Financial Overview of Vistagen Therapeutics

Vistagen Therapeutics is a late-stage biopharmaceutical company focused on developing a new class of rapid-onset neurocircuitry-focused intranasal product candidates called “pherines.” The company’s lead pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for the treatment of major depressive disorder, and refisolone for the treatment of vasomotor symptoms (hot flashes) due to menopause.

Since its inception, Vistagen has devoted substantial resources to advancing its neuroscience pipeline, including research, development, and contract manufacturing initiatives. As of June 30, 2026, the company had an accumulated deficit of approximately $490.3 million and incurred net losses of $69.7 million and $51.4 million for the fiscal years ended March 31, 2026 and 2025, respectively. The company expects losses to continue as it engages in further research, clinical and nonclinical development, contract manufacturing, and regulatory activities related to its product candidates.

Revenue

Vistagen’s revenue consists primarily of sublicense and other revenue recognized under its License and Collaboration Agreement with AffaMed Therapeutics, Inc. and its Exclusive Negotiation Agreement with Fuji Pharma Co., Ltd. For the three months ended June 30, 2026, the company recognized $1.5 million in sublicense and other revenue, compared to $0.2 million for the same period in 2025. The increase was primarily due to the recognition of $1.3 million of revenue under the Fuji Pharma agreement upon satisfaction of the related performance obligation.

Absent the achievement of milestones under the AffaMed agreement or the execution of similar agreements in the future, Vistagen expects sublicense and other revenue in future periods to be substantially lower than the amount recognized in the current period.

Research and Development Expense

Vistagen’s research and development expense has consisted primarily of external and internal costs related to the development of its product candidates. For the three months ended June 30, 2026, research and development expense was $10.9 million, compared to $11.7 million for the same period in 2025.

The decrease of $0.8 million was primarily due to a $1.0 million decrease in clinical development expense related to the company’s PALISADE program for fasedienol, partially offset by a $0.2 million increase in personnel costs. The company expects research and development expenses to continue to decrease in future periods as a result of cash preservation measures and the conclusion of certain clinical trials.

Future research and development expenses will depend on various factors, such as the progress and results of clinical trials, the number of trials required for regulatory approval, and the timing and costs of manufacturing the product candidates. The company cannot accurately estimate the nature, timing, and costs of the efforts necessary to complete the development of its product candidates.

General and Administrative Expense

General and administrative expense was $3.9 million for the three months ended June 30, 2026, compared to $4.4 million for the same period in 2025. The decrease of $0.5 million was primarily due to a $0.2 million decrease in personnel costs and decreases of $0.2 million in consulting and professional fees and $0.1 million in insurance, occupancy, and other costs.

Vistagen expects general and administrative expenses to remain at current levels as a result of its cash preservation measures. Future general and administrative expenses will depend on feedback from the FDA regarding the potential registrational pathway for fasedienol.

Other Income

Interest income, net, decreased for the three months ended June 30, 2026 compared to the same period in 2025 due to a decrease in amounts invested in interest-bearing securities.

Liquidity and Capital Resources

Vistagen has financed its operations primarily through the issuance and sale of equity securities, government research grants, strategic collaboration payments, and other revenues. As of June 30, 2026, the company had cash, cash equivalents, and marketable securities of approximately $31.7 million.

The company concluded that substantial doubt exists about its ability to continue as a going concern beyond twelve months from the issuance date of the financial statements. To fund its operations, Vistagen plans to seek additional financing through the sale of equity and/or debt securities, non-dilutive government grants and research awards, and/or non-dilutive strategic partnering collaborations.

However, there is no assurance that future financings or collaborations will be available to the company in sufficient amounts, on acceptable terms, or in a timely manner. The company’s future working capital requirements will depend on many factors, including the scope and success of its development programs and the availability of financing and collaborations.

Additionally, on August 4, 2026, Vistagen received a notification from Nasdaq granting the company an additional 180-day compliance period to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

Cash Flows

For the three months ended June 30, 2026, Vistagen used $14.7 million in net cash for operating activities, compared to $18.8 million for the same period in 2025. The decrease was primarily due to changes in operating assets and liabilities.

Net cash used in investing activities was $0.8 million for the three months ended June 30, 2025, consisting of purchases of marketable securities and property and equipment, partially offset by sales and maturities of marketable securities. There were no investing activities for the three months ended June 30, 2026.

Net cash provided by financing activities was $0.9 million for the three months ended June 30, 2026, primarily from the sale of common stock in at-the-market transactions, compared to $1.5 million for the same period in 2025.

Contractual Obligations and Critical Accounting Estimates

There have been no material changes in Vistagen’s contractual obligations and commitments or critical accounting estimates during the three months ended June 30, 2026, compared to the information disclosed in the company’s Annual Report.

Outlook and Analysis

Vistagen is a late-stage biopharmaceutical company focused on developing a new class of rapid-onset neurocircuitry-focused intranasal product candidates called “pherines.” The company’s lead pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for the treatment of major depressive disorder, and refisolone for the treatment of vasomotor symptoms (hot flashes) due to menopause.

The company has made significant progress in advancing its neuroscience pipeline, with several key developments in the past year:

• Fasedienol: Vistagen reported preliminary data from the open-label extension portion of its PALISADE-3 Phase 3 trial, showing that fasedienol was well-tolerated and demonstrated improvements in social anxiety symptoms over time. However, the company’s PALISADE-4 Phase 3 trial did not meet its primary endpoint, although a post-hoc analysis of a subpopulation with very severe social anxiety showed a positive result. Vistagen is preparing to meet with the FDA to discuss a potential registrational pathway for fasedienol.

• Itruvone: Vistagen’s intranasal pherine product candidate for the treatment of major depressive disorder has shown promising results in an exploratory Phase 2A study, and the company plans to pursue further Phase 2 development in the U.S.

• Refisolone: Vistagen’s intranasal pherine product candidate for the treatment of vasomotor symptoms due to menopause demonstrated statistically significant reductions in hot flashes compared to placebo in an exploratory Phase 2A study conducted in Mexico. The company has an open IND in the U.S. and plans to pursue further Phase 2 development.

Despite these advancements, Vistagen continues to face significant challenges. The company has incurred substantial losses since its inception and expects losses to continue as it engages in further research, development, and regulatory activities. Additionally, Vistagen concluded that substantial doubt exists about its ability to continue as a going concern beyond the next twelve months, and the company will need to secure additional financing to fund its operations.

The company’s future success will depend on its ability to successfully develop and commercialize its product candidates, as well as its ability to obtain the necessary financing and regulatory approvals. Vistagen’s neurocircuitry-focused approach to developing pherine product candidates represents a novel and potentially differentiated approach to addressing unmet medical needs in areas such as social anxiety disorder, major depressive disorder, and vasomotor symptoms due to menopause. However, the company faces significant competition and regulatory hurdles, and there is no guarantee that its product candidates will ultimately be successful.

Investors should closely monitor Vistagen’s progress in advancing its pipeline, its ability to secure additional financing, and any updates regarding its interactions with the FDA. The company’s future performance will be critical in determining its long-term viability and the potential value it can deliver to shareholders.