Hello. Welcome to the Cardiff Oncology clinical update conference call. At this time, all participants are on 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 one one 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 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, Chief Medical Officer Dr. Roger Sadhu, 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 onvansertib 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 31st, 2024. 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 expectation. With that, I turn the call over to Chief Executive Officer Mark Erlander. Mark? Yes. Thank you, Kiki, and good afternoon, everyone, and welcome to the CRDF-004 update conference call. We are very excited to share the latest news on our trial. Today's update represents an important step forward first-line RAS-mutated mCRC program. we believe that the dataset we are sharing today: one, reinforces the attractive trends we saw in our initial data release in December, with more patients and with more follow-up. Two, represents a proof of concept for the clinical benefit of adding onvansertib to the standard of care. Finally, it puts us on the path to move forward with discussions regarding the registration trial with the FDA. Before introducing our Chief Medical Officer and diving into the data, I would like to remind you of our drug candidate, onvansertib, on slide four. Onvansertib is a serine/threonine kinase inhibitor that targets the enzyme PLK1, which is a well-established oncology target. Onvansertib is a highly specific inhibitor of only PLK1. It is administered orally and has a short half-life of 24 hours. We believe this unique pharmacological profile avoids the toxicities seen in previous PLK inhibitors. With data from over 380 patients treated in multiple clinical trials, onvansertib has been well tolerated, paving the way for its potential use in combination with standard of care therapy. As a reminder, on slide five, in August of 2023, we announced that we were shifting our RAS-mutated mCRC program from the second line to the first-line study because of the discoveries that we had made. The intent of the CRDF-004 trial is fourfold. First, to select a phase 3 dose per FDA's Project Optimus. Second, to assess the efficacy contribution of onvansertib when combined with chemotherapy and bevacizumab in a randomized trial. Third, to characterize the safety profile of onvansertib in the first-line setting with two different chemo backbones, FOLFOX and FOLFIRI. Finally, to serve as a basis for meeting with the FDA to agree on our registrational path forward. Now, I'd like to introduce our Chief Medical Officer, Dr. Roger Sadhu, who recently joined Cardiff Oncology to lead our clinical development program into the registrational phase. As you can see on slide six, Dr. Sadhu brings deep expertise in metastatic colorectal cancer and oncology drug development, with a proven track record of advancing novel therapeutics from bench to bedside. While at Amgen, Dr. Sadhu led multiple phase 3 clinical trials on panitumumab, contributing to its global approval and played a key role in advancing several therapeutic candidates across oncology and hematology. Dr. Sadhu has made significant contributions to the understanding and treatment of RAS-driven cancers, particularly in mCRC. His work has been published in leading peer-reviewed journals, including the New England Journal of Medicine, and continues to influence the evolving landscape of targeted therapies in colorectal cancer. After leaving Amgen, Dr. Sadhu served as CMO at several biotech companies. Given Dr. Sadhu's track record and experience, he will serve a critical role in the success of our mCRC program moving forward. Roger? Thank you, Mark, and thank you to all the stakeholders listening to this call to better understand the impact onvansertib can have for patients with RAS-mutated mCRC. Slide eight shows the topics we will cover on this call. First, I will discuss the efficacy and safety data from the CRDF-004 trial as of the July 8, 2025, data cutoff. Second, we will provide an early look at progression-free survival, or PFS, and we will also present well-validated response-based predictors of PFS to show how rapid and deep response to therapy with onvansertib may translate to significant improvement in PFS as our trial matures. Third, Mark will discuss how the CRDF-004 data supports moving forward to the next step in our registrational program. Once you have the totality of this dataset, you will see why I was so excited to join Cardiff Oncology. You can see on slide nine that colorectal cancer is the third most common cancer worldwide, with 150,000 new cases and 50,000 deaths annually in the United States. The five-year relative survival rate is a low 15%, and the median progression-free survival for first-line mCRC is, on average, less than one year. On the right side of the slide, you can see that first-line RAS-mutated metastatic colorectal cancer, the last new drug approval, bevacizumab, occurred over 20 years ago. In 2014, the two existing chemotherapy regimens were combined to FOLFIRI. However, given the high toxicity of this combination, only the fittest patients are eligible. As an oncologist, I can tell you that patients with this disease are in urgent need for new therapies. Slide 10 provides useful benchmarks for our CRDF-004 trial data. We show the results from the only two positive phase 3 first-line trials of chemotherapy plus bevacizumab that reported retrospective outcomes by RAS mutation. These trials demonstrated an ORR delta up to 11% in the KRAS or RAS-mutated population evaluated in each trial. While PFS and OS were the primary endpoints for these trials, the observed ORR deltas were associated with significant improvement in progression-free survival. Keep these numbers in mind as we share the results of our CRDF-004 trial. On slide 11, we show the design of our CRDF-004 phase 2 trial. We completed enrollment in April 2025 with patients whose eligibility criteria included a documented KRAS or NRAS mutation and unresectable metastatic disease. Patients were randomized to either standard of care alone, 20 mg of onvansertib plus standard of care, or 30 mg of onvansertib plus standard of care. The primary endpoint was the objective response rate, or ORR, and the secondary endpoints include progression-free survival, or PFS, duration of response, or DOR, and safety. Additional pre-specified endpoints include early tumor shrinkage and depth of response, which I'll define and discuss later on this call. Patients' tumors are measured at baseline and then scanned every two months for the duration of their time on trial. The change in tumor size for RECIST v1.1 is assessed by blinded independent central review, or BICR. Slide 12 shows the intent-to-treat population of 110 patients, which are all patients that were randomized in the trial. You can also see the safety population of 104 patients who received at least one dose of study drug. Sixty patients remain on trial, and the vast majority have at least two post-baseline scans. Finally, the median follow-up time is approximately six months. Now, let's take a look at the data. Slide 13 shows the confirmed objective response data for CRDF-004 based on the ITT population. The top row highlights the confirmed objective response rate, which includes patients that have had a partial response or complete response that was subsequently confirmed. The 49% ORR in the 30 mg arm compares favorably to the 30% ORR control arm, with a 19% delta, which far exceeds the 11% benchmark delta I previously discussed. Although the study is not formally powered for efficacy comparison, we are observing a significant p-value of 0.018. We show in the second row confirmed ORR at six months because more rapid response to treatment with a targeted agent versus control indicates higher antitumor activity and better long-term patient outcomes. As you can see, the 30 mg onvansertib arm had more than double the confirmed ORR at six months compared to the control arm. The more rapid time to respond in the 30 mg onvansertib arm helps explain our higher delta versus standard of care in our initial data reported last December. Because this is an ongoing trial, on slide 14, you will see in the third row the ORR, which adds in unconfirmed responses from patients that are still on trial and may yet confirm. This increases all response rates, bringing the control arm to 43%, which is within the range observed in prior first-line mCRC trials. At the bottom half of the slide, you can see the best response on trial for all patients. Slide 15 displays the waterfall plot showing each individual patient's best response with all the scans they have had on the trial. The bars rising above the midline represent tumor growth, and bars falling below the midline represent tumor reduction. The yellow bars represent patients who have stable disease as defined by RECIST 1.1, and the teal bars represent patients who have demonstrated a partial response to treatment, meaning their tumor volume has shrunk by at least 30%. Patients with a complete response are shown in dark blue. Now, I'd like to turn your attention to those patients that have a complete or partial response. There are three categories. First, patients with a solid circle over their bar indicate that the response was confirmed by a subsequent scan. Second, there are patients with an open circle, and these patients remain on trial and have the ability to confirm their response in a future scan. Finally, patients with no circle above indicate that the patient discontinued from the trial without confirming their response. On the left side, you see the best response for the patients in the control arm, with the 20 mg cohort in the middle and the 30 mg cohort on the right side. Here, we can see that compared to the control, there are significantly more responses and confirmed responses, in particular at the 30 mg dose, once again demonstrating a dose-response relationship. What we find even more striking is the overall depth of response in the experimental arms and multiple patients achieving 100% tumor shrinkage with onvansertib, which did not occur in the control arm. The waterfall plot demonstrates each patient's single best response for all the scans they have had on the trial. In contrast, the spider plots shown on slide 16 illustrate how each patient's tumor size has changed over time. Earlier, I commented that a more rapid time to response correlates with better long-term patient outcomes. Here, I would like to highlight that deeper responses also correlate with better long-term patient outcomes. The 30 mg onvansertib arm shows a significant deepening of responses over time compared to the control arm. Now, with more patients and more follow-up, we continue to see the encouraging trend that we observed in our December 2024 data release. On slide 17, we parsed all patients by chemotherapy backbone, FOLFIRI on the left and FOLFOX on the right. You can clearly see that there is additive clinical efficacy and deeper responses when combining onvansertib with either chemotherapy backbones. On slide 18, we have the swimmer plots broken down by onvansertib dose. The teal-colored lines represent a best response of CR or PR, and the yellow-colored lines represent a best response of stable disease. The gray dots on the teal lines indicate when the patient first achieved a partial or complete response. On the plot, you can see that there are more responses with onvansertib, particularly in the 30 mg arm, when compared to the control arm. Patients in the 30 mg arm are more likely to respond on their first two-month scan than the control or the 20 mg arm. Finally, in the table on the right, we can compare the 30 mg onvansertib arm to the control arm. We observe that a higher proportion of 30 mg patients remain on trial, a higher proportion of 30 mg patients have left the trial to pursue curative surgery, and a lower proportion of 30 mg patients have had progressive disease. On slide 19, I would like to share a few examples of onvansertib-treated patients who have achieved the deepest responses. First, we observed confirmed CRs with both chemotherapy backbones and at both doses at 20 mg and 30 mg. Second, these patients have both target lesions, non-target lesions, and for some patients, visceral disease, which is a poor prognostic indicator. Third, some of these patients have been referred to curative surgery even though they presented with unresectable disease per protocol. These represent patients with difficult-to-treat disease that have high-quality responses, and they are only seen in the onvansertib arms. On slide 20, you will see that the baseline demographics and clinical characteristics appear generally well balanced across the treatment arms and the control group. While the numbers are small, we observe strong performance in the 30 mg onvansertib arm despite the higher proportion of patients with three or more metastatic organs involved and with liver metastases, both of which are poor prognostic indicators. In general, we believe our study population is representative of the first-line metastatic colorectal cancer population and in line with previous published studies. Slide 21 displays the table of all treatment-emergent adverse events. To remind you, every arm contains chemotherapy plus bevacizumab. The grade 3 or higher adverse event rate with onvansertib is generally comparable to the control arms. Onvansertib is well tolerated when added to chemotherapy plus bevacizumab, regardless of whether the regimen includes FOLFIRI or FOLFOX. On slide 22, we have calculated the relative dose intensity across the different arms. Relative dose intensity is the actual amount of study drug a patient receives over time compared to the planned dosing schedule. We did not observe any significant differences that would impact efficacy or safety. We are highly encouraged by the response trend in the CRDF-004 trial that I just reviewed. Given the importance of PFS for the registrational program, today we will also share an early look at progression-free survival from the trial and promising response-based data for well-validated predictors of PFS. On slide 24, we see the Kaplan-Meier PFS curves for the three arms of the trial. With a median follow-up of six months as of July 8, we observe separation between the 30 mg onvansertib arm in dark blue and control arm in yellow. While the median PFS has not been reached, there appears to be a dose-dependent effect in favor of the 30 mg dose, demonstrating a promising trend. As we wait for the PFS data to mature, today we can share response-based predictors of PFS that are well validated in first-line mCRC, which further support the potential for a positive PFS result from the trial. As seen on slide 25, a number of publications have correlated early tumor shrinkage and depth of response with PFS in large registrational or practice-changing first-line mCRC trials. We will present how our CRDF-004 data compared to these prior trials on the following slides. On slide 26, you can see data for early tumor shrinkage, or ETS, from three published studies and from CRDF-004. Early tumor shrinkage is defined as a 20% or greater reduction in tumor size at the first post-baseline scan. In the prior trials, the proportion of patients that achieved ETS in the experimental arms was higher than in the control arms, which was a validated predictor of improved PFS. We observed a similar promising trend in CRDF-004 that also appears dose-dependent. Though the trial is ongoing and most data will continue to mature, the ETS data presented here is final, given the results are based on the first imaging time point alone. On slide 27, we again show the spider plot, which indicates a dose-dependent increase in depth of response over time within our trial. In the box plot on the right, we show this quantitatively with a significant difference in depth of response for the 30 mg patients versus the control arm. On slide 28, you can see data for depth of response from the three published studies and from CRDF-004. Depth of response is defined as the deepest reduction in tumor size over the course of a patient's time on trial. The three studies have deltas in depth of response in experimental versus control that range from 5% - 27%, which was associated with significant PFS improvement. In our trial, we have a delta versus control of 16% for the 30 mg dose of onvansertib. As the data matures, we expect the delta in depth of response between the onvansertib arms and the control arm to widen, given the clear trends we see on the spider plots. Overall, we believe the early PFS data from the CRDF-004 trial, coupled with the supported early tumor shrinkage and depth of response data, is predictive of the potential for PFS improvement when adding onvansertib to standard of care in the first-line RAS-mutated mCRC. Now, i will turn it back to Mark to conclude the call. Thank you, Roger. I will now conclude with some remarks on the registrational path forward. We turn to the four objectives of the trial, beginning on slide three. You can see that based on the data we are sharing today, we believe we have substantial evidence supporting the proposal of the 30 mg dose for the registrational program, which we intend to discuss with the FDA. Next, we believe our objective response data, PFS data, and dose-dependent response signals all support the likelihood of meaningful clinical benefit of onvansertib in combination with the current standard of care. Additionally, we have shown that onvansertib in combination with both chemotherapy backbones and bevacizumab is well tolerated. As we say on slide 33, we believe that the current data supports moving forward with FDA interactions on the registrational program in the near term. Two years ago, we started on a journey. We followed our data, and we shifted our lead program to the first-line setup. The data we are sharing today, one, shows proof of concept for onvansertib in first-line RAS-mutated mCRC, and two, supports the next step in our path towards a seamless registrational trial for both accelerated and full approval. We believe this because today's data is randomized with the 30 mg arm clearly outperforming the control arm. The data compares favorably against previous practice-changing trials. Finally, because of the obvious rapid and deep responses we are seeing, our validated predictors of durable responses. We are very excited about the results we are seeing today, and we are very thankful for the patients, their supportive families, and the clinicians who are participating in the CRDF-004 trial. We look forward to providing a further update on the RAS-mutated mCRC program by Q1 2026. With that, I will now open the call for questions. Operator? Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Marc Frahm with TD Cowen. Your line is open. Yes, thanks for taking my questions. Thanks for the very detailed disclosures around all the patient-level data and their trajectories. Maybe just thinking forward to having this conversation with the FDA to kind of confirm the 005 final design, do you think this is enough data? Do you think you want to wait for these last few unconfirmed but ongoing responses to have the chance to confirm? Maybe is it best to wait for PFS data to really get a little bit more maturity to it as that trial progresses? I'll follow up. Thanks, Mark, for that question. We currently are evaluating the data that we've just presented to everyone. Our focus is to get in front of the FDA as soon as we can, and our intent is to get there before the end of the year. Clearly, we believe we do have a strong dataset. As we sit here today, we're right in the middle of a lot of the PK, the exposure response data. I think we have to kind of make that call in the next month or two, but we are really focused, and we do believe right now that we have the necessary data to move forward and to speak with the FDA later in the year. One of the questions that was being asked by this trial was also the relative merits of FOLFOX versus FOLFIRI. Do you think you need to end up selecting one of those to focus on, or can you kind of take a similar approach as in this trial of just taking everybody as an all-comers and just having subset analyses? Thanks, Mark. I'll turn that over to Roger, who will answer that. Thanks for the question. As we look at, in particular, on the waterfall plot, we can see that when you add onvansertib to either FOLFOX +BEV or FOLFIRI+BEV, we have additive clinical efficacy. At this point, we don't believe that we need to select one arm versus another. We will incorporate the design into the phase 3 trial and then look at outcomes by tomorrow when the results are available. Okay. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Edward Tenthoff with Piper Sandler. Your line is open. Great. Thank you very much, and congratulations on the data. It really looks encouraging in this large and, you know, largely unmet medical need here. One question for Roger, if I may. It just feels to me, but I wanted to bounce this off of you, that the control arm feels a little bit higher than kind of what we've seen in the past. Do you agree with that? Do you think there might be anything to explain that? I just have a quick follow-up on the safety. Sure. Thank you for the question. We look at our data, and the great thing about it is that it's in a randomized study. We are able to look at the contribution of onvansertib versus control in that fashion. We also report, as the study is ongoing, the data around patients that are confirmed and may yet confirm. When you look at the rates that we're seeing that may, in fact, become the ones that we see towards the end of the trial, those are more in line with what has been published in prior studies. Okay. Yep. That's helpful. On the safety side, it looks pretty clean. How big of a factor is this, do you think, in the conversations with the FDA? Do you anticipate presenting this data at a medical meeting later this year? You've gone into pretty decent detail here on the safety side, and I appreciate that. Thank you for the question. With respect to the safety, as you said, we believe the drug is very well tolerated in terms of the additive toxicity that it adds to chemotherapy plus bev is fairly modest when you look at the differences, especially the grade 3 and higher rates. The important identifier risk is hematologic or decreased neutrophils or neutropenia. Again, those grade 3 rates are relatively low compared to the standard of care. With respect to discussing the data with the FDA, we would certainly intend to discuss the totality of the data we have regarding efficacy and safety. The good safety profile is important for the overall risk-benefit profile, which at this point we believe is positive. Regarding your last question around a medical meeting, we're still discussing where and when this data would be the subject of a next substantive update, potentially next year. Great. Thank you so very much for the update. Thank you. Please stand by for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open. Thanks for taking our question. A couple in terms of, you know, the historical trials conducted in this setting, I'm curious if previous trials, do they before confirm, usually before confirmed response, or is it basically kind of a compilation of unconfirmed and confirmed responses? I'm just curious about comparing the confirmed population and the unconfirmed population with a delta of 13%. Also, you know, 10% on the, you know, on the 30 mg arm. Can you just kind of explain the dynamic there, the dynamic there? Hi, Andy. You kind of broke up. I'm sorry. You kind of broke up a little bit there, and we didn't quite hear the question. It was something about confirmed versus unconfirmed PRs and historical data, or? Let me try again. Basically, the question is, for historical trials conducted in the setting, do they actually confirm, or do they report unconfirmed plus a confirmed response? I mean, that's it. Right. I can answer that one. They all are confirmed. Those are confirmed PRs, those rates. For this 004 trial, there's obviously a data, the delta between the confirmed and non-confirmed. This kind of explains, you know, maybe the dynamic there for us. Yeah. I mean, I think what we're looking at there, Andy, is that it's first and foremost, I mean, we are in an ongoing trial. We wanted to first support the top line, which is confirmed PRs. We also wanted to be transparent and also show confirmed PRs and patients who've had a PR that may confirm in the future, simply to show all of the data. We also do show in this slide deck that there are a number of, there's 18 patients across the three arms that still have stable disease. Those all, some of those could actually turn into PRs. In particular, in the 30, there are several patients there that we think will be turning. I think that we're really trying to, in all, in totality, we're trying to show, Andy, the full picture, the snapshot of the data it is today, starting with confirmed, confirmed, and yet to confirm, as well as patients still that are stable that could turn into PRs. That's helpful. I'm just curious, do you get the p-value analysis for the confirmed population? Curious if you've done the same thing for just the overall ORR population. Yes. We have done that. It's in the [slam] line. It's about $0.06. Great. That's helpful. Thank you so much. Thank you. Absolutely. Please stand by for our next question. Our next question comes from the line of Maury Raycroft with Jefferies. Your line is open. Hi. Thank you for taking our questions. This is [Amin Ahm] for Maury. Two questions from us. First, can you discuss the discontinuation rate due to adverse events? Looks like there were only a few in the active arms. What were the reasons for those discontinuations? Also, can you talk about the, based on the early PFS curves, can you elaborate on the trend that you are seeing, especially for the 30 mg so far? Sure. I can take those questions. With respect to the rates of discontinuation that we showed, I'm focused on the onvansertib arm. For patients that discontinued in those arms, they were due to adverse events that investigators deemed due to the underlying chemotherapy and bevacizumab, but not to onvansertib. In the trial, we don't have any patients that discontinued treatment for any onvansertib-related adverse events. With respect to the PFS curve, as you can see, the median follow-up time is six months. Given the median progression-free survival time in first line is anywhere from 9 to 12 months, that's the reason for so much censoring. We do see some signs of early separation in the curve, in particular at the 30 mg versus the control. What I will say is that we'll certainly see how the data looks as the trial matures. As we've presented, that early tumor shrinkage, early responses, and depth of response are strongly correlated with improvements in progression-free survival. We're having a very active drug with onvansertib, and we're expecting those separations to continue and hopefully become even more clear with more patient follow-up. Thanks. Very helpful. Thank you. Please stand by for our next question. Our next question comes from the line of Kevin DeGeeter with Ladenburg Thalmann. Your line is open. Hey, great. Thanks for taking my question. Maybe just two for me. Can you help us just make sure we're comparing apples to apples with regard to the December update from 30 patients? Remind us again where those, you know, confirmed, unconfirmed. What's the right way to think about the kind of maturation of the response rate across these two updates? Thanks, Kevin, for your question. You know, when we started this trial and put out the December 10th data, that was very early on. It was really this 30 patients at that time, it was not really appropriate to start talking about intent to treat. You know, there's just not enough patients. We were really looking at just how the patients did. Obviously, as we have now fully enrolled and almost all the patients have now two scans, you know, we have now moved into looking at the data the way that you would look at data as you are looking at its performance in a registrational phase 3 trial, which means we're looking at the intent to treat population. I think that that's really why we transitioned to intent to treat. Great. Thank you for that. Maybe just a question for Sadhu. Could you just walk us through from your clinician perspective, you know, kind of what's the goal here for a patient in first-line CRC in terms of, you know, CRs versus, you know, referral to surgery versus duration of benefit? I mean, what would you want to see if you were just a practicing doc for your patients? What's the most relevant metric in your mind? I think for doctors in the clinic, and I used to be one, having early and deep responses is important for a number of reasons. For one, the immediate patient benefit, which can lead to improvement in disease-related symptoms, is important for patients that have first-line metastatic colorectal cancer. Certainly, if there's an opportunity to potentially cure a patient, that's first and foremost. Although our data doesn't enroll patients that are potentially resectable, that's a different question. If there's an opportunity to turn a patient into a potentially resectable case and cure, that definitely is top of mind. When you see the activity that we're seeing with onvansertib, we're thrilled at these early signals of very deep responses in tough-to-treat patients. Thanks for taking my questions. Our next question comes from the line of Christopher Liu with Lucid Capital Markets. Your line is open. Hey, guys. Thanks for the question, and congrats on the data. In terms of historical studies, there seems to be quite a large range for response rates for the current standard of care between 45%- 65%. I'm just curious, from your perspective, what causes those differences? If possible, is there any color on how the CRDF study might compare to some of those historical studies with those differences? Yeah. I can start out, and then I think Roger will chime in. You know, it's one of the things that sort of levels that kind of question is we want to make sure that we are comparing apples to apples. What that would be is that we're looking for previous historical registrational or practice-changing trials that are looking at FOLFIRI or FOLFOX with bevacizumab because that is the backbone that we are then adding on top of. Secondly, drilling down into that patient population, we are looking at those 50% of patients that have some sort of RAS mutation. When you kind of look through that lens, really, the number of trials is pretty limited. There's been no trial that's prospectively looked at the RAS mutant population as a whole because there hasn't been anything that's been specific to that population. We are the first. Having said that, that's how we look at this. We then, and that's why we showed the two trials there because those were two trials where, you know, it's really a delta around 10%, 11% between the control and the treated arms. That was really why we looked at those because those are the ones where they had gone back and then retrospectively identified those patients within those trials that had a RAS mutation. That's kind of how we've got to where we are. I'll turn it, Roger, you know, okay. Maybe a follow-up to that, but that's kind of my initial reaction to that question. Thank you. Please stand by for our next question. Our next question comes from the line of Albert Lowe with Craig- Hallum. Your line is open. Hi, guys. Thanks for taking my question. I know you're highlighting the kind of thing of the totality of the data with the FDA, and I know the design of the phase 3 is agreed upon. I was wondering if there are any points that you anticipate needing to be discussed with the FDA at this upcoming meeting regarding the phase 3 trial. I was wondering if you expect the size to maybe still be around this 320 patients that you had posed earlier. All right, Albert. Thanks for your question. As you know, we did have a Type C meeting previously with the FDA where we outlined, and they basically agreed to a seamless registrational trial going forward. However, we needed to identify the dose, which is the CRDF-004 trial that we're talking about today. They wanted to also see the efficacy data from this trial. I think where we're going is we will then be presenting, going to the FDA. Our intent is this year, toward the end of the year, going into them and really presenting that dose and also the protocol of that registrational trial. At this point in time, we don't really have any details, but our plan is to, our intent is to not only give an update of this trial in Q1 of next year, but also to give an update on the actual nuts and bolts and details of that registrational trial. I don't know if you have any other comments. That's kind of where we stand here right now, Albert. Thank you for outlining that. I guess based on what you were saying, potentially could track towards that trial starting after the update, so perhaps sometime after Q1 of this year. Is that right? We will be giving another guidance to all that once we have met with the FDA. I think then we will have the necessary information for investors so they can understand what the trial really looks like, how many patients, how it is powered, what is the design. All of those things, I think we will be really excited to share with investors once we've had the meeting and clarity with the FDA. Okay. That makes sense. Thank you. For me, one more quick question. I was wondering if you saw any treatment effects on ORR by any baseline characteristics. Roger, do you want to take that one? Thank you. We did try to look and see if there are any significant interactions between any baseline demographic factor and ORR. We did not find any. One of the reasons is that when you start to kind of look at each factor in a small trial, the error bars can be pretty large, but we didn't see anything that should impact the interpretation of efficacy at this point based on baseline. All right. Great. Thank you. Thank you. As a reminder, ladies and gentlemen, that's star one one to ask the question. I'm showing no further questions in the queue. I would now like to turn the call back over to Mark for closing remarks. Thank you. This concludes our conference call. All I can say is thank you again, all of you, for taking time to join us this afternoon. Ladies and gentlemen, that concludes today's conference call. You may now disconnect.