Tevogen Bio - 10-Q quarterly report FY

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM10-Q

(Mark One)

For the quarterly period ended March 31, 2026

OR

For the transition period from              to             

Commission file number: 001-41002

Tevogen Bio Holdings Inc.

(Exact name of registrant as specified in its charter)

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

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

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

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.

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐No ☒

The number of shares of registrant’s common stock outstanding as of May 12, 2026 was 4,187,505.

Table of Contents

TEVOGEN BIO HOLDINGS INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS

See accompanying notes to the unaudited consolidated financial statements.

TEVOGEN BIO HOLDINGS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

See accompanying notes to the unaudited consolidated financial statements.

TEVOGEN BIO HOLDINGS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

See accompanying notes to the unaudited consolidated financial statements.

TEVOGEN BIO HOLDINGS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

See accompanying notes to the unaudited consolidated financial statements.

TEVOGEN BIO HOLDINGS INC.

NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q (this “Report”). This discussion and other parts of this Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and intentions. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

References to the “Company,” “we,” “us,” and “our” in this section generally refer to Tevogen Bio Inc before the Business Combination and to Tevogen Bio Holdings Inc. and its subsidiary collectively from and after the Business Combination, unless the context otherwise requires.

Overview

We are a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ CTLs, to develop off-the-shelf, precision T cell therapies for the treatment of infectious diseases, cancers, and other disorders, with the aim of addressing the significant unmet needs of large patient populations. We believe the full potential of T cell therapies remains largely untapped, and aspire to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.

We believe our allogeneic, precision T cell technology, ExacTcell, has the potential to mainstream cell therapy with a new class of off-the-shelf T cell therapies with diverse applications across virology, oncology, and other areas. ExacTcell is a set of processes and methodologies to develop, enrich, and expand single human human leukocyte antigen (HLA) restricted CTL therapies with proactively selected, precisely defined targets. We are focused on using ExacTcell to develop therapeutics that are intended to be infused in patients other than the original donor. ExacTcell is designed to maximize the immunologic specificity of our products in order to eliminate malignant and virally infected cells while allowing healthy cells to remain intact. In addition, through our Tevogen.AI artificial intelligence initiative, we are exploring ways to deploy artificial intelligence-powered target detection to further accelerate our product development pace.

The first clinical product of ExacTcell, TVGN 489, is initially being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention of chronic, lingering symptoms of the disease (“Long COVID”). We have completed a Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients. No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm of the trial. Secondary endpoints showing a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity were also met. None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period.

In addition, through Tevogen.AI, we are focused on harnessing the potential of AI to expedite drug development, optimize laboratory processes and clinical trials, unravel complex biological data, improve patient outcomes, and pass on related savings to patients.

Our commercial success depends in part on our ability to obtain and maintain patent and other protection for our products and methods, preserve the confidentiality of our trade secrets, operate without infringing, misappropriating, or otherwise violating the valid, enforceable proprietary rights of others, and prevent others from infringing, misappropriating, or otherwise violating our proprietary rights. We rely on a combination of patents, patent applications, trademarks, and trade secrets to establish and protect our intellectual property rights. Our ability to stop third parties from making, using, selling, offering to sell, or importing our products without the right to do so may depend on the extent to which we have rights under valid and enforceable patents, trademarks or trade secrets that cover these activities.

We continue to build our intellectual property portfolio and seek to protect our proprietary position by, among other things, filing patent applications. Our patent estate includes patents and patent applications with claims relating to our product candidates, methods of use, and methods of preparing the product candidates. To date, our U.S. intellectual property portfolio includes three U.S. patents relating to TVGN 489 for the treatment of COVID-19, nine pending U.S. patent applications, including two patent applications relating to the treatment of COVID-19, six relating to the treatment of other viruses or cancer, and one related to artificial intelligence-driven T cell target identification and receptor engagement, as well as thirteen ex-U.S. patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, the United Arab Emirates, and the Patent Cooperation Treaty directed at viral specific T cells, methods of treating and preventing viral infections, methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, and systems for predicting immunologically active peptides with machine learning models, which have anticipated expiration dates through December 16, 2044.

In the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S. Patent No. 11,191,827 covering methods of treating COVID-19 infection using COVID-19 peptide specific CTLs; U.S. Patent No. 11,207,401 covering COVID-19 peptide-specific CTLs; and U.S. Patent No. 11,219,684 covering methods of manufacturing COVID-19 peptide specific CTLs. A pending utility patent application in the United States directed at viral specific T cells and methods of treating and preventing viral infections has an anticipated expiration of December 9, 2041. In addition, we own a registered trademark protection for “Tevogen Bio” (and design), and have applied for registered trademark protection for “AdapTcell,” “ExacTcell,” “PredicTcell,” and “Tevogen AI” with the United States Patent and Trademark Office.

We determine strategy for claim scope for our patent applications on a case-by-case basis, taking into account advice of counsel and our business model and needs. We file patents containing claims for protection of useful applications of our proprietary technologies and any product candidates, including new applications or uses we discover for existing technologies and product candidates, based on our assessment of their strategic value. We continuously reassess the number and type of patent applications, as well as our pending and issued patent claims, to ensure maximum coverage and value are obtained for our processes and compositions, given existing patent office rules and regulations.

As our patents were developed internally, historical expenditures related to their development were all expensed as incurred per GAAP. We believe these patents have significant value as the basis of our product pipeline. Our continued investment in our pipeline highlights our belief in future commercial viability of these products.

Since commencing operations in June 2020, we have devoted substantially all our efforts and financial resources to establishing corporate governance, recruiting essential staff, establishing research and development capability including securing laboratory space and equipment, conducting scientific research, securing intellectual property rights to our inventions related to our product candidates and ExacTcell, carrying out drug discovery including pre-clinical studies and our Phase 1 clinical trial of TVGN 489, raising capital, and pursuing the Business Combination.

To date, we have not generated any revenue. Our net loss for the three months ended March 31, 2026 and 2025 was $5.4 million and $10.4 million, respectively. Net loss for the three months ended March 31, 2026 was primarily attributable to non-cash, stock-based compensation expense, salaries and outside services. As of March 31, 2026, we had cash of $0.7 million.

In January 2025, we received a grant of $2.0 million from KRHP, to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers. In August 2025, we received a grant of $1.0 million from KRHP to advance Tevogen.AI. KRHP is affiliated with the Patel Family. KRHP also committed to provide an additional $7.0 million of grant funding to us to be used towards our ongoing operational expenses. In addition, in June 2025, we received a capital contribution of $500,000 from Ryan Saadi, our Chairman and Chief Executive Officer.

On July 3, 2025, we entered into the Sales Agreement with the Agent, pursuant to which we may issue and sell from time to time up to $50,000,000 of common stock through the Agent as our sales agent. Sales of our common stock through the Agent may be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, pursuant to our effective shelf registration statement on Form S-3 (File No. 333-288218) filed on June 20, 2025 with the Securities and Exchange Commission (the “SEC”) and declared effective on June 26, 2025, the base prospectus filed as part of such registration statement, and the prospectus supplement dated July 3, 2025.

On March 3, 2026, we filed a Certificate of Amendment to our Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of the State of Delaware to effect Reverse Stock Split, which was effective as of March 6, 2026 (the “Effective Date”). The common stock began trading on Nasdaq on a post-split basis at the open of business on the Effective Date.

Based on cash on hand as of the date of this Report of approximately $0.7 million, net proceeds of $0.1 million received from sales of common stock under the Sales Agreement subsequent to March 31, 2026, net proceeds of $3.0 million received from the sale of prefunded common stock purchase warrants, combined with the amounts available under our Loan Agreement, and the $7.0 million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to fund our operations for at least the next 12 months from the issuance date of our unaudited consolidated financial statements.

We do not expect to generate product revenue unless and until we obtain marketing approval or other authorization for and successfully commercialize TVGN 489 or another product candidate. We expect to incur expenses related to expanding our research and development capability, building our manufacturing infrastructure including through acquisitions, and developing our commercialization organization, including reimbursement, marketing, managed market, and distribution functions, and training and deploying a specialty medical science liaison team.

Components of our Results of Operations

Revenue

To date, we have not generated any revenue, and we do not expect to generate any revenue from the sale of products unless and until we obtain marketing approval or other authorization for and commercialize TVGN 489 or another product candidate.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including staffing, discovery efforts, preclinical studies, and clinical development of TVGN 489, and preclinical studies of other product candidates, and include:

Research and development activities are central to the biotechnology business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased study sizes, which also leads generally to longer patient enrollment times in later-stage clinical trials. We expect our research and development expenses to increase significantly over the next several years as we increase manufacturing, shipping, and storage of clinical batches required for clinical trials, incur increased personnel costs, including stock-based compensation, conduct planned clinical trials for TVGN 489 and other clinical and pre-clinical activities for other product candidates, and prepare regulatory filings for any of our product candidates.

The successful development of our current or future product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the development of any product candidates. The success of TVGN 489 and our other product candidates will depend on several factors, including the following:

A change in the outcome of any of these variables concerning the development, manufacturing, or commercialization activities of a product candidate could result in a significant change in the costs and timing associated with the development of that product candidate. For example, if we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, if there are safety concerns, or if we determine that the observed safety or efficacy profile would not be competitive in the marketplace, we could be required to expend significant additional financial resources and time on the completion of clinical development. We anticipate that product commercialization may take several years, and we expect to spend a significant amount in development costs.

General and Administrative Expenses

General and administrative expenses primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive compensation for employees. These expenses also encompass corporate facility costs such as rent, utilities, depreciation, and maintenance, as well as costs not classified under research and development expenses. Legal fees pertaining to intellectual property and corporate matters, as well as fees for accounting and consulting services, are also included in general and administrative expenses.

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts, and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers, accountants, and recruitment firms, among other expenses. Increased costs associated with being a public company also include expenses related to services associated with maintaining compliance with SEC and Nasdaq requirements, insurance, and investor relations costs. If any of our current or future product candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with sales and marketing efforts.

Interest Expense, Net

Interest expense, net consists primarily of interest on our former convertible promissory notes and Loan Agreement, partially offset by interest earned on bank deposits. (See “-Liquidity and Capital Resources-Sources of Liquidity” below.)

Merger Transaction Costs

Transaction costs we incurred in relation to the Business Combination were initially capitalized as deferred transaction costs up through the Closing Date, at which time such costs were charged to expense in our statements of operations less the amount of cash received in the Business Combination.

Change in Fair Value of Warrants

As the result of the Merger, we account for the warrants originally sold as part of Semper Paratus’s initial public offering (the “IPO”) in accordance with ASC 815, Derivatives and Hedging Contracts in Entity’s Own Equity (“ASC 815”) and ASC 480, Distinguishing Liabilities from Equity (“ASC 480”). The assessment considers whether the warrants are freestanding financial instruments and meet the definition of a liability pursuant to ASC 480 and meet all of the conditions for equity classification under ASC 815, including whether the warrants are indexed to our own shares of common stock, among other conditions. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter until settlement. Changes in the estimated fair value of the warrants are recognized as a non-cash loss on the unaudited consolidated statements of operations. Under these standards, our private placement warrants sold at the time of the IPO do not meet the criteria for equity classification and must be recorded as liabilities while the public warrants sold in connection with the IPO do meet the criteria for equity classification and must be recorded as equity.

Income Tax Provision

Since inception, we have incurred significant net losses. We have provided a valuation allowance against the full amount of our net deferred tax assets since, in the opinion of our management, based upon our historical and anticipated future losses, it is more likely than not that the benefits will not be realized.

Our utilization of our net operating loss carryforwards may be subject to a substantial annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, respectively, as well as similar state provisions.

Results of Operations

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Research and Development Expenses

We do not track our internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

Research and development expenses for the three months ended March 31, 2026 were $3.1 million, compared to $3.2 million for the three months ended March 31, 2025. The decrease was primarily attributable to lower personnel costs.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the three months ended March 31, 2026 and 2025:

General and administrative expenses for the three months ended March 31, 2026 were $2.3 million compared to $7.2 million for the three months ended March 31, 2025. The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense.

Interest Expense, Net

We recognized $71,166 in interest expense for the three months ended March 31, 2026 compared to $24,571 for the three months ended March 31, 2025. The increase was attributable primarily to the outstanding balance on the Facility.

Change in Fair Value of Warrants

We recognized a gain on change in fair value of derivative warrant liabilities of $25,831 during the three months ended March 31, 2026 and a gain of $13,857 during the three months ended March 31, 2025. The change in value during these periods was largely attributable to the changes in the price of underlying common stock and risk-free rates and decreases to the time until expiration of the warrants.

Non-GAAP Presentation of Loss from Operations

Since inception, we have incurred substantial operating losses, primarily driven by non-cash stock-based compensation expense, which does not directly impact our cash position or operating liquidity. Other significant contributors to our operating losses have included legal and professional fees, clinical and pre-clinical development expenses, other personnel expenses, and facilities expenses.

To enhance investors’ understanding of our historical results, we present below adjusted loss from operations, which is a non-GAAP measure that we define as loss from operations, calculated in accordance with GAAP, adjusted to exclude stock-based compensation expense. We believe adjusted loss from operations provides additional insight into the underlying capital efficiency of our business and helps investors evaluate our long-term operating performance by illustrating that a significant portion of our reported losses represents equity-based compensation expense rather than cash expenditures. Stock-based compensation is a key element of our employee and executive compensation and retention strategy and will continue to impact our reported GAAP results in future periods.

This non-GAAP measure should not be considered in isolation or as a substitute for GAAP financial information and may not be directly comparable to similarly titled measures reported by other companies. Investors are encouraged to review the reconciliations provided below together with our GAAP results included in the unaudited consolidated financial statements and the notes thereto appearing elsewhere in this Report.

A reconciliation of loss from operations to adjusted loss from operations is set forth below.

Liquidity and Capital Resources

Sources of Liquidity

As of March 31, 2026 we had $0.7 million in cash, as compared to $0.6 million in cash as of December 31, 2025. To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, grant funding, and proceeds from sales of common stock under the Sales Agreement. Since January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, $3.0 million from deposits related to the future sale of our Series A-1 Preferred Stock, and $6.0 million from the sale of our Series C Preferred Stock. In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below. As of March 31, 2026, we had drawn $6.4 million with a remaining $14.0 million available for future financing. In January and August 2025, we received a grant of $2.0 million and $1.0 million, respectively, and have a remaining commitment of a grant of $7.0 million from KRHP. In addition, in June 2025, we received a capital contribution of $500,000 from Dr. Ryan Saadi, our Chairman and Chief Executive Officer.

On July 3, 2025, we entered into the Sales Agreement, pursuant to which we may issue and sell from time to time up to $50,000,000 of shares of common stock through the Agent as our sales agent. Sales of our common stock through the Agent, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, pursuant to our effective shelf registration statement on Form S-3 filed on June 20, 2025, and the prospectus supplement dated July 3, 2025. Each time we wish to issue and sell common stock under the Sales Agreement, we will provide a placement notice to the Agent containing the parameters in accordance with which shares are to be sold, including, but not limited to, the number of shares of common stock to be issued, the time period during which sales are requested to be made, any limitation on the number of shares of common stock that may be sold in any one trading day, and any minimum price below which sales may not be made. The Agent will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock from time to time, based upon our instructions, including any price, time or size limits we may impose pursuant to and subject to the terms and conditions of the Sales Agreement. We are not obligated to make any sales of common stock under the Sales Agreement and may terminate the Sales Agreement at any time upon written notice. We will pay the Agent a commission on the gross proceeds.

As of the May 12, 2026, we have sold an aggregate of approximately 278,000 shares of common stock under the Sales Agreement at a weighted average price per share of $22.07 on a post-Reverse Stock Split basis, resulting in gross proceeds of approximately $6.1 million. After deducting total expenses of approximately $170,000, including commission to the Agent of approximately $154,000, net proceeds to us were approximately $5.9 million.

On May 11, 2026, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with the Patel Family pursuant to which we sold the Patel Family prefunded common stock purchase warrants (the “Prefunded Warrants”) exercisable for 375,000 shares of our common stock for an aggregate purchase price of approximately $3.0 million in a private investment in public equity transaction (the “PIPE”). Pursuant to the terms of the Securities Purchase Agreement, the Prefunded Warrants are exercisable at any time following issuance until exercised in full and may be exercised for cash or, subject to the terms of the Prefunded Warrants, on a cashless basis. The exercise price of each Prefunded Warrant is $0.0001 per share, payable upon exercise. The closing of the PIPE occurred on May 15, 2026. See Part II, Item 5 (Other Information) for more information on the PIPE.

Cash Flows

The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:

Cash Flows from Operating Activities

During the three months ended March 31, 2026, we used $2.7 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $5.4 million offset by non-cash stock-based compensation expense, depreciation expense, and the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

During the three months ended March 31, 2025, we used $3.3 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $10.4 million offset by $7.3 million in non-cash stock-based compensation expense, depreciation expense, and the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

Cash Flows from Investing Activities

During the three months ended March 31, 2026 and 2025, we did not have any cash flows from investing activities.

Cash Flows from Financing Activities

During the three months ended March 31, 2026, we received $2.9 million of net cash from financing activities attributable to $2.0 million in draws on the Loan Agreement and $0.9 million in proceeds pursuant to the Sales Agreement, net of offering costs.

During the three months ended March 31, 2025, we received $2.0 million of net cash from financing activities attributable to a draw on the Loan Agreement and $2.0 million attributable to the KRHP grant.

Funding Requirements

Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below, potential future sales of common stock under the Sales Agreement, and the $7.0 million of grant funding that KRHP has committed to provide to be used towards our ongoing operational expenses. On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor agreed to purchase shares of our Series A Preferred Stock for an aggregate purchase price of $8.0 million. On March 27, 2024, we entered into an agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million. We have not yet received $3.0 million of the $6.0 million purchase price for the Series A-1 Preferred Stock. Even if we receive such proceeds, we will still need additional capital to fully implement our business, operating, and development plans. On August 21, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million.

On June 6, 2024, we entered into the Loan Agreement, pursuant to which the Patel Family agreed to provide to us up to an initial amount of $36.0 million (the “Maximum Loan Amount”) under the Facility. The Patel Family is also the investor in our Series A, Series A-1, and Series C Preferred Stock. The Facility permits us to borrow up to $1.0 million monthly in a single monthly draw over a period of up to three years. Draws accrue interest at a fixed annual rate of the lower of (i) the daily secured overnight financing rate, measured on the date we receive the draw (the “Deposit Date”), plus 2.00% and (ii) 7.00%, accruing quarterly beginning on the Deposit Date and payable quarterly beginning on the three-month anniversary of the Deposit Date. Interest will be payable in shares of common stock with an effective purchase price of $75.00 per share, and each draw will mature 48 months after the Deposit Date. Prepayment will be permitted without penalty. We may repay or prepay any amount of outstanding principal balance under the Facility at our election in cash or in shares of common stock with an effective purchase price of the greater of $75.00 per share and the 10-day trailing volume weighted average price of the common stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements related to resale registration. Pursuant to the Loan Agreement, we also agreed to provide the Patel Family the $14 million Purchase Option and the Additional Amount Purchase Option (together, the “Optional PIPE”). The Optional PIPE would be priced at a 30% discount to the Trailing VWAP on the date such price first reaches at least $500.00 per share (the “Threshold Price Date”) and will be exercisable by the Patel Family by written notice within three business days after we have notified the Patel Family of the Threshold Price Date (the date of such notice, the “Threshold Price Notice Date”). Pursuant to the terms of the Loan Agreement, we issued to the Patel Family the Commitment Shares, subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of common stock in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date in the event we have satisfied all applicable closing conditions. There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement. As of March 31, 2026, we had drawn $6.4 million with a remaining $14.0 million available for future draws.

On July 3, 2025, we entered into the Sales Agreement, pursuant to which we may issue and sell from time to time up to $50,000,000 of shares of common stock through the Agent as our sales agent. See “—Liquidity and Capital Resources—Sources of Liquidity” above for more information on amounts sold under the Sales Agreement.

We expect to devote considerable financial resources to our ongoing and planned activities, particularly as we conduct our planned clinical trials of TVGN 489 and other product candidates.

Identifying potential product candidates and conducting pre-clinical testing and clinical trials is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success.

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance our pre-clinical studies and clinical trials. In addition, if we obtain marketing approval for TVGN 489 in any indication or for any other product candidate we are developing or develop in the future, we expect to incur commercialization expenses related to product manufacturing, sales, marketing, and distribution. Furthermore, we expect to continue to incur increased costs associated with operating as a public company. Accordingly, we will need additional funding to fully implement our business plans.

Our future capital requirements will depend on many factors, including:

As of March 31, 2026, we had cash of approximately $0.7 million. We believe that our cash balance, net proceeds of $0.1 million received pursuant to the Sales Agreement subsequent to March 31, 2026, the $14.0 million available under the Loan Agreement, the remaining commitment for a $7.0 million grant from KRHP, and the $3.0 million of net proceeds received from the sale of prefunded common stock purchase warrants in May 2026 will allow us to have adequate cash and financial resources to operate for at least the next 12 months from the date of issuance of our unaudited consolidated financial statements included in this Report. We do not plan to initiate a clinical trial until additional funding is received.

We regularly evaluate different strategies to obtain funding for operations for subsequent periods. These strategies may include but are not limited to private placements of securities, licensing and/or marketing arrangements, partnerships with other pharmaceutical or biotechnology companies, and public offerings of securities. We may not be able to obtain financing on acceptable terms and may not be able to enter into strategic alliances or other arrangements on favorable terms. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain sufficient funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect our business prospects.

Contractual Obligations and Commitments

We have material cash requirements arising from its contractual obligations, primarily consisting of operating lease commitments and debt obligations under notes payable and our Loan Agreement.

As of March 31, 2026, our short-term cash requirements (due within the next 12 months) totaled approximately $2.2 million, consisting of:

Our long-term cash requirements (due beyond 12 months) totaled approximately $7.5 million, consisting of:

We expect to fund these cash requirements through a combination of cash generated from operations and available financing arrangements. We continually evaluate our liquidity position and may seek to refinance or restructure certain obligations as they come due.

The commitment amounts above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions under the contracts. Our contracts with CROs, CMOs, and other third parties for the manufacture of our product candidates and to support pre-clinical research studies and clinical testing are generally cancelable by us upon prior notice and do not contain any minimum purchase commitments. Payments due upon cancellation consisting only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation are not included in the table above as the amount and timing of such payments are not known.

Critical Accounting Policies and Estimates

This discussion and analysis of our financial condition and results of operations is based on our unaudited consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of the unaudited consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our unaudited consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, the fair value of our common stock, the fair value of our convertible promissory notes, and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be 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. Actual results may differ from these estimates under different assumptions or conditions, including those factors set out in the “Risk Factors” section and elsewhere of our Annual Report, including the section entitled “Special Note Regarding Forward-Looking Statements.”

Our significant accounting policies are described in more detail in Note 3 to our unaudited financial statements contained in this Report and Note 3 to the audited financial statements included in the Annual Report. We did not identify any material policy changes related to critical accounting policies and estimates from what was previously disclosed in our Annual Report, except as described in Note 3 to our unaudited financial statements contained in this Report.

Recent Accounting Pronouncements

See Note 3 to our unaudited consolidated financial statements found in this Report for a description of recent accounting pronouncements applicable to our financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information under this item.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Report. Based upon the evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of the end of the period covered by this Report due to the material weakness in our internal control over financial reporting.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II - Other Information

Item 1. Legal Proceedings.

In the ordinary conduct of our business, we may be subject from time to time to legal proceedings. We currently have no material legal proceedings pending.

Item 1A. Risk Factors.

An investment in our common stock involves a high degree of risk. You should carefully consider the risks set forth in the “Risk Factors” section of our Annual Report, other information set forth in this Report, and the additional information in the other reports we file with the SEC. If any of the risks contained in those reports occur, our business, results of operation, financial condition, and liquidity could be harmed, the value of our securities could decline, and you could lose all or part of your investment. Except as described below, there have been no material changes in the risk factors set forth in the “Risk Factors” section of our Annual Report.

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.

Our common stock and our public warrants are listed on Nasdaq. We are required to meet specified financial and other requirements in order to maintain such listing, including a requirement that the closing bid price for our common stock remain above $1.00 and that the market value of our common stock is at least $50 million and the market value of publicly held shares of our common stock is at least $15 million.

On April 16, 2026, we received a letter from Nasdaq’s Listing Qualifications Staff (the “Staff”) notifying us that we no longer meet Nasdaq’s $50 million minimum market value for listed securities requirement pursuant to Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Requirement”) for continued listing on the Nasdaq Global Market based on Nasdaq’s review of the market value of the Company’s listed securities for the previous 30 consecutive business days. In addition, on April 17, 2026, we received a letter from the Staff notifying us that we no longer meet Nasdaq’s $15 million minimum market value of publicly held shares requirement under Nasdaq Listing Rule 5450(b)(2&3)(C) (the “MVPHS Requirement”, and together with the MVLS Requirement, the “Requirements”) based on Nasdaq’s review of the market value of the Company’s publicly held shares for the previous 30 consecutive business days. The notifications have no immediate effect on the Company’s listing or trading on the Nasdaq Global Market.

Nasdaq has provided us a period of 180 calendar days to regain compliance with each Requirement, or until October 13, 2026 for the MVLS Requirement (the “MVLS Compliance Date”) and October 14, 2026 for the MVPHS Requirement (the “MVPHS Compliance Date” and, together with the MVLS Compliance Date, the “Compliance Dates”). If, at any time before the applicable Compliance Date, our market value of listed securities closes at $50 million or more or our market value of publicly held shares closes at $15 million or more for a minimum of 10 consecutive business days and up to generally not more than 20 consecutive business days, the Staff will provide written notification to us that we have regained compliance with the applicable Requirement.

We intend to actively monitor the market value of its listed securities and publicly held shares. We may evaluate and consider available options for regaining compliance with the Requirements, as well as applying for a transfer to The Nasdaq Capital Market. However, there can be no assurance that we will take any specific action or be able to regain compliance with either Requirement or otherwise maintain compliance with Nasdaq listing rules.

If we fail to regain compliance with the Requirements or to meet other Nasdaq continued listing requirements, Nasdaq may take steps to delist our securities. Such a delisting would likely have a negative effect on the price of our securities and would impair your ability to sell or purchase the securities when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our securities to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our securities from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements. Additionally, if our securities are not listed on, or become delisted from, Nasdaq for any reason, and are quoted on the OTC Bulletin Board, an inter-dealer automated quotation system for equity securities that is not a national securities exchange, the liquidity and price of our securities may be more limited than if our securities were quoted or listed on Nasdaq or another national securities exchange. You may be unable to sell your securities unless a market can be established or sustained.

Item 5. Other Information.

On May 11, 2026, we entered into the Securities Purchase Agreement with existing investor the Patel Family for the issuance and sale of Prefunded Warrants in a private placement. Pursuant to the Securities Purchase Agreement, we agreed to sell to the Patel Family Prefunded Warrants exercisable for 375,000 shares of our common stock for an aggregate purchase price of approximately $3.0 million. The Prefunded Warrants are exercisable at any time following issuance until exercised in full and may be exercised for cash or, subject to the terms of the Prefunded Warrants, on a cashless basis. The exercise price of each Prefunded Warrant is $0.0001 per share, payable upon exercise. The closing of the PIPE (the “PIPE Closing”) occurred on May 15, 2026.

The Securities Purchase Agreement provides that the Prefunded Warrants may not be exercised to the extent that, after giving effect to such exercise, the Patel Family, together with its affiliates, would beneficially own more than 9.99% of our outstanding common stock (the “Beneficial Ownership Limitation”). The Patel Family may increase or decrease the Beneficial Ownership Limitation up to a maximum of 19.99% upon providing prior written notice to us, provided that any such increase will not become effective until the 61st day after such notice is delivered.

We have agreed to file a resale registration statement covering the resale of the shares of common stock issuable upon exercise of the Prefunded Warrants within 30 days after the PIPE Closing and to use commercially reasonable efforts to cause such registration statement to be declared effective within 60 days following the PIPE Closing, or within 90 days following the PIPE Closing in the event the registration statement is subject to a full review by the SEC, in each case as specified in the Securities Purchase Agreement. We have further agreed to maintain the effectiveness of such registration statement until such time as the shares of common stock issuable upon exercise of the Prefunded Warrants are no longer owned by the Patel Family or may be sold without volume or manner of sale restrictions pursuant to Rule 144 under the Securities Act. The Prefunded Warrants were sold in a transaction not involving a public offering pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Rule 506 of Regulation D under the Securities Act. The Patel Family represented that it is an accredited investor and is acquiring the securities for investment for its own account and not with a view toward resale or distribution.

Insider Trading Arrangements

During the three months ended March 31, 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted orterminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Item 6. Exhibits.

INDEX TO EXHIBITS

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.