earnings
confidence high
sentiment positive
materiality 0.70
Bicycle Therapeutics Q3 net loss $49.9M; FDA aligns on BT8009 Phase 2/3 trial for bladder cancer
BICYCLE THERAPEUTICS PLC
2023-Q3 EPS reported
-$3.95
- Net loss $49.9M ($1.26/share) vs $28.3M ($0.96/share) in Q3 2022; R&D expenses rose to $39.9M.
- Cash $572.1M as of Sep 30, 2023, up from $339.2M at Dec 31, 2022, including $215.1M net from July offering.
- FDA aligned on Phase 2/3 registrational trial (Duravelo-2) for BT8009 in metastatic bladder cancer; starts Q1 2024.
- BT8009 selected for FDA's CMC Development and Readiness Pilot (CDRP) program to expedite manufacturing.
- Company plans R&D Day on Dec 14, 2023, to provide updates on BT8009, BT5528, and BT7480.