Core Insights - Cardiff Oncology, Inc. announced positive results from the CRDF-004 Phase 2 clinical trial of onvansertib in combination with standard-of-care for first-line RAS-mutated metastatic colorectal cancer (mCRC), showing a 49% confirmed objective response rate (ORR) in the 30mg dose arm compared to 30% in the control arm [1][2][4] Trial Design - The CRDF-004 trial enrolled patients with documented KRAS or NRAS mutations and evaluated onvansertib added to standard-of-care regimens [3] - Patients were randomized into six arms, including different doses of onvansertib combined with standard-of-care or standard-of-care alone, with primary and secondary endpoints focused on ORR and progression-free survival (PFS) [3] Efficacy Data - The confirmed ORR was 30% for the control arm, 42% for the 20mg onvansertib plus SoC arm, and 49% for the 30mg onvansertib plus SoC arm [4] - At the 6-month mark, the ORR was 22% for the control arm, 33% for the 20mg dose, and 46% for the 30mg dose [4] - Early PFS data indicated a trend favoring the 30mg onvansertib dose compared to the control arm [9] Safety and Tolerability - Onvansertib was well-tolerated among the 104 patients dosed, with no major or unexpected toxicities reported [10] - Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event [10] Future Outlook - The company plans to engage in discussions with the FDA and advance towards the registrational CRDF-005 trial, with an update on the first-line mCRC program expected by Q1 2026 [11][12]

Core Insights - Cardiff Oncology, Inc. has made significant progress in its clinical trials, particularly with the completion of enrollment in the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC) [2][8] - The company appointed Dr. Roger Sidhu as Chief Medical Officer to guide the development of onvansertib through the registrational phase [2][6] - Positive clinical data was announced from an investigator-initiated trial of onvansertib in combination with paclitaxel for metastatic triple negative breast cancer (mTNBC), showing a 40% objective response rate [4] Financial Overview - As of June 30, 2025, Cardiff Oncology reported cash and investments totaling approximately $71.0 million, with a projected runway into Q1 2027 [9][10] - The net cash used in operating activities for Q2 2025 was approximately $8.3 million, a decrease from $9.2 million in the same period of 2024 [9] - Total operating expenses for the quarter were approximately $14.9 million, an increase of $2.2 million from $12.7 million in Q2 2024, primarily due to costs associated with clinical trials and key hires [11] Clinical Development Highlights - The CRDF-004 trial reached its targeted enrollment across 41 clinical sites in the U.S. [8] - The Phase 1b study of onvansertib in combination with paclitaxel demonstrated a safe and manageable toxicity profile, with myelosuppression being the most common adverse event [4] - A second patent was issued for the treatment of mCRC in bevacizumab-naïve patients, with an expiration date no earlier than 2043 [5][7]

Core Insights - Cyclacel Pharmaceuticals is developing plogosertib, a PLK1 inhibitor, as a potential treatment for fibrolamellar hepatocellular carcinoma (FLC), a rare liver cancer with no approved therapies [1][2][5] Group 1: Disease Overview - FLC primarily affects adolescents and young adults, with an estimated annual incidence in the US of 0.02 per 100,000 [3] - The five-year survival rate for FLC patients is approximately 30%, and the disease is often misdiagnosed as hepatocellular carcinoma (HCC) [3] - FLC is characterized by the presence of a unique DNAJB1-PKAc gene fusion, which is a common driver of the disease [4] Group 2: Research Findings - A recent study published in the journal Gut indicates that the DNAJ-PKAc fusion oncoprotein increases sensitivity to PLK1 inhibitors like plogosertib in FLC cells [1][2] - PLK1 is essential for the growth of FLC cells, and its inhibition leads to significant reduction in FLC growth while sparing normal liver cells [2] - The study suggests further evaluation of plogosertib in preclinical and clinical studies for FLC treatment [2] Group 3: Drug Development - Plogosertib is a selective and potent PLK1 inhibitor that has shown efficacy in human tumor xenografts at non-toxic doses [7] - Initial Phase 1 clinical study data indicate that plogosertib is well tolerated with no dose-limiting toxicity observed [8] - Cyclacel's strategy includes developing plogosertib for various solid tumors and hematological malignancies, with a focus on cancers associated with DNAJ-PKAc fusions [10]

Core Points - Cardiff Oncology, Inc. has appointed Dr. Roger Sidhu as Chief Medical Officer, succeeding Dr. Fairooz Kabbinavar, who will remain in an advisory role [1][2] - The company plans to share additional clinical data from its lead program in RAS-mutated metastatic colorectal cancer (mCRC) on July 29, 2025 [1][2][5] - Dr. Sidhu brings over 20 years of experience in oncology research and development, having previously held significant roles at Treadwell Therapeutics and Amgen [2][3][4] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers, with its lead asset being onvansertib [1][8] - The company is targeting RAS-mutated mCRC and has ongoing and planned trials for other indications, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [8] Leadership Transition - Dr. Sidhu's appointment is seen as a strategic move to advance the clinical program for onvansertib through late-stage development [2][6] - The company expressed gratitude to Dr. Kabbinavar for his leadership in progressing onvansertib's clinical development across multiple tumor types [2] Upcoming Events - Cardiff Oncology will host a conference call and live webcast on July 29, 2025, to present additional clinical data from the CRDF-004 trial [5][6] - The conference call will be accessible via the company's website, with a replay available afterward [5] Stock Option Grant - In connection with Dr. Sidhu's appointment, the Board of Directors approved a grant of non-qualified stock options to purchase 600,000 shares of common stock, with an exercise price of $3.86 per share [6][7] - The stock options will vest over four years, with 25% vesting after 12 months and the remainder vesting monthly over the following 36 months [7]

Core Insights - Cardiff Oncology, Inc. announced positive results from a Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC), showing a 40% objective response rate [1][2][5] - The trial demonstrated that the combination was well-tolerated with a manageable toxicity profile, primarily myelosuppression being the most common adverse event [5] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition across various cancers, with onvansertib as its lead asset [4] - The company is also exploring onvansertib in combination with standard of care treatments for other indications, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and small cell lung cancer [4] Clinical Trial Details - The Phase 1b trial was led by Antonio Giordano, MD, PhD, at Dana-Farber Cancer Institute, focusing on the safety, pharmacokinetics, and pharmacodynamics of the drug combination [5] - The study's primary endpoint was to assess safety and determine the recommended Phase 2 dose (RP2D), with secondary endpoints including pharmacokinetics and pharmacodynamics [5] - Patients in the trial had a median of 3 prior lines of chemotherapy, and the highest dose of onvansertib (18 mg/m²) resulted in a 40% objective response rate [5]

Core Insights - Cardiff Oncology, Inc. reported financial results for Q1 2025, highlighting progress in clinical trials and intellectual property expansion [1][4][6] Financial Performance - As of March 31, 2025, the company had approximately $79.9 million in cash, cash equivalents, and short-term investments [6][9] - Net cash used in operating activities for Q1 2025 was approximately $12.8 million, an increase of about $5.1 million from $7.7 million in Q1 2024 [6][11] - Total operating expenses for the three months ended March 31, 2025, were approximately $14.5 million, up from $11.1 million in the same period in 2024 [11][16] - The net loss attributable to common stockholders for Q1 2025 was $13.4 million, compared to a net loss of $10.0 million in Q1 2024 [16] Clinical Development - The company completed enrollment in the Phase 2 CRDF-004 trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) [2][10] - The trial involved 41 clinical sites in the U.S. and evaluated onvansertib in combination with standard of care therapies [10] - Additional clinical data from the ongoing CRDF-004 trial is expected in the first half of 2025 [3] Intellectual Property - Cardiff Oncology expanded its intellectual property portfolio with the issuance of a second patent covering the treatment of mCRC for bev-naïve patients [5][9] - The new U.S. patent No. 12,263,173 is set to expire no earlier than 2043 and covers the use of onvansertib in combination with bevacizumab across all lines of therapy for mCRC patients [5][9] Future Outlook - The company believes its current cash resources are sufficient to fund operations into Q1 2027 [7][9]

Core Viewpoint - Cardiff Oncology has received a patent for the use of onvansertib in combination with bevacizumab for treating all bev-naïve metastatic colorectal cancer (mCRC) patients, which is expected to enhance its market opportunities and growth potential [1][2]. Group 1: Patent and Treatment Scope - The newly issued patent covers the combination treatment of onvansertib and bevacizumab for all bev-naïve mCRC patients, including those with RAS mutations and RAS wild type, across all lines of therapy until at least 2043 [1]. - This patent expands the applicability of onvansertib beyond the current focus on first-line RAS-mutated patient populations, potentially redefining the standard of care for mCRC [2]. Group 2: Clinical Development - Onvansertib is currently being evaluated in a Phase 2 clinical trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for RAS-mutated mCRC patients [2]. - Initial data from the ongoing CRDF-004 trial was announced in December 2024, with additional clinical data expected in the first half of 2025 [2]. Group 3: Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [3]. - The company is targeting treatment-resistant tumors and aims to deliver superior clinical benefits compared to standard of care in indications such as mCRC, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [3].

Core Insights - Cardiff Oncology has completed patient enrollment in the Phase 2 CRDF-004 trial for onvansertib in RAS-mutated metastatic colorectal cancer (mCRC) [1][2] - The trial aims to evaluate the efficacy of onvansertib in combination with standard of care treatments [2] - Additional clinical data from the trial is expected to be reported in the first half of 2025 [3] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers [4] - The lead asset, onvansertib, is being tested in combination with standard treatments for RAS-mutated mCRC and other cancers [4] - The company aims to address treatment resistance and improve clinical outcomes compared to standard therapies [4]