IO Biotech Announces Q1 2024 Financial Results and Business Highlights

IO Biotech, a clinical-stage biopharmaceutical company, recently disclosed its financial performance and corporate updates for the first quarter ending March 31, 2024. The company focuses on developing innovative, immune-modulating cancer vaccines using its T-win® platform. These updates highlight significant milestones, changes in executive leadership, and financial status.

In clinical developments, IO Biotech has completed the enrollment of 407 patients in its pivotal Phase 3 trial (IOB-013/KN-D18). This trial investigates the efficacy of IO102-IO103 in combination with pembrolizumab for treating advanced melanoma. The primary endpoint, progression-free survival (PFS), will be analyzed once 226 events have occurred, anticipated in the first half of 2025. Additionally, an interim analysis of the overall response rate (ORR) is expected in Q3 2024, following one year of treatment for the first 225 randomized patients. Positive results could facilitate the submission of a Biologics License Application (BLA) to the U.S. FDA for accelerated approval.

Phase 2 trials are also progressing. The IOB-022/KN-D38 trial has completed enrollment, focusing on the combination of IO102-IO103 with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Updates from this study are expected to be presented at medical conferences in the fall of 2024. The IOB-032/PN-E40 trial, another Phase 2 study, has been expanded to include a randomized melanoma cohort. This trial examines the neoadjuvant and adjuvant use of IO102-IO103 with pembrolizumab in patients with resectable melanoma or SCCHN.

The company has also fortified its executive team with key hires, including Marjan Shamsaei as Senior Vice President, Commercial and Portfolio Lead, and Faiçal Miyara as Chief Business Officer. These appointments are part of IO Biotech's preparations for potential commercialization and partnerships.

During the American Association for Cancer Research (AACR) Annual Meeting in April 2024, IO Biotech presented a poster detailing non-clinical data that supports the dual mechanism of action of IO102-IO103. This data suggests that targeting both IDO1 and PD-L1 antigens may reduce immunosuppression and enhance the anti-tumor effect.

Financially, IO Biotech reported a net loss of $19.5 million for the first quarter of 2024, an increase from the $17.0 million loss in the same period the previous year. Research and development expenses rose to $14.3 million from $11.9 million, primarily due to activities related to the Phase 3 clinical trial of IO102-IO103. General and administrative expenses were relatively stable, totaling $5.9 million compared to $6.0 million in the previous year. The company ended the quarter with $118.0 million in cash and cash equivalents, down from $143.2 million at the end of 2023. Nonetheless, IO Biotech expects its cash reserves to sustain operations into the fourth quarter of 2025.

The company remains optimistic about its future, with multiple trials in progress and key interim analyses approaching. The outcome of these clinical trials will be critical in determining the next steps for IO Biotech's lead therapeutic candidate, IO102-IO103. The company's strategic hiring and financial planning reinforce its readiness for potential market entry and further development of its pipeline.