CRDF Stock Soars on Robust Efficacy Data From Colorectal Cancer Study

Core Viewpoint - Cardiff Oncology announced promising efficacy data from a mid-stage study of onvansertib in combination with standard-of-care chemotherapy for treating first-line RAS-mutated metastatic colorectal cancer, leading to a significant stock price increase of 54.9% [1][5]. Group 1: Study Results - The phase II CRDF-004 study showed that the 30 mg dose of onvansertib achieved an objective response rate (ORR) of 64%, nearly double the 33% ORR of the control arm [2]. - The 20 mg dose arm had an ORR of 50%, indicating that the 30 mg dose was more effective [2]. - Overall, patients treated with onvansertib had an ORR of 57% [2]. Group 2: Treatment Efficacy - Spider plots indicated that patients receiving the 30 mg dose experienced greater tumor size reduction over time compared to those in the control and 20 mg dose arms, with similar safety profiles for both doses [3]. - The combination therapy was well tolerated, with no major or unexpected toxicities reported [3]. Group 3: Future Plans - Management believes onvansertib could transform treatment for first-line RAS-mutated mCRC, with approximately 50,000 new diagnoses annually in the U.S. [4]. - Cardiff Oncology plans to share additional clinical updates in the first half of 2025 and may initiate a phase III registrational study based on positive results from the CRDF-004 study [6]. - The FDA has agreed that an interim analysis of ORR in the planned registrational study could support an accelerated approval pathway for the onvansertib/SOC combination [7]. Group 4: Financial Activities - Cardiff Oncology announced an underwritten offering of 15,384,619 shares at $2.60 per share, aiming to raise approximately $40 million for clinical costs and general corporate purposes [10][11]. - The transaction is expected to close on December 11, 2024, subject to customary conditions [12].