Cardiff Oncology, Inc.

Welcome to the Cardios of Oncology first 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 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 Kiki Patel of Gilmartian 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 unadvantaged 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 filed with the SEC for the year ended December 31, 2023. 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. 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 conference call for the first quarter of 2024 Business Update. It was less than a year ago that we announced that our Clinical Development Plan for Advancetid with focus on the first-line treatment of RAS-mutated metastatic colorectal cancer, or MCRC. The data we shared last August supported this move, and our focus on first-line MCRC addresses a large patient population, almost 50,000 new patients a year in the United States, for whom there have been no new therapies approved in 20 years. In the first quarter of 2024, three data sets added to the body of evidence supporting our first-line focus strategy. First was the ensemble data, which served as an independent and randomized data set that replicated the efficacy signals in very many patients observed in our Phase 1b2 trial. Second was our five posters presented at the annual meeting of the American Association for Cancer Research, or AACR. And finally was the publication of data in the peer-reviewed journal clinical cancer research from the Phase 1b portion of our Phase 1b2 K-RAS-mutated MCRC trial. I want to emphasize our conclusion that the collective data released in Q1 strongly supports our finding that adding on Vanstertip to standard care Oferi and Bevacizumab, which I will refer to as Bev, has significant efficacy in RAS-mutated MCRC patients that are BEV-naive, that is patients that have had no prior treatment with BEV. Now during today's call, we have three topics to cover. First, I will provide a summary of the promising data we presented last month at AACR. Next, we will discuss our lead program in MCRC and provide updates around our ongoing Cardiff 004 trial. And finally, we'll talk about our financial position that we disclose today in our Form 10Q. So let's begin. Last month, the American Association for Cancer Research held its 2024 Annual Meeting in San Diego, in which Cardiff Oncology presented a total of five posters, all of which are available on our website. One poster described the design of our ongoing Cardiff 004 trial, a second poster presented data that supports our first-line strategy in MCRC by providing new translational data from our Phase 1b2 trial and second-line KRAS-mutated MCRC. Three additional posters shared promising preclinical data in other cancer indications, including RAS wild-type MCRC, small-cell lung cancer, and ovarian cancer, demonstrating the broad opportunity we see for Onvansartan. I would like to highlight some of the important data we presented in the poster on our lead program in Ras Mutated MCRC. In this poster, we presented both clinical data from the Phase Ib2 trial and subsequent data from preclinical studies that forms the basis of the scientific rationale for our clinical findings. We also demonstrated that Bab-naive patients within this trial had a higher objective response rate and a longer progression for survival. The additional preclinical data, clinical data disclosed at AACR provides further evidence that Onvancitib and Bev have their pharmacological effect at two different nodes of the hypoxia pathway. We hypothesized that Onvancitib and Bev work in a synergistic manner, giving a one-two punch to the tumor. Our hypothesis was further strengthened by our preclinical in vivo data and three KRAS mutant MCRC xenograft models. Combination treatment with Onvancitib plus Ben resulted in significant superior anti-tumor activity compared to monotherapy with either agent. And importantly, the combination treatment also resulted in a greater decrease in tumor vascularization compared to either agent alone. This finding provides rationale for further exploration of the combination of ondansetib and BEV in additional indications where BEV is FDA approved. Collectively, the clinical and preclinical data presented at AACR in RAS mutated second-line MCLC provides further validation of our ongoing CARTF004 trial. We believe on vansertib will have a significant impact in the first-line setting, given that all patients are dev-naive. Now let's move on to our additional posters presented at AECR in therapeutic areas outside of our core focus of RAS-mutated MCRC. Today, most of the data we have generated in MCRC has been in RAS-mutated patients, and we are often asked if our therapy could work for patients who do not have a RAS mutation. At ACR, we shared encouraging preclinical data in RAS wild-type MCRC, meaning these models were derived from patients who did not have a RAS mutation. Our preclinical study in RAS wild-type MCRC patient-derived xenograft or PDX models aimed to assess the efficacy of Onvancitib as monotherapy and in combination with the EGFR inhibitor which is the standard of care for RAS wild-type and CRC patients. We evaluated models that were both sensitive to cetuximab and resistant to cetuximab. In summary, Onvancitib displayed robust antitumor activity as a single agent in cetuximab-sensitive and resistant PDX models. As for combination therapy, efficacy was enhanced when Onvancitib and cetuximab were combined. compared to monotherapy of either agent alone. In combination, Onvancitib and Cetuximab induced tumor stasis or regression in 90% for 18 of the 20 PDX models. Overall, we are exceptionally pleased with the RAS wild-type preclinical data presented at ACR, as it emphasizes that Onvancitib has broad spectrum activity in MCRC, independent of RAS mutational status. This provides sound rationale for us to consider future clinical trials in RAS wild-type NCFC. I now would like to share the data we presented at AACR demonstrating on vascular tibs anti-tumor activity across multiple tumor types outside of NCFC. If you recall, last September, we shared clinical data from our investigator-initiated trial in extensive-stage small-cell lung cancer where Onvansartib, as a single agent, demonstrated a confirmed partial response with 50% shrinkage of patient's tumor among the first seven patients treated on the trial. While we were impressed by Onvansartib's single agent activity, we believe a combination strategy would be the optimal approach to treating this aggressive disease. At that time, we disclosed that our clinical path forward in small cell lung cancer would be the combination strategy of onvansertib and paclitaxel, which is one of the standards of care for second line small cell lung cancer. At AACR, we presented preclinical evidence that supports this clinical plan. In vitro, the combination of onvansertib plus paclitaxel synergistically inhibited tumor proliferation in cell lines for small cell lung cancer. In vivo, the combination was well tolerated and highly effective in cisplatin-sensitive and resistant PDX models for small-cell lung cancer. These findings support the scientific rationale for a planned investigator-initiated trial combining ondansetib with paclitaxel as a promising treatment strategy for extensive-stage small-cell lung cancer patients. Our final poster, presented at ADCR, evaluated the combination of ondansetib plus carboplatin gemcitabine in high-grade serious ovarian cancer models, where both of these agents are standard of care. In vitro, Onvansertib was synergistic in combination with carboplatin, as well as with gemcitabine in an ovarian cell line. In vivo, both combinations demonstrated anti-tumor activity and platinum resistance ovarian cancer PDX models and were well tolerated. Overall, We believe that these data support the potential of Onvansertib to improve standard care treatment for platinum-resistant ovarian cancer patients. At the moment, we are still determining our path forward in this indication. So in summary, the data we presented at ADCR this year provided strong scientific rationale for the clinical development of Onvansertib across multiple tumor types and various combinations. And our RAS mutated MCRC data provided further validation of our lead program in our ongoing CARTIC-004 clinical trial. Now turning to our second agenda item, CARTIC-004 is our ongoing phase two trial evaluating first line patients with RAS mutated NCRC. Onvansertib is being added to the standard care, current standard care, which is either Folfiri plus Bev or Folfox plus Bev. We plan to enroll a total of 90 patients who will be randomized to receive either 20 mg of unvancitib plus standard of care, 30 mg of unvancitib plus standard of care, or standard of care alone. We are working closely with our partner, Pfizer Ignite, who is conducting the clinical execution of the trial, and we are highly confident in Pfizer's ability to operationally execute given their track record of success. Currently, we have 24 activated clinical trial sites. In August of 2023, when we decided to move forward with the CARTF004 trial, we forecasted that we would be able to share initial data from the trial in the Q2-Q3-2024 timeframe. As of today, and based on the actual enrollment trends at our activated sites for the past few months, Our expectation for the timing of an initial readout is now in the second half of this year, or Q3 to Q4. I want to make it clear that this timing for the readout is solely based on the pace of enrollment. We, together with Pfizer Ignite, feel confident in our ongoing site activation enrollment efforts, and we believe that we have all the right resources to meet this timing. We anticipate this initial top line data release will include objective response rate for approximately half of the 90 patients we expect to enroll in the trial. Now, I would like to turn the call over to Jamie to discuss our third agenda item, our first quarter 2024 financial update.