Cardiff Oncology, Inc.

Welcome to the Cardiff Oncology fourth quarter 2024 financial results and business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone, and you will then hear an automated message advising your hand is raised. 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. Oh, 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 the conference call, management will make forward-looking statements, including without limitation, statements related to guidance, results, and 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 describes 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?

Well, 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 10th, we released an initial cut of data from our ongoing Cardiff 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 Cardiff 004 enrollment activity and our registrational plans for advanced certificates. 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 Cardiff 004, which is our ongoing randomized phase two trial in first-line RAS mutant MCRC, evaluating two dose levels of Unvancertib combined with current standard of care regimens, Fulfiri or Fulfox, plus Bevacuvimab 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 30mg dose of UnvancerTIB demonstrated 64% ORR compared to a 33% ORR in the control arm. Second, the 30mg 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 profiles. 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 CARTF004 clinical trial results from the initial data cut, please refer to our corporate presentation or the investor call from December 10th posted on our investor relations website. We continue to expect to release additional clinical data from the Cardiff 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 valuable patients planned in the CARTF004 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 Q424 from another company that validates our registrational strategy, for the approval of Onvansertib and 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 accelerated and full approval for encorfinib from a single trial is the same as our registrational plans agreed with FDA for Advancertib, 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 Advancertib with the issuance of a new patent. The claims cover the method of using Advancertib 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 OnvancerTIP'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 can 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 anti-tumor activity in eight patient-derived xenograft for PDX models resistant to first-line therapies. The second poster evaluated the combination of Onvansertib and Inher2 in drug-resistant HR-positive breast cancer PDX models. The combination of Onvansertib plus Inher2 was well-tolerated, overcame Inher2 resistance, and displayed enhanced anti-tumor activity compared to each monotherapy. Overall, the combination of an HER2 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?