Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K (Report) includes forward-looking statements. All statements contained in this Report other than statements of historical fact, including statements regarding our future outcomes and results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Our business is subject to significant risks including, but not limited to: our ability to obtain substantial additional financing; our ability to successfully complete ongoing or future clinical trials of our product candidates within estimated timelines or at all, receive regulatory approval or be commercially successful; our dependence on third-party collaborators for the development, manufacturing, regulatory approval, and/or commercialization of our product candidates and other aspects of our business, which are outside of our full control; the effect of regulation by the U.S. Food and Drug Administration (the FDA) and other domestic and foreign regulatory agencies; current and potential future healthcare reforms; our ability to obtain, maintain and enforce patents on our products if/or when we receive regulatory approval of any of our products; the impact of competitive products, product development, commercialization potential and technological difficulties; the effect of our accounting policies; and other risks as detailed in the section entitled “Risk Factors” in this Annual Report.Further, even if our product candidates appear promising at various stages of development, our share price may decrease such that we are unable to raise additional capital without significant dilution or other terms that may be unacceptable to our management and our Board of Directors (the Board) or disadvantageous to our stockholders.
Moreover, the biopharmaceutical industry in which we operate is very competitive and rapidly changing. New challenges and risks emerge frequently. It is not possible for our management or Board to predict all challenges and risks we will face, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make in this Annual Report or otherwise. In light of these risks, challenges, uncertainties and assumptions, the future events and trends discussed in this Annual Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Accordingly, you should not rely upon the forward-looking statements in this Annual Report as predictions of future events. The events and circumstances reflected in the forward-looking statements in this Annual Report may not be achieved or occur in part or at all. Although we believe that the expectations reflected in the forward-looking statements in this Annual Report are reasonable as of the date of this Annual Report, we cannot guarantee future results, levels of activity, performance or achievements. We are under no duty to update any of the forward-looking statements in this Annual Report after the date of this Annual Report or to conform the forward-looking statements to actual results or revised expectations. If we do update one or more of the forward-looking statements in this Annual Report, no inference should be drawn that we will make additional updates with respect to those or any other forward-looking statements.
Business Overview
We are a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of non-systemic intranasal product candidates called pherines. Our broad and diverse neuroscience pipeline currently consists of five clinical-stage pherine product candidates, each with a novel mechanism of action (MOA) and positive clinical data in their targeted indication(s). Pherines specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons, and are designed to rapidly activate nose-to-brain neurocircuits believed to regulate brain areas without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits.
Our most advanced intranasal pherine product candidate is fasedienol, which is being investigated in our U.S. registration-directed PALISADE Program for the acute treatment of social anxiety disorder (SAD). Our PALISADE Program includes the PALISADE-1, PALISADE-2, PALISADE-3, and PALISADE-4 Phase 3 clinical trials and a small exploratory Phase 2 repeat dose study (the Repeat Dose Study). PALISADE-2 achieved its primary efficacy endpoint, as reported in August 2023. Neither PALISADE-1, completed in 2022, nor PALISADE-3, the randomized portion of which was completed in December 2025, achieved its primary endpoint.
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On May 8, 2026, we announced that the last patient had completed the last visit in the randomized portion of PALISADE-4, and we expect to announce topline results from the randomized portion of PALISADE-4 in the second quarter of calendar 2026. The FDA has granted Fast Track designation for the investigation of fasedienol for the acute treatment of SAD. We believe PALISADE-4, if successful, together with the positive results from PALISADE-2 and confirmatory evidence from our overall fasedienol development program in SAD, including the Repeat Dose Study and Open Label Extension data, as well as confirmatory evidence we plan to generate based on FDA feedback to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, may establish substantial evidence of the effectiveness of fasedienol in support of a potential New Drug Application (NDA) submission to the FDA for the acute treatment of SAD.
We have also reported positive results from an exploratory Phase 2A clinical trial for each of our next most advanced pherine product candidates, itruvone for treatment of major depressive disorder, and refisolone (formerly PH80) for both vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder (PMDD), as well as a pilot Phase 2A study of PH15 for improvement of psychomotor impairment due to mental fatigue and an exploratory Phase 2A study of PH284 for treatment of cancer cachexia. In April 2026, we announced receipt of a 'Study May Proceed' letter from the FDA under our U.S. Investigational New Drug (IND) application for refisolone for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.
In March 2026, our Board of Directors approved a reduction of approximately 20% in our workforce, intended to provide disciplined cash management while prioritizing efficient execution of the ongoing clinical studies in our PALISADE Program. See 'Liquidity and Capital Resources' below for additional discussion.
We are passionate about developing transformative treatment options with potential to meet clear and growing unmet needs and bring meaningful relief to patients underserved by the current standard of care for multiple highly prevalent indications, all while delivering long-term value to our stockholders.
Subsidiaries
Our wholly-owned subsidiaries consist of Pherin Pharmaceuticals, Inc, a Delaware corporation (Pherin), which we acquired in February 2023, and Vistastem, Inc., a California corporation founded in 1998 (Vistastem).
Components of Results of Operations
Sublicense and Other Revenue
Sublicense and other revenue consist of revenue recognized under the AffaMed Agreement and Negotiation Agreement with Fuji Pharma. Revenue is recognized as identified performance obligations are satisfied. See Note 11 to our consolidated financial statements for a complete description of the AffaMed Agreement and Fuji Pharma Negotiation Agreement.
Operating Expenses
Research and Development Expenses
To date, our research and development expenses consist primarily of external and internal costs related to the development of our product candidates and development programs. Our research and development expenses primarily include:
•External costs, including:
◦expenses incurred in connection with planning, preparing for and conducting clinical trials, including investigator grants and site payments, and pass-through expenses and expenses incurred under agreements with CROs, central laboratories and other vendors and service providers engaged to conduct our trials;
◦expenses incurred in connection with the discovery and preclinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
◦costs associated with consultants for chemistry, manufacturing, and control (CMC) development, and other manufacturing-related services;
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◦the cost of manufacturing compounds for use in our nonclinical studies and clinical trials, including under agreements with third parties, such as consultants and third-party contract manufacturers; and
◦costs related to compliance with development regulatory requirements.
•Internal costs, including:
◦employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions;
◦the costs of laboratory supplies and acquiring and developing preclinical study materials; and
◦facilities, depreciation and other expenses, which include allocated expenses for rent and maintenance of facilities, and supplies.
We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date.
Research and development activities are central to our business model. There are numerous factors associated with the successful development of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development.
Our future research and development expenses may vary significantly based on a wide variety of factors, such as:
•the number and scope, rate of progress, expense and results of our preclinical development activities and clinical trials;
•the number of trials required for regulatory approval;
•the number of sites included in each of our clinical trials;
•the length of time required to enroll eligible patients;
•the number of patients that participate in the trials;
•the ability to identify appropriate patients eligible for our clinical trials;
•the number of doses that patients receive during such clinical trials;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring requested by regulatory agencies;
•the duration of patient participation in the trials and follow-up;
•the phase of development of the product candidate;
•the efficacy and safety profile of the product candidate;
•the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
•maintaining a continued acceptable safety profile of our product candidates following approval, if any;
•the cost and timing of manufacturing our product candidates;
•significant and changing government regulation and regulatory guidance;
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•the impact of any business interruptions to our operations or to those of the third parties with whom we work;
•adverse effects on the financial markets, the global economy, the supply chain and our expenses due to pandemics or other epidemic diseases, geopolitical instability, inflation, rising interest rates and other factors; and
•the extent to which we establish additional strategic collaborations or other arrangements.
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. The process of conducting the necessary preclinical and clinical research and development to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates or any future candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our product candidates or any future candidates.
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General and Administrative Expenses
General and administrative expenses consist of salaries, bonuses, related benefits and stock-based compensation expense for personnel in executive, legal, finance and administrative functions; professional fees for legal, consulting, accounting and audit services; and travel expenses, technology costs and other allocated expenses. We expense general and administrative expenses in the periods in which they are incurred.
Results of Operations for the Years Ended March 31, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
Year Ended March 31,
Revenues:
Sublicense and other revenue $ 1,269 $ 486
Operating expenses:
Other income (expense)
Other income 7 5
Income taxes (7) (7)
Sublicense and Other Revenue
Sublicense and other revenue was $1.3 million for the year ended March 31, 2026, compared to $0.5 million for the year ended March 31, 2025, an increase of $0.8 million. The increase in sublicense and other revenue is due to timing of revenue recognized under the AffaMed Agreement.
As of March 31, 2026, approximately $0.4 million of deferred revenue under the AffaMed Agreement remained to be recognized, which we expect to recognize in fiscal 2027. Approximately $1.3 million of deferred revenue under the Negotiation Agreement with Fuji Pharma also remained as of March 31, 2026. The recognition of remaining deferred revenue under the Negotiation Agreement is dependent on the outcome of the Exclusive Negotiation Period, as further described in Note 11 to our consolidated financial statements included with this Annual Report.
The amount and timing of future sublicense and other revenue will also depend on the achievement of milestones under existing agreements, if any, and the execution of new licensing or sublicensing agreements, if any.
Research and Development Expenses
The following table summarizes our research and development expenses for the years ended March 31, 2026 and 2025 (in thousands):
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Year Ended March 31,
Clinical and nonclinical studies and development expenses by program
Other clinical stage candidates 1,230 3,103
Total clinical and nonclinical studies and development expenses 39,743 24,995
Consulting and professional services 1,559 1,565
Occupancy and all other costs 1,541 1,475
Total research and development expenses $ 54,974 $ 39,375
Research and development expense was $55.0 million for the year ended March 31, 2026 compared to $39.4 million for the year ended March 31, 2025, an increase of $15.6 million or 39.6%. The increase was primarily driven by higher clinical trial activity within our fasedienol program, partially offset by lower spend on our other clinical-stage pherine product candidates.
Clinical and nonclinical studies and development expenses by program increased by $14.7 million, from $25.0 million in fiscal 2025 to $39.7 million in fiscal 2026. PALISADE Program expenses increased by $16.6 million, from $21.9 million in fiscal 2025 to $38.5 million in fiscal 2026. The increase was attributable to three clinical studies within our U.S. registration-directed PALISADE Program, including our PALISADE-3 and PALISADE-4 Phase 3 clinical trials and the Repeat Dose Study conducted concurrently during fiscal 2026. By comparison, fiscal 2025 reflected only a partial period of activity for these studies as each was in earlier stages of enrollment and start-up. The fiscal 2026 increase reflects higher CRO costs, investigator and site payments, and pass-through expenses associated with the expanded scale of patient enrollment, dosing, and trial conduct activities.
Other clinical-stage product candidates under active development include refisolone and itruvone. Expenses for these candidates decreased $1.9 million, from $3.1 million in fiscal 2025 to $1.2 million in fiscal 2026, primarily reflecting reduced clinical and nonclinical activity as we prioritized resources toward our PALISADE Program.
Salaries and benefits expense increased by $1.0 million from $9.4 million in fiscal 2025 to $10.4 million in fiscal 2026, primarily due to increased headcount supporting our clinical development activities. Stock-based compensation decreased by $0.2 million from $1.9 million in fiscal 2025 to $1.7 million in fiscal 2026. Consulting and professional services expenses were substantially unchanged at $1.6 million in each of fiscal 2026 and 2025. Occupancy and all other costs were also substantially unchanged at $1.5 million in each of fiscal 2026 and 2025.
We expect that our research and development expense may fluctuate over the next fiscal year. The fluctuation depends on when we conduct nonclinical studies and clinical trials, and expand third-party contract manufacturing and regulatory activities required to advance further research and development of our current pherine product candidates and additional pherine product candidates, and when and to what extent we maintain, expand, protect and enforce our intellectual property portfolio, and hire additional headcount. At this time, we cannot accurately estimate or know the nature, timing and costs of these efforts that will be necessary to complete the preclinical and clinical development of any pherine product candidates we may develop. A change in the outcome of any number of variables with respect to product candidates we may develop could significantly change the costs and timing associated with the development of that product candidate.
General and Administrative Expenses
General and administrative expense was $18.4 million for the year ended March 31, 2026, compared to $17.1 million for the year ended March 31, 2025, an increase of $1.3 million or 7.8%. The increase was primarily attributable to higher corporate legal expense, including costs associated with the defense of pending shareholder litigation, higher salaries and wages, and higher consulting fees, partially offset by lower incentive bonus expense in fiscal 2026.
Our expectation for general and administrative expense is largely dependent on the results of the randomized portion of our PALISADE-4 clinical trial. We expect that our general and administrative expenses may increase substantially over the next fiscal year in the event of positive results from PALISADE-4. Under a positive scenario, we will prepare to submit a NDA to the FDA and begin commercialization efforts to support product launch or partnering of commercialization for
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fasedienol. However, in the event of negative results from PALISADE-4, we expect to further cash conservation efforts that were implemented following the announcement of negative results from the randomized portion of our PALISADE-3 clinical trial, resulting in an anticipated decrease to general and administrative expense.
Other income, net was $2.4 million for the year ended March 31, 2026, compared to $4.6 million for the year ended March 31, 2025, a decrease of $2.1 million, or 46%. The decrease was primarily attributable to lower average balances of cash, cash equivalents, and marketable securities during fiscal 2026 as compared to fiscal 2025, reflecting the use of cash to fund our operations.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. As of March 31, 2026, we have financed our operations and technology acquisitions primarily through the issuance and sale of our equity securities for cash proceeds of approximately $371.2 million, as well as from an aggregate of approximately $22.7 million of government research grant awards (excluding the fair market value of government-sponsored and funded clinical trials), strategic collaboration payments, intellectual property licensing payments, and other revenues. Additionally, we have issued equity securities with an approximate value at issuance of $41.3 million for non-cash acquisitions of product licenses, the Pherin Acquisition, and in settlements of certain liabilities, including liabilities for professional services rendered to us or as compensation for such services.
In May 2021, we entered into an Open Market Sale Agreement (the Sales Agreement) with Jefferies LLC (Jefferies) as sales agent, with respect to an at-the-market offering program (the ATM) under which we were permitted, at our option, to offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to $75.0 million through Jefferies. The aggregate offering price available under the Sales Agreement was increased to $100.0 million in February 2024 and to $175.0 million in June 2025. During our fiscal years ended March 31, 2026 and 2025, we sold an aggregate of 10,403,244 and 1,108,587 shares, respectively, under the Sales Agreement, for net proceeds of $30.6 million and $3.0 million, respectively, after sales agent commissions. We pay Jefferies a commission of up to three percent (3.0%) of the aggregate gross proceeds from any sales under the Sales Agreement.
As of March 31, 2026 and 2025, we had cash, cash equivalents, and marketable securities of $45.4 million and $80.5 million, respectively. As of June 15, 2026, the issuance date of the consolidated financial statements in this Annual Report, we concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least twelve months from the date these consolidated financial statements are issued.
When necessary and/or advantageous, we will seek additional capital to fund our planned operations through, among other options, (i) sales of our equity and/or debt securities in one or more public offerings and/or private placements, including sales of our securities under the Sales Agreement, (ii) non-dilutive government grants and research awards and/or (iii) non-dilutive strategic partnering collaborations to advance development and commercialization of our product candidates. However, no assurance can be provided that any such sales of our securities, awards, agreements or collaborations will occur in the future. While we may make additional sales of our equity securities, we do not have an obligation to do so.
Our future working capital requirements will depend on many factors, including, without limitation, potential impacts related to adjustments in the size of our staff, the scope and nature of opportunities related to our success or failure and the success or failure of certain other companies in nonclinical and clinical trials, including the development and commercialization of our current product candidates, and the availability of, and our ability to enter into financing transactions and research, development and commercialization collaborations on terms acceptable to us. In the future, to further advance the clinical development and commercialization of our product candidates, as well as support our operating activities, we plan to seek substantial additional financing, including both equity-based and/or debt-based capital and potentially from non-dilutive sources other than debt-based capital, and continue to carefully manage our operating costs, including, but not limited to, our clinical, nonclinical, and pre-commercialization programs. However, there can be no assurance that future financing will be available to us in sufficient amounts, in a timely manner, or on terms acceptable to us, if at all, or that current or future development and commercialization collaborations will generate revenue from future potential milestone payments or otherwise. See Note 2 to our consolidated financial statements contained in this Annual Report for additional information regarding our going concern assessment.
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Cash Flows
The following table summarizes changes in cash and cash equivalents for the fiscal years stated (in thousands):
Year Ended March 31,
Net cash used in operating activities $ (66,436) $ (42,097)
Net cash used in investing activities (877) (13,148)
Net cash provided by (used in) financing activities 30,971 3,210
Net decrease in cash and cash equivalents (36,342) (52,035)
Cash and cash equivalents at beginning of period 67,131 119,166
Cash and cash equivalents at end of period $ 30,789 $ 67,131
Operating Activities
Net cash used in operating activities for the year ended March 31, 2026 was $66.4 million, consisting primarily of our net loss of $69.7 million, adjusted for $4.2 million of non-cash charges primarily related to stock-based compensation expense and amortization of our operating lease right-of-use asset, and a $0.9 million use of cash for net changes in operating assets and liabilities.
Net cash used in operating activities for the year ended March 31, 2025 was $42.1 million, consisting primarily of our net loss of $51.4 million, adjusted for $4.5 million of non-cash charges primarily related to stock-based compensation expense and amortization of our operating lease right-of-use asset, and $4.8 million for net changes in operating assets and liabilities.
Investing Activities
Net cash used in investing activities for the year ended March 31, 2026 was $0.9 million, consisting of purchases of marketable securities and property and equipment, partially offset by the sale and maturity of marketable securities.
Net cash used in investing activities for the year ended March 31, 2025 was $13.1 million, consisting primarily of net purchases of marketable securities and, to a lesser extent, purchases of property and equipment.
Financing Activities
Net cash provided by financing activities during the year ended March 31, 2026 was $31.0 million, consisting primarily of net proceeds from the sale of our common stock in ATM transactions under the Sales Agreement.
Net cash provided by financing activities during the year ended March 31, 2025 was $3.2 million, consisting primarily of net proceeds from the sale of our common stock in ATM transactions under the Sales Agreement and to a lesser extent, proceeds from activity in our Employee Stock Purchase Plan.
Future Funding Requirements
Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities will not be sufficient to fund our operations beyond the next twelve months from the date of this Annual Report. We anticipate that we will continue to seek substantial additional funding, though the precise timing and nature of such additional funding may prove uncertain or unavailable to us. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. See "Risk Factors" above. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our current capital resources sooner than we expect. Additionally, the process of conducting nonclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
Our future capital requirements will depend on many factors, including:
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•the initiation, type, number, scope, costs, timing and results of, the recently completed randomized portion of PALISADE-4, our ongoing and planned nonclinical studies and clinical trials of product candidates or clinical trials of other potential product candidates we may choose to pursue in the future, including based on feedback received from regulatory authorities;
•the costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing if any product candidate is approved;
•the costs, timing and outcome of regulatory review of current or future product candidates;
•the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
•the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved, and should we decide to commercialize them on our own;
•our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payers and adequate market share and revenue for any approved products;
•costs associated with any products or technologies that we may in-license or acquire; and
•delays or issues with any of the above, including that the risk of each may be exacerbated any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.
Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders likely will, be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish potentially valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Contractual Obligations and Commitments
We lease our corporate office and laboratory space in South San Francisco, California. As of March 31, 2026, total undiscounted future aggregate operating lease commitments were $1.0 million, with approximately $0.8 million due during the year ending March 31, 2027, and the remaining due in periods ending March 31, 2028. These obligations are further described in Note 5 to our audited consolidated financial statements.
In addition, we enter into agreements in the normal course of business with certain vendors for the provision of goods and services, which includes third-party contract manufacturing services with CDMOs, development services with CROs, and research and development services from other industry consultants. These arrangements are generally cancelable by either party with notice, and we are not committed to any material non-cancelable purchase obligations as of March 31, 2026.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and
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events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 to our Consolidated Financial Statements included elsewhere in this Annual Report, we believe the following accounting estimates to be most critical to the preparation of our financial statements.
Research and Development Expenses, Prepaids, and Accruals
Research and development expenses consist of external and internal costs associated with our research and development activities, including our discovery and research efforts and the manufacturing, nonclinical and clinical development of our neuroscience product candidates. Research and development costs are expensed in the period incurred.
We have entered into various research and development contracts with CROs, CDMOs, clinical sites and other vendors and consultants. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of or after performance are reflected in the accompanying balance sheets as prepaid expenses or accrued liabilities, respectively. We record accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, we analyze progress of the services, including the phase or completion of events, invoices received and contracted costs. We hold discussions with applicable personnel and outside service providers regarding the status and progress of our manufacturing, nonclinical studies, clinical trials, and other contracted services. Significant judgments and estimates may be made in assessing the phase or completion of events to determine the expense and the resulting prepaid or accrued balances at the end of any reporting period. Our R&D accruals are most sensitive to assumptions about CRO progress on clinical trials, where invoices may lag actual services performed by several months. If our estimates of vendor progress differ from actual progress, our research and development expense and accrued liabilities could be materially different from the amounts reported. Non-refundable advance payments for goods and services, including fees for process development, are deferred and recognized as expense in the period that the related goods are consumed, or services are performed.
Costs incurred in obtaining product or technology licenses are charged immediately to research and development expense if, at acquisition, the product or technology licensed has not achieved regulatory approval or reached technical feasibility and has no alternative future uses.
A description of recently issued accounting pronouncements that may potentially impact our financial condition and results of operations is disclosed in Note 2 to our audited Consolidated Financial Statements appearing elsewhere in this Annual Report.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
The disclosures in this section are not required because we qualify as a "smaller reporting company," as such term is defined in Rule 12b-2 under the Exchange Act.
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Item 8. Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm 94
Consolidated Balance Sheets 95
Consolidated Statements of Operations and Comprehensive Loss 96
Consolidated Statements of Stockholders’ Equity 97
Consolidated Statements of Cash Flows 98
Notes to Consolidated Financial Statements 99
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors
Vistagen Therapeutics, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Vistagen Therapeutics, Inc. and subsidiaries (the Company) as of March 31, 2026 and 2025, the related consolidated statement of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the years in the two-year period ended March 31, 2026, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2026 and 2025, and the results of its operations and its cash flows for each of the years in the two-year period ended March 31, 2026, in conformity with U.S. generally accepted accounting principles.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has incurred recurring losses, negative cash flows from operations, and has an accumulated deficit that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ KPMG LLP
We have served as the Company’s auditor since 2024.
San Francisco, California
June 15, 2026
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CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
ASSETS
Current assets:
Prepaid expenses and other current assets 1,540 1,594
Property and equipment, net 427 476
Right-of-use asset - operating lease 801 1,335
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Notes Payable 96 —
Deferred revenue - current portion 1,710 2,588
Operating lease liability - current portion 699 561
Deferred revenue - non-current portion — 391
Operating lease liability - non-current portion 249 948
Commitments and contingencies (Note 13)
Stockholders’ equity:
Accumulated other comprehensive gain (loss) (2) 5
Total liabilities and stockholders’ equity $ 48,564 $ 84,341
See accompanying notes to consolidated financial statements
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
Year EndedMarch 31,
Revenues:
Sublicense and other revenue $ 1,269 $ 486
Operating expenses:
Other income, net:
Other income, net 7 5
Income taxes (7) (7)
Unrealized gain (loss) on marketable securities $ (7) $ 5
Basic and diluted net loss per common share $ (1.83) $ (1.67)
See accompanying notes to consolidated financial statements
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CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share amounts)
Shares Amount
Stock-based compensation expense — — 4,315 — — — 4,315
Stock-based compensation expense — — 3,997 — — — 3,997
Issuance of common stock upon exercise of stock options 2,330 — 8 — — — 8
See accompanying notes to consolidated financial statements
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CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended March 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 199 150
Loss on disposal of fixed assets — —
Amortization of operating lease right-of-use asset 534 485
Accretion of marketable securities (543) (389)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 36 (88)
Operating lease liability (561) (611)
Accounts payable and accrued expenses 828 5,681
Net cash used in operating activities (66,436) (42,097)
Cash flows from investing activities:
Purchases of laboratory and other equipment (151) (191)
Sales and maturities of marketable securities 21,575 12,027
Purchases of marketable securities (22,301) (24,984)
Net cash used in investing activities (877) (13,148)
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs 8 —
Issuance of note payable for insurance policy 1,020 —
Repayment of note payable (925) —
Net cash provided by financing activities 30,971 3,210
Net increase (decrease) in cash and cash equivalents (36,342) (52,035)
Cash and cash equivalents at beginning of period 67,131 119,166
Cash and cash equivalents at end of period $ 30,789 $ 67,131
Supplemental disclosure of cash flow information:
Cash paid for interest $ 33 —
See accompanying notes to consolidated financial statements
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1. Description of Business
Overview
Vistagen Therapeutics, Inc., a Nevada corporation (Vistagen, the Company, we, our, or us), is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and potentially commercialize a new class of non-systemic intranasal product candidates called pherines. Our clinical-stage neuroscience pipeline currently includes five clinical-stage intranasal pherine product candidates, each with a novel proposed mechanism of action (MOA) and at least one positive clinical study involving our targeted patient population. Pherines rapidly, specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons, and are designed to rapidly activate nose-to-brain neurocircuits believed to regulate brain areas without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits.
2.Basis of Presentation, Principles of Consolidation and Summary of Significant Accounting Policies
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP), and reflect the operations of Vistagen and our wholly owned subsidiaries. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). All material intercompany accounts and transactions have been eliminated in consolidation.
Liquidity and Going Concern
In order to complete the development of our neuroscience product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional capital. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through equity and/or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties. Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, we are unable to estimate the exact amount and timing of our capital requirements. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, that will occur.
We have incurred significant losses and negative cash flows from operations since inception. As of March 31, 2026, we had an accumulated deficit of $477.3 million and cash used in operations for the year ended March 31, 2026 was $66.4 million. We expect that our operating losses and negative cash flows will continue for the foreseeable future as we continue to develop our product candidates.
In accordance with Accounting Standards Codification (ASC) 205-40, Going Concern, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year from the date that these consolidated financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the consolidated financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about our ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the consolidated financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity and/or debt issuances and other potential sources such as partnerships cannot be considered probable at this time because these plans are not entirely within our control nor have these plans been approved by the Board as of the date of these consolidated financial statements.
As of March 31, 2026 and 2025, we had cash, cash equivalents, and marketable securities of $45.4 million and $80.5 million, respectively. As of June 15, 2026, the issuance date of the consolidated financial statements as of and for the year
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ended March 31, 2026, there is uncertainty about whether our combined cash, cash equivalents, and marketable securities will be sufficient to fund operations beyond twelve months from the issuance date of these consolidated financial statements and therefore we concluded that substantial doubt exists about our ability to continue as a going concern.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Estimates reflected in the accompanying consolidated financial statements include, but are not limited to, those relating to stock-based compensation, revenue recognition, research and development expenses, determination of right-of-use assets under lease transactions and related lease obligations, useful lives of property and equipment, deferred tax assets and liabilities and the related valuation allowance, and the assumptions used to value warrants. We base our estimates on historical experience, known trends and other market-specific or other relevant factors that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments which potentially subject us to significant concentration of credit risk consist of cash and cash equivalents. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have not experienced any losses in such accounts, and management believes that we are not exposed to significant credit risk due to the nature of the instruments held in the depository institutions.
Cash and Cash Equivalents
Cash and cash equivalents are considered to be highly liquid investments with maturities of three months or less at the date of purchase. Cash equivalents primarily represent funds invested in readily available money market accounts and short-term treasury notes. As of March 31, 2026, we had cash and cash equivalents balances deposited at multiple major financial institutions.
Property and Equipment
Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to ten years, or the remaining term of the lease). Repairs and maintenance costs are expensed as incurred, while expenditures that extend the useful life of an asset or add new functionality are capitalized and depreciated over the remaining useful life of the related asset.
Impairment of Long-Lived Assets
We evaluate our long-lived assets, which consist of property and equipment and right-of-use assets, whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. To date, we have not recorded any impairment losses on long-lived assets.
Deferred Offering Costs
Deferred offering costs include registration expenses related to our current registration statement on SEC Form S-3, which became effective on February 29, 2024,and expenses related to the Sales Agreement (as described in Note 8, Capital Stock). These expenses consist primarily of legal, accounting, SEC filing fees, and, as appropriate, Nasdaq filing fees.
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Upon the completion or partial completion of an applicable equity offering, the deferred expenses are charged to additional paid-in capital. If there are any deferred offering costs remaining at the expiration of our current registration statement on SEC Form S-3 or the equity financing agreement, or if the financing is abandoned, terminated or significantly delayed, such costs are charged to expense.
Revenue Recognition
Under ASC Topic 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Topic 606, we perform the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services we transfer to a customer.
At contract inception, once the contract is determined to be within the scope of ASC 606, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct combined performance obligation is identified. We then allocate the transaction price (that is, the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled, subject to the constraint on variable consideration. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized at the contract level is not significant.
License Rights — If the license to our intellectual property (IP) is determined to be distinct from the other promises or performance obligations identified in the arrangement, which generally include research and development services, we recognize revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. In assessing whether a license is distinct from the other promises, we consider relevant facts and circumstances of each arrangement, including the research and development capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, we consider whether the collaboration partner can benefit from the license for its intended purpose without the receipt of the remaining promises, whether the value of the license is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises and whether it is separately identifiable from the remaining promises. For licenses that are combined with other promises, we utilize judgment to assess the nature of the combined performance obligation and whether the license is the predominant promise within the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. If the license is the predominant promise, and it is determined that the license represents functional IP, revenue is recognized at the point in time when control of the license is transferred. If it is determined that the license does not represent functional IP, revenue is recognized over time using an appropriate method of measuring progress.
Customer Options — Our arrangements may provide a collaborator with the right to acquire additional goods or services in the future. If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the additional goods and services underlying the customer options are evaluated in order to determine if these additional goods or services are distinct from those included as a performance obligation at the outset of the arrangement. If the additional services are not determined to be distinct, the variable consideration pertaining to the customer option is added to the initial transaction price at the time in which the option exercise becomes probable. Any such adjustments to the transaction price are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. If the additional services are distinct, we evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. Material rights are recognized as a separate performance obligation at the inception of the arrangement. We allocate the transaction price to material rights based on the relative stand-alone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised or expires.
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Milestone Payments — At the inception of an arrangement that includes development milestone payments, we evaluate whether the milestones are considered likely to be achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue recognized would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our control, such as regulatory approvals, are not considered probable to be achieved until those approvals are received. We evaluate factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, we reevaluate the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Royalties — For arrangements that include sales-based royalties, including milestone payments based on a level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue resulting from licensing agreements.
Amounts due to us for satisfying the revenue recognition criteria or that are contractually due based upon the terms of the collaboration agreements are recorded as accounts receivable on the consolidated balance sheets. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognized as revenue within the one year following the balance sheet date are classified as current deferred revenue. Amounts not expected to be recognized as revenue within the one year following the balance sheet date are classified as deferred revenue, net of current portion.
Research and Development Expenses and Accruals
Research and development expenses are composed of both internal and external costs. Internal costs include salaries and employment-related expenses, including stock-based compensation expense, of scientific personnel and direct project costs. External research and development expenses consist primarily of costs associated with clinical and nonclinical development programs and are charged to expense as incurred.
We have entered into various research and development contracts with clinical research organizations, clinical development and manufacturing organizations, clinical sites and other vendors and consultants. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of or after the performance are reflected in the accompanying balance sheets as prepaid expenses or accrued liabilities, respectively. When evaluating the adequacy of the accrued liabilities, we analyze progress of the services, including the phase or completion of events, invoices received and contracted costs. We hold discussions with relevant employees and outside service providers as to assess the progress of clinical trials and services performed. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from our estimates. Nonrefundable advance payments for goods and services, including fees for process development, are deferred and recognized as expenses in the period that the related goods are consumed or services are performed.
Income Taxes
We account for income taxes using the asset and liability approach promulgated by ASC 740,Income Taxes, for financial reporting purposes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established, when necessary, to reduce the deferred tax assets to an amount expected to be realized.
Uncertain tax positions, for which our assessment is that there is a more than 50% probability of sustaining the position upon challenge by a taxing authority based on its technical merits, are subject to certain recognition and measurement
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criteria. The nature of the uncertain tax positions is often very complex and subject to change, and the amounts at issue can be substantial. We develop our cumulative probability assessment of the measurement of uncertain tax positions using internal experience, judgment and assistance from our professional advisors. We re-evaluate these uncertain tax positions on a quarterly basis based on a number of factors including, but not limited to, changes in facts or circumstances, changes in tax law, and effectively settled issues under audit and new audit activity. Any change in these factors could result in the recognition of a tax benefit or an additional charge to the tax provision.
Effective April 1, 2025, we adopted ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, on a prospective basis. ASU 2023-09 requires enhanced disclosures related to the effective tax rate reconciliation and income taxes paid. The adoption resulted in expanded disclosures in Note 10, Income Taxes, and did not affect our consolidated financial position, results of operations, or cash flows.
Leases
At the inception of a contractual agreement, we determine whether the contract is or contains a lease, by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, we record the associated lease liability and corresponding right-of-use asset upon commencement of the lease using the implicit rate or a discount rate based on a credit-adjusted secured borrowing rate commensurate with the term of the lease. When determining the lease term, we include options to extend or terminate the lease when it is reasonably certain, at inception, that we will exercise that option. Additionally, we evaluate leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease.
Operating lease assets represent our right to use an underlying asset for the lease term (Right-of-use assets) and operating lease liabilities represent our obligation to make lease payments arising from the lease. The lease payments used to determine our operating lease assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation, when determinable, and are recognized in determining our Right-of-use assets.
Operating lease liabilities with a term greater than one year and their corresponding right-of-use assets are recognized on the balance sheets at the commencement date of the lease based on the present value of lease payments over the expected lease term. We exclude short-term leases, if any, having initial terms of 12 months or less at lease commencement as an accounting policy election. Variable lease payments are amounts owed by us to a lessor that are not fixed, such as reimbursement for common area maintenance costs for our facility lease; and are expensed when incurred. Operating right-of-use assets are reflected in right-of-use assets in the accompanying balance sheets. Operating lease liabilities are reflected in operating lease obligations, current and non-current in the accompanying balance sheets.
Financing leases, formerly referred to as capitalized leases, are treated similarly to operating leases except that the asset subject to the lease is included in the appropriate fixed asset category, rather than recorded as a Right-of-use asset, and depreciated over its estimated useful life, or lease term, if shorter. We have not entered into any financing leases as of the balance sheet dates presented.
Internal-Use Software Development Costs
We capitalize qualifying costs incurred during the application development stage related to software developed for internal-use and amortize them over the estimated useful life of three years. Amortization of such costs begins when the project is substantially complete and ready for its intended use. Capitalized software development costs are classified as property and equipment, net on the consolidated balance sheet. We expense costs incurred related to the planning and post-implementation phases of development as incurred.
Stock-Based Compensation
Stock-based compensation is accounted for in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) and is measured at the grant date fair value for employee, officer, director and non-employee equity awards and is recognized over the requisite service period, which is generally the vesting period. We recognize forfeitures as they occur. Stock-based compensation is classified in the Consolidated Statements of Operations and Comprehensive Loss in the same manner in which the recipient's payroll or fees are classified.
The fair value of stock options is estimated using a Black-Scholes valuation model on the date of grant. This method requires that certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term
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of the option before exercise, expected volatility of our common stock, risk-free interest rate and expected dividend. Options granted have a maximum contractual term of ten years. We have limited historical stock option activity and therefore estimate the expected term of stock options granted using the simplified method, which represents the arithmetic average of the original contractual term of the stock option and its weighted-average vesting term. The expected volatility of stock options is estimated based on the average historical volatility of our own common stock. The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options. We have historically not declared or paid any dividends and we do not currently expect to do so in the foreseeable future, and therefore have estimated the dividend yield to be zero.
Fair Value Measurements
We measure certain assets and liabilities at fair value on a recurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. We use a three-tier fair value hierarchy to prioritize the inputs used in measuring fair value, which are as follows:
•Level 1 — Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities.
•Level 2 — Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
•Level 3 — Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).
Money market funds are highly liquid investments and are classified as Level 1. The pricing information for these assets is readily available and can be independently validated as of the measurement date. Available-for sale debt securities are valued using observable inputs from similar assets, or from observable data in markets that are not active. These assets are classified as Level 2.
Warrants Issued in Connection with Equity Financing
We evaluate the appropriate balance sheet classification of warrants we issue as either equity or as a derivative liability. In accordance with ASC 815-40, Derivatives and Hedging-Contracts in the Entity’s Own Equity (ASC 815-40), we classify a warrant as equity if it is “indexed to the Company’s equity” and meets several specific conditions for equity classification. A warrant is not considered “indexed to the Company’s equity,” in general, when it contains certain types of exercise contingencies or potential adjustments to its exercise price. If a warrant is not indexed to the Company’s equity or it has net cash settlement provisions that result in the warrants being accounted for under ASC 480, Distinguishing Liabilities from Equity or ASC 815-40, it is classified as a derivative liability which is carried on the consolidated balance sheets at fair value with any changes in its fair value recognized immediately in the Statements of Operations and Comprehensive Loss. AtMarch 31, 2026and 2025 all of our outstanding warrants were classified as equity.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in shareholders’ equity that result from transactions and economic events other than those with shareholders. For the year ended March 31, 2026, these changes related to unrealized gains and losses on our available-for-sale short-term investments. There were no reclassifications out of comprehensive loss for the years ended March 31, 2026 and 2025, respectively.
Net Loss Per Share
We calculate basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required for participating securities. Certain warrants participate in distributions of the Company. The Pre-Funded Warrants associated with the October 2023 Public Offering (see Note 8 below) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. The net loss attributable to common stockholders is
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not allocated to the warrant holders as the holders of warrants do not have a contractual obligation to share in losses. Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. Our potentially dilutive securities, including outstanding warrants to purchase common stock and outstanding stock options under our equity incentive plan, have been excluded from the computation of diluted net loss per share as their inclusion would be anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position.
The following table summarizes the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion in the calculation would be anti-dilutive:
As of March 31,
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. We manage our operations as a single reportable segment for the purposes of assessing performance and making operating decisions.
Related Parties
Transactions between related parties are considered to be related party transactions even though they may not be given accounting recognition. ASC 850, Related Party Disclosures (ASC 850) requires that transactions with related parties that would make a difference in decision-making shall be disclosed so that users of the financial statements can evaluate their significance.
Recently Adopted Accounting Principles
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-09 on a prospective basis effective April 1, 2025, resulting in enhanced income tax disclosures. See Note 10, Income Taxes, for the enhanced disclosures required under ASU 2023-09.
Issued Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires disaggregated disclosure of certain expense categories on the face of the income statement or in the notes. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and for interim reporting periods within annual reporting periods beginning after December 15, 2027. For us, this means the standard will first apply to our annual financial statements for the year ending March 31, 2028, and to our interim financial statements beginning with the quarter ending June 30, 2028. Early adoption is permitted. We are currently evaluating the impact of adoption.
In September 2025, the FASB issued ASU 2025-06, Intangibles — Goodwill and Other Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This guidance modernizes the accounting
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framework for internal-use software by providing clearer criteria for capitalization, including the requirement to assess whether significant development uncertainty exists. ASU 2025-06 is effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods. For us, this means the standard will first apply to our annual and interim financial statements beginning with the fiscal year ending March 31, 2029. Early adoption is permitted. We are currently evaluating the impact of this guidance on our consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which provides clarity on the required interim disclosures under Topic 270 by providing a comprehensive list of required interim disclosures, and clarifies the applicability of Topic 270. ASU 2025-11 is effective for interim reporting periods within fiscal years beginning after December 15, 2027. For us, this means the standard will first apply to our interim financial statements beginning with the quarter ending June 30, 2028. ASU 2025-11 may be adopted on a prospective or retrospective basis, and early adoption is permitted. We are currently evaluating the impact of this guidance on our consolidated financial statements.
In December 2025, the FASB issued ASU 2025-12, Codification Improvements, which includes 33 amendments to the Accounting Standards Codification intended to clarify existing guidance, correct technical errors, and address minor inconsistencies across a broad range of topics. ASU 2025-12 is effective for the Company for annual reporting periods beginning after December 15, 2026. For us, this means the standard will first apply to our annual financial statements for the year ending March 31, 2028. Early adoption is permitted. We have evaluated the amendments in ASU 2025-12 and do not expect adoption to have a material impact on our consolidated financial statements or disclosures.
We have considered all other recently issued accounting pronouncements and do not believe any are relevant to, or will have a material impact on, our consolidated financial position, results of operations, or cash flows other than those discussed above.
3. Fair Value Measurements
The following tables show our cash, cash equivalents and marketable securities at fair value as of March 31, 2026 and 2025 (in thousands):
Level 1 Level 2 Level 3 Total
Assets:
Cash and cash equivalents:
Cash and money market funds $ 30,789 $ — $ — $ 30,789
Marketable securities
Level 1 Level 2 Level 3 Total
Assets:
Cash and cash equivalents:
Cash and money market funds $ 67,131 $ — $ — $ 67,131
Marketable securities
The carrying amounts of our prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short term nature. We had no financial liabilities measured at fair value on a recurring basis at March 31, 2026 or 2025. There were no transfers between Levels 1, 2 or 3 for any of the periods presented.
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Our marketable securities consist solely of U.S. Treasury notes, for which the expected credit loss is considered to be zero. Accordingly, no allowance for credit losses has been recorded on our available-for-sale debt securities as of March 31, 2026 or 2025.
The following table summarizes our marketable securities as of March 31, 2026 and 2025 (in thousands):
Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value
Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value
4. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
As of March 31,
Computer equipment 49 31
Office furniture and equipment 8 25
Manufacturing equipment 211 211
Accumulated depreciation and amortization (1,073) (1,404)
Property and equipment, net $ 427 $ 476
We recognized depreciation expense of $0.2 million and $0.2 million for the years ended March 31, 2026 and 2025, respectively.
5. Leases
Operating Lease
We have a single lease for our headquarters, which includes office and laboratory space, in South San Francisco, California. The lease commenced in April 2013, and was subsequently amended in 2016 to extend the lease term to July 31, 2022, and included onefive-year extension option. For the purpose of determining the right-of-use asset and associated lease liability, we determined that we would likely exercise the five-year extension option through July 2027. On October 14, 2021, we entered into an amendment to the lease (the Lease Amendment), pursuant to which the term of the lease was
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extended from August 1, 2022 to July 31, 2027. Under the terms of the Lease Amendment, we have the option to renew the lease for an additional five-year term commencing on August 1, 2027. We did not include this renewal option in determining the lease term, as we were not reasonably certain to exercise either renewal option.
The following table summarizes the effect of operating lease costs in our consolidated statements of operations (in thousands):
Year EndedMarch 31,
Operating lease costs $ 645 $ 645
Maturities of lease liabilities as of March 31, 2026 were as follows (in thousands):
Year ending March 31, Amount
Thereafter —
Total minimum lease payments 1,008
Less: amount representing interest (60)
Present value of operating lease liabilities 948
Less: operating lease liabilities - current portion (699)
Operating lease liabilities - non-current portion $ 249
The lease had a remaining term of 1.3 years and 2.3 years as of March 31, 2026 and 2025, respectively. The lease liability was calculated based on a weighted-average discount rate of 8.54% as of March 31, 2026 and 2025. During the years ended March 31, 2026 and 2025, we made cash payments for amounts included in the measurement of lease liabilities of $0.7 million and $0.8 million, respectively.
6. Accrued Expenses
Accrued expenses are composed of the following (in thousands):
As of March 31,
Accrued research and development costs $ 7,886 $ 5,207
Accrued employee compensation costs 323 3,360
Accrued legal and professional service fees 493 234
7. Note Payable
In May 2025, we executed a 6.54% promissory note in the principal amount of $1.0 million in connection with certain insurance policy premiums. The note is payable in monthly installments of approximately $0.1 million, including principal and interest, through April 2026. As of March 31, 2026, the outstanding balance related to the premium financing was approximately $0.1 million. Interest accrued related to the premium financing arrangement was immaterial as of March 31, 2026.
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8. Capital Stock
Common Stock
October 2023 Public Offering
On October 2, 2023, we completed an underwritten public offering (the October 2023 Public Offering), whereby we offered and sold, for gross proceeds of approximately $100 million, a total of 15,010,810 shares of our common stock and a total of 3,577,240 pre-funded warrants to purchase up to 3,577,240 shares of common stock (the Pre-Funded Warrants). Each share of common stock and each Pre-Funded Warrant was issued together with a ratably allocated portion of warrants to purchase up to 9,294,022 shares of common stock with an exercise price of $5.38 per share (the T1 Warrants) and warrants to purchase 11,265,086 shares of common stock with an exercise price of $8.877 per share (the T2 Warrants). The net proceeds to us from the October 2023 Public Offering were approximately $93.5 million, after deducting expenses related to the offering, including commissions, legal expenses and other offering costs.
The Pre-Funded Warrants, T1 Warrants and T2 Warrants (collectively, the Warrants) are fully exercisable, only at the option of the holder. Holders may also exercise the T1 Warrants and T2 Warrants for Pre-Funded Warrants at their option. We may not effect the exercise of any Warrants, and a holder will not be entitled to exercise any portion of any of the Warrants, which, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by the holder of such Warrant (together with its affiliates) to exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, any holder may increase or decrease such percentage to any other percentage (not to exceed 19.99% if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5636(b) or any successor rule) upon at least 61 days’ prior notice from the holder to us subject to the terms of the respective warrant agreement.
We evaluated the terms of the Warrants issued and determined that they should be classified as equity instruments within additional paid-in capital. The Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the other equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such Pre-Funded Warrants do not provide any guarantee of value or return.
Open Market Sale Agreement
In May 2021, we entered into an Open Market Sale Agreement (the Sales Agreement) with Jefferies LLC (Jefferies) which enabled us, in our sole discretion, to offer and sell, from time to time, shares of our common stock for aggregate gross proceeds of up to $75.0 million. In February 2024, the aggregate gross proceeds available under the Sales Agreement was increased to $100 million, and in June 2025, the aggregate offering price available under the Sales Agreement was increased to up to $175 million. As of March 31, 2026, approximately $140.5 million of common stock remained available for sale under the Sales Agreement.
During the years ended March 31, 2026 and 2025, we sold an aggregate of 10,403,244 and 1,108,587 shares, respectively, under the Sales Agreement, for net proceeds of $30.6 million and $3.0 million, respectively, after sales agent commissions. We pay Jefferies a commission of up to three percent (3.0%) of the aggregate gross proceeds from any sales under the Sales Agreement.
We record transactions under the Sales Agreement on a settlement date basis. All legal fees and accounting expenses incurred in connection with the Sales Agreement are recorded as Deferred Offering Costs and are amortized to Additional Paid-in Capital as sales of shares are made under the Sales Agreement. The Sales Agreement will terminate upon the earlier of (i) the sale of all shares subject to the Sales Agreement or (ii) the termination of the Sales Agreement by Jefferies or by us, as permitted.
Refer to Note 15, Subsequent Events, for information regarding sales of common stock under the Sales Agreement after March 31, 2026.
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Warrant Exercises, Expirations and Modifications
At March 31, 2026, the following common stock warrants were outstanding:
(a) The warrants will expire 60 days after the later of (i) the date on which the Company first publicly discloses, whether by press release or Form 8-K filing, the top-line data for its PALISADE-3 Phase 3 clinical trial of fasedienol for the acute treatment of anxiety in adults with SAD, which occurred in December 2025, and (ii) the date on which the Company first publicly discloses, whether by press release or Form 8-K filing, the top-line data for its PALISADE-4 Phase 3 clinical trial of fasedienol for the acute treatment of anxiety in adults with SAD.
The weighted average exercise price of all outstanding warrants at March 31, 2026 is $7.30 per share. No outstanding warrant is subject to any down-round anti-dilution protection feature. All outstanding warrants are exercisable by the holders only by payment in cash of the stated exercise price per share, except the Pre-Funded Warrants and the T2 Warrants issued in connection with the October 2023 Public Offering, which may be exercised through a cashless exercise, via exchange of a portion of warrants to cover the exercise price.
There were no warrants exercised during the year ended March 31, 2026. During the year ended March 31, 2025, Pre-Funded Warrants to purchase 788,620 shares of common stock were exercised on a cashless basis, resulting in the issuance of 788,359 shares of common stock.
During the years ended March 31, 2026 and 2025, warrants to purchase 12,352 and 33,334 shares of common stock expired, with a weighted average exercise prices of $21.90 and $15.00 per share, respectively.
Reserved Shares
We had the following shares of common stock reserved for future issuance:
As of March 31,
At March 31, 2026, we have 217,605,705 authorized shares of our common stock not subject to reserves and available for future issuance.
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9. Stock-Based Compensation
Equity Incentive Plans
2016 Equity Incentive Plan
Our 2016 Stock Incentive Plan (the 2016 Plan) provided for the grant of stock options, restricted shares of common stock, stock appreciation rights and dividend equivalent rights to employees, officers, members of the board of directors, consultants and advisors of the Company. Upon the adoption of our 2019 Plan, no further grants were permissible under the 2016 Plan and 46,280 authorized shares were transferred to the 2019 Plan and became issuable therefrom. Any options or awards outstanding under the 2016 Plan remained outstanding and effective.
2019 Equity Incentive Plan
Our Board approved the Vistagen Therapeutics, Inc. 2019 Omnibus Equity Incentive Plan (the 2019 Plan) on May 27, 2019, and our stockholders adopted it and ratified all previously issued grants on September 5, 2019. The 2019 Plan provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards.
On June 28, 2021, our Board approved and, at our Annual Meeting of Stockholders on September 17, 2021, our stockholders approved certain amendments to the 2019 Plan (Amended 2019 Plan). Upon approval of the Amended 2019 Plan by our stockholders, the total number of shares authorized to be issued under the 2019 Plan increased to 600,000 shares. On May 29, 2024, our Board and stockholders approved certain amendments to the 2019 Plan (Amended and Restated 2019 Plan). Upon approval of the Amended and Restated 2019 Plan by our stockholders, the total number of shares authorized to be issued under the 2019 Plan increased to 5,000,000 shares.
At March 31, 2026, there were 1,122,097 registered shares of our common stock remaining available for grant under the Amended and Restated 2019 Plan.
Awards granted under our equity plans expire no later than 10 years from the date of grant. Options and restricted stock granted to employees typically vest over a four-year period but may have been granted with different vesting terms.
A summary of our stock option activity for the year ended March 31, 2026 is as follows (in thousands, except share and per share data and years):
Stock-Based Compensation Expense
The fair value of stock options granted was estimated using the following assumptions:
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Year Ended March 31,
Risk-free interest rate 3.6 % - 4.2 % 3.5 % - 4.5 %
Dividend yield — —
Stock-based compensation expense recognized for all equity awards has been included in the consolidated statements of operations and comprehensive loss as follows (in thousands):
Year Ended March 31,
Research and development expense $ 1,732 $ 1,938
General and administrative expense 2,265 2,377
Total stock-based compensation expense $ 3,997 $ 4,315
The weighted-average grant date fair value of options granted for the years ended March 31, 2026 and 2025 was $2.21 and $3.45 per share, respectively. For the years ended March 31, 2026 and 2025, the total fair value of options vested was $4.1 million and $4.0 million, respectively. The aggregate intrinsic value of options exercised for the years ended March 31, 2026 and 2025 was $0. As of March 31, 2026, total compensation cost not yet recognized related to unvested stock options was $5.3 million, which is expected to be recognized over a weighted-average period of 1.9 years.
2019 Employee Stock Purchase Plan
Our Board approved the Vistagen Therapeutics, Inc. 2019 Employee Stock Purchase Plan (the 2019 ESPP) on June 13, 2019. Our stockholders approved the 2019 ESPP at our annual meeting on September 5, 2019. The 2019 ESPP is intended to qualify as an employee stock purchase plan under Section 423 of the Internal Revenue Code. A maximum of 33,334 shares of our common stock were originally reserved for purchase under the 2019 ESPP. In May 2024, the 2019 ESPP was amended to increase the shares authorized to be issued under the 2019 ESPP to 1,000,000 shares.
The 2019 ESPP permits eligible employees who elect to participate in an offering under the 2019 ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the 2019 ESPP. The price of common stock purchased under the 2019 ESPP is equal to 85% of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. Each offering period is six months, with new offering periods commencing every six months on or about the dates of January 1 and July 1 of each year.
During the years ended March 31, 2026 and 2025, we issued 217,784 and 74,804 shares, respectively, of common stock in connection with the 2019 ESPP. As of March 31, 2026, there were 693,558 shares available for future purchase under the 2019 ESPP.
During the years ended March 31, 2026 and 2025, we recognized an immaterial amount of expense under the 2019 ESPP.
10. Income Taxes
For the fiscal years ended March 31, 2026 and 2025, the Company's pre-tax loss of $69.7 million and $51.4 million, respectively, was derived entirely from U.S. operations. The Company had no foreign operations during either period.
For each of the fiscal years ended March 31, 2026 and 2025, income tax expense consisted of current state income tax expense of approximately $7,000, with no federal, foreign or deferred income tax expense in either period.
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Income tax expense (benefit) differed from the amounts computed by applying the statutory federal income tax rate of 21% to pretax income (loss) as a result of the following:
Year Ended March 31,
Amount % Amount %
State income taxes, net of federal benefit 7 0.01 % 7 0.01 %
Tax effect of research and development credits (748) (1.08) % (2,204) (4.29) %
Tax effect of stock compensation — — % 309 0.60 %
Tax effect of other non-deductible items 430 0.62 % 618 1.20 %
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The 'All other' reconciling item for fiscal year 2026 consists of a return-to-provision adjustment relating to the difference between the estimated tax provision recorded as of March 31, 2025 and the actual amounts reflected in the fiscal year 2025 income tax return.
Income taxes paid, net of refunds received, for the years ended March 31, 2026 and 2025 were as follows (in thousands):
Year ended March 31,
Federal $ — $ —
State 3 —
Foreign — —
Total income taxes paid, net of refunds $ 3 $ —
State and local income taxes paid during the fiscal year ended March 31, 2026 consisted primarily of income taxes paid to the Commonwealth of Massachusetts.
Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows (in thousands):
Deferred tax assets:
Basis differences in property and equipment 38 —
Research and development credit carryforwards 7,731 6,875
Operating lease Right-of-Use asset 31 37
Capitalized research and development costs 11,734 15,087
Deferred revenue — 632
Accruals and other reserves 138 709
Total deferred tax assets net of valuation allowance — 24
Deferred tax liabilities:
Intangibles — (12)
Basis differences in property and equipment — (12)
Total deferred tax liabilities — (24)
Net deferred tax asset (liability) $ — $ —
The valuation allowance increased by $15.7 million and $17.2 million during the fiscal years ended March 31, 2026 and 2025, respectively.
We continually evaluates the likelihood of the realization of the deferred tax assets and adjusts the carrying amount of the deferred tax assets by the valuation allowance to the extent the future realization of the deferred tax assets is more likely than not. We consider many factors when assessing the likelihood of future realization of its deferred tax assets, including its recent cumulative earnings experience by tax jurisdiction, expectation of future taxable income or loss, the carryforward periods available to us for tax reporting purposes and other relevant factors. As of March 31, 2026, based on our history of earnings and its assessment of future earnings, management does not believe that it is more likely than not that future taxable income will be sufficient to realize the deferred tax assets. Therefore, a full valuation allowance has been applied to the deferred tax assets.
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As of March 31, 2026, we had U.S. federal net operating loss carryforwards of approximately $314.3 million. Federal net operating loss carryforwards of approximately $80.6 million generated through our fiscal year ended March 31, 2018 will expire in our fiscal years ending March 31, 2027 through March 31, 2038. Federal net operating loss carryforwards of approximately $233.7 million generated in fiscal years ending after March 31, 2018 will carry forward indefinitely, but are subject to an 80% taxable income limitation. As of March 31, 2026, we had state net operating loss carryforwards of approximately $63.7 million, which will expire in fiscal years ending in 2029 through 2045. State net operating loss carryforwards of approximately $10.8 million will carry forward indefinitely. We also have federal and state research and development tax credit carryforwards of approximately $8.6 million and $2.2 million, respectively. The federal tax credits will expire at various dates beginning with our fiscal year ending March 31, 2029 through March 31, 2045 unless previously utilized. The state tax credits do not expire and will carry forward indefinitely until utilized.
U.S. federal and state tax laws include substantial restrictions on the utilization of net operating loss carryforwards in the event of a change in a corporation's ownership. We have not performed a change in ownership analysis since our inception in 1998, and accordingly, some or all of our net operating loss carryforwards may not be available to offset future taxable income, if any
On July 4, 2025, the One Big Beautiful Bill was enacted (“OBBBA”), introducing significant and wide-ranging changes to the U.S. federal tax system. Significant components include restoration of 100% accelerated tax depreciation on qualifying property including expansion to cover qualified production property. Another major aspect includes the return to immediate expensing of domestic research and experimental expenditures (“R&E”) which in some cases may include retroactive application back to 2021 for businesses with gross receipts of less than $31 million or accelerated tax deductions of R&E that was previously capitalized for larger businesses. The legislation also reinstates EBITDA-based interest deductions for tax purposes and makes several business tax incentives permanent. Less favorable business provisions include limitations on tax deductions for charitable contributions.
The provisions of OBBBA most relevant to us are the restoration of immediate expensing for domestic R&E expenditures and the related transition rules for amounts previously capitalized under TCJA. For the fiscal year ended March 31, 2026, our first tax year subject to OBBBA, domestic R&E expenditures are currently deductible. With respect to the remaining unamortized balance of domestic R&E previously capitalized for tax years 2022 through 2024, we elected to continue amortizing the balance over its remaining recovery period. Because we maintain a full valuation allowance against its deferred tax assets, these changes did not result in a net income tax provision impact. We have not yet evaluated whether it qualifies for the small-business retroactive expensing election under OBBBA, which is available to taxpayers with average annual gross receipts of $31 million or less. The other significant provisions of OBBBA, including the changes to international tax rules (NCTI, FDDEI, and BEAT) and the modifications to Section 163(j) and bonus depreciation, do not have a material impact on us because it has no foreign operations, limited interest expense, and limited property and equipment.
We file income tax returns in the U.S. federal, and various U.S. state jurisdictions. We are subject to U.S. federal and state income tax examinations by tax authorities for tax years 2004 through 2026 due to net operating losses that are being carried forward for tax purposes, but we are not currently under examination by tax authorities in any jurisdiction.
Uncertain Tax Positions
As required by the uncertain tax position guidance in ASC No. 740, Income Taxes the we recognize the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority. We applied the uncertain tax position guidance in ASC 740 to all tax positions for which the statute of limitations remained open. Any estimates of tax contingencies contain assumptions and judgments about potential actions by taxing jurisdictions. Any interest and penalties related to uncertain tax positions would be included as part of the income tax provision.
Our unrecognized tax benefits at March 31, 2026 and 2025 relate entirely to research and development tax credits. The total amount of unrecognized tax benefits at March 31, 2026 and 2025 is $2.6 million and $2.4 million, respectively. If
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recognized, none of the unrecognized tax benefits would impact our effective tax rate. The following table summarizes the activity related to our unrecognized tax benefits (in thousands):
Year Ended March 31,
Unrecognized benefit - beginning of period $ 2,399 $ 4,931
Prior period position increases (decreases) — (3,329)
Current period tax position increases (decreases) 178 797
Unrecognized benefit - end of period $ 2,577 $ 2,399
Our conclusions regarding uncertain tax positions may be subject to review and adjustment at a later date based upon ongoing analysis of or changes in tax laws, regulations and interpretations thereof as well as other factors.
Our policy is to recognize interest and penalties related to income taxes as components of interest expense and other expense, respectively. We incurred no interest or penalties related to unrecognized tax benefits in the years ended March 31, 2026 or 2025. We do not anticipate any significant changes in our uncertain tax positions within twelve months of this reporting date.
11. Sublicense and Collaborative Agreements
The following table presents changes in contract assets and liabilities during the year ended March 31, 2026 (in thousands). Contract acquisition costs are included as a component of other assets on our consolidated balance sheets.
Balance atMarch 31, 2025 Additions Deductions Balance atMarch 31, 2026
Contract assets:
Deferred contract acquisition costs $ 130 $ — $ (74) $ 56
Contract liabilities:
AffaMed Agreement
In June 2020,we entered into a license and collaboration agreement (the AffaMed Agreement) with EverInsight Therapeutics Inc., a company incorporated under the laws of the British Virgin Islands, now AffaMed Therapeutics, Inc. (AffaMed), pursuant to which we granted AffaMed an exclusive license to develop and commercialize fasedienol for social anxiety disorder (SAD) and potentially other anxiety-related disorders in Greater China, South Korea and Southeast Asia (which includes Indonesia, Malaysia, Philippines, Thailand and Vietnam) (collectively, the Territory). AffaMed is responsible for all costs related to developing, obtaining regulatory approval of, and commercializing fasedienol for treatment of SAD, and potentially other anxiety-related indications, in the Territory. A joint development committee has been established between AffaMed and us to coordinate and review the development and commercialization plans with respect to fasedienol in the Territory.
We are responsible for pursuing clinical development and regulatory submissions of fasedienol for acute treatment of anxiety in adults with SAD, and potentially other anxiety-related indications, in the United States on a "best efforts" basis, with no guarantee of success. AffaMed may participate in the Phase 3 global clinical trial of fasedienol and will assume all direct costs and expenses of conducting such clinical trial in the Territory and a portion of the indirect costs of a global trial in which they participate. We will transfer all development data (nonclinical and clinical data) and our regulatory documentation related to fasedienol throughout the term as it is developed or generated or otherwise comes into our control. We will grant to AffaMed a Right of Reference to our regulatory documentation and our development data, but retain exclusive development and commercialization rights for fasedienol in the U.S. and throughout the rest of the world outside the Territory.
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Under the terms of the AffaMed Agreement, AffaMed paid us a non-refundable upfront license payment of $5.0 million in August 2020.Additionally, upon successful development and commercialization of fasedienol in the Territory, we are eligible to receive milestone payments of up to $172.0 million. Further, we are eligible to receive royalty payments on a country-by-country basis on net sales for the later of ten years or the expiration of market or regulatory exclusivity in the jurisdiction. Royalty payments will be reduced in jurisdictions where there is no market exclusivity during the royalty period, and maybe further reduced if there is generic competitive product present.
We have determined that we have one combined performance obligation for the license to develop and commercialize fasedienol in the Territory and related development and regulatory services. In addition, AffaMed has an option that, if exercised by AffaMed, could create manufacturing obligations for us during development upon exercise. This option for manufacturing services was evaluated and determined not to include a material right.
Development and commercialization milestones were not considered probable at inception and therefore were excluded from the initial transaction price. The royalties were excluded from the initial transaction price because they relate to a license of intellectual property and are subject to the royalty constraint.
We recognize revenue as the combined performance obligation is satisfied over time using an input method. Judgment is required to determine the level of effort attributable to the performance obligation included in the AffaMed Agreement and the period over which we expect to complete our performance obligation. The performance period or measure of progress was estimated at the inception of the AffaMed Agreement and is re-evaluated in subsequent reporting periods. This re-evaluation may shorten or lengthen the period over which we recognize revenue.
As of March 31, 2026 and 2025, we had short-term deferred revenue of $0.4 million and $1.3 million, respectively, related to the AffaMed Agreement. We had no long-term deferred revenue related to the AffaMed Agreement as of March 31, 2026 as compared to $0.4 million as of March 31, 2025. During the years ended March 31, 2026 and 2025, we recognized revenue of $1.3 million and $0.5 million, respectively, related to the performance obligation under the AffaMed Agreement, all of which was included in the deferred revenue balance at the beginning of each respective period. The remaining deferred revenue under the AffaMed Agreement will be recognized over the expected performance period.
Contract Acquisition Costs Related to the Affamed Agreement
In 2020,we made cash payments to Pherin aggregating $0.4 million for sublicense fees and consulting services exclusively related to the AffaMed Agreement. Additionally, in 2020 we issued 7,788 unregistered shares of our common stock, valued at $0.1 million, as partial compensation for consulting services exclusively related to the AffaMed Agreement. These sublicense fees and consulting payments and the fair value of the common stock issued, aggregating $0.5 million, were capitalized as other assets in our Consolidated Balance Sheets. Amortization expense related to the contract acquisition costs was immaterial for the years ended March 31, 2026 and 2025.
The AffaMed Agreement will expire on a jurisdiction-by-jurisdiction basis upon the latest to occur of expiration of the last valid claim under a licensed patent of fasedienol in such jurisdiction, the expiration of regulatory exclusivity in such jurisdiction or ten years after the first commercial sale of fasedienol in such jurisdiction.
Fuji Pharma Agreement
On September 1, 2023, we entered into an Exclusive Negotiation Agreement (the Negotiation Agreement) with Fuji Pharma Co., Ltd. (Fuji Pharma), a Tokyo Stock Exchange-listed, Japan-based pharmaceutical company with a significant research, development, and commercial focus on pharmacological therapies for women’s health conditions. Pursuant to the terms and conditions of the Negotiation Agreement, we agreed, for a limited period of time, to negotiate exclusively with Fuji Pharma for a potential exclusive license agreement to develop and commercialize PH80 (now known as refisolone) in Japan. PH80, our clinical-stage pherine product candidate focused primarily on the treatment of vasomotor symptoms (hot flashes) associated with menopause (the Potential Definitive Agreement). The Negotiation Agreement provides for an exclusive negotiation period beginning on the date of formal written notice being received by Fuji Pharma that we have selected a contract development and manufacturing organization to conduct preclinical toxicology studies for PH80 (the Payment Event), and terminating on the later to occur of (i) fourteen (14) months from the date of the Payment Event or (ii) ninety (90) days from the date that the U.S. Food and Drug Administration accepts our PH80 U.S. Investigational New
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Drug (IND) application for clinical development of PH80 in the U.S. for the treatment of vasomotor symptoms (hot flashes) due to menopause (the Exclusive Negotiation Period).
As consideration for the Exclusive Negotiation Period, Fuji Pharma agreed to make a payment to us of $1.5 million (the Purchase Price), payable upon occurrence of the Payment Event. The Payment Event occurred in October 2023, and we received payment of the Purchase Price in full in November 2023. The Purchase Price is non-refundable, except upon a material breach of the Negotiation Agreement by the Company; however, should the Company and Fuji Pharma enter into the Potential Definitive Agreement, the Purchase Price will be creditable against any upfront fee due in connection with the execution of such Potential Definitive Agreement. Neither the Company nor Fuji Pharma is obligated to enter into the Potential Definitive Agreement, and if the Company and Fuji Pharma have not entered into the Potential Definitive Agreement on or before the end of the Exclusive Negotiation Period, either the Company or Fuji Pharma may terminate any further negotiations.
As of March 31, 2026, the entire amount remaining unrecognized under the Negotiation Agreement of $1.3 million was classified as deferred revenue, current portion, on the consolidated balance sheets. During the years ended March 31, 2026 and 2025, we recognized no revenue under the Negotiation Agreement. The remaining deferred revenue under the Negotiation Agreement will be recognized upon expiration of the Exclusive Negotiation Period, which is currently expected in June 2026, or accounted for as a creditable prepayment under ASC 606, should an exclusive license agreement be reached with Fuji Pharma prior to the date of expiration.
12. Related Party Transactions
In August 2023, in connection with his retirement, we entered into a consulting agreement, as subsequently amended, with our former Chief Financial Officer, Jerrold D. Dotson, to assist in transition matters related to the employment of our new Chief Financial Officer. The agreement currently expires December 31, 2026. We incurred expenses under the agreement of $120,000 and $120,000, during the years ended March 31, 2026 and 2025, respectively.
13. Commitments, Contingencies, Guarantees and Indemnifications