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Vistagen Reports Fiscal Year 2026 Second Quarter Financial Results and Provides Corporate Update PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder is Comp

Key Takeaway: Vistagen has announced its financial results for the second quarter of fiscal year 2026 and provided updates on its clinical trials. The PALISADE-3 Phase 3 trial for its treatment, fasedienol, is concluded, with topline results expected by the end of the year. The company aims to address social anxiety disorder, potentially providing the first FDA-approved acute treatment for this condition. A financial overview reveals increased expenses and net losses, yet Vistagen maintains a strong cash position and recently expanded its leadership team.

Market Sentiment Analysis

POSITIVE FACTORS

  • On track to report topline data from PALISADE-3 trial by year-end.
  • Potential to be the first FDA-approved acute treatment for social anxiety disorder.
  • Inegration of experienced board member Paul Edick into leadership.
  • Strong cash position with $77.2 million on hand.

CONCERNS & RISKS

  • Net loss increased to $19.4 million compared to last year.
  • R&D expenses rose significantly, indicating higher financial pressure.
  • Risks associated with completing ongoing clinical trials.

Full Press Release Details

Vistagen Reports Fiscal Year 2026 Second Quarter Financial Results and Provides Corporate Update
PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder is Complete Topline results expected by calendar year end
SOUTH SAN FRANCISCO, Calif. (BUSINESS WIRE) - November 13, 2025 - 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 second quarter ended September 30, 2025, and provided a corporate update.
"As we conclude the second quarter of our fiscal year, we are encouraged by our progress and remain confident in the path ahead," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We are on track to report topline data from the randomized portion of our PALISADE-3 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder this quarter, followed by the randomized portion of our PALISADE-4 Phase 3 trial in 2026. We have built strong momentum toward the primary goal of our PALISADE program, developing what we hope could be the first FDA-approved acute treatment of social anxiety disorder for the 30 million adults living with this serious and potentially life-threatening condition."
Fasedienol for the Acute Treatment of Social Anxiety Disorder
Earlier this month, Vistagen announced that the last patient completed the randomized, double-blinded portion of its PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder.
Topline results from this randomized portion of the PALISADE-3 Phase 3 trial are expected in the fourth quarter of this calendar year.
A duplicate and concurrent Phase 3 trial, PALISADE-4, involves the same public speaking challenge study design as PALISADE-3. Topline results from the randomized, double-blinded portion PALISADE-4 are expected in the first half of 2026.
Corporate Highlights
In October, Vistagen announced the appointment of Mr. Paul Edick to its Board of Directors. Mr. Edick was also appointed to serve on Vistagen's Audit and Compensation Committees.
Financial Results for Fiscal Year 2026 Second Quarter Ended September 30, 2025
Research and development (R D) expense
R D expense was $15.9 million for the three months ended September 30, 2025, as compared to $10.2 million for the three months ended September 30, 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 $4.4 million for the three months ended September 30, 2025, as compared to $4.2 million for the three months ended September 30, 2024.
Net loss was $19.4 million for the three months ended September 30, 2025, as compared to $13.0 million for the three months ended September 30, 2024.
Other financial highlights
Cash, cash equivalents, and marketable securities were $77.2 million as of September 30, 2025.
Conference Call and Webcast
Vistagen will host a conference call and live audio webcast today, November 13, 2025, at 5 00 p.m. Eastern Time to provide a corporate update of the Company's progress. 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 joining the call via dial-in, please use the details below.
Conference ID 6458570
Participant Toll-Free Dial-In Number 1(800) 715-9871
Participant International Dial-In Number 1(646) 307-1963
Headquartered in South San Francisco, CA, 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 intranasal product candidates called pherines. Pherines specifically and selectively bind as agonists on peripheral receptors on human nasal chemosensory neurons and are designed to rapidly trigger olfactory bulb-to-brain neurocircuits believed to regulate brain areas involved in behavior and autonomic nervous system activity. They 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 is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding the timing of topline data from the randomized portions of the PALISADE-3 and PALISADE-4 Phase 3 trials and the primary goal of the PALISADE program. 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 will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful, or that Vistagen will be able to successfully replicate the results of past studies of any of its product candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and or completing ongoing clinical trials, including PALISADE-3, PALISADE-4, a small exploratory Phase 2B clinical trial designed to assess efficacy, safety and tolerability of a repeat dose of fasedienol in adults with SAD, which we refer to as the Repeat Dose Study and or any other clinical trial conducted by Vistagen as a part of its PALISADE program, as currently expected or at all submission of a NDA to the FDA for any of Vistagen's product candidates, including fasedienol the ability of any clinical trial information from the PALISADE program or otherwise submitted by Vistagen to the FDA to successfully support a NDA the FDA's determination that our trials and or results from Vistagen's PALISADE development program are adequate to support NDA approval 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 government shutdowns, disruptions and personnel turnover, staff reductions or otherwise, 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. Risks that may impact the outcome of these forward-looking statements are more fully discussed in the section entitled "Risk Factors" in Vistagen's Annual Report on Form 10-K for the fiscal year ended March 31, 2025, and Quarterly Report on Form 10-Q for the period ended 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.
markmcp vistagen.com
Michelle P. Wellington
mwellington vistagen.com
VISTAGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
September 30, 2025 March 31, 2025
(unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 62,786 $ 67,131
Marketable securities 14,389 13,351
Prepaid expenses and other current assets 1,759 1,594
Total current assets 78,934 82,076
Property and equipment, net 516 476
Right-of-use asset - operating lease 1,074 1,335
Other assets 405 454
Total assets $ 80,929 $ 84,341
LIABILITIES AND STOCKHOLDERS ' EQUITY
Current liabilities
Accounts payable $ 1,831 $ 653
Accrued expenses 8,417 8,810
Note payable 658 -
Deferred revenue - current portion 2,141 2,588
Operating lease obligation - current portion 597 561
Total current liabilities 13,644 12,612
Deferred revenue - non-current portion 336 391
Operating lease obligation - non-current portion 610 948
Total liabilities 14,590 13,951
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value 10,000,000 shares authorized at September 30, 2025 and March 31, 2025 no shares outstanding at September 30, 2025 and March 31, 2025 - -
Common stock, $0.001 par value 325,000,000 shares authorized at September 30, 2025 and March 31, 2025 38,895,568 and 29,001,481 shares issued at September 30, 2025 and March 31, 2025, respectively 39 29
Additional paid-in capital 512,398 481,956
Treasury stock, at cost, 4,522 shares of common stock held at September 30, 2025 and March 31, 2025 (3,968) (3,968)
Accumulated other comprehensive income 14 5
Accumulated deficit (442,144) (407,632)
Total stockholders' equity 66,339 70,390
Total liabilities and stockholders' equity $ 80,929 $ 84,341
VISTAGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Three Months Ended September 30, Six Months Ended September 30,
2025 2024 2025 2024
Revenues
Sublicense and other revenue $ 258 $ 183 $ 502 $ 267
Total revenues 258 183 502 $ 267
Operating expenses
Research and development 15,915 10,215 27,693 $ 17,863
General and administrative 4,396 4,195 8,667 $ 8,762
Total operating expenses 20,311 14,410 36,360 $ 26,625
Loss from operations (20,053) (14,227) (35,858) $ (26,358)
Other income, net
Interest income, net 630 1,273 1,342 $ 2,671
Other income 6 - 4 -
Loss before income taxes (19,417) (12,954) (34,512) (23,687)
Income taxes - (7) - $ (7)
Net loss $ (19,417) $ (12,961) $ (34,512) $ (23,694)
Unrealized gain on marketable securities 13 20,000 14 22
Comprehensive loss $ (19,404) $ (12,941) $ (34,498) $ (23,672)
Basic and diluted net loss per common share $ (0.54) $ (0.42) $ (1.02) $ (0.77)
Weighted average common shares outstanding, basic and diluted 35,749,160 30,632,347 33,850,346 30,617,970

Frequently Asked Questions

What are the topline results for fasedienol expected?

Topline results from the PALISADE-3 trial for fasedienol are anticipated by year's end.

What was Vistagen’s R&D expense for Q2 of FY 2026?

Vistagen reported $15.9 million in R&D expenses for Q2 of FY 2026.

Who was appointed to Vistagen's Board of Directors in October?

Mr. Paul Edick was appointed to Vistagen's Board of Directors this October.

What is Vistagen's primary goal with the PALISADE program?

The main goal is to develop the first FDA-approved treatment for social anxiety disorder.

What is the cash position of Vistagen as of September 2025?

Vistagen's cash, cash equivalents, and marketable securities totaled $77.2 million.

Last updated: Nov 13, 2025