Cardiff Oncology Reports First Quarter 2025 Results and Provides Business Update
- Strong cash position of $79.9M with runway extending into Q1 2027
- Successful completion of Phase 2 trial enrollment for first-line RAS-mutated mCRC
- New patent protection until 2043 covering broader patient population
- Expanded intellectual property portfolio strengthening market position
- Increased operating expenses by $3.4M compared to Q1 2024
- Higher cash burn rate with net cash used in operations up by $5.1M from previous year
Insights
Cardiff completes Phase 2 enrollment for RAS-mutated colorectal cancer treatment, strengthening intellectual property position until 2043.
Cardiff Oncology has achieved a significant clinical milestone with the completion of enrollment in their randomized Phase 2 CRDF-004 trial evaluating onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC). This patient population represents an area of substantial unmet need, with the company noting there have been "no therapeutic advancements in decades" for these patients.
The trial spans 41 clinical sites across the U.S. with a three-arm design comparing two different doses of onvansertib (20mg and 30mg) plus standard of care versus standard of care alone. Patients receive onvansertib in combination with either FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. This design will provide comparative efficacy data and help determine optimal dosing strategy.
The study's primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety. The company expects to report additional clinical data from this trial in the first half of 2025.
Cardiff has also strengthened its intellectual property position with a new patent (U.S. patent No. 12,263,173) that expires no earlier than 2043. This patent significantly expands coverage to include all bevacizumab-naïve mCRC patients regardless of RAS mutation status, across all lines of therapy. This broader protection enhances the commercial potential of onvansertib should it demonstrate positive clinical outcomes.
With the trial fully enrolled, the company is now positioned to generate the efficacy and safety data needed for potential regulatory discussions with the FDA as they pursue their stated mission to deliver a transformative therapy for RAS-mutated mCRC and potentially other cancers through their PLK1 inhibition approach.
Cardiff maintains $79.9M cash runway into Q1 2027 despite 66% increase in burn rate to support advancing clinical programs.
Cardiff Oncology reported a solid financial position with
However, the financial data reveals a significant acceleration in cash utilization that merits investor attention. Net cash used in operating activities for Q1 2025 was
Total operating expenses rose to
At the current quarterly burn rate, the cash position theoretically provides about 6.2 quarters of funding, which aligns with management's runway projection. This financial position should support Cardiff through several important clinical readouts, including the upcoming data from the CRDF-004 trial expected in the first half of 2025.
The increased spending reflects typical cost escalation as clinical programs advance toward later stages of development, and the company appears to be balancing investment in clinical development with maintaining sufficient financial resources to reach key inflection points in their oncology programs.
- Completed enrollment in randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) -
- Expanded intellectual property portfolio with second patent covering treatment of all bev-naïve patients, including RAS-mutated and RAS wild-type mCRC, across all lines of therapy -
- Cash and investments of
SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.
“Our lead program for onvansertib has remained on track in 2025 with the successful completion of enrollment in our trial in first-line RAS-mutated mCRC, underscoring our deep commitment to serving a patient population that has seen no therapeutic advancements in decades,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “Furthermore, we expanded our intellectual property portfolio through the issuance of a second patent covering all mCRC, regardless of tumor mutational status, across all lines of therapy. As we continue to generate clinical data and move toward regulatory discussions with the FDA, we remain focused on our mission to deliver a transformative therapy that could redefine the standard of care for RAS-mutated mCRC and for other cancers.”
Upcoming expected milestones
- Additional clinical data from the ongoing CRDF-004 trial in mCRC expected in 1H 2025
Company highlights for the quarter ended March 31, 2025, and subsequent weeks include:
- Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC
- The Phase 2 CRDF-004 trial has reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have mCRC and a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab (bev) or FOLFOX plus bev. Patients are randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety.
- Announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients
- U.S. patent No. 12,263,173 has an expiration date of no earlier than 2043. The claims of the new patent cover the method of using onvansertib in combination with bev in any line of therapy for the treatment of mCRC patients who have not previously been treated with bev. The newly issued patent encompasses all mCRC patients, with RAS-mutated or RAS wild-type mCRC.
First Quarter 2025 Financial Results:
Liquidity, cash burn, and cash runway
As of March 31, 2025, Cardiff Oncology had approximately
Net cash used in operating activities for the first quarter of 2025 was approximately
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.
Operating results
Total operating expenses were approximately
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
kiki@gilmartinir.com
Media Contact:
Meghan Bianco
Taft Communications
609-544-5446
Meghan.bianco@rfbinder.com
| Cardiff Oncology, Inc. | ||||||||
| Condensed Statements of Operations | ||||||||
| (in thousands, except for per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Royalty revenues | $ | 109 | $ | 205 | ||||
| Costs and expenses: | ||||||||
| Research and development | 10,477 | 8,008 | ||||||
| Selling, general and administrative | 4,014 | 3,130 | ||||||
| Total operating expenses | 14,491 | 11,138 | ||||||
| Loss from operations | (14,382 | ) | (10,933 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest income, net | 941 | 926 | ||||||
| Other income (expense), net | 7 | (4 | ) | |||||
| Total other income (expense), net | 948 | 922 | ||||||
| Net loss | (13,434 | ) | (10,011 | ) | ||||
| Preferred stock dividend | (6 | ) | (6 | ) | ||||
| Net loss attributable to common stockholders | $ | (13,440 | ) | $ | (10,017 | ) | ||
| Net loss per common share — basic and diluted | $ | (0.20 | ) | $ | (0.22 | ) | ||
| Weighted-average shares outstanding — basic and diluted | 66,524 | 44,678 | ||||||
| Cardiff Oncology, Inc. | ||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,095 | $ | 51,470 | ||||
| Short-term investments | 55,792 | 40,276 | ||||||
| Accounts receivable and unbilled receivable | 405 | 773 | ||||||
| Prepaid expenses and other current assets | 2,419 | 2,535 | ||||||
| Total current assets | 82,711 | 95,054 | ||||||
| Property and equipment, net | 805 | 898 | ||||||
| Operating lease right-of-use assets | 1,034 | 1,169 | ||||||
| Other assets | 257 | 69 | ||||||
| Total Assets | $ | 84,807 | $ | 97,190 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,629 | $ | 4,821 | ||||
| Accrued liabilities | 8,946 | 7,897 | ||||||
| Operating lease liabilities | 716 | 710 | ||||||
| Total current liabilities | 13,291 | 13,428 | ||||||
| Operating lease liabilities, net of current portion | 640 | 813 | ||||||
| Total Liabilities | 13,931 | 14,241 | ||||||
| Stockholders’ equity | 70,876 | 82,949 | ||||||
| Total liabilities and stockholders’ equity | $ | 84,807 | $ | 97,190 | ||||
FAQ
What are the key financial metrics for Cardiff Oncology (CRDF) in Q1 2025?
What is the status of Cardiff Oncology's CRDF-004 clinical trial?
What is the significance of Cardiff Oncology's new patent for mCRC treatment?
When will Cardiff Oncology (CRDF) release additional clinical data from the CRDF-004 trial?
What are the primary and secondary endpoints of Cardiff Oncology's CRDF-004 trial?
