VistaGen Therapeutics (VTGN) Q4 2025 Earnings Call June 17, 2025 05:00 PM ET Company Participants Mark McPartland - Senior Vice President, Investor RelationsShawn Singh - President, Chief Executive Officer and DirectorCindy Anderson - CFOAndrew Tsai - SVP Conference Call Participants None - AnalystMyles Minter - Research Analyst - Healthcare Operator Good day everyone and thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year End twenty twenty five Corporate Update Conference Call and W ...

Financial Data and Key Metrics Changes - Research and development expenses increased to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million for the same period last year, primarily due to increases in research, clinical and nonclinical development, and contract manufacturing expenses [14] - General and administrative expenses rose to $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million for the same period last year, mainly due to increased headcount and consulting fees [15] - The net loss attributable to common shareholders was $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million for the same period last year [16] - As of March 31, 2025, the company had $80.5 million in cash, cash equivalents, and marketable securities [16] Business Line Data and Key Metrics Changes - The lead product candidate, Fascidinol, is in Phase III development for the acute treatment of social anxiety disorder (SAD), with ongoing trials expected to provide substantial evidence for a new drug application [7][9] - Itruvone, another product candidate, is being developed for major depressive disorder (MDD) and has shown promising results in a Phase 2a study [10] - PH-80, focused on women's health, is advancing towards additional Phase II clinical development, with an IND submission anticipated in the second half of the year [10] Market Data and Key Metrics Changes - The company is targeting a large market for social anxiety disorder, with over 31 million adults in the U.S. affected by this condition [7] - The regulatory landscape is evolving positively, with the FDA showing interest in expediting approvals for innovative treatments addressing unmet medical needs [12][13] Company Strategy and Development Direction - The company aims to deliver transformative treatment options for patients while building shareholder value through its innovative pipeline of non-systemic intranasal product candidates [6][17] - The focus remains on advancing clinical trials and preparing for regulatory submissions to support the development of its product candidates [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of its clinical stage product candidates and the positive regulatory environment, emphasizing the importance of effective communication with the FDA [12][13] - The company is committed to rigorous operational execution in its clinical trials to ensure successful outcomes [9][27] Other Important Information - The company participated in the FDA's CEO Listening Tour, which aimed to improve communication and guidance between the FDA and industry leaders [12] - Management highlighted the importance of innovative mechanisms of action in addressing public health needs, particularly in the context of social anxiety disorder [44] Q&A Session Summary Question: Changes with FDA leadership and impact on interactions - Management noted that there have been no changes in their review team and expressed hope for improved communication with the FDA [22][23] Question: Timing for PALISADE IV - The modest delay in PALISADE IV was attributed to stringent subject eligibility requirements and enhancements made to improve study execution [26][27] Question: Enrollment completion for PALISADE III - Management confirmed that they would announce enrollment completion once the last patients complete their safety follow-up, with top-line data expected six to eight weeks thereafter [30] Question: Variability in placebo arm results - Management indicated that efforts have been made to limit variability in PALISADE III and IV, aiming to replicate the success seen in PALISADE II [31][32] Question: Screening and eligibility criteria - The slowdown in recruitment was primarily due to rigorous screening and eligibility criteria, ensuring that only suitable candidates are enrolled [46][47]

Exhibit 99.1 Vistagen Reports Fiscal Year 2025 Financial Results and Provides Corporate Update PALISADE-4 Phase 3 Trial topline results expected in the first half of 2026 Topline results of PALISADE-3 Phase 3 Trial of fasedienol for acute treatment of social anxiety disorder expected in the fourth quarter of this year Company showcases promising clinical-stage pipeline of five novel intranasal pherine candidates targeting six highly prevalent and underserved disorders SOUTH SAN FRANCISCO, Calif. — (BUSINESS ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K x Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: March 31, 2025 or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission file number: 001-37761 Vistagen Therapeutics, Inc. (Exact name of registrant as specified in its charter) Nevada 20-5093315 (State or other jurisdiction of incorporation or organ ...

VistaGen Therapeutics (VTGN) 2025 Conference June 05, 2025 11:40 AM ET Speaker0 All right, we're going to get started with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies. Thanks for tuning in and it's my pleasure to have Sean Singh, CEO of Vistagen joining me today. Welcome Sean. Speaker1 Thanks Andrew. Great to see you again. Speaker0 Great. So maybe a brief introduction about Vistagen, what you're working on and what you're trying to achieve and milestones over the next six to twel ...

Company Overview - Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is advancing its lead candidate fasedienol for the treatment of Social Anxiety Disorder (SAD) [2] Product Development - The progress of fasedienol is based on the company's ongoing research and development efforts aimed at addressing the needs of patients with SAD [2]

Vistagen Therapeutics, Inc. (NASDAQ:VTGN) Q3 2025 Earnings Call Transcript February 13, 2025 5:00 PM ET Company Participants Mark McPartland - Senior Vice President of Investor Relations Shawn Singh - Chief Executive Officer and Director Cindy Anderson - Chief Financial Officer Josh Prince - Chief Operating Officer Conference Call Participants John Boyle - William Blair Operator And good day. Thank you for standing by. Welcome to VistaGen Therapeutics Third Quarter Fiscal Year 2025 Corporate Update Conferen ...

VistaGen Therapeutics, Inc. (VTGN) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8%. A quarter ago, it was expected that this company would post a loss of $0.40 per share when it actually produced a loss of $0.42, delivering a surprise of -5%.Over the last four quarters, the company has sur ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________. Commission File Number: 001-37761 VISTAGEN THERAPEUTICS, INC. (Exact name of registrant as specified in its chart ...

Exhibit 99.1 Vistagen Reports Fiscal Year 2025 Third Quarter Financial Results and Corporate Update Fasedienol U.S. registration-directed PALISADE Phase 3 Program for acute treatment of social anxiety disorder progressing with ongoing PALISADE-3, PALISADE-4 and Repeat Dose trials Vistagen highlights clinical-stage pipeline with five novel pherine product candidates with positive ef icacy signals and potential to transform standards of care for multiple high prevalence indications SOUTH SAN FRANCISCO, Calif. ...