VTGN on Nasdaq

Vistagen Therapeutics, Inc.

American pharmaceutical preparations company based in South San Francisco1

In its 2026 annual report the company says: “We are a late clinical-stage therapeutics company focused on developing and potentially commercializing new medicines for patients with social anxiety disorder, depression, menopausal hot flashes, psychomotor impairment due to mental fatigue, and cancer cachexia.”4 Its shares trade on Nasdaq under the symbol VTGN.1

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Last updated Oct 21, 2026.

Overview

$1.3MRevenue, fiscal 20262
-$69.7MNet income, fiscal 20262

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  • TickerVTGN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSouth San Francisco, California1
  • Incorporated inNV3
  • Business address343 Allerton Avenue, South San Francisco, Ca 940803
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

We are a late clinical-stage therapeutics company focused on developing and potentially commercializing new medicines for patients with social anxiety disorder, depression, menopausal hot flashes, psychomotor impairment due to mental fatigue, and cancer cachexia. Each of the five clinical-stage intranasal pherine product candidates in our neuroscience pipeline has a novel neurocircuitry-focused proposed mechanism of action (MOA) and at least one positive clinical study in its targeted patient population. Leveraging our deep understanding of nose-to-brain neurocircuitry, we have designed our intranasal pherine product candidates are designed to rapidly, specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons and rapidly activate neurocircuits believed to regulate brain areas, without requiring systemic absorption or uptake into the brain to achieve de…4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2026

-5683.7%Operating margin2
-5491.3%Net margin2
161.1%Revenue growth, 20262
-196.2%Return on equity2

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Research and development100¢$55.0M
  • Income tax0¢$7.0K

Out of $1.3M in revenue.2 The company lost money this year.

Financial statements

Revenue5672$1.3M in 2026
-$500.0K0$500.0K$1.0M$1.5M2020: $0$020202021: $1.1M$1.1M20212022: $1.1M$1.1M2022+2%2023: -$227.0K-$227.0K20232024: $1.1M$1.1M20242025: $486.0K$486.0K2025−54%2026: $1.3M$1.3M2026+161%
Operating income85961072-$72.1M in 2026+194% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$24.6M-$24.6M20192020: -$20.8M-$20.8M2020−15%2021: -$17.9M-$17.9M2021−14%2022: -$47.8M-$47.8M2022+166%2023: -$59.3M-$59.3M2023+24%2024: -$33.0M-$33.0M2024−44%2025: -$56.0M-$56.0M2025+70%2026: -$72.1M-$72.1M2026+29%
Net income85961072-$69.7M in 2026+183% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$24.6M-$24.6M20192020: -$20.8M-$20.8M2020−16%2021: -$17.9M-$17.9M2021−14%2022: -$47.8M-$47.8M2022+166%2023: -$59.2M-$59.2M2023+24%2024: -$29.4M-$29.4M2024−50%2025: -$51.4M-$51.4M2025+75%2026: -$69.7M-$69.7M2026+36%

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2026-03-312025-03-31
Total revenues$1.3M$486.0K
Research and development$55.0M$39.4M
General and administrative$18.4M$17.1M
Total operating expenses$73.4M$56.5M
Loss from operations-$72.1M-$56.0M
Interest income, net$2.4M$4.6M
Other income, net$7.0K$5.0K
Loss before income taxes-$69.7M-$51.4M
Income taxes-$7.0K-$7.0K
Net loss-$69.7M-$51.4M
Unrealized gain (loss) on marketable securities-$7.0K$5.0K
Comprehensive loss-$69.7M-$51.4M
Loss per share, basic (in dollars per share)-$1.83-$1.67
Loss per share, diluted (in dollars per share)-$1.83-$1.67
Weighted average common shares outstanding, basic (in shares)38.1M shares30.9M shares
Weighted average common shares outstanding, diluted (in shares)38.1M shares30.9M shares

Compare Vistagen Therapeutics, Inc. with another company

Corporate structure

Vistagen Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Vistagen Therapeutics, Inc.

  • Commodore Capital LP Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Aug 14, 2026 (6 filings since Apr 14, 2022)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Aug 14, 2026 (5 filings since Feb 11, 2022)
  • TCG Crossover GP I, LLC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Aug 14, 2026
  • TCG Crossover GP II, LLC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest May 15, 2026 (2 filings since Oct 16, 2023)
  • GREAT POINT PARTNERS LLC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Feb 17, 2026 (8 filings since Oct 12, 2023)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Feb 17, 2026 (2 filings since Sep 8, 2025)
  • STEMPOINT CAPITAL LP Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Feb 17, 2026 (3 filings since Feb 12, 2024)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Feb 13, 2026 (4 filings since Feb 14, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Jan 30, 2026 (3 filings since Feb 13, 2024)
  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on Vistagen Therapeutics, Inc., latest Feb 14, 2025 (2 filings since Oct 16, 2023)
  • CITADEL ADVISORS LLC Filed SC 13G/A on Vistagen Therapeutics, Inc., latest Nov 14, 2024 (3 filings since Oct 16, 2023)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Vistagen Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Oct 5, 2023)
  • Vistagen Therapeutics, Inc. South San Francisco, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Vistagen Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$1.5M2 Mar 31, 2026$1.9M2 Mar 31, 2025−20.2%
Accumulated depreciation$1.1M2 Mar 31, 2026$1.4M2 Mar 31, 2025−23.6%
Property and equipment, net$427.0K2 Mar 31, 2026$476.0K2 Mar 31, 2025−10.3%
Operating-lease assets (leased space)$801.0K2 Mar 31, 2026$1.3M2 Mar 31, 2025−40.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$30.8M2 Mar 31, 2026$67.1M2 Mar 31, 2025−54.1%
Marketable securities, current$14.6M2 Mar 31, 2026$13.4M2 Mar 31, 2025+9.5%

Properties, in its own words

Our corporate headquarters and laboratories are located at 343 Allerton Avenue, South San Francisco, California 94080, where we occupy approximately 10,900 square feet of office and lab space under a lease expiring on July 31, 2027, which contains a 5-year option to renew. We believe that our facilities are suitable and adequate for our current and foreseeable needs.

Item 2 of the 10-K filed Jun 15, 2026.4

Leadership

Who has led Vistagen Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (22)

Former names

  • Excaliber Enterprises, Ltd.Sep 11, 2007 to Jun 8, 20113

Timeline

  1. Oct 9, 20268-K Executive or director change42
  2. Sep 25, 20268-K Regulation FD disclosure43
  3. Sep 24, 20268-K Other events44
  4. Sep 22, 20268-K Other events45
  5. Sep 11, 20268-K Shareholder vote46
  6. Aug 14, 20268-K Results of operations47
  7. Aug 6, 20268-K Regulation FD disclosure; Other events48
  8. Aug 5, 20268-K Listing notice or transfer49
  9. Jul 31, 20268-K Executive or director change; Regulation FD disclosure50
  10. Jun 30, 20268-K Regulation FD disclosure; Other events51
  11. Jun 17, 20268-K Executive or director change52
  12. Jun 15, 20268-K Results of operations53
  13. May 25, 2011New chief executive Shawn Singh becomes CEO14

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.54) a share, on Nov 13, 2025.54

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results47
  2. Jun 15, 2026Reported quarterly or annual results53
  3. Feb 12, 2026Reported quarterly or annual results55
  4. Nov 13, 2025Reported quarterly or annual results56
  5. Aug 7, 2025Reported quarterly or annual results57
  6. Jun 17, 2025Reported quarterly or annual results58
  7. Feb 13, 2025Reported quarterly or annual results59
  8. Nov 7, 2024Reported quarterly or annual results60

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

310 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 117 major events, 92 insider forms, 51 large holders, 1 private raises, 29 other. The latest 20:

  1. Oct 9, 20268-K EDGAR
  2. Sep 25, 20268-K EDGAR
  3. Sep 24, 20268-K EDGAR
  4. Sep 22, 20268-K EDGAR
  5. Sep 11, 20268-K EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 202610-Q EDGAR
  8. Aug 14, 20268-K EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 14, 2026SCHEDULE 13G/A EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Aug 5, 20268-K EDGAR
  13. Jul 31, 20264 EDGAR
  14. Jul 31, 20263 EDGAR
  15. Jul 31, 2026DEFA14A EDGAR
  16. Jul 31, 2026DEF 14A EDGAR
  17. Jul 31, 20268-K EDGAR
  18. Jul 2, 20264 EDGAR
  19. Jul 2, 20264 EDGAR
  20. Jul 2, 20264 EDGAR

The 310 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

5 open-market trades by officers, directors and large owners since October 2021: 4 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 7, 2023COMMODORE CAPITAL LP10% ownerBuy775,756$23.15$18.0MForm 4
Aug 18, 2022GIN JERRY BDirectorBuy200,000$0.18$36.0KForm 4
Aug 17, 2022Adler Reid G.Chief Legal OfficerBuy300,000$0.17$51.0KForm 4
Aug 17, 2022Singh ShawnPresident and CEOBuy600,000$0.17$102.0KForm 4
Jul 12, 2022VHCP Management II, LLC10% ownerSale60,000$0.89$53.4KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2026Shawn K. SinghJ.D.63$650.0K$1.2M78
2026Nick B. TresslerMBA53$5$866.5K78
2026Elissa S. Cote51$5$696.1K78
2026Reid G. AdlerJ.D.72$450.0K$637.5K78
2026Joshua S. PrinceMBA$415.0K$602.5K78
2025PresidentChief Executive Officer and Director$650.0K$2.5M78
2025Chief Legal Officer$450.0K$1.2M78
2025Chief Operating Officer$410.0K$1.1M78

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Feb 2, 2023Filed a private offering of equity Form D: $2.8 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 49. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Commodore Capital LP2,788,620$630.2K0.0%New
Vanguard Capital Management LLC1,574,200$355.8K0.0%No change
Two Sigma Investments, LP847,992$191.6K0.0%+378,373
Renaissance Technologies LLC730,500$165.1K0.0%+439,200
Ikarian Capital, LLC519,077$117.3K0.0%No change
AdvisorShares Investments LLC438,643$99.1K0.0%+161,533
Luminus Management LLC403,115$91.1K0.1%+7,062
Geode Capital Management, LLC365,002$82.5K0.0%−88,389
ADAR1 Capital Management, LLC351,141$79.4K0.0%−400,000
BlackRock, Inc.345,432$78.1K0.0%−103,075
Group One Trading LLC304,385$68.8K0.0%+284,510
Verdad Advisers, LP293,343$66.3K0.1%+108,405
Vanguard Fiduciary Trust Co217,700$49.2K0.0%No change
Jane Street Group, LLC164,827$37.3K0.0%−107,984
Boothbay Fund Management, LLC134,571$30.4K0.0%No change
State Street Corp121,114$27.4K0.0%No change
XTX Topco Ltd118,380$26.8K0.0%−34,469
Northern Trust Corp80,823$18.3K0.0%+8,168
Stempoint Capital LP616,749$17.3K0.0%−616,749
Citadel Advisors LLC68,839$15.6K0.0%New
UBS Group AG57,830$13.1K0.0%−20,906
Osaic Holdings, Inc.43,888$10.1K0.0%+39,755
Confluence Wealth Services, Inc.32,610$7.4K0.0%New
Scientech Research LLC30,283$6.8K0.0%New
StoneX Group Inc.10,840$6.6K0.0%−4,358

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Vistagen Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARVistagen Therapeutics, Inc.1
  • CIK0001411685
  • Employer ID (EIN)20-50933154
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inNevada4
  • Fiscal year endsMarch 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address343 Allerton Avenue, South San Francisco, CA 940801
  • Phone650-577-36001
  • Shares outstanding44,376,911 as of Aug 10, 202613
  • Public float$137.7M as of Sep 30, 20254
  • AuditorKPMG LLP, San Francisco, California PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 11, 20071
  • Filings907 in all: 8-K (267), 4 (249), 10-Q (55), SC 13G/A (36), CORRESP (30), 3 (28), SC 13G (27), UPLOAD (21)1
    All 48 form types

    SCHEDULE 13G/A (20), 10-K (18), DEF 14A (15), 424B5 (13), EFFECT (13), DEFA14A (12), S-1/A (11), D (8), 8-K/A (7), PRE 14A (7), S-3 (6), S-1 (5), S-3/A (5), S-8 (5), 10-Q/A (4), CT ORDER (4), SC 13D (4), 424B3 (3), 424B4 (3), NT 10-Q (3), SCHEDULE 13G (3), 10QSB (2), 3/A (2), 4/A (2), FWP (2), NT 10-K (2), SC 13D/A (2), 10-K/A (1), 10KSB (1), 5 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), POS AM (1), PRER14A (1), RW (1), S-8 POS (1), SB-2 (1), SC 14F1 (1), SC 14F1/A (1)

  • Latest filingsAnnual report (10-K) Jun 15, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jul 31, 2026
    Latest 8-K (8-K) Oct 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareVTGNNasdaq

From the cover page of the 10-K filed Jun 15, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Vistagen Therapeutics, Inc. names in Item 1A of its 10-K filed Jun 15, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Business
  • The successful development of pharmaceutical products is highly uncertain.
  • Our business is highly dependent on the success of fasedienol and, to a lesser extent, our other product candidates. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize fasedienol or one or more of our other product candidates, or if we experience delays in doing so, our business will be materially harmed.
  • We are a clinical-stage biopharmaceutical company with no recurring revenues from product sales or approved products. We are not profitable and have incurred losses in each period since our inception. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, and commercialization of our product candidates.
  • We have never generated revenue from product sales and may never be profitable.
  • We will need substantial additional capital to execute our business plan, and if we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our research and development programs, personnel, pre-commercialization or commercialization efforts.
  • Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success.
  • We may not realize the expected benefits from our workforce reduction and we may incur additional costs implementing it or other difficulties.
  • Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish significant rights to our technologies or product candidates.
  • Risks Related to Product Development, Regulatory Approval
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for the development and potential approval of our product candidates.
The other 63 risks
  • We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates.
  • If our clinical trials fail to replicate results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
  • We may incur unexpected costs or experience material delays in completing, or ultimately be unable to complete, the contract manufacturing, nonclinical and clinical development and commercialization of our product candidates.
  • Our clinical development activities could be materially delayed or otherwise adversely affected by difficulties enrolling and randomizing patients in our clinical trials.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining regulatory approvals for the commercialization of our product candidates.
  • Interim, topline and preliminary data from our nonclinical studies or clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be significantly harmed.
  • We depend heavily on the success of one or more of our current product candidates and we cannot be certain that we will be able to obtain regulatory approval for or commercialize any of our product candidates.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained.
  • If any of our product candidates are ultimately approved and regulated as controlled substances, we, our CDMOs, as well as future distributors, prescribers, and dispensers will be required to comply with additional regulatory requirements which could delay the marketing of our product candidates, and increase the cost and burden of manufacturing, distributing, dispensing, and prescribing our product candidates.
  • We have concentrated a significant portion of our research and development efforts on the treatment of neuropsychiatric disorders, a field that faces certain challenges in drug development.
  • Even if any of our product candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
  • If we fail to develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.
  • Competitive products may reduce or eliminate the commercial opportunity for our product candidates, if approved. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective and/or safer than ours, our ability to develop and successfully commercialize our product candidates may be adversely affected.
  • If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our product candidates.
  • Product liability lawsuits against us or any of our future collaborators could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of our product candidates.
  • Cyberattacks or other failures in our telecommunications or information technology systems, or those of our collaborators, CDMOs, CROs, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations.
  • We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • Our future growth may depend, in part, on our ability to penetrate markets outside of the U.S., where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Risks Related to Managing Our Business and Operations
  • We depend heavily on our key senior managerial personnel, third-party consultants and others and our ability to compete in the biopharmaceutical industry depends upon our ability to retain such highly qualified personnel. The loss of their services or our inability to hire such personnel could materially harm our business.
  • We may not be able to hire and/or retain a sufficient number of employees or employees with the required expertise to develop our product candidates or operate our business successfully.
  • Our employees, independent contractors, consultants, collaborators, CDMOs and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • Unfavorable domestic or global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Remote working arrangements could significantly increase our digital and cybersecurity risks.
  • Current politics in the U.S. could diminish the value of the pharmaceutical industry, thereby diminishing the value of our securities.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to assist in conducting our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
  • Our use of third party CDMOs to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, raw materials, active pharmaceutical ingredients (APIs) or drug products when needed or at an acceptable cost.
  • Failure of any third-party CDMO to comply with cGMP requirements for applicable drug/device combination products could significantly affect supplies of our product candidates.
  • If any third-party CDMO of our product candidates is unable to increase the scale of its production of our product candidates or increase the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.
  • We may need to maintain licenses for APIs from third parties to develop and commercialize some of our product candidates, which could increase our development costs and delay our ability to commercialize those product candidates.
  • Risks Related to Government Regulation
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • While we have in the past and may in the future seek designations for our product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or regulatory exclusivity, there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
  • Some of our programs have been partially supported by government grant awards. Although we do not currently rely on government funding nor do we have a present intent to seek further grant funding from governmental agencies, should that change, such funding may not be available to us in the future or subject us to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S. industry.
  • Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
  • Healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
  • Off-label use or misuse of our product candidates may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.
  • Reduction in staffing and/or inadequate funding for the FDA or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We are subject to evolving global data protection laws and regulations, which may require us to incur substantial compliance costs, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.
  • Additional laws and regulations governing international operations could negatively impact or restrict our operations.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
  • Risks Related to Our Intellectual Property Rights
  • If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us, which would have a material adverse impact on our business, results of operations, financial condition and prospects.
  • The patent positions of biopharmaceutical companies, including our patent portfolio with respect to our product candidates, involve complex legal and factual questions, and, therefore, the issuance, scope, validity, and enforceability of any patent claims that we may be granted cannot be predicted with certainty.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Even if patents are granted in the U.S. or other countries, third parties may challenge the validity, enforceability, or scope of such issued patents or any other issued patents we own or license, which may result in such patents being narrowed, invalidated, or held unenforceable.
  • Third parties may initiate legal proceedings against us, alleging that we infringe their intellectual property rights, which may prevent or delay our product development efforts and stop us from commercializing candidate products or increase the costs of commercializing them if approved. Also, we may file counterclaims or initiate other legal proceedings against third parties to challenge the validity or scope of their intellectual property rights, the outcomes of which also
  • would be uncertain and a failure to prevail in such proceedings could have a material adverse effect on the success of our business.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We do not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • Some intellectual property that we have licensed may have been discovered through government-funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit our exclusive rights, subject us to an expenditure of resources with respect to reporting requirements and limit our ability to contract with non-U.S. manufacturers.
  • If we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation by extending the patent terms or obtaining regulatory and data exclusivity for our product candidates, our business may be materially harmed.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Risks Related to our Securities
  • If we fail to regain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be
  • negatively impacted. Moreover, there can be no assurance that we will be able to regain compliance with such Nasdaq continued listing standards in the future.
  • Market volatility may affect our stock price and the value of your investment.
  • There may be issuances of shares of preferred stock in the future.
  • We incur significant costs to ensure compliance with corporate governance, federal securities law and accounting requirements.

Legal proceedings

Cesario et al. v. Vistagen Therapeutics, Inc. et al. (Northern District of California). On February 13, 2025, John Cesario and David Preka (the Cesario Plaintiffs) filed a civil action, pro se (i.e., acting on their own behalf rather than through an attorney), in the United States District Court for the Northern District of California (Case No. 4:25-cv-01510) (the Complaint) against the Company and its Board, certain of its executive officers, professional services and financial advisors, and industry analysts. The Cesario Plaintiffs filed an amended complaint on March 10, 2025 (the First Amended Complaint). On September 3, 2025, the Company filed a motion to dismiss the First Amended Complaint. On October 9, 2025, the Court granted the Cesario Plaintiffs leave to amend the First Amended Complaint, and on November 3, 2025, the Cesario Plaintiffs filed a proposed second amended complaint (the Second Amended Complaint). On December 4, 2025, the Court granted the Cesario Plaintiffs leave to file the Second Amended Complaint, and the Second Amended Complaint was filed with the Court on the same day. The Court also denied the Company’s motion to dismiss the First Amended Complaint as moot at the same time. On December 24, 2025, the Company filed a motion to dismiss the Second Amended Complaint. The Cesario Plaintiffs also purported to serve one of the Individual Defendants, Jon Saxe, who filed a motion to dismiss the Second Amended Complaint at the Court’s instruction on February 22, 2026. A court-ordered settlement conference is currently scheduled for June 15, 2026. A hearing on the Company and Mr. Saxe’s motions to dismiss the Second Amended Complaint is currently scheduled for July 14, 2026.

The opening of Item 3, Legal Proceedings.4

Sources

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