Cardiff Oncology(US:CRDF)2023-11-02 22:21Clinical Development & Efficacy - Onvansertib demonstrates a clinical signal of efficacy and tolerability [2, 18] - The company plans to generate data from the first-line RAS-mutated mCRC CRDF-004 trial in mid-2024 [3, 5, 11, 14, 32, 36] - In a mCRC study of 135 patients, data identified resistance mechanisms [7] - Onvansertib/paclitaxel combination achieved significant tumor regression [9] - In BC1117 mice models, complete response was observed in 6 out of 11 mice (54%) [10] - In BC1080 mice models, complete response was observed in 5 out of 8 mice (62%) [10] - Phase 1b/2 data from second-line KRAS-mutated mCRC showed a 73% ORR in bev naïve patients versus approximately 25% for historical controls, and a 15-month median PFS in bev naïve patients versus approximately 7-8 months for historical controls [31] Financial Position - The company's financial position is strong as of Q3 2023, with a cash runway extending into 2025 [11, 18, 33] - As of September 30, 2023, the company had $814 million in cash and investments [17] - Net cash used in Operating Activities for Q3 2023 was $8 million [17] Strategic Objectives - The company is focused on generating data from the first-line RAS-mutated mCRC [5, 14] - The company is developing earlier-stage programs in Pancreatic, SCLC, and TNBC through investigator-initiated trials [30, 37] - The company is expanding its pipeline through preclinical studies of new combinations and indications [35, 37]