Cardiff Oncology Inc Stock Price, News & Analysis

Cardiff Oncology (Nasdaq: CRDF), a clinical-stage biotech company focused on PLK1 inhibition for cancer therapies, has announced its participation in three major investor conferences in September 2025.

The company will attend the Wells Fargo Healthcare Conference (09/05), the Morgan Stanley Global Healthcare Conference (09/08), and the H.C. Wainwright Global Investment Conference (09/09). CEO Mark Erlander will present a fireside chat at the H.C. Wainwright conference at 10:30 AM ET, which will be available via webcast on the company's website.

Cardiff Oncology (Nasdaq: CRDF) announced positive data from its Phase 2 clinical trial evaluating onvansertib combined with standard-of-care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial demonstrated a 49% confirmed objective response rate (ORR) in the 30mg onvansertib arm versus 30% in the control arm.

Key highlights include:

• Dose-dependent response across all endpoints including ORR, early tumor shrinkage, and depth of response
• Early PFS data showing favorable trend for 30mg onvansertib dose
• Well-tolerated safety profile with neutropenia as the most common treatment-emergent adverse event

The company plans to engage with FDA regarding the registrational CRDF-005 trial and expects to provide a program update by Q1 2026.

Cardiff Oncology (Nasdaq: CRDF) announced Q2 2025 financial results and significant clinical progress. The company completed enrollment in its randomized Phase 2 CRDF-004 trial for onvansertib plus standard of care in first-line RAS-mutated metastatic colorectal cancer. Key highlights include the appointment of Dr. Roger Sidhu as Chief Medical Officer and positive data from a Phase 1b trial showing 40% objective response rate for onvansertib with paclitaxel in metastatic triple negative breast cancer.

Financially, Cardiff reported $71.0 million in cash and investments as of June 30, 2025, with a projected runway into Q1 2027. Q2 operating expenses increased to $14.9 million, up from $12.7 million year-over-year, primarily due to clinical trial costs and personnel expenses. The company also secured a new USPTO patent for onvansertib treatment in mCRC, extending protection until 2043.

Cardiff Oncology (NASDAQ: CRDF) has appointed Dr. Roger Sidhu as Chief Medical Officer, succeeding Dr. Fairooz Kabbinavar who will transition to an advisory role. Dr. Sidhu brings over 20 years of oncology leadership experience, including significant expertise in mCRC clinical trials and RAS biology. He previously served as CMO and acting CEO at Treadwell Therapeutics and held key positions at Amgen, where he led Phase 3 trials for panitumumab. The company also announced a conference call scheduled for July 29, 2025, at 4:30 PM ET to share additional clinical data from its randomized Phase 2 CRDF-004 trial, which evaluates onvansertib plus standard of care for first-line RAS-mutated metastatic colorectal cancer treatment. As part of his compensation package, Dr. Sidhu received an inducement grant of options to purchase 600,000 shares at $3.86 per share, vesting over four years.

Cardiff Oncology announced positive Phase 1b clinical trial results for onvansertib combined with paclitaxel in treating metastatic triple-negative breast cancer (mTNBC). The trial, presented at ASCO 2025, demonstrated a 40% objective response rate at the highest dose (18mg/m2) of onvansertib. The study, led by Dana-Farber Cancer Institute, enrolled heavily pretreated patients with a median of 3 prior chemotherapy lines. Notable results included two confirmed and two unconfirmed partial responses, with three responses observed in patients previously exposed to paclitaxel. The drug combination showed a manageable safety profile, with myelosuppression as the most common side effect. The positive results validate preclinical data showing synergy between onvansertib and paclitaxel, suggesting potential for treating mTNBC, an aggressive breast cancer subtype with significant unmet medical needs.

Cardiff Oncology (NASDAQ: CRDF) has announced its Q1 2025 financial results and business updates. The company has completed enrollment in its Phase 2 CRDF-004 trial evaluating onvansertib combined with standard of care for first-line RAS-mutated metastatic colorectal cancer (mCRC) across 41 U.S. clinical sites. Cardiff has also strengthened its intellectual property with a new patent extending to 2043, covering onvansertib treatment for all bevacizumab-naïve mCRC patients. Financially, the company reported $79.9 million in cash and investments as of March 31, 2025, with a projected runway into Q1 2027. Operating expenses increased to $14.5 million, up from $11.1 million in Q1 2024, primarily due to clinical trial costs and development of onvansertib. Additional clinical data from the CRDF-004 trial is expected in 1H 2025.

Cardiff Oncology (CRDF) has secured a new U.S. patent (No. 12,263,173) for its drug onvansertib in combination with bevacizumab (bev) for treating metastatic colorectal cancer (mCRC) patients. The patent, extending through 2043, covers treatment for all bev-naïve patients, including both RAS-mutated and RAS wild-type mCRC across all therapy lines.

This follows a previous patent for first-line treatment of bev-naïve patients with KRAS mutations. Onvansertib, a PLK1 inhibitor, is currently under evaluation in a Phase 2 randomized trial (CRDF-004) in combination with FOLFIRI/bev or FOLFOX/bev for first-line treatment of mCRC patients with RAS mutations. Initial trial data was released in December 2024, with additional results expected in first half of 2025.

Cardiff Oncology (CRDF), a clinical-stage biotech company focused on PLK1 inhibition for cancer therapies, has granted stock options as an employment inducement. The company issued non-qualified stock options for 35,040 shares to one new employee on April 14, 2025.

The options were granted under Nasdaq Listing Rule 5635(c)(4) with an exercise price of $2.79 per share, matching Cardiff's closing stock price on April 14, 2025. The vesting schedule spans 4 years, with 25% vesting after the first year and the remainder vesting monthly over the following 36 months, contingent on continued employment.

Cardiff Oncology (CRDF) has completed patient enrollment in its Phase 2 CRDF-004 trial, evaluating onvansertib combined with standard of care for first-line RAS-mutated metastatic colorectal cancer (mCRC) treatment. The trial, conducted across 41 U.S. clinical sites, involves patients with documented KRAS or NRAS mutations and unresectable disease.

The study design includes three arms where patients receive either 20mg onvansertib plus standard of care (FOLFIRI/FOLFOX with bevacizumab), 30mg onvansertib plus standard of care, or standard of care alone. The trial's primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival, duration of response, and safety.

Initial results were released in December 2024, with additional clinical data expected in the first half of 2025.