Vistagen Therapeutics, Inc. filings document regulatory and corporate events for a Nasdaq-listed late clinical-stage biopharmaceutical company. Recent Form 8-K disclosures cover clinical program updates for fasedienol in the PALISADE social anxiety disorder program, FDA-related developments for refisolone under an IND application, and Regulation FD materials such as corporate presentations.
The company’s filings also record governance and capital-structure matters, including board departures, Audit Committee composition and Nasdaq listing-rule compliance, employee retention awards under the Amended and Restated 2019 Omnibus Equity Incentive Plan, and workforce and cash-management actions tied to clinical-development priorities.
Vistagen Therapeutics, Inc. amended and restated its Change in Control Executive Severance Plan, effective October 7, 2026. The change allows certain severance benefits after the company terminates an Eligible Employee without Cause even when the termination is not connected to a Change in Control. A termination by an employee for Good Reason generally qualifies during the period beginning three months before and ending eighteen months after a Change in Control.
For a qualifying termination outside a Change in Control, benefits generally require timely execution and non-revocation of a release of claims. They include a lump-sum payment based on monthly base salary and the applicable severance period, plus a lump-sum payment based on COBRA premiums and the benefits continuation period if the employee or eligible dependents timely elect coverage. Employees generally need at least 12 months of full-time service; all current executive officers are considered eligible.
Vistagen Therapeutics, Inc. (VTGN) began using a new corporate presentation dated September 2026, outlining its neuroscience pipeline, led by fasedienol for acute treatment of social anxiety disorder. PALISADE-2, with 140 participants, met its primary endpoint: fasedienol’s change from baseline on SUDS was 5.8 points better than placebo (p=0.015). PALISADE-1, PALISADE-3 and PALISADE-4 did not demonstrate statistically significant improvements on their respective primary endpoints.
Vistagen describes a proposed next U.S. Phase 3 study using LSAS in everyday-life settings, with a six-week treatment period and planned enrollment of 350 adults; its design is to be finalized based on FDA feedback. The proposed dose is 3.2 µg as needed, up to six times daily. The presentation also reports an exploratory Phase 2a itruvone study in major depressive disorder: HAM-D score changes were -17.8 points at 6.4 µg and -10.9 points with placebo (p=0.022). These product candidates have not received FDA marketing authorization or clearance.
Vistagen Therapeutics, Inc. presented exploratory findings on fasedienol nasal spray in participants with very severe social anxiety disorder, defined as a baseline Liebowitz Social Anxiety Scale (LSAS) score of 95 or higher. Across subgroup analyses from two randomized, double-blind, placebo-controlled studies, participants treated with fasedienol experienced anxiety-symptom improvements compared with placebo, measured by the Subjective Units of Distress Scale (SUDS).
In the PALISADE-4 Phase 3 trial, a post-hoc analysis found a statistically significant average SUDS benefit in the very-severe subgroup, although the trial did not meet its primary endpoint in the total population. In an exploratory Phase 2a repeat-dose study, a prespecified very-severe subgroup showed statistically significant average SUDS improvement after one dose; a second dose 10 minutes later produced an even greater numerical improvement. Vistagen described safety and tolerability results as favorable and consistent with the overall study populations, with no serious drug-related safety signals identified. The findings remain subject to completion of a full analysis and audit of the complete data set.
Vistagen Therapeutics, Inc. (VTGN) reported preliminary data from the open-label extension of its PALISADE-4 Phase 3 study evaluating intranasal fasedienol for the acute treatment of social anxiety disorder. In 322 adults using 3.2 µg fasedienol as needed, up to six times daily for as long as 12 months, treatment was well-tolerated with no new drug-related safety findings, a 1.6% discontinuation rate due to adverse events and no serious adverse events related to fasedienol.
Exploratory efficacy analyses showed clinically relevant improvements over four months. Mean baseline LSAS score was 99.3 (very severe); mean LSAS improvement reached 31.4 points at Month 4, with 65% of participants achieving ≥20‑point improvement. Mean baseline SPIN score was 48.5 (severe), with a 14.9‑point improvement and 59% achieving ≥10‑point improvement by Month 4. Vistagen states that these OLE results add to its fasedienol dataset and is preparing to meet with the FDA during the current quarter to consider a proposed new registrational Phase 3 trial, while noting that the randomized portion of PALISADE-4 previously did not meet its primary endpoint in the overall population.
Vistagen Therapeutics, Inc. (VTGN) reports the results of its 2026 Annual Meeting of Stockholders held on September 10, 2026. Stockholders elected four directors to the Board, approved on an advisory basis the compensation of named executive officers, and ratified KPMG LLP as independent registered public accounting firm for the fiscal year ending March 31, 2027.
Director nominees Jon S. Saxe and Douglas J. Williamson each received over 7.3 million votes in favor, while Ann M. Cunningham and Shawn K. Singh each received over 4.6 million votes in favor and were all elected by plurality. The say-on-pay proposal received 6,625,045 votes for, and KPMG’s ratification received 22,495,649 votes for, with relatively limited opposition.
Vistagen Therapeutics, Inc. is the issuer of Common Stock, par value $0.001 per share, CUSIP 92840H400. OrbiMed Advisors LLC and OrbiMed Capital LLC report that they now beneficially own 0 shares of this common stock, representing 0.0% of the class. They report no sole or shared voting or dispositive power over any Vistagen common shares, confirming ownership of 5 percent or less of the class and that they hold 0.0% on behalf of other persons.
Vistagen Therapeutics, Inc. received an updated Schedule 13G/A from TCG Crossover funds and Chen Yu regarding beneficial ownership of its common stock through warrants. The filing reports TCG Crossover I and its GP as beneficially owning 740,101 shares issuable upon exercise of Tranche I and Tranche II Warrants, representing 1.8% of the common stock on an as-converted basis. TCG Crossover II and its GP are reported as beneficially owning 2,220,303 warrant shares, or 5.1%. Chen Yu, as sole managing member of both general partners, may be deemed to beneficially own 2,960,404 warrant shares, or 6.7%, all subject to a 9.99% Beneficial Ownership Limitation that restricts warrant exercises above that level. The ownership calculations use 41,032,453 shares of common stock outstanding as of June 12, 2026, plus the respective warrant shares assumed exercised.
Vistagen Therapeutics, Inc. reported a net loss of $13.0 million for the quarter ended June 30, 2026, improving from a $15.1 million loss a year earlier. Revenue rose to $1.5 million from $0.2 million, driven by sublicense and collaboration activity. Operating expenses remained high at $14.8 million, largely for research and development of its pherine-based neuroscience pipeline.
Cash, cash equivalents and marketable securities totaled $31.7 million, down from $45.4 million at March 31, 2026, with $14.7 million used in operating activities during the quarter. The company disclosed substantial doubt about its ability to continue as a going concern within one year without additional financing and expects continuing losses. Nasdaq granted an extension until February 1, 2027 to regain compliance with the $1.00 minimum bid price requirement.
Vistagen advanced multiple clinical programs. For lead candidate fasedienol in social anxiety disorder, one Phase 3 trial (PALISADE-2) was previously positive, while others did not meet primary endpoints; post-hoc analyses showed nominal benefits in very severe patients. The company believes it now meets ICH E1 exposure recommendations and plans FDA discussions on a potential registrational path. Refisolone and itruvone also progressed, with refisolone cleared to proceed in U.S. Phase 2 for menopausal hot flashes.
Commodore Capital LP, Commodore Capital Master LP, Robert Egen Atkinson and Michael Kramarz report beneficial ownership of Vistagen Therapeutics, Inc. common stock on a passive Schedule 13G basis. As of June 30, 2026, they may be deemed to beneficially own 4,244,590 shares of common stock.
This consists of 2,788,620 common shares, Tranche 1 Warrants to purchase up to 1,394,310 shares, and Tranche 2 Warrants to purchase up to 61,660 shares, representing 9.9% of the class. The Tranche 1 and Tranche 2 Warrants are subject to a 9.99% Beneficial Ownership Limitation, so an additional 1,628,354 Tranche 2 Warrants are excluded from the reported beneficial ownership.
Vistagen Therapeutics reported fiscal 2027 first quarter results and a corporate update centered on its intranasal pherine pipeline. Revenue was $1.5 million, mainly from recognizing $1.2 million tied to the expiration of an exclusivity period under a Fuji Pharma agreement. Research and development expense was $10.9 million and general and administrative expense was $3.9 million, both modestly lower than a year earlier as the company executes cash preservation initiatives.
Net loss was $13.0 million, improving from $15.1 million in the prior-year quarter. Cash, cash equivalents, and marketable securities totaled $31.7 million as of June 30, 2026, which Vistagen believes will fund operations into 2027 but not for more than a year from now. Clinically, the lead candidate fasedienol did not meet the primary endpoint in the overall PALISADE-4 Phase 3 population, but exploratory and post-hoc analyses in patients with very severe social anxiety showed nominally statistically significant improvements versus placebo, with a favorable safety profile. The company has achieved ICH-recommended exposure levels and is planning FDA discussions on a potential Phase 3 registrational path, while also advancing itruvone and refisolone and adding experienced neuroscience leadership.