IO Biotech (OTC: IOBTQ) is a clinical-stage oncology biopharmaceutical company developing therapeutic cancer vaccines. The company has no approved products and generates no product revenue, funding operations entirely through capital raises. Its lead candidate, Cylembio, is being evaluated in a potentially registrational Phase 3 trial (IOB-013/KN-D18) in combination with pembrolizumab as first-line treatment for advanced melanoma. IO Biotech fully enrolled 407 patients in that trial as of November 2023, ahead of schedule. The primary endpoint of progression-free survival is event-driven, requiring 226 events, with readout expected in Q3 2025. The company plans to submit a Biologics License Application to the FDA in 2025. Net cash used in operating activities was $82.3 million in FY2024, compared to $71.7 million in FY2023, reflecting a pre-revenue burn profile. Total general and administrative expenses were $23.7 million in FY2024. IO Biotech files as a smaller reporting company.

Revenue model

IO Biotech generates no product revenue. The company is pre-commercialization and has funded operations through equity financing. Net cash provided by financing activities was $0 in FY2024 and $71.9 million in FY2023.

Products and services

Lead pipeline asset: Cylembio (therapeutic cancer vaccine), evaluated in Phase 3 combination with pembrolizumab for first-line advanced melanoma (IOB-013/KN-D18 trial, 407 patients enrolled as of November 2023). BLA submission to FDA planned for 2025.

Customers and end markets

End market is oncology, specifically advanced melanoma patients. No commercial customers as of the filing date. Clinical trial participants are the current subject population.

Value-chain role

Drug developer occupying the clinical-stage research and development role. No manufacturing, sales, or distribution capabilities established. Potential future commercialization may involve third-party sales and marketing arrangements.

Geographic exposure

Operations subject to U.S. FDA regulatory pathway. Data privacy obligations under EU GDPR and UK GDPR indicate clinical or operational activity in the EEA and United Kingdom.

Source: SEC 10-K, filed 2025-03-31

Industry: Pharmaceutical Preparations Peers: Evaxion A/S Forward Pharma A/S Damora Therapeutics Inc