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CytomX Therapeutics, Inc. (CTMX -1.84%)
Q2Â 2020 Earnings Call
Aug 6, 2020, 5:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, ladies and gentlemen, welcome to the CytomX Therapeutics Second Quarter 2020 Financial Conference Call. [Operator Instructions]
I would now like to introduce your host for today's conference call, Christopher Keenan, Vice President of Investor Relations. Chris, please go ahead.
Christopher Keenan -- Vice President of Investor Relations and Corporate Communications
Thank you, Valerie. Good afternoon and thank you for joining us. Earlier today we issued a press release that includes a summary of our recent progress and second quarter 2020 financial results. This press release and a recording of this call can be found under the Investors and News section of our website at cytomx.com.
With me today are CytomX's President and Chief Executive Officer and Chairman, Dr. Sean McCarthy and CytomX's Chief Financial Officer, Carlos Campoy.
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 uncertainties 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-Q filed today. We undertake no obligation to update any forward-looking statements whether as a result of new information, future developments or otherwise.
I would like to turn the call over to Sean.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Great. Thank you, Chris, and good afternoon everyone. Thanks for joining us. It's a pleasure to be here to provide an update on our progress during the second quarter of 2020. I'll begin today's call with a brief overview of our recent achievements, including our presentations at ASCO 2020 and the next steps for our lead clinical programs. I'll also comment briefly on our preclinical discovery progress and we'll then turn the call over to Carlos to review our second quarter financial results. We'll then open the call up for questions.
At CytomX, we are pioneering a novel class of therapeutic antibodies, designed to target cancer tissue, allowing for the development of an innovative pipeline of novel cancer therapies. Over the past decade, we have built a strong scientific foundation for our novel technology, which has the potential to change the way we think about antibody therapeutics. Our technology called the Probody platform is designed to direct an antibodies anti-cancer activity toward tumor tissue and away from normal healthy tissue, allowing us to attack new classes of targets that have previously been considered inaccessible to conventional antibody approaches.
Our primary strategy is to use our technology to make first-in-class anti-cancer drugs for the potential treatment of a wide range of cancers by targeting these previously undruggable targets. We're also utilizing our technology to discover and develop potentially best-in-class immunotherapies.
We have four clinical stage programs, advancing toward or already in Phase 2 clinical studies. These are CX-2029, a Probody drug conjugate targeting CD71, that we are advancing with a Phase 2 studies in multiple tumor types, including head and neck and non-small cell lung cancers. CX-2009, a Probody drug conjugate targeting CD166 that we are advancing into Phase 2 studies in breast cancer. CX-072, a Probody therapeutic targeting PD-L1 that we are advancing in combination with CX-2009 in triple-negative breast cancer. And BMS-986249, an anti-CTLA-4 Probody therapeutic currently in a randomized Phase 2 study in melanoma, which is being run by our partner Bristol-Myers Squibb.
In parallel with building and advancing our broad clinical pipeline, we have formed many strong partnerships with leading biopharmaceutical companies, including BMS, Amgen, AbbVie and Astellas, all of whom are advancing novel product candidates, utilizing our technology. We have integrated research and development capabilities and our ambition is to ultimately commercialize our products, ourselves and with our partners as we build our long-term, sustainable, values based organization.
I'd like to spend some time laying out the high level strategy for each of our four clinical assets and how the data we presented at ASCO 2020 has pointed the way to our Phase 2 programs, as we evaluate the full potential of each product candidate in further detail.
Let's begin with the CX-2029, a Probody drug conjugate targeting CD71. CD71 is also known as the transferrin receptor, a protein that is highly expressed on many cancer types. But due to its involvement in iron metabolism has been traditionally thought of as undruggable. We know, in fact, that antibody drug conjugates targeting CD71 are not developable to use a lethal toxicity at low doses in animal models. However, given the high potential of CD71, as a novel anti-cancer target, we have investigated whether our Probody technology can allow us to achieve therapeutic levels of an anti-CD71 drug conjugate in cancer patients, potentially unlocking this first-in-class approach across a range of different cancer types.
Our Phase 1 results presented at ASCO 2020 show for the first time that by employing our technology CD71 can indeed be targeted successfully in patients with advanced cancers. Our dose escalation study achieved therapeutic levels of CX-2029 and objective confirmed single agent responses were observed in patients with squamous non-small cell lung cancer and with head and neck squamous cell cancer.
The principal dose limiting toxicity seen in this Phase 1 study was anemia, which was managed with red blood cell transfusions. These promising Phase 1 results for CX-2029 are particularly important, because targeting CD71 is likely the most rigorous test we have conducted to-date to assess our Probody technology and these results we believe underscore the broad potential of our platform.
These Phase 1 data also resulted in CytomX earning a $40 million milestone payment from AbbVie, our partner for this program, which we received in the second quarter. CytomX continues to lead clinical developments in this global co-development and commercialization alliance. We expect to initiate Phase 2 expansion cohorts of CX-2029 at the dose of 3 milligrams per kilogram every three weeks in head and neck squamous cell carcinoma, squamous non-small cell lung cancer, squamous esophageal carcinoma and DLBCL in the second half of 2020 with potential for the first data readouts in late 2021.
Turning now to CX-2009, our wholly owned drug candidate targeting the previously undruggable target at CD166. CD166 is widely expressed across multiple tumor types and we believe has broad potential as a novel anti-cancer target. However, like CD71, CD166 is present on many normal tissues, ruling it out as a target for conventional therapeutic antibody approaches. To unlock the potential in this novel pathway, we have designed CX-2009, a CD166 targeting Probody conjugated to the well-characterized cytotoxic payload, DM4.
Similar to our experience with CX-2029 that we just discussed, our Phase 1 dose escalation study with CX-2009 in patients with selected advanced solid tumors, achieves therapeutic exposures of the drug candidate. And we observed evidence of single agent anti-cancer activity in several tumor types, including breast cancer and ovarian cancer. CX-2009 was generally well tolerated. The principal dose limiting toxicities were ocular, anticipated and well documented secular of DM4 conjugates. And that we intend to manage with ocular prophylaxis in ongoing studies.
With Phase 1 now complete for this asset, our program strategy is presently focused on breast cancer. Of note, CD166 expression is high in greater than 80% of hormone receptor positive HER2-negative breast cancer patients and then approximately 50% of patients with triple-negative breast cancer. In our Phase 1 study, we observed durable clinical activity in both of these breast cancer populations, despite these patients being very heavily pre-treated. Significant unmet medical need remains in breast cancer and accordingly, we previously announced the initiation of a Phase 2 expansion study of CX-2009 in hormone receptor positive HER2-negative breast cancer. We didn't like to pause this study in March 2020, due to the impact of the COVID pandemic.
However, our team has used the intervening period, resulting from the pandemic to further refine the study with a focus on patient enrollment criteria, including prior treatment regimens. This revised trial will continue to evaluate CX-2009 monotherapy, at 7 milligrams per kilogram administered every three weeks and we aim to enroll at least 40 patients. We expect to reinitiate the study during the second half of 2020.
We're also preparing to initiate Phase 2 expansion studies of CX-2009 in triple-negative breast cancer. Both as monotherapy and in combination with our wholly owned anti-PD-L1 Probody CX-072. We have previously reported single agent activity for CX-072 in triple-negative breast cancer. And have also presented our preclinical data that provide experimental rationale for combination treatment of CX-2009 with PD inhibition, consistent with the well-established benefits of combining chemotherapy and checkpoint inhibition. We're excited to also get this work under way in the second half of this year.
These Phase 2 studies of CX-2009 in hormone receptor positive and triple-negative breast cancers are important next steps in our further evaluation of the potential of this novel first-in-class drug candidate and we are working toward initial data by the end of 2021.
Moving on now to our PD-L1 inhibitors CX-072 in further detail. Updated data from our Phase 1/2 trial of CX-072, from multiple expansion cohorts continue to show durable anti-tumor activity in patients with IO-sensitive tumors such as triple-negative breast cancer, anal squamous cell carcinoma, cutaneous squamous cell carcinoma and tumors with high mutational burden. This data was presented at ASCO 2020.
I'd like to spend a few moments here highlighting the high to mutational burden cohort for CX-072, which is illustrative of the unique and potentially differentiated clinical profile of this asset. 14 patients with various advanced tumor types with high TMB were treated with CX-072 at 10 mg per kg of 10 efficacy evaluable patients, three confirmed partial responses and one confirmed -- one complete response were observed. The partial responses were in colorectal cutaneous squamous cell carcinoma and neuroendocrine carcinoma and the complete responses in a patient with anal squamous cell carcinoma. CX-072 was well tolerated with only 2% grade three or higher immune related adverse events. These data are particularly of note, in view of Merck's approval in mid-June this year, KEYTRUDA in solid tumors with high TMB.
As we now conclude our first clinical expirations of CX-072, which is the first Probody therapeutic to be evaluated in humans, we're very encouraged that our platform is functioning as designed and these findings provide rationale for differentiation of CX-072 from other PD inhibitors and support combination strategies with CX-2009 and other anti-cancer agents.
Turning now to another exciting application of our technology in cancer immunotherapy and our work with our partner Bristol Myers Squibb, who presented data during the second quarter for two anti-CTLA-4 Probody programs, BMS-986249 and BMS-986288, which I will refer to you as BMS-249 and BMS-288, respectively.
At ASCO, BMS presented the first clinical data for BMS-249, a Probody version of the anti-CTLA-4 antibody ipilimumab. This is a novel therapeutic strategy to enhance CTLA-4 exposure in the tumor micro-environment, while potentially sparing systemic toxicity. The trial evaluated BMS-249 as monotherapy or in combination with the anti PD-1 antibody nivolumab in patients with advanced cancers and doses ranging from 240 milligrams to 2,400 milligrams of the Probody, which for reference is approximately 3 mg to 30 mg per kg. Ipilimumab is typically used a clinically at doses of 1 mg to 3 mg per kg.
Safety data from the Phase 1 trial showed that BMS-249 was generally well tolerated as monotherapy, and in combination with nivo. The types of treatment-related adverse events were consistent with those seen with the parent molecule, ipilimumab and the incidence of grade three and above adverse events were supportive of the Probody mechanism of action.
Based on these Phase 1 findings, BMS has initiated a randomized cohort expansion, evaluating the tolerability and activity of BMS-249 in combination with nivo versus nivo with or without ipilimumab in metastatic melanoma. The advancement of BMS-249 into this study triggered a milestone payment of $10 million from BMS to CytomX, it was received in the second quarter. This is an important study that has the potential to provide additional validation of this novel product candidate.
Staying with CTLA-4 for a few moments also in Q2 at AACR, BMS presented preclinical data for BMS-249 and also BMS-288, which is a Probody of a non-fucosylated version of ipilimumab. BMS-249 and BMS-288 demonstrated equivalent inter tumoral pharmacodynamic activity and comparable anti-tumor activity relative to their parental antibodies. These data also showed that the Probody versions are significantly safer than each underlying antibody, demonstrating highest non-severely toxic doses in animal models that were five-fold and three-fold improved, respectively. These data support the strategy of using our Probody technology to expand therapeutic index for CTLA-4 therapy and are strongly consistent with the clinical experience to-date that BMS has reported with BMS-249. The non-fucosylated Probody BMS-288 is also in the clinic in a Phase 1 dose escalation study.
Before I turn over to Carlos for a review of our financials, I'd like to provide brief updates on three earlier stage programs at CytomX that are emerging as a potential second wave of product candidates in our pipeline.
Let me begin with CX-904 our T-Cell Bispecific Probody targeting EGFR and CD3, partnered with Amgen. We believe the application of our Probody technology has the potential to enable solid tumor targeting of this modality. Such targeting with unmasked T-Cell Bispecifics has been very challenging for the field, due to narrow or non-existent therapeutic windows. We continue to advance this candidate toward IND enabling studies and expect to file in late 2021.
Turning to CX-2043, our wholly owned EpCAM targeting Probody drug conjugate. CX-2043 was developed utilizing CytomX Probody technology and ImmunoGen's drug conjugate technology and arose from our previous strategic collaboration. We continue to advance at candidate toward IND enabling studies.
Lastly, as part of the strategic collaboration with Astellas that we announced in the first quarter for which we received an $80 million upfront payment. We have now launched discovery activities surrounding the development and ultimate commercialization of novel T-cell engaging bispecific antibodies in masked form. This is our second alliance in this exciting area of research and we have high hopes for this Probody format.
With that, let me hand the call over to Carlos to review our financial update.
Carlos Campoy -- Senior Vice President and Chief Financial Officer
Thank you, Sean. I would now like to review the financial highlights for the second quarter ending June 2019. Revenue for the quarter was $16.6 million, compared to $9 million in the corresponding period in 2019. The increase is primarily due to a higher percentage of project completion of CX-904, our Amgen EGFR product candidate and also the recognition of revenue related to the $80 million upfront payment received under the Astellas agreement that we entered into in March 2020.
Research and development expenses were $24 million for the quarter, compared to $30.8 million in the corresponding period in 2019. The decrease was largely attributed to one-time licensing fee paid in 2019, and a decrease in clinical trial related activities in 2020. We ended the quarter with cash, cash equivalents and investments totaling $346 million, compared to $296 million as of December 31, 2019. We expect our strong balance sheet to allow us to meet projected operating requirements into the second half of 2022, assuming no new collaborations or financing.
With that, I'll turn the call back to Sean.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Great, thanks, Carlos. So, let me wrap things up here and then we'll go to questions. In summary, CytomX made broad progress across our clinical and preclinical programs during the second quarter, as we further advanced our technology, partnerships and lead drug candidates to several important inflection points. We have continued to show leadership in defining new therapeutic antibody modalities with potential to address significant unmet medical needs in the treatment of cancer.
A mission that remains is important as ever, despite the unprecedented challenges being posed by the COVID-19 pandemic. We've now brought two previously undruggable targets into play in the oncology field with our platform CD166 and CD71, both of which we believe have broad potential in multiple cancer types. And we'll be learning a lot more about these product candidates from our Phase 2 studies that we expect to start to read out in late 2021. We're further extending our undruggable target strategy with the advancement of our Bispecific program targeting CD3 and EGFR and with the drug conjugate targeting EpCAM, these preclinical programs, that's taking great shape as our next INDs.
We have also continued with our cancer immunotherapy strategy, leveraging clinically validated targets. The clinical data for our wholly owned anti-PD-L1 Probody CX-072 has continued to mature, affording us unique opportunities to advance innovative combination therapies starting with the CX-072 plus CX-2009 in triple-negative breast cancer.
Our collaborative work with BMS on CTLA-4 has also provided important proof points for our platform, both clinical and preclinical and we're delighted to see BMS-249 continuing to advance in the randomized Phase 2 melanoma study in combination with nivo. Our broad partnership strategy has also continued to deliver with $130 million of cash proceeds so far this year, including the initiation of a major new alliance with Astellas and the progression of many additional preclinical programs across our collaborations, adding to the strengths and depths of our pipeline.
We continue to enjoy a robust cash position and remain highly focused on making the biggest difference we can for cancer patients as we continue to build our company. Regarding COVID-19, CytomX has continued to execute very well despite the uncertainties and challenges presented by the pandemic. All of us at the company hope that you and your families are well and keeping safe during this time.
And I would like to close by thanking our employees, our patients, our investigators, clinical trials staff and everyone involved in helping us continue to drive forward with our mission of developing new medicines for the treatment of major unmet medical needs in oncology.
With that, I'll hand the call back to Chris. And we'll open up for questions.
Christopher Keenan -- Vice President of Investor Relations and Corporate Communications
Thank you, Sean. Valerie, please open the Q&A session.
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question comes from Peter Lawson of Barclays. Your line is open.
Unidentified Participant
Hey guys, this is [Indecipherable] on for Peter, and thanks for taking the question. Just maybe initially on the expansion study for CX-2009. Just wondering, if you could give us a little bit more color and details on the revised patient enrollment criteria for the study. And also based on your discussions with the FDA, what is the bar you need to hit and what would be considered positive results in both HER2-negative breast cancer, as well as, triple negative. Thank you.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Great, thanks for the questions. So, regarding patient enrollment, the kinds of things that we're looking at obviously are given that the Phase 1 data 2009 was generated in a very heavily pre-treated patient population with a median number of prior treatments of seven or eight depending upon whether it's TNBC or hormone receptor positive. Obviously, we're looking to enroll a substantially less heavily pre-treated patient population in the study, so we've been fine-tuning that in the recent months. Also, given the evolution of the landscape giving a little bit more thought to prior treatment regimens that are allowed in this study in regards to the patient population. So, those are the kinds of things that we're doing in this intervening period.
Regarding the bar for activity, still I want to emphasize this is still a relatively early exploration of 2019 in breast cancer. It is a rapidly evolving field, both in hormone receptor positive and triple-negative. We haven't yet had formal discussions with FDA on these types of matters. But the -- in triple-negative, of course, we're very well aware of the approval now for the -- of cusatuzumab and the activity that we've seen with that molecule in hormone receptor positive where cusatuzumab is also active. So, we're mindful of the need to be competitive in this evolving landscape.
Unidentified Participant
Great. Thank you. And then maybe just a question on BMS-249. Do you have any idea of when we can see the -- the next data readout from that study?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Unfortunately we don't at this stage. They are actively enrolling patients or have been. We can't speak to their timelines unfortunately or to impact that COVID may be having on their enrollment. So, we're just going to have to wait and see how that unfolds.
Unidentified Participant
Great, thank you for taking the questions.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
You're welcome.
Operator
Thank you. Our next question comes from Etzer Darout of Guggenheim Securities. Your line is open.
Etzer Darout -- Guggenheim Securities -- Analyst
The first one for me is a little clarity on the CX-072 combination with CX-2009, if that -- what you said was that you plan to sort of initiate a study there in the second half of this year. And then just a quick question on the Astellas Bispecific collaboration, obviously hematologic malignancies are where we've seen sort of the most success, but it's also kind of more crowded. I wondered, if you could talk about -- a little bit about maybe where you and Astellas plan to sort of concentrate or focus sort of your energy, if you will, in terms of sort of the Bispecific landscape and where you may find indications, I guess, that are more appropriate for the technology. Thanks.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Great. Hi, Etzer. Thanks for the questions. So, yes, we are actively gearing up to start an expansion cohort or a expansion cohorts of 2009 in triple-negative, both as a monotherapy and in combination with 072. I want to reiterate that we have seen single agent activity for both Probodies 072 and 2009 in triple-negative. So, we think this is an exciting experiment to do with the potential for competitive differentiation further down the road. So that study, we aim to get up and running second half.
With regards to Astellas, we haven't guided on the specific focus of the programs there in terms of tumor types. I would just say broadly speaking, that our strategy in using our Probody masking technology on CD3 Bispecifics is from the CytomX point of view is largely directed at solid tumors, where we see the need for substantial improvements because this has been a very tough area to break into for reasons a very, very narrow and compressed therapeutic window with solid tumor target. So, broadly speaking, we've developed the technology to address solid tumors. It certainly could have application in hematologic, I can't speak specifically for Astellas.
Etzer Darout -- Guggenheim Securities -- Analyst
Great. And congrats on the progress.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Great. Thank you very much.
Operator
Thank you. Our next question comes from Terence Flynn of Goldman Sachs. Your line is open.
Terence Flynn -- Goldman Sachs -- Analyst
Hi, thanks for taking the question. I was just wondering on 2029, regarding the Phase 2 program. I know you ran through, it sounds like three different tumor types were focused on there. Can you maybe just give us some insight in terms of how many patients you think would be eligible. If you look at US, EU5 and Japan for treatment here with 2029, just trying to kind of think about the potential market opportunity. Thank you.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Hi, Terence. Great question. So, let me just run through the four expansions again for clarity. So, the squamous head and neck, squamous non-small cell lung, squamous esophageal and then DLBCL. The first two indications, we demonstrated confirmed partial responses in Phase 1 dose escalation. Squamous esophageal, we've shown preclinical activity in xenograft models, similarly DLBCL strong preclinical activity in that indication that's the first hematologic indications, that's one that has arisen through our discussions with our collaborator, AbbVie. They have a strong interest in hematologic malignancies, as you know.
In terms of penetration of the patient population, of the market size in the line of therapy, it's really too early to tell at this stage. We are optimistic based on the Phase 1 data. Of course, that we have a very unique active single agent against a previously undruggable target that has shown in some of the case studies that we presented previously at ASCO, some pretty profound tumor regressions in patients with very late stage, very heavy tumor burden. The therapeutic window is clearly there at 3 mg per kg. We need to do more work to -- work to establish how wide that therapeutic window is, which will dictate ultimately how far forward in lines of therapy, we can bring this exciting drug candidate. So, Terence, we just have a lot more work to do there, but we're excited and we think this program is going to have broad potential.
Terence Flynn -- Goldman Sachs -- Analyst
Okay. Thanks so much.
Operator
Thank you. Our next question comes from Biren Amin of Jefferies. Your line is open. Make sure your phone is not on mute please.
Biren Amin -- Jefferies -- Analyst
Thanks. Yes, hi guys, thanks for taking my questions. So, on CX-2029 for the dose expansion cohort. Have you made any adjustments in this cohort that could lead to lower grade three or higher anemias or neutropenias that you observed in the dose escalation part?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Hi, Biren. Well, I would just say that we're -- a couple of things, on the hematologic side with 2029. The -- as we've discussed previously, these are anticipated adverse events with this payload and to some extent with this target. We are doing more work to understand the etiology of the anemia over time. But in terms of steps that we're taking, they would include treating patients with red blood cell generating growth factors like EPO derivatives and that's really all we can say right now.
But I want to just remind everybody that the Phase 1 experience demonstrated that we were able to manage the anemia with red blood cell transfusions. This is something that oncologists are very used to doing given many decades of experience with chemotherapies. And we're continuing to get a handle on the overall therapeutic window -- we'll continue to get a handle on the therapeutic window at this target and this agent as time goes on.
Biren Amin -- Jefferies -- Analyst
And on the dose expansion, are you enrolling for patients with high CD71 expression?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
We're not -- let me answer the question this way, we don't believe we have enough data yet, either preclinical or clinical to draw any conclusions, regarding the target level versus response. One of the things to consider is that CD71 is such an interesting target, because it cycles so rapidly off the cell surface and then back. Its an unusual target where expression level may or may not ultimately correlate with responses. So, we're not -- we're not drawing -- we're not making too many assumptions about this at this stage and so selection strategies will be developed over time.
Biren Amin -- Jefferies -- Analyst
Great. Thanks for taking my questions.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
You're welcome.
Operator
Thank you. Our next question comes from Mara Goldstein of Mizuho. Your line is open.
Mara Goldstein -- Mizuho Securities -- Analyst
Hey, thanks for taking the questions. So, I had a question on CX-072 and the environment for triple-negative cancers -- triple-negative breast cancer therapies. And if you should decide that, that is not the best indication, given the competitive landscape. Is there a sort of plan B of what you might look -- what comment -- what other trials you might look at. That's first of all.
And second of all, I do have a question on CX-2029, and the decision to focus on squamous tumors rather than non-squamous? And is there something in the biology that we should be aware of?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Hi, Mara. Great questions.
Mara Goldstein -- Mizuho Securities -- Analyst
Thank you.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
So, with regards to CX-072, you know a lot of this is about follow the data, and as our data has continued to emerge and mature over time for CX-072 monotherapy and 2009. The concept of combining the two of these agents, which as I mentioned earlier, both have single agent later at TNBC, combining them in that indication we think makes a lot of sense, in the context of the current competitive landscape, on the assumption that the activity of the two together has the potential to do something interesting, really interesting. So, we'll see -- we'll run this expansion and we'll see what we get. You are right, the landscape is evolving, it's not a huge patient population, but we're really interested to see what this combination can do in TNBC.
The question of -- is squamous tumors and actually, I'm sorry, let me answer the second part of your question on 072, which really relates to the program strategy overall, which is, as I said, we continue to follow the data where we've evolved toward a combination strategy as, you know, rather than driving the monotherapy to registration. That's where the competitive landscape, we see is just way too crowded for us to -- at this point without a partner to invest in driving the monotherapy to registration at least at this stage. We do remain interested in potentially finding a partner for this asset over time and that could help inform future strategy as well.
Regarding squamous tumors in 2029, again, follow the data. The clinical observations are really interesting and the kind of, thing you keep your eyes open for when you run Phase 1 studies. We are intrigued by the activity that we've seen in squamous head and neck and squamous lung. Why might that be it and is it a real signal in terms of that relative to other tumor types? That's why we need to run the expansions. Why might it be the case? Could relate to target. But as we just discussed, we have a very early understanding in target versus response with CD71 we need to learn more there.
Could it relate to the micro-environment? Possible. So, we just need to do more work. But we think it's an intriguing clinical hypothesis and sometimes Phase 1 studies give you these great opportunities to follow the data into Phase 2 and that's exactly what we're doing. So, we'll be learning more.
Mara Goldstein -- Mizuho Securities -- Analyst
Okay. And if I can just also squeeze one more in, and just I know obviously Bristol isn't in charge of the program for 249. But can you just remind us what is maybe the next financial milestone for that program?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
So, for 249 for the ipi Probody it would likely be the initiation of a registrational study. But I'd have to go back and check that.
Mara Goldstein -- Mizuho Securities -- Analyst
Okay. Thank you.
Operator
Thank you. Our next question comes from Mohit Bansal of Citi. Your line is open.
Mohit Bansal -- Citi -- Analyst
Great, thanks for taking my question. So, just wanted to probe a little bit further on the fucosylated Probody approach. If I'm -- so can you please help us understand what fucosylation actually -- what difference does that make to the Probody or antibody. And if I'm not mistaken, it seems like if ipi's non-fucosylated version was also tested in clinic. So, is there any -- anything you have learned from that compound, which could be used in here?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Hi, Mohit. Thanks for the question. So, the concepts -- and this is articulated in the AACR poster that BMS presented a few months back. The concept is that non-fucosylation of ipi increases its ability to deplete Intratumoral Tregs based on the way that interacts with the target and Treg cells in the tumor. So, the basic idea is that increased Intratumoral Treg depletion by the non-fucosylated antibody results in more potent anti-cancer activity, because many believe that Treg depletion is the principal mechanism through, which CTLA-4 blockade works.
Challenge is that the more potent you make ipi and by making the NF version. The more toxic it gets, because it activates immune cells, peripherally more effectively as well in part by -- again by more powerfully down regulating Immunosuppressive Tregs. So, if you look at the AACR poster what it shows, it's actually really beautiful work. It shows that the underlying -- the potency of the underlying antibodies for each -- for ipi and for the NF is maintained with the Probody despite the masks. So, that's consistent with unmasking in the tumor.
From a toxicity standpoint, they demonstrated that the HNSTD, the highest non-severely toxic dose for ipi and for the NF Probody were five and three-fold higher based on the masking that we achieved with the Probody. And in the case of the the non-fucosylated, you can see from the data how much more toxic the NF Probody -- the antibody is and how the Probody protects. So, the basic idea is with the NF Probody is we've got a more active antibody. But it's more toxic we can improve the therapeutic window of NF we can further improve on the 249 ipi Probody. So, it's kind of a next generation ipi Probody, if you like. I hope, that makes sense.
Mohit Bansal -- Citi -- Analyst
No, this is very helpful. And if I may ask one more. It seems like your R&D expense quarter-over-quarter was declined significantly, so maybe question for you Carlos. I mean, how should we think about to the expense, especially in R&D going forward, especially, when you are starting some more trials, and probably the enrollment will speed up now?
Carlos Campoy -- Senior Vice President and Chief Financial Officer
Yes. That makes sense. You noticed it's -- we had a significant number of expenses that happened in Q1 that are one-time, particularly, around licensing fees that were associated with the milestones that we received in Q1. So, Q1 was the aberration not Q2, and you should see it continue at a lower level than what you saw in Q1, but we haven't really guided for the full-year R&D expense line.
Mohit Bansal -- Citi -- Analyst
Very helpful. Thank you very much.
Operator
Thank you. Our next question comes from Joe Catanzaro of Piper Sandler. Your line is open.
Joe Catanzaro -- Piper Sandler -- Analyst
Hey, guys. Thanks so much for taking my question here. Maybe just one quick one, just wondering, if you have any thoughts or whether the recent EpCAM for the BCMA, ADC and ocular tox discussion provides any insight or future plans around CX-2009 whether it's collecting the data. Or just how the FDA thinks about that toxicity in the context of an advanced cancer population?
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Yes. Hi, Joe. Great question. Certainly something that we're looking at and at the time being we have and continue to remain confident that we can manage ocular toxicities with the regimen that have been used previously with DM4 conjugates. But we're certainly going to learn everything we can from those discussions and make any additional modifications or improvements that we may be able to make, but work-in-progress.
Joe Catanzaro -- Piper Sandler -- Analyst
Okay, that's it from me. Thanks for taking my question.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
You're welcome. Thanks.
Operator
Thank you. I'm showing no questions at this time. I'd like to turn the call back to Dr. McCarthy for any closing remarks.
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Great, thank you very much. Once again, I'd like to thank everyone for listening in today, we had a another very strong quarter. And as I said, despite the many challenges presented to all of us by the COVID-19 situation very proud of the team and proud of our progress as we move the pipeline and platform forward. So, I hope everybody stays well, stay safe and we'll forward to talking to you all again soon.
Operator
[Operator Closing Remarks]
Duration: 43 minutes
Call participants:
Christopher Keenan -- Vice President of Investor Relations and Corporate Communications
Sean A. McCarthy -- President, Chief Executive Officer and Chairman
Carlos Campoy -- Senior Vice President and Chief Financial Officer
Unidentified Participant
Etzer Darout -- Guggenheim Securities -- Analyst
Terence Flynn -- Goldman Sachs -- Analyst
Biren Amin -- Jefferies -- Analyst
Mara Goldstein -- Mizuho Securities -- Analyst
Mohit Bansal -- Citi -- Analyst
Joe Catanzaro -- Piper Sandler -- Analyst
