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]

WARREN, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today shared the risk-adjusted net present value (rNPV) estimate of $9 billion to $11 billion for TVGN-489, an allogeneic precision T cell therapy and the first clinical-stage product from its proprietary ExacTcell™ platform. TVGN-489 is being developed for the treatment of SARS-CoV-2 infection in high-risk vulnerable patients and for Long-COVID in patients with evidence of a persistent viral ...

Core Insights - Tevogen Bio Holdings Inc. has announced the potential value and forecast for its pipeline product, TVGN 930, aimed at treating non-solid tumor malignancies associated with Epstein-Barr Virus (EBV) [1][2] Financial Projections - The cumulative 5-year top-line revenue forecast for TVGN 930 is approximately $3.5 billion, reflecting the company's innovative drug development model [2] - The risk-adjusted Net Present Value (rNPV) for TVGN 930 is projected to exceed $250 million in the US alone [7] Market Opportunity - There are currently no approved vaccines for EBV, creating a significant therapeutic gap that TVGN 930 aims to fill [4] - The accessible market in the US for TVGN 930 could potentially cover up to 40,000 patients across five rare disease indications [7] Additional Applications - The treatment of multiple sclerosis through tighter EBV control presents an additional opportunity for the product [3]

Core Viewpoint - Tevogen Bio Holdings Inc. emphasizes the ongoing need for effective SARS-CoV-2 treatments, particularly for individuals with weakened immune systems, highlighting the potential of its investigational therapy TVGN 489 to enhance immunity and eliminate the virus [1][3] Group 1: Product Development and Clinical Trials - TVGN 489 is an allogeneic SARS-CoV-2-specific Cytotoxic CD8+ T lymphocyte immunotherapy developed using the ExacTcell platform, targeting the entire viral genome rather than just a single protein [1] - Positive clinical trial data indicates that in the treatment arm, viral elimination reached over 99% in all patients by day 14, with no disease progression or Long COVID observed [6] - The treatment was well-tolerated across all dose levels, and CTLs persisted in treated patients for up to six months, suggesting a durable immune response [6] Group 2: Market Context and Challenges - The emergence of the XFG variant of SARS-CoV-2 underscores the ongoing threat of COVID-19, particularly for vulnerable populations, necessitating continuous surveillance and treatment efforts [3] - The company acknowledges the challenges posed by mutation-prone viruses, indicating that targeting only the spike protein is insufficient for effective treatment [3] Group 3: Future Outlook - Tevogen's leadership expresses confidence in the potential of TVGN 489 to provide necessary immune support for high-risk patients, emphasizing the importance of innovative therapies in the face of evolving viral threats [3]

Core Insights - Tevogen Bio Holdings Inc. has significant internally developed assets that are not reflected on its balance sheet but represent substantial long-term value [1][3] - The company plans to provide detailed information and valuation of these assets in the near future [1] Asset Overview - Key assets include PredicTcell™, which utilizes AI algorithms to predict peptide–T cell receptor interactions, thereby accelerating development and expanding the pipeline [1] - AdapTcell™ employs AI models to decode HLA–T cell interactions, enhancing immune system insights and revealing new therapeutic paths [2] Intellectual Property and Technology - Tevogen holds three granted U.S. patents and has twelve pending U.S. patents, including two related to artificial intelligence [6] - The company has strategic collaborations with Microsoft and Databricks to support its AI technology [6] Drug Development and Clinical Pipeline - The ExacTcell™ platform focuses on highly purified, target-specific CD8+ cytotoxic T lymphocytes (CTL) [6] - The clinical pipeline includes therapeutics designed to treat cancers while allowing patients to continue oncology care, with potential expansion into non-oncology indications [6] Financial Position - Tevogen has access to a line of credit and is well-capitalized for current operations [6] - The company is establishing internal GMP manufacturing capabilities [6] Facilities - Tevogen operates a drug discovery lab in Philadelphia and has its headquarters in New Jersey [6]