Vistagen (VTGN) last patient completes PALISADE-3 Phase 3 portion

Rhea-AI Filing Summary

Vistagen Therapeutics (VTGN) furnished a Regulation FD update announcing that the last patient has completed the randomized, double-blind, placebo-controlled public speaking challenge portion of its PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder.

The company attached a press release as Exhibit 99.1. The information was furnished under Item 7.01 and is not deemed filed under Section 18 of the Exchange Act.

Insights

Biotech clinical development analyst

Administrative clinical milestone; no efficacy data disclosed.

The company reports completion of the last patient for the public speaking challenge portion of PALISADE-3, a Phase 3 trial of fasedienol in social anxiety disorder. This indicates the specified trial activity has finished enrollment/procedures for that portion.

Because the disclosure provides no efficacy or safety results, it does not change the risk-benefit view of the program. As an Item 7.01 furnishing, it is an informational update rather than a financial or regulatory event.

Subsequent communications may present topline results or additional milestones, but none are included in this excerpt. Impact on timelines, outcomes, or cash needs is not addressed here.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did Vistagen (VTGN) announce in this update?

The company announced the last patient completed the public speaking challenge portion of its randomized, double-blind, placebo-controlled PALISADE-3 Phase 3 trial of fasedienol.

What is being studied in PALISADE-3?

PALISADE-3 evaluates fasedienol for the acute treatment of social anxiety disorder.

Does this filing include efficacy or safety results?

No. It reports completion of a trial portion but provides no efficacy or safety data.

How was this information provided to the market?

It was furnished under Item 7.01 (Regulation FD Disclosure) and is not deemed filed under Section 18 of the Exchange Act.

Where can I find more details from Vistagen?

A press release with the announcement is included as Exhibit 99.1.

What trial design details were mentioned?

The portion completed was a randomized, double-blind, placebo-controlled public speaking challenge.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 11/04/2025 - 04:10 PM Learn about SEC filing dates

FALSE000141168500014116852024-09-232024-09-23

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): November 3, 2025

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 94080

(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:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))

o 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 o

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 o

Item 7.01 Regulation FD Disclosure.

On November 3, 2025, Vistagen Therapeutics, Inc. (the “Company”) issued a press release to announce that the last patient has completed the randomized, double-blind, placebo-controlled public speaking challenge portion of the Company’s PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

Disclaimer.

The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.1 filed herewith be deemed 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.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits Index

Exhibit No.						Description
99.1						Press Release issued by Vistagen Therapeutics, Inc., dated November 3, 2025
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: November 4, 2025			By:			/s/ Shawn K. Singh
						Shawn K. Singh President and Chief Executive Officer