Cardiff Oncology (NasdaqCM:CRDF) Update / briefing March 25, 2026 04:30 PM ET Company ParticipantsHeinz-Josef Lenz - University Professor of Medicine, Preventive Medicine, and Cancer BiologyMani Mohindru - Interim CEOScott Kopetz - Professor and Deputy Chair in the Department of Gastrointestinal Medical OncologyConference Call ParticipantsMarc Frahm - Managing Director and Senior Research AnalystMaury Raycroft - Equity Research AnalystModeratorPlease be advised that today's conference is being recorded. I w ...

Core Insights - Cardiff Oncology, Inc. is hosting a KOL webinar to discuss the treatment landscape for first-line RAS-mutated metastatic colorectal cancer (mCRC) on March 25, 2026 [1] - The webinar will feature key opinion leaders Scott Kopetz, M.D., Ph.D., FACP and Heinz-Josef Lenz, M.D., alongside interim CEO Mani Mohindru, focusing on the clinical data of onvansertib and its potential in mCRC management [2] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing innovative cancer treatments through PLK1 inhibition, with its lead asset onvansertib currently in a Phase 2 trial for first-line treatment of RAS-mutated mCRC [6] - Onvansertib targets a significant patient population with high unmet needs and is also being investigated in other PLK1-driven cancers, demonstrating robust clinical activity in challenging tumors [6] Key Opinion Leaders - Scott Kopetz, M.D., Ph.D., FACP, is a recognized leader in colorectal cancer research, focusing on new treatment approaches for molecularly defined colorectal cancers and has led numerous clinical studies [3] - Heinz-Josef Lenz, M.D., is a professor with a focus on molecular mechanisms of cancer and biomarker-driven treatment approaches, holding leadership roles in national oncology research initiatives [4] Webinar Details - Interested parties can register for the live webcast on Cardiff Oncology's website, with a replay available post-discussion [5]

Preclinical results in therapy-resistant HER2-low breast cancer models demonstrate enhanced antitumor activity and reversal of resistance with PLK1 inhibitionSAN DIEGO, March 19, 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 that new preclinical data highlighting the potential of its highly specific oral PLK1 inhibitor, onvansertib, in combination with tra ...

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies through PLK1 inhibition [3] Group 1: Upcoming Conferences - Company management will participate in three investor conferences in March 2026, including the TD Cowen 46th Annual Health Care Conference on March 4, Barclays 28th Annual Global Healthcare Conference on March 10, and Leerink Partners Global Healthcare Conference on March 11 [2] Group 2: Company Overview - Cardiff Oncology's lead asset, onvansertib, is a specific oral PLK1 inhibitor currently in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), targeting a large, underserved patient population [3] - Onvansertib is also being investigated in other PLK1-driven cancers through ongoing investigator-initiated trials and has demonstrated robust clinical activity in difficult-to-treat tumors [3] - The company's goal is to target tumor vulnerabilities to overcome treatment resistance and improve clinical outcomes for patients [3]

Summary of Cardiff Oncology FY Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Lead Program**: Onvansertib, a highly selective PLK1 inhibitor targeting first-line RAS mutated metastatic colorectal cancer (mCRC) [2][3] Core Points and Arguments - **Market Opportunity**: The colorectal cancer market is significant, with approximately 150,000 new cases annually and over 55,000 expected deaths by 2027. The five-year survival rate for metastatic colorectal cancer remains low at 15% [7][8]. - **Unmet Need**: There are currently no approved drugs specifically for RAS mutated mCRC, highlighting a substantial unmet medical need [8][9]. - **Efficacy Data**: - Onvansertib demonstrated a confirmed overall response rate (ORR) of 72% when combined with FOLFIRI and bevacizumab, representing a 30% improvement over the standard of care [4][20]. - The median progression-free survival (PFS) has not yet been reached in the onvansertib arm, while the standard of care arm has a median PFS of approximately 11 months [21][22]. - The study showed favorable dose-dependent trends and PFS hazard ratios, indicating potential for practice-changing outcomes in underserved populations [5][22]. - **Regulatory Path**: The company plans to finalize a path to registration for onvansertib in frontline RAS-mutated mCRC after discussions with the FDA, aiming to provide a full plan within the first half of 2026 [6][27]. Competitive Landscape - **Current Treatments**: The standard of care for first-line mCRC has remained largely unchanged, primarily involving combinations of chemotherapy with bevacizumab [8][9]. - **Unique Positioning**: Onvansertib is positioned as the only program specifically designed for the entire RAS-mutated population, differentiating it from mutation-specific therapies currently in development [9][10]. Additional Insights - **Combination Potential**: Onvansertib shows promise not only in mCRC but also in other RAS-driven cancers, such as chronic myelomonocytic leukemia (CMML) [30][31]. - **Cash Position**: Cardiff Oncology reported $58.3 million in cash equivalents, sufficient to fund operations into the first quarter of 2027, although this does not include significant investments for the phase 3 study [33][34]. - **Clinical Benefit**: The company believes that the totality of data, including ORR, PFS, and hazard ratios, supports the clinical benefit of onvansertib, which is compelling for regulatory discussions [36][39]. Future Outlook - **Upcoming Milestones**: Cardiff Oncology plans to share more detailed data from the ongoing phase 2 study and regulatory feedback in the first half of 2026, with a focus on advancing to phase 3 trials [31][32][27].

Drug Development and Clinical Trials - Onvansertib, a highly selective PLK1 inhibitor, is being developed for various cancers, including RAS-mutated metastatic colorectal cancer (mCRC) and small cell lung cancer (SCLC) [16]. - The ongoing CRDF-004 trial for RAS-mutated mCRC has enrolled 110 patients, comparing onvansertib (20mg and 30mg) in combination with standard-of-care (SoC) therapies against SoC alone [22]. - The confirmed objective response rate (ORR) for onvansertib at 30mg was 72.2%, compared to 43.2% for SoC, with a p-value of 0.051 [25]. - Median progression-free survival (PFS) for onvansertib at 30mg was not reached (NR) compared to 10.97 months for SoC, with a hazard ratio (HR) of 0.37 [25]. - A Phase 1b/2 trial of onvansertib in combination with NALIRIFOX for metastatic pancreatic ductal adenocarcinoma (mPDAC) is currently open for enrollment [27]. - In a Phase 2 trial for SCLC, preliminary data showed a disease control rate (DCR) of 57% among seven patients, with one confirmed partial response [31]. - Onvansertib demonstrated a 40% objective response rate in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC) [36]. - Onvansertib is the only oral PLK1 inhibitor in active clinical development, with over 400 patients dosed across multiple clinical programs [98]. Regulatory and Compliance Issues - The FDA has agreed to a seamless Phase 3 trial design for onvansertib, contingent on CRDF-004 results, with endpoints including ORR and overall survival [23]. - The FDA review process for marketing applications typically takes ten months for non-priority drugs, with potential extensions for additional information [69]. - Post-approval, the FDA imposes substantial testing and surveillance requirements to monitor the drug's safety and efficacy, which can impact market potential [72]. - The company is subject to the U.S. Foreign Corrupt Practices Act, which prohibits bribery of foreign officials to obtain business [77]. - The company must comply with the federal Anti-Kickback Statute, which prohibits remuneration to induce referrals for healthcare services [78]. - The Patient Protection and Affordable Care Act (ACA) increased Medicaid rebates from 15.1% to 23.1% and imposed new fees on pharmaceutical manufacturers [88]. - The Inflation Reduction Act of 2022 requires manufacturers to negotiate drug prices with Medicare starting in 2026 and imposes rebates for price increases above inflation [90][91]. - The company faces significant penalties for violations of healthcare laws, including civil, criminal, and administrative penalties, which could adversely affect operations [87]. - The company must navigate complex data privacy laws, including HIPAA and GDPR, which can result in significant penalties for non-compliance [94]. - The company is subject to extensive regulations in the European Union, requiring marketing authorization and pricing approvals for biologics [93]. - Compliance with various federal, state, and local laws regarding safe working conditions and environmental protection may incur significant costs [95]. - Increased scrutiny of healthcare interactions has led to investigations and prosecutions in the industry, impacting compliance efforts [86]. Financial Position and Capital Requirements - As of December 31, 2025, the company reported an accumulated total deficit of approximately $430.0 million and a net loss attributable to common stockholders of approximately $45.9 million for the fiscal year 2025 [107]. - The company's cash, cash equivalents, and short-term investments balance was approximately $58.3 million, with working capital of approximately $43.7 million as of December 31, 2025 [109]. - The management has expressed substantial doubt about the company's ability to continue as a going concern without additional capital [110]. - The company has not successfully developed or commercially marketed any product candidate to date, and it does not expect to commercialize its product candidate for at least several years [114]. - The company may need to raise substantial additional capital to develop and commercialize onvansertib, which could delay or reduce its product development programs [109]. - The company has incurred losses since its formation and expects to continue incurring substantial net losses for the foreseeable future [107]. Intellectual Property and Competitive Landscape - As of December 31, 2025, the company holds 51 issued patents and 65 pending patent applications globally, critical for protecting proprietary technologies [47]. - The intellectual property portfolio includes 25 patent families related to onvansertib, with patents expiring between 2039 and 2045, covering various cancer treatment methods [48]. - The company has exclusive rights to develop combination therapies involving onvansertib and anti-androgen drugs, enhancing potential treatment options for multiple cancers [49]. - The company’s ability to protect its intellectual property is challenged by recent changes in patent laws and potential litigation costs [203]. - Competitors may develop more effective technologies, which could undermine the company's competitive advantage if intellectual property is not adequately protected [207]. - The company faces uncertainties regarding the level of protection provided by its patents, which may be challenged in court by competitors [209]. - Substantial costs may be incurred due to litigation or proceedings related to patent and intellectual property rights, potentially diverting management's attention [210]. - Competitors may have filed patent applications that could block or compete with the company's potential products, leading to costly interference proceedings [212]. Operational Risks and Challenges - The company relies on third-party manufacturers and distributors for the supply and distribution of onvansertib used in clinical studies [55]. - The company is currently addressing a notice from Nerviano alleging a material breach of the license agreement, which could significantly affect its business if unresolved [52]. - The company emphasizes the importance of protecting proprietary information through confidentiality agreements, although such measures can be challenging to enforce [54]. - The company relies on third-party vendors for conducting preclinical studies and clinical trials, which may lead to delays or additional expenses if these vendors fail to perform satisfactorily [120]. - Limited capacity for recruiting and managing clinical trials could impair the timing of obtaining FDA approval for the product candidate [121]. - The company faces a competitive disadvantage due to limited resources compared to larger pharmaceutical companies, which may affect the success of its product candidate [122]. - Regulatory approval processes are lengthy and unpredictable, with no assurance that the product candidate will receive approval from the FDA or foreign authorities [134]. - The company has not previously submitted a Biologics License Application (BLA) or New Drug Application (NDA) for its product candidate, creating uncertainty regarding future regulatory approval [138]. - Clinical trials may be suspended or discontinued due to unexpected side effects or safety risks, which could hinder the approval process [140]. - The company may face significant liability if adverse health effects occur during clinical trials, impacting its ability to proceed with development [141]. - The approval of companion diagnostics is crucial for the commercialization of the product candidate, and failure to obtain such approvals could adversely affect revenue [142]. - The company must continuously enhance its capabilities in drug development, which may require hiring qualified personnel and managing third-party consultants effectively [127]. - The company faces substantial enforcement actions, including civil and criminal penalties, if it fails to comply with healthcare regulations, which could adversely affect its business and financial condition [143]. - The FDA's review and approval process for product candidates is lengthy, expensive, and uncertain, potentially taking several years to satisfy requirements for safety and efficacy [146]. - The company may not be able to commercialize its product candidate without FDA approval, which is critical for generating revenue in the United States [145]. - Competition from established pharmaceutical and biotechnology companies, as well as academic institutions, poses a significant threat, as many competitors have greater financial resources and expertise [153]. - The company relies on third-party manufacturers for production, and any failure to meet regulatory compliance or production volumes could delay development and commercialization [157]. - The ability to manufacture the product candidate in commercial quantities is uncertain, which could prevent successful commercialization if FDA approval is obtained [163]. - Market acceptance of the product candidate among physicians, patients, and third-party payors is crucial for revenue generation, and lack of acceptance could significantly reduce potential revenues [166]. - The company must ensure compliance with Good Manufacturing Practices (GMP) requirements, as failure to do so could result in fines, delays, or withdrawal of product approval [162]. - The approval process for new products can be affected by government funding and agency disruptions, which may hinder timely product development and commercialization [151]. - The company is pursuing supply agreements with manufacturers, but may face challenges in securing long-term agreements on commercially reasonable terms [158]. - The company relies on third-party contract manufacturers for product formulation and manufacturing, exposing it to risks that could delay clinical trials or increase costs [169]. - The company does not have internal drug discovery capabilities and depends on in-licensing or acquiring product candidates from third parties to expand its pipeline [173]. - The company has 31 employees as of December 31, 2025, and future growth will impose significant responsibilities on management to attract and retain skilled personnel [182]. - The company faces potential product liability claims that could exceed its insurance coverage, which may materially harm its business [176]. - The company is subject to ongoing inspections by regulatory agencies, and failure to comply could result in sanctions that adversely affect its business [171]. - The company may need to change third-party manufacturers, which could delay product development and increase costs significantly [172]. - The company is exposed to risks from natural disasters that could disrupt operations and adversely affect financial condition [183]. - The company must comply with various privacy and data security laws, which may require significant capital and resources to ensure compliance [188]. - General economic conditions, including healthcare reform and geopolitical issues, may negatively impact the company's business and financial condition [189]. - The company may delay or terminate product candidate development if the perceived market opportunity does not justify further investment [180]. Market Opportunity and Strategic Partnerships - The American Cancer Society estimates 108,860 new cases of colon cancer and 49,990 new cases of rectal cancer in the US for 2026, highlighting the significant market opportunity for onvansertib [41]. - Pfizer Ignite will oversee the clinical activities of the new CRDF-004 trial for first-line RAS-mutated mCRC, expanding the existing partnership established in November 2021 [46].

Core Insights - Cardiff Oncology reported positive results from the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC), showing a robust objective response rate (ORR) of 72.2% with the 30 mg onvansertib + FOLFIRI/bev combination, compared to 43.2% with standard of care (SoC) [1][5] - The trial also demonstrated a significant improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.37, indicating a strong potential for onvansertib to enhance patient outcomes [1][5] - The company plans to advance the 30 mg dose of onvansertib into a registrational program, with detailed data and plans expected in the first half of 2026 [1][2] Clinical Development - The CRDF-004 trial results indicate a consistent, dose-dependent treatment benefit, with nearly a 30% improvement in response rate over the control arm and encouraging durability trends in PFS [2][5] - The company has not observed significant added toxicity with the 30 mg onvansertib dose in combination with FOLFIRI/bev, supporting its advancement into registrational development [5] Financial Performance - For the year ended December 31, 2025, Cardiff Oncology reported total operating expenses of approximately $49.6 million, a slight increase from $49.3 million in 2024, primarily due to higher selling, general, and administrative expenses [8][14] - The company reported a net loss of $45.876 million for 2025, compared to a net loss of $45.455 million in 2024, with a net loss per common share of $0.69 [14] - As of December 31, 2025, Cardiff had approximately $58.3 million in cash and cash equivalents, sufficient to fund operations into the first quarter of 2027 [7] Leadership Changes - In January 2026, Cardiff announced executive leadership changes to support its transition into late-stage clinical development, appointing Mani Mohindru as interim Chief Executive Officer [4] - The company is actively searching for a permanent Chief Executive Officer and Chief Financial Officer to strengthen its leadership team [4]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies through PLK1 inhibition [3] - The company will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a live webcast available for interested parties [1][2] Company Overview - Cardiff Oncology is advancing innovative cancer treatments, particularly targeting PLK1 inhibition, which is recognized as a validated oncology target with significant potential to change clinical practice [3] - The lead asset, onvansertib, is an oral PLK1 inhibitor currently in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large patient population with high unmet needs [3] - Onvansertib is also being investigated in other PLK1-driven cancers through ongoing investigator-initiated trials and has demonstrated robust clinical activity as a single agent in challenging tumors [3]

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Core Viewpoint - Cardiff Oncology Inc. experienced a significant decline of approximately 32% in stock price following management and trial updates, indicating investor concern over leadership changes and clinical trial focus [1][9]. Management Changes - Mani Mohindru has been appointed as interim CEO, effective immediately, following the resignation of CEO Mark Erlander and CFO James Levine [1][2]. - Brigitte Lindsay has been promoted to Chief Accounting Officer to ensure financial continuity, having been with the company for over 14 years [2]. Clinical Trial Update - Cardiff Oncology provided an update on the CRDF-004 trial, which is a Phase 2 study evaluating onvansertib in combination with standard care regimens for patients with RAS-mutated metastatic colorectal cancer [3]. - The trial showed a 72.2% confirmed objective response rate in the 30 mg dose group of onvansertib with FOLFIRI/bevacizumab, compared to 43.2% in the standard care group, approaching statistical significance (p-value = 0.051) [4]. - Progression-free survival was statistically significant for the 30 mg onvansertib plus FOLFIRI/bevacizumab group (p-value = 0.048), with median progression-free survival not yet reached in the treatment groups [5]. Future Plans - Based on the trial results, the company plans to advance the 30 mg dose of onvansertib with FOLFIRI/bevacizumab into a registrational trial for first-line patients with RAS-mutated metastatic colorectal cancer, pending FDA consultation [6]. - The focus will be narrowed to onvansertib in combination with FOLFIRI, which may reduce the total addressable market in the frontline setting to 12%-20% from a previous estimate of 40%-50% [8]. Analyst Commentary - Analysts from William Blair expressed concerns regarding the abrupt management changes and the narrowed focus on onvansertib with FOLFIRI, leading to a reduction in the probability of success from 50% to 45% [8]. - Despite the concerns, William Blair maintains an Outperform rating for the stock [9].