VTGN

Exploratory analyses of patients with very severe social anxiety disorder demonstrated nominally statistically significant improvement in recently reported clinical studies FDA engagement planned during the current quarter regarding potential future Phase 3 path forward for fasedienol in social anxiety disorder Appointments of Angel S. Angelov, M.D., MBA, as Chief Medical Officer and Douglas J. Williamson, M.D. to the Board add decades of neuroscience drug development experience SOUTH SAN FRANCISCO, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Vistagen (Nasdaq: VTGN), 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, today reported financial results for the fiscal year 2027 first quarter ended June 30, 2026, and provided a corporate update. “Since reporting PALISADE-4 results in June, we have moved swiftly to define next steps for fasedienol, evaluate strategic options, and preserve cash,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “We look forward to meeting with the FDA in the near term to discuss the path forward for our fasedienol Phase 3 program in social anxiety disorder." Recent Corporate Highlights Fasedienol for Acute Treatment of Social Anxiety Disorder Announced preliminary data from the open label extension (OLE) portion of PALISADE-3. Based on an analysis of subjects who elected to participate in the OLE portion of the trial, fasedienol, taken as needed before or during anxiety-provoking social or performance situations in daily life for up to 12 months, was observed to be well-tolerated, with no new drug-related safety findings or trends identified. Preliminary exploratory efficacy data over the first four months of treatment showed improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory. Because the OLE portion of PALISADE-3 was open-label and uncontrolled, these exploratory efficacy observations were not based on a comparison to placebo and should be interpreted with caution. Announced topline and post-hoc data from the randomized portion of PALISADE-4, a Phase 3 study designed to assess the efficacy, safety, and tolerability of fasedienol for the acute treatment of social anxiety disorder. Although in the overall trial population fasedienol did not achieve its primary endpoint, in a post-hoc analysis of a subpopulation of patients with very severe social anxiety, fasedienol showed nominally statistically significant improvement compared to placebo. Favorable safety and tolerability data of fasedienol were consistent with previous placebo-controlled clinical trials. Announced topline results from an exploratory Phase 2 repeat dose study of fasedienol, designed to assess the efficacy, safety, and tolerability of two 3.2 µg doses of fasedienol administered ten minutes apart compared with a single 3.2 µg dose and placebo, for the acute treatment of social anxiety. Although the study was not designed to demonstrate, and did not demonstrate, statistically significant differences between the treatment groups, both active treatment arms showed numerical separation from placebo. Both treatment arms also separated numerically from placebo in a prespecified analysis of patients with very severe social anxiety, with nominally statistically significant responses for the single dose arm compared with placebo and as pooled, consistent with results previously observed in this very severe subpopulation in PALISADE-4. Achieved minimum fasedienol patient exposures recommended under International Council for Harmonisation (ICH) Technical Requirements for Pharmaceuticals for Human Use with over 1,500 subjects receiving at least a single exposure to fasedienol, over 300 subjects with at least 6-months of exposure, and over 100 subjects with at least 12 months of exposure. Regulatory Advanced planning and preparation for meeting with the FDA regarding a potential future registration- directed development pathway for fasedienol for the acute treatment of social anxiety disorder, building on the totality of data generated to date. Received FDA's "Study May Proceed" letter for refisolone under the Company's open U.S. Investigational New Drug (IND) application for treatment of moderate-to-severe vasomotor symptoms (hot flashes) due to menopause. Strategic and Corporate Updates Appointed Angel S. Angelov, M.D., MBA, as Chief Medical Officer, and Douglas J. Williamson, M.D., to the Board of Directors, leaders with decades of neuroscience clinical and regulatory experience supporting the Company’s next phase of late-stage drug development. Continued disciplined capital allocation and cost-management initiatives designed to prioritize key clinical and regulatory milestones while extending the Company's operating runway. Continued evaluating strategic opportunities intended to leverage the Company's differentiated pherine pipeline and neuroscience expertise. Financial Results for Fiscal Year 2027 First Quarter Ended June 30, 2026 Revenue Revenue recognized for the period was primarily attributable to the expiration of the exclusivity period under the Company’s Exclusive Negotiation Agreement with Fuji Pharma Co., Ltd. during the quarter, triggering the recognition of $1.2 million of revenue related to the agreement. All cash payable to the Company under this agreement was received in prior periods. Research and Development (R&D) Expense Research and development expense was $10.9 million for the quarter ended June 30, 2026, compared with $11.7 million for the quarter ended June 30, 2025. The change in R&D expense was primarily attributable to activities supporting U.S. registration-directed development of fasedienol for the acute treatment of social anxiety disorder, manufacturing and manufacturing-related activities, and development of the Company's pherine product candidates. Research and development expenses are expected to continue to decrease in future periods as a result of the Company’s cash preservation measures and the conclusion of PALISADE-4 and the Repeat Dose Study. However, future R&D expense trends will depend on FDA feedback regarding a potential registrational pathway for fasedienol. General and Administrative (G&A) Expense General and administrative expense was $3.9 million for the quarter ended June 30, 2026, compared with $4.4 million for the quarter ended June 30, 2025. General and administrative expenses are expected to remain at current levels as a result of the Company’s cash preservation measures following its March 2026 reduction in force. As with R&D expense trends, future G&A expense trends will be dependent on feedback from the FDA regarding the potential registrational pathway for fasedienol. Net Loss Net loss was $13.0 million for the quarter ended June 30, 2026, compared with $15.1 million for the quarter ended June 30, 2025. Cash Position Cash, cash equivalents, and marketable securities were $31.7 million as of June 30, 2026. Based on current operating plans, Vistagen believes its cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2027 but are not expected to be sufficient to extend the Company’s cash runway for more than a year from now. About VistagenVistagen (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 most advanced intranasal pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of 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 belief about the meaningfulness of the efficacy signal in a subgroup of patients in PALISADE-4 with very severe social anxiety disorder, statements regarding efficacy signals observed in the Repeat Dose Study across prespecified analyses, which remain subject to change upon completion of a full analysis and audit of the complete data set from the study, Vistagen’s belief about the meaningfulness of data from the OLE portion of PALISADE-3, the significance of such signals to the overall body of clinical evidence supporting fasedienol’s therapeutic potential, the Company’s plans for upcoming discussions with the FDA regarding the potential registrational pathway for fasedienol, Vistagen’s expectations regarding anticipated trends for R&D and G&A expense in future periods, Vistagen’s plans to remain financially disciplined, and Vistagen’s belief that its cash resources will support operations into 2027 but is not expected to be sufficient to extend cash runway for more than a year from now. 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. Because the Repeat Dose Study was not powered to demonstrate statistical significance, there can be no assurance that the numerical trends and nominally significant findings described in this press release will be replicated in future, adequately powered clinical trials, or that the FDA will view such findings as supportive of a registrational pathway for fasedienol. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting future clinical trials as currently expected or at all; Vistagen’s ability to replicate numerical trends and nominally significant findings from studies in the PALISADE Program or that the FDA will view such findings as supportive of a registrational pathway for fasedienol; Vistagen’s 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; 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 Annual Report on Form 10-K for the period ended March 31, 2026, and Quarterly Report on Form 10-Q for the period ended June 30, 2026, 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. Investor Inquiries: [email protected] Media Inquiries: [email protected]

Repeat dose of fasedienol demonstrated favorable safety and tolerability similar to single dose Efficacy signals were observed across primary and secondary endpoints in repeat dose and single dose Prespecified analysis of patients with very severe social anxiety disorder demonstrated nominally statistically significant improvement Efficacy signals and responder analyses provide additional supportive evidence for discussion with the FDA regarding fasedienol registrational pathway SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- 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 the topline results of its exploratory Phase 2 repeat dose study evaluating fasedienol nasal spray in adult subjects with social anxiety disorder. The three-arm, multicenter, randomized, double-blind, placebo controlled clinical study (N=61), which included an open label extension, was designed to assess the efficacy, safety, and tolerability of two 3.2 µg doses of fasedienol administered ten minutes apart compared with a single 3.2 µg dose and placebo, for the acute treatment of anxiety induced by a public speaking challenge. The study was not designed to demonstrate statistically significant differences between treatment groups. The exploratory study met its safety objective, demonstrating that a second dose administered within ten minutes of the first dose produced safety and tolerability data comparable to single-dose administration, with no new safety findings and overall safety findings consistent with previous clinical studies. In addition, both active treatment arms in the primary endpoint analysis, LS mean change in subjective units of distress (SUDS) score from Visit 2 (baseline speech, V2) to Visit 3 (randomized speech, V3), showed numerical separation from placebo, although the differences between treatment groups and placebo were not statistically significant (p=0.2)1. Primary Endpoint The primary efficacy results showed numerical separation from placebo in mean SUDS change from V2 to V3: Pooled fasedienol (N=40): -15.0, p=0.10(Cohen’s d effect size=0.46) Repeat dose fasedienol (N=19): -15.4, p=0.17(Cohen’s d=0.44) Single dose fasedienol (N=21): -14.7, p=0.14, (Cohen’s d=0.47) Placebo (N=21): -6.8. In the prespecified analysis of patients with very severe social anxiety disorder as defined by a baseline Liebowitz Social Anxiety Scale (LSAS) score of ≥ 95, fasedienol showed nominally2 statistically significant responses for the single dose arm compared with placebo and as pooled: Pooled fasedienol (N=24): -16.2, p=0.04 (Cohen’s d=0.78) Repeat dose fasedienol (N=10): -17.5, p=0.08 (Cohen’s d=0.74) Single dose fasedienol (N=14): -15.3, p=0.05 (Cohen’s d=0.80) Placebo (N=13): -1.6 The treatment effect for repeat dose fasedienol was numerically larger, although the smaller sample size and variability resulted in a higher p-value. The findings in the very severe group of patients defined by LSAS ≥95 are consistent with results previously observed in the randomized portion of the Company’s PALISADE-4 Phase 3 trial for the acute treatment of social anxiety disorder, where in a post-hoc analysis of patients with very severe social anxiety defined by LSAS ≥95, fasedienol also demonstrated a nominally statistically significant improvement compared with placebo (p=0.036). Secondary Endpoints Responder rates for the Clinician Global Impression of Improvement (CGI-I) and the Patient Global Impression of Change (PGI-C) secondary endpoints were directionally higher for fasedienol than placebo, providing consistency across primary and secondary endpoints for the total population in the study. In addition, the fasedienol responder rates in the repeat dose arm were more than twice those observed with placebo. CGI-I responder rates: 40% for pooled fasedienol (n=40), 47% for repeat dose fasedienol (n=19),33% for single dose fasedienol (n=21), and 19% for placebo (n=21) PGI-C responder rates: 33% for pooled fasedienol (n=40), 42% for repeat dose fasedienol (n=19), 29% for single dose fasedienol (n=21), and 19% for placebo (n=21) Responder rates were also directionally higher for fasedienol compared with placebo for the very severe social anxiety disorder subpopulation, with repeat dose rates at four times or more than those observed with placebo. CGI-I responder rates: 40% for pooled fasedienol (n=24), 60% for repeat dose fasedienol (n=10), 29% for single dose fasedienol (n=14), and 15% for placebo (n=13) PGIC responder rates: 33% for pooled fasedienol (n=24), 50% for repeat dose fasedienol (n=10), 29% for single dose fasedienol (n=14), and 8% for placebo (n=13) Exploratory Endpoint A prespecified exploratory analysis in V2 to V3 change of anticipatory anxiety prior to the beginning of the public speaking challenge showed a larger decrease in mean SUDS score for fasedienol compared with placebo, with the repeat dose and pooled fasedienol showing nominal statistical significance (where anticipatory anxiety is the average of SUDS measures taken 3 minutes and 4 minutes prior to the start of the speech): Pooled fasedienol (N=40): -13.8, p=0.03 (Cohen’s d=0.61) Repeat dose fasedienol (N=19): -19.3, p=0.01 (Cohen’s d=0.83) Single dose fasedienol (N=21): -8.7, p=0.2 (Cohen’s d=0.40) Placebo (N=21): -0.9 "We are encouraged by the directionally favorable efficacy signals observed in this FDA-informed study,” said Dr. Angel Angelov, Chief Medical Officer of Vistagen. “Although not designed to show statistical significance, the study showed consistent findings across multiple efficacy measures and contributes to our growing understanding of how patients may benefit from fasedienol, including its repeat dose use. As observed in the post-hoc analyses from our PALISADE-4 Phase 3 trial, the pronounced separation from placebo within the very severe social anxiety disorder subpopulation reflects an enhanced fasedienol signal and minimized placebo change in very severe social anxiety disorder patients. Together with the broad body of clinical evidence from Phase 2 and Phase 3 studies, these results will help inform our discussions with the FDA regarding a potential registrational pathway for fasedienol.” 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 FasedienolFasedienol, Vistagen’s most advanced neurocircuitry-focused investigational pherine product candidate, is in U.S. Phase 3 clinical development for 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 psychiatric disorders. Unlike benzodiazepines, fasedienol has no observed potentiation of GABA-A receptors. Because of its innovative no-systemic neurocircuitry-focused proposed MOA, Vistagen believes fasedienol has the potential to achieve rapid-onset anxiolytic effects for individuals with social anxiety disorder 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 treatment of social anxiety disorder. About VistagenVistagen (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 most advanced intranasal pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of 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 topline efficacy signals observed in the repeat dose study across prespecified analyses, which remain subject to change upon completion of a full analysis and audit of the complete data set from the study, the significance of such signals to the overall body of clinical evidence supporting fasedienol’s therapeutic potential, and Vistagen’s plans for upcoming discussions with the FDA regarding the potential registrational pathway for fasedienol. 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 any future clinical trials, receive regulatory approval or be commercially successful. Because the repeat dose study was not powered to demonstrate statistical significance, there can be no assurance that the numerical trends and nominally significant findings described in this press release will be replicated in future, adequately powered clinical trials, or that the FDA will view such findings as supportive of a registrational pathway for fasedienol. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to Vistagen’s 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; submission of a NDA to the FDA for any of Vistagen's product candidates, including fasedienol; and the ability of any clinical trial information submitted by Vistagen to the FDA to successfully support an NDA. These risks and others are more fully discussed in the section entitled “Risk Factors” in Vistagen’s Annual Report on Form 10-K for the period ended March 31, 2026, 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. Investor Inquiries: [email protected] Media Inquiries: [email protected] Footnotes Based on the prespecified ANCOVA model from the statistical analysis plan. All other p-values were calculated using two-sided t-tests. The study did not achieve statistical significance on the planned primary endpoint, therefore all subsequent analyses showing significance are classified as nominally statistically significant.

We recently compiled a list of the 7 Best Psychedelic Stocks to Buy According to Analysts. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is one of the best psychedelic stocks on our list. TheFly reported on June 30 that VTGN announced topline findings from the PALISADE-4 Phase 3 trial evaluating intranasal fasedienol for the acute treatment of social anxiety disorder. The study did not meet its primary endpoint, with fasedienol failing to demonstrate a statistically meaningful improvement compared with placebo based on the change from baseline in SUDS scores. The trial also showed no treatment advantage over placebo across secondary endpoints. However, fasedienol maintained a favorable safety and tolerability profile, consistent with observations from earlier placebo-controlled clinical studies. Separately, earlier on June 15, Vistagen Therapeutics, Inc. (NASDAQ:VTGN) reported its financial results for the fiscal year ended March 31, 2026, along with a corporate update. Research and development expenses increased to $55.0 million from $39.4 million in the prior fiscal year, primarily due to activities supporting the PALISADE Program for fasedienol, manufacturing efforts, and development of the company’s pherine candidates. General and administrative expenses rose to $18.4 million compared with $17.1 million a year earlier. The company recorded a net loss of $69.7 million for the fiscal year, compared with $51.4 million in the previous period. As of March 31, 2026, VTGN reported $45.4 million in cash, cash equivalents, and marketable securities, which it expects to support operations into 2027. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is a clinical-stage neuroscience company developing rapid-onset intranasal therapies for psychiatric disorders. It is often categorized among psychedelic stocks due to its focus on mental health innovation, though its proprietary therapies are not classic psychedelics. While we acknowledge the potential of VTGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Completed randomized portion of PALISADE-4 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder; topline results expected this month Completed randomized portion of fasedienol Phase 2 repeat dose study; topline results expected in third quarter 2026 Achieved minimum ICH E1 safety exposure recommendations across fasedienol clinical program Reported preliminary positive data from open-label extension portion of PALISADE-3 Phase 3 trial Received FDA "Study May Proceed" letter under refisolone Investigational New Drug (IND) application to support further clinical development in the U.S. for treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause SOUTH SAN FRANCISCO, Calif., June 15, 2026--(BUSINESS WIRE)--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 ended March 31, 2026, and provided a corporate update. "We made meaningful progress in fiscal 2026, advancing three significant late-stage programs in our novel pherine pipeline for people living with social anxiety disorder, depression, and menopausal hot flashes," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We expect topline results from the randomized portion of our PALISADE-4 Phase 3 trial later this month. If successful, we believe that PALISADE-4, together with the positive results from our PALISADE-2 Phase 3 trial and further evidence we plan to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of effectiveness in support of a potential fasedienol NDA for the acute treatment of social anxiety disorder. We remain steadfast in our commitment to helping improve lives underserved by current treatment options." Corporate and Program Highlights Fasedienol for the Acute Treatment of Social Anxiety Disorder Completed the randomized portion of the PALISADE-4 Phase 3 trial evaluating fasedienol for the acute treatment of social anxiety disorder; topline results from the randomized portion of PALISADE-4 are expected in June 2026. Refined the PALISADE-4 statistical analysis plan (SAP), incorporating baseline pre-dose Subjective Units of Distress Scale (SUDS) scores as a prespecified covariate in the primary efficacy analysis. While there is no guarantee the refinements to the PALISADE-4 SAP will result in a positive outcome for the study, the Company 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. Reported preliminary positive data from the ongoing open-label extension portion of the PALISADE-3 Phase 3 trial of fasedienol demonstrating fasedienol has been well-tolerated, with no new drug-related safety findings or trends identified, and a clinically relevant improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN) over the first four months of treatment. Achieved minimum exposure recommendations outlined in the ICH E1 guideline, with more than 1,500 individuals exposed to fasedienol, including more than 400 subjects with six months of exposure and more than 100 subjects with twelve months of exposure. Although the Company believes the minimum ICH E1 recommendations have been met, it has not yet aligned with the FDA on the specific patient exposure requirements to support a potential fasedienol NDA submission. Completed the randomized portion of the fasedienol Phase 2 repeat dose study, designed to incorporate FDA feedback to evaluate the effect of repeat dosing of fasedienol, potential dosing interval for repeat dose, as well as potential dose response and duration of effect; topline results from the randomized portion of the study expected in the third quarter of 2026. Refisolone for Treatment of Vasomotor Symptoms (Hot Flashes) Due to Menopause Received FDA "Study May Proceed" clearance under an Investigational New Drug (IND) application to support further clinical development of refisolone in the United States as a potential rapid-onset, hormone-free, and non-systemic treatment option for women experiencing moderate to severe vasomotor symptoms due to menopause. Presented data at The Menopause Society 2025 Annual Meeting in Orlando, Florida, in October 2025, demonstrating refisolone’s potential as a rapidly-acting pherine product candidate for treating vasomotor symptoms (hot flashes) due to menopause. Itruvone for Treatment of Major Depressive Disorder Continued preparations for future clinical development activities designed to advance itruvone as a potential rapid-onset treatment for major depressive disorder. Leadership and Corporate Updates Appointed Angel S. Angelov, M.D., MBA, as Chief Medical Officer, bringing significant neuroscience and clinical development expertise to Vistagen. Appointed Nick Tressler, MBA, as Chief Financial Officer, adding more than 20 years of financial leadership experience in the life sciences industry and expertise in corporate finance, operational execution, and strategic growth initiatives. Appointed Elissa Cote as Chief Corporate Development Officer, adding nearly 30 years of business development, strategic planning, licensing, and partnership experience to support advancement of Vistagen's pherine pipeline and strategic initiatives. Implemented targeted cost-management initiatives designed to prioritize capital allocation toward key clinical milestones and extend operating runway. Received the Platinum Bell Seal for Workplace Mental Health from Mental Health America and earned Great Place To Work® Certification, reflecting Vistagen's commitment to employee well-being and workplace culture. Financial Results for Fiscal Year Ended March 31, 2026 Research and Development Expense Research and development expense was $55.0 million for the fiscal year ended March 31, 2026, compared with $39.4 million for the fiscal year ended March 31, 2025. The change was primarily attributable to activities supporting the U.S. registration-directed PALISADE Program for fasedienol, manufacturing and CMC activities, and development of the Company's pherine product candidates. General and Administrative Expense General and administrative expense was $18.4 million for the fiscal year ended March 31, 2026, compared with $17.1 million for the fiscal year ended March 31, 2025. Net Loss Net loss was $69.7 million for the fiscal year ended March 31, 2026, compared with $51.4 million for the fiscal year ended March 31, 2025. Cash Position Cash, cash equivalents, and marketable securities were $45.4 million as of March 31, 2026. Based on current operating plans, Vistagen believes its cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2027. 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 most advanced intranasal pherine product candidates are fasedienol in U.S. Phase 3 development for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of 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 and its Phase 2 repeat dose study; Vistagen’s beliefs about the significance of achieving minimum patient exposure recommendations referenced in the ICH E1 guidance; the favorable safety and tolerability data of fasedienol observed to date; statements regarding indication of favorable safety data and improvements observed over time by patients in the OLE portion of PALISADE-3; Vistagen’s belief that the Company is well-positioned to execute its strategic objectives while maintaining financial discipline and flexibility; statements regarding 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; the continued development of refisolone, itruvone, and Vistagen's other pherine product candidates; and Vistagen's belief that its cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2027. 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; 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 Annual Report on Form 10-K for the period ended March 31, 2026, 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260615159406/en/ Contacts Investor Inquiries: [email protected] Media Inquiries: [email protected]

HealthEquity (HQY) came out with quarterly earnings of $1.24 per share, beating the Zacks Consensus Estimate of $1.11 per share. This compares to earnings of $0.97 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +11.57%. A quarter ago, it was expected that this provider of services for managing health care accounts would post earnings of $0.89 per share when it actually produced earnings of $0.95, delivering a surprise of +6.74%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. HealthEquity, which belongs to the Zacks Medical Services industry, posted revenues of $354.64 million for the quarter ended April 2026, surpassing the Zacks Consensus Estimate by 0.06%. This compares to year-ago revenues of $330.84 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. HealthEquity shares have lost about 5.5% since the beginning of the year versus the S&P 500's gain of 9.9%. While HealthEquity has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for HealthEquity was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.17 on $348.13 million in revenues for the coming quarter and $4.60 on $1.41 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Services is currently in the top 33% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. VistaGen Therapeutics, Inc. (VTGN), another stock in the broader Zacks Medical sector, has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.42 per share in its upcoming report, which represents a year-over-year change of +2.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. VistaGen Therapeutics, Inc.'s revenues are expected to be $0.5 million, up 5100% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report HealthEquity, Inc. (HQY) : Free Stock Analysis Report VistaGen Therapeutics, Inc. (VTGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

We recently compiled a list of the 10 Best Penny Stocks Under $1 According to Hedge Funds. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is also among the best penny stocks. TheFly reported on May 12 that VTGN shared early findings from the continuing extension phase of its Phase 3 PALISADE-3 study evaluating fasedienol for acute social anxiety disorder. Participants who entered the extension study used 3.2 micrograms of fasedienol as needed in real-world anxiety-triggering situations for up to 12 months, with dosing allowed multiple times daily and no new safety concerns observed. Exploratory outcomes over four months showed improvement on clinician-rated Liebowitz Social Anxiety Scale and Social Phobia Inventory measures. Overall tolerability remained strong with no identified adverse trends, and patients reported gradual benefit over time, supporting continued development of intranasal therapy for anxiety treatment. Previously, on May 8, Vistagen Therapeutics, Inc. (NASDAQ:VTGN) reported that the final participant completed the last scheduled visit in the randomized, double-blind, placebo-controlled phase of its PALISADE-4 Phase 3 trial evaluating fasedienol nasal spray for acute social anxiety disorder. The study’s open-label extension is continuing. PALISADE-4 is a U.S. multicenter trial assessing the single-dose treatment effect of fasedienol on anxiety symptoms during a controlled public speaking challenge, using the Subjective Units of Distress Scale as the primary endpoint. Eligible participants from the blinded phase who joined the extension may continue using the therapy in everyday situations up to six times daily for as long as 12 months. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is a clinical-stage biopharmaceutical company based in South San Francisco. It develops rapid-onset intranasal CNS therapies (“pherines”) for psychiatric and neurological disorders. While we acknowledge the potential of VTGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 8 Most Oversold Large Cap Stocks to Buy and 10 Best Cancer Stocks to Buy for the Long Term. Disclosure: None. Follow Insider Monkey on Google News.

This article first appeared on GuruFocus. Release Date: February 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vistagen Therapeutics Inc (NASDAQ:VTGN) completed the randomized portion of the Palisade 3 phase 3 trial in social anxiety disorder, marking significant progress in their clinical stage neuroscience program. The company is implementing innovative approaches, including artificial intelligence and machine learning, to analyze data from their studies, potentially enhancing their statistical models and regulatory strategy. Vistagen Therapeutics Inc (NASDAQ:VTGN) is advancing their women's health program with the planned submission of an investigational new drug application for Raficione, targeting vasomotor symptoms due to menopause. The company has $61.8 million in cash equivalents and marketable securities, providing a solid financial position to support ongoing and future projects. Vistagen Therapeutics Inc (NASDAQ:VTGN) is focused on addressing significant unmet needs in social anxiety disorder and women's health, guiding their long-term strategic efforts. The Palisade 3 trial experienced a higher placebo response, necessitating refinements and retraining to mitigate this issue in the ongoing Palisade 4 trial. The company acknowledges the inherent risks and uncertainties in forward-looking statements, which could lead to material differences in actual results. Vistagen Therapeutics Inc (NASDAQ:VTGN) faces potential regulatory challenges, as any changes to their statistical analysis plan (SAP) would require resubmission and alignment with the FDA. The open label extension studies, while providing valuable insights, are inherently uncontrolled and exploratory, which may limit the robustness of the data. The company's reliance on AI and machine learning for data analysis introduces uncertainty, as the identification of covariants and their impact on study outcomes is not guaranteed. Warning! GuruFocus has detected 3 Warning Signs with VTGN. Is VTGN fairly valued? Test your thesis with our free DCF calculator. Q: In the Palisade 3 data, how did the individual curves look at every interval out to 5 minutes? Was there a separation at all across any of those time points, with fazodinol versus placebo? A: At this point, we've only released the top-line results publicly. We are still analyzing the data, particularly looking into individual respondents and subgroups, where we do see definite differences. Josh Prince, Chief Operating Officer Q: If you decide to tweak the SAP plan for Palisade 4, would you need to notify and get an official buy-in from the FDA? Is there a risk to modifying the SAP plan? A: Any changes to the SAP would require resubmission and alignment with the FDA before locking the database and obtaining top-line results. The SAP for Palisade 3 was already submitted and approved without feedback from the FDA. Josh Prince, Chief Operating Officer Q: Should you modify the plan, would you need to backfill to the original enrollment target, or are there no changes to the enrollment? A: Changes to the SAP would not affect the enrollment or the planned enrollment for the study. The key is that the SAP is locked in before database lock and applied to the total population for the study. Josh Prince, Chief Operating Officer Q: Could you provide any color on what details you saw from Palisade 3 that led to the refinements you outlined? A: One of the differences in Palisade 3 compared to Palisade 2 was a higher placebo response. We are reinforcing training at sites to minimize this, ensuring protocols and scripts are followed precisely, and avoiding any interactions that could increase placebo effects. Josh Prince, Chief Operating Officer Q: Can you discuss your regulatory path forward and confidence in it if Palisades 4 hits or misses? A: Regulatory outcomes depend on FDA regulations, guidance, and the totality of data. If Palisade 4 is successful, it will complement Palisade 2 with broader information for the acute treatment of social anxiety disorder. If it doesn't hit, we will focus on the totality of evidence across the program. Sean Singh, President and CEO Q: Have you noticed any impact on enrollment since the announcement on December 17th? A: No, enrollment has continued as planned and projected for Palisade 4. Josh Prince, Chief Operating Officer Q: How could the Palisade 3 outcome and potentially Palisade 4 be different by amending the SAP? A: We are using AI and machine learning to identify covariants that may influence outcomes. If we find any, we would need to modify the SAP and discuss it with the FDA. Sean Singh, President and CEO Q: Can you explain the discrepancy between the 39.7 million shares outstanding and the weighted average of 42 million for the quarter? A: The discrepancy includes pre-funded warrants, which are factored into the weighted average calculation. Nick Tressler, Chief Financial Officer For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Management attributed the PALISADE-3 top-line results to a higher-than-expected placebo response compared to the successful PALISADE-2 study. The company is utilizing proprietary AI and machine learning technologies to analyze data across all PALISADE studies to identify predictors of drug response and nonspecific placebo effects. Operational refinements for the ongoing PALISADE-4 trial include site rationalization, retraining on protocol adherence, and enhanced audio monitoring to minimize subject comfort that could drive placebo responses. Strategic focus has shifted toward a 'weight of evidence' approach, aiming to present the totality of data from both randomized and open-label trials to the FDA. Company-wide cash preservation measures were implemented during the quarter to extend the operational runway and maintain flexibility for the Pherin pipeline. The open-label extension studies are being used to gather real-world evidence on fasedienol usage patterns and long-term safety in daily anxiety-provoking situations. Management is evaluating potential modifications to the Statistical Analysis Plan (SAP) for PALISADE-4 to include covariates identified through AI analysis, pending FDA alignment. A successful PALISADE-4 trial, combined with PALISADE-2, is intended to serve as the basis for a New Drug Application (NDA) for the acute treatment of social anxiety disorder. The company plans to submit a U.S. Investigational New Drug (IND) application for refisolone in the first half of 2026 to support Phase II development for menopause symptoms. Future regulatory discussions will likely incorporate innovative statistical models that account for explanatory variables discovered during the current cross-study analytical work. Current cash reserves of $61.8 million are expected to be sufficient to complete the randomized portion of the PALISADE-4 trial. Official USAN adoption of the name 'refisolone' for the PH80 candidate marks a transition toward formal clinical development in women's health. The company acknowledged that if PALISADE-4 fails to separate from placebo, the regulatory path would rely entirely on the 'weight of evidence' from the broader program data. Management noted that any changes to the SAP must be finalized and socialized with the FDA before the PALISADE-4 database lock to remain valid for regulatory review. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management confirmed that while an SAP is already approved, they may resubmit a modified version if AI analysis identifies significant covariates. Any such changes must be aligned with the FDA before the database is locked and top-line results are unblinded. Modifying the SAP would not require changes to the current enrollment targets of approximately 236 to 238 patients. The company identified that deviations from the strict protocol script and informal 'chatting' with subjects at clinical sites may have contributed to higher placebo effects. Corrective actions include hyper-focused feedback based on audio recordings of site interactions to ensure strict adherence to the public speaking challenge design. Management declined to speculate on specific approval scenarios but emphasized that the FDA considers the 'totality of data' and 'risk-benefit' for high-need populations. The strategy remains focused on building a body of evidence that includes both randomized trials and open-label longitudinal data. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

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 SOUTH SAN FRANCISCO, Calif., February 12, 2026--(BUSINESS WIRE)--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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260212959012/en/ Contacts Investor Inquiries: Mark A. McPartland [email protected] Media Inquiries: Michelle P. Wellington [email protected]