Quarterly ResultMay 12, 2026, 04:12 PM
Immunome Submits NDA for Varegacestat; Q1 Net Loss $53.8M
AI Summary
Immunome Inc. reported its first-quarter 2026 financial results and provided a comprehensive business update. The company submitted a New Drug Application (NDA) to the U.S. FDA in April 2026 for varegacestat for desmoid tumors, following positive Phase 3 RINGSIDE data. Immunome also advanced its ADC pipeline with IND clearance for IM-1617 and ongoing Phase 1 trials for IM-1021 and IM-3050. For Q1 2026, the company reported a net loss of $53.8 million and ended the quarter with $582.7 million in cash, expected to fund operations into 2028.
Key Highlights
- NDA submitted to US FDA in April 2026 for varegacestat for desmoid tumors.
- Phase 3 RINGSIDE data for varegacestat selected for oral presentation at 2026 ASCO.
- IND clearance received for IM-1617 in April 2026; Phase 1 trial to start Q2 2026.
- Q1 2026 net loss was $53.8 million, compared to $41.6 million in Q1 2025.
- Cash and cash equivalents totaled $582.7 million as of March 31, 2026.
- Research and development expenses increased to $46.4 million from $36.9 million YoY.
- Initial lymphoma data for IM-1021 Phase 1 study expected in 2026.