Tevogen Inc. 10-Q

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 and our Annual Report on Form 10-K for the year ended December 31, 2025, 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 Inc. and its subsidiary collectively from and after the Business Combination, unless the context otherwise requires. Overview We are a healthcare company focused on addressing unmet needs across biotechnology, technology, and healthcare services. Our business includes Tevogen Bio, our biotechnology initiative focused on developing off-the-shelf cellular immunotherapies, and Tevogen.AI, our initiative leveraging artificial intelligence and advanced data analytics to advance precision medicine. We also recently established Tevogen Healthcare Services, a healthcare services initiative intended to support longer-term efforts to improve healthcare affordability, accessibility, and efficiency. Through Tevogen Bio, we are 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 and improving the affordability and accessibility of life-saving medicines. 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 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. 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. Through Tevogen.AI, we are focused on harnessing the potential of AI to transform drug development by accelerating target detection, reducing failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. Our current artificial intelligence technologies are PredicTcell™, which applies machine learning to analyze and understand immunologically active peptides, and AdapTcell™, which enables in-silico experimentation to inform genetics and proteomics while building a high-resolution map of HLA specificity. Tevogen Healthcare Services is an emerging initiative and remains at an early stage of development. 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. 14 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 21 ex-U.S. patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, and the United Arab Emirates, 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 trademark registration at the United States Patent and Trademark Office for “Tevogen Bio” (and design) and have pending trademark applications 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 preclinical 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 June 30, 2026 and 2025 was $5.8 million and $5.5 million, respectively. Our net loss for the six months ended June 30, 2026 and 2025 was $11.2 million and $15.9 million, respectively. Net loss for the three and six months ended June 30, 2026 was primarily attributable to non-cash, stock-based compensation expense, salaries and outside services. As of June 30, 2026, we had cash of $1.1 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 Chairperson 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 pursuant to our effective shelf registration statement on Form S-3 (File No. 333-288218) filed on June 20, 2025 with 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. 15 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 the 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. 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 the Pre-funded Warrants 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 Pre-funded 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 Pre-funded Warrants, on a cashless basis. The exercise price of each Pre-funded Warrant is $0.0001 per share, payable upon exercise. The closing of the PIPE occurred on May 15, 2026. Based on cash on hand as of June 30, 2026 of approximately $1.1 million, 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. Effective July 30, 2026, we changed our name from Tevogen Bio Holdings Inc. to Tevogen Inc. 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: ● acquisition of supplies and equipment and leasing lab spaces; ● expenses incurred to conduct the necessary preclinical studies required by the U.S. Food and Drug Administration to obtain the regulatory approval necessary to conduct TVGN 489 clinical trials; ● salaries, benefits, and other related costs for personnel engaged in research and development functions; ● costs of funding research performed by third parties, including pursuant to agreements with contract research organizations (“CROs”), and investigative site costs to conduct our preclinical studies and clinical trials; ● manufacturing costs, including expenses incurred under agreements with contract manufacturing organizations (“CMOs”), including manufacturing scale-up expenses, and the cost of acquiring and manufacturing preclinical study and clinical trial materials; ● costs of outside consultants, including their fees, stock-based compensation, and related travel expenses; ● costs of laboratory supplies and acquiring materials for preclinical studies and clinical trials; and ● facility-related expenses, which include direct depreciation costs of equipment and expenses for rent and maintenance of facilities and other operating costs. 16 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 preclinical 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: ● with respect to products other than TVGN 489, successfully completing preclinical studies; ● successfully initiating future clinical trials; ● successfully enrolling patients in and completing clinical trials; ● applying for and receiving marketing approvals from applicable regulatory authorities; ● obtaining and maintaining intellectual property protection and regulatory exclusivity for TVGN 489 and any other product candidates we are developing or may develop in the future and enforcing, defending, and protecting these rights; ● making arrangements with third-party manufacturers, or establishing adequate commercial manufacturing capabilities; ● establishing sales, marketing, and distribution capabilities and launching sales of our products, if and when approved, whether alone or in collaboration with others; ● market adoption of TVGN 489 and any other product candidates, if and when approved, by patients and the medical community; ● competing effectively with potential therapeutic alternatives in our target disease areas; and ● adequate reimbursement by private and public payors including health technology appraisal entities in non-U.S. countries. 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. 17 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.) 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 gain or 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. 18 Results of Operations Comparison of the three months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025: Three months ended June 30, 2026 2025 Operating expenses: Research and development $ 3,282,557 $ 2,699,991 General and administrative 2,379,819 2,744,545 Total operating expenses 5,662,376 5,444,536 Loss from operations (5,662,376 ) (5,444,536 ) Interest expense, net (98,387 ) (38,033 ) Change in fair value of warrants (1,177 ) (21,410 ) Net loss $ (5,761,940 ) $ (5,503,979 ) 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 June 30, 2026 and 2025: Three months ended June 30, 2026 2025 Personnel costs $ 619,677 $ 525,108 Stock-based compensation 2,136,272 1,720,666 Other clinical and preclinical development expenses 305,692 208,727 Facilities and other expenses 220,916 245,490 Total research and development expenses $ 3,282,557 $ 2,699,991 Research and development expenses for the three months ended June 30, 2026 were $3.3 million, compared to $2.7 million for the three months ended June 30, 2025. The increase was primarily attributable to an increase in non-cash stock-based compensation expense. General and Administrative Expenses The following table summarizes our general and administrative expenses for the three months ended June 30, 2026 and 2025: Three months ended June 30, 2026 2025 Personnel costs $ 482,063 $ 330,763 Stock-based compensation 1,152,352 1,518,667 Legal and professional fees 626,822 824,536 Facilities and other expenses 118,582 70,579 Total general and administrative expenses $ 2,379,819 $ 2,744,545 General and administrative expenses for the three months ended June 30, 2026 were $2.4 million compared to $2.7 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense, partially offset by higher personnel costs. 19 Interest Expense, Net We recognized $98,387 in interest expense for the three months ended June 30, 2026 compared to $38,033 for the three months ended June 30, 2025. The increase was attributable primarily to the outstanding balance on the Facility. Change in Fair Value of Warrants We recognized a loss on change in fair value of derivative warrant liabilities of $1,177 during the three months ended June 30, 2026 and a loss of $21,410 during the three months ended June 30, 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. Comparison of the six months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025: Six months ended June 30, 2026 2025 Operating expenses: Research and development $ 6,417,367 $ 5,895,059 General and administrative 4,645,929 9,905,824 Total operating expenses 11,063,296 15,800,883 Loss from operations (11,063,296 ) (15,800,883 ) Interest expense, net (169,553 ) (62,604 ) Change in fair value of warrants 24,654 (7,553 ) Net loss $ (11,208,195 ) $ (15,871,040 ) 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 six months ended June 30, 2026 and 2025: Six months ended June 30, 2026 2025 Personnel costs $ 1,286,077 $ 1,284,504 Stock-based compensation 4,021,590 3,547,013 Other clinical and preclinical development expenses 674,416 573,378 Facilities and other expenses 435,284 490,164 Total research and development expenses $ 6,417,367 $ 5,895,059 Research and development expenses for the six months ended June 30, 2026 were $6.4 million, compared to $5.9 million for the six months ended June 30, 2025. The increase was primarily attributable to higher non-cash stock-based compensation expense. General and Administrative Expenses The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025: Six months ended June 30, 2026 2025 Personnel costs $ 939,435 $ 891,675 Stock-based compensation 2,116,626 6,985,020 Legal and professional fees 1,370,241 1,851,787 Facilities and other expenses 219,627 177,342 Total general and administrative expenses $ 4,645,929 $ 9,905,824 General and administrative expenses for the six months ended June 30, 2026 were $4.6 million compared to $9.9 million for the six months ended June 30, 2025. The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense. 20 Interest Expense, Net We recognized $169,553 in interest expense for the six months ended June 30, 2026 compared to $62,604 for the six months ended June 30, 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 $24,654 during the six months ended June 30, 2026 and a loss of $7,553 during the six months ended June 30, 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 preclinical 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. Three months ended June 30, 2026 2025 Loss from operations $ (5,662,376 ) $ (5,444,536 ) Adjustment: Stock-based compensation 3,288,624 3,239,333 Adjusted loss from operations $ (2,373,752 ) $ (2,205,203 ) Six months ended June 30, 2026 2025 Loss from operations $ (11,063,296 ) $ (15,800,883 ) Adjustment: Stock-based compensation 6,138,216 10,532,034 Adjusted loss from operations $ (4,925,080 ) $ (5,268,849 ) Liquidity and Capital Resources Sources of Liquidity As of June 30, 2026 we had $1.1 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 June 30, 2026, we had drawn $6.4 million, with a remaining $11.0 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 June 2025, we received a capital contribution of $0.5 million from Dr. Ryan Saadi, our Chairperson and Chief Executive Officer. In addition, in May 2026, we raised gross proceeds of $3.0 million from the sale of pre-funded warrants to purchase shares of common stock, as described below. 21 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 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 August 10, 2026, we have sold an aggregate of approximately 319,000 shares of common stock under the Sales Agreement at a weighted average price per share of $19.96 on a post-Reverse Stock Split basis, resulting in gross proceeds of approximately $6.4 million. After deducting total expenses of approximately $176,000, including commission to the Agent of approximately $160,000, net proceeds to us were approximately $6.2 million. On May 11, 2026, we entered into the Securities Purchase Agreement with the Patel Family pursuant to which we sold the Patel Family the Pre-funded Warrants, which are exercisable for 375,000 shares of our common stock for an aggregate purchase price of approximately $3.0 million in the PIPE. Pursuant to the terms of the Securities Purchase Agreement, the Pre-funded 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 Pre-funded Warrants, on a cashless basis. The exercise price of each Pre-funded Warrant is $0.0001 per share, payable upon exercise. The closing of the PIPE occurred on May 15, 2026. Cash Flows The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025: Six months ended June 30, 2026 2025 Cash provided by (used in) Operating activities $ (5,739,172 ) $ (6,497,766 ) Investing activities - - Financing activities 6,268,955 5,900,000 Net change in cash $ 529,783 $ (597,766 ) Cash Flows from Operating Activities During the six months ended June 30, 2026, we used $5.7 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $11.2 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 six months ended June 30, 2025, we used $6.5 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $15.9 million offset by $9.3 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. 22 Cash Flows from Investing Activities During the six months ended June 30, 2026 and 2025, we did not have any cash flows from investing activities. Cash Flows from Financing Activities During the six months ended June 30, 2026, we received $6.3 million of net cash from financing activities attributable to $3.0 million in proceeds from pre-funded warrants, net of offering costs, $2.0 million in draws on the Loan Agreement and $1.3 million in proceeds pursuant to the Sales Agreement, net of offering costs. During the six months ended June 30, 2025, we received $5.9 million of net cash from financing activities attributable to $3.4 million in draws on the Loan Agreement, $2.0 million attributable to the KRHP grant, and $500,000 in capital contributions from Dr. Saadi. 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 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 Trailing VWAP as of the trading day prior to payment, subject to certain requirements related to resale registration. There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement. As of June 30, 2026, we had drawn $6.4 million with a remaining $11.0 million available for future draws. 23 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 preclinical 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 preclinical 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: ● the progress, costs, and results of our planned clinical trials of TVGN 489 and other planned and future clinical trials; ● the scope, progress, costs, and results of our preclinical testing and clinical trials of TVGN 489 for additional combinations, targets, and indications; ● the number of and development requirements for additional indications for TVGN 489 or for any other product candidates; ● our ability to scale up our manufacturing processes and capabilities to support clinical trials of TVGN 489 and other product candidates we are developing and may develop in the future; ● the costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates we are developing and may develop in the future; ● potential changes in the regulatory environment and enforcement rules; ● our ability to establish and maintain strategic collaboration, licensing, or other arrangements and the financial terms of such arrangements; ● the costs and timing of future commercialization activities, including product manufacturing, sales, marketing, and distribution, for TVGN 489 and other product candidates we are developing and may develop in the future for which we may receive marketing approval; ● our ability to obtain and maintain acceptance of any approved products by patients, the medical community, and third-party payors; ● the amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any other product candidates we are developing or develop in the future for which we receive marketing approval; ● potential changes in pharmaceutical pricing and reimbursement infrastructure; ● the availability of raw materials for use in production of our product candidates; and ● the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending any intellectual property-related claims. 24 As of June 30, 2026, we had cash of approximately $1.1 million. We believe that our cash balance, the $11.0 million available under the Loan Agreement, and the remaining commitment for a $7.0 million grant from KRHP 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 our contractual obligations, primarily consisting of operating lease commitments and debt obligations under notes payable and our Loan Agreement. As of June 30, 2026, our short-term cash requirements (due within the next 12 months) totaled approximately $2.1 million, consisting of: ● approximately $1.7 million related to notes payable, ● approximately $0.3 million of operating lease commitments, and ● approximately $0.1 million of interest due on draws under our Loan Agreement. Our long-term cash requirements (due beyond 12 months) totaled approximately $7.5 million, consisting of: ● approximately $6.4 million related to the Loan Agreement, and ● approximately $1.1 million of operating lease commitments. 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 preclinical 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. 25 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. 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.