A Phase 2, Three-arm, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol (PH94B) Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension

This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.

Start Date09 Jan 2025

Sponsor / Collaborator

Vistagen Therapeutics, Inc.

NCT06615557

/ RecruitingPhase 3

US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-4)

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-4 and choose to enter the distinct open-label extension phase of the study.

Start Date16 Sep 2024

Sponsor / Collaborator

Vistagen Therapeutics, Inc.

NCT06358651

/ Active, not recruitingPhase 3

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study.

Start Date28 Mar 2024

Sponsor / Collaborator

Vistagen Therapeutics, Inc.

100 Clinical Results associated with Aloradine

100 Translational Medicine associated with Aloradine

100 Patents (Medical) associated with Aloradine

Literatures (Medical) associated with Aloradine

01 Mar 2024·Human psychopharmacology

Effect of fasedienol (PH94B) pherine nasal spray and steroidal hormones on electrogram responses and autonomic nervous system activity in healthy adult volunteers

Article

Author: Monti, Louis ; Lappalainen, Jaakko ; Hanover, Rita ; Salmán, Ester ; Baker, Ross A. ; Smith, Mark

Abstract:

Objective:

Fasedienol (PH94B) is a pherine compound formulated as a nasal spray that is hypothesized to regulate olfactory‐amygdala circuits of fear and anxiety. Fasedienol's effect on the local electrogram of nasal chemosensory neurons (EGNR) and autonomic nervous system (ANS) responses versus steroidal hormones and controls in healthy adults is reported.

Methods:

Eight males and 8 females randomly received aerosolized control (propylene glycol) and study drugs (fasedienol, 17β‐estradiol, progesterone, cortisol, and testosterone, 0.4 μg each in propylene glycol) onto the nasal septum mucosal lining at 30‐min intervals over 2 sessions. EGNR was continuously monitored; autonomic parameters were recorded before and after administration.

Results:

Fasedienol significantly increased EGNR amplitude (males: 5.0 vs. 0.6 mV, p < 0.001; females:5.7 vs. 0.6 mV, p < 0.001), and rapidly reduced respiratory rate (p < 0.05), heart rate (p < 0.01), and electrodermal activity (p < 0.05) versus control. EGNR and ANS responses after steroidal hormone administration were similar to control. 81% reported feeling less tense/more relaxed after receiving fasedienol, but not after receiving either control or steroidal hormones.

Conclusions:

Intranasal fasedienol, but not control or steroidal hormones, activated EGNR and rapidly reduced ANS responses, consistent with sympatholytic effects. Combined with subjective reports, results suggest fasedienol may provide acute relief in anxiety conditions.

01 Feb 2024·Drugs

A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder

Review

Author: Norred, Michael A ; Hamner, Mark B ; Zuschlag, Zachary D

Post-traumatic stress disorder (PTSD) is a debilitating disorder inflicting high degrees of symptomatic and socioeconomic burdens. The development of PTSD results from a cascade of events with contributions from multiple processes and the underlying pathophysiology is complex, involving neurotransmitters, neurocircuitry, and neuroanatomical pathways. Presently, only two medications are US FDA-approved for the treatment of PTSD, both selective serotonin reuptake inhibitors (SSRIs). However, the complex underlying pathophysiology suggests a number of alternative pathways and mechanisms that may be targets for potential drug development. Indeed, investigations and drug development are proceeding in a number of these alternative, non-serotonergic pathways in an effort to improve the management of PTSD. In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders.

01 May 2022·Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy AssociationQ1 · MEDICINE

Medial Patellofemoral Ligament Reconstruction Using Adductor-Transfer and Adductor-Sling at Nonanatomic Femoral Attachment Sites Leads to Unfavorable Graft-Length Change Patterns: A Descriptive Biomechanical Study

Q1 · MEDICINE

Article

Author: Dong, Shikui ; Chen, Jiebo ; Xu, Junjie ; Zhao, Jinzhong ; Qiao, Yi ; Han, Kang ; Ye, Zipeng ; Xu, Caiqi

PURPOSE:

To compare the graft length change patterns in nonanatomic adductor-transfer (AT) and adductor-sling (AS) medial patellofemoral ligament (MPFL) reconstruction with those in anatomic MPFL reconstruction (MPFLR) and to investigate the favorable isometric ranges (FIRs) of knee flexion.

METHODS:

Eight small fresh-frozen cadaveric knees were mounted in a knee-customized jig with tensioned muscles to measure graft length changes from two patellar points to four femoral attachments using a linear variable displacement transducer. Femoral attachments were at the MPFL footprint center (MPFL-C) in anatomic MPFLR, adductor magnus (AM) footprint center (AM-C) in AT, and at 5-mm (AM-5) or 10-mm (AM-10) points proximal to AM-C in AS. The FIRs of these femoral attachments were determined after zeroing the graft length changes at different initial fixation angles.

RESULTS:

Anatomic MPFL-C resulted in almost isometric graft length changes from 0° to 90°. At AM-C, the graft length changes displayed an increase from 0° to 45° and significantly greater length changes than those at MPFL-C from 60° to 90°. The graft length changes at both AM-5 and at AM-10 continuously increased with knee flexion angles and presented significantly larger graft length changes than those at MPFL-C and at AM-C from 30° to 90° and 60° to 90°, respectively. After zeroing graft length changes at different fixation angles, the FIRs of the MPFL-C covered all knee flexion angles, regardless of the patellar attachments and initial fixation angles. Moreover, with the smaller FIRs of AM-C observed at any fixation angle when compared with MPFL-C, fixing the graft at 0° to 30° in AT allowed the FIRs to cover the whole functional flexion range. However, the significantly larger graft length changes of both AM-5 and AM-10 resulted in extremely limited FIRs at any fixation angle.

CONCLUSION:

Anatomic MPFL-C resulted in a favorable graft length change range (less than 2 mm) at 0° to 90° of knee flexion, which was close to the isometric graft behavior. However, nonanatomic attachments of AM-C in AT, and both AM-5 and AM-10 in AS caused significant anisometric graft length change patterns and limited FIRs. Moreover, AT had a smaller range of graft length change but wider FIRs compared to AS, indicating superior graft behavior for MPFLR.

CLINICAL RELEVANCE:

Anatomic MPFLR is preferable for the treatment of in skeletally immature patients, followed in preference by nonanatomic AT. Nonanatomic AS should be performed cautiously.

News (Medical) associated with Aloradine

12 Feb 2026

·www.biospace.com

Vistagen Reports Fiscal Year 2026 Third Quarter Financial Results and Provides Corporate Update

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.--(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. 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 . 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 . 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 Contacts Investor Inquiries: Mark A. McPartland markmcp@vistagen.com Media Inquiries: Michelle P. Wellington mwellington@vistagen.com

Phase 3Phase 2Clinical ResultFinancial StatementExecutive Change

12 Feb 2026

·www.vistagen.com

Vistagen Reports Fiscal Year 2026 Third Quarter Financial Results and Provides Corporate Update

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. --(BUSINESS WIRE)--Feb. 12, 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. 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 Source: Vistagen

Phase 3Phase 2Clinical ResultFinancial StatementExecutive Change

17 Dec 2025

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Vistagen Announces Topline Results from PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder

SOUTH SAN FRANCISCO, Calif.--(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 announced that the PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not demonstrate a statistically significant improvement on the primary endpoint of change on the Subjective Units of Distress Scale (SUDS). The trial did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the Subjective Units of Distress Scale (SUDS) score for fasedienol (13.6 +/-1.54 standard error, SE) compared with placebo (14.0 +/-1.51 SE), a LS mean difference of 0.4 (p = not significant). There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previous clinical trials. “We are disappointed by the unexpected results of this public speaking challenge trial, which are inconsistent with positive outcomes observed in Phase 2 and our PALISADE-2 Phase 3 study,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “We are thoroughly reviewing the results of the study, evaluating the potential impact of the results on our ongoing studies and plan to seek feedback from the FDA. In parallel, we are implementing company-wide cash preservation measures in an effort to enhance operational efficiency, provide cash runway into 2027, and maintain strategic optionality across our pherine pipeline. I’d like to thank the patients, coordinators, and investigators, as well as the development team at Vistagen, for their time and efforts in conducting this trial.” 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 a single dose of fasedienol in reducing anxiety symptoms during a simulated public speaking challenge using the Subjective Units of Distress Scale (SUDS). PALISADE-3 subjects who choose to continue with the open label extension of the study can use fasedienol for up to twelve months in their daily lives. About Fasedienol Fasedienol is a modulator of the olfactory-limbic amygdala fear/anxiety neurocircuits. It specifically and selectively binds as an agonist on peripheral receptors on human nasal chemosensory neurons and is designed to rapidly trigger olfactory bulb-to-brain neurocircuits believed to regulate brain areas involved in behavior and autonomic nervous system activity. Fasedienol is designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving it the potential to be a safer alternative to other pharmacological options if successfully developed and approved. Neurocircuit modulation occurs without binding to neurotransmitter receptors in the brain, giving it a differentiated tolerability profile coupled with no positive signal of abuse potential based on nonclinical data. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fasedienol 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 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 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, statements regarding Vistagen’s plans to review the results of the PALISADE-3 clinical trial and evaluate the potential impact of the results of PALISADE-3 on ongoing clinical studies, Vistagen’s plans to seek feedback from the FDA, the therapeutic potential of fasedienol as an acute treatment for social anxiety disorder, and Vistagen’s expectation that its cash preservation measures and efforts to enhance operational efficiency will be sufficient to provide cash runway into 2027 and will maintain strategic optionality across its pherine pipeline. 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; submission of a New Drug Application (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 Quarterly Report on Form 10-Q for the period ended September 30, 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.

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Indication	Highest Phase	Country/Location	Organization	Date
Phobic Disorders	Phase 3	China	Affamed Therapeutics (Us), Inc.	30 Jan 2022
Phobic Disorders	Phase 3	-	Vistagen Therapeutics, Inc.	30 Jan 2022
Anxiety Disorders	Phase 3	United States	Vistagen Therapeutics, Inc.	24 May 2021
Phobia, Social	Phase 3	United States	Vistagen Therapeutics, Inc.	24 May 2021
Adjustment disorders	Phase 2	United States	Vistagen Therapeutics, Inc.	12 Oct 2021
Depressive Disorder	Phase 2	United States	Vistagen Therapeutics, Inc.	12 Oct 2021
Premenstrual Dysphoric Disorder	Phase 2	United States	Vistagen Therapeutics, Inc.	12 Oct 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04404192 (CTgov)	Phase 2	Adjustment disorders \| Premenstrual Dysphoric Disorder \| Depressive Disorder ... View more	41	PH94B (PH94B)	scduahpdod(xeebgnhvpq) = kwpmdzruch ttdftuikdj (zbeqqacrjh, 1.31) View more	-	05 Feb 2026
				Placebo (Placebo)	scduahpdod(xeebgnhvpq) = wapqkotddb ttdftuikdj (zbeqqacrjh, 1.22) View more
NCT06358651 (PALISADE-3, BusinessWire) Manual	Phase 3	Phobia, Social	-	Fasedienol	xgxfcoqhih(wqupwvkgnf) = jvdywykonp iakvfvjdtt (kthgvzseki, 1.54) Not Met	Negative	17 Dec 2025
				Placebo	xgxfcoqhih(wqupwvkgnf) = ezpakzygrw iakvfvjdtt (kthgvzseki, 1.51) Not Met
NCT05011396 (Palisade-2, CTgov)	Phase 3	Phobia, Social \| Anxiety Disorders	228	PH94B Nasal Spray (PH94B)	mbmbrolvrs(vockhxlrcn) = fzhsiltogp rmeihciwgc (xiygmvmhfo, 12.11) View more	-	24 Nov 2025
				Placebo Nasal Spray (Placebo)	mbmbrolvrs(vockhxlrcn) = uiodgeweyu rmeihciwgc (xiygmvmhfo, 11.58) View more
NCT05030350 (CTgov)	Phase 3	Phobia, Social \| Anxiety Disorders	481	PH94B	igjwsdende = lqzdvmaivl cybyorsgie (mwtvgnabrk, ofhqzrsbyv - uvixafxxzu) View more	-	21 Oct 2025
NCT04754802 (PALISADE-1, CTgov)	Phase 3	Phobia, Social \| Anxiety Disorders	224	PH94B Nasal Spray (PH94B)	mpwvxgkxjb(uiywscqtey) = lucqfdqppu ekwwefhfek (gcvjfgcysz, 11.67) View more	-	12 Sep 2025
				Placebo Nasal Spray (Placebo)	mpwvxgkxjb(uiywscqtey) = ycgswevzjn ekwwefhfek (gcvjfgcysz, 12.42) View more
NCT05011396 (PALISADE-2, Corporate Publications) Manual	Phase 3	Phobia, Social	141	PH94B	mpegshztkt(tlvrwlcvqu) = zprjqmyxat axfxclzyvd (akpdstzugu ) Met View more	Positive	07 Aug 2023
				Placebo	mpegshztkt(tlvrwlcvqu) = vylmpnmckd axfxclzyvd (akpdstzugu ) Met View more
NCT05030350 (Corporate Publications) Manual	Phase 3	Phobia, Social	481	PH94B	qmtuzihbro(qdljxzkfeu) = csjdycwyog gwzwpefkhh (uxvuasppuh ) View more	Positive	22 Mar 2023
NCT04754802 (PALISADE-1, Corporate Publications) Manual	Phase 3	Phobia, Social	-	PH94B	pqikjdzhwa(slvpfgpkyn) = the trial did not meet its primary endpoint pagvsnsxbz (gnojdleqps ) View more	Negative	22 Jul 2022
				Placebo

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