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Vistagen Therapeutics, Inc.

For the period ended May 8, 2026. Filed May 8, 2026.

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About 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.

May 8, 2026 · Filed May 8, 2026

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VTGN$0.16-0.8%Stored close · as of Nov 6, 2026
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EX-99.1 · Forward-looking Statements

Forward-looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding the expected timing for topline results from the randomized portion of PALISADE-4; the design of the PALISADE-4 clinical trial and its ability to evaluate the efficacy and safety of fasedienol to reduce anxiety symptoms in patients with social anxiety disorder; continued analysis of datasets from the PALISADE-1, PALISADE-2 and PALISADE-3 Phase 3 studies; the refinements to the PALISADE-4 SAP, and the ability of the refined PALISADE-4 SAP to result in a positive outcome for PALISADE-4; Vistagen’s belief that the refined SAP reflects established statistical principles supporting the use of baseline covariates in randomized clinical trials and is consistent with publicly available FDA guidance; Vistagen’s belief that successful results from its PALISADE Phase 3 development program, including PALISADE-4, could provide substantial evidence of fasedienol’s effectiveness in support of a potential NDA submission to the FDA; fasedienol’s potential to achieve rapid-onset anxiolytic effects for individuals with social anxiety disorder on an acute, as-needed basis. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. 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 Vistagen and its management, are inherently uncertain. As with all pharmaceutical product candidates, there are substantial risks and uncertainties in the process of development and potential 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 Vistagen’s pherine product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference , include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including those that are a part of Vistagen’s Phase 3 development of fasedienol in the PALISADE program, as currently expected or at all; submission of a NDA to the FDA for any of Vistagen's product candidates, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the FDA to successfully support an NDA; Vistagen's dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, which are outside of Vistagen's full control; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen’s patents, including patents related to Vistagen’s fasedienol and other pherine product candidates; fluctuating costs of materials and other resources and services required to conduct Vistagen’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen’s product candidates. These risks are more fully discussed in the section entitled “Risk Factors” in Vistagen’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025, and Quarterly Report on Form 10-Q for the period ended December 31, 2025, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen’s SEC filings are available on the SEC’s website at 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 Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.

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