CRDF
Cardiff OncologyADocument history
Earnings documents stored for CRDF.
Investor releaseQuarter not tagged2026-05-22CRDF: First Quarter 2026 Results
Zacks Small Cap Research
CRDF: First Quarter 2026 Results
By John Vandermosten, CFA NASDAQ:CRDF READ THE FULL CRDF REPORT HERE 1Q:26 Financial Results Cardiff Oncology, Inc. (NASDAQ:CRDF) reported first quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on May 14th, 2026. For the three-month period ending March 31st, 2026 Cardiff reported revenues of $41,000 and operational expense of $12.9 million. Loss per share was $0.18. Operational expenses fell 11% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ending March 31st, 2026 and versus the same prior quarterly period: Revenues of $41,000 compared to $109,000 and represent Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib; Research and development expenses totaled $6.8 million, down 35% from $10.5 million attributable to a reduction in clinical trial expenses and a decrease in preclinical activities for the CRDF-004 clinical trial; Selling, General & Administrative expenses were $6.1 million, up 53% from $4.0 million. Increases relate to employee severance agreements and an increase in stock-based compensation attributable to the modification of stock options. These increases were offset by a decline in Outside Services and Professional Fees and Facilities and Other costs; Net interest income of $0.5 million was down compared with prior period amounts due to reduced interest income on lower cash levels and other expense of $1,000 compared to other income of $7,000; Net loss was $12.4 million vs. a net loss of $13.4 million or $0.18 and $0.20 per share, respectively. As of March 31st, 2026, cash, equivalents and short-term investments totaled $46.1 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for 1Q:26 was $12.3 million versus $12.8 million for 1Q:25. Cardiff’s cash is expected to support operating activities until 1Q:27. The company will need to raise additional capital to fund the CRDF-005 Phase III registrational study. Nerviano Dispute Earlier this year, Nerviano Medical Sciences sent written notice to Cardiff alleging that it was in a material breach of the onvansertib license agreement between the two. Brief details of the interaction were included in the 2025 Form 10-K. Nerviano attributed the breach to the failure of Cardiff to name...
Investor releaseQuarter not tagged2026-05-15Cardiff Oncology Reports First Quarter 2026 Results and Provides Business Update
GlobeNewswire
Cardiff Oncology Reports First Quarter 2026 Results and Provides Business Update
Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting Leadership additions position Company to execute on key upcoming clinical and regulatory milestones SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. "This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “In April, we had a successful End-of-Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib's potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year.” Clinical Highlights Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) Annual Meeting 2026 The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation...
Investor releaseQuarter not tagged2026-05-15Cardiff Oncology: Q1 Earnings Snapshot
Associated Press
Cardiff Oncology: Q1 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Thursday reported a loss of $12.3 million in its first quarter. On a per-share basis, the San Diego-based company said it had a loss of 18 cents. The results did not meet Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 13 cents per share. The molecular diagnostic company posted revenue of $41,000 in the period, which also missed Street forecasts. Three analysts surveyed by Zacks expected $136,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF
Investor releaseQuarter not tagged2026-02-25Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update
GlobeNewswire
Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update
Reported positive update from Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating: • Robust ORR of 72.2% (vs 43.2% with combined SoC of FOLFOX/bev and FOLFIRI/bev) • Significant improvement in PFS over combined SoC (HR: 0.37, p<0.05) Data support selection of 30 mg onvansertib dose in combination with FOLFIRI/bev for planned registrational program; detailed data and registrational plans expected in the first half of 2026 SAN DIEGO, Feb. 24, 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 financial results for the full year ended December 31, 2025, and provided a business update. “Cardiff Oncology has entered 2026 with strong clinical momentum and a clear path for advancing onvansertib, our lead program, in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Our focus in 2025 was on rigorous clinical execution, which allowed us to generate increasingly compelling evidence supporting onvansertib’s potential to improve patient outcomes in RAS-mutated mCRC, culminating in the latest positive data cut announced earlier this year. The CRDF-004 trial demonstrated a consistent, dose-dependent treatment benefit when onvansertib was added to FOLFIRI/bev, including a near 30% improvement in response rate over the control arm and encouraging durability trends as measured by progression-free survival. These data are in line with what we had previously seen in our second-line trial in bev-naive patients treated with onvansertib + FOLFIRI/bev. Given that it has been over two decades since there has been meaningful innovation for this patient population, we believe these results represent a transformative step forward.” Continued Dr. Mohindru, “Based on these results, we plan to advance the 30 mg dose of onvansertib with FOLFIRI/bev into our proposed registrational program and expect to provide detailed data and registrational plans after discussions with the FDA in the first half of 2026. As we transition into late-stage clinical development and continue to strengthen our leadership and operational teams, we remain focused on disciplined execution, progressing our lead program toward a potential new sta...
Investor releaseQuarter not tagged2026-02-25Cardiff Oncology: Q4 Earnings Snapshot
Associated Press Finance
Cardiff Oncology: Q4 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Tuesday reported a loss of $7.2 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 11 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. The molecular diagnostic company posted revenue of $243,000 in the period, which also beat Street forecasts. Four analysts surveyed by Zacks expected $130,000. For the year, the company reported a loss of $45.9 million, or 69 cents per share. Revenue was reported as $593,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF
Investor releaseQuarter not tagged2025-11-07Cardiff Oncology Reports Third Quarter 2025 Results and Provides Business Update
GlobeNewswire
Cardiff Oncology Reports Third Quarter 2025 Results and Provides Business Update
– Announced positive data from the ongoing Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer – – Expects to report an update from the Phase 2 CRDF-004 trial in Q1 2026 – – Cash and investments of $60.6 million as of September 30, 2025, projected runway into Q1 2027 – SAN DIEGO, Nov. 06, 2025 (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 financial results for the third quarter ended September 30, 2025, and provided a business update. “This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC. At the July 8, 2025 data cutoff, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR, faster time to response, deeper tumor regression, and early signs of separation in the progression-free survival curves when compared to standard of care alone,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The study is on track for the next clinical update in the first quarter of 2026, where we’ll look for a continuation of onvansertib’s favorable tolerability profile and more mature duration of response and progression-free survival data.” Continued Dr. Erlander, “Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients.” Company highlights for the quarter ended September 30, 2025: Announced positive data from the ongoing CRDF-004 Phase 2 randomized trial evaluating two doses of onvansertib in combination with standard of care (“SoC”) for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) As of the July 8, 2025 data cut-off, the Phase 2 CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate (“ORR”) in the 30mg onvansertib arm compared to the control arm in the intent-to-tre...
Investor releaseQuarter not tagged2025-11-07Cardiff Oncology: Q3 Earnings Snapshot
Associated Press Finance
Cardiff Oncology: Q3 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Thursday reported a loss of $11.3 million in its third quarter. On a per-share basis, the San Diego-based company said it had a loss of 17 cents. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share. The molecular diagnostic company posted revenue of $120,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF
Investor releaseQuarter not tagged2025-07-30Cardiff Oncology Reports Second Quarter 2025 Results and Provides Business Update
GlobeNewswire
Cardiff Oncology Reports Second Quarter 2025 Results and Provides Business Update
- Appointed Dr. Roger Sidhu as Chief Medical Officer - - Completed enrollment in randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) - - Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in mTNBC at ASCO 2025 - - Cash and investments of $71.0 million as of June 30, 2025, projected runway into Q1 2027 - - Company to hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT to share updated clinical data from the CRDF-004 trial - SAN DIEGO, July 29, 2025 (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 financial results for the second quarter ended June 30, 2025, and provided a business update. “In the second quarter, we achieved an important milestone by completing enrollment in our ongoing CRDF-004 trial evaluating onvansertib plus standard of care for the treatment of first-line RAS-mutated mCRC,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “As we evolve into a late-stage clinical development company, we were excited to appoint Dr. Sidhu as our new Chief Medical Officer to provide expert guidance in advancing onvansertib through the registrational phase of development. We’re pleased to welcome him to the team and are confident that his expertise will be instrumental as we work toward bringing this potential therapy to patients.” Conference Call and Webcast on Clinical Data from Ongoing CRDF-004 Trial in mCRC Cardiff Oncology will host a live conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share clinical data from the ongoing CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at https://investors.cardiffoncology.com/news-events/events. A replay will be available in the investor relations section on the company's website following the completion of the call. Company highlights for the quarter ended June 30, 2025, and subsequent weeks include: Appointed Dr. Roger Sidhu as Chief Medical Officer In June 2025, the company appointed Roger Sidhu, MD, as Chief Medical Off...
Investor releaseQuarter not tagged2025-07-30Cardiff Oncology: Q2 Earnings Snapshot
Associated Press Finance
Cardiff Oncology: Q2 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Cardiff Oncology, Inc. (CRDF) on Tuesday reported a loss of $13.9 million in its second quarter. The San Diego-based company said it had a loss of 21 cents per share. The results did not meet Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 19 cents per share. The molecular diagnostic company posted revenue of $121,000 in the period, also falling short of Street forecasts. Three analysts surveyed by Zacks expected $150,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRDF at https://www.zacks.com/ap/CRDF
Investor releaseQuarter not tagged2025-05-10Cardiff Oncology First Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
Simply Wall St.
Cardiff Oncology First Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
Net loss: US$13.4m (loss widened by 34% from 1Q 2024). US$0.20 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 22%. Earnings per share (EPS) missed analyst estimates by 7.7%. Looking ahead, revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 5.7% from a week ago. You should always think about risks. Case in point, we've spotted 5 warning signs for Cardiff Oncology you should be aware of, and 3 of them are significant. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-05-09Cardiff Oncology Reports First Quarter 2025 Results and Provides Business Update
GlobeNewswire
Cardiff Oncology Reports First Quarter 2025 Results and Provides Business Update
- Completed enrollment in randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) - - Expanded intellectual property portfolio with second patent covering treatment of all bev-naïve patients, including RAS-mutated and RAS wild-type mCRC, across all lines of therapy - - Cash and investments of $79.9 million as of March 31, 2025, projected runway into Q1 2027 - SAN DIEGO, May 08, 2025 (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 financial results for the first quarter ended March 31, 2025, and provided a business update. “Our lead program for onvansertib has remained on track in 2025 with the successful completion of enrollment in our trial in first-line RAS-mutated mCRC, underscoring our deep commitment to serving a patient population that has seen no therapeutic advancements in decades,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “Furthermore, we expanded our intellectual property portfolio through the issuance of a second patent covering all mCRC, regardless of tumor mutational status, across all lines of therapy. As we continue to generate clinical data and move toward regulatory discussions with the FDA, we remain focused on our mission to deliver a transformative therapy that could redefine the standard of care for RAS-mutated mCRC and for other cancers.” Upcoming expected milestones Additional clinical data from the ongoing CRDF-004 trial in mCRC expected in 1H 2025 Company highlights for the quarter ended March 31, 2025, and subsequent weeks include: Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC The Phase 2 CRDF-004 trial has reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have mCRC and a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab (bev) or FOLFOX plus bev. Patients are randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response...
TranscriptFY2024 Q42025-02-27FY2024 Q4 earnings call transcript
Earnings source - 34 paragraphs
FY2024 Q4 earnings call transcript
Welcome to the Cardiff Oncology Fourth Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference call over to Kiki Patel of Gilman Group – I am sorry, Gilmartin Group, my reading. Please go ahead.
Thank you, operator. Joining us on the call today from Cardiff Oncology, our Chief Executive Officer, Mark Erlander, and Chief Financial Officer, Jamie Levine. During this conference call, management will make forward-looking statements, including, without limitation, statements related to guidance, results and the timing of data readouts for onvansertib clinical trials. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company described in the section titled Risk Factors in its annual report on Form 10-K filed with the SEC for the year ended December 31, 2024. Cardiff Oncology undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. With that, I turn the call over to Chief Executive Officer, Mark Erlander. Mark?
Thank you, Kiki, and good afternoon, everyone, and thank you for joining our business update conference call. The fourth quarter of 2024 was significant for Cardiff Oncology. On December 10, we released an initial CRDF data from our ongoing CRDF-004 trial in first-line RAS-Mutated Metastatic Colorectal Cancer or mCRC, which we believe was highly encouraging and served as a basis for us to successfully complete a $40 million capital raise. On today's call we address four topics. First, we will briefly review the data we previously released from our lead program in mCRC and then provide an update on CRDF-004 enrollment activity and our registrational plans for onvansertib. Second we'll discuss our intellectual property strategy including the advances made in 2024 and what we expect for 2025. Third, we will share highlights from two preclinical posters we presented at the San Antonio Breast Cancer Symposium in December. And finally we'll discuss our financial position that we disclosed today in our Form 10-K filing. I begin with a review of the previously disclosed data from CRDF-004, which is our ongoing randomized Phase 2 trial in first-line RAS-mutated mCRC evaluating two dose levels of onvansertib combined with current standard of care regimens FOLFIRI or FOLFOX plus bevacizumab or bev versus standard of care alone. In December, we released an initial data set as of November 26, 2024 for the first 30 patients on the trial. Overall, we were pleased with the efficacy signal observed in the trial. First, as of the data cutoff date patients on the 30 mg dose of onvansertib demonstrated a 64% ORR compared to a 33% ORR in the control arm. Second, the 30 mg arm demonstrated deeper tumor responses than the other arms. Specifically, the five deepest tumor regressions seen across the entire trial are in patients receiving the 30 mg dose of onvansertib. Based on the data released, we believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as an initial signal that onvansertib is a biologically active drug candidate for the treatment of mCRC. Finally, I would like to highlight onvansertib's favorable safety profile, which is an important differentiating factor over previous PLK1 inhibitors that have failed in the clinic due to toxicity concerns. Over 380 patients have been dosed with onvansertib across multiple clinical trials to date and the treatment has been well tolerated. For the full CRDF-004 clinical trial results from the initial data cut, please refer to our corporate presentation or the investor call from December 10, posted on our Investor Relations website. We continue to expect to release additional clinical data from the CRDF-004 trial, in the first half of 2025. Next, I will share the current status of our mCRC program, as it pertains to enrollment and our registrational strategy. First, regarding enrollment. In December, we mentioned that we expected to complete enrollment of the 90 evaluable patients planned in the CRDF-004 trial, in early 2025. Today, I can share that this week, we closed the trial to new patients entering screening. We anticipate complete enrollment in the trial, in the next few weeks. Secondly, there is an important FDA approval in Q4 2024 from another company that validates our registrational strategy for the approval of onvansertib in mCRC. Specifically, Pfizer announced the results from its BREAKWATER trial, evaluating its drug encorafenib in first-line mCRC patients, with a BRAF mutation. And to be clear, this is a totally separate patient population from our RAS-mutated mCRC focus. Pfizer's BREAKWATER trial achieved accelerated approval using ORR from a subset of patients, at an interim time point and subsequently achieved a statistically significant and clinically meaningful improvement, in progression-free survival, which is their endpoint for full approval. The regulatory pathway used by Pfizer to pursue accelerating full approval for encorafenib, from a single trial, is the same as our registrational plans agreed with FDA for onvansertib and therefore, reinforces the validity of our strategy. I now move on to our second agenda topic, our intellectual property strategy. In Q4, 2024, we strengthened our intellectual property portfolio for onvansertib, with the issuance of a new patent. The claims cover the method of using onvansertib in combination with bev for the treatment of KRAS-mutated mCRC patients, who have not previously been treated with bev. The patent aligns with the target patient population of our lead mCRC program, and has an expected expiration date of no earlier than 2043. We believe the new patent underscores the groundbreaking nature of our discovery, demonstrating onvansertib's powerful synergy with bev in inhibiting angiogenesis. We continue to explore new opportunities to convert the novel discoveries, we have made regarding the role of PLK1 inhibition into new intellectual property and you could expect to hear more on these efforts, later this year. Now, I will move to the third item of our agenda. In December, we presented two poster presentations at the San Antonio Breast Cancer Symposium, reporting preclinical data from our breast cancer program. The objective of the first poster was to evaluate onvansertib in combination with paclitaxel, as a potential therapeutic strategy for hormone receptor positive or HR-positive breast cancer patients, after progression on endocrine therapy and CDK4/6 inhibitors. In vitro onvansertib demonstrated synergistic activity, with paclitaxel and HR-positive breast cancer cell lines. In vivo, the combination exhibited robust antitumor activity in eight patient-derived xenograft or PDX models resistant to first-line therapies. The second poster evaluated the combination of onvansertib and ENHERTU in drug-resistant HR-positive breast cancer PDX models. The combination of onvansertib plus ENHERTU was well tolerated, overcame ENHERTU resistance and displayed enhanced antitumor activity compared to each monotherapy. Overall, the combination of ENHERTU with onvansertib, represents a promising therapeutic strategy for HR-positive breast cancer patients resistant to first-line therapies. We believe these posters highlight the broad potential of onvansertib, some of which we are currently evaluating through our investigator-initiated trials. For our last agenda item, I will turn the call over to Jamie to talk about our fourth quarter financials. Jamie?
Thank you, Mark. Earlier today, we issued a press release and filed a Form 10-K with the SEC which contain our financial results for the full year ending December 31, 2024. Turning to our balance sheet. Cash and short-term investments as of December 31, 2024 totaled $91.7 million, which includes the net proceeds of the $40 million capital raise, we successfully completed in December with new and existing health care dedicated institutional investors. Our cash used in operating activities was $10.3 million in Q4 2024, which is in line with our typical quarterly cash burn. Based on the cash spend forecasted for our ongoing clinical programs, we believe that our current cash resources provide us with runway into the first quarter of 2027. Finally, I'd like to point out that today we also filed a shelf registration statement on Form S-3, which replaces our previous shelf that was due to expire in April of this year. It has always been our practice to maintain an active shelf registration statement. And for clarity the S-3 we filed today did not involve the issuance of any shares. With that, I'll turn the call back over to Mark.
Thank you Jamie. As you could hear from our remarks today, we are highly encouraged by the efficacy results from the CRDF-004 trial and that we shared in December and we look forward to sharing additional updates from the trial in the first half of this year. With that I would like to take a moment to thank the clinical investigators and importantly, the patients and their families whose participation in the trial is enabling our clinical development efforts. We continue to believe that onvansertib has the potential to change the treatment paradigm for the large number of patients who are diagnosed with RAS-Mutated mCRC each year. With that, I will now open the call up for questions. Operator?
Great. Thank you. At this time, we will conduct the question-and-answer session. [Operator Instructions] Our first question comes from Marc Frahm with TD Cowen. Your line is now open.
Hi. This is Alex [ph] on for Mark. Thanks for taking my question. So can you give us any sense of when exactly in the first half that data update is coming and in what context? And then in that update how many new patients do you expect will become valuable for ORR? And also how mature do you expect those PFS curves to be? Thank you.
Thanks Alex for that question. At this point in time, what our goal is to really to our next update to actually give a more mature and substantive update since the 30-patient update. So at this point that's really what we have planned to do. When it comes to PFS, I think that this is probably too early for PFS within the first half of this year. But that's something that, obviously, we will be updating beyond this first half.
Great. Thank you.
Please standby for the next question. Our next question comes from Joe Catanzaro at Piper Sandler. Your line is now open.
Great. Hey, everybody. Thanks for the update. Thanks for taking my question. Maybe a couple for me here. Can you just speak to your thoughts around when you will make the dose selection decision and whether that will come together with your interactions with the FDA and converting 004 to a potential registrational trial. Just maybe walk through the cadence of those decision points? And then I have a follow-up. Thanks.
Thanks Joe for that question. Really our goal as you know this is the -- CRDF-004 is based on Project Optimus. And our goal really is to get in front of the FDA as soon as possible. And there's really two topics that we will be talking to the FDA about. The first, of course, is the dose which is 30 versus 20. And then the second really is the -- really finalizing the trial design for the registrational trial the 005. So, I mean from our point of view our goal is to get to the FDA as soon as possible. This may or may not be all 90 patients. It could be less. Of course it will depend on looking at that signal with the 30 and 20. So I think that that's really where we are right now. And of course that after that meeting with the FDA that will give us clarity and that will be the gating factor for going into the registrational 005 trial.
Okay, got it. So my follow-up relates to your comments Mark on the BREAKWATER trial of encorafenib. Not terribly familiar with the data off the top of my head here. So, my question is whether the response rate delta that they observed in that trial that supported an accelerated approval aligns with what you've seen thus far in the 004 study?
Yes. Certainly Joe great question. Certainly is consistent. Their ORR was 61% versus 40%. So I think that it's certainly consistent with what we have shown so far with the first 30 patients.
Okay, great. That’s it for me. Thanks for taking my question.
Thank you, Joe. Appreciate it.
Thank you. Our next question comes from Andy Hsieh at William Blair. Your line is now open.
Thanks for the update and taking our questions. Two for me if you don't mind. One is really kind of your evolving thinking in terms of the velocity of tumor size reduction. So basically looking at the December data one of the most obvious observations is really the slope of the control arm is relatively flat over time. And then it deepens as you alluded to Mark on the call for the 20-milligram and 30 milligram. So, I'm curious if that data based on some of the prior CRC experience could de-risk or inform how you think about endpoints approvable endpoints such as PFS and OS. So that's question number one. Question number two has to do with also BREAKWATER. So in that trial the patient number that's required for the accelerated approval was about 100 patients each arm. So, I'm curious if that's kind of that could potentially form the framework of your upcoming discussion with the FDA in the context of the accelerated approval pathway? Thank you.
Thanks Andy for both of those questions. Yes going after that first one clearly there has been data in CRC first line in previous trials showing that earlier responses and deeper responses have a correlation and are associated with greater PFS and OS. So that's something that is known. And I think moving on to the BREAKWATER well certainly their 110 per arm was what they went after for their interim. Certainly we are looking at that. We will be of course talking to the FDA to finalize the specifics around our assumptions and our trial design when we do meet with them. But certainly one point that you make Andy, which is a good one is that what BREAKWATER showed was that fewer patients are needed for the accelerated and of course the full approval. So, thank you for both those questions.
Great. Thank you.
Thank you.
Thank you. Our next question comes from Robert Burns at H.C. Wainwright. Your line is now open.
Hi guys. Thanks for taking my questions and again congrats on the amazing data that you reported late last year. I guess just one follow-up for me. So obviously we know about the CodeBreak 301 trial. And although KRAS G12C is a minor component in colorectal cancer I wanted to get your thoughts as to how you view that agent especially also the pan-RAS agents that are also being developed in the space?
Great. Robert thanks for both those questions. The G12C inhibitors as you mentioned, there is an approval of the Amgen's drug last year but that was really in second line. And that of course is just with G12C, which you know is a very small sliver of the KRAS and RAS-mutated patients. It's about – makes up about 4% of RAS-mutated patients. So I think that from what we look at there it's really – it's not really too – it doesn't really impact what we're doing in first line, since they are in second line and such a small. And we also do have G12C mutations patients with those mutations within our trials. So that's the – with the RevMed, the G12X program, clearly the signal is in the non-small cell as well as the pancreatic or the PDAC. And so we don't see as much activity with their agents for what they've reported in the colorectal but we certainly are keeping an eye on their progress and what they're doing in this space.
Awesome. Thanks for taking my questions and congrats again.
Thank you, Robert.
Thank you. Please stand-by for the next question. The next question comes from Albert Lowe with Craig-Hallum. Your line is now open.
Hi, everyone. Thanks for taking my question. I was just wondering it's great to see the enrollment is going to complete over the next few weeks here. So do you think we'll be able to see all of the 90 patients included in this first half update?
Yes. Albert, thank you for that question. Yes, we are very pleased and excited that we're really within a couple of weeks of finishing the enrollment. We did have 60 patients dosed by – in December, when we reported out the 30 patients which had at least one post-baseline scan. And so we continue to – obviously, we'll be continuing to treat these patients. And our goal really for this first half and reporting out the next update is really to make sure it's a substantive and really more mature update from the trial. So we leave it at that at this point.
Okay. I see. Thank you.
Thanks, Albert.
[Operator Instructions] All right. I'm showing no other questions at this time. So this will conclude the question-and-answer session. I would now like to turn it back to Mark for closing remarks.
Thank you operator, and thank you all again for – everyone here for joining us this afternoon for this call.
Thank you for your participation in today's conference. This does conclude the program and you may now disconnect.

