Cardiff Oncology plans randomized Phase 2 mCRC trial (ONSEMBLE) with topline data in 2H 2024; cash runway into 2025

Cardiff Oncology, Inc.

Phase 1b/2 mCRC data show ORR 35%, mPFS 9.3 mo, median DoR 11.7 mo; historical controls ORR 5-13%, mPFS 4.5-5.7 mo.
ONSEMBLE trial to enroll ~150 patients randomized 1:1:1 to SoC ± 20/30 mg onvansertib; primary endpoint ORR.
Phase 2 PDAC trial: 1 PR, 3 SD in 5 evaluable patients; additional data expected Q2/Q3 2023.
Company stops independent funding of prostate cancer program; will focus on mCRC and PDAC.
Cash resources expected to fund operations into 2025; investigator-initiated trials in TNBC and SCLC ongoing.

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