Core Insights - Tevogen Bio Holdings Inc. has launched a new initiative called Tevogen Generics to address the increasing focus on pharmaceutical affordability in the U.S. [1] - The initiative aims to expedite domestic manufacturing of unbranded pharmaceuticals and active pharmaceutical ingredients (APIs) to enhance national self-reliance in vital treatments [2] - Tevogen Generics is the third strategic pillar of Tevogen Bio, alongside its existing operations in specialty immunotherapy and artificial intelligence [3][7] Company Leadership - Sadiq Khan, the Chief Commercial Officer, has been appointed as the Interim Head of Tevogen Generics, bringing extensive experience in global commercial operations [2] Strategic Objectives - The primary goal of Tevogen Generics is to make high-quality, essential medicines accessible to all, aligning with national interests in healthcare affordability [7]

Core Viewpoint - Tevogen Bio Holdings Inc. is launching Tevogen Generics to address the increasing national focus on pharmaceutical affordability, coinciding with recent tariff-related statements from President Donald Trump [1][2]. Group 1: Company Initiatives - Tevogen Generics is established as the third strategic pillar of Tevogen Bio Holdings Inc., alongside Tevogen Bio and Tevogen.AI [3][7]. - The initiative aims to expedite domestic manufacturing of unbranded pharmaceuticals and active pharmaceutical ingredients (APIs), enhancing national self-reliance in vital treatments [2]. Group 2: Leadership and Management - Sadiq Khan, the Chief Commercial Officer, has been appointed as the Interim Head of Tevogen Generics, bringing decades of experience in global commercial operations [2].

Core Insights - Tevogen Bio Holdings Inc. is focused on immunotherapy and artificial intelligence, with recent presentations highlighting their advancements in AI-driven technology for T cell therapies [1][3][4] Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company developing off-the-shelf, genetically unmodified precision T cell therapies aimed at treating infectious diseases and cancers [4] - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and multiple pending patents related to artificial intelligence [4] Recent Developments - Mittul Mehta, the Chief Information Officer, presented at the AI x Bio Philly event, showcasing Tevogen.AI's technology that accelerates the discovery and development of precision T cell therapies [1][3] - The proprietary technology utilizes computational modeling to predict T cell receptor engagement with immunologically active HLA+ peptide complexes [3] Industry Context - The AI x Bio Philly event gathered innovators, entrepreneurs, and investors to discuss the impact of AI on biotechnology, indicating a growing intersection between these fields [2]

Core Viewpoint - Tevogen Bio Holdings Inc. is advancing its efforts in immunotherapy and artificial intelligence, particularly through its proprietary AI-driven technology aimed at enhancing the development of precision T cell therapies [1][3]. Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company focused on developing off-the-shelf, genetically unmodified precision T cell therapies to address infectious diseases and cancers, targeting significant unmet needs in large patient populations [4]. - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and numerous pending patents related to artificial intelligence [4]. Recent Developments - Mittul Mehta, the Chief Information Officer, presented at the AI x Bio Philly event, showcasing Tevogen.AI's technology that utilizes computational modeling to predict T cell receptor engagement with immunologically active HLA+ peptide complexes [1][3]. - The AI x Bio Philly event, hosted by various organizations, gathered innovators and investors to discuss the impact of AI on biotechnology [2]. Leadership and Vision - Tevogen Bio is led by a team of experienced industry leaders and scientists, emphasizing the importance of accessible personalized therapeutics as the next frontier in medicine [5]. - The leadership believes that innovative business models are essential for sustaining medical innovation in the current healthcare landscape [5].

Core Insights - Tevogen Bio Holdings Inc. is focused on advancing patient-centric solutions through immunotherapy and artificial intelligence, with a commitment to developing off-the-shelf, genetically unmodified T cell therapeutics for infectious diseases and cancers [1] - The company emphasizes the significant insider ownership, with approximately 74% of outstanding shares held by executive officers and board members, indicating strong confidence in the company's mission and progress [2][3] Company Overview - Tevogen's clinical-stage immunotherapy, Tevogen Bio, aims to create innovative treatments for infectious diseases and cancers [1] - The artificial intelligence initiative, Tevogen.AI, is designed to enhance drug discovery, clinical trial efficiency, and patient access [1] Insider Ownership - Insiders have only sold shares to meet tax obligations related to restricted stock vesting, showcasing their commitment to the company [2] - The high level of insider ownership is noted as a unique advantage compared to other companies in the industry [2] Market Position - The company operates solely in the U.S. and is described as tariff-insensitive, which may provide a buffer against current market volatility [3]

Core Insights - Tevogen Bio Holdings Inc. is focused on advancing patient-centric solutions through immunotherapy and artificial intelligence, with a commitment to developing off-the-shelf, genetically unmodified T cell therapeutics for infectious diseases and cancers [1] - The company emphasizes the significant insider ownership, with approximately 74% of outstanding shares held by executive officers and board members, indicating strong confidence in the company's mission and progress [2][3] Company Overview - Tevogen's clinical-stage immunotherapy, Tevogen Bio, aims to create innovative treatments for infectious diseases and cancers [1] - The artificial intelligence initiative, Tevogen.AI, is designed to enhance drug discovery, clinical trial efficiency, and patient access [1] Insider Ownership - The high level of insider ownership (74%) is noted as a unique advantage compared to other companies in the industry, with insiders primarily selling shares only to meet tax obligations [2] - CEO Dr. Ryan Saadi highlighted the collective confidence of insiders in the company's progress and potential, especially in the context of current market volatility [3] Market Position - Tevogen operates solely in the U.S. and is described as being tariff-insensitive, which may provide a competitive edge in the current economic climate [3]

Financial Performance and Funding - The company has not generated revenue from product sales and has a history of significant losses[17] - The company is relying on an additional $8.0 million of grant funding that has not yet been received to meet liquidity needs[17] - The company anticipates substantial additional financing will be required to achieve its business objectives[17] - The company has a limited operating history with no products approved for commercial sale and has never generated revenue from product sales, resulting in significant losses[17] Product Development and Regulatory Challenges - The company is highly dependent on its first product candidate, TVGN 489, for the treatment of COVID-19 and Long COVID[13] - The FDA regulatory approval process for product candidates is lengthy and time-consuming, which may cause delays[17] - The FDA regulatory approval process for product candidates is lengthy and time-consuming, with potential delays and disruptions in development[17] - The company is developing additional product candidates through the use of its ExacTcell technology[13] - The company is subject to extensive ongoing regulatory requirements and may face challenges in establishing sales and marketing capabilities[20] Clinical Trials and Market Entry - The company has limited experience in designing and implementing preclinical and clinical trials, which are complex and expensive[17] - The company may encounter difficulties in enrolling patients for clinical trials, which could impact development timelines[17] - The company may encounter difficulties in enrolling patients for clinical trials, which could hinder development timelines[17] - The company may face challenges in establishing sales and marketing capabilities for its product candidates[17] Competition and Manufacturing Risks - The company may face substantial competition and will need to grow the size of its organization to meet market demands[20] - The manufacture of cell therapies involves numerous risks, and establishing manufacturing capabilities may not be successful[20] - The company may not obtain marketing approval for product candidates due to failures by third parties[20] Market and Operational Risks - The company is subject to various risks and uncertainties that may materially affect its business and financial condition[15] - The price of the company's common stock may fluctuate significantly, influenced by various market factors and operational challenges[20]

WARREN, N.J., March 26, 2025 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech company leveraging AI-driven immunotherapy drug discovery, is pleased to share that Founder and CEO, Ryan Saadi, MD, MPH, has been named to the 2025 Health Care Power List by NJBIZ. This recognition highlights Dr. Saadi’s leadership and commitment to advancing healthcare innovation and accessibility in New Jersey and beyond. This announcemen ...

Core Viewpoint - Tevogen Bio has filed a new patent for its T cell vaccine, which utilizes its proprietary Tevogen.AI-powered PredicTcell technology to stimulate a T cell response, targeting the entire viral genome to mitigate mutation risks [1][2][8] Group 1: Vaccine Development - The T cell vaccine aims to provide a broader immune response by targeting the entire viral genome, similar to the lead product candidate TVGN 489, thus reducing the risk of mutations evading immune detection [2][8] - The development of this vaccine will not affect the previously announced topline forecasts of $1 billion each for Tevogen Bio Oncology and Specialty Care [3] Group 2: Strategic Focus - The current focus of the T cell vaccine development is on national security and protecting the U.S. military against biological threats, with potential for broader applications in the future [4] - The company emphasizes the importance of public trust and transparency throughout the vaccine development process [4] Group 3: Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company that develops precision T cell therapies to address significant unmet needs in infectious diseases and cancers [5] - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and multiple pending patents [5][6]

WARREN, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- Mittul Mehta, Chief Information Officer & Head of Tevogen.AI at Tevogen Bio ("Tevogen Bio Holdings Inc." or "Company") (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech company, recently joined industry leaders at Proskauer's AI discussion panel, "Attuned AI: Shaping AI to Empower Your Industry," held on March 6, 2025, in New York City. Along with Mittul Mehta, the event featured Brooker Belcourt, General Manager of Finance from Perplexity, and ...