Investment Warrant were offered and sold in transactions exempt from registration under the Securities Act of 1933, as amended ("Securities Act"), in reliance on Section 4(2) thereof and Rule 506 of Regulation D thereunder. Platinum represented that it was an "accredited investor" as defined in Regulation D. The proceeds from the sale of the Investment Note and the proceeds received upon exercise of the Investment Warrants are expected to be used for general corporate purposes.
On March 11, 2013, the Company presented key developments of CardioSafe 3D, its pluripotent stem cell-based bioassay system for heart toxicity, and on March 12, 2013 the Company presented key enhancements to LiverSafe 3D, its human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues at the Society of Toxicology's 52nd Annual Meeting. Press releases containing summaries of the information presented are attached to this Current Report on Form 8-K as Exhibit 99.1 and 99.2, respectively.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, is being furnished pursuant to Item 7.01 of Form 8-K, "Regulation FD Disclosure." This information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
See Exhibit Index.
The descriptions of Agreement, Investment Note and Investment Warrant under Item 2.03 do not purport to be complete, and are qualified in their entirety by reference to the full text of the Agreement, form of Investment Note and form of Investment Warrant, attached as Exhibit 10.1, 10.2 and 10.3, respectively, to the Current Report on Form 8-K filed with the Securities and Exchange Commission on October, 16, 2012, and are incorporated herein by reference.
| VistaGen Therapeutics, Inc. |
| By: | /s/ Shawn K. Singh |
| Name: Shawn K. Singh | |
| Title: Chief Executive Officer |
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Exhibit No.
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Description
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EX-99.1
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Press Release, dated March 11, 2013
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EX-99.2
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Press Release, dated March 12, 2013
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VistaGen Therapeutics to Present CardioSafe 3D(TM) Developments at Society of Toxicology's 52nd Annual Meeting
Poster Will Discuss Expanded and Improved Applications of Novel Pluripotent Stem-Based Screening System for Heart Toxicity
SOUTH SAN FRANCISCO, CA--(Marketwire - Mar 11, 2013) - VistaGen Therapeutics, Inc. (OTCQB : VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces it will feature key developments involving CardioSafe 3D™, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 11, 2013, at 7:30 am PDT.
Dr. Hai-Qing Xian, Senior Scientist, will present VistaGen's poster titled "Development of Improved hESC-Based High-Throughput Screening Assays for Cardiotoxicity Assessment," which will detail the following expanded functional and electrophysiological results:
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Optimized differentiation protocols that, without selection, reproducibly yield more than 80% human cardiomyocytes (human heart cells) that function reliably in various established and newly developed assays relevant to cardiac drug effects
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The use of patented technology involving the CD172a cell surface marker, allows the purification of substantially pure (more than 95%) human cardiomyocytes
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The development of a series of fluorescence or luminescence-based high-throughput assays that are used to assess drug-induced: 1) necrosis; 2) apoptosis; 3) mitochondrial toxicity; and 4) oxidative stress of human cardiomyocytes
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New assays are validated using compounds that include: 1) inhibitors of protein kinases; 2) DNA intercalating agents; 3) ion-channel blockers; and 4) compounds that block the surface expression of critical ion-channels
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The assays measured drug effects with high sensitivity, yielding results consistent with known human biology of the compounds
H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, stated, "I am very pleased with these results, because they confirm that our stem cell-based human cardiomyocyte screening systems will provide improved capabilities and resolution for our cardiac drug rescue programs, which we believe will contribute to the efficient and rapid identification of safer and highly effective new drug therapies."
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.
VistaGen’s small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen’s Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue, predictive toxicology and metabolism screening activities, further development of stem cell-based bioassay systems, clinical development and commercialization of AV-101 for neuropathic pain or any other disease or condition, its ability to enter into strategic predictive toxicology, metabolism screening, drug rescue and/or drug discovery, development and commercialization collaborations and/or licensing arrangements with respect to one or more drug rescue variants, cell therapies or AV-101, risks and uncertainties relating to the availability of substantial additional capital to support its research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to any drug rescue variant or cell therapy identified and developed by VistaGen, or AV-101. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For more information:
Shawn K. Singh, J.D. Chief Executive Officer VistaGen Therapeutics, Inc. www.VistaGen.com 650-244-9990 x224 Investor.Relations@VistaGen.com | Mission Investor Relations IR Communications Atlanta, Georgia www.MissionIR.com 404-941-8975 Investors@MissionIR.com |
VistaGen Therapeutics to Present Enhancements and Expanded Validation of LiverSafe 3D(TM) at Society of Toxicology's 52nd Annual Meeting
SOUTH SAN FRANCISCO, CA--(Marketwire - Mar 12, 2013) - VistaGen Therapeutics, Inc. (OTCQB : VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces that it will present key enhancements to LiverSafe 3D™, its human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 12, 2013, at 11:00 am PDT.
Dr. Kristina Bonham, Senior Scientist, Hepatocyte Biology Project Leader, will present VistaGen's poster titled "Selection of CYP3A4+ hESC-derived Hepatocytes for Drug Metabolism and Toxicity Assays," which will detail the following expanded data:
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3A4BLA-hepatocytes (human liver cells) can be used to: monitor the differentiation of mature hepatocytes; sort for mature hepatocytes; monitor drug induction of the CYP3A4 gene, the crucial adult enzyme responsible for metabolizing approximately 50% of existing drugs; and develop in vitro assays for drug metabolism and toxicity
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Using appropriate reagents, the 3A4BLA system can be used to select and enrich stem cell-derived functionally mature hepatocytes
H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, stated, "These data demonstrate that we have substantially improved our LiverSafe 3D™ and now have the potential to identify and purify human hepatocytes with more mature functions, as well as provide a novel assay for drugs that effect CYP3A4 enzyme expression, activity and key drug-drug interactions." Dr. Snodgrass continued, "I am excited by the fact that further improvements in our differentiation protocols have enabled our scientists to produce cultures with more than 80% mature hepatocytes expressing CYP3A4 without cell enrichment, which will dramatically accelerate our initiation of drug rescue programs focusing on both liver and heart toxicity."
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to
generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.
VistaGen’s small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen’s Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue, predictive toxicology and metabolism screening activities, further development of stem cell-based bioassay systems, clinical development and commercialization of AV-101 for neuropathic pain or any other disease or condition, its ability to enter into strategic predictive toxicology, metabolism screening, drug rescue and/or drug discovery, development and commercialization collaborations and/or licensing arrangements with respect to one or more drug rescue variants, cell therapies or AV-101, risks and uncertainties relating to the availability of substantial additional capital to support its research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to any drug rescue variant or cell therapy identified and developed by VistaGen, or AV-101. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For more information:
Shawn K. Singh, J.D. Chief Executive Officer VistaGen Therapeutics, Inc. www.VistaGen.com 650-244-9990 x224 Investor.Relations@VistaGen.com | Mission Investor Relations IR Communications Atlanta, Georgia www.MissionIR.com 404-941-8975 Investors@MissionIR.com |