Blog: VISTAGEN THERAPEUTICS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

Item 7.01 Regulation FD.

On September 8, 2022, Vistagen Therapeutics, Inc. (the “Company”) issued a press
release announcing the completion of the interim analysis of PALISADE-2, the
Company’s second Phase 3 clinical trial assessing drug candidate PH94B as an
acute treatment of anxiety in adults with Social Anxiety Disorder (“SAD”), which
concluded that PALISADE-2 should continue as planned.

The information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or
otherwise subject to the liabilities of that section, nor shall they be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended (the “Securities Act”) or the Exchange Act, except as may be expressly
set forth by specific reference in such a filing.

Item 8.01 Other Events.

On September 8, 2022, the Company announced that, based on the recommendation of
the independent biostatisticians who conducted the interim analysis of
PALISADE-2 to proceed with the Phase 3 clinical trial of PH94B an acute
treatment of anxiety in adults with SAD, the Company will continue PALISADE-2 as
planned to the full enrollment of 208 subjects, without any adjustment to the
size of the study. The Company expects topline results from the PALISADE-2 trial
in the first half of 2023. Independent biostatisticians reviewed unblinded data
from the 140 subjects who completed PALISADE-2 before the Company paused
enrollment in the study in July 2022, following announcement of topline results
from PALISADE-1, its first Phase 3 clinical trial of PH94B in SAD. The Company
does not itself have access to unblinded data from PALISADE-2.

Forward- Looking Statements

This Current Report on Form 8-K contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act and Section 21E of the
Exchange Act, including those relating to the development of PH94B, the
Company’s clinical trials, clinical and regulatory timelines, possible or
assumed future results of operations, business strategies, potential growth
opportunities and other statement that are predictive in nature. These
forward-looking statements are based on current expectations, estimates,
forecasts and projections about the industry and markets in which the Company
operates and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions,
including, but not limited to, “expect,” “anticipate,” “intend,” “plan,”
“believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and
similar expressions and the negatives of those terms. These statements relate to
future events or our financial performance and involve known and unknown risks,
uncertainties, and other factors which may cause actual results, performance or
achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements. Such
factors include those set forth in the Company’s filings with the Securities and
Exchange Commission (“SEC”). Prospective investors are cautioned not to place
undue reliance on such forward-looking statements, which speak only as of the
date of this press release. The Company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events or otherwise.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits Index


Exhibit No.              Description
   99.1         Press Release issued by Vistagen
              Therapeutics, Inc., dated
              September 8, 2022.
    104       Cover Page Interactive Data File
              (embedded within the Inline XBRL
              document)



——————————————————————————–

© Edgar Online, source Glimpses

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s