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Tevogen Bio Holdings Inc.

For the period ended Dec 31, 2025. Filed Mar 31, 2026.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2025 · Filed Mar 31, 2026

TVGN$5.59+0.5%Stored close · as of Nov 6, 2026
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

For the fiscal year ended December 31,2025

OR

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number:001-41002

Tevogen Bio Holdings Inc.

(Exact name of registrant as specified in its charter)

Delaware98-1597194
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
15 Independence Boulevard, Suite #210 Warren, New Jersey07059
(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code:(877) 838-6434

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per share Warrants, each exercisable for one share of Common Stock for $575 per shareTVGN TVGNWThe Nasdaq Stock Market LLC The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes☐No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒No☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒No☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer☐Accelerated filer☐
Non-accelerated filer☒Smaller reporting company☒
Emerging growth company☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐No☒

The aggregate market value of the common stock held by non-affiliates of the registrant, computed by reference to the price at which the common stock was last sold on The Nasdaq Stock Market on June 30, 2025 (the last business day of the registrant’s most recently completed second fiscal quarter), was $63.7 million.

The number of shares of registrant’s common stock outstanding as of March 27, 2026 was 4,164,205.

Portions of the registrant’s Definitive Proxy Statement relating to the registrant’s 2026 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Definitive Proxy Statement will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2025.

Table of Contents

FORM 10-K

INDEX

Page
PART I
Item 1Business6
Item 1ARisk Factors40
Item 1BUnresolved Staff Comments80
Item 1CCybersecurity80
Item 2Properties81
Item 3Legal Proceedings81
Item 4Mine Safety Disclosures81
PART II
Item 5Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities82
Item 6[Reserved]82
Item 7Management’s Discussion and Analysis of Financial Condition and Results of Operations82
Item 7AQuantitative and Qualitative Disclosures About Market Risk94
Item 8Financial Statements and Supplementary Data94
Item 9Changes in and Disagreements With Accountants on Accounting and Financial Disclosure94
Item 9AControls and Procedures94
Item 9BOther Information95
Item 9CDisclosure Regarding Foreign Jurisdictions that Prevent Inspection95
PART III
Item 10Directors, Executive Officers, and Corporate Governance96
Item 11Executive Compensation96
Item 12Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters96
Item 13Certain Relationships and Related Transactions, and Director Independence96
Item 14Principal Accounting Fees and Services96
PART IV
Item 15Exhibits and Financial Statement Schedule97
SIGNATURES100

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K (this “Annual Report”) contains statements that constitute “forward-looking statements” for purposes of the federal securities laws. Forward-looking statements include, but are not limited to, statements that discuss future events, hopes, expectations, beliefs, intentions, or strategies regarding the future, projections of results of operations or financial condition, changes in the markets in which we compete, and trends in our business. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions or their opposites may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Annual Report may include, for example, statements about:

●the development of, potential benefits of, and patient access to our product candidates for the treatment of infectious diseases, cancer, and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID;
●our ability to develop additional product candidates, including through the use of our ExacTcellTM technology;
●the anticipated benefits of ExacTcell;
●our expectations regarding our future clinical trials;
●our manufacturing plans;
●our ability to generate revenue in the future;
●our ability to manage, grow, and diversify our business and execute our business initiatives and strategy;
●expectations regarding the healthcare and biopharmaceutical industries;
●the potential liquidity and trading of our securities;
●the future business, operations, and financial performance of our Company.

The forward-looking statements contained in this Annual Report are based on management’s current expectations, assumptions, and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the factors set forth below in “Summary of Risk Factors.”

Forward-looking statements should be considered in light of these factors and the factors described elsewhere in this Annual Report, including in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” You should read these factors and the other cautionary statements made in this Annual Report as being applicable to all related forward-looking statements wherever they appear in this Annual Report. It is not possible to predict or identity all such risks. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable law.

Unless the context otherwise requires or unless stated otherwise, references to “Tevogen”, “we,” “us,” “our,” “the Company” and “our Company” refer to Tevogen Bio Holdings Inc. and its consolidated subsidiary.

We are subject to a variety of risks and uncertainties, including risks that could have a material adverse effect on our business, financial condition, results of operations, and cash flows. The following summary of the principal factors that make an investment in our securities speculative or risky should not be relied upon as an exhaustive summary of the material risks facing us. You should read the following summary together with the more detailed description of risks under “Risk Factors” in Part I, Item 1A of this Annual Report and the other information contained in this Annual Report before investing in our securities. Capitalized terms not otherwise defined below have been defined elsewhere in this Annual Report.

Risks Related to Our Financial Position and Need for Additional Capital

●We have a limited operating history, no products approved for commercial sale, have never generated revenue from product sales, and have a history of significant losses.
●We are relying in part on an additional $7.0 million of grant funding that we have not yet received to meet our liquidity needs.
●We will require substantial additional financing to achieve our business objectives and to fund our operations.

Risks Related to Development, Regulatory Review, and Product Approval

●Regulation of cellular therapy product candidates is rigorous, complex, uncertain, and subject to change.
●We have limited experience designing and implementing preclinical and clinical trials, which are complex, expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes.
●We may be unable to develop, receive regulatory approval for, and commercialize our product candidates.
●We may encounter substantial delays and disruptions in the development of our product candidates.
●The FDA regulatory approval process is lengthy and time-consuming.
●We may never receive regenerative medicine advanced therapy designation for any product candidate, and this designation may not lead to a faster development or regulatory review or approval process.
●Our business is highly dependent on our first product candidate, TVGN 489.
●Results from our clinical trials may change and are subject to audit, validation, and verification procedures.
●Initial results and results of earlier trials may not be predictive of future results.
●Our TVGN 489 proof-of-concept clinical trial results may be less reliable than results in larger clinical trials.
●Changes in product candidate manufacturing or formulation may result in additional costs or delay.
●ExacTcell is unproven and may not result in marketable products.
●We may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during development.
●We may encounter difficulties enrolling patients in our clinical trials.
●We may be required to suspend, repeat, or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed.
●We may not achieve our projected development goals in the time frames we announce and expect.
●Disruptions at government agencies could hinder or prevent product development and commercialization.
●Development of product candidates in combination with other therapies presents additional regulatory risks.
●We could fail utilizing new and evolving technologies, such as artificial intelligence (“AI”), in our business.

Risks Related to Business Development and Commercialization

●Our commercial success depends upon attaining significant market acceptance of our product candidates.
●Regulated biologics may be subject to biosimilar competition.
●The incidence and prevalence of target patient populations are based on estimates and third-party sources.
●We will face extensive ongoing regulatory requirements and regulatory review after regulatory approval.
●We may be unable to establish sales and marketing capabilities.
●Failure to comply with or adapt to changes in data protection, privacy, and similar laws could materially and adversely harm our business.
●Increasing use of AI could lead to liability, violation of data security and privacy laws, or reputational damage.
●Computer systems may fail or suffer security breaches.
●Coverage and reimbursement may be limited or unavailable in certain market segments.
●Healthcare reform may negatively impact our ability to sell our product candidates profitably.
●We could violate healthcare fraud and abuse, false claims, and health information privacy and security laws.
●We could fail to comply with environmental, health and safety laws and regulations.

Risks Related to Manufacturing and Reliance on Third Parties

●The manufacture of cell therapies is subject to a multitude of manufacturing risks.
●Our efforts to establish manufacturing capabilities will involve time and expense and may not be successful.
●The loss of suppliers or their inability to supply us with adequate materials could harm our business.
●We may not obtain marketing approval for or successfully commercialize product candidates as a result of failures by third parties.
●We may not be able to establish collaborations on commercially reasonable terms.

Risks Related to Intellectual Property

●We may be unable to obtain and maintain sufficient patent protection for our product candidates or ExacTcell.
●Our patent protection could be reduced or eliminated for non-compliance with patent agency requirements.
●We may not be able to protect our intellectual property rights throughout the world.
●Changes in patent law could diminish the value of patents in general.
●We may become involved in lawsuits to protect or enforce our intellectual property.
●Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.
●Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights.
●Others may claim an ownership interest in our intellectual property and our product candidates.
●We may be unable to protect the confidentiality of our proprietary information.
●We may be subject to claims asserting that our agents have wrongfully used or disclosed alleged trade secrets.
●Our trademarks and trade names may be inadequately protected.
●Intellectual property rights do not necessarily address all potential threats.

Risks Related to Our Business

●We are highly dependent on our key personnel.
●We may face substantial competition.
●We will need to grow the size of our organization.
●We may not realize the benefits of any acquisitions, strategic alliances, or similar arrangements that we enter into.
●Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization.
●We may be limited in our ability to use our net operating loss carryforwards.

Risks Related to Being a Public Company and Ownership of Securities

●The price of our common stock, par value $0.0001 per share (the “Common Stock”), or warrants to purchase our Common Stock (the “Warrants”) may fluctuate significantly.
●If we fail to meet Nasdaq’s continued listing requirements, our Common Stock and our outstanding public warrants to purchase Common Stock could be delisted
●We have previously failed to timely file certain periodic reports with the SEC and could fail to timely file such reports in the future.
●We may not have the funds necessary to satisfy our future obligations under the terms of our outstanding preferred stock (the “Preferred Stock”).
●We incur increased costs due to operating as a public company, and our management devotes substantial time to compliance initiatives and corporate governance practices.
●We may issue additional shares of our Common Stock or other equity securities without your approval.
●We are an “emerging growth company” and a “smaller reporting company”.
●Our management team has limited experience managing a public company.
●Analysts may not publish research about us or may change their recommendation regarding our Common Stock.
●We could become subject to securities litigation or stockholder activism.
●We may be required to take write-downs or write-offs, restructuring and impairment or other charges.
●We could fail to maintain proper and effective internal control over financial reporting.
●Sales of a substantial number of our securities by existing securityholders could cause their price to fall.
●Certain individuals have substantial control over us.
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.