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4週前
Vistagen Announces Preliminary Positive Data in Ongoing Open-Label Extension Portion of PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety DisorderMay 12, 2026 7:30 AM
Business Wire Fasedienol nasal spray has been well-tolerated in patients with social anxiety disorder with no new drug-related safety findings after as-needed use in daily life for up to 12 months Clinically relevant improvement in social anxiety over time was observed on both clinician-administered and patient-reported scales over four months Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder. In a recent analysis of subjects who elected to participate in the OLE portion of PALISADE-3 (safety population: n=341), administration of 3.2 µg of fasedienol – taken as needed, up to six times per day in real-world, anxiety-provoking situations in daily life for up to 12 months – has been well-tolerated, with no new drug-related safety findings or trends identified. Exploratory efficacy data over the first four months of treatment demonstrated a clinically relevant improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN). “Social anxiety disorder surfaces in the everyday moments of people's lives,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “Among our core goals is giving patients the ability to manage their anxiety in the daily life situations that matter most to them. We’re continually encouraged by the improvements observed over time when patients in our open-label studies self-administer fasedienol as they feel it’s needed.” Preliminary Safety Data In the OLE portion of PALISADE-3, as of May 8, 2026, fasedienol nasal spray, taken as-needed, up to six times a day, was observed to be well-tolerated in adults with social anxiety disorder. The rate of discontinuation due to adverse events was 2.6% (9/341), with no discontinuations attributed to fasedienol. Substantially all (>95%) of TEAEs were mild or moderate in severity. The only TEAEs occurring in > 5% of subjects were headache (10.9%, 37/341) and upper respiratory infection (11.4%, 39/341). There were no Serious Adverse Events related to fasedienol. No safety signals of concern were identified related to laboratory values, ECGs, physical examinations, and vital sign assessments following exposure to fasedienol. Preliminary Exploratory Efficacy Data Liebowitz Social Anxiety Scale (LSAS) The OLE portion of PALISADE-3 explored the change from baseline (study entry) on the LSAS, a 24-item clinician-administered scale (range 0-144), which measures fear and avoidance experienced over time due to social anxiety disorder during anxiety-provoking social and performance situations. The recent analysis of a data cut from the initial four-month period in the OLE portion of PALISADE-3 demonstrated a clinically relevant improvement over time on the LSAS for subjects participating in the OLE: At study entry, the mean baseline LSAS score (99.2, n=341) indicated very severe social anxiety (≥80). At Month 1, mean improvement on the LSAS was 16.3 points (n=305, 38% had a ≥ 20 point-improvement). At Month 2, mean improvement on the LSAS was 22.4 points (n=269, 49% had a ≥ 20 point-improvement). At Month 3, mean improvement on the LSAS was 24.1 points (n=248, 54% had a ≥ 20 point-improvement). At Month 4, mean improvement on the LSAS was 25.4 points (n=228, 56% had ≥ 20 point-improvement). Improvements were observed on both the fear and avoidance subscales, suggesting that patients engaging in daily life have experienced less fear and avoidance of anxiety-provoking situations. Moreover, subjects who did not respond to fasedienol administered in the simulated single-dose, clinic-based public speaking challenge during the randomized portion of PALISADE-3 showed comparable change at Month 1 and Month 4 compared to the total population in both LSAS mean improvement (Month 1 = 13.4 and Month 4 = 20.8) and LSAS response of ≥20 point improvement (Month 1 = 40% and Month 4 = 50% of subjects). Social Phobia Inventory (SPIN) The OLE portion of PALISADE-3 also explores the change from baseline on the SPIN, a 17-item patient-reported scale (range 0-64) which measures fear, avoidance, and physiological components of social phobia over time. The recent analysis of the initial four-month data cut from the OLE portion of PALISADE-3 demonstrated a clinically relevant improvement over time on the SPIN for subjects participating in the OLE: At study entry, the mean baseline SPIN score (48.7, n=341) indicated severe social anxiety (≥41). At Month 1, mean improvement on the SPIN was 7.9 points (n=305, 35% had a ≥ 10-point improvement). At Month 4, mean improvement on the SPIN was 12.4 points (n=228, 55% had a ≥ 10-point improvement). “The magnitude of improvement on both the LSAS and the SPIN scales through four months of treatment in patients with very severe social anxiety support the potential clinical meaningfulness of these findings,” said Dr. Michael R. Liebowitz, a consultant and clinical advisor to Vistagen, the innovator of the LSAS, former Columbia University psychiatrist, founder and former director of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and former Managing Director of The Medical Research Network LLC in New York City. The Company believes that the interim safety and exploratory efficacy results of the OLE are consistent with the safety and efficacy previously reported in the fasedienol Long Term Safety Study (LTSS) data1 and results of a randomized, double-blind, placebo-controlled Phase 2 crossover study of fasedienol in a real-world setting conducted by Dr. Liebowitz2. Results from both prior studies suggest that as-needed self-administration of fasedienol prior to anxiety-provoking real-world situations in daily life was accompanied by a persistent change in the overall severity of social anxiety disorder. Specifically, both studies showed a reduction in fear and anxiety, and less frequent avoidance, as measured by the LSAS over the course of fasedienol usage. About the OLE Portion of PALISADE-3 The OLE is a voluntary extension of the randomized double-blind, placebo-controlled portion of the PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder, available to participants who choose to continue in the study per the study protocol. It is designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (up to six times daily, maximum daily dose of 19.2 µg fasedienol) in adults with social anxiety disorder over time in daily life. Monthly safety and tolerability assessments include monthly change in adverse events (AEs), laboratory values, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign assessments. The study is also evaluating the change from baseline over time in standard clinical measurements (the LSAS and the SPIN) as participants use fasedienol in real-world social situations in their daily lives. Endpoints of the OLE portion of PALISADE-3 include a monthly evaluation of the change from baseline at study entry on the LSAS and a Month 1 and Month 4 evaluation of change from baseline at study entry on the SPIN patient self-report questionnaire. Both scales provide a validated psychological assessment of the severity of social anxiety disorder, with a focus on fear, avoidance, and physiological discomfort in social and performance situations. About PALISADE-3 PALISADE-3 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 public speaking challenge study designed to evaluate the efficacy and safety of fasedienol in reducing anxiety symptoms during a simulated single-dose, clinic-based public speaking challenge using the Subjective Units of Distress Scale (SUDS). PALISADE-3 subjects who chose to continue with the open-label extension of the study can use fasedienol as needed in their daily lives up to six times per day for up to twelve months. In December 2025, Vistagen announced topline results from the randomized portion of PALISADE-3. The single-dose randomized portion of the study did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the SUDS for fasedienol (13.6 +/-1.54 standard error, SE) compared with placebo (14.0 +/-1.51 SE). There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previously completed clinical trials. About Ongoing PALISADE Program Clinical Trials The ongoing clinical trials in Vistagen’s PALISADE Phase 3 Program for fasedienol for the acute treatment of social anxiety disorder include the open label extension portion of its PALISADE-3 and PALISADE-4 Phase 3 trials and a small exploratory Phase 2 randomized, placebo-controlled trial designed to assess efficacy, safety and tolerability of a repeat dose of fasedienol in adults with social anxiety disorder in a public speaking challenge in a clinical setting (Repeat Dose Study). PALISADE-4 is a multi-center, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in subjects with social anxiety disorder induced by a public speaking challenge conducted in a clinical setting. On May 8, 2026, the Company announced that the last patient completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4. PALISADE-4 subjects who chose to continue with the open-label extension of the study can use fasedienol as needed in their daily lives up to six times per day for up to twelve months. PALISADE-4 remains on track for topline data in the second quarter of 2026. Topline results for the exploratory Phase 2 Repeat Dose Study are expected in the third quarter of 2026. Vistagen believes that PALISADE-4, if successful, together with the positive results from its PALISADE-2 Phase 3 trial and further evidence Vistagen plans to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of fasedienol’s effectiveness in support of a potential New Drug Application (NDA) submission to the FDA for the acute treatment of social anxiety disorder. About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company 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. Vistagen’s pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options, if successfully developed and approved. Vistagen’s pherine pipeline currently consists of five clinical-stage investigational product candidates focused on improving the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com. Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding indication of improvements observed over time by patients in the OLE portion of PALISADE-3; the ability of preliminary findings from the OLE portion of PALISADE-3 to support the potential clinical meaningfulness; indications of safety data from the OLE portion of the PALISADE-3; the Company’s belief that the results of the OLE are consistent with the previously reported LTSS data and a Phase 2 crossover study of fasedienol; Vistagen’s other beliefs about the understandings drawn from the preliminary OLE data; statements regarding the expected timing for topline results from the randomized portion of PALISADE-4 and the Repeat Dose Study; and 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. 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 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 Vistagen’s 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 fasedienol PALISADE Phase 3 program, as currently expected or at all; Vistagen’s ability to 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; 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; the scope and enforceability of Vistagen’s patents, including patents related to Vistagen’s pherine product candidates; and other technical and unexpected hurdles in the development, manufacture and/or potential commercialization of Vistagen’s product candidates. These risks and others are more fully discussed in the section entitled “Risk Factors” in Vistagen’s 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 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 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. References: Lappalainen, J et al. (2023). A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults with Social Anxiety Disorder (SAD). American Society of Clinical Psychopharmacology (ASCP) 2023 Annual Meeting. Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L (2016). Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety 33: 1081-1089. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512521110/en/ Investor Inquiries:
IR@vistagen.com Media Inquiries:
media@vistagen.com Original: Vistagen Announces Preliminary Positive Data in Ongoing Open-Label Extension Portion of PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder
US Market News
1月前
Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment of Social Anxiety DisorderMay 8, 2026 7:30 AM
Business Wire Topline results for the randomized portion of PALISADE-4 are expected in the second quarter of 2026 Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company’s Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder. The open label extension (OLE) portion of the PALISADE-4 study remains ongoing. “The completion of the randomized portion of PALISADE-4 is another important step for our fasedienol Phase 3 program in social anxiety disorder, and we expect to announce topline results this quarter,” said Shawn Singh, President and Chief Executive Officer. “We extend our sincere thanks to the participants, clinical investigators, site staff, and contract research organization whose hard work, collaboration, and commitment brought this portion of the study to completion.” PALISADE-4 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in reducing anxiety symptoms in adults with social anxiety disorder during a simulated anxiety-provoking public speaking challenge conducted in a clinical setting using the Subjective Units of Distress Scale (SUDS) as the primary endpoint. Participants in the randomized portion of PALISADE-4 who chose to continue with the OLE portion of the study can use fasedienol in their daily lives up to six times per day for up to twelve months. As previously announced, Vistagen continues to analyze datasets from the randomized portions of the PALISADE-1, PALISADE-2, and PALISADE-3 Phase 3 studies for fasedienol for the acute treatment of social anxiety disorder, including with the assistance of collaborators and proprietary artificial intelligence and machine learning methodologies. Based on these analyses, Vistagen refined the statistical analysis plan (SAP) for PALISADE-4 to incorporate each participant’s distress level immediately prior to dosing, as measured by the SUDS (pre-IP SUDS), into the primary efficacy analysis. While there is no guarantee the Company’s refinements to the PALISADE-4 SAP will result in a positive outcome for the study, Vistagen believes the refined SAP reflects established statistical principles supporting the use of baseline covariates in randomized clinical trials consistent with U.S. Food and Drug Administration (FDA) guidance regarding adjustments for covariates (Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, May 2023). The FDA has informed the Company that it has no comments on the refinements to the PALISADE-4 SAP. No changes were made to the PALISADE-4 clinical study protocol as a result of the ongoing dataset analyses or refinement of the PALISADE-4 SAP. The FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of social anxiety disorder. Vistagen believes that PALISADE-4, if successful, together with the positive results from its PALISADE-2 Phase 3 trial and further evidence Vistagen plans to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of fasedienol’s effectiveness in support of a potential New Drug Application (NDA) submission to the FDA for the acute treatment of social anxiety disorder. About Social Anxiety Disorder Social anxiety disorder is a highly prevalent, serious, and sometimes life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. While often experienced on a long-term basis, social anxiety disorder can manifest acutely when triggered by anxiety-provoking social and performance situations in daily life, causing anxiety, distress, and the fear of embarrassment, judgment, and humiliation. Social anxiety disorder can also significantly disrupt social life and hinder occupational functioning, as well as increase the risk of depression and substance use disorders, suicidal ideation, and suicide. About Fasedienol Nasal Spray for Acute Treatment of Social Anxiety Disorder Fasedienol is Vistagen’s lead neurocircuitry-focused pherine product candidate in U.S. Phase 3 clinical development for the acute treatment of anxiety in adults with social anxiety disorder. Fasedienol's proposed mechanism of action (MOA) is fundamentally differentiated from all FDA-approved anti-anxiety medications. When administered intranasally in microgram-level doses, neurocircuitry-focused fasedienol modulates the nasal-limbic amygdala fear and anxiety neurocircuits involved in the pathophysiology of social anxiety disorder. Fasedienol is pharmacologically active without requiring apparent systemic absorption or uptake into the brain to achieve its rapid-onset anxiolytic effects. Fasedienol also has no observed binding on certain cellular receptors isolated from the brain that are associated with known drug abuse liability potential (for example, dopamine and opiate receptors) when activated by certain other pharmaceutical compounds for neuropsychiatric and neurological disorders. Unlike benzodiazepines, fasedienol has no observed potentiation of GABA-A receptors. Because of its innovative non-systemic neurocircuitry-focused proposed MOA, Vistagen believes fasedienol has the potential to achieve rapid-onset anxiolytic effects for individuals with social anxiety disorder on an acute, as-needed basis, with a significantly reduced risk of unwanted side effects and safety concerns, such as potential drug-drug interactions, abuse, misuse, and addiction, associated with certain current oral and other systemically absorbed neuropsychiatric pharmaceuticals that act directly on neurons in the brain and are sometimes prescribed off-label for the acute treatment of social anxiety disorder. About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company 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. Vistagen’s pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options, if successfully developed and approved. Vistagen’s pherine pipeline currently consists of five clinical-stage investigational product candidates focused on improving the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260508181101/en/ Investor Inquiries:
IR@vistagen.com
Media Inquiries:
media@vistagen.com Original: Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment of Social Anxiety Disorder
US Market News
4月前
Vistagen Reports Fiscal Year 2026 Third Quarter Financial Results and Provides Corporate UpdateFebruary 12, 2026 4:30 PM
Business Wire
PALISADE-4 Phase 3 Trial of fasedienol for acute treatment of Social Anxiety Disorder proceeding, with topline results from the randomized portion of the trial expected in the first half of 2026
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today reported financial results for its fiscal year 2026 third quarter ended December 31, 2025, and provided a corporate update.
“We have reviewed available data from PALISADE-3 and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to our ongoing PALISADE-4 Phase 3 trial. We expect topline results from the randomized portion of PALISADE-4 in the first half of 2026,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “With outside collaborators and their proprietary artificial intelligence and machine learning methodologies, we are conducting an extensive analysis across all available PALISADE Program datasets to potentially inform modifications to the statistical analysis plan for PALISADE-4 and our regulatory strategy.”
“We have implemented targeted, company-wide cash preservation initiatives and remain committed to disciplined capital allocation and preserving strategic flexibility as we approach key clinical milestones in 2026. We believe we are well-positioned to complete PALISADE-4 and advance preparations and planning for the pherine pipeline.”
Program Updates
Fasedienol for the Acute Treatment of Social Anxiety Disorder
The Company expects topline results for the randomized portion of its ongoing PALISADE-4 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder in the first half of 2026.
In December 2025, Vistagen announced topline results from the randomized portion of its PALISADE-3 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder. PALISADE-3 did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the Subjective Units of Distress (SUDS) score for fasedienol compared with placebo. The fasedienol safety data in the randomized portion of PALISADE-3 were favorable and consistent with previously reported results from other fasedienol Phase 3 clinical trials. No drug-related severe or serious adverse events were reported for fasedienol in the randomized portion of PALISADE-3 or in prior fasedienol Phase 3 clinical trials.
Refisolone (formerly PH80) for the treatment of vasomotor symptoms (hot flashes) due to menopause
The Company received an adoption statement from the United States Adopted Names Council (USAN) officially designating PH80, its hormone-free, non-systemic product candidate for treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause and potentially other women’s health indications, by the generic name “refisolone.”
Vistagen is currently preparing an Investigational New Drug application (IND) for submission to the U.S. Food and Drug Administration (FDA), with a planned submission in the first half of 2026, to facilitate further Phase 2 clinical development of refisolone in the U.S. as a potential treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.
In previously completed placebo-controlled Phase 2A clinical trials, refisolone demonstrated statistically significant reductions in the frequency and severity of hot flashes. The Phase 2A trials were conducted in Mexico by Pherin Pharmaceuticals, now a wholly owned subsidiary of Vistagen.
Corporate Updates
In December, Vistagen announced the appointment of Nick Tressler as Chief Financial Officer.
Financial Results for Fiscal Year 2026 Third Quarter Ended December 31, 2025
Research and development (R&D) expense
R&D expense was $14.2 million for the three months ended December 31, 2025, as compared to $11.3 million for the three months ended December 31, 2024. The increase in R&D expense was primarily due to higher research, development, and contract manufacturing expenses, as well as headcount related to the U.S. registration-directed PALISADE Program for fasedienol in social anxiety disorder.
General and administrative (G&A) expense
G&A expense was $5.6 million for the three months ended December 31, 2025, as compared to $4.0 million for the three months ended December 31, 2024. This increase in G&A expense was primarily due to increases in consulting and professional fees.
Net loss
Net loss was $18.9 million for the three months ended December 31, 2025, as compared to $14.1 million for the three months ended December 31, 2024.
Other financial highlights
Cash, cash equivalents, and marketable securities were $61.8 million as of December 31, 2025.
Conference Call and Webcast
Vistagen will host a conference call and live audio webcast today, February 12, 2026, at 5:00 p.m. Eastern Time to provide a corporate update of the Company’s progress. The conference call is being webcast live, and a link can be found under “Events” in the Investors section of Vistagen's website. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes before the call. The webcast will be archived on Vistagen’s website shortly after the call and will be available for at least 90 days.
For participants interested in participating in the call via dial-in, please follow the link below to pre-register. After registering, you will be provided with access details via email.
https://edge.media-server.com/mmc/p/mggzveh9/
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company 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. Vistagen’s pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options if successfully developed and approved. Vistagen’s pherine pipeline currently consists of five investigational product candidates focused on improving the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, Vistagen’s anticipated timing for the announcement of top-line results from the randomized portion of PALISADE-4, potential of analyses across the PALISADE Program datasets to modify the statistical analysis plan for PALISADE-4 and Vistagen’s regulatory strategy, Vistagen’s belief that company-wide cash preservation initiatives will enable Vistagen to complete PALISADE-4 and advance preparations and planning for the pherine pipeline, and Vistagen’s plans to submit an IND to the FDA to facilitate further Phase 2 clinical development of refisolone in the U.S. 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 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 Vistagen’s 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 the PALISADE Phase 3 program for fasedienol in social anxiety disorder, as currently expected or at all; Vistagen’s ability to 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; 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 and uncertainties resulting from disruptions and personnel turnover, staff reductions or otherwise, either within Vistagen or at the FDA, other government agencies and comparable foreign regulatory authorities; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen’s patents, including patents related to Vistagen’s 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 and others are more fully discussed in the section entitled “Risk Factors” in Vistagen’s 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 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 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.
VISTAGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
December 31,
2025
March 31,
2025
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
47,371
$
67,131
Marketable securities
14,399
13,351
Prepaid expenses and other current assets
1,475
1,594
Total current assets
63,245
82,076
Property and equipment, net
480
476
Right-of-use asset - operating lease
939
1,335
Other assets
392
454
Total assets
$
65,056
$
84,341
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
1,280
$
653
Accrued expenses
9,254
8,810
Note payable
379
—
Deferred revenue - current portion
1,999
2,588
Operating lease obligation - current portion
617
561
Total current liabilities
13,529
12,612
Deferred revenue - non-current portion
176
391
Operating lease obligation - non-current portion
431
948
Total liabilities
14,136
13,951
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2025 and March 31, 2025; no shares outstanding at December 31, 2025 and March 31, 2025
—
—
Common stock, $0.001 par value; 325,000,000 shares authorized at December 31, 2025 and March 31, 2025; 39,624,839 and 29,001,481 shares issued at December 31, 2025 and March 31, 2025, respectively
40
29
Additional paid-in capital
515,878
481,956
Treasury stock, at cost, 4,522 shares of common stock held at December 31, 2025 and March 31, 2025
(3,968
)
(3,968
)
Accumulated other comprehensive income
13
5
Accumulated deficit
(461,043
)
(407,632
)
Total stockholders’ equity
50,920
70,390
Total liabilities and stockholders’ equity
$
65,056
$
84,341
VISTAGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
December 31,
Nine Months Ended
December 31,
2025
2024
2025
2024
Revenues:
Sublicense and other revenue
$
303
$
234
$
804
$
501
Total revenues
303
234
804
$
501
Operating expenses:
Research and development
14,223
11,305
41,914
$
29,168
General and administrative
5,626
4,049
14,299
$
12,811
Total operating expenses
19,849
15,354
56,213
$
41,979
Loss from operations
(19,546
)
(15,120
)
(55,409
)
$
(41,478
)
Other income, net:
Interest income, net
647
1,031
1,989
$
3,702
Other income
—
—
9
—
Loss before income taxes
(18,899
)
(14,089
)
(53,411
)
(37,776
)
Income taxes
—
—
—
$
(7
)
Net loss
$
(18,899
)
$
(14,089
)
$
(53,411
)
$
(37,783
)
Unrealized gain (loss) on marketable securities
(1
)
(11,000
)
8
11
Comprehensive loss
$
(18,900
)
$
(14,100
)
$
(53,403
)
$
(37,772
)
Basic and diluted net loss per common share
$
(0.45
)
$
(0.46
)
$
(1.46
)
$
(1.23
)
Weighted average common shares outstanding, basic and diluted
42,234,405
30,711,872
36,655,195
30,649,384
View source version on businesswire.com: https://www.businesswire.com/news/home/20260212959012/en/
Investor Inquiries:
Mark A. McPartland
markmcp@vistagen.com
Media Inquiries:
Michelle P. Wellington
mwellington@vistagen.com
Original: Vistagen Reports Fiscal Year 2026 Third Quarter Financial Results and Provides Corporate Update