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 Insights - Tevogen Bio has appointed David E. Banko as Global Head of Government Affairs and Patient Access, bringing over 30 years of experience in market access and health policy [1][2][3] - Mr. Banko will focus on advancing patient access to Tevogen's therapies, engaging with payers, and ensuring Health Technology Assessment readiness, which are critical for the company's commercialization strategies [2][4] - Tevogen Bio is a clinical-stage specialty immunotherapy company developing precision T cell therapies for infectious diseases and cancers, with a strong emphasis on patient accessibility and innovative business models [5][6][7] Company Strategy - The appointment of Mr. Banko is seen as a significant step towards commercialization readiness, emphasizing the need for defined value propositions for various stakeholders in the healthcare ecosystem [4] - Tevogen Bio aims to secure appropriate coding, coverage, and reimbursement for its therapies at launch, which is essential for market access [2][4] - The company has reported positive safety data from its proof-of-concept clinical trials and holds key intellectual property assets, including three granted patents and several pending patents related to artificial intelligence [6] Leadership and Expertise - Mr. Banko's previous roles include positions at Cordis Corp and B. Braun Medical Inc., where he successfully enhanced market access for innovative technologies [3] - Tevogen Bio's leadership team consists of experienced industry leaders and scientists focused on drug development and global product launch [7] - The company believes that accessible personalized therapeutics represent the next frontier of medicine, necessitating disruptive business models to sustain innovation [7]

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 ...

Group 1 - Tevogen Bio, a clinical-stage specialty immunotherapy biotech company, is leveraging AI to enhance precision medicine and operational efficiencies [2][3][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 related to AI [5][6] - Tevogen Bio aims to make advanced therapies more accessible and affordable by combining proprietary datasets with generative AI models [3][5] Group 2 - The recent AI discussion panel featured industry leaders discussing the transformative impact of AI across finance, biotech, and legal sectors [2][4] - The event highlighted the importance of tailoring AI applications to address unique challenges within each industry [3][4] - Tevogen Bio's leadership emphasizes the need for disruptive business models to sustain medical innovation and ensure patient accessibility [5][6]

On Tuesday, D Boral Capital initiated coverage on Tevogen Bio Holdings Inc. TVGN, a clinical-stage immunotherapy company.The company’s lead pipeline product, TVGN-489, is a SARS-CoV-2-specific therapy.Tevogen’s pipeline includes preclinical programs targeting Epstein-Barr virus-associated lymphomas (TVGN -930), human papillomavirus-related cervical cancer (TVGN -920), multiple sclerosis (TVGN -601), and HPV-related mouth and throat cancer (TVGN-960).Also Read: Amazon To Launch AI Reasoning Model In June, Re ...

Core Insights - Tevogen Bio has secured a total of $10 million in non-dilutive grant funding from KRHP LLC, with $2 million already received and an additional $8 million contingent on the Grantor's review of the Company's progress, particularly in its artificial intelligence initiative, Tevogen.AI [1][8] Funding and Financials - The $8 million grant is non-dilutive, meaning it will not affect existing shareholders [1][4] - Tevogen Bio reported operating expenses of $9.7 million for the first three fiscal quarters of 2024, indicating efficient operations [3][8] Technological Advancements - Tevogen.AI has improved the PredicTcell platform by utilizing an expanded dataset of viruses and diseases, supported by wet lab science, to enhance predictive modeling capabilities [2][8] - The Company is expanding its team to further develop predictive models [2] Business Model and Strategy - Tevogen Bio's business model emphasizes long-term success without excessive capital raises or shareholder dilution, aiming for sustainability in the biotech sector [4][5] - The leadership believes that accessible personalized therapeutics represent the next frontier of medicine, necessitating innovative business models to sustain medical innovation [6][5]

Core Insights - Tevogen Bio's Founder and CEO, Ryan Saadi, has been recognized in the 2025 NJBIZ Power 100 for his influence in New Jersey's business landscape [1] - The company focuses on developing affordable and accessible T cell therapies for viral infections and cancers using its proprietary ExacTcell technology [2][7] - Tevogen Bio aims to challenge high drug development costs with an efficient business model, emphasizing sustainability and patient accessibility [3][4] Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company utilizing CD8+ cytotoxic T lymphocytes to create precision T cell therapies for infectious diseases and cancers [4] - The company has reported positive safety data from its proof-of-concept clinical trial, with key intellectual property assets wholly owned and not subject to third-party licensing [4] - Tevogen Bio's leadership believes that personalized therapeutics and innovative business models are essential for sustaining medical innovation [5] Recent Developments - A proof-of-concept trial utilizing ExacTcell technology yielded highly positive results, which have been published in Blood Advances [2][7] - The launch of Tevogen.AI and a partnership with Microsoft are significant steps towards making therapies more accessible [2][7]

Core Viewpoint - Tevogen Bio aims to set new efficiency standards in the biotech industry, demonstrating that innovation and cost-effectiveness can coexist while addressing rising drug development costs and aligning with drug price reform efforts [1][2]. Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company focused on developing off-the-shelf, genetically unmodified precision T cell therapies using CD8+ cytotoxic T lymphocytes to treat infectious diseases and cancers, targeting significant unmet needs in large patient populations [3]. - 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, with some related to artificial intelligence [3]. - Tevogen Bio's leadership emphasizes the importance of sustainability and commercial success through patient accessibility and innovative business models [3][4]. Leadership and Team - The company is led by a team of experienced industry leaders and distinguished scientists with expertise in drug development and global product launches [4]. - Tevogen Bio's leadership believes that accessible personalized therapeutics represent the next frontier of medicine, necessitating disruptive business models to sustain medical innovation [4]. Market Position - Tevogen Bio has a market capitalization per team member that is 600% higher than the industry average, indicating a strong market position [7]. - The current ownership breakdown includes 79% insiders, 1% independent board members, 7% lead investors, 6% SPAC sponsors, and 8% others [7]. - The company's assets are believed to be valued in the billions, although these are not reflected on the balance sheet due to US GAAP restrictions on capitalizing internally developed intangible assets [7].