Cardiff Oncology Reports Second Quarter 2026 Results and Provides Business Update

Rhea-AI Summary

Market reaction after 2Q26 earnings report: CRDF -7.61%

-7.61% $0.97

15m delay

-7.61% Vs previous close

$0.97 Last Price

$0.97 $1.10 Day Range

$75.47M Market Cap

0.7x Rel. Volume

Following this news, CRDF has declined 7.61%, reflecting a notable negative market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.97.

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Market Context

The stock is down -7.6% following this news. Historical earnings event 884635 recorded a -24.77% 24-...

Analysis

The stock is down -7.6% following this news. Historical earnings event 884635 recorded a -24.77% 24-hour reaction. This report again paired clinical progress with financing requirements and ongoing cash use, while the NMS licensing dispute represented a material business risk.

Key Figures

Confirmed ORR: 72.2% Confirmed ORR: 42.1% PFS hazard ratio: 0.55 (95% CI: 0.15–2.09) +5 more

8 metrics

Confirmed ORR 72.2% 30 mg onvansertib plus FOLFIRI/bevacizumab arm, Phase 2 CRDF-004

Confirmed ORR 42.1% FOLFIRI/bevacizumab alone arm, Phase 2 CRDF-004

PFS hazard ratio 0.55 (95% CI: 0.15–2.09) BICR assessment, onvansertib plus FOLFIRI/bevacizumab vs. FOLFIRI/bevacizumab

PFS hazard ratio 0.57 (95% CI: 0.20–1.65) Investigator assessment, onvansertib plus FOLFIRI/bevacizumab vs. FOLFIRI/bevacizumab

Registered direct offering $10 million Completed offering of common stock and warrants

Cash and investments $34.5 million As of June 30, 2026

Operating cash use $24.1 million Six months ended June 30, 2026

Cash runway Q3 2027 Based on current expectations and projections

Previous Earnings Reports

5 past events · Latest: May 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 14	Q1 earnings report	Positive	-3.5%	Clinical progress, FDA meeting, Phase 3 preparation, and cash runway update
Feb 24	FY2025 earnings report	Positive	+12.3%	Positive Phase 2 data, improved PFS, cash position, and leadership update
Nov 06	Q3 earnings report	Positive	-2.7%	Phase 2 data showed improved response rate and early PFS separation
Jul 29	Q2 earnings report	Positive	-24.8%	Phase 2 enrollment completion, leadership appointment, and positive clinical data
May 08	Q1 earnings report	Positive	+1.1%	Trial enrollment completion, patent extension, and cash runway update

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Among five prior earnings events, three showed positive company news followed by negative 24-hour price reactions.

Key Terms

plk1 inhibition, objective response rate, progression-free survival, hazard ratio, +2 more

6 terms

plk1 inhibition medical

"a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies"

PLK1 inhibition means blocking the activity of the enzyme Polo‑like kinase 1, a protein that helps cells divide. For investors, it signals a drug approach aimed at slowing or stopping fast‑growing tumors by disrupting the cell’s “division machinery,” but it also raises safety and trial‑success questions because the same process is important in healthy tissues; clinical results and side‑effect profiles drive the investment impact.

objective response rate medical

"clinically meaningful improvements in confirmed objective response rate (“ORR”)"

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

"clinically meaningful improvements in confirmed objective response rate (“ORR”) and progression-free survival"

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

"Secondary endpoint of PFS hazard ratio ("HR") of 0.55"

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.

registered direct offering financial

"Cardiff announced a $10 million registered direct offering of common stock and warrants"

A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.

end-of-phase 2 meeting regulatory

"Following completion of a successful EoP2 meeting, Cardiff aligned with the FDA"

An end-of-phase 2 meeting is a formal discussion between a drug developer and a regulatory agency to review mid-stage clinical results and agree on the plan and requirements for the larger, final tests needed for approval. It matters to investors because the meeting can clarify what evidence regulators will require, shape the cost and timeline for the next phase, and reduce uncertainty about whether a drug can advance toward market — like a checkpoint that determines whether a project gets the green light to move to the next, expensive stage.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC

Following successful End-of-Phase 2 meeting with FDA, Company aligned on key elements of registrational trial; plans to initiate study in Q1 2027, subject to securing additional financing

Completed $10 million Registered Direct offering, extending cash runway

SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced financial results for the second quarter ended June 30, 2026, and provided a business update.

“The second quarter was an important period of progress for Cardiff, highlighted by the presentation of positive Phase 2 data at ASCO and our continued progress in preparation for a planned registrational trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “The updated CRDF-004 results reinforced our confidence in the selected registrational dose and regimen of 30 mg onvansertib in combination with FOLFIRI/bevacizumab. This regimen has demonstrated deep and durable tumor shrinkage over time, reflecting the synergistic mechanisms of action, while maintaining a well-tolerated safety profile with no overlapping or new toxicities when added to standard-of-care therapy.”

Dr. Mohindru continued, “Following our successful End-of-Phase 2 meeting with the FDA, we are preparing to initiate the planned Phase 3 trial in the first quarter of 2027, subject to securing additional financing. We believe the totality of data generated to date strengthens onvansertib’s potential to become an important new treatment option for patients with first-line RAS-mutated metastatic colorectal cancer, an area where there remains significant unmet need.”

Clinical and Regulatory Highlights

Presented Positive Results from Randomized, Controlled Phase 2 CRDF-004 Trial at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting

In June, Cardiff presented positive results from CRDF-004, its ongoing, randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (“SoC”) regimens in patients with first-line RAS-mutated metastatic colorectal cancer (“mCRC”), in a rapid oral presentation at the 2026 ASCO Annual Meeting.

The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib plus SoC regimen for the registrational program. The selected regimen, 30 mg onvansertib in combination with FOLFIRI/bevacizumab (“bev”), demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in confirmed objective response rate (“ORR”) and progression-free survival (“PFS”) compared to SoC alone, with no additive adverse events observed. Data highlights from the ongoing Phase 2 trial, based on a March 18, 2026 data cut, are listed below, with the full press release available here:

• The 30 mg onvansertib plus FOLFIRI/bev arm achieved a confirmed ORR of 72.2% compared to 42.1% for FOLFIRI/bev alone, a 30% ORR improvement over SoC. The responses were deeper and more durable in the onvansertib arm.
• Secondary endpoint of PFS hazard ratio ("HR") of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) for patients treated with 30 mg onvansertib plus FOLFIRI/bev vs. FOLFIRI/bev by Blinded Independent Central Review ("BICR") and investigator assessment ("IA"), respectively.
• Four patients remained on onvansertib treatment beyond 15 months, including two patients beyond 20 months.
• Onvansertib in combination with SoC regimens continued to be well-tolerated, with no major or unexpected toxicities and no additive adverse events observed.

The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

Completed Successful End-of-Phase 2 (“EoP2”) Meeting with FDA and Advanced Phase 3 Readiness Activities

• Following completion of a successful EoP2 meeting, Cardiff aligned with the FDA on key design elements for its planned registrational Phase 3 trial of onvansertib in first-line RAS-mutated mCRC.
• The planned randomized, controlled Phase 3 trial is expected to evaluate 30 mg onvansertib in combination with FOLFIRI/bev compared to SoC FOLFIRI/bev as first-line therapy in patients with RAS-mutated mCRC. Cardiff is preparing to initiate the trial in the first quarter of 2027, subject to securing additional financing.

Preclinical Highlights

Presented New Preclinical Data at the 2026 American Association for Cancer Research (“AACR”) Annual Meeting Supporting the Rationale for Onvansertib in Combination with Antibody-Drug Conjugates (“ADCs”)

• In April, Cardiff presented new preclinical data at the 2026 AACR Annual Meeting supporting the rationale for onvansertib in combination with ADCs. The data demonstrated that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan, driving tumor regression and overcoming resistance in HER2-low breast cancer models.
  

Corporate Update

• In February 2026, the Company received written notice from its licensor, Nerviano Medical Sciences S.r.l. (“NMS”), alleging that the Company was in material breach of the license agreement. NMS subsequently purported to terminate the license agreement based on the Company’s alleged material breach. The Company filed a lawsuit in May 2026 in the U.S. District Court for the Southern District of California seeking a declaratory judgment that it is not in material breach and injunctive relief requiring NMS to continue performing under the license agreement. The Company believes that NMS’s purported termination is legally ineffective, factually unsupported and procedurally improper, and the Company plans to continue performing under the license agreement.
• In July, Cardiff announced a $10 million registered direct offering of common stock and warrants to support working capital and general corporate purposes. The full press release is available here.

Second Quarter 2026 Financial Results

Liquidity, cash burn, and cash runway

As of June 30, 2026, Cardiff Oncology had approximately $34.5 million in cash, cash equivalents, and short-term investments. The amount as of June 30, 2026 does not include proceeds from the registered direct offering completed subsequent to quarter end.

Net cash used in operating activities for the six months ended June 30, 2026 was approximately $24.1 million, an increase of $3.0 million from $21.1 million for the same period in 2025.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into the third quarter of 2027.

Operating results

Total operating expenses were approximately $22.6 million for the six months ended June 30, 2026, a decrease of $6.8 million from $29.4 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $9.4 million in R&D expenses, mainly related to the completion of clinical trials, as well as fewer patients still on treatment in the Phase 2 mCRC trial, and a reduction in preclinical activities as the Company focuses on its upcoming Phase 3 mCRC trial. The decrease in expenses was partially offset by an increase of $2.6 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options, as well as an increase in attorney costs related to Cardiff Oncology’s ongoing licensing dispute.

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; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. (NMS) with respect to our license agreement with NMS; 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) (unaudited)
	Three Months Ended June 30,								Six Months Ended June 30,
	2026				2025				2026				2025
Royalty revenues	$	104			$	121			$	145			$	230
Costs and expenses:
Research and development		5,915				11,580				12,680				22,057
Selling, general and administrative		3,804				3,318				9,930				7,332
Total operating expenses		9,719				14,898				22,610				29,389
Loss from operations		(9,615	)			(14,777	)			(22,465	)			(29,159	)
Other income (expense), net:
Interest income		382				835				888				1,776
Other income (expense), net		1				(1	)			0				6
Total other income (expense), net		383				834				888				1,782
Net loss		(9,232	)			(13,943	)			(21,577	)			(27,377	)
Preferred stock dividend		(6	)			(6	)			(12	)			(12	)
Net loss attributable to common stockholders	$	(9,238	)		$	(13,949	)		$	(21,589	)		$	(27,389	)
Net loss per common share — basic and diluted	$	(0.14	)		$	(0.21	)		$	(0.32	)		$	(0.41	)
Weighted-average shares outstanding — basic and diluted		68,397				66,526				68,373				66,525

Cardiff Oncology, Inc. Condensed Balance Sheets (in thousands) (unaudited)
	June 30, 2026				December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	9,197			$	17,470
Short-term investments		25,323				40,834
Accounts receivable and unbilled receivable		189				182
Prepaid expenses and other current assets		883				1,642
Total current assets		35,592				60,128
Property and equipment, net		450				578
Operating lease right-of-use assets		360				629
Other assets		927				549
Total Assets	$	37,329			$	61,884
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,986			$	8,087
Accrued liabilities		6,354				7,577
Operating lease liabilities		457				730
Total current liabilities		10,797				16,394
Operating lease liabilities, net of current portion		—				102
Total Liabilities		10,797				16,496
Stockholders’ equity		26,532				45,388
Total liabilities and stockholders’ equity	$	37,329			$	61,884