Boundless Bio Secures FDA IND for BBI-940, Opens KOMODO-1 Trial with $107.6M Runway
Boundless Bio’s FDA accepted its IND for BBI-940 and opened enrollment in the KOMODO-1 first-in-human trial targeting ER+/HER2- and TNBC-LAR breast cancers, aiming for proof-of-concept by mid-2028. The company ended 2025 with $107.6 million cash runway into late 2028 and reduced net loss to $58.2 million.
1. Clinical Progress and Trial Milestones
Boundless Bio received FDA acceptance for its Investigational New Drug application for BBI-940 in January 2026 and has initiated enrollment in the KOMODO-1 first-in-human trial. The trial will evaluate the oral kinesin degrader in ER+/HER2- and TNBC-LAR breast cancer patients, with an initial proof-of-concept readout expected in the second half of 2028.
2. Detailed Financial Results
As of December 31, 2025, the company held $107.6 million in cash, cash equivalents, and short-term investments, providing funding into late 2028. Fourth-quarter R&D expenses decreased to $9.8 million from $13.3 million a year earlier, and full-year R&D fell to $44.8 million from $55.3 million. G&A expenses were $4.2 million in Q4 versus $5.0 million, with full-year G&A at $18.7 million compared to $18.0 million. Net loss narrowed to $12.9 million for Q4 (from $16.4 million) and $58.2 million for the full year (from $65.4 million).
3. Strategic Portfolio Prioritization
In January 2026 the company halted enrollment in the Phase 1/2 POTENTIATE trial of BBI-355 and BBI-825 to concentrate resources on the BBI-940 program. Management cited market considerations and available clinical data in reprioritizing its oncology pipeline toward its most promising ecDNA-directed therapeutic candidate.