Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

Rhea-AI Summary

Cardiff Oncology (Nasdaq: CRDF) reported positive Phase 2 CRDF-004 results in first-line RAS-mutated metastatic colorectal cancer and provided full-year 2025 financials and a business update.

The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed ORR of 72.2% versus 43.2% for combined SoC, and showed improved PFS (HR: 0.37, p<0.05). The company held $58.3M cash, expecting runway into Q1 2027, and named an interim CEO while searching for permanent CEO and CFO.

Positive

• ORR 72.2% for 30 mg onvansertib + FOLFIRI/bev
• PFS HR 0.37 versus combined standard of care (p<0.05)
• $58.3M cash supports operations into Q1 2027

Negative

• Cash runway extends only into Q1 2027, limiting long-term visibility
• Interim CEO appointed; permanent CEO and CFO search is ongoing

News Market Reaction – CRDF

+12.35%

26 alerts

+12.35% News Effect

+19.1% Peak in 27 hr 40 min

+$15M Valuation Impact

$132M Market Cap

1.1x Rel. Volume

On the day this news was published, CRDF gained 12.35%, reflecting a significant positive market reaction. Argus tracked a peak move of +19.1% during that session. Our momentum scanner triggered 26 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $15M to the company's valuation, bringing the market cap to $132M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ORR (30 mg arm): 72.2% ORR (SoC arms): 43.2% PFS hazard ratio vs SoC: 0.37 +5 more

8 metrics

ORR (30 mg arm) 72.2% Phase 2 CRDF-004, onvansertib 30 mg + FOLFIRI/bev

ORR (SoC arms) 43.2% Combined standard-of-care FOLFOX/bev and FOLFIRI/bev

PFS hazard ratio vs SoC 0.37 Phase 2 CRDF-004, PFS vs combined SoC, p<0.05

Cash & investments $58.3M As of December 31, 2025

Operating expenses 2025 $49.6M Year ended December 31, 2025

Operating expenses 2024 $49.3M Year ended December 31, 2024

CMML trial size 9 patients Phase 1 onvansertib monotherapy in CMML

CMML preliminary efficacy 40% of patients Investigator-sponsored Phase 1 CMML trial

Market Reality Check

Price: $1.91 Vol: Volume 932,115 vs 20-day ...

low vol

$1.91 Last Close

Volume Volume 932,115 vs 20-day average 1,783,487 (relative volume 0.52x) ahead of this update. low

Technical Trading below 200-day MA of 2.61, at 1.70 and 65.93% under 52-week high of 4.99.

Peers on Argus

CRDF was down 3.11% pre-news while peers were mixed: GNLX down 4.61%, SKYE up 5....

1 Up 1 Down

CRDF was down 3.11% pre-news while peers were mixed: GNLX down 4.61%, SKYE up 5.74%, others modestly positive. Moves are not uniformly aligned, indicating stock-specific factors rather than a clear sector trend.

Common Catalyst Several oncology peers reported program updates or conference participation, pointing to an environment focused on cancer pipelines and investor outreach.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	-2.7%	Q3 2025 results plus positive Phase 2 CRDF-004 data and cash runway.
Jul 29	Q2 2025 earnings	Positive	-24.8%	Q2 2025 financials with CRDF-004 enrollment completion and new IP.
May 08	Q1 2025 earnings	Positive	+1.1%	Q1 2025 results, strong cash and CRDF-004 enrollment completion.
Feb 27	FY 2024 results	Positive	+4.4%	FY 2024 update with strong response rates and financing completed.
Nov 07	Q3 2024 earnings	Positive	-24.7%	Q3 2024 results and positive second-line mCRC trial update.

Pattern Detected

Earnings and business updates that highlight clinical progress have often been followed by volatile or negative next-day moves, with three of the last five tagged earnings releases seeing declines despite largely positive operational commentary.

Recent Company History

Across the last five earnings/annual updates since Nov 2024, Cardiff consistently paired financials with progress on onvansertib in RAS-mutated mCRC and broader oncology efforts. Cash runway repeatedly extended into Q1 2027, while operating expenses trended higher with clinical investment. Market reactions were mixed to negative on several occasions despite positive trial signals, suggesting investors scrutinized burn and execution risk around late-stage development—context that frames today’s full-year 2025 report and Phase 2 update.

Historical Comparison

-9.3% avg move · In the past five earnings or annual updates, CRDF’s average next-day move was -9.31%, often negative...

earnings

-9.3%

Average Historical Move earnings

In the past five earnings or annual updates, CRDF’s average next-day move was -9.31%, often negative despite favorable clinical signals. Today’s full-year 2025 update with strong Phase 2 data fits this pattern of cautious market response.

Earnings updates show steady progression of onvansertib from early Phase 2 signals toward more mature randomized data, alongside maintained cash runway into Q1 2027 and growing investment in late-stage development.

Market Pulse Summary

The stock surged +12.3% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +12.3% in the session following this news. A strong positive reaction aligns with the article’s combination of robust Phase 2 efficacy signals and a stated cash runway into Q1 2027. Historically, however, earnings-linked updates for CRDF have averaged a -9.31% move, indicating past skepticism around burn and execution. Investors would likely watch future registrational trial design, operating expenses near $49.6M, and any financing needs as potential factors influencing durability of gains.

Key Terms

objective response rate, progression-free survival, hazard ratio, phase 2, +4 more

8 terms

objective response rate medical

"achieved a confirmed objective response rate (“ORR”) of 72.2%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

hazard ratio medical

"PFS over combined SoC (HR: 0.37, p<0.05)"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

phase 2 medical

"randomized Phase 2 CRDF-004 trial in first-line RAS-mutated"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 1 medical

"investigator-sponsored Phase 1 trial evaluating onvansertib monotherapy"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

intent-to-treat medical

"As of the January 22, 2026 cutoff in the intent-to-treat population"

A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.

monotherapy medical

"Phase 1 trial evaluating onvansertib monotherapy in CMML"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

standard of care medical

"in combination with standard of care (“SoC”) regimens in patients"

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

AI-generated analysis. Not financial advice.

Reported positive update from Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating:
• Robust ORR of 72.2% (vs 43.2% with combined SoC of FOLFOX/bev and FOLFIRI/bev)
• Significant improvement in PFS over combined SoC (HR: 0.37, p<0.05)

Data support selection of 30 mg onvansertib dose in combination with FOLFIRI/bev for planned registrational program; detailed data and registrational plans expected in the first half of 2026

SAN DIEGO, Feb. 24, 2026 (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 full year ended December 31, 2025, and provided a business update.

“Cardiff Oncology has entered 2026 with strong clinical momentum and a clear path for advancing onvansertib, our lead program, in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Our focus in 2025 was on rigorous clinical execution, which allowed us to generate increasingly compelling evidence supporting onvansertib’s potential to improve patient outcomes in RAS-mutated mCRC, culminating in the latest positive data cut announced earlier this year. The CRDF-004 trial demonstrated a consistent, dose-dependent treatment benefit when onvansertib was added to FOLFIRI/bev, including a near 30% improvement in response rate over the control arm and encouraging durability trends as measured by progression-free survival. These data are in line with what we had previously seen in our second-line trial in bev-naive patients treated with onvansertib + FOLFIRI/bev. Given that it has been over two decades since there has been meaningful innovation for this patient population, we believe these results represent a transformative step forward.”

Continued Dr. Mohindru, “Based on these results, we plan to advance the 30 mg dose of onvansertib with FOLFIRI/bev into our proposed registrational program and expect to provide detailed data and registrational plans after discussions with the FDA in the first half of 2026. As we transition into late-stage clinical development and continue to strengthen our leadership and operational teams, we remain focused on disciplined execution, progressing our lead program toward a potential new standard of care in first-line RAS-mutated mCRC.”

Company highlights for the quarter ended December 31, 2025, and subsequent weeks

Positive update from randomized Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (“mCRC”) support advancement of the onvansertib program into registrational development

• In January 2026, Cardiff reported a positive update from CRDF-004, a randomized Phase 2 trial evaluating onvansertib in combination with standard of care (“SoC”) regimens in patients with first-line RAS-mutated mCRC. As of the January 22, 2026 cutoff in the intent-to-treat population, the 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) of 72.2%, compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed.
  
• Based on these results, the Company expects to advance the 30 mg dose of onvansertib in combination with FOLFIRI/bev into planned registrational development. Cardiff expects to share detailed Phase 2 CRDF-004 data and, after discussions with the FDA, provide registrational plans for onvansertib in combination with FOLFIRI/bev in first-line RAS-mutated mCRC in the first half of 2026.
  

Executive leadership team transitioned to support late-stage development

• In January 2026, Cardiff announced executive leadership changes to support the Company’s transition into late-stage clinical development and advancement toward key clinical and corporate milestones. Mani Mohindru, PhD, a member of Cardiff’s Board of Directors since 2021 and an experienced biotechnology executive, was appointed interim Chief Executive Officer. Brigitte Lindsay was promoted to Chief Accounting Officer, ensuring continuity within the Company’s finance function. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.
  

Presentation of investigator-sponsored clinical data in chronic myelomonocytic leukemia (“CMML”) at the American Society of Hematology (“ASH”) Annual Meeting

• In December 2025, clinical data from an investigator-sponsored Phase 1 trial evaluating onvansertib monotherapy in CMML were presented at ASH 2025. In the dose-escalation trial (N=9), onvansertib was generally well-tolerated and demonstrated preliminary efficacy in approximately 40% of patients, including one patient achieving an optimal bone marrow response. These clinical findings further validate onvansertib’s potential activity across both hematologic and solid tumors.
  

Full Year 2025 Financial Results

Liquidity and Cash Runway

As of December 31, 2025, Cardiff Oncology had approximately $58.3 million in cash, cash equivalents, and short-term investments. Based on its current operating and clinical plans and projected expenditures, the Company believes that its existing cash resources are sufficient to fund operations into the first quarter of 2027.

Operating Results

Total operating expenses for the year ended December 31, 2025 were approximately $49.6 million, compared to $49.3 million for the year ended December 31, 2024. The $0.3 million increase was primarily attributable to an increase in SG&A expense, driven mainly by strategic advisory services and incremental employee separation costs recorded in the current period. This increase was partially offset by lower R&D expenses related to clinical trial activity and outside services. The reduction in R&D expenses was partially offset by an increase in stock-based compensation expense during the current period.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

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, 2025, 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.

Investor Contact:
Candice Masse
astr partners
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

Cardiff Oncology, Inc. Condensed Statements of Operations (in thousands, except for per share amounts)
		Year Ended December 31,
		2025				2024
Royalty revenues		$	593			$	683
Costs and expenses:
Research and development			35,329				36,852
Selling, general and administrative			14,224				12,482
Total operating expenses			49,553				49,334
Loss from operations			(48,960	)			(48,651	)
Other income (expense), net:
Interest income			3,104				3,259
Other income (expense), net			5				(39	)
Total other income (expense), net			3,109				3,220
Net loss			(45,851	)			(45,431	)
Preferred stock dividend			(25	)			(24	)
Net loss attributable to common stockholders		$	(45,876	)		$	(45,455	)
Net loss per common share — basic and diluted		$	(0.69	)		$	(0.95	)
Weighted-average shares outstanding — basic and diluted			66,841				47,650

Cardiff Oncology, Inc. Condensed Balance Sheets (in thousands)
		December 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	17,470			$	51,470
Short-term investments			40,834				40,276
Accounts receivable and unbilled receivable			182				773
Prepaid expenses and other current assets			1,642				2,535
Total current assets			60,128				95,054
Property and equipment, net			578				898
Operating lease right-of-use assets			629				1,169
Other assets			549				69
Total Assets		$	61,884			$	97,190
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	8,087			$	4,821
Accrued liabilities			7,577				7,897
Operating lease liabilities			730				710
Total current liabilities			16,394				13,428
Operating lease liabilities, net of current portion			102				813
Total Liabilities			16,496				14,241
Stockholders’ equity			45,388				82,949
Total liabilities and stockholders’ equity		$	61,884			$	97,190

FAQ

What were the Phase 2 CRDF-004 efficacy results for CRDF (Nasdaq: CRDF)?

The 30 mg onvansertib + FOLFIRI/bev arm achieved a 72.2% ORR versus 43.2% for combined SoC. According to Cardiff Oncology, the arm also showed improved PFS (HR: 0.37, p<0.05), supporting registrational planning.

Does Cardiff plan a registrational program for onvansertib (CRDF) after CRDF-004?

Yes — Cardiff plans to advance the 30 mg onvansertib dose with FOLFIRI/bev into registrational development. According to Cardiff Oncology, detailed data and registrational plans are expected after FDA discussions in H1 2026.

How much cash does Cardiff Oncology (CRDF) have and how long will it last?

Cardiff reported approximately $58.3 million in cash, cash equivalents, and short-term investments. According to Cardiff Oncology, these resources are expected to fund operations into the first quarter of 2027.

Did CRDF-004 show added toxicity with onvansertib alongside FOLFIRI/bev for CRDF (CRDF)?

No significant added toxicity was observed with onvansertib plus FOLFIRI/bev in CRDF-004. According to Cardiff Oncology, the 30 mg dose demonstrated efficacy improvements without a meaningful increase in toxicity.

What leadership changes did Cardiff Oncology (CRDF) announce in January 2026?

Cardiff appointed Mani Mohindru as interim CEO and promoted Brigitte Lindsay to chief accounting officer. According to Cardiff Oncology, the company is conducting a search for a permanent CEO and CFO to support late-stage development.

Were there additional clinical data for onvansertib beyond colorectal cancer in the 2025 update for CRDF?

Yes — investigator-sponsored Phase 1 CMML data presented at ASH 2025 showed preliminary efficacy in about 40% of patients with tolerability. According to Cardiff Oncology, these findings support activity across hematologic and solid tumors.