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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- First patient dosed in Phase 2 first-line trial in patients with RAS-mutated mCRC for new lead program with the support of FDA and clinical execution from Pfizer Ignite -

Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

- New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients -

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

- Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting -

Cardiff Oncology Announces First Patient Dosed in Randomized First-line RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)

SAN DIEGO, Feb. 26, 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 fireside chat and 1x1 investor meetings at the Cowen 44th Annual Health Care Conference, which is taking place at the Marriott Copley Place in Boston from March 4-6, 2024.

Cardiff Oncology to Present at the Cowen 44th Annual Health Care Conference

- Management will hold a conference call on Thursday, February 29 at 4:30 p.m. ET/1:30 p.m.

Cardiff Oncology to Report Fourth Quarter and Full Year 2023 Results and Provide Business Update

- Findings from the Phase 1b portion of company's Phase 1b/2 study in second-line KRAS-mutated mCRC highlight the safety and promising efficacy of onvansertib in combination with standard-of-care - - These peer-reviewed published data are part of the Phase 1b/2 data Cardiff Oncology announced in August 2023 and informed the shift to investigation in first-line in RAS-mutated mCRC (CRDF-004)- SAN DIEGO , Jan. 17, 2024 /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 the findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) disclosed by Cardiff Oncology in August 2023 have been published in the peer-reviewed journal Clinical Cancer Research , a journal of the American Association for Cancer Research. The publication underscores the safety profile of onvansertib when combined with the standard-of-care (SoC) chemotherapy+bevacizumab.

Cardiff Oncology Announces Publication of Data from Phase 1b study in second-line KRAS-mutated mCRC in Clinical Cancer Research

SAN DIEGO , Nov. 20, 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 and 1x1 investor meetings at the 35th Annual Piper Sandler Healthcare Conference, which is taking place at the Lotte New York Palace in New York from November 28-30, 2023. Details of the fireside chat can be found below.

Cardiff Oncology to Present at the 35th Annual Piper Sandler Healthcare Conference

Cardiff Oncology, Inc. (NASDAQ:CRDF ) Q3 2023 Earnings Conference Call November 2, 2023 4:30 PM ET Company Participants Kiki Patel - IR, Gilmartin Group Mark Erlander - CEO Jamie Levine - CFO Conference Call Participants Mark Frahm - TD Cowen Joe Catanzaro - Piper Sandler Companies Andy Hsieh - William Blair & Company Operator Welcome to the Cardiff Oncology third-quarter 2023 financial results and corporate update conference call. [Operator Instructions].

Cardiff Oncology, Inc. (CRDF) Q3 2023 Earnings Call Transcript

- Advance to first-line RAS-mutated metastatic colorectal cancer (mCRC) for lead program based on positive clinical and preclinical data and guidance from FDA -  - Expanded relationship with Pfizer, which will provide clinical execution of new Phase 2 randomized first-line mCRC trial of onvansertib + standard-of-care (SoC) versus SoC, with interim topline data expected in mid-2024 - - Advance to first-line mPDAC with plan to initiate new Phase 2 investigator-initiated trial of onvansertib + SoC - - Onvansertib monotherapy demonstrates single agent activity in Phase 2 investigator-initiated trial in refractory patients with extensive stage small cell lung cancer - - Cash, cash equivalents, and short-term investments of approximately $81.4 million as of September 30, 2023, projected runway into 2025 - - Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m.

Cardiff Oncology Reports Third Quarter 2023 Results and Provides Business Update

- Management will hold a conference call on Thursday, November 2 at 4:30 p.m. ET/1:30 p.m.

Cardiff Oncology to Report Third Quarter 2023 Financial Results and Provide Business Update

Cardiff Oncology (CRDF) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

Cardiff Oncology (CRDF) Loses -29.75% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

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Cardiff Oncology Inc. CRDF, +0.62% shares surged 32% on favorable data from two cancer drug trials — metastatic pancreatic ductal adenocarcinoma and small cell lung cancer treatment.

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Pancreatic Cancer Program - Pancreatic cancer Phase 2 trial of onvansertib + SoC in the second-line setting demonstrated greater efficacy vs. historical controls with ORR of 19% (vs.

Cardiff Oncology Announces Positive Clinical Data in Pancreatic Cancer and Small Cell Lung Cancer, including Single-Agent Activity from Onvansertib Monotherapy

SAN DIEGO , Sept. 5, 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 present at the Baird Global Healthcare Conference on September 12, 2023 and the H.C.

Cardiff Oncology to Present at Upcoming Investor Conferences in September

- New lead program in first-line RAS-mutated metastatic colorectal cancer (mCRC) and expanded Pfizer relationship; interim topline data expected in mid-2024 - - Advance to first-line mCRC follows strong signal from new clinical and preclinical findings and guidance from FDA, and represents an increased market opportunity - - Cash, cash equivalents, and short-term investments of approximately $89.4 million as of June 30, 2023, projected runway into 2025 - SAN DIEGO , Aug. 9, 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 financial results for the second quarter ended June 30, 2023, and provided a business update. "2023 has been transformative for Cardiff Oncology, highlighted by the advancement of our lead program to the first-line mCRC setting and an expansion of our relationship with Pfizer," said Mark Erlander, Ph.D.

Cardiff Oncology Reports Second Quarter 2023 Results and Provides Business Update

- Advance to first-line RAS-mutated mCRC follows the strong signal from new clinical and preclinical data, and agreement with FDA -  - First-line mCRC represents substantial increase in patient impact and market opportunity over second-line -  - Pfizer Ignite will be responsible for the clinical execution of new first-line mCRC trial with interim topline data expected in mid-2024 -  - Cash position on June 30, 2023 was $89.4 million; sufficient to fund operations into 2025 and through interim topline results from mCRC trial -  - Company will hold a conference call today at 5:00 p.m. ET/2:00 p.m.

Cardiff Oncology Announces New Lead Program in First-Line Metastatic Colorectal Cancer and Expanded Pfizer Relationship

SAN DIEGO , July 24, 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 on July 24, 2023, non-qualified stock option awards to purchase an aggregate of 50,016 shares of its common stock were granted to one new employee. The stock options were granted as inducements material to the new employee becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4).

Cardiff Oncology Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

First Patient Dosed in ONSEMBLE Phase 2 Randomized Trial of Onvansertib in Patients with KRAS/NRAS-mutated Metastatic Colorectal Cancer (mCRC) Introduced full membership of Scientific Advisory Board (SAB) Announced appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer Cash, cash equivalents, and short-term investments of approximately $97 million as of March 31, 2023, projected runway into 2025 SAN DIEGO , May 4, 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 financial results for the first-quarter ended March 31, 2023, and provided a business update. "We are delighted to have dosed the first patient in our Phase 2 ONSEMBLE trial.

Cardiff Oncology Reports First-Quarter 2023 Results and Provides Business Update

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.

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