Cardiff Oncology, Inc.

Welcome to the Cardiff Oncology Second 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 1 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 Gale Martin Group. Please go ahead.

Thank you, Operator. Joining us on the call today from Cardiff Oncology are 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 our advanced research 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, 2023. 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 for the second quarter of 2024. These are certainly energizing times at Cardiff Oncology as we activate sites, enroll patients in our Cardiff 004 trial in RAS-mutated metastatic colorectal cancer, or MCRC. The interactions we're having with the physicians and other professionals at the trial sites reinforce our own excitement at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the U.S. alone. Specifically, the totality of the data from our Phase 1b2 and Ensembl second-line MCRC trials demonstrates Onvancitib has the potential to shift the treatment paradigm for all RAS-mutated MCRC, not just subgroups of K-RAS. We say this because, first, There have been no new therapies approved for these patients over the past 20 years. Second, there are no competing clinical trials for this patient population. And third, unlike prior PLK1 inhibitors, Onvansertib is well-tolerated when combined with chemotherapy, which also opens the door to other chemo combinations for additional cancer indications. So let's dive in. On today's call, we will cover four topics. First, I will discuss our lead program in MCRC and provide updates around our ongoing CARTF004 trial. Second, I will provide an update on our pancreatic cancer program. Third, I will provide a brief overview of our continued encouraging preclinical data demonstrating on vascular tubes activity and other cancer indications with unmet clinical need beyond RAS-mutated MCRC. And finally, we will talk about our financial position that we disclosed today in our Form 10Q. So let's begin. This quarter, we have been intensely focused on the clinical execution of our CARTF004 trial, evaluating the contribution of Onvansertib in first-line RAS-mutated MCRC. As a reminder, CARTF004 is our ongoing Phase 2 trial evaluating Onvansertib in combination with current standard care, which consists of either Fulfuri plus Bev or Fulfox plus Bev. The trial is currently active in 33 sites, and we plan to enroll 90 patients who will be randomized to receive either a 20-milligram or a 30-milligram dose of Onvansertib plus standard care or standard care alone. Our team at Cardiff Oncology, alongside our clinical execution partner, Pfizer Ignite, is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment. We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been judiciously screening patients across our active sites. Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year as we previously guided. We expect this will include objective response rate data for approximately half of the patients we plan to enroll in the trial. Now I'd like to turn to our second agenda item, an update on our pancreatic cancer program focused on metastatic pancreatic ductal adenocarcinoma, or PDAC. In September of last year, we released data from our Phase II trial for metastatic PDAC in the second-line setting. In this single-arm trial, patients received on vansartib in combination with the chemotherapy regimen of liposomal, arenatecan, leukoborin, and 5-FU. After discussing the results with our investigators, we decided the next step of our PDAC program would be an investigator-initiated trial in the first-line setting, combining on Banser-TIB with standard of care gem Abraxas. Today, we are sharing an update to our plans in metastatic PDAC because earlier this year, Nellie Fox was approved for first-line metastatic PDAC after the NAPOLE-3 trial showed significantly greater improvement in overall survival and progression-free survival with first-line nalarifox compared to jamabraxane. As a result of this change to the first-line standard of care, we have decided to support a first-line investigator-initiated PDAC trial that combines onvansertib with nalarifox. And recall that three of the four drugs that comprise the nalarifox first-line regimen for the same drug combined with ondansertib in our prior second-line PDAC trial. This new trial will replace the first-line PDAC investigator-initiated trial combining ondansertib with gemabraxane, which was still in an early stage and had not started to enroll patients. We will provide further updates on the ondansertib Malary Fox investigator-initiated trial in the coming months. Now I'd like to transition to the third item on our agenda, which is our continued success in identifying other cancer indications where Onvancitib may be clinically efficacious. Previously, in preclinical studies, Onvancitib has been shown to have activity in GRAS wild-type MCRC, ER-positive breast cancer, triple negative breast cancer, and platinum-resistant ovarian cancer. Last month, we published preclinical data on a new indication within ovarian cancer in the peer-reviewed journal, Cell Death and Disease, which is a portfolio member of the journal, Nature. Specifically, the data evaluate on vancertib and ovarian cancers that are resistant to PARP inhibitors. In the published study, the combination of on vancertib and allopurib, a PARP inhibitor approved in ovarian cancer, was tested both in vitro and in vivo in BRCA1-mutated and wild-type ovarian cancer models. In vitro, the combination of Onvancitib and Alloperib was synergistic in ovarian cancer cell lines and demonstrated inhibition of tumor growth. In vivo, the combination was well-tolerated, slowed tumor progression, and prolonged survival in patient-derived xenograft models resistant to Alloperib. Resistance to Alloperib has been observed in clinical settings and has been a challenge to overcome. Moreover, these findings underscore the ability of Onvancitib to overcome resistance to PARP inhibitors in high-grade serious ovarian carcinomas, which could make a significant impact in the treatment landscape for ovarian cancer. Overall, we are still determining our path forward in ovarian cancer. However, we are highly encouraged by the totality of the data generated from our recent publication and AACR poster that demonstrate Onvancitib's ability to effectively resensitize ovarian cancer to treatment. Now, I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter 2024 financial update.