Welcome to the Cardiff Oncology third-quarter 2023 financial results and corporate update conference call. As a reminder, this call is being recorded today, November 2, 2023. I would now like to turn the conference call over to Kiki Patel of Gilmartin 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 limitations, statements related to guidance, results, and the timing of the area for our advantage and 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 entitled Risk Factors in our annual report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 2, 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. Slides for today's investor call can be found on the homepage and Events and Presentations tab on the Cardiff Oncology website at www.cardiffoncology.com. With that, I'll turn the call over to Chief Executive Officer, Mark Erlander. Mark?

Thank you, Kiki, and good afternoon, everyone. And thank you for joining our third-quarter 2023 financial results and corporate update conference call. As you can see on slide 3, this past quarter was transformational for Cardiff Oncology. In August, we announced strong data from our lead program in KRAS-mutated metastatic colorectal cancer, the conclusions from a highly supportive meeting with the FDA, and the expansion of our relationship with Pfizer. Then in September, we released data with two earlier stage programs in pancreatic cancer and small cell lung cancer, which included a clear efficacy signal from onvansertib monotherapy in both indications. Today, we would like to put all of this in context and explain our strategy to you all and demonstrate how we can create shareholder value going forward. As we all know, these are challenging times for publicly listed biotech companies, but Cardiff Oncology has a collection of strengths from which to build value. As we list on slide 4, these include, first and foremost, our drug onvansertib, which has shown clear signals of efficacy and tolerability in combination with chemotherapies and as a single agent in our clinical trials across multiple indications. Second, onvansertib is the only PLK1 specific inhibitor in clinical development, meaning onvansertib is the first-in-class molecule for this well-understood target for cancer therapy. Third, onvansertib can combine synergistically with and is well tolerated in many first-line and second-line standard of care regimens. This enables us to address some of the most common and deadliest cancer indications in early lines of therapy where there are large patient populations that could be positively impacted. The fact that we are targeting first-line patients in both metastatic colorectal cancer and pancreatic cancer are good examples of that. Fourth, we have clear third-party support for our plan, and this includes the FDA and Pfizer. Finally, we have the financial resources to pursue our strategy in a thoughtful and methodical manner with the cash runway into 2025. As we go to slide 5, we show the three objectives for Cardiff Oncology that we believe will create value for all of our stakeholders. And let me be very clear. Our primary focus is our lead program in RAS-mutated metastatic colorectal cancer. We are currently working closely with Pfizer Ignite to execute the clinical development plan that the FDA has agreed to and to generate data from our first-line CRDF-004 clinical trials in mid-2024. Our second objective is to continue to generate additional clinical data from our trials in pancreatic cancer, small cell lung cancer, and triple-negative breast cancer, which we plan to do in a capital-efficient manner through investigator-initiated trials. Finally, our third objective is rooted in our conviction that PLK1 inhibition has an even larger role to play in cancer therapy. As we have for other clinical programs, we will make data-driven decisions with strong commercial logic to explore new promising combinations and cancer indications. Our current efforts focused on cost-effective preclinical study. By executing towards these objectives, we can create significant value for all of our stakeholders, and we believe that data and the plans we announced in the third quarter from a shareholder perspective reduce the risk of our clinical development plan while increasing the reward potential given the larger commercial opportunity that we are now pursuing. Let's move to slide 6. Here, we're summarizing the key accomplishments during the third quarter of our lead program in metastatic colorectal cancer. As you know, in August, we shared a series of findings from our second-line Phase 1b/2 clinical trial in KRAS-mutated metastatic colorectal cancer. About a quarter of the patients who came into our second-line trial were not treated with bevacizumab or bev in their prior first-line treatment. For these bev-naive patients, we saw strong responses to the combination of our drug onvansertib with the second-line standard of care, which includes bev, specifically 73% of bev-naive patients had a confirmed objective response to treatment versus historical controls that had demonstrated a rate of around 25%. And these patients also remained on our trial for a median time of 15 months before their disease progressed versus historical controls of seven to eight months. We were highly encouraged by these data, which suggested that there was a new mechanism of action of onvansertib at blood that was previously unknown. Observing a threefold increase in response rate, a doubling in the median progression-free survival in bev-naive patients was a signal too strong for us to ignore. So as a next step, we investigated the underlying science through a 12-month, multi-phase preclinical program. The preclinical work led us to conclude that both onvansertib and bev have independent mechanisms of action that work together to restrict a tumor's blood supply, thereby significantly decreasing the tumor growth. We next asked, why is this clinical finding only observed in bev-naive patients and not in patients who were treated with bev in the first-line setting? To answer this question, we engaged an independent research firm called Tempus to conduct a clinical study that analyzed tumor biopsy data from 135 KRAS-mutated metastatic colorectal cancer patients. This analysis showed that once patients were exposed to bev in the first-line setting, the tumor genomics changed. This change is consistent with generating tumor resistance to onvansertib and death in the second-line setting. We believe this explains why we observed strong positive clinical results in our Phase 1b/2 trial in the bev-naive but not the bev-exposed patient populations. Now armed with these findings, we shared our clinical and preclinical data with the FDA in a Type C meeting in June of this year. The FDA suggested we move our clinical development program of onvansertib up to the first-line setting where all patients are bev-naive and where we have the opportunity to positively impact the largest patient population of RAS-mutated metastatic colorectal cancer. We responded to the FDA's suggestion by proposing a development plan with two clinical trials. The first trial, CRDF-004, will provide randomized data for both efficacy and dose confirmation. Then, we can conduct a subsequent registrational CRDF-005, where the FDA provided clear guidance for a path to both accelerated approval and full approval from one trial. Finally, we shared the full data package and FDA conclusions with members of our Scientific Advisory Board, which includes representatives from Pfizer. As you know, Pfizer initially invested in Cardiff Oncology two years ago, having seen full development of the clinical, preclinical, and FDA response I just described, they proposed that Pfizer Ignite conduct the CRDF-004 first-line clinical trial. Now, every partnership that Pfizer Ignite considers undergoes close internal scrutiny by the Chief Scientific Officer, along with other key scientific team members at Pfizer. They gauge the potential of each project, ensuring collaborations are mutually beneficial and aligned with Pfizer's broader goals. As we announced in August, our new relationship with Pfizer Ignite allows us to leverage their clinical development horsepower to execute our CRDF-004 clinical trial, while importantly, Cardiff Oncology maintains full economic ownership and control of onvansertib. This month, November, the first group of our planned 30 clinical trial sites across the United States for CRDF-004 will be open to enrollment. We anticipate enrolling patients shortly thereafter and plan to report preliminary results in the middle of next year. With this, I'd like to turn now to our earlier-stage programs, which are highlighted on slide 7. In September, we announced signals of efficacy in metastatic pancreatic cancer from two clinical trials, which support our planned path forward in the first-line setting. The first trial CRDF-001 evaluates onvansertib's efficacy and tolerability in the second-line setting of pancreatic ductal adenocarcinoma or metastatic PDAC. From CRDF-001, we reported four of our 21 patients, or 19%, achieved an objective partial response. As of the data cutoff of September 13, 2023, three of the four patients with partial responses were still awaiting their confirmatory scans. As of today, November 2, one of these three patients, patient 42, has now shown further deepening of response at their four-month scan, representing a second confirmed partial response on this trial. We are still awaiting confirmatory scans for the remaining two patients with unconfirmed partial responses who remained on treatment, one for about eight months and another for over nine months, which is much longer than the historical median progression-free survival of 3.1 months for second-line treatment. Overall, for all evaluable patients, we reported a median progression-free survival of five months, which is encouraging since this approaches the benchmark of the first-line median progression-free survival, which is 5.5 months, indicating yet another strong signal of efficacy in this indication. The second trial in pancreatic cancer is an investigator-initiated biomarker discovery trial in metastatic PDAC, where the onvansertib effect on tumors is being evaluated as a single agent. As you recall from our last call, the data we presented in September showed effects on tumor biomarkers with onvansertib monotherapy after only 10 days of treatment. Because of these encouraging results that we observed today with onvansertib from both trials, we plan to move to the first-line setting through a new investigator-initiated trial to be conducted at the Oregon Health and Science University Knight Cancer Institute. This first-line design enables us to potentially have the greatest opportunity to impact these challenging diseases at the earliest possible stage when the chances of patients responding to treatment are the highest. Finally, and important, this approach allows us to generate data in a capital-efficient manner. In September, we also presented the first look at data from an investigator-initiated trial in refractory extensive-stage small cell lung cancer. The trial treats patients with onvansertib monotherapy and is being conducted at the University of Pittsburgh Medical Center. Of the first seven patients treated as of September 26, 2023, one had a confirmed partial response, three stable disease, and three progressive disease. Seeing a confirmed partial response, which the investigator assessed as a 50% shrinkage of the tumor from treatment with onvansertib monotherapy, provides a clear signal of onvansertib's efficacy in this challenging disease. Our current plans are to continue enrollment in this trial, but as we reported in September, our expectation is that a future clinical path forward in small cell lung cancer is most likely to include a combination regimen of onvansertib with second-line standard of care paclitaxel. Finally, the investigator-initiated trial in triple-negative breast cancer continues to enroll, and we'll provide data from that trial when it becomes available. Okay, so so far, I've discussed our ongoing programs and plans, but our third objective to create value for our stakeholders is to investigate new therapeutic indications for onvansertib. For example, the recent discovery of the power of the onvansertib-bev combination indicates that we should aggressively explore, through preclinical models, indications where bev is FDA approved. This includes RAS wild-type colorectal cancer, lung, liver, kidney, cervical, and ovarian cancer. We also know that onvansertib is anti-mitotic, given that PLK1 plays a critical role in cellular mitosis, which is the process through which a cancer cell divides from one cell to two. There is extensive literature suggesting that the combination of two anti-mitotic agents could be synergistic, and we have been exploring this combination in preclinical models with dramatic results. To give one example, I will share some new preclinical data for hormone-receptor positive, or HR-positive, breast cancer. These results are shown on slide 8. Breast cancer is the most common form of cancer diagnosed today in the United States, and hormone-receptor, or HR-positive breast cancer represents about 80% of breast cancer cases. In metastatic HR-positive breast cancer, tumor cells can develop resistance to first-line treatment, in part by overexpressing PLK1. Paclitaxel, an anti-mitotic agent, is a common second-agent therapy, making it an ideal drug to explore in combination with onvansertib in this setting. The data on slide 6 shows how treatment with onvansertib, paclitaxel, and the two agents combined impacts patient-derived xenograft models resistant to first-line treatment with palbociclib in HR-positive breast cancer. We observed highly significant tumor regression with the combination, with over 50% of the tumors within each model having a complete response to the combination treatment. As we look at this here at Cardiff Oncology, we believe this data supports our broader vision for onvansertib, and we remain committed to a cost-effective approach using preclinical models to validate additional indications and combinations. Now, I will turn it over to our CFO, Jamie Levine, to go over the financial results for the third quarter, 2023. Jamie?

Thank you, Mark. Earlier today, we issued a press release summarizing our financial results for the third quarter, and on slide 9, we share the financial highlights. You can also find additional information in our Form 10-Q for the third quarter filed with the SEC earlier today. Turning to our balance sheet, cash and short-term investments as of September 30, 2023 totaled $81.4 million and net cash used in operating activities for the third quarter of 2023 was approximately $8 million. Based on our current expectations and projections, we believe our cash resources are sufficient to fund operations into 2025. With that, I'll turn the call back over to Mark.

Thank you, Jamie. And as we close today, you can see from the data we have generated today, we here at Cardiff Oncology truly believe we have a pipeline in a product, and we have found highly capital-efficient ways to explore the efficacy signals. And with data expected mid-next year from our first-line RAS-mutated metastatic colorectal cancer trial, we have an important near-term catalyst from our lead program. So while we recognize the challenges facing the broader biotech industry, we believe that the strength of our data, the clarity and support we received from our recent FDA meeting, our expansion of our relationship with Pfizer, and our strong financial position clearly show that Cardiff Oncology has the potential to create enormous value for our stakeholders, including our shareholders, and most importantly, the patients we intend to serve. With that, I will now open the call up for questions. Operator?

Our first question comes from Mark Frahm with TD Cowen.

Thanks for taking my questions. First, on the clinical side, at the last update, there were three unconfirmed PDAC responses. I'm wondering if some of those patients have had a chance to undergo a confirmatory scan in the last month or two, and if so, were any of them able to confirm? On the finance side, Jamie, can you talk about the expense trajectory as the first-line trial and colorectal trial start to ramp up along with some of these other ISTs? I know it's not a significant change for you, but as those begin, I'd appreciate your insights.

Thank you, Mark, for your question. Regarding the CRDF-001 PDAC trial, we previously announced four partial responses, with one confirmed during our September call. Today, we are updating that we have a second patient showing a deepening response, now confirmed as a partial response. We still have two patients awaiting their next scans; one has been receiving treatment for eight months, while the other has been treated for over nine months. We intend to provide further updates on the trial in the future. Now I'll hand it over to Jamie, unless you need any additional clarification, Mark.

No, no. That's very helpful. Thanks.

So Mark, from an expense trajectory, what we'd say is we have a few trials that are actually going to be winding down. As we've talked about, our plans in mCRC for the Phase 1b/2 trial will be winding down. We're also shifting away from our second-line PDAC trial into the first-line IIT that Mark discussed earlier. So that's happening at the same time as we are ramping up our CRDF-004 trial. When we look at our overall expenses, our net expenses going forward will increase, but not significantly. I think when you put that together with the $81 million we have at the end of the third quarter, you can see we burned $8 million this quarter, which is in line with where we've been in the past. That’s the basis of our statement that our current cash extends into 2025.

Great. Thanks, very helpful.

Sure.

Our next question comes from the line of Joe Catanzaro with Piper Sandler.

Hey, everybody. Appreciate you taking my questions. Maybe just a couple from me on the 004 study. I would love to just get your sense around your level of confidence regarding being able to generate these interim data by mid-'24, given dosing hasn't started yet. I'm wondering if you have any internal projections on how quickly you can enroll these planned 90 patients. And then have you said whether this data readout is triggered by a specific number of patients reaching a specific amount of follow-up? Any details there would be helpful. Thanks.

Well, hi, Joe. Yes, we remain very optimistic about being able to put out the first interim data or preliminary data from the trial. As you know, we are working very closely with Pfizer Ignite. We are pleased because Pfizer Ignite is conducting and implementing the CRDF-004 randomized trial. We do believe that we will have data to discuss. Now, keep in mind, we will be closely monitoring the trial. The trial itself is an open-label trial, so we will be able to watch the progress as we start to enroll patients. But we do remain confident in being able to provide information sometime mid-next year.

Okay, that's helpful. And then in terms of the actual data readout, my follow-up there was whether that's triggered by something formally in the protocol as it relates to the number of patients and the amount of follow-up.

No, it's not. It's really we're watching as it's open-label. So it will depend on the magnitude of the effect that we see. But there is no trigger in the protocol.

Okay, got it. That's very helpful. Thanks for taking my question.

Sure, Joe.

Our next question comes from the line of Andy Hsieh with William Blair.

Great, thanks for taking my questions and congratulations on all the progress. Two questions, if you don't mind. One has to do with, Mark, I believe when you were conducting the Phase 1b/2 study before, there was a strategy employed to minimize the adverse events from switching between bolus 5-FU and infusional 5-FU. I'm curious if that strategy is also being employed in 004 and 005. And then I'd love to hear your thoughts on the IP strategy in terms of market exclusivity. Thank you.

Okay. With the first question, Andy, regarding the bolus, we will continue to have that as an option for the treatment arms. However, in the control arm, the FDA has requested that we consider it to be standard care to have the 5-FU bolus. We will continue to apply what we've done in the Phase 1b/2 trial. Your second question, maybe, Andy, could you please repeat that again so I can make sure I answer it correctly?

Thank you. At this time, I would now like to turn the conference back over to Mark Erlander for closing remarks.

Well, thank you all for your time, and this concludes our conference call. Thank you once again for joining us this afternoon.

This concludes today's conference call. Thank you for participating. You may now disconnect.