Company Overview: Tevogen Bio Holdings Inc.

Business Focus and Technology

• Type: Clinical-stage biotechnology and immunotherapy company.
• Core Technology: ExacTcell™ — an allogeneic, precision T cell (CTL) therapy platform using naturally occurring, genetically unmodified CD8+ cytotoxic T lymphocytes.
• Approach: Development of off-the-shelf, ready-to-use T cell therapies targeting infectious diseases, cancers, and other disorders. These therapies are designed to recognize multiple antigens simultaneously, reducing issues related to viral mutations and drug resistance.
• Differences from Existing Therapies:
  • Uses naturally occurring CTLs from donors, not genetically engineered cells.
  • Targets specific HLA class I molecules with precisely selected peptide targets.
  • Produces multi-target T cell products that can be stored and administered rapidly, with a goal of broad availability.

Key Product Candidate

• TVGN 489:
  • Developed as an off-the-shelf allogeneic T cell therapy for COVID-19, especially vulnerable populations like immunocompromised, high-risk elderly, and Long COVID sufferers.
  • Completed a Phase 1 clinical trial in January 2023 showed
    • No dose-limiting toxicities or significant adverse events.
    • Rapid viral load reduction.
    • No development of Long COVID during a 6-month follow-up.
  • Targets multiple SARS-CoV-2 genome segments, shown to be less affected by viral mutations.
  • Cells are sourced from healthy donors recovered from COVID-19, expanded, and stored for infusion.
  • Designed for rapid outpatient infusion, compatible with HLA typing, and capable of producing hundreds of doses per donor.
  • Planning future pivotal trials, particularly targeting COVID-19 patients with B cell malignancies.

Development and Pipeline

• Pipeline includes:
  • Trials targeting COVID-19, Long COVID, HPV-related cancers, hepatitis B, EBV-related diseases including multiple sclerosis (MS) and lymphomas.
  • Preclinical programs for HPV, HBV, EBV, and cancer targeting, including antibody-coated cancer cell approaches.
• Progress:
  • Completed Phase 1 for TVGN 489.
  • Planning additional Phase 2 and pivotal trials based on initial data.
  • Working on expanding HLA coverage and developing next-generation products with T cell receptor sequencing and AI.

Corporate Actions

• Business Combination: Completed on February 14, 2024, with Semper Paratus Acquisition Corporation.
• Name Change: Semper Paratus converted to Tevogen Bio Holdings Inc.

Employees and Size

• Employees: 18 full-time employees as of March 21, 2025.
• Employees are focused on: R&D, clinical development, regulatory, manufacturing, and commercialization strategy.

Financial Status

• Revenue: None reported; company has not generated product sales.
• Market Capitalization: Approx. $21.4 million (as of June 28, 2024).
• Outstanding Shares: 183,893,433 shares of common stock as of March 21, 2025.
• Funding: Reliant on grant funding ($2 million received, with an additional $8 million expected) and capital from earlier financings, but has not yet secured significant revenue or profitability.

Summary of Risks and Agreements

• The company is dependent on successful clinical trial progress, regulatory approvals, and future funding.
• They rely on third-party manufacturing for clinical trials with efforts underway to develop proprietary manufacturing capabilities.
• Faces competition from other biotech firms and biosimilar challenges.
• Holds patents covering its technologies, with expiration dates extending into 2044.

Note: No actual revenue, net income, or customer base figures are provided in the given document.