8-K: Cardiff Oncology Announces Positive Clinical Trial Updates and Year-End Financial Results

Cardiff Oncology reports positive clinical data from its second-line ONSEMBLE trial and announces the first patient dosed in its first-line Phase 2 trial for RAS-mutated metastatic colorectal cancer, alongside its 2023 financial results.

Summary

• Cardiff Oncology announced financial results for the fourth quarter and full year ended December 31, 2023, along with clinical updates.
• The company's cash and equivalents totaled $75 million as of December 31, 2023, which is projected to fund operations into Q3 2025.
• Net cash used in operating activities for 2023 was approximately $30.9 million, a decrease from $33.8 million in 2022.
• Total operating expenses for 2023 were approximately $45.9 million, an increase from $40.3 million in 2022.
• The company provided a clinical update on the Phase 2 randomized second-line ONSEMBLE trial in mCRC, which was discontinued in August 2023.
• The ONSEMBLE trial showed a 50% objective response rate (ORR) in bev-naive patients treated with onvansertib plus standard of care.
• No clinical responses were observed in patients who received standard of care alone or in patients previously exposed to bevacizumab.
• The first patient was dosed in the randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer.
• The CRDF-004 trial is designed to confirm the dose of onvansertib and generate safety and efficacy data when added to standard of care.
• Interim topline results from the CRDF-004 trial are expected in mid-2024.
• Cardiff Oncology plans to initiate a Phase 3 trial, CRDF-005, contingent upon the results of CRDF-004.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to the promising clinical data, the initiation of the first-line trial, and the strong cash position. The collaboration with Pfizer Ignite and the FDA's agreement on the accelerated approval pathway further boost the positive outlook.

Positives

• The company has a strong cash position of $75 million, providing a runway into Q3 2025.
• The ONSEMBLE trial data provides further evidence of onvansertib's efficacy in bev-naive patients.
• The first patient dosed in the first-line trial is a significant milestone.
• The company is working with Pfizer Ignite, which should improve the execution of the trial.
• The FDA has agreed to an accelerated approval pathway based on ORR.

Negatives

• The ONSEMBLE trial was discontinued in August 2023, which may have resulted in lost time and resources.
• Total operating expenses increased by $5.6 million year-over-year.
• The company reported a net loss of $41.4 million for the year.

Risks

• Clinical trials are lengthy and expensive with uncertain outcomes.
• Clinical trials may be suspended or discontinued due to unexpected side effects or safety risks.
• Results of preclinical studies or clinical trials could be unfavorable or delayed.
• The company may need additional financing.
• There are risks related to business interruptions, including COVID-19 and cyber-attacks.
• There are uncertainties of government or third-party payer reimbursement.
• The company depends on key personnel.
• There is substantial competition in the market.
• There are uncertainties of patent protection and litigation.
• The company depends on third parties.
• There are risks related to failure to obtain FDA clearances or approvals.

Future Outlook

The company anticipates interim topline data from the first-line mCRC trial in mid-2024 and plans to initiate a Phase 3 trial contingent on the Phase 2 results. The company believes its current cash resources are sufficient to fund operations into Q3 2025.

Management Comments

• 2024 is a pivotal year for Cardiff Oncology and we are excited for our upcoming randomized data readout from our lead program in first-line mCRC later this year, said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology.
• The mCRC data we shared in August 2023, and the ONSEMBLE data we are disclosing today, demonstrates onvansertibs contribution to the standard of care of bevacizumab (bev) and chemotherapy in treating RAS-mutated mCRC.
• By moving our lead program to the first-line setting, all patients on the CRDF-004 trial will be bev nave, said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.
• We strongly believe that we are on the cusp of a transformative advance in the treatment landscape for mCRC, said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.
• We are pleased that the CRDF-004 trial is underway and look forward to providing clinical development support to advance onvansertib in RAS-mutated mCRC, which we believe has the potential to make an impact in patients with metastatic colorectal cancer, said Adam Schayowitz, Ph.D., MBA, Head, Product Teams, Portfolio & Program Management at Pfizer Oncology.

Industry Context

The announcement is significant as it highlights progress in a space with limited new therapies approved in the last 20 years for RAS-mutated mCRC. The collaboration with Pfizer Ignite also indicates a growing trend of biotech companies partnering with larger pharmaceutical firms for clinical trial execution.

Comparison to Industry Standards

• The 50% ORR in bev-naive patients in the ONSEMBLE trial is promising compared to standard of care alone, which showed no responses in this trial.
• The move to first-line treatment is a strategic shift, as first-line treatments often have a larger market and greater impact on patient outcomes.
• The collaboration with Pfizer Ignite is similar to other biotech companies partnering with larger firms to leverage their clinical trial expertise.
• The FDA's agreement on ORR as an acceptable endpoint for accelerated approval is consistent with the regulatory pathway for oncology drugs.

Stakeholder Impact

• Shareholders may view the clinical trial progress and financial stability positively.
• Employees may be encouraged by the company's progress and future prospects.
• Patients with RAS-mutated mCRC may benefit from the potential new treatment options.
• The collaboration with Pfizer Ignite may enhance the company's credibility with suppliers and partners.

Next Steps

• The company will continue enrollment in the first-line Phase 2 trial, CRDF-004.
• Interim topline results from the CRDF-004 trial are expected in mid-2024.
• Cardiff Oncology plans to initiate a Phase 3 trial, CRDF-005, contingent upon the results of CRDF-004.

Key Dates

Keywords

Onvansertib, mCRC, RAS-mutated, Colorectal Cancer, Clinical Trial, PLK1 Inhibitor, Phase 2, Phase 3, Pfizer Ignite, FDA, Bevacizumab, FOLFIRI, FOLFOX, Objective Response Rate, ORR