Welcome to the Cardiff Oncology third-quarter 2023 financial results and corporate update conference call. [Operator Instructions]. 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 the 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 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, 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 the 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…

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 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?

[Operator Instructions]. Our first question comes from the line of Mark Frahm with TD Cowen.

Thanks for taking my questions. Maybe first on the clinical side, at the last update, there were three unconfirmed PDAC responses. Just -- I'm not sure if maybe some of those patients have had a chance to have a confirmatory scan in the last month or two, and if so, were any of them able to confirm? And then on the finance side, maybe, Jamie, can you just talk through the expense trajectory here as the first-line trial and colorectal starts to ramp up and some of these other ISTs? I know it's not a big lift on your part, but just as some of those start up as well.

Okay. Well, thanks, Mark, for your question. So regarding the CRDF-001 PDAC trial, as you as you stated, we had four PRs that we announced with one being confirmed on our September call. What we're announcing today is the continuing and following these patients. And now we have a second patient who had a deepening response and confirm -- and now has a confirmed PR. We have two remaining patients who have not had their next scan, one's been on treatment for eight months and the other's still on treatment for over nine months. And so we planned at some date in the future, we will update that trial, but that's where we stand today. And I will now turn it to Jamie to -- unless, Mark, there's any more clarity you need on that.

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 of the Phase 1b/2 trial, it's going to be winding down. We're also shifting away from our second line PDAC trial into the first line IIT that Mark talked about earlier on the call. So that's happening at the same time as we are ramping up our CRDF-004 trial. So when we look at our overall expenses, our net expenses going forward, we do expense -- we do expect that they're going to increase but not significantly. And I think when you put that together with the $81 million we have at the end of the third quarter, you can see, once again, we burned $8 million this quarter. That's in line with where we've been in the past. And so that is the basis on which we make the 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 competence around 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 bullish in 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. And Pfizer Ignite, we're very pleased because Pfizer Ignite is actually conducting and implementing and executing the CRDF-004 randomized trial. And so we are going off of where those projections are. And we do believe that we will be able to have data to talk about. Now, keep in mind, we'll be watching the trial. The trial itself is an open-label trial. So we'll be able to watch the progress of that as we start to enroll patients. But we do remain confident to be able to give 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 formerly 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's going to depend on the magnitude of the effect that we do see. So 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 event from switching between bolus 5-FU and infusional 5-FU. I'm just curious if that strategy is also being employed in 004 and 005. And then I'd love to hear, obviously with this expanded pipeline development plan, 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're continuing to have that be an optional for the treatment arms. And -- but in the control arm, the FDA has asked that they consider it to be standard care to have the 5-FU bolus. But we will continue to do what we've done in the Phase 1b/2 trial. Your second question, maybe, Andy, maybe you could repeat that again just so I make sure I answer that 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 and thank you once again for joining us this afternoon.

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