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Tevogen Values TVGN-489 at $9–$11 Billion rNPV, Its First Clinical Product From the Proprietary ExacTcell™ Allogeneic T Cell Platform
Globenewswire· 2025-09-08 13:27
Core Insights - Tevogen Bio Holdings Inc. estimates the risk-adjusted net present value (rNPV) of its product TVGN-489 to be between $9 billion and $11 billion, targeting treatment for SARS-CoV-2 and Long-COVID in high-risk patients [1][3] Clinical Trial Findings - In a Phase I proof-of-concept trial, two cancer patients received TVGN-489 and were able to proceed to stem cell transplants shortly after treatment, with no complications from COVID-19 observed [2] - High-risk ambulatory patients showed significant viral elimination, with ≥88% of patients achieving viral clearance by Day 4 and >99% by Day 14 [7] - No disease progression or recurrent COVID-19 cases were reported in the treatment arm during a six-month follow-up [7] Revenue Projections - Tevogen's cumulative revenue projections for TVGN-489 over five years indicate a strong market potential, with the rNPV reflecting only U.S. revenue potential and not the broader ExacTcell™ technology platform [3][4] Future Plans - The company plans to provide ongoing updates regarding the valuation of its internally developed assets, including product pipeline developments [4]
Tevogen Shares Valuation of Key Assets and Potential Forecast For Pipeline Product Focused on EBV Associated Leukemia and Lymphomas
Globenewswire· 2025-09-04 19:48
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]
Tevogen Underscores the Importance of Precision Immunotherapies, Including TVGN 489 for Vulnerable Individuals Infected with SARS-CoV-2
Globenewswire· 2025-09-03 20:15
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]
Tevogen Bio Highlights Proprietary Assets and Upcoming Valuation Disclosure
Globenewswire· 2025-08-27 19:20
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]
Tevogen Expresses Gratitude to Yale for Recognition of Dr. Ryan Saadi and Company’s Mission of Health Equity
Globenewswire· 2025-08-26 18:50
Core Insights - Tevogen Bio Holdings Inc. has been recognized by Yale University for its commitment to health equity and the leadership of its Founder and CEO, Dr. Ryan Saadi [2] - The company operates with a lean, capital-efficient business model, fully owning its core intellectual property to minimize costs and complexity in developing CD8+ T cell therapies [3] - Dr. Saadi emphasized that affordability and accessibility are foundational to Tevogen's operations, achieving significant milestones with lower capital expenditure compared to industry norms [4] Business Model and Strategy - Tevogen's business model is designed to withstand market pressures through a capital-efficient structure, focusing on off-the-shelf, genetically unmodified therapies [3] - The company has avoided the typical billion-dollar burn rate seen in the industry, maintaining a lean cash run rate while preserving equity [4] - Tevogen aims to deliver innovative therapies that not only improve patient outcomes but also achieve commercial success at a lower cost [4] Recognition and Impact - The recognition from Yale highlights the impact of Tevogen's mission on making healthcare more affordable and accessible [2] - Dr. Saadi's vision is acknowledged as a significant contribution to the healthcare landscape, reinforcing the company's commitment to health equity [2][4]
Tevogen Sees Continued Growth in Institutional Ownership in Q2 2025; 72% of Holders Increased or Maintained Positions
Globenewswire· 2025-08-25 19:10
Core Viewpoint - Tevogen Bio Holdings Inc. has reported a significant increase in institutional ownership of its common stock, indicating growing confidence from long-term investors in the company's scientific and operational progress [2][3]. Institutional Ownership Update - As of June 30, 2025, institutional ownership of Tevogen common stock rose by 24% compared to March 31, 2025, following a 60% increase in the first quarter [2]. - The number of institutional holders increased from 51 to 55, with 72% of these holders either increasing or maintaining their positions [2]. Key Contributors - Major contributors to the second quarter growth in institutional ownership were Morgan Stanley and BlackRock, which collectively increased their holdings by 80% [2]. Management Commentary - The Head of Investor Relations at Tevogen stated that the increase in institutional ownership is a positive sign, reflecting the company's scientific advancements and operational milestones, such as positive clinical data and progress towards internal GMP cell manufacturing capabilities [3].
Tevogen Recognized in BINJE's BEST Health Care 2025 for Advancing Health Equity and Sustainable Biopharma
GlobeNewswire News Room· 2025-08-22 19:25
Core Insights - Tevogen Bio Holdings Inc. has been recognized in BINJE's BEST Health Care 2025 for its commitment to health equity and innovation in sustainable biopharma [1][2] - The company's focus is on developing affordable and safe T cell therapies for acute viral infections and cancers, utilizing its proprietary ExacTcell™ platform [2] Company Overview - Tevogen Bio is dedicated to advancing health equity by ensuring access to life-saving medications through a sustainable biopharma model [2] - The company operates a lean, capital-efficient structure that avoids licensing overhead by fully owning its core intellectual property [2] - Tevogen's CD8+ T cell therapies are designed to reduce manufacturing complexity and costs, aligning with U.S. healthcare priorities [2] Technological Advancements - The launch of Tevogen.AI aims to accelerate therapeutic discovery and development through advanced algorithms and partnerships with Microsoft and Databricks [2] Recognition and Community - Tevogen expresses gratitude to BINJE and congratulates other honorees in the health care sector for their achievements [3]
Tevogen Recognized in BINJE’s BEST Health Care 2025 for Advancing Health Equity and Sustainable Biopharma
Globenewswire· 2025-08-22 19:25
Core Insights - Tevogen Bio Holdings Inc. has been recognized in BINJE's BEST Health Care 2025 for its commitment to health equity and innovation in sustainable biopharma [1][2] - The company's focus is on developing affordable T cell therapies for acute viral infections and cancers, utilizing its proprietary ExacTcell™ platform [2] Company Overview - Tevogen Bio is dedicated to advancing health equity by ensuring access to life-saving medications through a sustainable biopharma model [2] - The company operates a lean, capital-efficient structure that avoids licensing overhead by fully owning its core intellectual property [2] - Tevogen's CD8+ T cell therapies are designed to reduce manufacturing complexity and costs, aligning with U.S. healthcare priorities [2] Technological Advancements - The launch of Tevogen.AI aims to accelerate therapeutic discovery and development through advanced algorithms and partnerships with Microsoft and Databricks [2] Recognition and Community - Tevogen expresses gratitude to BINJE and congratulates other honorees in the health care sector for their achievements [3]
REPEAT -- Tevogen Bio Enters Into Agreement for Up to $50 Million in Financing to Advance R&D and Clinical Development Efforts
Globenewswire· 2025-08-19 19:40
Core Viewpoint - Tevogen Bio Holdings Inc. has secured a financing agreement of up to $50 million, which includes a $36 million line of credit and a potential $14 million private placement, following the elimination of $94.9 million in liabilities, aimed at supporting its R&D efforts and expanding its intellectual property portfolio [1][2][3]. Financing Details - The financing structure consists of a $36 million line of credit, allowing access to $1 million per month at an interest rate of the lower of the daily SOFR plus 2.0% or 7.0%, with a maturity of four years after each draw [3]. - The $14 million private placement can be executed at the counterparty's option once the share price reaches $10, priced at a 30% discount to that price [4]. Business Model and R&D Focus - Tevogen's innovative business model is designed to enhance research and development, particularly for its initial product, TVGN 489, derived from the ExacTcell™ technology platform [2]. - The company currently holds three granted US patents and has nine pending US patent applications, along with twelve ex-US patent applications, indicating a strong intellectual property position [2][6]. Leadership and Vision - Tevogen is led by a team of experienced industry leaders and scientists, emphasizing the importance of accessible personalized therapeutics as the next frontier in medicine [7]. - The company aims to provide affordable and accessible personalized T cell therapies to address significant unmet needs in large patient populations [5][6].
Tevogen Delivers Stronger Second Quarter and First Half 2025 Financial Results with Reduced Expenses and Growth Momentum
Globenewswire· 2025-08-19 16:10
Core Viewpoint - Tevogen Bio Holdings Inc. reported improved operational efficiency and reduced losses in its financial results for Q2 2025, indicating a positive trajectory towards anticipated revenue by the end of 2026 [1][2][3]. Financial Performance - For the three months ended June 30, 2025, the loss from operations was $5.4 million, a decrease from $8.6 million in the same period of 2024 [2][7]. - The net loss for the quarter was $5.5 million, compared to $9.7 million in Q2 2024, reflecting a significant improvement in financial performance [2][7]. Operational Strategy - The company is focused on maximizing capital efficiency and has access to sufficient financing to support its growth plans [3][7]. - Tevogen is in the process of establishing its own GMP manufacturing facility, which is a strategic move to enhance production control and accelerate product development timelines [4][7]. Market Position and Future Outlook - Tevogen acknowledges the limited growth in the market but emphasizes that it is building infrastructure, advancing AI, and strengthening internal capabilities [3][7]. - The company is exploring options to address its current limited tradable float to better meet investor demand [3][7].