UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 5, 2022
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Nevada | 000-54014 | 20-5093315 |
(State or other jurisdiction of
incorporation) | (Commission File Number) | (IRS Employer
Identification Number) |
343 Allerton Ave. South San Francisco, California 94090 |
(Address of principal executive offices) |
(650) 577-3600
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | VTGN | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐
Item 8.01 Other Events.
On May 5, 2022, VistaGen Therapeutics, Inc. (the “Company”) issued a press release to announce a key regulatory update from the U.S. Food and Drug Administration (“FDA”) on its PALISADE Phase 3 Program for PH94B for the acute treatment of anxiety in adults with social anxiety disorder (“SAD”).
The FDA indicated the following regarding the Company’s late-stage development of PH94B for acute treatment of SAD: (i) nonclinical and clinical data in studies completed to date provide no signal of abuse potential; (ii) receptor binding data do not show that PH94B has affinity for abuse-related sites, such as dopamine, opiate or GABA; (iii) intravenous administration of PH94B to animals provides no overt behavioral responses; (iv) no additional nonclinical studies are needed to evaluate the abuse potential of PH94B; and (v) while the need for a human abuse potential (“HAP”) study with PH94B may be revisited by the FDA upon completion of the Company’s current and planned clinical trials, because nonclinical and clinical studies completed to date provide no signal of abuse potential, at this time, conducting a HAP study of PH94B is not necessary. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
Exhibit No. | | Description |
| | | |
| | Press Release issued by VistaGen Therapeutics, Inc., dated May 5, 2022 |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | VistaGen Therapeutics, Inc. |
| | | |
| Date: May 5, 2022 | By: | /s/ Shawn K. Singh |
| | | Shawn K. Singh Chief Executive Officer |
