R&D-driven loss at Vistagen (Nasdaq: VTGN) as PALISADE-4 Phase 3 advances
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Vistagen Therapeutics reported fiscal 2026 third quarter results showing higher spending as it advances late-stage neuroscience programs. Revenue was modest at $0.3 million, while research and development expense rose to $14.2 million from $11.3 million, and general and administrative expense increased to $5.6 million from $4.0 million. Net loss widened to $18.9 million compared with $14.1 million a year earlier.
Cash, cash equivalents, and marketable securities totaled $61.8 million as of December 31, 2025. The PALISADE-4 Phase 3 trial of fasedienol in social anxiety disorder is ongoing, with topline results from the randomized portion expected in the first half of 2026 after refinements informed by PALISADE-3, which did not meet its primary endpoint. The company is also preparing a U.S. IND filing in the first half of 2026 for refisolone (PH80) in menopausal hot flashes and has implemented cash preservation initiatives to support completing PALISADE-4 and advancing its pherine pipeline.
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Insights
Losses increased as Vistagen funds Phase 3 fasedienol and prepares refisolone, supported by a moderate cash cushion.
Vistagen is in an investment-heavy phase. For the quarter ended December 31, 2025, R&D rose to
On the pipeline side, PALISADE-3 failed its primary endpoint but showed favorable safety, and management is refining PALISADE-4 and its statistical plan, with topline data expected in the first half of
Liquidity is a key variable: cash, cash equivalents, and marketable securities were
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 12, 2026
(Exact name of registrant as specified in its charter)
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(650 ) 577-3600
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act o
Item 2.02 Results of Operations and Financial Condition.
On February 12, 2026, Vistagen Therapeutics, Inc. (the “Company”) issued a press release announcing financial results for its fiscal year 2026 third quarter ended December 31, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Disclaimer.
The information contained in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits Index
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by Vistagen Therapeutics, Inc., dated February 12, 2026, furnished herewith | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Vistagen Therapeutics, Inc. | ||||||||
Date: February 12, 2026 | By: | /s/ Shawn K. Singh | ||||||
| Shawn K. Singh President and Chief Executive Officer | ||||||||
Exhibit 99.1
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) — February 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.
Investor Inquiries:
Mark A. McPartland
markmcp@vistagen.com
Media Inquiries:
Michelle P. Wellington
mwellington@vistagen.com
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 | |||||||||||||||||||
FAQ
How did Vistagen Therapeutics (VTGN) perform in its fiscal 2026 third quarter?
Vistagen reported a wider net loss as it increased investment in late-stage programs. For the quarter ended December 31, 2025, net loss was $18.9 million versus $14.1 million a year earlier, driven mainly by higher research and development and general and administrative expenses.
What were Vistagen Therapeutics (VTGN) key expenses and revenue for the quarter ended December 31, 2025?
For the fiscal 2026 third quarter, Vistagen generated $0.3 million in sublicense and other revenue. Research and development expense was $14.2 million and general and administrative expense was $5.6 million, both higher than the prior-year period, reflecting expanded clinical and corporate activities.
What is the status of Vistagen’s PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder?
Vistagen’s PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder is ongoing. The company expects topline results from the randomized portion in the first half of 2026, following refinements based on PALISADE-3 data, including retraining, site rationalization, and operational changes.
What were the PALISADE-3 Phase 3 results for fasedienol in social anxiety disorder?
In December 2025, Vistagen reported topline results from PALISADE-3’s randomized portion, where fasedienol did not achieve its primary endpoint on the SUDS score versus placebo. However, safety data were favorable, with no drug-related severe or serious adverse events across PALISADE-3 and prior Phase 3 trials.
How much liquidity does Vistagen Therapeutics (VTGN) have as of December 31, 2025?
As of December 31, 2025, Vistagen held $61.8 million in cash, cash equivalents, and marketable securities. Total assets were $65.1 million, liabilities were $14.1 million, and stockholders’ equity was $50.9 million, giving a snapshot of the company’s financial position.
What is refisolone (PH80), and what are Vistagen’s plans for it?
Refisolone (formerly PH80) is Vistagen’s hormone-free, non-systemic intranasal candidate for moderate to severe menopausal hot flashes. The company plans to submit an IND to the U.S. FDA in the first half of 2026, aiming to support further Phase 2 development in vasomotor symptoms.
What cash preservation or corporate actions did Vistagen (VTGN) highlight in this update?
Vistagen stated it has implemented targeted, company-wide cash preservation initiatives and remains focused on disciplined capital allocation. Management believes these steps help position the company to complete the PALISADE-4 trial and continue preparations and planning across its pherine-based pipeline programs.
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Vistagen Therapeutics Inc
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Biotechnology
Pharmaceutical Preparations
United States
SOUTH SAN FRANCISCO