Cardiff Oncology Reports Second Quarter 2024 Results and Provides Business Update - Initial readout from first-line RAS-mut. mCRC randomized CRDF-004 trial expected in 2H 2024 - - Published preclinical data underscores the ability of onvansertib to overcome resistance to PARP inhibitors in high-grade serous ovarian carcinomas - - Five abstracts presented at AACR provide strong scientific rationale for the clinical development of onvansertib across multiple tumor types and various combinations - - Cash and e ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 CARDIFF ONCOLOGY, INC. (Exact Name of registrant as specified in its charter) Delaware 27-2004382 (State or other jurisd ...

SAN DIEGO, May 29, 2024 (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 company management will participate in a company presentation and 1x1 investor meetings at the Jefferies Healthcare Conference, which is taking place at the Marriott Marquis in New York from June 5-6, 2024. Details of the presentations can be found below. Presenters: Mark Erlander, CEO ...

Xesai Cardiff Oncology, Inc. (NASDAQ:CRDF) is a San Diego-based clinical-stage biotech focusing on developing innovative cancer treatments. CRDF's leading drug candidate, Onvansertib, is a first-in-class oral Polo-like Kinase 1 [PLK1] inhibitor that interferes with cancer cell division and may hinder cancer growth. Onvansertib is an ongoing trial as a monotherapy in combination with SoC treatments for mCRC, mPDAC, SCLC, and TNBC. Early data suggests it's efficient in overcoming resistance to other treatment ...

Cardiff Oncology Contact: SAN DIEGO, May 13, 2024 (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 company management will present at two upcoming investor conferences in May 2024. Details of the presentations can be found below. H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ Location: The Nasdaq Headquarters, New York City Presenter: Mar ...

Cardiff Oncology, Inc. (NASDAQ:CRDF) Q1 2024 Results Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Kiki Patel - Investor Relations, Gilmartin Group Mark Erlander - Chief Executive Officer Jamie Levine - Chief Financial Officer Conference Call Participants Mark Frahm - TD Cowen Joseph Catanzaro - Piper Sandler Andy Hsieh - William Blair Operator Welcome to the Cardiff Oncology First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are i ...

Cardiff Oncology Reports First Quarter 2024 Results and Provides Business Update - In RAS wild-type mCRC, preclinical data presented at AACR demonstrated onvansertib's antitumor activity both as a single agent and in combination, highlighting its broad activity across all mCRC - - Cash and equivalents of $67 million as of March 31, 2024, projected runway into Q3 2025 - SAN DIEGO, May 2, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develo ...

Clinical Trials and Efficacy - Onvansertib, a highly selective PLK1 inhibitor, has shown a 29% objective response rate (ORR) in the ongoing TROV-054 trial for KRAS-mutated metastatic colorectal cancer (mCRC) with a median duration of response of 12.0 months[67]. - The CRDF-004 trial for first-line treatment in RAS-mutated mCRC is expected to enroll approximately 90 evaluable patients, with initial data anticipated in the second half of 2024[63]. - In the ONSEMBLE trial, patients who were bevacizumab naïve had an ORR of 73% and a median progression-free survival of 15 months, significantly higher than historical controls[71]. - The Phase 2 trial in first-line mPDAC will assess the combination of onvansertib with Gemzar and Abraxane, with the primary endpoint being ORR[75]. - The objective response rate (ORR) in the Phase 2 trial for mPDAC was 19%, significantly higher than the historical control of 7.7%[79]. - Median progression-free survival (mPFS) in the same trial was 5.0 months, compared to 3.1 months with standard care[79]. - The disease control rate (DCR) in the Phase 2 trial for SCLC was 57%, with 4 out of 7 patients showing either confirmed partial response or stable disease[82]. Safety and Tolerability - Onvansertib has demonstrated favorable safety and tolerability, with no Grade 4 treatment-emergent adverse events (TEAEs) observed in the combination arms of the trials[71]. - Onvansertib has shown synergistic effects in combination with various cytotoxic agents, enhancing its potential efficacy across multiple cancer therapies[60]. Financial Performance - Total revenues for Q1 2024 were $205,000, up from $83,000 in Q1 2023, reflecting a significant increase in sales-based royalties[86]. - Research and development expenses decreased by $1.0 million to $8.0 million in Q1 2024 compared to $9.1 million in Q1 2023, primarily due to reduced clinical trial costs[88]. - As of March 31, 2024, the company had working capital of $58.1 million, down from $67.0 million at the end of 2023[91]. - Net cash used in operating activities for Q1 2024 was $7.7 million, a slight improvement from $8.7 million in Q1 2023[96]. - The company reported a net loss of $10.0 million for Q1 2024, compared to a net loss of $11.2 million in Q1 2023[97]. - Cash and cash equivalents totaled $67.2 million as of March 31, 2024, sufficient to meet funding requirements for at least the next 12 months[92]. - Net cash provided by investing activities for Q1 2024 was $4.6 million, down from $7.3 million in Q1 2023[99]. Future Plans and Regulatory Aspects - The company plans to initiate CRDF-005, a Phase 3 trial with registrational intent, contingent upon the results of CRDF-004, focusing on objective response rate as an interim endpoint[64]. - The ongoing clinical programs include five trials targeting various cancers, including mCRC and metastatic pancreatic ductal adenocarcinoma (mPDAC)[61]. - The FDA has agreed that a seamless trial design with ORR as an interim endpoint is acceptable for pursuing accelerated approval for onvansertib[64]. - The company emphasizes the importance of tumor genomics and biomarker assays in refining patient response assessments in its clinical development programs[57].

- Management will hold a conference call on Thursday, May 2 at 4:30 p.m. ET/1:30 p.m. PT - SAN DIEGO, April 25, 2024 (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 it plans to release financial results for the first quarter ended March 31, 2024 on Thursday, May 2 after the close of trading. Conference Call and Webcast Cardiff Oncology will host a conference ...

RAS-mutated mCRC – In RAS-mutated mCRC, novel preclinical finding demonstrates onvansertib inhibits the tumor's ability to adapt to hypoxia resulting in a significant decrease in both tumor vascularization and growth – – Enhanced clinical efficacy signal in bev naïve patients in Phase 1b/2 trial is consistent with results of randomized ONSEMBLE trial providing two independent data sets in second-line mCRC validating our strategy to evaluate onvansertib in combination with chemo/bev in RAS-mutated first-line ...