Skip to main content

Tevogen Bio Holdings Inc

For the period ended Dec 31, 2023. Filed Apr 29, 2024.

View on SEC.gov

About this filing

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.

FY2023 · Filed Apr 29, 2024

TVGN$5.59+0.5%Stored close · as of Nov 6, 2026
See the whole filing, with its images and exhibits

Cover page

Show cover page

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

(Mark One)

☒ Annual Report Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended December 31,2023

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)

Delaware85-1284695
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
15 Independence Boulevard, Suite #410 Warren, New Jersey07059
(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code:(877) 838-6436

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 shareTVGNThe Nasdaq Stock Market LLC
Warrants, each exercisable for one share of Common Stock for $11.50 per shareTVGNWThe 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 Section 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, a 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 Act).

Yes**☐** No**☒**

The aggregate market value of the registrant’s common stock held by non-affiliates as of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, computed by reference to the price at which the common stock was last sold on The Nasdaq Stock Market LLC on that date, was approximately $25,451,000.

The total number of shares of common stock outstanding as of April 26, 2024, was 164,614,418.

DOCUMENTS INCORPORATED BY REFERENCE

None.

FORM 10-K

INDEX

Page
PART I
Item 1Business7
Item 1ARisk Factors37
Item 1BUnresolved Staff Comments77
Item 1CCybersecurity77
Item 2Properties78
Item 3Legal Proceedings78
Item 4Mine Safety Disclosures78
PART II
Item 5Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities79
Item 6[Reserved]80
Item 7Management’s Discussion and Analysis of Financial Condition and Results of Operations80
Item 7AQuantitative and Qualitative Disclosures About Market Risk85
Item 8Financial Statements and Supplementary Data85
Item 9Changes in and Disagreements With Accountants on Accounting and Financial Disclosure85
Item 9AControls and Procedures86
Item 9BOther Information86
Item 9CDisclosure Regarding Foreign Jurisdictions that Prevent Inspection86
PART III
Item 10Directors, Executive Officers, and Corporate Governance87
Item 11Executive Compensation93
Item 12Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters103
Item 13Certain Relationships and Related Transactions, and Director Independence104
Item 14Principal Accounting Fees and Services109
PART IV
Item 15Exhibits and Financial Statement Schedule110

EXPLANATORY NOTE

Prior to February 14, 2024, Semper Paratus Acquisition Corporation (“Semper Paratus”) was a special purpose acquisition company formed for the purpose of effecting a merger, stock purchase, reorganization, or similar acquisition or business combination with one or more businesses. On February 14, 2024 (the “Closing Date”), subsequent to the end of the fiscal year ended December 31, 2023, the fiscal year to which this Annual Report on Form 10-K (this “Annual Report”) relates, Semper Paratus completed the previously announced business combination pursuant to that certain Agreement and Plan of Merger by and among Semper Paratus, Semper Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Semper Paratus (“Merger Sub”), SSVK Associates, LLC, Semper Paratus’s sponsor (the “Sponsor”), in its capacity as purchaser representative, Tevogen Bio Inc, a Delaware corporation (“Tevogen Bio”), and Dr. Ryan Saadi, in his capacity as seller representative (the “Merger Agreement”).

As contemplated by the Merger Agreement, on the Closing Date, Merger Sub merged with and into Tevogen Bio, with Tevogen Bio being the surviving company and a wholly owned subsidiary of Semper Paratus (the “Merger,” and together with the other transactions contemplated by the Merger Agreement, the “Business Combination”). In connection with the closing of the Business Combination (the “Closing”), we changed our name from “Semper Paratus Acquisition Corporation” to “Tevogen Bio Holdings Inc.”

As of the open of trading on February 15, 2024, our common stock and public warrants began trading on The Nasdaq Stock Market LLC (“Nasdaq”) as “TVGN” and “TVGNW,” respectively.

Substantially concurrently with the filing of this Annual Report, we will be filing Amendment No. 2 to our Current Report on Form 8-K originally filed on February 14, 2024, which will include the audited financial statements of Tevogen Bio for the year ended December 31, 2023, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations and unaudited pro forma condensed combined financial information of the Company and Tevogen Bio as of December 31, 2023, and for the year then ended. Interested parties should refer to our Current Reports on Form 8-K for more information.

Except as otherwise expressly provided herein or as the context otherwise requires, the information in this Annual Report does not reflect the consummation of the Business Combination, which, as discussed above, occurred subsequent to the period covered hereunder.

As used in this Annual Report, unless otherwise noted or the context otherwise requires: (i) references to the “Company,” “Tevogen,” “we,” “us,” “our,” and similar terms refer to Tevogen Bio Holdings Inc. (f/k/a Semper Paratus Acquisition Corporation) and its subsidiaries; (ii) references to “Semper Paratus” are to Semper Paratus Acquisition Corporation prior to the close of the Business Combination; (iii) references to “Tevogen Bio” are to Tevogen Bio Inc. (f/k/a Tevogen Bio Inc) prior to the close of the Business Combination; (iv) references to “Sponsor” are to SSVK Associates, LLC; and (v) references to “Original Sponsor” are to Semper Paratus Sponsor LLC.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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 ExacTcell platform;
●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; and
●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.

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 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.
●There is substantial doubt about the ability to continue as a going concern due to cash on hand.
●We will require substantial additional financing to pursue our business objectives.

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.

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.
●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.
●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 and Warrants may fluctuate significantly.
●Sales of a substantial number of our securities by existing securityholders could cause their price to fall.
●We may not have the funds necessary to satisfy our future obligations under the terms of our Preferred Stock.
●Failure to meet Nasdaq continued listing requirements could result in delisting of our securities.
●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 have no current plans to pay regular cash dividends on our Common Stock.
●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.
●Certain individuals have substantial control over us.
●We may redeem warrants at a time that is disadvantageous to warrant holders.
●A warrant holder exercising warrants on a “cashless basis” will receive fewer shares of Common Stock from such exercise than through a cash exercise.
●Our public warrants may never be in the money and they may expire worthless.
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.