Q4 2024 CytomX Therapeutics Inc Earnings Call
Good afternoon, everyone. Thank you for sustaining by.
Welcome to the Cytometer Therapeutics fourth quarter 2024 financial results call.
Please be advised that today's call is being recorded.
Speaker Change: I'd now like to hand, the call over to your host for today, Chris Ogden <unk> Chief Financial Officer. Please go ahead.
Chris Ogden: Thank you good afternoon, and thank you for joining us.
We begin I'd like to remind everyone that during this call, we'll be making forward looking statements.
Chris Ogden: Because forward looking statements relate to the future.
Chris Ogden: They are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control.
Chris Ogden: Important risks and uncertainties are set forth in our most recent public filings with the SEC.
Chris Ogden: At SEC Gov.
Chris Ogden: We undertake no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise.
Chris Ogden: Earlier. This afternoon, we issued a press release that includes a summary of our 2020 for full year financial results and highlight recent progress that they telmex.
Chris Ogden: We encourage everyone to read today's press release, and the associated materials, which have been filed with the SEC.
Chris Ogden: Additionally, the press release recording of this call and our SEC filings can be found under the investors and news section of our website.
Speaker Change: With me on the call today is Dr. Sean Mccarthy, <unk>, Chief Executive Officer and Chairman.
Speaker Change: <unk> will provide an update on our pipeline and company progress before I walk through the financials for 2024, we will then conclude with a Q&A session.
Sean Mccarthy: With that I'll now turn the call over to Sean.
Sean: Thanks, Chris and good afternoon, everyone.
Sean: I'm pleased to be here with you today to provide updates on our continued progress at <unk> towards our mission of urgently advancing our priority therapeutic pipeline for the maximum benefit of cancer patients.
Sean: As a pioneer in the field of antibody masking and conditional activation, we continue to direct our powerful technology platform towards major unmet needs in oncology.
Sean: We're seeing broad strategic interest in antibody majewski, and <unk> is uniquely positioned with expertise and capabilities to deliver novel mast therapeutics across multiple treatment modalities, including antibody drug conjugates T cell engages and cytokines.
Sean: Our current clinical programs have been built on over a decade of scientific and clinical expertise and follow a clear design principles aimed at ultimately selecting the cancer type of interest the tumor target and the relevant effector function in order to deliver differentiated cancer therapies.
Sean: 2024 was a very productive year for us, including including the advancement of two new programs into the clinic.
CX 2051, and CX 801.
Sean: In January 2025, we announced the prioritization of these programs and the streamlining of our organization extending our cash runway to Q2 of 2026 supporting our ability to deliver upon key clinical milestones.
Sean: We see our lead program CX 251, as a highly differentiated first in class ADC that is designed to address a large unmet need in colorectal cancer and build significant value for <unk>.
Sean: CX 801 is a mass version of interferon Alpha with we believe broad potential as a next generation targeted immunotherapy.
Sean: 2025 promises to be an exciting year for <unk>, where we expect to generate initial clinical data for both CX 2051, and VX 801 that we believe could drive significant near term value creation.
Chris Ogden: I'd like to cover our recent progress in our pipeline before handing over to Chris who will review our financials.
Chris Ogden: I'll start with our lead program CX 2051, our first in class masked ADC targeting epithelium cell adhesion molecule.
Chris Ogden: We are the only organization so our knowledge addressing this target and this unique way.
Chris Ogden: Canada has been viewed as a high potential opportunity for many years due to its pan tumor expression and it's particularly high expression in colorectal cancer.
However, <unk> is also expressed at moderate to high levels of normal tissues, which was prohibited the successful development of systemic therapeutics against this target.
Chris Ogden: There is strong evidence that cabot targeting with locally delivered approaches can achieve clinical anticancer activity, including the multi specific antibody core journey that is currently being re launched in the EU for the localized treatment of intraperitoneal malignant ascites.
Chris Ogden: Despite success with localized therapies. However, prior systemic <unk> targeting strategies have not been able to reach therapeutically active drug levels in patients and these include the T cell engages to let them at another antibody approaches we showed early promise, but were unable to deliver a viable therapeutic window due to dose limiting.
Chris Ogden: Toxicities in the pancreas liver and gastrointestinal tract.
Chris Ogden: CX 2051 is a probiotic ADC comprising a high affinity <unk> antibody with a peptide mask and the protease cleavable mask linker that has been validated in prior clinical work by <unk>.
Chris Ogden: In designing <unk> 501, our goal is to mitigate potential on target toxicities as a localized <unk> preferentially to tumor tissue pre clinically <unk> 501 has shown a wide potential therapeutic index and potent anti cancer activity in multiple <unk> expressing.
Chris Ogden: <unk>.
Chris Ogden: The payload on CX 205, Wildcat 59 is a tough way to summarize one inhibitor selected specifically to treat total one sensitive tumors and in particular colorectal cancer.
Chris Ogden: The total one inhibitor <unk> is of course, a key component in the treatment of metastatic CRC and the first and second line settings, and so it's well established that this cash that can respond well to this class of drug.
Chris Ogden: The global unmet need in colorectal cancer is one of the most significantly in oncology with more than $1 9 million, new cases annually and limited new treatments emerging for patients over the last two decades.
Chris Ogden: Unfortunately, there is also an increasing percentage of new CRC cases diagnosed as metastatic and a concerning trend of growing incidents and younger patient populations.
Chris Ogden: First and second line treatment of metastatic CRC are still primarily based on systemic chemotherapy regimens that include identity can or exile placid.
Chris Ogden: In the later line setting patient options remain highly inadequate in patients that have generally had three or more prior lines of therapy current standard of care only achieve low to mid single digit objective response rates and median progression free survival of only two to four months.
Chris Ogden: We advanced <unk> pipeline into the clinic in Q2 last year and we have been pleased with the execution and enrollment in the study to date.
Chris Ogden: We are currently focused in late line CRC with enrolled patients generally having received at least three prior systemic therapies.
Chris Ogden: Given the consistently high levels of <unk> expression in CRC, we are not pre selecting patients for <unk> expression in our phase one study or for disease characteristics, such as K, Ras mutational status or liver metastases.
Chris Ogden: And dose escalation, thus far we've been encouraged by the <unk> 501 safety profile, having successfully dose escalated to levels that we predict based on preclinical modeling to be biologically active.
Chris Ogden: And that we're confident could not be achieved with an unmasked ADC.
Chris Ogden: As we continue in dose escalation our expectation is that the maximum tolerated dose of <unk> thousand 51 will be largely driven by the cytotoxic payload.
Chris Ogden: Specifically, we will be fully characterizing the anticipated Gi toxicities.
Chris Ogden: <unk>, such as neutropenia, and anemia that is commonly associated with <unk> inhibitors.
Chris Ogden: We're currently evaluating the seventh dose level in our dose escalation and we have also begun to selectively backfill at certain dose levels to gain additional experience with the drug.
Chris Ogden: Overall, we believe our early clinical experience with <unk> 501 is showing that this first in class ADC is performing as designed.
Chris Ogden: Underpinning it as prioritization is the lead program for <unk> and our focus on bringing this therapy to patients as quickly as possible.
Chris Ogden: We remain on track to provide initial phase one data in CRC and the first half of 2025, and we expect to be in a position to define next steps for the program in the second half of the year.
Chris Ogden: Now moving to CX 801, our mast pro body interferon Alpha <unk>, which is also making good early progress in phase one.
Chris Ogden: Interferon Alpha is a well validated therapeutic.
Chris Ogden: It's one of the first immunotherapy has to be approved for cancer treatment.
Chris Ogden: Interferon has established single agent anti cancer activity in multiple tumor types, including renal cancer bladder cancer and melanoma.
Chris Ogden: Over time, its systemic interferon has fallen out of clinical use in oncology, primarily due to its poor tolerability arising from systemic toxicities.
However, it's fair on Alpha is a powerful driver of T cell activation and adds to your presentation, making it an ideal combination agent with checkpoint inhibitors.
Chris Ogden: Similarly to <unk> has been shown recently that localized interferon alpha <unk> can be very effective as an anticancer therapy.
Chris Ogden: Specifically, the recently approved gene therapy at <unk> and coding interferon Alpha <unk> achieved a 51% complete response rate in patients with bladder cancer <unk>.
Chris Ogden: We are reaffirming that this potent cytokine can indeed achieve robust antitumor responses in patients.
Chris Ogden: It's also been shown that interferon can potentiate the clinical effects of PD, one inhibition, including a Merck sponsored study demonstrating a 60% response rate with Keytruda in combination in combination with Keytruda.
In combination with interferon Alpha <unk> and advanced PD, one naive melanoma. This combination does not further developed however, due to grade three or higher adverse events occurring at approximately 50% of patients.
Chris Ogden: 801 is designed to harness the proven power of interferon alpha <unk> by reducing systemic activity and localizing therapeutic activity to the tumor microenvironment.
Chris Ogden: We initiated a phase one dose escalation study of CX 801 in the third quarter of 2024 focused in the advanced metastatic melanoma setting.
Chris Ogden: We've made very good progress to date in this study and we're currently enrolling the fourth the monotherapy dose escalation cohort.
Chris Ogden: Importantly, as of the third dose level, we had already achieved doses that surpassed the approved dose of unmask interferon Alpha <unk> Styler Sean.
Chris Ogden: Our translational science program for today's ASR, one is multifaceted and includes systemic anti tumor analysis of PD Biomarkers that will give us insights into the molecular performance of the drug candidate.
Chris Ogden: And we hope the induction of an inflammatory tumor microenvironment conducive to PD one combination therapy.
Chris Ogden: Our goal is to present initial phase <unk> translational data for 801 in the second half of this year.
Chris Ogden: Based on our progress to date, we also anticipate initiation of combination therapy with Keytruda in 2025 under the collaboration and supply agreement, we secured with Merck last year.
Chris Ogden: Overall, we believe <unk> is well positioned to demonstrate clinical proof of concept in advanced melanoma, where the unmet need remains very high.
Chris Ogden: Longer term, we see <unk> as a foundational combination agent, which can potentially address the large population of cancer patients, who do not respond to checkpoint inhibitors or who are refractory to immunotherapy.
Chris Ogden: Turning next to our research collaborations or partnerships continue to be very important to us in 2024 and remain so in 2025.
Chris Ogden: I am very pleased to say that in February of this year, we achieved another $5 million milestone payment and our Astellas T cell engage a collaboration as a result of astellas selecting our collaborations clinical candidate to advance into GOP toxicology studies.
Chris Ogden: We look forward to continued progress with Astellas as well as strong execution in our discovery programs with Bristol Myers Squibb.
Speaker Change: Amgen Mcdonough and Regeneron.
Speaker Change: Right now the majority of our partnered discovery programs are masked T cell engages an area in which <unk> and our partners continue to see significant potential.
Regarding our first partner T cell engage a program entered into the clinic CX 904, we communicated earlier this year a reduction in capital allocation to this program given our overall pipeline priorities and pending ongoing dialogue with our partner Amgen regarding potential next steps.
Speaker Change: Based on CX 904, clinical observations to date and our respective priorities cytogenetics and Amgen have jointly decided not to continue CX 904 development.
Speaker Change: We continue T cell engaged a discovery work with Amgen.
Speaker Change: We remain optimistic about the potential of future mouse T cell engages and really look forward to making additional progress on this modality within our partnerships.
Chris Ogden: With that let me turn the call over to Chris for updates on our finances.
Chris Ogden: Thank you Sean.
Chris Ogden: Throughout 2024, we remain disciplined in our capital allocation with a focus on progressing our clinical pipeline for the initial phase one data.
Chris Ogden: Entering 2025, we are now positioned to achieve initial data readouts for CX 2051, and <unk> hundred one.
Sean Mccarthy: As Sean highlighted earlier in January of this year, we made a focused set of trade offs that extend our cash runway and direct capital primarily to our lead programs CX 2051, and <unk> hundred one.
Sean Mccarthy: Now I'll turn to our 2024 financial results.
Sean Mccarthy: As of December 31, 2024, we ended the year with a $100 6 million in cash cash equivalents and investments compared to $174 $5 million in cash at the end of 2023.
Sean Mccarthy: With our prioritization efforts, we expect that our cash balance will continue to fund <unk> operations into the second quarter of 2026.
Sean Mccarthy: Consistent with our prior approach to cash runway guidance, our cash guidance does not assume any additional milestones from existing collaborations or any new business development, which we have a strong track record of achieving.
As Shawn mentioned earlier, we recently achieved a $5 million milestone and our Astellas T cell engagement collaboration and we are funded to continue to execute programs under our research alliances.
Sean Mccarthy: Turning to revenue and operating expenses for the year total revenue was $138 1 million compared to $101 2 million for the corresponding period in 2023.
Sean Mccarthy: The increased revenue was attributed to our BMS collaboration as well as our collaborations with Madonna Astellas and Regeneron.
Sean Mccarthy: Total operating expenses for the full year were $113 1 million compared to $107 7 million in 2023.
Sean Mccarthy: <unk> four operating expenses increased $5 4 million, primarily due to a $5 million milestone payment to abbvie for initiation of phase one for CX 2051 <unk>.
Sean Mccarthy: Excluding this milestone operating expenses were essentially flat to 2023.
Sean Mccarthy: R&D increased by $5 7 million from last year to $83 4 million in 2024 also driven by the milestone payment for CX 2051 phase one start.
Sean Mccarthy: G&A expenses were essentially flat during 2024 decreasing by <unk> 3 million to $29 7 million for the year ended December 31 2024.
Sean Mccarthy: We remain committed to disciplined capital allocation and resource management.
Sean Mccarthy: We believe we are well positioned to progress our <unk>.
Sean Mccarthy: <unk> pipeline deals.
Sean Mccarthy: <unk> deliver value to shareholders and ultimately bring new treatment options to cancer patients.
Sean Mccarthy: With that I will turn the call back to Sean for closing remarks.
Sean Mccarthy: Thanks, Chris and thanks, everyone for joining us today, we look forward to sharing additional updates in the coming months, including the first look at how <unk> is performing and colorectal cancer.
Sean Mccarthy: To close I want to recognize and sincerely. Thank the patients who join our studies there.
Sean Mccarthy: And their families.
Sean Mccarthy: Cynical investigators and our dedicated team here at <unk>, we've never been more committed to our vision mission and values at sites. So we look forward to an exciting year ahead with that operator, let's go ahead and open up the call for Q&A.
Sean Mccarthy: To ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.
Sean Mccarthy: Our first question comes from.
Speaker Change: Roger song with Jefferies. Your line is open.
Roger Song: Great. Thanks for taking the question, maybe just one related to two.
Roger Song: <unk> thousand 51, so given you are enrolling patients.
Roger Song: We're seeing and then how should we think about the first half date update.
Roger Song: And that patient number and then what kind of data we're going to show what's the expectation.
Roger Song: For the data readout for the first half.
Roger: Yeah, Hi, Roger Thanks for the question.
Roger Song: We're expecting it to be a meaningful updates.
Roger Song: We do anticipate this initial look will include.
Roger Song: An initial characterization of the safety profile of the drug.
Roger Song: Up to and including doses as we said that we are predicting based on our preclinical work or in the therapeutically active range.
Roger Song: We've been pleased with the Escalations, so far given the prior history with other systemic <unk> strategies, having hit roadblocks as very early in dose escalation. So yes.
Roger Song: So from that standpoint, so far so good of course this.
Roger Song: Initial update.
Roger Song: Well first update our first presentation of data.
Roger Song: It will include an initial assessment of antitumor activity across these first few cohorts.
Roger Song: And.
Roger Song: That activity data could take the form of Pharmacodynamic markers.
Roger Song: Schumer stabilization.
Roger Song: Of course, potentially tumor shrinkage and of course, if we see anything approximating or equivalent to resist responses in this very late line.
Roger Song: CRC patient population, we would be absolutely thrilled.
Roger Song: Yeah.
Roger Song: Yeah got it and then in terms of the AOR.
Roger Song: You will give us some.
Roger Song: Updates in second half and then also you have you say you were moving to the <unk> combination. So how should we think about the timing and the criteria are moving to the pen barrel. If all after you gave US tomorrow did update thank you.
Yes, great question.
Roger Song: As I mentioned.
Roger Song: <unk> thousand 51, we've been pleased with the operational <unk>.
Roger Song: Execution and the <unk> hundred one studies, so far having really just started that that phase one study and already now being in the fourth dose level.
Roger Song: The starting dose was.
Roger Song: It was pretty decent and Thats allowed us to go pretty quickly to not be treating patients with doses that are higher than the approved dose of <unk>.
Roger Song: <unk> interferon alpha so.
Roger Song: So that's encouraging.
Roger Song: We've been able to quickly go through those initial cohorts, we do see the potential to those those first few dose levels.
Roger Song: We do see the potential to initiate the keytruda combo in second half.
Roger Song: If I had to guess I would say that the sequencing would be the combo initiation would precede any data presentation, but we do remain on track based on our ongoing translational work looking at tumor biopsies to two.
Roger Song: To be sharing some initial data by the end of the year.
Roger Song: Excellent. Thank you.
Roger Song: Youre welcome.
Roger Song: Thank you.
Speaker Change: Our next question comes from Joe Catanzaro with Piper Sandler Your line is open.
Roger Song: Great.
Roger Song: Hey, everybody. Thanks for taking my question, maybe a couple on 2051, so I think <unk> been saying for a little while now that you've entered therapeutically active doses based on preclinical data.
Roger Song: Hey, Youre, saying youre in the seven dose cohorts. So wondering how many of those seven dose cohorts sort of fall into that category are predicted to be within therapeutic the active doses I guess I'm just trying to get a sense of sort of what percent in this initial disclosure will fall within that category. Thanks.
Speaker Change: Yes, Hi, Joe.
Speaker Change: So the first couple of cohorts as we've disclosed previously.
Speaker Change: We're.
Speaker Change: Single patient doses are single patient cohorts excuse me.
Speaker Change: Doses that we would predict to be outside of the therapeutic active range, but entering.
At dose level, three we would predict.
Speaker Change: Again based on the animal modeling that.
Speaker Change: Just on what's generally known about total one adcs that we will be starting to get into that range and of course that would increase as we continued the escalation. So I think a significant number of patients by the time, we're ready to share data.
Speaker Change: We will have been treated with doses in that range of course I want to emphasize again that this is a.
Speaker Change: Late line patient population, we are enrolling predominantly patients who have had at least three prior lines of systemic therapy and.
Speaker Change: So we think the.
Speaker Change: The bar is fairly low here for actual clinical activity.
Speaker Change: Okay, Great and then maybe a follow up so.
Speaker Change: I think you'd noted not enrolling.
Speaker Change: Based on K, Ras status or liver Mets, so I'm wondering if any expectations whatsoever.
Speaker Change: Are you seeing differential activity as it relates to some of those features like Hey, Ross status of presence absence of liver Mets or maybe even anything else that you are thinking about.
Speaker Change: Thanks.
Speaker Change: Yes.
Speaker Change: Yes, Theres no obvious.
Speaker Change: There is no obvious biology.
Speaker Change: Yes, it would.
Speaker Change: <unk> suggests that at time.
Speaker Change: Well, let me start by saying that kind of expression. We're just reiterating the dotcom expression is high.
Speaker Change: More than 90% of CRC patients and we've validated that with our our own work and we are measuring <unk> levels of course in every patient that we treat so we'll have that data for this study. There's no reason to suggest that there is a connection between K Ras mutational status.
Speaker Change: Our net cash or liver Mets.
Speaker Change: The point, we're making is that.
Speaker Change: We're enrolling the full patient population at this time to characterize the drug.
Speaker Change: Across the full CRC population and we'll see what we get I mean, if it turns out that we get.
Speaker Change: Data that suggests that suggests that the drug is.
Speaker Change: More suited to a particular subset then we may investigate that but at this point.
Speaker Change: We're enrolling.
Speaker Change: Broad patient population.
Speaker Change: Okay got it that's helpful. Thanks for taking my questions.
Speaker Change: Yes.
Speaker Change: Youre welcome.
Palm Rama: Thank you. Our next question comes from on a Palm Rama with J P. Morgan Your line is open.
Speaker Change: Hi, guys. This is <unk> on for Jeff.
Speaker Change: Just following up on the previous line of question 14 locations in the fall.
Speaker Change: Next 2051.
Speaker Change: While it's not increase like the Broadcom next question.
Speaker Change: Published.
To help guide what level of capacity would be beneficial.
Speaker Change: Yes that is a broad literature on <unk> expression across.
Speaker Change: Most tumors, including colorectal and I think it's well established that at.
Speaker Change: <unk> is highly expressed in this tumor type in fact at Cam was first described as a colorectal cancer marker.
Speaker Change: A very long time ago actually.
Speaker Change: So, yes, I think it's pretty well established that CRC as a Hyatt Com Express and most most patients.
Speaker Change: Sure.
Speaker Change: I anticipate that our clinical results.
Speaker Change: We'll validate that.
Speaker Change: Thank you so much for taking my question.
Speaker Change: Youre welcome.
Speaker Change: Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson: Great. Thank you so much thanks for taking the questions.
Peter Lawson: Just on the priority with prioritization of CSF <unk> ADC is that driven by the expression levels, you kind of talked about and just kind of going on within the space. So you are right.
Peter Lawson: <unk> seen signals there and you also have seen any signals outside CSA today.
Peter Lawson: Yes, Hi, Peter that's helpful to you.
Peter Lawson: Help me.
Peter Lawson: Help me clarify.
Reiterate that this phase one study of <unk> hundred five one is being conducted entirely in the CRC setting.
Peter Lawson: We're only enrolling.
Peter Lawson: Static CRC patients and as I mentioned patients who have been treated.
Peter Lawson: The patient population that we're that we're seeing that we're treating.
Peter Lawson: Our.
Peter Lawson: For the most part.
Peter Lawson: Okay.
Peter Lawson: For the most part been treated with three at least three prior lines of systemic therapy.
Peter Lawson: So the question is okay, why Wi focused in CRC is several answer to that first of all when you just look at <unk> biology, and the target itself.
Peter Lawson: CRC has really.
Peter Lawson: The indication that jumps out with the highest broadest most consistent most.
Speaker Change: Homogeneous expression.
Speaker Change: From patient to patient and as I said is actually where we're at cameras first described as a tumor marker.
Speaker Change: That said that kind of is highly expressed in most other solid tumors. So this is a pipeline.
Speaker Change: In our product opportunity in the long run.
Speaker Change: If we see a signal in CRC Theres no question about that.
Speaker Change: The other reason to select CRC is.
Speaker Change: I need.
Speaker Change: Yeah, Matt need is just is just.
Speaker Change: Huge and so it's an area where patients need new treatments they've been waiting for them for decades.
Speaker Change: We're trying to make a difference here.
Speaker Change: And then the third is that this drug.
Speaker Change: This drug candidate with a total one inhibitor was really always designed with colorectal cancer in mind as the first place to go because.
Speaker Change: Theres not much. This spin is kind of a wide open field adcs in colorectal cancer, and we know that CRC responds to total one inhibition as I mentioned in my prepared remarks, we are in a TTM is.
Speaker Change: A component of standard of care therapy in the first and second line on a global basis.
Speaker Change: Quite effective.
Speaker Change: The earliest stage of treatment of CRC.
We know that CRC can response type of one inhibition. So we think for this particular program.
Speaker Change: We think the combination of the two.
Speaker Change: The tumor type of interest the target selection and the effector mechanisms payload, it's already been optimized and delivers.
Speaker Change: I think compared to some of our prior work with Adcs.
Speaker Change: Higher overall probability of technical success.
Speaker Change: Just the guys to be really clear that if we if we are fortunate enough to see a signal.
Speaker Change: In CRC.
Speaker Change: Then that would negate many other tumor types that are known to be responsive to type one inhibitor inhibition, but also expressed at high levels.
Speaker Change: Got you Okay. Thank you and then just.
Speaker Change: And as we think about.
Speaker Change: As you move forward kind of what puts the robot for success.
Speaker Change: I think in third line fourth line CRC.
Speaker Change: While in the fourth line. Unfortunately for patients. The bar is the bar is low I mean.
Response rates in the single digits too.
Speaker Change: Drugs like.
Speaker Change: Long serve you answer if even in combination with Bevacizumab.
Speaker Change: Frequency.
Speaker Change: <unk>.
Speaker Change: With just a few months of PFS and so this is a very underserved.
Speaker Change: A highly underserved patient population in the fourth line.
Speaker Change: It's also.
Speaker Change: What we hear from our advisors and.
Speaker Change: Investigators and Kols is that even in the third line setting.
Speaker Change: Current standard of care, which is which is which is for.
Speaker Change: For the most part Bev long surf.
Speaker Change: Is also highly inadequate in its southern adequate that many many patients in the third line setting.
Speaker Change: Go onto trials.
Speaker Change: Or being held on.
Speaker Change: One therapy there.
Speaker Change: As a precursor to getting onto trials and so I think that really underscores number one how how high the unmet need is and really how low the bar is obviously, we have high ambitions for this drug but we think for this initial look in this late stage patient population.
Speaker Change: Think quite frankly.
Speaker Change: Any evidence of resist responses would be a real winner.
Speaker Change: Got you.
Speaker Change: That initial look of that phase one data.
Speaker Change: <unk>.
Speaker Change: Do you want to see tumor shrinkage once.
Speaker Change: But what's the bar there you think for success in your mind.
Speaker Change: Yes.
Speaker Change: As I already mentioned I think we're looking at a number of things we're looking at.
Speaker Change: Evidence of.
Speaker Change: Pharmacodynamic.
Speaker Change: Activity.
Speaker Change: <unk> tumor biopsies evidence of tumor stabilization because CRC approvals those drugs I mentioned earlier all that have been approved in the third line setting third or fourth line.
Speaker Change: For the most part have been approved based on.
Speaker Change: On PFS type measure.
Speaker Change: The measures.
Speaker Change: It's very difficult to achieve our objective responses in this patient population. So if you can keep patients from.
Speaker Change: From progressing.
Speaker Change: In and of itself is a is a success.
Speaker Change: Evidence of Cima stabilization evidence of.
Speaker Change: Tumor shrinkage and that of course.
Speaker Change: The Holy Grail for us in the studies, if we can see in this early first look in this late line patient population is to see if we can deliver.
Speaker Change: Deliver objective.
Speaker Change: <unk> responses.
Speaker Change: Perfect. Thank you so much thanks for taking the questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one one on your telephone again that is star one one to ask a question.
Speaker Change: Our next question comes from Mitch.
Speaker Change: Mitchell Kapoor with H C. Wainwright your line is open.
Speaker Change: Good afternoon. This is Dan on for <unk>. Thanks for taking our questions. We wanted to ask where you might present, the phase <unk> CRC data would this likely be a press release event any lean towards first quarter second quarter, and then jumping on the therapeutic active range kind of discussion how many more dose levels do you plan to test and where does the seventh dose.
Speaker Change: Level compared to the non human primate preclinical talk thank you.
Speaker Change: Yes, thanks for the questions in terms of where to present.
Speaker Change: We're keeping our options open there.
Speaker Change: So.
Speaker Change: We will provide further guidance into in due course.
Speaker Change: In terms of that.
Speaker Change: The escalation.
Speaker Change: The second and third questions are of course connected.
Speaker Change: The escalation into the seven dose level.
Speaker Change: If we clear that dose level, we will continue to we will continue to escalate.
Speaker Change: We'll have to we'll have to see how that goes so at this point.
Speaker Change: Yeah.
Speaker Change: That's where we are and we'll have to see.
Speaker Change: I would say that the.
Speaker Change: The.
Speaker Change: When we talk about predictive active range of the drug.
Speaker Change: That is based on modeling.
Speaker Change: That is including our experience from mass and cinema August monkey experiments.
Speaker Change: Gather with understanding in general of other total $1 Adcs are more experienced others have had in the clinic.
Speaker Change: With this type of strategy.
Speaker Change: Thank you.
Speaker Change: Youre welcome.
Speaker Change: Thank you.
Speaker Change: Not showing any further questions in the queue.
Speaker Change: I would now like to turn it back over to Dr. Sean Mccarthy, Chairman and CEO for closing remarks.
Sean Mccarthy: Well thanks, everyone for.
Sean Mccarthy: Joining us today, we look forward to providing additional updates throughout the year and hope Youll have a good rest of the day.
Sean Mccarthy: This concludes today's conference call.
Sean Mccarthy: Thank you for participating you may now disconnect.
Sean Mccarthy: Okay.
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No.
Sean Mccarthy: Okay.
Sean Mccarthy: [music].
Sean Mccarthy: Sure.
Sean Mccarthy: Okay.