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

businesswire.com

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

Refisolone (formerly PH80) for the treatment of vasomotor symptoms (hot flashes) due to menopause

Corporate Updates

Financial Results for Fiscal Year 2026 Third Quarter Ended December 31, 2025

Research and development (R&D) expense

General and administrative (G&A) expense

Net loss

Other financial highlights

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.

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