Cardiff Oncology, Inc.

Welcome to the Cardiff Oncology fourth quarter and full year 2023 financial results and corporate update conference call. At this time, all participants are in 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. 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 over to Lawrence Watts of the Gilmartin Group. Please go ahead.

Thank you, Operator. Joining us on the call today from the Department of Oncology are Chief Executive Officer, Mark Erlander, Chief Medical Officer, Dr. Farooz Kabinova, 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 on-ventative 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 our annual report on Form 10-K for the year ended December 31, 2023, filed with the SEC earlier today. Cardiac 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. Slides for today's investor call can be found on the homepage and the events and presentations tab of the Cardiff Oncology website at www.cardiffoncology.com. With that, I will turn the call over to Chief Executive Officer Mark Allender.

Thank you. Thank you, Lawrence. Good afternoon, everyone, and thank you for joining the call. We have some very important new clinical data to share on the call today which we think is highly relevant to our current first-line metastatic colorectal cancer program. As you may be aware, last year we made a highly consequential decision to shift our MCRC program from the second line to the first-line setting. There were three factors that drove our decision. The first was the clinical signal from our second-line MCRC trial. The second was the new mechanism of action we discovered for our advanced retic. And the third was a strong support from the FDA for the first-line clinical development plan. What's new today is that for the first time, we are releasing data from our Ensembl trial, adding powerful support to our first-line strategy. And as we'll discuss, what's different with the Ensembl clinical data is that it's independent, it's randomized, and it's prospective. You'll hear more about each of these attributes today and by the end. I hope you've agreed that ensemble data has substantial support for our first-time program. So let's dive in. Slide two shows the three topics we'll cover on today's call. First, we'll talk briefly about 2023 and what a transformational year it has been for cardiac oncology and for the clinical development of our drug, on to answer tip. Secondly, as I mentioned, We'll share clinical data from our randomized second-line ensemble trial. And then finally, we'll talk about our financial position that we disclosed today in our Form 10-K. On slide four, we show the highlights of the significant announcements we made in 2023. In August, we provided our MCRC clinical update, where we announced the discovery of a novel mechanism of action for our advanced RTIP, which was previously unknown. and the critical role that it plays in the HIP-1-alpha pathway inhibiting vascularization of tumors. The data we presented, showing evidence for complementary mechanisms of action for imbacitib and bevacilumab, which we will refer to as BEV, could explain the strength of our clinical data in NCRC. And after discussing the clinical and underlying mechanism with the FDA in June of last year, we received strong support setting further we announced the pfizer through its pfizer ignite program which means providing cheap clinical execution for the carnet 004 trial at the time we made all these decisions we were already enrolling patients in the ensemble trials in the second line setting so in august we announced we would discontinue the trial to focus our efforts and resources on the larger patient population and the significant unmet need in the first-line setting. In September of last year, we held a second update call to announce state-of-the-art programs outside of MCRC. From our second-line pancreatic cancer trial, we announced four initial partial responses from the 21 patients, and today we can provide an update on those four patients by sharing that three of the four initial responses were confirmed on a subsequent scan. We also announced our decision to shift our pancreatic program to a first-line setting with an investigator-initiated trial combining Onvansertib with standard care gemabraxate. Finally, we announced new data from our refractory extensive stage small lung cancer investigator-initiated trial where we observed a confirmed PR among the first seven patients. Importantly, this is the first clinical data generated using Onvansertib as a single agent. Looking at the range of our announcements in 2023, you can believe that the year was a truly transformational for Cardiff Oncology. Just have this break for a second. I'm sorry, but I am losing my voice. So I'm going to ask my CFO, James, to continue with his remarks on the call. I'll be available for Q&A at the end of the call. Thank you.