Welcome to our dedicated page for Cardiff Oncology news (Ticker: CRDF), a resource for investors and traders seeking the latest updates and insights on Cardiff Oncology stock.
Cardiff Oncology, Inc. (Nasdaq: CRDF) is a clinical-stage biotechnology company dedicated to developing novel cancer therapies. Leveraging their proprietary PLK1 inhibition technology, Cardiff Oncology focuses on creating innovative treatments for various cancers with significant unmet medical needs.
Cardiff Oncology's lead therapeutic asset is onvansertib, a highly selective Polo-like kinase 1 (PLK1) inhibitor. This investigational drug is currently being evaluated in clinical trials for its effectiveness in treating multiple types of cancer, including RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC).
Recent achievements include promising clinical data for onvansertib monotherapy and combination therapy in mPDAC and SCLC trials. The mPDAC Phase 2 trial reported a 19% objective response rate (ORR) and a median progression-free survival (mPFS) of 5.0 months, compared to historical controls with an ORR of 7.7% and mPFS of 3.1 months. In SCLC, onvansertib monotherapy has demonstrated encouraging single-agent activity.
Cardiff Oncology continues to expand its clinical programs and research partnerships. They announced a first-line trial in mPDAC in collaboration with Oregon Health & Science University (OHSU) Knight Cancer Institute, exploring both monotherapy and combination therapy with standard care. Furthermore, the company highlights an ongoing Phase 1b/2 study for KRAS-mutated mCRC, which has shown a favorable safety profile and promising efficacy results.
Financially, Cardiff Oncology reported a strong cash position with approximately $81.4 million in cash, cash equivalents, and short-term investments as of September 30, 2023. Their operational strategy is supported by partnerships and ongoing research endeavors, which are projected to fund operations into 2025.
The company's forward-looking initiatives include the advancement of their lead program in RAS-mutated mCRC to the first-line setting and continuous exploration of onvansertib's potential in various cancer treatments. Investors and stakeholders can stay updated through regular business updates and conference calls hosted by Cardiff Oncology.
Cardiff Oncology (Nasdaq: CRDF) has announced the pricing of an oversubscribed underwritten registered direct offering of 15,384,619 common stock shares at $2.60 per share, aiming to raise approximately $40 million in gross proceeds. The offering attracted new mutual fund and healthcare dedicated investors, alongside existing investors' support.
The company plans to use the net proceeds to fund clinical costs for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) and for working capital. TD Cowen is leading the offering as book-runner, with William Blair, H.C. Wainwright & Co., and Craig-Hallum also participating in various roles. The offering is expected to close around December 11, 2024.
Cardiff Oncology (NASDAQ: CRDF) announced positive initial data from its Phase 2 CRDF-004 trial evaluating onvansertib combined with standard-of-care (SoC) in first-line RAS-mutated metastatic colorectal cancer patients. The trial demonstrated a 64% objective response rate (ORR) in the 30mg onvansertib dose arm versus 33% ORR in the control arm.
The 30mg dose showed superior results compared to the 20mg dose (64% vs. 50% ORR) with deeper tumor regression. The drug was well-tolerated at both doses. The randomized trial enrolled patients with KRAS or NRAS mutations, combining onvansertib with FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Additional clinical data is expected in 1H 2025.
Cardiff Oncology (Nasdaq: CRDF) has been granted U.S. patent No. 12,144,813 by the USPTO, protecting the use of onvansertib in combination with bevacizumab for treating KRAS mutated metastatic colorectal cancer (mCRC) patients who haven't previously received bevacizumab treatment. The patent extends protection through 2043. Onvansertib, a PLK1 inhibitor, is currently being evaluated in a Phase 2 randomized trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for first-line treatment of RAS-mutated mCRC patients. Initial data is expected by end of 2024.
Cardiff Oncology (CRDF) reported Q3 2024 results highlighting positive Phase 2 trial results of onvansertib combined with FOLFIRI and bev in second-line KRAS mutant mCRC. The trial showed a 7.7x greater clinical benefit in bev naïve patients. The company expects an initial data readout from first-line RAS-mutated mCRC randomized CRDF-004 trial by end of 2024. Financial highlights include $57.7 million in cash and equivalents, with quarterly cash burn of $10.5 million. Operating expenses increased to $12.8 million, up $1.8 million year-over-year. Current cash runway extends into Q1 2026.
Cardiff Oncology announced the publication of Phase 2 trial data in the Journal of Clinical Oncology, evaluating onvansertib combined with FOLFIRI and bevacizumab for second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC). The study showed significant results, particularly in bevacizumab-naïve patients, demonstrating a 77% objective response rate compared to 10% in bevacizumab-exposed patients. The treatment combination showed a median progression-free survival of 14.9 months in bevacizumab-naïve patients versus 6.6 months in bevacizumab-exposed patients. Based on these findings, the company has initiated CRDF-004, a Phase 2 randomized trial for first-line treatment, with initial data expected in H2 2024.
Cardiff Oncology (Nasdaq: CRDF) reported Q2 2024 results and provided a business update. Key highlights include:
1. Initial readout from first-line RAS-mut. mCRC randomized CRDF-004 trial expected in 2H 2024.
2. Preclinical data shows onvansertib's potential to overcome PARP inhibitor resistance in ovarian cancer.
3. Five abstracts presented at AACR support onvansertib's development across multiple tumor types.
4. Cash and equivalents of $60 million as of June 30, 2024, with projected runway through Q3 2025.
5. Q2 2024 operating expenses increased to $12.7 million from $12.3 million in Q2 2023.
6. Net cash used in operating activities for Q2 2024 was $9.2 million, up from $7.1 million in Q2 2023.
Cardiff Oncology (Nasdaq: CRDF), a clinical-stage biotechnology company focusing on PLK1 inhibition for cancer therapies, has announced its plan to release second quarter 2024 financial results on Thursday, August 8 after market close. The company will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on the same day to discuss the results and provide a business update. Interested parties can access the webcast through the 'Investors' section of Cardiff Oncology's website. A replay of the call will be available in the investor relations section following the event.
Cardiff Oncology (Nasdaq: CRDF), a clinical-stage biotechnology firm specializing in PLK1 inhibition to develop cancer therapies, will present at the Jefferies Healthcare Conference in New York on June 5-6, 2024. CEO Mark Erlander will present on June 5, 2024, from 8:30 to 8:55 AM ET in Track 8. The company will also hold 1x1 meetings with investors. Interested parties can access live webcasts and replays of the presentations via Cardiff Oncology's website.
Cardiff Oncology (Nasdaq: CRDF), a clinical-stage biotechnology company, will present at two investor conferences in May 2024. The first, H.C. Wainwright 2nd Annual BioConnect Investor Conference, will be held at the Nasdaq Headquarters in New York City on May 20, 2024, at 2:30 PM ET. The second, Cowen 5th Annual Oncology Innovation Summit, will be a virtual event on May 29, 2024, at 1:30 PM ET. CEO Mark Erlander will represent Cardiff Oncology in fireside chats at both events. Interested parties can access live webcasts via Cardiff Oncology's website, with replays available post-event.
Cardiff Oncology, Inc. (Nasdaq: CRDF) reported Q1 2024 results and provided a business update, highlighting strong efficacy in RAS-mutated mCRC and onvansertib's potential across various cancers. The company has $67M in cash, projecting runway into Q3 2025. Key milestones include upcoming data readouts, trials, and preclinical data presentations. Financially, total operating expenses decreased, with funds expected to last into Q3 2025.
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