VTGN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• We are a late clinical-stage biopharmaceutical company focused on leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of rapid-onset neurocircuitry-focused intranasal product candidates called pherines. Our pherine product candidates are designed …

• In May 2026, we announced preliminary data from the ongoing real-world open label extension (OLE) portion of our PALISADE-3 Phase 3 clinical trial. Based on an analysis of subjects who elected to participate in the OLE portion of PALISADE-3 (n=341 subjects), as of the May 8, 2026, data cutoff date, …

• In June 2026, we announced topline and post-hoc data from the randomized portion of PALISADE-4, our U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in reducing anxiety sy…

• The post-hoc analysis for the very severe social anxiety disorder subpopulation (defined by LSAS ≥95) excludes data from one site (n=15) for irregularities documented and communicated before database lock that led to site disqualification from the trial. The post-hoc analysis also excluded data to a…

• In June 2026, we also announced that we achieved the minimum fasedienol patient exposures as recommended under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E1, the international regulatory standard governing safety database exposure recomm…

Text removed vs the prior filing · source: 10-Q · 2026-02-12

• We are a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and potentially commercialize a new class of intranasal product candidates called pherines. Our broad and diverse neuroscience pipeline currently consists of five clinica…

• Our most advanced intranasal pherine product candidate is fasedienol, which is being investigated in our U.S. registration-directed PALISADE Program for the acute treatment of social anxiety disorder (SAD). There are four Phase 3 trials of fasedienol for the acute treatment of SAD in our PALISADE Pr…

• We have also reported positive results from an exploratory Phase 2A clinical trial for each of our next most advanced pherine product candidates, itruvone for treatment of major depressive disorder, and refisolone (formerly PH80) for both vasomotor symptoms (hot flashes) due to menopause and premens…

• SAD is a highly prevalent, serious, and life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. With onset typically early in life, usually during adolescence, SAD persists for many years thereafter, with a reported mean duration of about 20 years. Individual…

• Fasedienol, our lead clinical-stage product candidate, is a synthetic neurocircuitry-focused intranasal pherine in an ongoing U.S. registration-directed Phase 3 clinical development program for the acute treatment of anxiety in adults with SAD. Fasedienol's proposed MOA is fundamentally differentiat…

Text added vs the prior filing · source: 10-Q · 2026-08-14

• Cesario et al. v. Vistagen Therapeutics, Inc. et al. (District of Nevada). On April 10, 2026, the Cesario Plaintiffs filed a stockholder derivative action, pro se, in the District of Nevada (Case No. 2:26-cv-01128) against the Company, and certain current and former Board members, executive officers…

• Securities Class Action Lawsuit and Derivative Actions in the Northern District of California. On January 15, 2026, a putative class action complaint (the Class Action Complaint) was filed by alleged stockholder Dan Eller against the Company, Shawn Singh, and Joshua Prince(the Class Action Defendant…

• The Company believes the claims asserted in the Class Action Complaint are wholly without merit, and intends to defend them vigorously.

• Two stockholder derivative actions were filed against the Company, as nominal defendant, and certain of the Company's current and former officers and directors, in the United States District Court for the Northern District of California, captioned Do v. Singh et al. (Case No. 4:26-cv-02656) (the Do …

• relate the Derivative Actions to the Class Action were granted on July 13, 2026, and July 2, 2026, respectively, and a stipulation consolidating the Derivative Actions and staying the consolidated Derivative Actions pending resolution of the Class Action was filed with the Court on July 13, 2026. Th…

Text removed vs the prior filing · source: 10-Q · 2026-02-12

• Eller v. Vistagen Therapeutics, Inc. et al. On January 15, 2026, a putative class action complaint (the Class Action Complaint) was filed by alleged stockholder Dan Eller against the Company and certain of its executive officers (the Defendants) in the United States District Court for the Northern D…

• The Company believes all allegations asserted in the Class Action Complaint are wholly without merit, and intends to defend them vigorously.

Text added vs the prior filing · source: 10-Q · 2026-08-14

• •we require substantial additional financing to execute our long-term business plan, including further development and commercialization of our pherine product candidates, and to continue to operate as a going concern;

• •if we fail to regain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted;

• •we depend heavily on the success of fasedienol and, to a lesser extent, our other pherine product candidates, and we cannot be certain that ongoing or future clinical trials will produce successful results or that we will be able to obtain regulatory approval for fasedienol or any of our current or…

• •failures of ongoing or future nonclinical or clinical trials of our product candidates, such as our PALISADE-1, PALISADE-3 and PALISADE-4 clinical trials, or material delays in the completion and/or commencement of our ongoing or planned nonclinical or clinical trials, could result in increased cos…

• •we are focused on novel neuroscience drug development, a field that has seen very limited success. The ability to successfully develop product candidates in this field is extremely difficult and is subject to a number of unique challenges;

Text removed vs the prior filing · source: 10-Q · 2026-02-12

• •we require substantial additional financing to execute our business plan, including further nonclinical and clinical development, contract manufacturing and potential commercialization of our product candidates;

• •if we fail to regain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted;

• •we depend heavily on the success of our product candidates, and we cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates;

• •failures of ongoing or future nonclinical or clinical trials of our product candidates, or material delays in the completion and/or commencement of our ongoing or planned nonclinical or clinical trials, could result in increased costs to us and could delay, prevent or limit our ability to generate …

• •we are focused on novel neuroscience drug development, a field that has seen very limited success. The ability to successfully develop product candidates in this field is extremely difficult and is subject to a number of unique challenges;