Vistagen Therapeutics, Inc.
For the period ended Aug 6, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Aug 6, 2026 · Filed Aug 6, 2026
Contents
Forward-Looking Statements
This Current Report on Form 8-K and the exhibit furnished herewith contain forward-looking statements within the meaning of the federal securities laws, including, without limitation, without limitation, statements regarding topline efficacy signals observed in the repeat dose study across prespecified analyses, which remain subject to change upon completion of a full analysis and audit of the complete data set from the study, the significance of such signals to the overall body of clinical evidence supporting fasedienol’s therapeutic potential, and the Company’s plans for upcoming discussions with the U.S. Food and Drug Administration (“FDA”) regarding the potential registrational pathway for fasedienol. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by the Company and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of the Company’s product candidates, including fasedienol, will successfully complete any future clinical trials, receive regulatory approval or be commercially successful. Because the repeat dose study was not powered to demonstrate statistical significance, there can be no assurance that the numerical trends and nominally significant findings described in the exhibit furnished herewith will be replicated in future, adequately powered clinical trials, or that the FDA will view such findings as supportive of a registrational pathway for fasedienol. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the Company’s ability to successfully employ cash preservation measures and/or secure adequate financing for its operations, including financing or collaborative support for continued clinical development of its product candidates; submission of a New Drug Application (“NDA”) to the FDA for any of the Company's product candidates, including fasedienol; and the ability of any clinical trial information submitted by the Company to the FDA to successfully support an NDA. These risks and others are more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the period ended March 31, 2026, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the SEC. Vistagen’s SEC filings are available on the SEC’s website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.