HOOKIPA Pharma Reports $43.5M Net Loss for 2024, Improved Revenue and Restructuring Plan

HOOKIPA Pharma Inc. reported a net loss of $43.5 million for the year ended December 31, 2024, a significant improvement from the $81.58 million net loss reported in 2023. This improvement is largely attributed to a $23.8 million increase in revenue from collaboration and licensing, reaching $43.9 million in 2024 compared to $20.1 million in 2023. The increase stemmed from accelerated revenue recognition due to the termination of the collaboration agreement with Roche, along with milestone payments received from Gilead. Research and development expenses decreased by $17.9 million, primarily due to the company's restructuring plan which included pausing clinical development of certain programs.

Significant changes in 2024 included a restructuring plan resulting in an approximately 80% reduction in the workforce by the end of the first half of 2025. This plan also involved pausing clinical development of the eseba-vec program for HPV16+ head and neck cancers and the termination of the Phase 1/2 clinical trial for this indication. The company received a $19.8 million payment related to research incentive programs in February 2025. Furthermore, discussions regarding a potential combination with Poolbeg Pharma plc were terminated in February 2025. The company also received IND clearance from the FDA for HB-700 in April 2024.

Key operational developments included the completion of enrollment in the Phase 1/2 clinical trial for eseba-vec, with final Phase 2 data expected in the second half of 2025. Positive preliminary Phase 2 data for eseba-vec in combination with pembrolizumab were presented at ASCO and SITC, showing a 52% objective response rate. The company also completed enrollment in the Phase 1b clinical trial for HB-500, with primary completion expected in the second half of 2025. As of January 31, 2025, HOOKIPA employed 82 full-time and 5 part-time employees.

The company's financial highlights included milestone payments of $10 million from Roche in April 2024 and $5 million from Gilead in July 2024. The company's pipeline includes HB-700, a KRAS mutant-targeting immunotherapy, and Gilead-partnered programs HB-400 for HBV and HB-500 for HIV, all in various stages of clinical development. The company's technology platform is based on engineered arenaviruses designed to induce robust immune responses.

HOOKIPA Pharma's outlook remains uncertain, with substantial doubt regarding its ability to continue as a going concern. The company anticipates needing substantial additional funding to advance its product candidates and sustain operations. The company's future success depends on several factors, including successful clinical trials, regulatory approvals, and market acceptance of its product candidates. The company acknowledges numerous risks, including those related to its financial position, clinical development, regulatory approvals, competition, and intellectual property.