CytomX Therapeutics, Inc. (CTMX) Q4 2020 Earnings Call Transcript

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CytomX Therapeutics, Inc. (CTMX -1.84%)
Q4 2020 Earnings Call
Feb 24, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, thank you for standing by. Welcome to the CytomX Therapeutics Fourth Quarter and Full Year 2020 Financial Results Call. Please be advised that today's call is being recorded.

I would now like to hand the conference over to your host for today, Chau Cheng, CytomX's Vice President, Investor Relations and Corporate Communications. Please go ahead.

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

Thank you, Victor. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarthy, CytomX's President, Chief Executive Officer and Chairman; Dr. Amy Peterson; Chief Development Officer; and Carlos Campoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our fourth quarter and full year 2020 financial and highlights 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 a recording of this call can be found under the Investors and News section of our website at cytomx.com.

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 the 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 would like to turn the call now over to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Thank you, Chau, and good afternoon, everyone. Thanks for joining us today. 2020 was a highly productive year for CytomX's in spite of the COVID pandemic, as we continue to execute our strategic plan to deliver on the promise of our technology platform for transforming the lives of people with cancer and building a sustainable oncology focused commercial organization for the long-term. To that end we are well on our way, as we continue to work diligently toward initial readouts in 2021, from ongoing phase-II work on our lead conditionally activated antibody drug conjugates, CX-2009, or praluzatamab ravtansine and CX-2029.

Let me begin by reiterating, that we are the leader in the emerging field of conditional activation of antibody therapeutics. Our approach, the Probody platform, is designed to increase the exposure of therapeutic antibodies in cancerous tissue, compared to normal tissue by leveraging the protease-rich tumor microenvironment. We believe that disease localization of therapeutic antibodies will be an important therapeutic concept for many years to come, and we're only at the beginning of what this approach will ultimately do.

CytomX is blazing the trail of conditional activation and we believe this can lead to important advances in oncology, and perhaps in other therapeutic areas. CytomX has demonstrated versatility of conditional activation across multiple antibody modalities, including immune checkpoint inhibitors, antibody drug conjugates, and bispecific antibodies. Our robust clinical pipeline now comprises five Probody therapeutic candidates, four of which are in phase-II evaluations across nine cancer types. We have purposefully applied our Probody technology to two different complimentary therapeutic strategies, that we believe offer an appropriate balance of risk.

Firstly, we've advanced Probody therapeutics directed against validated immune-oncology targets, such as CTLA-4 PD-L1 with the goal of developing best-in-class assets and expanding the reach of these foundational anti-cancer therapies.

Secondly and in contrast, we have challenged ourselves to drug the undruggable, and in doing so, create potentially first-in-class cancer therapies, for which we all agree there remains enormous unmet medical need. This strategy has led us to exciting programs evaluating CX-2009 and CX-2029 antibody drug conjugates against novel tumor antigens, CD-166 and CD-71 respectively. Moreover, our two therapeutic strategies dovetail into novel combination approaches, such as our ongoing phase-II study combining CX-2009 with CX-072, our proprietary anti-PD-L1 inhibitor in triple negative breast cancer, thus illustrating the potential of our platform to unlock novel and potentially powerful combination strategies.

I'll now briefly summarize our Probody therapeutic pipeline before handing over to Amy for some additional detail. CX-2009 is a wholly owned conditional antibody drug conjugate, targeting CD-166. Currently in a three-arm phase-II study and HER2 non-amplified breast cancer, which we initiated in the fourth quarter of 2020. Given that breast cancer remains the second leading cause of cancer deaths in women, and about 80% of breast cancers HER2 non-amplified, we believe the opportunity for CX-2009 is significant. The target of CX-2009, CD-166, is a glycoprotein that among other functions, plays an important role in the formation and maintenance of tissue architecture. While its biological roles are not fully understood, CD-166 is an attractive target to us, since it is expressed at high levels in many types of tumors, including breast cancer. However, CD-166 is also broadly expressed in normal tissues, thereby compromising its potential role as a conventional ADC target. CX-2009, has demonstrated single agent clinical activity in several cancer types, including breast, ovarian and lung, and head neck cancers. We anticipate the initial data from our ongoing phase-II breast cancer study toward the end of this year.

Turning to CX-2029, a conditional antibody drug conjugate that targets CD-71, which is also now in phase-II. CD-71 is a [transmembrane] glycoprotein receptor ubiquitously expressed in most normal tissues that functions in cellular iron uptake through its interaction with transferrin. CD-71 is over-expressed on many cancers, to allow tumor cells to meet their increased iron requirement for growth. While the high expression on malignant cells and its ability to be readily internalized, make CD-71 an intensively studied target for the delivery of drugs into malignant cells, it has remained an elusive and undruggable target to date, due to its broad expression on normal cells. Using our Probody platform, we believe we have created a therapeutic window for CD-71, and in partnership with AbbVie, we are now exploring this asset in phase-II expansions in four different tumor types, with initial data anticipated in the fourth quarter of this year.

In addition to our progress with CX-2009 and CX-2029, we're also very pleased to report that our partner, Bristol-Myers Squibb, continues enrollment in its ongoing randomized phase-I/IIA study of the anti-CTLA-4 Probody BMS 986249 in patients with previously untreated unresectable stage III/IV melanoma, and BMS has expanded the scope of the Part IIB, evaluation to include three new cohorts. These new cohorts are enrolling patients with advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. BMS also continues enrollment into a phase-I study of a second anti-CTLA-4 Probody, BMS 986288. In addition to this continued clinical progress in our alliance with BMS, we look forward to continuing collaborative discovery and development activities toward generation of additional Probody therapeutics in oncology.

Turning now to our preclinical pipeline, where we continue to explore and leverage our platform, and specifically to our third investigational antibody drug conjugate, CX-2043, which targets EpCAM, also known as TROP-1. EpCAM has been regarded as a high potential oncology target for decades, but efforts to generate systemic anti-EpCAM therapeutics have, to-date, not been successful. However, locally derived approaches have shown some success and in fact, a recombinant fusion protein that targets EpCAM, has recently been submitted to the FDA for approval in bladder cancer, but this agent has to be instilled directly into the bladder. This is because EpCAM, or epithelial cell adhesion molecule, as the name suggests, is present on the majority of normal epithelial tissues and conventional anti-EpCAM biologics, administered systemically, have significant dose-limiting toxicities.

In contrast, our anti-EpCAM conditional ADC, CX-2043, designed to be delivered systemically, as shown in preclinical studies, potent antitumor activity across multiple cancer types and superior tolerability in animal models compared to the corresponding unmasked conventional ADC. CX-2043 is currently in IND-enabling studies, and an IND application is anticipated for late 2021.

Another preclinical candidate, which we continue to advance toward the clinic, is CX-904. Our T-cell engaging bispecific Probody that we're developing in partnership with Amgen. CX-904 targets the CD-3 receptor on T-cells and the epidermal growth factor receptor, or EGFR on tumor cells. Now although both EGFR and CD-3 are validated in their own rights, we see this combination as undruggable for conventional bispecific approaches due to the extraordinary potency of both mechanisms when combined. In collaboration with Amgen, we continue our work toward unlocking potential in this target combination with our Probody platform with the goal of IND filing this year.

Staying with the bispecific theme, we're also excited about our recently initiated drug discovery activities under our collaboration with Astellas, also aimed at broadening the therapeutic window of bispecific T-cell engagers.

Now I'd like to hand the call over to Amy for a deeper dive into our lead programs and where we're taking them. Amy?

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Thank you, Sean. Hi, everyone. I'm going to start with CX-2009 or praluzatamab ravtansine and lay out our strategy for demonstrating the value we believe is inherent in this asset. CX-2009 is a potentially first-in-class conditionally activated ADC, with the potential to address two major subsets of breast cancer. At the 2020 San Antonio Breast Cancer Symposium, we provided clinical updates from our phase-I work in patients with HER2 non-amplified breast cancer, as well as translational data. The clinical update reinforced data previously reported at ASCO. Two confirmed responses occurred in patients with hormone receptor positive disease, and compelling but unconfirmed responses were observed in three patients with triple-negative breast cancer, including one patient who had progressed on paclitaxel pembrolizumab, and subsequently progressed on sacituzumab govitecan.

Encouragingly, our data to-date suggests that CX-2009 does not appear to show cross resistance to other approved breast cancer treatments, in either hormone receptor positive or triple-negative disease. The clinical benefit rate, or CBR, was 41% at 16 weeks and 28% at 24 weeks. These data indicate that responses can occur early on and can be durable. Furthermore, these data speaks to the potential tolerability of this agent, and indeed, there are a handful of patients that remained on treatment for nearly a year.

CX-2009 was generally well tolerated with manageable adverse event profile at the recommended phase-II dose of 7 mgs per kg every three weeks, and ocular toxicity was the most frequently observed adverse event. Also at San Antonio, we provided data from exploratory translational study. In circulation, CX-2009 was found to be predominantly intact, that is, it remained masked. Conversely, unmasked antibody drug conjugate was measurable to an appreciable percent in tumor specimens, biopsied four days following the first infusion. Furthermore, the concentration of activated intratumoral CX-2009 was found to be significantly correlated with CD-166 expression. This further supports investigation as to whether CD-166 selection could be used to enrich the patient population. We believe that collectively, these data underscore the potential of targeting CD-166 with CX-2009 and support its initial phase-II investigation in breast cancer.

Let me just provide a quick recap on the design of the phase-II study. CX-2009 will be investigated in three parallel enrolling arms. Arm A will evaluate monotherapy CX-2009 in patients with hormone receptor positive HER2 non-amplified breast cancer. This is the largest subset of breast cancer, representing over two-thirds of all patients with breast cancer. Arm B will evaluate monotherapy CX-2009 in patients with triple-negative breast cancer. Arm C also enrolling patients with TNBC, will evaluate CX-2009 in combination with pacmilimab or CX-072, our conditionally activated anti PD-L1 antibody.

Our previously reported preclinical work on CD-166 in combination with PD inhibition and that of others provides clear rationale for combining ADCs with checkpoint inhibitors, and we're excited about this first clinical evaluation of a Probody/Probody combination. Each arm is expected to enroll approximately 40 evaluable patients and ocular prophylaxis is mandatory. The primary endpoint of the study will be objective response rate based on central radiology review, other endpoints include duration of response, CVR-16 and 24 and progression-free and overall survival. Analysis will be performed separately for each arm on efficacy evaluable patients.

CD-166 is highly expressed by IHC and greater than 80% of hormone receptor positive breast cancer, thus, we will not select for CD-166 expression in Arm A. High CD-166 expression has been observed in approximately 50% of triple-negative breast cancers. So we will require that patients tumors express CD-166 in order to be eligible for Arms B or C. We started the study in December of last year and anticipate initial data to be available in the fourth quarter of this year.

Moving on to CX-2029, our anti CD-71 conditionally activated antibody drug conjugate employing the MMAE payload. At ASCO 2020, we provided the first data ever demonstrating successful targeting of this receptor with an ADC approach. We provided an additional update in the fourth quarter, focusing on the 12 patients with squamous histology that enrolled into the study, including four patients with squamous non-small cell lung cancer and eight patients with head and neck squamous cell carcinoma. That analysis highlighted that of the four patients enrolled with squamous lung, one achieved a best response of stable disease lasting approximately six months, and two had confirmed partial responses. One with the duration of response approaching six months. The fourth patient was enrolled at 1 mg per kg, a dose not expected to be clinically active and progressed on study.

For head and neck squamous cell carcinoma, all eight patients received two or three mgs per kg. We observed a best response of stable disease or better in seven of the eight patients, including one patient with a confirmed partial response, who remained on treatment for nine months and one patient with stable disease, who remained on treatment for eight months. Of these 12 patients, none discontinued treatment due to an adverse event.

In all patients, the most commonly occurring grade 3 or higher adverse event was anemia, which was predictable and manageable using one of four interventions; red blood cell transfusion, growth factor support, dose delay or dose reduction. No patient discontinued CX-2029 treatment for anemia. While anemia is an expected payload toxicity from MMAE, the rate and severity were higher than what has been reported with other MMAE ADCs, and we're continuing to work with experts in the field to investigate the mechanisms contributing to this toxicity, which could include CD-71 biology and red blood cell production, as well as the effects of various interventions, so that we may better mitigate the side effect in the phase-II expansion study.

Taken together, the exciting results from our phase-I dose escalation for CX-2029 have led us in collaboration with our partner, AbbVie, to launch a phase-II multi-cohort study, evaluating patients with squamous non-small cell lung, head and neck squamous cell carcinoma, esophageal or GEJ cancer or diffuse large B-cell lymphoma. As previously announced, we dosed the first patient in this trial in November of last year, and with sites actively recruiting patients, we anticipate initial data to be available in the fourth quarter of 2021.

With that, I would like to turn the call over to Carlos to review our financials.

Carlos Campoy -- Senior Vice President and Chief Financial Officer

Thank you, Amy. We have continued to successfully finance CytomX's operations. Just last month, we raised approximately $108 million in net proceeds from a follow-on public equity offering, which added to the $360 million in cash, cash equivalents and short-term investments we had as of December 31, 2020, puts us in a strong financial position. We believe our strengthened balance sheet will allow us to continue to advance our clinical pipeline of conditionally activated antibodies, to introduce new product candidates from our Probody platform technology into human testing, and to meet projected operating requirements into 2023.

Let me now highlight some of the financial results for the quarter and year ended December 31, 2020. The total revenues were $16 million and $100 million for the quarter and full year, respectively, compared to $8 million and $57 billion for the corresponding periods in 2019. Research and development expenses were $22 million and $113 million for the quarter and full year, respectively, compared to $36 million and $132 million in 2019. General and administrative expenses were essentially flat for the quarter and full year compared to 2019, amounting to $9 million for the quarter and $36 million for the year.

With that, I'll turn the call back to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Great. Thanks, Carlos. So 2020 was a highly productive year for CytomX, in which we saw our clinical stage pipeline advance to now encompass phase-II evaluations of four Probody therapeutics across nine cancer types; all while contending with the challenges posed by the COVID-19 pandemic. We have demonstrated that our Probody technology has the potential to widen or create therapeutic window, first-in-class and validated oncology targets, and we continue to execute on our strategic plan to deliver on the promise of our technology, by transforming the lives of people with cancer.

Our leadership in the research, discovery and development of conditionally activated antibody candidates, positions us well for future growth as we now drive to important phase-II datasets with CX-2009 and CX-2029, and also advance our pipeline broadly.

We're pleased with the ongoing progress within our strategic partnerships, especially the recent commitments from BMS to expand their evaluation of BMS-986249 in three additional tumor types beyond melanoma. In addition to deepening, broadening and advancing our unique pipeline of Probody therapeutics throughout 2020, we continue to build strength throughout the company, including the appointments of Miss Halley Gilbert and Dr. Mani Mohindru, to our Board of Directors. Their appointments exemplify our commitment to creating a stronger and more inclusive board, and also underscore our strong corporate culture of diversity, equity and inclusion across our entire organization and in the community at large.

I'd like to take a brief moment here to sincerely thank CytomX board member, Dr. Charles Fuchs, for his valuable guidance of friendship over the years. Effective April 1, Charlie will step down from CytomX Board after taking a new role at Genentech, and we wish him the very best.

In summary, 2020 was a year like no other, but I am proud to say CytomX came out stronger in every dimension. I'd like to convey my gratitude and appreciation to our entire CytomX team for their incredible efforts in 2020. Also to our partners and our investors for their continued support.

We look forward to speaking with you all again soon as this exciting year progresses. We plan to host a virtual analyst and investor briefing in April with key opinion leaders and to provide you with background on our Probody technology, our conditional ADC strategies and the outlook for the year ahead.

With that, let's open the call up for Q&A. So back to the operator.

Questions and Answers:

Operator

[Operator Instructions.]. Our first question will come from the line of Terence Flynn from Goldman Sachs. You may begin.

Terence Flynn -- Goldman Sachs -- Analyst

Hi, good afternoon. Thanks for taking the question. Maybe two for me, was just wondering, if you can give us some perspective on the clinical trial environment right now and maybe kind of end of last year into this year, are sites generally back open and enrolling patients? And then how does this factor into your enrollment timelines over the course of the year? And then the second question I have is -- relates to 2009. Obviously, the treatment paradigm for triple-negative breast has been evolving here. There's been a second entry of a PD-1 as well as TRODELVY, and just wondering how you expect 2009 to be positioned here, if it's approved? Thank you.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Hi Terence, thanks for the question. Let me make a couple of general comments on our experience at sites and enrollment, then I'll hand over to Amy, who may want to add and then Amy will address the 2009 question as well. So we certainly -- as you all know, last year, in fact, gosh almost a year ago, we were all wondering what was going to happen with COVID. We did in fact, at that time, with our 2009 phase-I expansion, we did slow that down. We paused enrollment, and we took advantage of that pause to rewrite the study as a formal phase-II study, which is what we've launched at the end of last year. We have, I would say, seen like others, that enrollments across the pipeline has come back over the course of the -- toward the back end of 2020. Still not ideal in certain ways, mostly limited by one's ability to obviously get into sites. That said, we remain -- we feel pretty good about our guidance on data for the 2009 and 2029 programs by the end of this year.

So with that, let me hand over to Amy to comment particularly on your question on 2009 and triple negative.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Yup. Got it. Thanks. So regarding the recent entrance of PD-1, yes, we are aware of that in the frontline. And what we actually are excited about, is that CX-072, when we looked at the data in the phase-I study, we actually enrolled a cohort of triple-negative breast cancer and saw some very compelling signs of activity in this disease specifically.

So we know checkpoint inhibition works. We know our checkpoint inhibitor works. We know that right now, the best partner with checkpoint inhibitor happens to be chemotherapy. ADC's are a sort of modified version of chemotherapy, and we certainly have observed single-agent activity with 2009. So we're looking forward to that combination in Part C.

Now how we position 2009, what we have shown in our corporate presentation, is we do have a patient, and I mentioned her in the earnings call, we do have a patient with triple-negative breast cancer who had very large volume disease, ulcerating through the skin. She received pembrolizumab with paclitaxel as her frontline therapy and her best response to that was disease progression. She then got sacituzumab and her best response to that was disease progression. On our study, she had an early and marked response. Unfortunately, she developed keratitis, needed to come off-treatment to have that treated. By the time she resolved, her disease had to be remeasured. She progressed and we couldn't reinitiate treatment per RESIST. But she still had a dramatic response, even at that time after two cycle -- really, I want to say, 16 weeks on treatment.

So as we think about positioning 2009, in triple-negative breast cancer, sacituzumab, we're well aware, has accelerated approval. We understand what accelerator approval looks like for them. We also are aware that as of this date, we have no reason to believe that there's cross resistance to either checkpoint inhibitor or sacituzumab with monotherapy 2009, and that's exemplified in the response that we saw in the patient I just described.

So for accelerated approval, we would have to go after approved therapies, which would be a checkpoint based therapy in the front line and sacituzumab potentially thereafter. And we'll be looking to see how we position it further as we get data. I hope that answers your question.

Terence Flynn -- Goldman Sachs -- Analyst

Great. Thanks so much.

Operator

And our next question will come from the line of Peter Lawson from Barclays. You may begin.

Mitchell -- Barclays Bank -- Analyst

HI everyone. This is Mitchell [Phonetic] on for Peter. The first question I have is, what is the bar for efficacy for CD-71 therapies, and what would be considered positive results from the phase-II expansion to support moving forward with the program? And then kind of along those lines, what is the scope of data we can expect from CX-2029 for 2021, and how many patients of data about -- could we expect?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Thanks for the question, Mitchell. Let me give a couple of general comments. Obviously, given the scope of the work that we're doing with CD-71 in multiple indications and also the novelty of the target, we're not in a position to really comment on specific bars or expectations at this point. We're super excited about these studies, and in terms of in terms of scope of data, so just to recap, those four indications are squamous non-small cell lung, squamous head and neck, esophageal GEJ and DLBCL and we've guided in recent months that we're looking to data from the first couple cohorts by the end of this year. Our goal is to enroll up to 25 patients in each of these arms. So where will we be exactly by the end of the year, not sure, but we're working toward, as I said, disclosure of data across those two cohorts by the end of this year. Does that help?

Mitchell -- Barclays Bank -- Analyst

Absolutely. Thank you very much. Our next question comes from the line of Boris Peaker from Cowen. You may begin.

Boris Peaker -- Cowen -- Analyst

All right. Thanks for taking my question. Maybe the first one, just a quick one. When you assess the CD-166 level, curious, is that a fresh biopsy or using archival tissue, and how does that impact the measurement?

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Sean, you want me to answer that or...

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Go ahead, Amy, please.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Okay. Thanks. Yeah, it is a mix. Breast cancer patients tend to have archival tissue. Of course, we enrolled more than just breast cancer patients. So it's a mix of some fresh, but for the most part, it's archival. And what we are doing now, is really trying to better understand the role that CD-166 plays in the biology of cancer, and how its expression may or may not change over time. I think it's important to remember, it is an adhesion molecule, and so there may not be specific pressures to up-regulate or down-regulate as the tumor progresses. But at this point in time, we're beginning to investigate and trying to understand expression levels and then therefore, what's the best timing of tissue acquisition for our study. But for the studies that we have ongoing, we will allow archival tissue.

Boris Peaker -- Cowen -- Analyst

Got you. That's helpful. Also, I'm curious on BMS. You mentioned that they started enrollment of a second CTLA-4 Probody. Just curious, can you comment what's the difference between the first one and the second one?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Let me chip in on that one. So yes, that's been in the works for a while. The second one, what we call 288, is a Probody version of a non-fucosylated version of ipi. And so the strategy there that BMS has been taking, and of course they can speak to it much more effectively than we can, the strategy is that the non-fucosylated version is intended to be a more potent version of ipi, because it's a more effective depleter of intratumoral Tregs. And BMS presented data at AACR last year, actually on both the ipi Probody and the non-fucosylated Probody showing how the Probody approach can enhance therapeutic window for both. So the goal of this second program is to even further broaden the reach of CTLA-4 therapy in the long run.

Boris Peaker -- Cowen -- Analyst

Great. Thank you very much for taking my questions.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Very well.

Operator

Our next question will come from the line of Mara Goldstein from Mizuho Securities. You may begin.

Gabriel Fung -- Mizuho Securities -- Analyst

Hi team. This is Gabriel on behalf of Mara Goldstein. Thanks for taking our questions. So just a couple of questions here. How should we think about the data readout for 2029 in fourth quarter? Was there a particular reason as to why two of the tumor types are prioritized? Or was it just that they have happened to enroll faster, probably the head and neck in the non-small cell lung group? And another question here on, again, the BMS expansion into the three different tumor types. To the extent that you can comment, what do you think would have prompted BMS to choose those specific tumor types? And if they did any additional studies to meet them there? That's it, thank you.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, great. Thanks for the questions, Gabriel. Let me comment on the 2029, and then I'm sure Amy will be happy to comment on the BMS question. We're really very pleased about the additional work that BMS is doing in these additional tumor types. So yeah, with regards to the 2029, it's a pretty straightforward answer, really, which is that we -- the first two cohorts of lung and head and neck, where we saw such promising activity in the phase-I dose escalation, it's the kind of signal that you look for in phase-I. So we're just kind of making an assumption, I suppose that, that will carry the enrollment into those two cohorts with a little bit of initial momentum. So that's really the thinking. It's not really based on anything else at this point in time. So Amy, yes, comments on BMS 249?

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Sure. I can't say exactly what led them in on this. I can speculate on this, which is certainly, they know what a signal would look like, would need to look like. They have the randomized study going on with melanoma, right, that's the killer experiment in a way. And with hepatocellular, they know what responses look like, given the ipi/nivo combination that they have accelerated approval on, and so I think they know what success would need to look like there. So I think it's a -- these are two indications, that will give a clear picture of what the combination can bring to the table, and I would imagine that castrate-resistant prostate cancer and triple-negative breast cancer is yet other areas to expand into, that have not yet reaped the benefits of IO-IO combos.

Gabriel Fung -- Mizuho Securities -- Analyst

Great. Thanks for the details.

Operator

Our next question comes from the line of Robert Burns from H.C. Wainwright. You may begin.

Robert Burns -- H.C. Wainwright. -- Analyst

Hi guys. Thanks for taking my questions. Just two, if I may, for right now. So although I recognize the highly advanced nature of the patients in the HR-positive, HER2 negative breast cancer, metastatic breast cancer cohort in phase-I, considering that the overwhelming majority or CD-166 high and at the monotherapy efficacy of 2009 in this population, appears that it may demonstrate a lower response rate to that TN and TNBC. Are you considering any potential combinatorial strategies to potentially enhance the response rate of 2009, for example, in combination with SERD? And if not, how do you view the potential of SERDs in that relapsed/refractory sort of setting? And then I've got one more after that.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Let me ask Amy to comment on that one. Great question, and hi, Robert. Thanks.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Happy to do so. So if I got it right, the questions were the -- well a potentially lower ORR in hormone receptor positive than in triple negative. I want to take a step back and just say, having responses in hormone receptor positive disease is actually encouraging, period, right? When you think about their disease and where it's located, they have bone disease, and you don't actually always get resist responses in these patients. So the other surrogates of activity that we look at, are things like clinical benefit rate at 24 weeks, and those are the things that we will be looking at in the phase-II.

When it comes to -- so we're equally encouraged by the data that we've observed in both cohorts or in each cohort, let me say it that way. When it comes to combinations, with SERD's being hormonal based, typically, what will happen is patients will exhaust hormonal therapy, however it is delivered, and at the time that they've been refractory or progressed on two/three and with a CDK4/6 inhibitor, for example, and they're continuing to progress. Oftentimes, the physician will start to think about more traditional cytotoxic light chemotherapy, and so they may not go back to SERDs or hormonal based therapy.

The other thing that drives the physician to think more toward chemotherapy is the disease in the patient. So while I said most of the time, they have hone disease, that's usually how it will start, but once they get aggressive or more aggressive, it will involve the lung and the liver and so visceral involvement is something that physicians will often use as a guide to start more traditional cytotoxic-based based chemotherapy, and that's what we would expect where CX-2009 would be positioned initially. In combination, I think right now, we're in the beginning phases, I'd love to be able to figure out how to move this into earlier lines of therapy, be it hormonal, be it in combination with a hormonal agent or other. But right now, it's first things first and look for the monotherapy in this setting.

Robert Burns -- H.C. Wainwright. -- Analyst

Okay. That's completely fair. Thank you, Amy. And my last question for now, so have you done any additional correlative studies regarding CD-71 expression in the antitumor efficacy with 2029? And if so, what has that shown to date?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Really early on that, still, Robert. Great question. It's certainly an important question, from the data we presented so far, really is a little early to tell. But we're highly interested in understanding more about that. It's an abundant target in many different tumors. It's also a rapidly internalizing target. And so the properties of this target, we just need to study more. So there's not really a whole lot we can say right now.

Robert Burns -- H.C. Wainwright. -- Analyst

Awesome. Thank you.

Operator

Our next question will come from the line of Etzer Darout from Guggenheim. You may begin.

Paul Jeng -- Guggenheim -- Analyst

Hey, this is Paul on for Etzer. Thanks for taking our questions. Hoping to get a little more color on what we can expect from the Analyst Day in April? Is there potential to see any sort of clinical update for 2009 or 2029 at that time, or at any other conferences ahead of the plan for fourth quarter disclosures?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, hi Paul, thanks for the question. No. So the goal of the Analyst Day that we're planning for April will be, really more of the outlook for the year ahead. So we'll be talking more about the platform, our approach to conditional activation, which I think is of increasing interest to a lot of people, given the broad emerging interest in these types of approaches to localize antibody activity, we'll be talking about our strategies for conditional ADC's and how to really think about these novel agents, and we'll talk about in more detail, the design of our ongoing studies and insofar as -- so I wouldn't expect any new data at this update, that's really more the outlook for the year ahead. We have not yet communicated on specific timing or venue for our Q4 data updates that will be coming a bit later in the year.

Paul Jeng -- Guggenheim -- Analyst

Great. Thanks. That's really helpful. And then just one more. With your recent raise, wondering if you could provide some comments on how you're currently thinking about capital allocation versus pipeline priorities?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Great question for Carlos.

Carlos Campoy -- Senior Vice President and Chief Financial Officer

Sure. So as we stated before, this additional raise positions us really well to continue to fund our clinical stage pipeline, but also allows us to introduce new programs that are currently in pre-clinical stage into human testing and that takes us into 2023. So that's about the extent of the guidance of where we're investing our money.

Paul Jeng -- Guggenheim -- Analyst

Great. Thank you.

Operator

Thank you. And our last question will come from the line of Mohit Bansal from Citigroup. You may begin.

Mohit Bansal -- Citigroup -- Analyst

Great. Thank you for squeezing me in, and congrats on all the progress. I was just wondering, so Amy, you mentioned that -- and Sean you also mentioned, that basically, CD-166 is a novel target. So expectations, probably it is hard to understand at this point. But just looking across the board, ADC's as a monotherapy treatment have come a long way and the kind of responses we are seeing in the like of Trodelvy and other ADC's out there, they are getting even late lines of therapy, they're getting 30% plus kind of responses. So to that extent, do you think that could be an expectation as a monotherapy, you kind of had to get to that kind of mark to make a mark in these kind of tumors? And if -- to that extent, you may have to get that, can you [enrich] the patients with some way to make sure that you select the patients who benefit the most from these drugs?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yes. Thanks for the question, Mohit. And you're dead right, ADC's have come a long way, and we and others, of course, continue to see an enormous amount of potential if we can continue to unlock novel targets such as we've been doing at CytomX. Again, just to reiterate some of our earlier comments, we're not in a position to comment on specific expectations for these ongoing studies. We are in this business to make a difference, of course. And so that is our objective. We want to make the biggest difference we can in the tumor types we're looking at. And we, of course, will be continuing to look at enrichment strategies over time because we all want to make sure we get the right drugs to the right patients.

And, as Amy mentioned, we have our ongoing strategies, particularly in the triple-negative setting to be prospectively selecting patients for target for CD-166. We think that's going to help. And we don't think that's necessary at this stage in the hormone receptor positive setting because of just how high the target is expressed in that patient population, but enrichment across the board is something that we continue to think about a lot.

Mohit Bansal -- Citigroup -- Analyst

Thank you, Sean.

Operator

And at this time, I would like to hand the conference back over to Chau Cheng for his closing remarks.

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

On behalf of the executive team, I'd 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.

Operator

[Operator Closing Remarks].

Duration: 46 minutes

Call participants:

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Carlos Campoy -- Senior Vice President and Chief Financial Officer

Terence Flynn -- Goldman Sachs -- Analyst

Mitchell -- Barclays Bank -- Analyst

Boris Peaker -- Cowen -- Analyst

Gabriel Fung -- Mizuho Securities -- Analyst

Robert Burns -- H.C. Wainwright. -- Analyst

Paul Jeng -- Guggenheim -- Analyst

Mohit Bansal -- Citigroup -- Analyst

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