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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Welcome to the Cardiff Oncology Fourth Quarter and Full Year 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.
I would now like to turn the conference over to Laurence Watts, 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. Fairooz Kabbinavar; 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 vented 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. 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 will be found on the home page under the Events and Presentations tab of the Cardiff Oncology website at www.cardincology.com
With that, I will turn the call over to Chief Executive Officer, Mark Erlander.
Thank you, Laurence. 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 study. There were 3 factors that drove our decision. The first was the clinical signal from our second-line mCRC trial. The second was a new mechanism of action we discovered for onvansertib, 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 ONSEMBLE trial, adding powerful support to our first-line strategy. And as we'll discuss, what's different with the ONSEMBLE clinical data is that it's independent, it's randomized and its perspective. You'll hear more about each of these attributes today. And by the end, I hope you agree that our [ data ] adds substantial support for our first-line program. So that's given.
Slide 2 shows the 3 topics we'll cover on today's call. First, we'll talk briefly about 2023 and what a transformational year it has been for Cardiff Oncology and for the clinical development of our drug on onvansertib. Secondly, as I mentioned, will share clinical data from our randomized second-line ONSEMBLE trial. And then finally, we'll talk about our financial position that we disclosed today in our Form 10-K.
On Slide 4, we showed 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 action for onvansertib, which was previously unknown. And the critical role that it plays in the HIF 1 Health pathway inhibiting fast utilization of terminals. The data we presented showing evidence of complementary mechanisms of action for onvansertib, which we will refer to as bev, could explain the strength of our clinical data and mCRC. And after discussing the clinical and underlying mechanism with the FDA in June of last year, we received strong support with a decision to move our program to the first line bev.
Further, we announced with Pfizer Ignite program, is providin the clinical execution for the [indiscernible] trial. At the time they made all these decisions, we were already enrolling patients in the ONSEMBLE trial 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 stated core programs outside of mCRC from our second-line [ B-grade ] of cancer trial. We announced 4 initial partial responses from the 21 patients and today, we can provide an update on those 4 patients by sharing that 3 of the 4. Initial responses were confirmed on a subsequent scan.
We also announced our decision to shift our [indiscernible] program to a first-line setting with an investigator initiated trial combining onvansertib with standard of care [indiscernible], Finally, we announced new data from our refractory extensive stage small lung cancer investigator machine trial, what we observed a confirmed PR among the first 7 patients. Importantly, as is the first clinical data generated using onvansertib as a single agent.
Looking at the range of our announcements in 2023, we believe that the year was a truly transformational for Cardiff Oncology -- break for a second. I'm sorry, but I am losing my voice. So I have as CFO, James, to continue with remarks on the call. I'll be available for Q&A at the end of the call, thank you.
Thanks, Mark. On Slide 5, we transition to our second item on the agenda, the new clinical data we're announcing today. Recall that our mCRC program includes 3 clinical trials, and we want to very clearly discuss what's significant in each one. The Phase Ib/II trial in KRAS mutated mCRC generated the initial signal of efficacy on which we based our mCRC clinical development program and the trial is now complete. Based on the strength of the preliminary data from the single-arm Phase Ib/II trial, we proceeded with our originally designed next step of our clinical development program by implementing the second line ONSEMBLE trial which would provide randomized data comparing onvansertib plus standard of care to standard of care alone. However, as the Phase Ib/II data matured, we saw a powerful and unexpected positive signal from the data.
We identified a subgroup of patients, specifically those who had not had prior treatment with BEV in the first-line setting that achieved higher response rates than what would have been expected.
As we state on Slide 8, we discussed our findings, including both the Phase Ib/II clinical data and the new mechanism of action I mentioned at the start of the call, with the FDA, which led to their strong support for us to discontinue the ONSEMBLE trial and shift our clinical program to the first-line setting. CRDF-004 is our randomized first-line RAS-mutated mCRC trial, for which we just announced the first patient was dosed, and Pfizer Ignite is providing clinical execution.
As you see on Slide 9, today, we are sharing new clinical data from the CRDF 003 ONSEMBLE trial. We had enrolled 23 patients in Ensemble prior to making the decision to discontinue this trial. While we closed the trial to new enrollment, those patients who are already enrolled continued treatment for protocol and the majority of the patients enrolled remain on the trial today. As you'll see, there are important findings in the ONSEMBLE clinical data that validate our decision to shift to the first line.
I'll now turn the call over to Dr. Fairooz Kabbinavar, our Chief Medical Officer, to review our clinical data. As a reminder, Dr. Kabbinavar is a medical oncologist with 35 years of experience who led the colorectal cancer program at UCLA, and he was heavily involved in the registrational trials that led to the approval of BEV in metastatic colorectal cancer.
Thank you, Jamie, and thank you, Mark. It's my pleasure to present the new randomized clinical data from a CRDF-003 ONSEMBLE trial.
On Slide 10, you can see the ONSEMBLE trial design. This trial enrolled second-line RAS mutated metastatic colorectal cancer patients with unresectable, but measurable disease. Patients randomized across 3 arms. One was a control arm where patients received standard of care chemotherapy consisting of FOLFIRI plus BEV. In the 2 experimental arms, patients received a dose of one onvansertib in each of the first 5 days following the FOLFIRI plus BEV infusion. One arm included a 20-milligram daily dose of one onvansertib. The other arm included a 30-milligram daily dose of one onvansertib. The primary end point was objective response rate and the dosing schedule was the same as in our Phase Ib/II trial.
Looking at the enrollment at the top of Slide 11, you can see that at the time down ONSEMBLE trial discontinue, 23 patients have been randomized across the 3 arms. Importantly, one patient was never treated because a patient withdrew consent and let the trial prior to receiving any therapy. This reduces the treated patient population available for safety to 22 patients only. Also one additional patient withdrew consent and led the trial before receiving any post baseline scan. So 21 of the 23 patients were not evaluable for efficacy.
Both patients who left the trial were randomized to the control arm and both were bev exposed, so the withdrawal from the trial does not impact any of the conclusions drawn from the data on the following slides.
On Slide 12, I'd like to define exactly what we mean by Bev naive and BevXpose. In our second line mCRC patients, trials, enrolled patients would have already received first-line therapy that may or may not have included BEV. A bev-naive patient is simply a patient whose prior therapy did not include Bev. So these patients -- so these patients would have received only FOLFOX chemotherapy in their first-line treatment before coming into our second line trial.
In our second line ONSEMBLE trial 7 of our 21 patients evaluable for efficacy for bev.naive. We refer to the other 14 evaluable patients in our trial as bev.expose, meaning the prior first-line therapy included by in addition to FOLFOX chemotherapy. So the critical question we had is we want the ONSEMBLE trial with a mature over the past 6 months, there'll be high response rates with sulfur bev-naive patients in our Phase Ib2 single-arm trial continued to be observed in the ONSEMBLE randomized trial. And I'm excited to show you the results on the next slide.
Slide 13. iis the waterfall plot, which shows each patient's best response to therapy over the course of the treatment. As you can see, the answer to my question, the bev.naive patients receiving Onvansertib with FOLFIRI plus bev once again, have the most robust response to treatment.
Now allow me to walk you through what this slide is showing. Starting from the top of the slide, you can see that we have segregated the 21 evaluable patients into 2 groups. So the 7 bev.naive patients are on the left, the 14 bev.expose patients are on the right, which each of these cohorts, we further divide the data into external arm patients who received onvansertib plus standard of care FOLFIRI plus bev and the control arm patients on FOLFIRI plus Bev without onvansertib. Looking at the graph, the bars above the midline represent tumor growth and the bars below the midline represent tumor shrinkage. A steel-colored bar represents an objective partial response meaning the patient had 30% of greater reduction in the tumor size.
A light red bar represents progressive disease, which is an increase of more than 20% in the tumor size. And a yellow bar represents a stable disease, which is between these 2 numbers. At the bottom of the slide, you can see the dose of on onvansertib received by each experimental on patients, either patients either 20 milligrams or 30 milligrams shown in blue boxes above the patient number. And the first 3 digits of the patient number is a clinical trial site number. As you scan from left to right on the waterfall plot, you can see that the 3 patients with the greatest tumor shrinkage observed our bev-naive patients receiving onvansertib plus standard of care. This is highly encouraging and consistent with what we would have expected based on our prior Phase Ib/II trial data.
On the next few slides, we'll pass this [ waterfall plot ] into sections and draw additional conclusions. As we call out on Slide 14, you can see that for the bev naive patients, the only objective responses were observed -- we observed were in patients that received standard of care plus onvansertib. Given this is a randomized trial, it's also important to point out and we did not see any responses in the control arm of bev naive patients that received standard of care alone without on onvansertib. In addition, by looking at the first 3 digits of each patient number, you can see that each BEV naive patient was enrolled at a different trial site so that the Bev-naive finding is not the result of any buyers coming out of a single trial site. Specifically in the bev-naive patients that did respond, one patient received on onvansertib demonstrated a 44% reduction in the tumor size and the second patient had a 43% reduction. Importantly, both these patients have confirmed partial responses, and we see these partial responses at both 20 milligrams and 30-milligram dose of one onvansertib. A third bev naive patients who received onvansertib had a 20% reduction in the tumor size, which is very close to the 30% threshold to qualify for a partial response. I would like you to keep this question in your mind as I'll provide more details in the next few slides.
On Slide 15, we focus on the 14 patients in the bev exposed cohort and you can see that in both the experimental and control arms, there were no objective responses observed. And certainly, the size of effect appears to be less than what we see in the Bev-naive cohort.
And on Slide 16, you can see that the bev naive and bev expose control arm patients appear to have very similar responses to the standard of care therapy. On Slide 17, we are looking at the [ spider ] plots on the Bev-naive patients. You can see that on the left, our patients in the experimental arm -- the steel lines in the plot allow you to see the trajectory of the 2 patients with confirmed partial responses. The plot on the right shows the Bev-naive control arm patients who did not receive on onvansertib. Importantly, the 2 control arm patients with tumor shrinkage at their 2 months can both subsequently progressed at their 4-month scan and left the trial.
Now on Slide 18, I'd like to provide some context around the patient I mentioned earlier, who had a 27% reduction in the tumor size at the 6-month scan. On this 6-month scan, a suspicious new metastatic lesion was noted in the patient's lung. So the treating physician decided to discontinue on onvansertib, but continue treating the patient with standard of care FOLFIRI plus Bev. The lung lesion was later confirmed by biopsy to be a valued tier of fungal infection, unrelated to the patient's cancer and not a new tumor lesion.
And the patient's age on scan, the tumors increased sufficiently for it to be considered progressive disease. But more importantly, during this 2-month period between the 6-month and 8-month scan when the tumor progress, the patient was not receiving any onvansertib, but was only on FOLFIRI plus bev.
In summary, on Slide 19, I'd like to reiterate the 3 attribute to non ONSEMBLE data that Mark and Jamie mentioned at the start of the call, now that you have seen all the data. First, the ONSEMBLE trial was independent because it's a second clinical trial at a different point in time than our earlier Phase Ib/II trial, showing once again and bev naive patients have a strong response to therapy that includes on onvansertib with FOLFIRI and bev. Second, the ONSEMBLE trial was a randomized trial. Thereby removing all clinical bias, where we see that bev-naive patients in the control arm of FOLFIRI plus bev without on onvansertib had no objective responses.
And finally, the ONSEMBLE trial was prospectively designed. The original bev.naive finding in the Phase Ib/II trial was from a retrospective look back at the data. However, we have seen the bev naive signal before enrolling the ONSEMBLE trial and had prospectively planned to value the differences in response rates between the Bev-naive and Bev exposed patients in a randomized fashion.
And importantly, when we look at the safety data that is included in the appendix of this material, we see that on onvansertib when combined with chemotherapy plus bev is well tolerated with no major unexpected toxicity that was observed.
On Slide 20, I'll conclude my remarks reminding you of the new mechanism of action we discovered for on onvansertib and that Mark mentioned at the start of the call. This mechanism of action explains why we believe we are seeing this clear efficacy signal in Bev. naive patients. As we discussed in detail in August, we believe that the robust responses we are seeing are due to a novel mechanism of action that we have discovered for on onvansertib role in the hypoxia response pathway.
It is well known the tumors outgrow their blood supply and become hypoxic, meaning they become starve of oxygen and nutrients. Tumors respond to this hypoxic stress by producing the HIF-1 alpha protein HIF stands for a hypoxia-inducible factor I alphaprotein, which tells on hundreds of genes that allow the tumor to survive in the hypoxic environment. One of those mechanisms involve the tumor secreting in vascular endothelial growth factor, A, VEGFA, to promote the formation of creation of new blood vessels to bring oxygen and nutrients to the cancer cells.
As you can see on Slide 21, bev works by neutralizing VEGFA, inhibiting the creation of new vasculature. But on onvansertib, plays a role upstream of VEGF by inhibiting HIF-1 directly and thereby blocking all its downstream effects. This shows while on onvansertib an bev complementary in a Bev.naive setting by deploying 2 separate hits on the tumor angiogenic pathway and its survival mechanisms.
In conclusion, in my 35 years as a medical oncologist, I've never been as excited as I am now to see the kind of efficacy signal we are observing across our clinical trials.
Now I'm going to hand this call back over to Jamie to continue the discussion further. Jamie?
Thank you, Fairooz. We will conclude the call with a few comments about CRDF-004. Turning now to Slide 23. You can see that colorectal cancer is a major public health issue. It's both a highly prevalent form of cancer and it is challenging to treat. And recently, there have been a number of reports that CRC is becoming more common in younger adults, thus increasing our responsibility to develop more effective therapies beyond the current standard of care. On the right side of the slide, you can see how our decision to move from second line to first line substantially increases the number of metastatic colorectal cancer patients who may benefit from adding onvansertib to the current standard of care.
On Slide 24, you can see that the first-line standard of care for RAS-mutated mCRC consists only of chemotherapy with BEV, a regimen that hasn't changed in 20 years. So this large patient population is in need of new therapies directed at all RAS mutations.
Slide 25 provides the study design for our CRDF-004 trial. Similar to the ONSEMBLE trial CRDF 004 includes mCRC patients whose tumors have a RAS mutation and are unresectable. A key difference for CRDF-004 is that all patients are first line and therefore, have not previously been exposed to bev. The trial will randomize 90 patients across 3 arms: first, a control arm consisting of standard of care with FOLFIRI bev or FOLFOX bev, and then 2 experimental arms looking at standard of care chemotherapy plus bev and a 20-milligram or a 30-milligram daily dose of Onvansertib, the same doses as in the ONSEMBLE trial.
Our primary endpoint for the trial will be objective response rate and the secondary endpoints are duration of response and progression-free survival. Let me provide a few additional details about the CRDF-004 enrollment. Our clinical operations efforts, together with Pfizer Ignite are going well with a critical mass of 20 clinical trial sites activated as of today. And as we announced, we've dosed our first patient. Based on the current robust screening activity observed and our current enrollment projections, we expect to meet our goal of releasing data from the trial in mid-2024. And we anticipate this initial release will include objective response rate data for approximately half the patients we expect to enroll in the trial.
On Slide 26, I'll cover our third agenda item, our financial position as of December 31, 2023. As we disclosed today in our Form 10-K filing, we had $74.8 million in cash and investments as of December 31, 2023. And our cash used in operating activities was $7.1 million in Q4 '23. Today, we have greater clarity on our expected future expenses, and so we can be more precise about our forecasted cash runway. Specifically, we believe that our current cash resources provide us with cash runway into the third quarter of 2025, which is beyond the expected readout from the CRDF 004 trial.
Finally, on Slide 27, we summarize why the ONSEMBLE data we released today is so relevant for our first-line mCRC strategy and our ongoing CRDF trial. First, ONSEMBLE is the second independent and randomized data set reproducing the robust efficacy signal for Onvansertib plus standard of care in bev-naive patients, and this supports our currently enrolling first-line trial where all patients are bev naive.
Secondly, no bev-naive patients in the ONSEMBLE control arm showed an objective response to treatment without onvansertib, suggesting onvansertib is critical to the robust responses observed in the experimental arm. And finally, both of the 2 onvansertib doses appear to be active, which suggests the 2 experimental arms of the CRDF-004 trial could be combined when evaluating the trial data for efficacy. For all these reasons, we continue to believe our shift to the first-line setting is the best strategy for all of our stakeholders, particularly the large number of patients, 48,000 per year in the U.S. with RAS-mutated MCRC that may benefit from a new approach to treating their disease.
With that, we'll open the call up for questions. Operator?
[Operator Instructions] Our first question comes from Marc Frahm with TD Cowen.
Congrats on the data that you're able to release. But maybe first off, just obviously, just the first patient today, but any sense for kind of how much data you'll be able to release in the middle of the year from the 004 trial? And then for the data today from ONSEMBLE, any characteristics you can kind of provide on the baseline, like were there any differences in like left and right sidedness and things like that, that might explain a little bit of the difference in response rates.
I can start. First of all, like we said on the call, we're going to be putting data out when we have approximately about half of the patients enrolled in the trial. And the second thing was regarding the ONSEMBLE data. We have looked at that. We haven't seen any differences, but we come from the side of this, but we -- but we did not present that here.
Okay. And sorry, just on that update, is that once you've enrolled or that you have mature response data on half the question?
Where we're looking is at least one scan after the baseline.
Our next question comes from Joseph Catanzaro with Piper Sandler.
Maybe first on the ONSEMBLE data. I'm wondering if you guys performed a PFS analysis. I'm looking at the swimmer plot even sort of considering both BEV naive and Bev.expose, it feels like there's a pretty good even maybe emerging PFS signal that you're seeing in this randomized data. So I'm wondering if you did that analysis and maybe what it's saying -- and I have maybe one follow-up.
Thanks, Joe, for that question. We have intended it rigorously. We were waiting for more follow-up for us to look at that since there is a small number of patients, but we agree with you that it looks like there is an emerging signal.
Okay. And then for the frontline trial, is there any safety running on the backbone of FOLFOX? Just trying to get a sense of maybe historically how the neutropenia compares with FOLFOX relative to FOLFIRI and then maybe relatedly, the expected split between FOLFIRI and FOLFOX as the backbone, I'm thinking back to some earlier preclinical data from a couple of years back that suggested on onvansertib and irinotecan, there's some cooperativity there. So hopefully, that question makes sense.
Yes. Joe, let me first start by talking about the preclinical data. We actually have shown publicly that we have synergy with both oxaliplatin as well as irinotecan in in [indiscernible] model preclinically, and we have not seen any toxicity as well. For your questions regarding the FOLFOX in the first -- in our first line trial, I'm going to turn it over to Fairooz, our CMO here.
Joe, so the question about regarding any safety run-in for the FOLFOX bev plus on onvansertib. Yes, for the first 9 patients will be well after the first 10 patients have been dosed and those patients will be evaluated by the safety review committee. And once we -- it is determined that FOLFOX plus on onvansertib plus bev, there's no additional toxicity beyond what is expected of FOLFOX Bev,then that arm will continue to accrue to its full completion of the full complement of the patients. So yes, there is a safety valve built into this trial. And we don't expect, based on how onvansertib partners with other chemotherapy brands, we don't expect any major toxicity issues. And even the -- and giving you a lot more detailed information, even though there were 2 patients with neutropenia that was seen in the ONSEMBLE trial was at the lower end -- lower dose at 20 milligrams, notat 30, and then these patients that neutropenia resolved just by holding the treatment or delaying the treatment for 7 in one patient, 7 days and another patient 10 days. And those patients still continue on treatment without any of those reductions.
Our next question comes from Andy Hsieh with William Blair.
Great. Mark, I hope you feel better soon. I want to dig a little -- just want to dig a little deeper on several top line results. Maybe on 2 topics. One is on liver metastases and maybe second on dose response. Maybe I'll go first on the dose response. Maybe perhaps you could comment on whether you see some sort of dose response or both are active? And how do you think about those doses going forward. specifically on the liver metastases, I think if I did the calculation right, it's about 77% of the patients have some sort of liver metastases. That's kind of on the higher side. Have you looked at the 2 responders? Do they have liver metastases and I think the emerging data is suggesting that these patients are particularly hard to treat. And maybe there's a potential hypothesis on the mechanistic side of advantage that's active in this population. And a couple of follow-ups.
Okay. Well, Andy, for the dose response, if I understood your question correctly, we are seeing similar activity, albeit small data numbers, but we are seeing similar activity between the 2 doses, the 20 mg to 30 mg, if that's what you're asking. And from that, that's why we're concluding that we can combine those arms together to look at efficacy in the 004 trial.
As far as the liver met, we have not analyzed that robustly yet. But I would say that in our Phase Ib/II trial, we showed that there was no difference in the response in patients who had liver met versus those that didn't that there was no division of the response there is irrespective of liver [indiscernible]. Jamie iff you can add.
Yes. So Andy, just building up on what Mark has said in the Phase Ib/II trial, we looked at multiple other factors trying to see were there any other features that would impact this responses that we're seeing in bev-naive patients. And to give you a very short answer, absolutely, no clinical feature appear to play a role in the significant robust responses that we've seen in in the bev naive patients. So we looked at literality of the tumors, right and left tumors, both responded equally. We look at missions with liver mets, not liver mets, they all seem to respond well. We looked at patients who had agenda did not impact the outcome. So we think at this point, based on what we have seen in the Phase Ib/II trial, and that is the bar naive, if you will, that plays a significant role in the dramatic synergy that you're seeing between BEV and on onvansertib plus chemotherapy.
I see. That's very helpful. So maybe moving out of the -- sorry, I asked it before, before we move on. So in terms of managing neutropenia for the ongoing 004 study, are you considering doing growth factor prophylaxis for patients?
So it's the -- the 3 things that we normally would use, hold the dose or delay the next dose allow the bone marrow to recover. If it doesn't recover, then we use growth factors according to ASCO guidelines. And then subsequently, I mean, we also have the option of doing dose reduction depending on which drug cause is the culprit. But again, we're back to IB 12 trial and others. We have not found a reason for us to dose decrease. So we have all 3 options that will standard that we would normally use in managing these patients. But at this point, we don't think it's going to be a big issue.
Got it. That's helpful. And then so outside of I believe small cell lung cancer in the [indiscernible] update was 1 PR 3 stable disease patients. Do you have any update on that cohort? Or that's kind of the latest data?
I can say that we don't have any update as the PR has moved to another academic institution, and so that has somewhat slowed down the accrual in that particular trial.
I see. Great. Congratulations on the progress.
Thank you. Thank you, Andy. There are no further questions at this time. I'd like to turn the call back over to James Levine for closing remarks.
Thank you, operator. This concludes our conference call, and thanks again for joining us this afternoon. Bye-bye.
Thank you for your participation. This does conclude the program. You may now disconnect. Good day.