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CRDF

Cardiff OncologyD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-17
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Earnings documents stored for CRDF.

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Investor releaseQuarter not tagged2026-08-17

CRDF: Second Quarter Earnings

Zacks Small Cap Research
By John Vandermosten, CFA NASDAQ: CRDF READ THE FULL CRDF RESEARCH REPORT 2Q:26 Financial Results Cardiff Oncology, Inc. (NASDAQ: CRDF) reported second quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on August 11th, 2026. The company highlighted the Phase II data presented at ASCO at the end of May and shared its plans to initiate its pivotal onvansertib study in 1Q:27. Additional capital will be required to start the trial. Management also pointed to the $10 million registered direct offering that was completed in mid-July, which extends the cash runway. Regarding the Nerviano (NMS) dispute, in June Cardiff filed a motion for preliminary injunction requesting a halt to the termination, which was opposed by NMS. The injunction is awaiting decision while the two parties are conducting an Early Neutral Evaluation. In the meantime, Cardiff is advancing the onvansertib program towards the pivotal Phase III CRDF-005 study and has updated survival data for the CRDF-004 study as of late June. For the three-month period ended June 30th, 2026, Cardiff reported revenues of $104,000 and operating expense of $9.7 million. Loss per share was $0.14. Operating expenses fell 35% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ended June 30th, 2026 and versus the same prior quarterly period: Revenue of $104,000 compared to $121,000 and represents Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib; Research and development expenses totaled $5.9 million, down 49% from $11.6 million, predominantly due to a reduction in clinical trial expenses related to CRDF-004. Salaries, stock-based compensation and facilities costs also fell; Selling, General & Administrative expenses were $3.8 million, up 15% from $3.3 million. Increases in outside services and professional fees related to the Nerviano dispute, salaries, and facilities costs were partially offset by a decline in stock-based compensation; Net interest income of $382,000 was down compared with prior period amounts due to reduced interest income on lower cash levels. Other income of $1,000 compared to other expense of $1,000; Net loss was $9.2 million vs a net loss of $13.9 million, or $0.14 and $0.21 per share, respectively. As of June 30th, 2026, cash,…Read full document

By John Vandermosten, CFA NASDAQ: CRDF READ THE FULL CRDF RESEARCH REPORT 2Q:26 Financial Results Cardiff Oncology, Inc. (NASDAQ: CRDF) reported second quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on August 11th, 2026. The company highlighted the Phase II data presented at ASCO at the end of May and shared its plans to initiate its pivotal onvansertib study in 1Q:27. Additional capital will be required to start the trial. Management also pointed to the $10 million registered direct offering that was completed in mid-July, which extends the cash runway. Regarding the Nerviano (NMS) dispute, in June Cardiff filed a motion for preliminary injunction requesting a halt to the termination, which was opposed by NMS. The injunction is awaiting decision while the two parties are conducting an Early Neutral Evaluation. In the meantime, Cardiff is advancing the onvansertib program towards the pivotal Phase III CRDF-005 study and has updated survival data for the CRDF-004 study as of late June. For the three-month period ended June 30th, 2026, Cardiff reported revenues of $104,000 and operating expense of $9.7 million. Loss per share was $0.14. Operating expenses fell 35% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ended June 30th, 2026 and versus the same prior quarterly period: Revenue of $104,000 compared to $121,000 and represents Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib; Research and development expenses totaled $5.9 million, down 49% from $11.6 million, predominantly due to a reduction in clinical trial expenses related to CRDF-004. Salaries, stock-based compensation and facilities costs also fell; Selling, General & Administrative expenses were $3.8 million, up 15% from $3.3 million. Increases in outside services and professional fees related to the Nerviano dispute, salaries, and facilities costs were partially offset by a decline in stock-based compensation; Net interest income of $382,000 was down compared with prior period amounts due to reduced interest income on lower cash levels. Other income of $1,000 compared to other expense of $1,000; Net loss was $9.2 million vs a net loss of $13.9 million, or $0.14 and $0.21 per share, respectively. As of June 30th, 2026, cash, equivalents, and short-term investments totaled $34.5 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for the first six months of 2026 was $24.1 million versus $21.1 million. Following the end of the quarter, Cardiff executed a $10 million capital raise. Cash is expected to support operating activities into 3Q:27. The company will require additional capital to fund and initiate the CRDF-005 Phase III registrational study. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

Investor releaseQuarter not tagged2026-08-11

Cardiff Oncology Reports Second Quarter 2026 Results and Provides Business Update

GlobeNewswire
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”) reg…Read full document

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 Masseastr [email protected] Media Contact:Amy BonannoLyra Strategic [email protected]

Investor releaseQuarter not tagged2026-08-11

Cardiff Oncology: Q2 Earnings Snapshot

Associated Press

SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Tuesday reported a loss of $9.2 million in its second quarter. On a per-share basis, the San Diego-based company said it had a loss of 14 cents. The results exceeded Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 17 cents per share. The molecular diagnostic company posted revenue of $104,000 in the period, which met Street forecasts. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF

Investor releaseQuarter not tagged2026-06-02

Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting

GlobeNewswire
-​ The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -​ -​ 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -​ -​ Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -​ - Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -​ - Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -​ - Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib - SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients wit…Read full document

-​ The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -​ -​ 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -​ -​ Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -​ - Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -​ - Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -​ - Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib - SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC. “RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers,” said Dr. Lenz. “With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients.” Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved: Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm. Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively. Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months. Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC. No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone. Safety/Tolerability:Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms. “We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC,” said Mani Mohindru, PhD, President and Chief Executive Officer. “The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months.” The ASCO presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation. Conference Call and WebcastThe investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded. CRDF-004 Trial DesignThe CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety. For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308). About OnvansertibOnvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC. Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). 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 StatementsCertain 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. with respect to our license agreement with Nerviano; 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 [email protected] Media Contact: Amy Bonanno Lyra Strategic Advisory [email protected]

Investor releaseQuarter not tagged2026-05-22

CRDF: First Quarter 2026 Results

Zacks Small Cap Research
By John Vandermosten, CFA NASDAQ:CRDF READ THE FULL CRDF REPORT HERE 1Q:26 Financial Results Cardiff Oncology, Inc. (NASDAQ:CRDF) reported first quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on May 14th, 2026. For the three-month period ending March 31st, 2026 Cardiff reported revenues of $41,000 and operational expense of $12.9 million. Loss per share was $0.18. Operational expenses fell 11% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ending March 31st, 2026 and versus the same prior quarterly period: Revenues of $41,000 compared to $109,000 and represent Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib; Research and development expenses totaled $6.8 million, down 35% from $10.5 million attributable to a reduction in clinical trial expenses and a decrease in preclinical activities for the CRDF-004 clinical trial; Selling, General & Administrative expenses were $6.1 million, up 53% from $4.0 million. Increases relate to employee severance agreements and an increase in stock-based compensation attributable to the modification of stock options. These increases were offset by a decline in Outside Services and Professional Fees and Facilities and Other costs; Net interest income of $0.5 million was down compared with prior period amounts due to reduced interest income on lower cash levels and other expense of $1,000 compared to other income of $7,000; Net loss was $12.4 million vs. a net loss of $13.4 million or $0.18 and $0.20 per share, respectively. As of March 31st, 2026, cash, equivalents and short-term investments totaled $46.1 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for 1Q:26 was $12.3 million versus $12.8 million for 1Q:25. Cardiff’s cash is expected to support operating activities until 1Q:27. The company will need to raise additional capital to fund the CRDF-005 Phase III registrational study. Nerviano Dispute Earlier this year, Nerviano Medical Sciences sent written notice to Cardiff alleging that it was in a material breach of the onvansertib license agreement between the two. Brief details of the interaction were included in the 2025 Form 10-K. Nerviano attributed the breach to the failure of Cardiff to name…Read full document

By John Vandermosten, CFA NASDAQ:CRDF READ THE FULL CRDF REPORT HERE 1Q:26 Financial Results Cardiff Oncology, Inc. (NASDAQ:CRDF) reported first quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on May 14th, 2026. For the three-month period ending March 31st, 2026 Cardiff reported revenues of $41,000 and operational expense of $12.9 million. Loss per share was $0.18. Operational expenses fell 11% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ending March 31st, 2026 and versus the same prior quarterly period: Revenues of $41,000 compared to $109,000 and represent Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib; Research and development expenses totaled $6.8 million, down 35% from $10.5 million attributable to a reduction in clinical trial expenses and a decrease in preclinical activities for the CRDF-004 clinical trial; Selling, General & Administrative expenses were $6.1 million, up 53% from $4.0 million. Increases relate to employee severance agreements and an increase in stock-based compensation attributable to the modification of stock options. These increases were offset by a decline in Outside Services and Professional Fees and Facilities and Other costs; Net interest income of $0.5 million was down compared with prior period amounts due to reduced interest income on lower cash levels and other expense of $1,000 compared to other income of $7,000; Net loss was $12.4 million vs. a net loss of $13.4 million or $0.18 and $0.20 per share, respectively. As of March 31st, 2026, cash, equivalents and short-term investments totaled $46.1 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for 1Q:26 was $12.3 million versus $12.8 million for 1Q:25. Cardiff’s cash is expected to support operating activities until 1Q:27. The company will need to raise additional capital to fund the CRDF-005 Phase III registrational study. Nerviano Dispute Earlier this year, Nerviano Medical Sciences sent written notice to Cardiff alleging that it was in a material breach of the onvansertib license agreement between the two. Brief details of the interaction were included in the 2025 Form 10-K. Nerviano attributed the breach to the failure of Cardiff to name a Nerviano employee as joint inventor for US patents 12,144,813 and 12,263,173. Cardiff maintains that there is no breach and that the agreement does not require Cardiff to name Nerviano employees on patents that have been developed exclusively by Cardiff. It seeks injunctive relief requiring Nerviano to continue performing under the agreement and for the court to declare that it did not breach the agreement. Details of the event are in a Form 8-K filed on May 19th, 2026. The patent licensed by Nerviano has an expiry of May 2030 and it is likely that a full five years of patent term extension (PTE) will be allowed. With the PTE, the effective end of protection is 2035. We believe that the wording in the original license arrangement will be key to the outcome. While we do not provide legal opinions and lack complete visibility into the patents' development, we can point investors to the language in the agreement dated March 13th, 2017 with Cardiff’s predecessor Trovagene. The language states that Trovagene/Cardiff has entire rights to intellectual property it solely develops: 10.2 Ownership of Inventions. Subject to the terms hereof, including the licenses and other rights granted hereunder, all Inventions shall be owned as follows: Nerviano shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Nerviano (or solely by such persons and Third Parties performing work for Nerviano) in the performance of the Development Plan or other activities undertaken under this Agreement (“After-Developed Nerviano Inventions”). All After-Developed Nerviano Inventions will be included in the license and right granted under Article 3 above; Trovagene shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Trovagene (or solely by such persons and Third Parties performing work for Trovagene) in the performance of the Development Plan or other activities undertaken under this Agreement; (c) The Parties shall jointly own all Joint Inventions (as defined below). Nerviano’s rights in and to each Joint Invention (including all patent rights and other intellectual property rights to it) will be included in the license and rights granted under Article 2 above, and, subject to such license and rights, each Party may make, use, sell, keep, license or assign its interest in Joint Inventions and otherwise undertake all activities a sole owner might undertake with respect to such Joint Inventions, without the consent of and without accounting to the other Party. “Joint Inventions” means Inventions for which it is determined, in accordance with United States patent law, that both: (i) one or more employees, consultants or agents of Nerviano or any other persons obligated to assign such Invention to Nerviano; and (ii) one or more employees, consultants or agents of Trovagene or any other persons obligated to assign such Invention to Trovagene, are joint inventors. Starting a New Chapter On January 27th, 2026, the Cardiff board of directors announced that it had appointed a new chief executive officer in an interim role and would seek a new executive team to lead the company. Dr. Mani Mohindru took the reins of the company and was later confirmed as permanent President and CEO as disclosed in an April 9thpress release. Two other executive appointments were concurrently announced in that same release including Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, as Chief Operating Officer. AACR Poster Cardiff presented a poster at the 2026 American Association for Cancer Research (AACR) Annual Meeting held in San Diego, California from April 17 to 22. The title of the poster is PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models. It summarized preclinical work that examined the combination of trastuzumab deruxtecan (T-DXd) (Enhertu) with onvansertib and its effect on patient-derived xenograft models. Tumor volumes were measured using monotherapy of T-DXd and onvansertib and the combination of the two compared with a control. The xenograft models consistently showed that the combination therapy limited and even reversed tumor growth. The poster concluded that onvansertib enhances T-DXd efficacy and overcomes its resistance across triple negative breast cancer (TNBC) and hormone receptor positive (HR+) breast cancer models. The combination induces synergistic DNA damage and apoptosis. The authors claim that PLK1 inhibition offers a strategy to deepen and prolong T-DXd response in advanced HER2-low breast cancer resistant to first-line therapies. Next Steps for Onvansertib Following meetings with the FDA, Cardiff has essentially finalized its design of the anticipated Phase III registrational trial for onvansertib in 1H:26. The trial will be designated CRDF-005 and will evaluate 30 mg of onvansertib with FOLFIRI and bevacizumab (bev) vs. the standard of care of FOLFOX/bev and FOLFIRI/bev. In its latest investor presentation, management provided a preliminary trial design that seeks to enroll first line mCRC patients that are KRAS and NRAS positive presenting unresectable tumors. Dual primary endpoints are anticipated to be ORR and PFS with secondary endpoints of DoR and OS. We expect more detail after funding arrangements are clear. Source: Cardiff May 2026 Corporate Presentation SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 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Investor releaseQuarter not tagged2026-05-15

Cardiff Oncology Reports First Quarter 2026 Results and Provides Business Update

GlobeNewswire
Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting Leadership additions position Company to execute on key upcoming clinical and regulatory milestones SAN DIEGO, May 14, 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 first quarter ended March 31, 2026, and provided a business update. "This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “In April, we had a successful End-of-Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib's potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year.” Clinical Highlights Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) Annual Meeting 2026 The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation…Read full document

Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting Leadership additions position Company to execute on key upcoming clinical and regulatory milestones SAN DIEGO, May 14, 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 first quarter ended March 31, 2026, and provided a business update. "This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “In April, we had a successful End-of-Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib's potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year.” Clinical Highlights Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) Annual Meeting 2026 The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation is available here. Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026. Key Opinion Leader Engagements Highlight Onvansertib Clinical Data and Opportunity in mCRC In March, Cardiff hosted a KOL webinar featuring internationally recognized leaders in colorectal cancer research, Drs. Scott Kopetz and Heinz-Josef Lenz. The webinar focused on the evolving treatment landscape in first-line RAS-mutated mCRC and onvansertib’s potential as a novel therapeutic approach in the management of RAS-mutated mCRC. A replay of the webcast is available in the Events section of the Company’s website. Announced Positive Update from our Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC In January, Cardiff provided topline data from its ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bevacizumab (bev) arm achieved a confirmed objective response rate (ORR) of 72.2% compared to 43.2% across the combined standard-of-care (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. More details available here. Preclinical Highlights Company Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) Annual Meeting Supporting Rationale for Onvansertib in Combination with Antibody Drug Conjugates Cardiff presented new preclinical data at the AACR Annual Meeting in April demonstrating that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd), driving tumor regression and overcoming resistance in HER2-low breast cancer models. More details are available here. Corporate Update Key Leadership Appointments Strengthen Executive Team to Support Company’s Next Phase of Growth In April, the Company announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff's commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential. First Quarter 2026 Financial Results Liquidity, cash burn, and cash runway As of March 31, 2026, Cardiff Oncology had approximately $46.1 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the first quarter of 2026 was approximately $12.3 million, a decrease of approximately $0.5 million from $12.8 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 first quarter of 2027. Operating results Total operating expenses were approximately $12.9 million for the three months ended March 31, 2026, a decrease of $1.6 million from $14.5 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $3.7 million in R&D expenses, mainly clinical trial expenses and preclinical activities, partially offset by an increase of $2.1 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options. 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 [email protected] Media Contact: Amy Bonanno Lyra Strategic Advisory [email protected]

Investor releaseQuarter not tagged2026-05-15

Cardiff Oncology: Q1 Earnings Snapshot

Associated Press

SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Thursday reported a loss of $12.3 million in its first quarter. On a per-share basis, the San Diego-based company said it had a loss of 18 cents. The results did not meet Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 13 cents per share. The molecular diagnostic company posted revenue of $41,000 in the period, which also missed Street forecasts. Three analysts surveyed by Zacks expected $136,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF

Investor releaseQuarter not tagged2026-02-25

Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

GlobeNewswire
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 sta…Read full document

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 [email protected] Media Contact: Amy Bonanno Lyra Strategic Advisory [email protected]

Investor releaseQuarter not tagged2026-02-25

Cardiff Oncology: Q4 Earnings Snapshot

Associated Press Finance

SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Tuesday reported a loss of $7.2 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 11 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. The molecular diagnostic company posted revenue of $243,000 in the period, which also beat Street forecasts. Four analysts surveyed by Zacks expected $130,000. For the year, the company reported a loss of $45.9 million, or 69 cents per share. Revenue was reported as $593,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF

Investor releaseQuarter not tagged2025-11-07

Cardiff Oncology Reports Third Quarter 2025 Results and Provides Business Update

GlobeNewswire
– Announced positive data from the ongoing Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer – – Expects to report an update from the Phase 2 CRDF-004 trial in Q1 2026 – – Cash and investments of $60.6 million as of September 30, 2025, projected runway into Q1 2027 – SAN DIEGO, Nov. 06, 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 third quarter ended September 30, 2025, and provided a business update. “This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC. At the July 8, 2025 data cutoff, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR, faster time to response, deeper tumor regression, and early signs of separation in the progression-free survival curves when compared to standard of care alone,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The study is on track for the next clinical update in the first quarter of 2026, where we’ll look for a continuation of onvansertib’s favorable tolerability profile and more mature duration of response and progression-free survival data.” Continued Dr. Erlander, “Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients.” Company highlights for the quarter ended September 30, 2025: Announced positive data from the ongoing CRDF-004 Phase 2 randomized trial evaluating two doses of onvansertib in combination with standard of care (“SoC”) for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) As of the July 8, 2025 data cut-off, the Phase 2 CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate (“ORR”) in the 30mg onvansertib arm compared to the control arm in the intent-to-tre…Read full document

– Announced positive data from the ongoing Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer – – Expects to report an update from the Phase 2 CRDF-004 trial in Q1 2026 – – Cash and investments of $60.6 million as of September 30, 2025, projected runway into Q1 2027 – SAN DIEGO, Nov. 06, 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 third quarter ended September 30, 2025, and provided a business update. “This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC. At the July 8, 2025 data cutoff, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR, faster time to response, deeper tumor regression, and early signs of separation in the progression-free survival curves when compared to standard of care alone,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The study is on track for the next clinical update in the first quarter of 2026, where we’ll look for a continuation of onvansertib’s favorable tolerability profile and more mature duration of response and progression-free survival data.” Continued Dr. Erlander, “Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients.” Company highlights for the quarter ended September 30, 2025: Announced positive data from the ongoing CRDF-004 Phase 2 randomized trial evaluating two doses of onvansertib in combination with standard of care (“SoC”) for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) As of the July 8, 2025 data cut-off, the Phase 2 CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate (“ORR”) in the 30mg onvansertib arm compared to the control arm in the intent-to-treat population. While the median progression-free survival (“PFS”) has not yet been reached, early PFS data show a trend favoring the 30mg onvansertib arm versus control. Dose dependent responses were observed across all endpoints, including ORR, PFS, early tumor shrinkage, and depth of response. Onvansertib continues to be well-tolerated, with no major or unexpected toxicities observed. An update from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC is expected in 1Q 2026. Third Quarter 2025 Financial Results: Liquidity, cash burn, and cash runway As of September 30, 2025, Cardiff Oncology had approximately $60.6 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the third quarter of 2025 was approximately $10.8 million, an increase of $0.3 million from $10.5 million for the same period in 2024. 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 $12.1 million for the three months ended September 30, 2025, a decrease of $0.7 million from $12.8 million for the same period in 2024. The decrease in operating expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities. 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 and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and metastatic triple negative breast cancer (mTNBC). 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 [email protected] Investor Contact: Candice Masse astr partners [email protected] Media Contact: Amy Bonanno Lyra Strategic Advisory [email protected]

Investor releaseQuarter not tagged2025-11-07

Cardiff Oncology: Q3 Earnings Snapshot

Associated Press Finance

SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Thursday reported a loss of $11.3 million in its third quarter. On a per-share basis, the San Diego-based company said it had a loss of 17 cents. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share. The molecular diagnostic company posted revenue of $120,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF

Investor releaseQuarter not tagged2025-07-30

Cardiff Oncology Reports Second Quarter 2025 Results and Provides Business Update

GlobeNewswire
- Appointed Dr. Roger Sidhu as Chief Medical Officer - - 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”) - - Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in mTNBC at ASCO 2025 - - Cash and investments of $71.0 million as of June 30, 2025, projected runway into Q1 2027 - - Company to hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT to share updated clinical data from the CRDF-004 trial - SAN DIEGO, July 29, 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 second quarter ended June 30, 2025, and provided a business update. “In the second quarter, we achieved an important milestone by completing enrollment in our ongoing CRDF-004 trial evaluating onvansertib plus standard of care for the treatment of first-line RAS-mutated mCRC,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “As we evolve into a late-stage clinical development company, we were excited to appoint Dr. Sidhu as our new Chief Medical Officer to provide expert guidance in advancing onvansertib through the registrational phase of development. We’re pleased to welcome him to the team and are confident that his expertise will be instrumental as we work toward bringing this potential therapy to patients.” Conference Call and Webcast on Clinical Data from Ongoing CRDF-004 Trial in mCRC Cardiff Oncology will host a live conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share clinical data from the ongoing CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at https://investors.cardiffoncology.com/news-events/events. A replay will be available in the investor relations section on the company's website following the completion of the call. Company highlights for the quarter ended June 30, 2025, and subsequent weeks include: Appointed Dr. Roger Sidhu as Chief Medical Officer In June 2025, the company appointed Roger Sidhu, MD, as Chief Medical Off…Read full document

- Appointed Dr. Roger Sidhu as Chief Medical Officer - - 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”) - - Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in mTNBC at ASCO 2025 - - Cash and investments of $71.0 million as of June 30, 2025, projected runway into Q1 2027 - - Company to hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT to share updated clinical data from the CRDF-004 trial - SAN DIEGO, July 29, 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 second quarter ended June 30, 2025, and provided a business update. “In the second quarter, we achieved an important milestone by completing enrollment in our ongoing CRDF-004 trial evaluating onvansertib plus standard of care for the treatment of first-line RAS-mutated mCRC,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “As we evolve into a late-stage clinical development company, we were excited to appoint Dr. Sidhu as our new Chief Medical Officer to provide expert guidance in advancing onvansertib through the registrational phase of development. We’re pleased to welcome him to the team and are confident that his expertise will be instrumental as we work toward bringing this potential therapy to patients.” Conference Call and Webcast on Clinical Data from Ongoing CRDF-004 Trial in mCRC Cardiff Oncology will host a live conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share clinical data from the ongoing CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at https://investors.cardiffoncology.com/news-events/events. A replay will be available in the investor relations section on the company's website following the completion of the call. Company highlights for the quarter ended June 30, 2025, and subsequent weeks include: Appointed Dr. Roger Sidhu as Chief Medical Officer In June 2025, the company appointed Roger Sidhu, MD, as Chief Medical Officer. Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy. Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in metastatic triple negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 The Phase 1b study of onvansertib in combination with paclitaxel in mTNBC was led by Antonio Giordano, MD, PhD at Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School. Onvansertib in combination with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at RP2D of 18mg/m2 (n=10), with two confirmed partial responses and two unconfirmed partial responses. The combination was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event. Overall, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC. 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. 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 reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. The Company is holding a conference call today to share an update on the ongoing trial. Second Quarter 2025 Financial Results: Liquidity, cash burn, and cash runway As of June 30, 2025, Cardiff Oncology had approximately $71.0 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the second quarter of 2025 was approximately $8.3 million, a decrease of $0.9 million from $9.2 million for the same period in 2024. 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 $14.9 million for the three months ended, June 30, 2025, an increase of $2.2 million from $12.7 million for the same period in 2024. The increase in operating expenses was primarily due to costs associated with our CRDF-004 clinical trial, other clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, as well as salaries and wages for key hires and additional stock option grants. 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 and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and metastatic triple negative breast cancer (mTNBC). 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 [email protected] Investor Contact: Kiki Patel, PharmD Gilmartin Group 332-895-3225 [email protected] Media Contact: Meghan Bianco Taft Communications 609-544-5446 [email protected]

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook