{"url_path":"/sec/vtgn/8-k/2026-06-30/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-30","source_url":"https://www.sec.gov/Archives/edgar/data/1411685/0001628280-26-046143-index.html","accession_number":"0001628280-26-046143","cik":"0001411685","ticker":"VTGN","issuer_name":"Vistagen Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1411685/0001628280-26-046143-index.html","primary_entity_key":"0001411685","primary_entity_name":"Vistagen Therapeutics, Inc."},"word_count":616,"has_tables":true,"body_markdown":"Item 8.01 Other Events\n\nOn June 30, 2026, the Company announced that the PALISADE-4 Phase 3 trial of intranasal fasedienol did not achieve its primary endpoint, as measured by the least squares (“LS”) mean change from baseline on the Subjective Units of Distress Scale (“SUDS”) score for fasedienol (-9.5+/-1.7 standard error (“SE”)) compared with placebo (-11.4+/-1.7 SE), with a difference in the LS means of 1.9 (p=0.427). There was no treatment difference between fasedienol and placebo for the secondary endpoints. Favorable safety and tolerability data of fasedienol were consistent with previous placebo-controlled clinical trials.\n\nIn a post-hoc analysis of a subpopulation of patients with very severe social anxiety defined by a baseline score at screening of 95 or greater on the Liebowitz Social Anxiety Scale (“LSAS”) (n=123), fasedienol was nominally statistically significant as measured by the LS mean change from baseline on the SUDS score for fasedienol (-12.8+/-3.4 SE) compared with placebo (-3.7 +/-3.4 SE), with a difference in the LS means of -9.1 (p=0.036).\n\nForward-Looking Statements\n\nThis Current Report on Form 8-K and the exhibits furnished herewith contain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding the Company’s plans to meet with the U.S. Food and Drug Administration (the “FDA”), the planned regulatory path forward for fasedienol potentially consisting of a single, multi-dose Phase 3 trial with the LSAS as the primary endpoint and confirmatory evidence from trials completed as a part of the PALISADE Phase 3 program, the Company's plans to transition from the acute treatment of social anxiety disorder symptoms to a potential registrational pathway focused on the overall treatment of social anxiety disorder over time, the Company’s belief about the meaningfulness of the efficacy signal in a subgroup of patients in PALISADE-4 with very severe social anxiety disorder and the totality of data across the fasedienol development program, the Company’s plans to remain financially disciplined and focused on evaluating opportunities to maximize the value of fasedienol and the other late clinical-stage pherine product candidates in its pipeline, the success, cost, timing and potential indications of the Company’s product development activities and clinical trials, and the Company’s belief that its cash resources will support operations into 2027. 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. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by the Company and its management, are inherently uncertain. Risks that may impact the outcome of these forward-looking statements are more fully discussed in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2026, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the SEC. The Company'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 report 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."}