Cardiff Oncology CRDF announced robust efficacy data from an ongoing mid-stage study evaluating two doses of its lead investigational candidate, onvansertib (20 mg and 30 mg), in combination with standard-of-care (SOC) chemotherapy to treat first-line RAS-mutated metastatic colorectal cancer (mCRC) patients. The stock rallied 54.9% on Tuesday following the encouraging news. The primary endpoint of the study was objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), duration of response and safety.

Per the data from the phase II CRDF-004 study, treatment with the 30 mg dose of onvansertib, a PLK1 inhibitor, demonstrated an ORR of 64%, almost double the 33% ORR observed in the control arm (SOC alone). The 30 mg dose arm also demonstrated a higher ORR compared with the 50% ORR observed in the 20 mg dose arm. Overall, patients treated with onvansertib demonstrated an ORR of 57%.

The company also shared spider plots in the press release which show that patients receiving the 30mg dose of onvansertib with SOC experienced greater tumor size reduction over time compared to those in the control and 20mg dose arms with similar safety profiles for both doses. The combo therapy was also well tolerated in the CRDF-004 study with no major or unexpected toxicities observed.

Based on the encouraging data readout, management believes that onvansertib has the potential to revolutionize the treatment paradigm for the first-line RAS-mutated mCRC patient population. Approximately 50,000 new patients with this mCRC indication are diagnosed in the United States, annually.

In the past three months, shares of Cardiff Oncology have rallied 47.7% against the industry’s 6.2% decline.

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CRDF’s Next Steps in Onvansertib Development for mCRC

Cardiff Oncology expects to share additional clinical updates from the mid-stage study in the first half of 2025. Subject to positive results from the phase II CRDF-004 study, Cardiff plans to initiate a phase III CRDF-005 registrational study for the onvansertib/SOC combo to treat patients with first-line RAS-mutated mCRC.

Furthermore, the FDA has also agreed with the company that an interim analysis of ORR in the planned registrational study can provide the basis for an application seeking approval for the onvansertib/SOC combo under an accelerated pathway. Under such circumstances, PFS and overall survival data will be designated as endpoints for full approval.

We note that last year, Cardiff discontinued its phase II ONSEMBLE study evaluating onvansertib in combination with SOC therapy to treat patients with second-line RAS-mutated mCRC. The strategic decision was taken to focus the company's resources on its phase II CRDF-004 study in the first-line setting, where there is a higher unmet need.

Besides the mCRC indication, Cardiff Oncology is also currently evaluating the safety and preliminary efficacy of onvansertib in combination with Onyvide (nanoliposomal irinotecan), fluorouracil and leucovorin in a phase II CRDF-001 study to treat second-line patients with metastatic pancreatic ductal adenocarcinoma.

CRDF Issues Underwritten Offering to Raise Funds for Operations

In a separate press release, Cardiff Oncology announced the pricing of an underwritten offering of 15,384,619 shares of its common stock at an offering price of $2.60 per share, before deducting underwriting discounts and commissions.

The company expects to raise approximately $40 million in gross proceeds from the underwritten offering. Net proceeds, after deducting underwriting discounts and commissions and offering expenses, will be used to fund clinical costs for onvansertib in first-line RAS-mutated mCRC and for working capital and other general corporate purposes.

The transaction is expected to close on Dec. 11, 2024, subject to the fulfillment of certain customary conditions.

Cardiff Oncology, Inc. Price and Consensus

Cardiff Oncology, Inc. price-consensus-chart | Cardiff Oncology, Inc. Quote

CRDF’s Zacks Rank and Stocks to Consider

Cardiff Oncology currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industryare Alnylam Pharmaceuticals ALNY, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Alnylam Pharmaceuticals’ loss estimates have narrowed from 42 cents to 39 cents per share for 2024, while that for 2025 has narrowed from 47 cents to 13 cents. ALNY shares have lost 3% in the past three months.

Alnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

In the past 60 days, Pfizer’s earnings estimates have risen from $2.66 to $2.92 per share for 2024, while that for 2025 has increased from $2.86 to $2.94. PFE shares have lost 12.4% in the past three months.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.78 to $4.29 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 10.9% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

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