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spk05: Good afternoon, everyone. Thank you for standing by. Welcome to the Cytomics Therapeutics fourth quarter and full year 2021 financial results call. Please be advised that today's call is being recorded. I would now like to hand the call over to your host today, Chaoqing Cytomics' Vice President, Investor Relations and Corporate Communications. Please go ahead.
spk02: Thank you, Michelle. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarty, CITOMX's Chief Executive Officer and Chairman, Dr. Amy Peterson, President and Chief Operating Officer, and Chris Obden, Vice President, Finance and Accounting. Earlier today, we issued a press release that includes a summary of our fourth quarter and full year 2021 financial results and highlight the important progress we made during the year. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release and recording of this call can be found under the Investors and News section of our website at sitomics.com. Please note that during today's call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks, including the uncertainty surrounding the COVID-19 pandemic. that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with SEC at SEC.gov, including our Form 10-K filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. With that, I'd like to turn the call now over to Sean.
spk04: Thanks, Chao, and good afternoon, everyone. Thanks for joining us today for an update on recent progress at Citomics. Before I begin, I'd like to note that on February 14th, we issued an 8K announcing that our Chief Financial Officer, Carlos Campoy, has begun a temporary personal leave of absence. We very much look forward to Carlos' return. In the interim, our Vice President of Finance, Chris Ogden, who joins us on the call today, has assumed the role of Principal Accounting Officer and will oversee day-to-day operations of our finance functions. I would also like to congratulate Amy on her recent promotion to President and Chief Operating Officer of Cytomics, an expanded role in which she will have responsibility for all aspects of product development as we advance towards potential registrational studies and beyond. I would like to start today's call by taking a step back to comment on our overarching corporate strategy, and to reflect on our many accomplishments over the past year, resulting from sustained and relentless execution by the Cytomix team. I'll then hand the call over to Amy to provide updates on our broad and increasingly mature therapeutic pipeline. Cytomix is a clinical stage oncology-focused biopharmaceutical company dedicated to destroying cancer differently. We are utilizing our industry-leading proprietary ProBody platform to create biologic therapeutics to make the biggest possible difference we can to the lives of people with cancer. Our ambition is to build a long-term, multi-product, commercial biopharmaceutical company. Our innovative platform is designed to enable conditional activation of therapeutic candidates within the tumor microenvironment, minimizing drug activity in healthy tissues, resulting in more selective targeting of tumor tissues. we have established conditional activation as a strategic area of current biologics research and development in the industry. We believe our innovative approach has the potential to improve cancer treatment in three ways. Firstly, allowing the pursuit of high potential targets that were previously considered undruggable due to their ubiquitous expression on normal tissues. Secondly, enhancing a potential product's therapeutic window, the balance between tolerability and anti-tumor activity, with particular focus on potent immunotherapies. And thirdly, enabling the development of new combination therapies, including immunotherapies, by improving tolerability. We are employing our platform to address some of the biggest challenges today in oncology biologics R&D. These include the validation of potential new targets for antibody drug conjugates, opening solid tumor opportunities for T-cell engaging bispecific antibodies, and increasing the therapeutic window for immune modulators such as cytokines and checkpoint inhibitors. We have utilized our multi-modality pro-body platform to build a deep clinical pipeline that now encompasses six novel product candidates, four of which are currently in multiple phase two clinical studies across nine cancer types. The breadth, depth, and range of our pipeline is unmatched in the field of conditional activation, We have treated more than 400 patients with ProBody Therapeutics, and we have probed key translational questions in the clinic to validate the performance of our platform. And we continue to add to our strong intellectual property portfolio, which now comprises over 550 issued and pending patents. Our product candidates include the conditionally activated ADCs, Pralusatumab-Ravtanzine, which targets CD166, and CX2029, which targets CD71. These Phase II clinical programs highlight our strategy of leveraging our technology to pursue high-potential, previously undruggable targets. Our pipeline also encompasses the anti-CTLA-4 probody, BMS 986249, and the probody immune checkpoint inhibitor, pacmelamab, targeting PD-L1, both of which are also in Phase II studies. These product candidates highlight our strategy of using the probody platform to improve therapeutic window for potent immunotherapies broadening the clinical utility of these important pathways. In addition to our Phase II programs, our versatile and tunable platform has continued to deliver new product candidates for advancement into the clinic. CX904 is our first conditionally activated T-cell engaging bispecific antibody, targeting EGFR on tumor cells and the CD3 receptor on T-cells. In January 2022, the IND for this program was cleared by the FDA and we're in the process of initiating a first in human phase one study in patients with advanced solid tumors. Our integrated corporate strategy has and continues to encompass the formation of major partnerships with pharmaceutical and biotechnology companies. To date, we have formed multiple strategic alliances with major multinational pharma companies, including AbbVie, Amgen, Astellas, and Bristol-Myers Squibb. These alliances not only broaden the impact of our technology platform, by increasing the number of pro-body therapeutic candidates being advanced into clinical studies, but they have also added considerable financial resources in the form of non-dilutive capital, enabling us to consistently maintain balance sheet strength over the years. Today, we have reported a 2021 year-end cash balance of $305 million, which provides funding well into 2023, without taking into account any potential cash flows from existing or new partnerships. Chris will provide you with an overview of our financials momentarily. Our successful financing of Cytomics, coupled with our prudent financial management, has allowed us to aggressively advance our pipeline to key upcoming milestones and value inflection points and to build a broad early-stage pipeline that extends beyond our six clinical-stage assets as we continue to innovate and reinforce our lead in the field of conditional activations. Let me now hand the call over to Amy to walk through our many exciting achievements in the pipeline in 2021 and also our outlook for 2022. Thank you, Sean.
spk01: I am very excited about the progress we are making at Cytomix and look forward to continuing to deliver on our goal of building our company for the long term and making real our promise to positively impact the lives of people with cancer. In 2021, we made significant advancements despite contending with the COVID-19 pandemic. Let me begin with Prelazatumab-Tanzane, our wholly-owned Phase II asset. As Sean mentioned, Prelazatumab is a CD166-directed, conditionally-activated ADC with first-in-class potential in breast cancer, and we recently published full data from our Phase I monotherapy dose escalation study in clinical cancer research. In this paper, we reported encouraging anti-cancer activity in patients with either triple negative or hormone receptor positive HER2 non-amplified breast cancer. In particular, the clinical benefit rate defined as any partial or complete response or stable disease at 16 or 24 weeks was 41% and 28% respectively, and despite a median of seven prior therapies. the treatment landscape in breast cancer continues to evolve, especially in the area of ADCs, with the recent results from the DESTINEO-3 study evaluating trastuzumab-durex-tcan in patients with HER2-low breast cancer, and, of course, the anticipated Phase III results from sasituzumab in patients with hormone-receptor-positive breast cancer. ADCs are clearly making an impact in breast cancer, and we are excited about the potential for prelazatumab Let me discuss the design of our ongoing Phase II study in a bit more detail. The tolerability and activity of Pralose Attenbath monotherapy is being assessed in arms A and B in approximately 40 efficacy-evaluable patients with either hormone receptor-positive disease or triple negative disease, respectively. Our enrollment criteria in all arms exclude patients with HER2-amplified breast cancer meaning we are enrolling patients with either HER2-low or HER2-null breast cancer, the latter being a sizable population that is not addressed by trastuzumab DERIX-TCAN. The primary endpoint in all arms is response rate by central radiology review, and the key secondary endpoint, particularly important for arm A, is CBR24. The definition of efficacy evaluable includes high expression of CD166. Of note, our phase one experience with hormone receptor positive disease showed high CD166 expression in more than 90% of patients, and arm A is an unselected population. For TNBC, we saw more heterogeneous expression levels in phase one, and for this reason, we're selecting patients for CD166 expression. Enrollment into the trial continues at over 40 sites globally, and we anticipate having initial data in arms A and B in the second half of 2022. Let's now move to arm C, which is evaluating the combination of prelazatumab and pacmelamab, our PD-L1 probody, in patients with PD-L1 positive, CD166 expressing triple negative breast cancer. Each agent has shown single agent activity in triple negative breast cancer, and we are excited to see what this combination can do for patients. Enrollment is ongoing, and we expect results from this arm to be available in 2023. I would now like to discuss CX2029, our program assessing the anti-CD71 ADC in partnership with AbbVie. To briefly recap, In December 2021, we reported encouraging results for our ongoing Phase II expansion of this program in patients with late-stage metastatic squamous non-small cell lung cancer, an area of high unmet clinical need. Specifically, we reported a preliminary response rate of 18.8% and a disease control rate of 87.5%, in 16 patients with squamous lung cancer who had received both prior platinum-based treatment and checkpoint inhibition. This is a growing patient population with a high unmet need. To put these preliminary monotherapy results into context, several randomized studies conducted in the second or third line squamous lung setting report a response rate to docetaxel between 8% and 11%. This response rate is in patients who were checkpoint inhibitor naive. As an additional reference point, nivolumab, approved by the FDA in 2015 for the treatment of patients with previously treated metastatic squamous non-small cell lung cancer as monotherapy, reported a response rate of 12.8% in the third line setting. Given the prior treatment regimens in our study and the unselected nature of the study population, we are encouraged by the activity. Enrollment continues towards our goal of 25 efficacy-evaluable patients, and we expect to provide a data update on all efficacy-evaluable patients in the second half of 2022. To briefly recap, both prelazatumab and CX2029 are first-in-class conditionally activated ADCs directed against tumor targets that were previously deemed undruggable a core element of our strategy to destroy cancer differently. I'd like to now turn our efforts to use our platform to improve the therapeutic window for potential immunotherapies, starting with CTLA-4 and BMS 986249, the pro-body version of ipilimumab we created with our partner, Bristol-Myers Squibb. CTLA-4 targeted therapy is a foundational immuno-oncology strategy. and treatment with ipilimumab as a monotherapy or in combination with nivolumab has resulted in clinically meaningful anti-tumor activity in a variety of malignancies, highlighted by the recently updated median overall survival of 72.1 months for the combination in the Phase III melanoma Checkmate 067 study. The durability of responses to anti-CTLA-4 therapy continues to highlight the importance and uniqueness of this target. However, CTLA-4 blockade has a narrow therapeutic window, and we believe that broader potential of CTLA-4 therapy could be realized through the application of our ProBody platform. We believe our CTLA-4 targeting ProBody therapeutic may be able to effectively localize the anti-CTLA-4 antibody activity to the tumor microenvironment. thereby limiting systemic toxicities often seen with ipilimumab, potentially improving the benefit-risk profile of an anti-CTLA-4-containing regimen. The Phase I study conducted by BMS and previously reported at ASCO 2020 evaluated doses of BMS-986249 monotherapy that were equivalent to up to 30 milligrams per kilogram of unmasked ipilimumab and in combination with 480 milligrams of nivolumab, doses that were equivalent to up to 15 milligrams per kilogram of unmasked ipilimumab. This is remarkable in that a dose of 3 milligrams per kilogram of ipilimumab was not tolerable in combination with an equivalent dose of nivolumab as shown in the 2013 Phase I study reported in the New England Journal. Our partner, Bristol-Myers Squibb, is currently evaluating BMS 986249 plus nivolumab in a randomized phase two study against ipilimumab plus nivolumab in patients with untreated advanced melanoma. This novel combination is also being evaluated in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple negative breast cancer. In addition, BMS is conducting a phase one study with BMS 986288 our probody of a non-feucosylated version of ipilimumab, again, as monotherapy and in combination with nivolumab in patients with advanced solid tumors. Continuing with our work on potent immune modulators, the tremendous versatility of our platform is allowing us to expand the reach of probody therapeutics to T-cell engaging bispecific antibodies, or TCBs. Unmasked TCBs, even at very low concentrations, can engage normal tissue even with low antigen expression of the target. This results in significant and sometimes quite harmful side effects and has limited the dose and applicability of this extremely potent anti-tumor immune mechanism, particularly for solid tumors. We believe our ProBody platform has the potential to meaningfully widen the therapeutic window for TCBs, by localizing their therapeutic activity and target engagement to the tumor microenvironment. We have demonstrated this concept in non-clinical models and are now moving into the clinic in collaboration with Amgen with our first pro-body T cell bispecific, CX904. CX904 is a conditionally activated TCB targeting the epidermal growth factor receptor or EGFR and CD3 and is our most advanced program utilizing this modality. We submitted the IND in December of 2021, and as noted by Sean earlier, we are in the process of initiating the first in human phase one study in patients with advanced solid tumors now, marking the sixth therapeutic candidate and the third treatment modality to enter the clinic from our ProBody platform. Another exciting and emerging application of this powerful and versatile platform is in the field of cytokines. Our interest in this area stems from the fact that systemic toxicity and poor exposure have limited the clinical success of this important and highly potent class of immune modulators. By leveraging our deep understanding of the tumor microenvironment and our masking technologies, we have engineered a protease-activatable version of interferon-alpha-2b that incorporates both affinity-based peptide and steric masking technologies. In preclinical studies, we have already seen that the dually masked interferon alpha 2B provides an improved therapeutic window, and we are driving this program towards clinical candidate selection. From my comments today, I hope I have conveyed to you the breadth and depth of our platform and pipeline, and the progress that we are making towards our commitment to destroying cancer differently. With that, I'll turn the call over to Chris, for a financial review.
spk10: Thank you, Amy. Cytomix entered 2022 with a strong balance sheet. As of December 31st, 2021, as Sean mentioned earlier, we had $305 million in cash, cash equivalents, and investments, which we project will fund the operations of the company well into 2023. For the fourth quarter of 2021, Revenue was $20 million compared to $16 million for the corresponding period in 2020. The increase was largely related to the CD71 collaboration with AbbVie. R&D expenses increased $15 million to $37 million during the three months ended December 31st, 2021, compared to the corresponding period in 2020. The increase was driven by personnel expenses, clinical trial activities, and consulting and contract services to support our preclinical and clinical portfolio. G&A expenses were $9.5 million during the three months ended December 31st, 2021, an increase of $300,000 compared to the same period in 2020, due mainly to increased personnel-related expenses. Before I hand the call back to Sean for his closing remarks, I want to reiterate Sean's point earlier on prudent financial management at Cytomics. As we advance our pipeline to key inflection points, we will remain judicious with our capital and continue to marshal our cash resources thoughtfully. Sean?
spk04: Thanks, Chris and Amy. To wrap up, Cytomics had a very strong 2021. and we have entered 2022 intensely focused on continued pipeline execution. Across multiple targets and within our broad and deep therapeutic pipeline, we have clearly demonstrated that conditional activation is a versatile approach to enhancing or indeed creating a therapeutic window for high potential cancer treatments, and we see enormous opportunity for our technology. We have much more work to do to destroy cancer, and our different approach, leveraging our industry-leading ProBody platform, offers unique opportunities to make a real impact. As our pipeline continues to grow and mature, we are working in increasingly defined areas of unmet medical need, as evidenced by the encouraging clinical activity of CX2029 in lung cancer and our ongoing Phase II studies of Pralizatumab in breast cancer and of our anti-CTLA-4 probody in melanoma. The substantial investments we have made in recent years in our platform and in our pipelines position us well to build long-term value as we drive towards key milestones in 2022 for our most advanced programs, whilst also advancing many new product candidates towards the clinic. I want to extend my sincere thanks to the Cytomix team for their ongoing dedication and commitment to our vision and mission. And in closing, our thoughts are with everyone impacted by the unfolding events in Ukraine, and we hope for a peaceful solution to the crisis. With that, operator, We can now open the call up for Q&A.
spk05: Thank you. If you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. And our first question comes from the line of Gavin Scott with J.P. Morgan. Your line is open. Please go ahead.
spk08: Hi. Thanks for the update, and thanks for taking our questions. Just a question on CX. and RMB in the TNVC breast cancer population. I'm just curious on the opportunity in the CD166 positive TNVC, and is there any stratification criteria in the protocol to see, I guess, pre-specified analysis across CD166 expression levels?
spk04: Yeah, hey Gavin, thanks for the question. Let me kick that one off. So as Amy mentioned a few moments ago, across arms A and B, with arm A, what we observed in phase one and in the public databases is high expression of CD166 in the majority of patients. So in arm A, we're not selecting for, target selection is not a criteria for enrollment. In contrast to arm B, where in our phase one experience and also looking in the public databases, you can see that CD166 is more heterogeneous, and so we are utilizing a patient selection strategy for RMB. We do require in both RMs A and B CD166 high for the definition of efficacy evaluable. That's something that we're not discussing in a lot of detail right now in terms of where that cutoff is going to be, We need to learn more about the target in triple negative in particular. And given, as you know, that it's a diagnosis of exclusion with a fairly heterogeneous histological definition. So more to come on that as we go through the year.
spk08: Great. Thank you.
spk05: Thank you. And our next question comes from the line of Kavari Pullman with BTIG. Your line is open. Please go ahead.
spk06: Yeah, good afternoon, and thanks for the update. For TNBC study again, are you enrolling patients who are Tredelvi experienced, and will we see any data for that?
spk04: Yeah, great. Thanks for the question. So if I could just repeat it. So the question is, are we enrolling patients who are experienced? And the short answer is yes, we do expect to see some patients for sure having experienced Tredelvi. I want to remind everyone that in our previously reported clinical study, we did see a very intriguing response in a patient who had progressed Tredelvi. on Tredelvi, on sasituzumab. So we have evidence that Pradizazumab can work in that patient population. We are enrolling in the U.S. and ex-U.S., and so we would expect, given the approval in the U.S. and the pending approvals ex-U.S., that we would end up with a somewhat mixed patient population, some of whom have and some of whom have not been treated with Tredelvi.
spk06: And regarding the EGFR-CD3 bispecific, the triple meeting poster shows a 2 plus 2 design for this molecule. Can you talk about your rationale for using 2 plus 2 format? Because I believe that format is mostly used for better safety, but 904 is already masked to provide tumor-directed activity.
spk04: Yes, good question, and thanks for pointing out some of our previously published work on the program. So just to be clear, the 2 plus 2 you're referring to is the dual antigen for both CD3, two CD3s and two EGFRs, I believe, correct? Correct. Yeah. So we haven't disclosed the actual molecular anatomy of 904 to this point. We have done a considerable amount of additional optimization of that program to ultimately reach 904 as the clinical candidate in collaboration with our partner Amgen. And so actually the structure of 904 is not yet disclosed.
spk06: Got it. Thank you. And thanks for taking my questions.
spk04: You're welcome.
spk05: Thank you. And our next question comes from the line of Joe Cannizzaro with Piper Sandler. Your line is open. Please go ahead.
spk11: Hey, thanks for taking my questions. Maybe the first one from me. I think for CX2029's initial Phase II readout, ahead of that, you characterized the size of the data sets as, you know, going to show meaningful progress towards the planned 25 patients per cohort in that study. So maybe with that, at this point, I guess, how would you characterize expectations for sample size for 2009's initial Phase II monotherapy readouts? Thanks, and I have a follow-up.
spk04: Yeah, hi, Joe. Thanks for the question. So to recap the goals of the Phase II, the three-arm study, the goal is to enroll 40 4-0 efficacy-available patients in each arm. And we are making very good progress with enrollment. As you may recall, we had a few bumps in the road last year, but the team has done an amazing job. And we are making progress. Our guidance at this point is data from ARMS A and B, initial data this year. We do expect it to be meaningful numbers of patients. We're not quite ready to comment on a specific number at this point.
spk11: Okay, got it. And if I could just ask a follow-up. I was scanning through the 2009 publication and I noticed a figure that showed a strong correlation between unmasked antibody in the tumor and expression of CD166, and I'm trying to understand what the cause-effect relationship there is. If you could help with that, that'd be great.
spk04: Yeah, it's a great question, and thanks for studying the publication in detail. There's a lot in there that we wanted to report. I don't want to get into too many details here, but there's a lot still to learn about the sequence of events with regard to probody functionality, and One can imagine this derives from a relationship between activation and target level and the order in which the probody actually becomes converted into the active form. So it's an intriguing observation. There's a little bit written in the paper about that, but we think it provides some interesting translational insight into how this platform functions.
spk11: Okay, got it. Thanks for taking my question. You're welcome.
spk05: Thank you. And our next question comes from the line of Mara Goldstein with Mizuho. Your line is open. Please go ahead.
spk09: Hi. Thank you for taking my question. This is support from Mara Goldstein. My question is on CF 2009. So the data is now expecting the second half of 2022. Given that it was previously guided in 2022, Is it fair to characterize that as a slight delay? And just wondering if you can provide a little bit of color about that. Yeah, that would be good.
spk04: Well, good question. You know, I would not characterize it as a delay. I think that it's obviously a refinement of our guidance, which we wanted to give today. We are, given this is a fairly substantial phase two study, we are working towards giving meaningful updates, and so giving ourselves a little bit more time to get data that will provide us with pointers to the next steps in the products development, and also providing be able to share that with external stakeholders we think is the right thing to do. So we don't want to, we see no need to communicate data that is too premature.
spk09: Got it. Thank you.
spk05: Thank you. And our next question comes from the line of Roger Song with Jefferies. Your line is open. Please go ahead.
spk07: Great. Thank you for taking our questions. Just quickly, to confirm some of the logistics, for 2029, you are expecting the non-smell cell lung cancer update in second half. Any comments around the other cohort, like GEJ and the DLBCL data readout? Similarly, for the 904, any color on the data timing will be helpful. Thank you.
spk04: Yeah. Hi, Roger. Thanks for the questions. So, yeah, so regarding 2029 second half, as you can see, we've got a significant amount of data that the team is working towards disclosing in second half of this year, so it's going to be an important time for the pipeline for the company. We're not ready yet to say really anything else about the additional cohorts in 2029. Enrollment continues in esophageal and gastroesophageal junction. As you know, DLBCL is also included in that expansion phase, so we'll provide additional commentary as the year goes on. With regards to 904, just getting that up and running, team did a great job getting the IND cleared, and I would not expect any data from 904 this year. We need to get into dose escalation get going. And as you know, with agents like this, T cell engaging bispecifics, you know, starting doses tend to be on the low side. So, we're going to give ourselves some time there as well. So, not ready to guide on data for 904 at this stage.
spk07: Got it. Thank you.
spk04: You're welcome.
spk05: Thank you, and our next question comes from the line of Mitchell Kapoor with H.C. Wainwright. Your line is open. Please go ahead.
spk12: Hey there. Thanks for taking the questions. The first one, I just wanted to ask on Arm C of the Phase II of pralazetamab, you know, what kind of added benefit could we expect from pacmelamab to show in TNBC, and how should we think about it being positive when we compare to separation from monotherapy?
spk04: Yeah, thanks for the question, Mitch. Let me hand that one over to Amy.
spk01: Hi, Mitch. Thanks for the question. One thing that I want to state is we have demonstrated monotherapy activity with each of these agents in triple negative breast cancer. So we reported on monotherapy activity with pacmelamab in the phase one expansion in triple negative breast cancer, and not only triple negative breast cancer, but a very difficult subset of triple negative breast cancer to treat, which is inflammatory breast cancer. So we observed activity. We also observed activity in triple negative breast cancer with 2009. When it comes to what you might see from the combination, it's not yet clear what we need to see. We know that checkpoint inhibition works. in combination with chemotherapy, pembrolizumab being approved and maintaining its approval in frontline triple negative breast cancer. And so we know what we think it might need to look like, but we aren't necessarily able to say anything more specific about what we're hoping to see. I think if we think about response rates with sasituzumab as monotherapy in this setting in the mid-30s, We would want to see something that is compelling in a patient population that is possibly refractory to sasituzumab.
spk12: Great. Thank you very much. And then just thinking about any potential milestones we could see this year, could you talk about any of those that we could see from collaborators today?
spk04: Yeah, thanks, Mitch, for the question. We haven't disclosed any additional milestone structures in our alliances at this point. As I mentioned in my remarks early on in my comments today, our cash runway projection of well into 2023 does not take into account any milestones or any new BD activity. And, you know, we have, you know, as I said, consistently been able to finance the company through a mix of dilutive and non-dilutive capital, and we expect that to continue to be the case.
spk12: Great. Thank you very much. You're welcome.
spk05: Thank you. Thank you. And our next question comes from the line of Peter Lawson with Barclays. Your line is open. Please go ahead.
spk03: Hey, thanks for taking the questions. Just as regards to the updates, thanks for the timing around updates in the second half. Anything you can say around kind of the number of patients or time on therapy for the triple negative and HR-positive HER2-negative ARMs?
spk01: Hi, Peter. This is Amy. Thanks for the question. So for ARM-A, which is hormone receptor-positive breast cancer, one of the key secondary endpoints is going to be CBR24, which is CBR or stable disease through 24 weeks. And obviously that takes six months to get if you're going to get to 24 weeks. So there is a time component to this, and response rates are not necessarily the strongest indicator of activity in this particular disease. We'll see what the details of the data are with Durex-Tcan, and of course, we're interested to see what happens with sasituzumab in this setting with regard to response rates. But we're really focusing on CBR24 and then, of course, PFS, because if you think about what might be the next study, it's going to be, depending on what the data show us, and if they're hinting in a way that favors activity with this, it would be a randomized study where PFS might be the endpoint. So we'll be looking at at those endpoints very carefully in RM-A. For RM-B, and there we're talking about patient population of approximately 40, 4-0 efficacy of valuable patients. So a population that we can look at, that we can get our heads around, and that we can begin to define the point estimates for the pivotal study. That's what we're talking about when we say a meaningful patient sample size. The same thing for triple negative breast cancer. Here, of course, response rates can be the basis for accelerated approval. However, as you already know, we need durability of those responses. You can't just get the first confirmation and report the response rate. durability of response are going to be the two key endpoints that we're focusing on in that patient population. And again, a meaningful patient population. And what do I mean by meaningful? Something where if we look at it, we would know how to take this molecule into the next study, with the next study having an eye towards registration.
spk03: Gotcha. Thank you. Same question, really, for 2029 in non-small cell lung cancer, kind of how much of an update are we going to get? Is that kind of a durability plus additional patients?
spk01: So I think, yeah, the same principles apply here, Peter. Of course, the population is slightly smaller. It's 25 efficacy-evaluable, but again, it's efficacy-evaluable patients who had at least one post-baseline assessment. And there, again, we're looking at response rates and durability of the response, PFS. Those are all the things that will help inform whether this molecule goes forward and how it goes forward. It's a slightly smaller sample size. Confidence intervals might be a little bit wider, but we should have some understanding.
spk03: Gotcha. Thank you. And then just a final question on 904. Thanks for the details around data next year, et cetera. But what indications should we be thinking about? Is that going to be predominantly non-small-cell lung cancer?
spk04: So, too early to comment on any specific indication. I would just observe that EGFR is a widely expressed tumor antigen with a lot of unharnessed potential, I would say, across many different tumor types. So, You know, we're excited about this product candidate, and as we mentioned, you know, the phase one design is a dose escalation in solid tumors initially, and together with our partner Amgen, one could envisage some further focusing of that study over time into specific tumor types, obviously that express EGFR, of which there are many.
spk03: Perfect. Okay. Thank you so much. You're welcome.
spk05: At this time, I would like to hand the call back over to Chow Chin for his closing remarks.
spk02: On behalf of the executive team, I would like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.
spk05: This does conclude today's conference call. Thank you all for participating. You may now disconnect. Have a great day.
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