10-K annual report · filed Apr 2, 2025

Tevogen Bio Holdings Inc. (TVGN) FY2024 10-K Annual Report

Short answer

Tevogen Bio Holdings Inc. (TVGN) filed its fiscal 2024 10-K annual report with the SEC on Apr 2, 2025.

  • Top risk flagged: Regulatory risk: FDA's evolving framework on allogeneic T cell therapy and AI use, with draft guidance increasing compliance costs and potential delays

FY2024 key financial metrics · XBRL

Net income
−$14M
−20289.7% YoY
EPS (diluted)
−$0.07
+97.1% YoY
ROE
205.7%
+205.3 pp YoY
Operating cash flow
−$12M
−771.8% YoY

Source: XBRL data from the Tevogen Bio Holdings Inc. (TVGN) FY2024 10-K on SEC EDGAR. USD.

Tevogen Bio Holdings Inc. FY2024 10-K analysis

AI summary of each section, grounded in the filing text

Business Overview

  • Core business: Clinical-stage immunotherapy developing off-the-shelf, precision allogeneic CD8+ T cell therapies for infectious diseases, cancers, and other disorders
  • New emphasis on TVGN 489 for COVID-19 and Long COVID, with Phase 1 proof-of-concept trial completed Jan 2023 and pivotal trial planned for B cell malignancy patients
  • Strategic shift: Completed business combination with Semper Paratus Acquisition Corp in Feb 2024 to become publicly listed as Tevogen Bio Holdings Inc
  • Notable metric: TVGN 489 progressed from pre-discovery to clinic in 18 months, achieving persistence of infused cells for 6 months and no significant adverse events
  • Unique fact: ExacTcell technology delivers off-the-shelf T cell therapies that are not genetically modified, aiming to reduce severe side effects seen in CAR-T platforms

Management Discussion & Analysis

  • Revenue $0, no product sales, consistent with prior year; no expected revenue until product approval and commercialization
  • Net loss $13.7M in 2024 vs $60.5M in 2023; loss from operations $53.6M in 2024 vs $8.8M; operating expenses rose to $53.6M from $8.8M
  • Best performing segment: Change in fair value of convertible promissory notes gain $48.5M in 2024 vs loss $50.4M in 2023; Worst: R&D expenses surged to $31.0M from $4.4M mainly due to stock-based compensation
  • Cash flow: Operating cash outflow $12.0M in 2024 vs $8.2M; Financing inflows $12.3M in 2024 vs $4.0M, including $2.0M Series A, $6.0M Series C preferred stock, $1.0M loan draw; Capex minimal
  • Outlook: Sufficient cash and credit available for 12+ months; plans to expand R&D, manufacturing, commercialization; key risks from clinical development, regulatory approvals, commercialization timing

Risk Factors

  • Regulatory risk: FDA's evolving framework on allogeneic T cell therapy and AI use, with draft guidance increasing compliance costs and potential delays
  • Geopolitical/macro risk: Reliance on $8.0 million grant funding expected Q2 2025 from KRHP LLC critical for liquidity amid no secured additional financing
  • Operational risk: Dependence on procuring consistent, virus-free third-party donor T cells impacting manufacturing reliability and supply chain stability
  • Competitive risk: Novel immunotherapy approach faces risk of market share loss to established and emerging therapies with better clinical trial histories
  • Financial risk: Significant $8.0 million capital need with limited operating history and no commercial products, risking dilution or operational downscaling if additional funding unavailable

Generated from the filing text; verify against the original. How to read a 10-K

Ask about this 10-K

Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.