Core Insights - Tevogen Bio Holdings Inc. recognizes Dr. Curtis Patton for his significant contributions to the field of medicine and the company, particularly in advancing its ExacTcell™ precision T cell platform and achieving revenue forecasts exceeding $1 billion [3][4]. Company Overview - Tevogen is a next-generation healthcare enterprise focused on affordability, efficiency, and scientific rigor, leveraging AI and precision T cell therapy platforms to develop life-saving therapies [6]. - The company has completed a proof-of-concept clinical trial for its allogeneic T cells, with a pipeline that includes programs in virology, oncology, and neurology [7]. Technological Advancements - Tevogen.AI aims to transform drug development by enhancing target detection and optimizing clinical trial design through proprietary predictive technologies, utilizing cloud services from major tech providers [8]. Strategic Initiatives - The company is exploring future initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions, reflecting its mission to advance sustainable innovation and broaden patient access [9].

Core Insights - Tevogen Bio Holdings Inc. has been recognized in the 2025 New Jersey Power List by NJBIZ for its influence on the state's economic and innovation landscape [1][2] Company Overview - Tevogen is a next-generation healthcare enterprise focused on affordability, efficiency, and scientific rigor, utilizing AI and precision T cell therapy platforms [4] - The company is committed to advancing life-saving therapies across various therapeutic areas and aims to broaden patient access through innovative healthcare solutions [7] Technological Advancements - The ExacTcell™ platform is a key innovation, with a pipeline addressing infectious diseases, oncology, and neurology [2][5] - Tevogen.AI technology is designed to enhance drug development by improving target detection and clinical trial design, leveraging cloud services from major tech providers [6] Financial Projections - Tevogen anticipates approximately $1 billion in first-year specialty-care revenue and a cumulative five-year revenue forecast of $18–22 billion [2] Expansion and Commitment - The company is expanding its operations with a new 17,428-square-foot manufacturing facility and headquarters, which will centralize R&D and regulatory functions [3]

Core Insights - Heartbeam Inc's shares increased significantly by 43.3% to $0.86 in pre-market trading following the announcement of its regulatory strategy after the FDA's Not Substantially Equivalent decision on its Electrocardiogram Synthesis Software [1][2] Company Developments - Heartbeam is exploring multiple regulatory options, including an appeal process or a 510(k) resubmission to demonstrate that its device is equivalent to legally marketed products [1] Market Movements - Other notable pre-market stock movements include: - SMX PLC surged 73.1% to $30.12 after a previous jump of 194% [6] - Zenta Group Co Ltd gained 26.7% to $3.18 [6] - Waton Financial Ltd rose 21.1% to $3.74 [6] - Verrica Pharmaceuticals Inc increased by 9.7% to $7.36 after announcing a $50 million private placement [6] - Conversely, several companies experienced declines, such as: - FBS Global Ltd fell 24.3% to $0.51 [6] - Tilray Brands Inc declined 15% to $0.88 following a reverse stock split announcement [6] - Solo Brands Inc dipped 14.4% to $7.19 after reporting disappointing third-quarter results [6]

Core Viewpoint - Tevogen Bio Holdings Inc. emphasizes its commitment to capital-efficient operations and sustainable practices in the biotechnology industry, as highlighted in its quarterly report for Q3 2025 [1][8]. Financial Performance - The company reported a loss from operations of $5.7 million for Q3 2025, a 6% decrease compared to Q3 2024 [2][3]. - For the nine months ended September 30, 2025, the operating loss was $21.5 million, reflecting a 51% reduction compared to the same period in 2024 [2][3]. - Total operating expenses for Q3 2025 were $5.7 million, down from $6.1 million in Q3 2024 [3]. - Research and development expenses for Q3 2025 were $3.1 million, compared to $3.3 million in Q3 2024 [3]. - General and administrative expenses decreased to $2.6 million in Q3 2025 from $2.8 million in Q3 2024 [3]. Non-GAAP Financial Metrics - On a non-GAAP basis, the adjusted loss from operations was $2.5 million for Q3 2025, a 10% reduction from $2.8 million in Q3 2024 [5][6]. - For the nine months ended September 30, 2025, the adjusted loss from operations was $7.8 million, a 25% decrease from $10.4 million in the same period of 2024 [5][7]. Strategic Focus - The company aims to transition from traditional high-cost drug development to a more efficient model that emphasizes patient affordability while maintaining profitability [8]. - Tevogen is committed to scalable science and responsible execution, focusing on broad patient access in its pipeline for infectious diseases and oncology [8].

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]