Financial Performance - For the three months ended September 30, 2025, the net loss was $5.7 million, compared to a net loss of $5.9 million for the same period in 2024[142]. - The net loss for the nine months ended September 30, 2025, was $21.6 million, significantly higher than the $4.3 million net loss for the same period in 2024[142]. - As of September 30, 2025, the accumulated deficit stood at $135.0 million, with cash reserves of $1.0 million[142]. - The company has not generated any revenue since its inception in June 2020[142]. - The net loss for the nine months ended September 30, 2025, was $21.6 million, compared to a net loss of $4.3 million for the same period in 2024[167]. - For the nine months ended September 30, 2025, total operating expenses were $21.5 million, significantly lower than $44.2 million for the same period in 2024[167]. - The adjusted loss from operations for the nine months ended September 30, 2025, was $7.8 million, compared to $10.4 million for the same period in 2024[178]. - The company reported cash used in operating activities of $10.1 million for the nine months ended September 30, 2025, compared to $9.0 million for the same period in 2024[182]. Research and Development - The first clinical product, TVGN 489, has completed a Phase 1 trial with no dose-limiting toxicities and met secondary endpoints, including a rapid reduction of viral load[132]. - Tevogen.AI is focused on using artificial intelligence to expedite drug development and improve patient outcomes[133]. - The company aims to mainstream cell therapy through its ExacTcell technology, targeting infectious diseases and cancers[130]. - Research and development expenses for the three months ended September 30, 2025, were $3.1 million, a decrease from $3.3 million in the same period of 2024, primarily due to lower stock-based compensation[162]. - Research and development expenses for the nine months ended September 30, 2025, were $9.0 million, a substantial decrease from $28.2 million in 2024, largely due to lower stock-based compensation[168]. - The company expects to incur increased expenses related to ongoing clinical trials and commercialization efforts for product candidates, particularly TVGN 489[195]. Funding and Financial Strategy - Tevogen has received a total of $3.0 million in grants from KRHP LLC to support the development of precision T cell therapeutics and Tevogen.AI[145]. - A Loan Agreement with the Patel Family provides for an unsecured line of credit of up to $36.0 million, with terms allowing for monthly draws[144]. - The company raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes since January 2021[179]. - Between July 3, 2025, and September 30, 2025, the company sold approximately 2.9 million shares of common stock at a weighted average price of $1.10, resulting in gross proceeds of approximately $3.2 million[181]. - The company plans to utilize the remaining $7.0 million grant commitment from KRHP for ongoing operational expenses[190]. - The company anticipates needing additional funding to fully implement its business, operating, and development plans[195]. - The company is exploring various funding strategies, including private placements and partnerships, but may face challenges in obtaining favorable terms[198]. Expenses and Obligations - General and administrative expenses for the three months ended September 30, 2025, were $2.6 million, down from $2.8 million in 2024, mainly due to reduced legal and professional fees[163]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $12.5 million, down from $16.0 million in 2024, attributed to lower legal fees and personnel costs[169]. - Interest expense for the three months ended September 30, 2025, was $0.1 million, compared to $0.0 million in 2024, primarily related to the outstanding balance on the Facility[164]. - The total contractual obligations as of September 30, 2025, amount to $8,570,291, with $2,067,295 due within one year[199]. - Operating lease commitments are $2,430,736, with $327,740 due within one year[199]. - Notes payable obligations total $1,651,000, all due within one year[200]. - The loan agreement repayment is $4,488,555, with $88,555 due within one year and $4,400,000 due in more than three years[199]. Operational Developments - As of the report date, the company has approximately $1.0 million in cash on hand, with additional funding sources ensuring operations for at least the next 12 months[147]. - As of September 30, 2025, the company had cash of approximately $1.0 million, down from $1.3 million as of December 31, 2024[179]. - Tevogen Bio has doubled its leased space and extended the lease term until February 2033, consolidating operations in Warren, New Jersey[202]. - The company is focused on scaling up manufacturing processes to support clinical trials for TVGN 489 and other product candidates[197]. - The company is assessing the costs and timing of future commercialization activities for TVGN 489 and other candidates[197]. - The company is evaluating the potential impact of changes in pharmaceutical pricing and reimbursement infrastructure[197]. Accounting and Compliance - The company has not identified any material changes in critical accounting policies from the previous annual report[204].

Core Insights - Tevogen Bio Holdings Inc. has achieved a clinical milestone by completing T cell target identification for five additional human leukocyte antigen (HLA) restrictions, expanding the accessibility of its ExacTcell™ platform [1][4] - The identification of these additional HLA targets allows for the treatment of approximately 65% of the U.S. population, significantly increasing coverage for minority populations [2][3] - The investigational T cell therapy, TVGN 489, has demonstrated 100% viral clearance in high-risk patients with COVID-19, with no reinfections or cases of Long COVID reported [7] Company Developments - The ExacTcell™ platform employs advanced immunological screening to identify immune system targets across various HLA types, aiming to provide treatments for a broader range of infectious diseases and cancers [4] - The selection of additional HLA targets is aimed at ensuring equitable access to treatments for patients of diverse racial and ethnic backgrounds [3] Market Context - Long COVID has affected approximately 35 million U.S. adults, leading to an estimated economic burden of $2.6 trillion to $3.7 trillion, highlighting the urgent need for effective treatments like Tevogen's T cell therapies [3] - The expansion of patient eligibility through multi-HLA targeting is a significant step towards universal T cell therapeutics, enhancing the potential market for Tevogen's products [7]

Core Viewpoint - Tevogen Bio Holdings Inc. aims to clarify its financial position by addressing the accumulated deficit reported under U.S. GAAP, emphasizing the need for a more comprehensive understanding of its financial metrics through non-GAAP measures [1][2][3]. Financial Position - The company has raised a total of under $42 million since its inception up to June 30, 2025 [3]. - As of June 30, 2025, the GAAP financial statements show an accumulated deficit of $129 million, which includes non-cash expenses of approximately $88 million [3]. - After accounting for a cash balance and additional capital raised of over $8.8 million, the total stockholders' deficit is reported to be under $9.5 million [3]. Non-GAAP Metrics - Tevogen plans to provide a fully reconciled set of non-GAAP metrics following the filing of its Form 10-Q for Q3 2025 to give investors a clearer picture of its financial health [2]. - The company emphasizes the distinction between cash and non-cash components in its financial results to enhance investor understanding [3]. Capital Efficiency - The commentary from the CFO highlights the company's strong capital efficiency and low cash burn rate, which is crucial for its ongoing operations and future growth [3].

Core Insights - Tevogen Bio Holdings Inc. emphasizes its biopharma model focused on sustainability and patient affordability, aiming to make precision medicine accessible to all [1] - The company is developing T cell therapies that are off-the-shelf, well-tolerated, and affordable, with a focus on cancers, neurologic diseases, and viral infections, particularly targeting Long COVID [2][2] - Tevogen values its first clinical product, TVGN 489, at $9–$11 billion rNPV, with projected 5-year top-line revenue of approximately $6.5 billion for liver cancer prevention related to chronic Hepatitis B [7] Recent Financial Announcements - Tevogen's financial outlook includes significant revenue projections from its product pipeline, particularly in the context of addressing high-risk chronic Hepatitis B infections [7] Recent Artificial Intelligence Announcements - Tevogen.AI has completed the alpha phase and begun beta build of its proprietary PredicTcell™ model in collaboration with Microsoft and Databricks, which is expected to drastically reduce target analysis time and save billions in drug development costs [7] - The company has received an international patent publication for its AI technology that predicts immunologically active peptides [7] Recent Corporate Announcements - Tevogen has received multiple patents related to Covid-19 and viral infections, enhancing its intellectual property portfolio [5][6] - A dedicated contact channel for Long COVID inquiries has been established, reflecting the global demand for effective solutions [7]

Core Insights - Tevogen Bio is experiencing significant public interest in its investigational precision T cell therapy, TVGN 489, which is being developed for COVID-19 and Long COVID [1][2] - The CEO of Tevogen Bio highlighted the urgent need for effective solutions for Long COVID patients, emphasizing the company's commitment to advancing its research [2] - The clinical trial for TVGN 489 has shown a favorable safety profile and has provided insights for further development, with results published in a peer-reviewed journal [2] Development Plans - Tevogen is preparing for the next stage of development for TVGN 489 and plans to collaborate with government initiatives, Long COVID patient organizations, and major healthcare providers to expedite the process [3][7] - The company has established a dedicated communication channel for Long COVID updates to manage the high volume of patient inquiries [4][7] Financial Strategy - Tevogen is focused on maximizing capital efficiency and maintaining access to financing to support its growth and commercialization efforts [4]

Core Insights - Tevogen Bio Holdings Inc. has made significant advancements in its PredicTcell™ platform, which aims to enhance precision immunotherapy through advanced machine learning and transformer-based models, supported by Microsoft and Databricks [1][3] Development Progress - The alpha version of PredicTcell was trained on over 124,000 records with transformer-based architecture and 91,000 records using traditional machine learning, achieving recall levels of approximately 92–97% and precision between 38–43% [2] - The beta version has expanded its training dataset to around 1.4 million records, with a total dataset exceeding 6.7 billion records, significantly increasing the number of features for training from 22 to 27 [5][6] Clinical Implications - The advancements in the PredicTcell platform could lead to T-cell therapies that reliably bind to their target, potentially transforming clinical success rates and reducing drug development costs [3][6] - Insights from Tevogen's ExacTcell™ platform and positive Phase 1 trial results inform the beta version's focus on higher precision in identifying virology targets [3] Market Potential - The company aims to raise efficacy standards in T-cell therapies, unlock new markets in immunotherapy, and improve patient access to life-saving therapies across various diseases, including infectious diseases and oncology [3][6]

Core Insights - Tevogen Bio Holdings Inc. emphasizes the potential of its investigational precision T cell therapy, TVGN 489, for treating Long COVID, which affects an estimated 20 million Americans [2][5] - Recent peer-reviewed studies indicate the presence of residual SARS-CoV-2 proteins and RNA long after acute infection, suggesting a viral reservoir that contributes to Long COVID symptoms [3] - TVGN 489 is designed to target multiple SARS-CoV-2 proteins across the entire viral genome, showing efficacy in reducing viral load and persisting in patients for at least 6 months without interfering with their immune responses [4] Scientific Evidence - Peer-reviewed studies published in notable journals report the detection of residual SARS-CoV-2 proteins and RNA for months to years post-infection, indicating chronic immune inflammation linked to Long COVID [3] - These findings support the development of therapeutic approaches aimed at eliminating residual virus and restoring immune homeostasis [3] Product Development - TVGN 489, derived from Tevogen's ExacTcell™ platform, is an off-the-shelf cytotoxic CD8+ T lymphocyte therapy targeting multiple viral proteins, not limited to the Spike protein [4] - In proof-of-concept trials, TVGN 489 demonstrated efficacy in reducing viral load across all patients, with CTLs persisting for at least 6 months [4] Company Outlook - The CEO of Tevogen expresses optimism regarding TVGN 489's potential to restore homeostasis in Long COVID patients, highlighting the company's preparations for clinical manufacturing [5]

Core Insights - Tevogen Bio Holdings Inc. expresses gratitude to the U.S. Department of Health and Human Services for addressing Long COVID through roundtables focused on patient experiences and research [1] - Approximately 20 million adults in the U.S. are affected by Long COVID, leading to significant economic consequences due to workforce absenteeism and productivity losses [2] - Tevogen's investigational drug, TVGN 489, shows promising results in clinical trials and may play a crucial role in addressing the Long COVID public health crisis [3] Company Developments - The CEO of Tevogen emphasizes the importance of addressing the lasting consequences of SARS-CoV-2, highlighting the potential of TVGN 489 to restore health for those affected by Long COVID [4] - Tevogen is committed to developing accessible and affordable personalized therapeutics through its ExacTcell™ platform, which focuses on precision T cell therapies [4]

Core Insights - Tevogen Bio Holdings Inc. will have its Chief Information Officer, Mittul Mehta, participate in the Startup Forum at the Databricks DATA + AI World Tour on October 8, 2025 [2][3] - The Startup Forum will focus on insights from venture capital leaders and early-stage innovators regarding scaling companies with Databricks [3] Company Participation - Mittul Mehta will join industry peers such as Chris Gervais, CTO of Codametrix, and Stavros Papadopoulos, CEO of TileDB, in a discussion moderated by Tony Pezzullo, Principal at SignalFire [3] - Mehta will discuss Tevogen.AI's use of advanced data and AI technologies, particularly the PredicTcell™ platform, which was developed in collaboration with Microsoft and Databricks to enhance precision immunotherapy development [3] Event Details - The Databricks DATA + AI World Tour will be held at the Sheraton Boston Hotel [4]

Core Insights - Tevogen Bio Holdings Inc. estimates the risk-adjusted Net Present Value (rNPV) for its product TVGN 116, aimed at liver cancer prevention in high-risk chronic Hepatitis B patients, to exceed approximately $325 million in the US alone [1][3] - The cumulative 5-year top-line revenue forecast for TVGN 116 is projected to be around $6.5 billion, reflecting the company's innovative and efficient drug development model [2] Financial Projections - The current rNPV for TVGN 116 is based on the understanding of unmet medical needs and the competitive landscape, with adjustments made at each milestone in the product development lifecycle [3] - Tevogen's progress with its first clinical-stage product, TVGN 489, demonstrates the rapid achievement of development milestones [3] Strategic Outlook - The company’s drug development model is positioned as a potential blueprint for sustainable medical innovation in the future [2]