Cardiff Oncology

Cardiff Oncology, Inc. is an oncology therapeutics company, which engages in the development of drugs that target mitosis for the treatment of various types of cancer. It is focused on developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. The firm's clinical programs include KRAS-Mutated Metastatic Colorectal Cancer (mCRC), Resistant Metastatic Castration-Resistant Prostate Cancer (mCRPC) and relapsed or refractory Acute Myeloid Leukemia (AML). The company was founded by Gabriel M. Cerrone, L. David Tomei, Samuil Umansky, and Hovsep Melkonyan in 1999 and is headquartered in San Diego, CA.

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Cardiff Oncology reports strong Q3 performance and strategic growth plans

Cardiff Oncology's Q3 2023 performance reflects strong progress with positive data from their lead program and promising efficacy of onvansertib, supported by a solid financial position.
While the company faces challenges in maintaining clinical trial progress and managing expenses, strategic strengths like the expanded partnership with Pfizer and focus on shareholder value creation position them well for future growth.
Opportunities lie in advancing their lead program, exploring new therapeutic indications, and leveraging collaborations to drive market penetration and enhance competitiveness in the oncology space.

Cardiff Oncology reports strong Q4 performance and strategic advancements

Cardiff Oncology's Q4 2023 earnings call highlighted a strategic shift in their mCRC program, positive clinical data from the ONSEMBLE trial, and a strong financial position. While facing challenges in addressing various analyst inquiries, the company is well-positioned to capitalize on opportunities in expanding their treatment portfolio and leveraging trial data for market differentiation.

Cardiff Oncology reports positive data and strong financial position

Cardiff Oncology's Q1 2024 earnings call highlighted positive data on onvansertib, ongoing trials, and a healthy financial position. Challenges include trial enrollment pace and follow-up data requirements. However, the company has opportunities for growth through successful trials and leveraging preclinical data.

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SAN DIEGO , March 28, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced that the first patient was  dosed this month with its investigational drug onvansertib in its Phase 2 ONSEMBLE trial (NCT05593328). The trial is designed to demonstrate a clinically meaningful difference in response and onvansertib's contribution to standard of care (SoC) FOLFIRI/bevacizumab for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).

Cardiff Oncology Announces First Patient Dosed in ONSEMBLE Phase 2 Randomized Trial of Onvansertib in Patients with Metastatic Colorectal Cancer

Here is how Cardiff Oncology (CRDF) and Lantheus Holdings (LNTH) have performed compared to their sector so far this year.

Has Cardiff Oncology (CRDF) Outpaced Other Medical Stocks This Year?

- SAB includes recognized leaders with expertise in oncology drug development, pharmaceutical industry dynamics and translational research – - SAB will continue to provide insight and guidance on the strategy to advance onvansertib through later-stage clinical development - SAN DIEGO , March 6, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today formally introduced the full membership of its Scientific Advisory Board (SAB). The SAB is comprised of a distinguished group of academic and industry experts who bring depth and breadth of knowledge in oncology drug development, clinical trial design, translational science and clinical research.

Cardiff Oncology Formally Introduces Scientific Advisory Board

Phase 1b/2 trial in lead KRAS-mutated metastatic colorectal cancer (mCRC) program continues to show our lead candidate onvansertib demonstrates an objective response rate, durability and progression-free survival that substantially exceed those seen in historical control trials Strengthened leadership team with appointments of Fairooz Kabbinavar, MD, FACP, as CMO, Tod Smeal, Ph.D., as CSO and Charles Monahan, R.Ph.

Cardiff Oncology Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update

SAN DIEGO , Feb. 27, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced that company management will participate in a corporate panel discussion and 1x1 investor meetings at the Cowen 43rd Annual Health Care Conference, which is taking place at the Boston Marriott Copley Place from March 6 – 8, 2023. Details of the panel discussion can be found below.

Cardiff Oncology to Present at the Cowen 43rd Annual Health Care Conference

Brings world class capabilities and deep expertise in colorectal cancer and other solid tumor indications to advance the clinical development of onvansertib  Served as the lead investigator for two practice-changing trials of bevacizumab (Avastin®) combinations leading to the approval of bevacizumab in metastatic colorectal cancer (mCRC)1,2 SAN DIEGO , Feb. 2, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced that it has strengthened its leadership team with the appointment of Fairooz Kabbinavar, MD, FACP, as chief medical officer (CMO).  Dr. Kabbinavar will oversee the clinical development program for the Company's investigational drug onvansertib and will report directly to Chief Executive Officer, Mark Erlander, PhD.

Cardiff Oncology Announces the Appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer

SAN DIEGO , Jan. 10, 2023 /PRNewswire/ -- 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 fireside chat at B. Riley Securities' 3rd Annual Oncology Conference, which is taking place virtually from January 18 – 19, 2023.

Cardiff Oncology to Present at B. Riley Securities' 3rd Annual Oncology Conference

SAN DIEGO , Nov. 21, 2022 /PRNewswire/ -- 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 fireside chats and 1x1 investor meetings at the 34th Annual Piper Sandler Healthcare Conference and the JMP Securities Hematology and Oncology Summit taking place on November 29 – December 1, 2022, and December 6 – 7, 2022, respectively. Details of the fireside chats can be found below.

Cardiff Oncology to Present at Upcoming Investor Conferences

SAN DIEGO , Nov. 8, 2022 /PRNewswire/ -- 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 and participate in 1x1 investor meetings at the Jefferies London Healthcare Conference, which is taking place in London, UK from November 15 – 17, 2022. Details of the presentation can be found below.

Cardiff Oncology to Present at the Jefferies London Healthcare Conference

Data from Phase 1b/2 trial in KRAS-mutated metastatic colorectal cancer (mCRC), per September 12 th announcement, show durable responses to treatment and support initiation of ONSEMBLE, a randomized Phase 2 trial in KRAS/NRAS-mutated mCRC Cash, cash equivalents, and short-term investments of approximately $114 million as of September 30, 2022, provide projected runway into 2025 SAN DIEGO , Nov. 3, 2022 /PRNewswire/ -- 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 and recent highlights for the third quarter ended September 30, 2022. "We recently announced Phase 1b/2 data that demonstrate onvansertib's ability to generate durable responses in KRAS-mutated mCRC patients, with various underlying mutations, when combined with standard-of-care FOLFIRI/bevacizumab.

Cardiff Oncology Reports Third Quarter 2022 Results and Provides Business Updates

In a tremendous overreaction, Cardiff lost 41% of its value over the discontinuation of a prostate cancer trial on September 13, 2022,. Combined ESMO 2022 oncology conference reportings by Amgen, Mirati Therapeutics and Cardiff show Onvansertib is best-in-class in metastatic colorectal cancer, the lead indication.

Cardiff Oncology: 41% Loss In One Day For A Best-In-Class Colorectal Cancer Treatment

Next trial in RAS-mutated mCRC (ONSEMBLE) is a randomized Phase 2 trial to demonstrate onvansertib's contribution to SoC and position for a possible accelerated approval opportunity; topline data expected in 2H 2024 Data from ongoing Phase 1b/2 trial in KRAS-mutated mCRC show durable responses to treatment, with a median duration of response (mDoR) of 11.7 months for all doses and 12.5 months for the recommended phase 2 dose  Initial data in Phase 2 trial in second-line pancreatic ductal adenocarcinoma (mPDAC) show 1 partial response (PR), 3 stable disease (SD) achieved in 5 evaluable patients treated with onvansertib plus SoC Based on its current expectations and projections, the Company's current cash resources are sufficient to fund its operations into 2025 Company management is hosting a webcast and conference call today at 4:30 PM ET SAN DIEGO , Sept. 12, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced plans to conduct a randomized Phase 2 trial of onvansertib in combination with standard-of-care (SoC) FOLFIRI/bevacizumab in second-line RAS-mutated mCRC, durability of responses from its ongoing Phase 1b/2 clinical trial in KRAS-mutated mCRC and additional business updates.

Cardiff Oncology Announces Plans for a Randomized Trial in Metastatic Colorectal Cancer (mCRC), Durability of Responses in Ongoing Phase 1b/2 Trial in mCRC and Additional Business Updates

Durable responses to treatment, with a median duration of response (mDoR) of 11.7 months, reported in Phase 1b/2 clinical trial of onvansertib plus FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC Observed mDoR is supported by preclinical findings that demonstrate onvansertib in combination with irinotecan can overcome intrinsic and refractory resistance to irinotecan in patient-derived xenograft models Patients with a ≥90% decrease in KRAS mutant allele frequency (MAF), a response biomarker, in the first cycle of treatment had significantly higher ORR and longer PFS in Phase 1b/2 trial and an Expanded Access Program (EAP) SAN DIEGO , Sept. 10, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced new preclinical and clinical data from its program in KRAS-mutated mCRC.

Cardiff Oncology Announces New Preclinical and Clinical Data from Program in KRAS-mutated Metastatic Colorectal Cancer (mCRC) at the ESMO Congress 2022

SAN DIEGO , Sept. 6, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the publication of two abstracts that have been accepted for poster presentations at the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place both virtually and at the Paris Expo Porte de Versailles in Paris, France from September 9 – 13, 2022.

Cardiff Oncology Announces Upcoming Poster Presentations at the ESMO Congress 2022

Event to feature discussions on the planned development pathway for onvansertib in KRAS-mutated metastatic colorectal cancer and updates on other development programs Event to take place at 4:30 PM ET on Monday, September 12, 2022 SAN DIEGO , Aug. 29, 2022 /PRNewswire/ -- 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 will host a webcast and conference call to provide a clinical and corporate update on Monday, September 12, 2022. The event will feature discussions on the planned development pathway for onvansertib in KRAS-mutated metastatic colorectal cancer and updates on other development programs.

Cardiff Oncology to Host Webcast and Conference Call to Provide a Clinical and Corporate Update on September 12, 2022

Today, we circle back on small developmental concern Cardiff Oncology for the first time since the fourth quarter of 2021. The company's primary drug candidate is targeting several indications in combination therapy with large potential markets.

Cardiff Oncology: Down But Not Out

Initial preclinical data in ovarian cancer presented at AACR showed treatment with onvansertib plus olaparib leading to a statistically significant survival benefit compared to treatment with either agent alone Data from Phase 2 metastatic castration-resistant prostate cancer (mCRPC) clinical trial presented at AACR showed higher disease control rates with increasing onvansertib dose density Biomarker data from Phase 2 mCRPC clinical trial presented at AACR showed treatment response correlating with mutations in MTOR and PTEN , two key genes in the PI3K signaling pathway Cash, cash equivalents, and short-term investments of approximately $122 million as of June 30, 2022 SAN DIEGO , Aug. 4, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced company highlights and financial results for the second quarter ended June 30, 2022. "We remain focused on advancing our research and development priorities, in particular our lead clinical trial program in KRAS-mutated metastatic colorectal cancer (mCRC)," said Mark Erlander, PhD, chief executive officer of Cardiff Oncology.

Cardiff Oncology Reports Second Quarter 2022 Results and Provides Business Updates

Cardiff Oncology (CRDF) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Cardiff Oncology (CRDF) Expected to Beat Earnings Estimates: Can the Stock Move Higher?

SAN DIEGO , July 5, 2022 /PRNewswire/ -- 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 fireside chat and one-on-one meetings at the William Blair Biotech Focus Conference 2022, which is taking place at The St. Regis New York on July 12 – 13, 2022. The fireside chat will be pre-recorded and available on-demand beginning on Monday, July 11, 2022.

Cardiff Oncology to Present at the William Blair Biotech Focus Conference 2022

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Cardiff Oncology started taking a beating from the early days of the biotech bear market, in September 2021. The company is the first to correctly target PLK1, a target in several solid tumors, in all KRAS-mutated cancers.

Cardiff Oncology: Upcoming Readouts And Several Green Lights

Despite producing decent data, the stock has kept falling. Today it is in the penny stock zone, and we do not recommend penny stocks as investments.

Cardiff Oncology: Risky Investment

SAN DIEGO, May 17, 2022 /PRNewswire/ -- 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 fireside chat and one-on-one meetings in-person at the H.C. Wainwright Global Investment Conference, which is taking place in Miami, Florida from May 23 – 26, 2022.

Cardiff Oncology to Present at the H.C. Wainwright Global Investment Conference

Cardiff Oncology (CRDF) delivered earnings and revenue surprises of -8.70% and 1.33%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Cardiff Oncology (CRDF) Reports Q1 Loss, Misses Revenue Estimates

Reported new Phase 1b/2 data from lead KRAS-mutated metastatic colorectal cancer (mCRC) clinical program showing objective response rate and median progression-free survival that substantially exceed those recorded in historical control trials Announced new data from Phase 2 metastatic castration-resistant prostate cancer (mCRPC) trial showing clinically meaningful disease control rates that rose with increasing onvansertib dose density Presented new genomic analyses from Phase 2 mCRPC trial that show a positive association between treatment response and alterations in MTOR and PTEN, two key genes in the PI3K signaling pathway Reported new preclinical data that show onvansertib combining with a PARP inhibitor to overcome PARP inhibitor resistance in BRCA1-mutant and wild-type patient-derived xenograft ovarian cancer models Cash, cash equivalents, and short-term investments of approximately $129.4 million as of March 31, 2022 SAN DIEGO , May 5, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced recent company highlights and financial results for the first quarter ended March 31, 2022. "With a strong balance sheet and clinical data highlighting onvansertib's potential to improve patient outcomes by combining synergistically with the standard-of-care, we believe we are well positioned for success," said Mark Erlander, Ph.D.

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