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Operator
Good day and welcome everyone to the ImmunoGen first quarter FY15 financial results conference call. Today's call is being recorded. At this time for opening remarks and introductions, I would like to turn the call over to the Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please, go ahead.
Carol Hausner - Executive Director of IR & Corporate Communications
Thank you. Good morning. At 6:30 AM this morning, we issued a press release that summarizes our financial results for our first quarter ended September 30, 2014. I hope you've all had a chance to review it. If not, it's available on our website.
During today's call, we will make forward-looking statements. Our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which also can be accessed through our website.
In our call today, our Chief Executive Officer, Dan Junius, will provide an update on ImmunoGen. Our Chief Development Officer, Dr. Charlie Morris, will discuss our wholly-owned clinical compounds in greater depth. Our Chief Financial Officer, Dave Johnston, will discuss our financial results and guidance. We'll then open the call to questions after these updates. Dan?
Dan Junius - President & CEO
Thank you, Carol. Good morning, everybody. ADCs continue to be an area of keen interest for drug development, with over 35 agents in development across more than 20 firms for a vast array of cancers.
We are executing our business strategy of using our leadership in ADCs to develop novel therapies that can make a meaningful difference for individuals with cancer. There are already 11 high potential ADCs in the clinic with our technology, three wholly owned by us and eight through our partnerships with Amgen, Roche, Sanofi, and other leading healthcare companies. We expect this number of clinical programs to increase markedly over the next year.
In the few months since our last call, we've made meaningful progress with our wholly-owned programs, each of which has the potential to address sizable medical needs. We are evaluating IMGN853, specifically for the treatment of difficult ovarian and endometrial cancers and expect to have the data needed to make key decisions for this agent in 2015. Updated IMGN529 clinical data is to be reported at ASH in December and dose finding with this promising agent for B-cell malignancies is ongoing. Dose finding with IMGN289 is ongoing as well, with first data reporting expected in 2015. IMGN779 is on track for IND filing in 2015. You'll hear more from Charlie about these in just a moment.
At the same time we're advancing our compounds, our partners continue to be very active. Kadcyla sales now annualize to over $600 million. Last week, Roche reiterated that they expect the readout for MARIANNE this quarter. Roche also reiterated, that assuming favorable results, they expect to apply next year for marketing approval of Kadcyla for first-line treatment of HER2-positive metastatic breast cancer, off the MARIANNE trial and for second-line use in advanced HER2-positive gastric cancer off the GATSBY trial. They also have three trials underway with Kadcyla for different early HER2-positive breast cancer indications.
Sanofi now has four promising compounds in the clinic through their collaboration with us: CD19 targeting SAR3419, in Phase II for diffuse large B-cell lymphoma; CD38 targeting SAR650984, in Phase II for multiple myeloma; SAR566658, in Phase I expansion for CA6-positive solid tumors; and SAR408701, which advanced into the clinic last quarter, for the treatment of CEACAM5-positive solid tumors.
Amgen, Bayer and Biotest continue to make progress with their clinical stage compounds. Two of these are with Amgen and one each with Bayer and Biotest.
Our more recent partners, Lilly, Novartis and CytomX, also continue to make progress. Novartis provided some insight on two of the ADCs they're advancing with our technology during their R&D day this summer. Earlier this month, they took the last three of the six licenses available to them under our collaboration agreement.
I'll now ask Charlie to discuss our promising wholly-owned programs in greater detail. Charlie?
Charlie Morris - EVP & Chief Development Officer
Thanks, Dan. Good morning, everyone. I will start with our most advanced wholly-owned compound, IMGN853, which precision targets folate receptor alpha, an antigen highly expressed on many ovarian and endometrial cancers, as well as on several other types of solid tumor.
As you know, we are pursuing a two-pronged strategy designed to enable us to expeditiously advance 853 deeper into clinical testing by gaining information on the activity of 853 in key cancers, at the same time that we're assessing further optimization of its dosing schedule.
During dose finding with a once every three-week dosing schedule, we saw evidence of activity with 853 in both ovarian cancer and in endometrial cancer, the predominant cancers enrolled in that study. We have shared details on the activity seen with an advisory board of the key opinion leaders. They're impressed with our single agent data and enthusiastic about further development of the product.
We are now assessing 853 specifically for the treatment of platinum-resistant ovarian cancer and relapsed or refractory endometrial cancer, with it administered once every three weeks at its recommended Phase II dose.
We're pleased with the dose established, comfortably above the dose at which activity was first seen, but below the level associated with dose limiting side effects. Enrollment in both of these cohorts is progressing well.
These patients are also being pre-screened for targeted expression prior to enrollment in this part of the trial. As you recall, during the dose finding phase in which patients weren't pre-screened, 853 demonstrated activity in patients whose tumors highly expressed its target, consistent with expectations based on the mechanism of action.
The information we gained about the activity of 853 in these two cancer types will help us refine its clinical program such as to cancers to be targeted and likely trial size necessary for appropriate statistical powering for further studies.
The second aspect of the testing underway is to ensure we take 853 forward with the best dosing schedule. Recall our research conducted earlier this year indicated that dosing 853 more frequently than once every three weeks may provide patients with greater exposure to the therapy, while keeping post-dosing levels in the blood below the threshold associated with side effects.
That research suggested the best schedule for 853 may be weekly dosing for three weeks, followed by a skip week before receiving weekly dosing. We've been assessing escalating doses of 853 using this modified weekly schedule. We are pleased to report that our findings to date are consistent with our expectations based on our modeling. We expect to establish the maximum tolerated dose of this schedule in the next few months.
We intend to report findings that we have from these assessments as a package in 2015, targeting ASCO. In the interim, we plan to provide program updates, including decisions made about the dosing schedule.
I'll turn now to our IMGN529 agent for B-cell malignancies. This CD37-targeting ADC is currently in the dose finding portion of a Phase I trial, assessing it as single agent in patients with non-Hodgkin lymphoma. The first data from this trial were presented at ASCO in June and show we'd already seen evidence of activity with 529 in doses as low as 0.2 and 0.4 milligram per kilogram administered once every three weeks. We believe part or all of the activity seen at those low doses could be from the antibody part of 529, which is highly active. The steps taken to address side effects seen at low doses have enabled dose escalation to continue. We're excited to be reporting updated findings at the ASH meeting in December.
Once we've established its recommended Phase II dose, we intend to begin evaluating 529 in disease-specific patient populations.
Dose finding also is ongoing with IMGN289, our EGFR-targeting ADC. We've been studying it administered weekly, but don't want to rule out examining of the schedules as appropriate as we have for our other agents. Once we establish its recommended Phase II dose, we plan to assess 289 specifically for the treatment of cancers at the high expresses of EGFR and which have limited treatment options today.
Such cancers include squamous cell head and neck cancers, squamous and non-squamous cell lung cancers and many breast, gastric and other GI tumors. We are targeting reporting initial findings with this compound at the medical conference in 2015.
Lastly, our IMGN779 compound for acute myeloid leukemia remains on track for IND filing in the second half of 2015. It is the first ADC with one of our new DNA-acting payload agents, which we refer to as IGNs and has an exciting profile pre-clinically. We'll be presenting additional pre-clinical data for 779 at ASH as well. With that, I will turn the call over to Dave to discuss the financials.
Dave Johnston - EVP & CFO
Thanks, Charlie. As Carol noted, we issued a press release this morning with our fiscal -- with our first quarter of the FY15 financial results. I'll discuss the highlights. Then I will review our guidance for FY15.
For the quarter ended September 30, 2014, we reported a net loss of $22.3 million or $0.26 per share, compared to a net loss of $11.2 million or $0.13 per share for the same quarter of last year. Revenues in our first quarter of FY15 were $13.2 million, as compared to $17.2 million for the same quarter of last year, reflecting that our non-cash revenue from amortization of upfront license fees was lower in the current period than in the prior year period, $1.8 million versus $7.8 million respectively.
As we've said previously, such revenue tends to be lumpy. For example, we reported earlier this month that Novartis took the remaining three licenses under the agreement with them, which will trigger, recognizing $22.7 million of amortization revenue in the second quarter of FY15. Our cash revenues were greater in aggregate for the first quarter of this year compared with last year and include $4.2 million in royalties earned on sales of Kadcyla, compared to $2.1 million in the same period last year. As a reminder, we receive and recognize royalties on Kadcyla sales one quarter in arrears.
Operating expenses for our first quarter of FY15 were $35.1 million, compared with $28.6 million in the first quarter of last year. These consisted of $28 million of R&D expense in the first quarter of this year, compared to $22 million in the same period last year. $7.1 million in G&A expense this year, compared to $6.5 million in the same quarter of last year.
We ended the quarter with $121.8 million of cash and marketable securities, compared with $142.3 million as of June 30, 2014. We continue to have no debt.
Cash used on operations was $18.9 million in the first three months of FY15, down from $23.6 million in the same period last year. Capital expenditures were $1.7 million in the first quarter compared with $600,000 in the same period of last year.
Our FY15 guidance remains unchanged from what we issued on August 2, 2014. Specifically, revenues are expected to be between $100 million and $105 million, operating expenses to be between $160 million and $165 million, net loss to be between $60 million and $65 million, cash used in operations between $55 million and $60 million, and capital expenditures to total between $7 million and $9 million.
Lastly, we expect to end the fiscal year with between $75 million and $85 million in cash. We believe our current financial resources, combined with expected cash inflows from partners, are enough to fund us through the establishment of proof of concept for our lead programs and that a development of our own portfolio of important new therapies will result in the greatest creation of value for our shareholders. With that, let me turn the call back over to Dan.
Dan Junius - President & CEO
Thanks, Dave. We expect quite a bit of activity with both our wholly-owned programs, as well as our partner programs over the coming quarter. We will provide you updates on those. Let me review, what we expect to see happening across both of those categories.
I'll start with the wholly-owned compounds. IMGN529 investigators will be reporting updated clinical data on this novel ADC for B-cell malignancies at ASH in December, which should provide insight into our excitement about this compound.
There also will be new pre-clinical data reported on 529 at ASH. We expect the recommended Phase II dose to be established for 529 in the coming months and for it to begin disease-specific testing in 2015.
For IMGN853, our folate receptor alpha-targeting ADC, we expect to establish the recommended Phase II dose, with a modified weekly schedule over the next few months.
We'll also have findings from evaluating IMGN853 every three weeks, specifically for the treatment of platinum-resistant ovarian cancer and relapsed refractory endometrial cancer.
We plan to select the best dose among those -- between those two and schedule to take forward -- take that forward into more advanced testing and potentially could have this information by ASCO. Our plan is to report the findings we have from these evaluations at a medical conference in 2015. Right now, we're targeting ASCO.
For IMGN289, our novel EGFR-targeting ADC, we expect dose finding to continue, with a possible exploration of alternative schedules and to report findings in 2015, either at ASCO or at our medical conference later in the year. Once we establish its recommended Phase II dose, we plan to move 289 into disease-specific testing. We would expect this to start during 2015.
For IMGN779, our CD33-targeting ADC, for acute myeloid leukemia, we'll report additional pre-clinical data for this novel compound at ASH. We're on track to submit its IND in the second half of next year.
Let me make a couple more comments around our partner compounds. First of all, we would expect to see several presentations on partner compounds in December at ASH. For Kadcyla, Roche continues to project reporting the readout for MARIANNE before year-end, with a full dataset to be presented at a later date. With positive data, Roche is projecting filing for marketing approval of Kadcyla for first-line treatment of HER2-positive metastatic breast cancer in 2015 off of the MARIANNE results. Our understanding that this could be Kadcyla alone, Kadcyla plus PERJETA, or both depending on the study findings.
Roche is also projecting filing for marketing approval of Kadcyla for second-line treatment of advanced HER2-positive gastric cancer in 2015, using the GATSBY results, again, assuming positive data. We would expect presentation of both MARIANNE and the GATSBY data in 2015; although, that's not -- that's our estimate. It's not something that's been confirmed by Roche. Roche has projected having the first data from its KRISTINE neo-adjuvant trial in late 2015.
As noted earlier, we expect multiple compounds to advance into the clinic through our partnerships over the course of 2015, as well as our own IMGN779 ADC. We expect several partner compounds to advance further in clinical testing, as well as multiple data presentations on partnered compounds.
So all in all, we expect the coming quarters to be very active for ImmunoGen. With that, let me turn it back to Carol. We'll be opening the call for the question-and-answer period.
Carol Hausner - Executive Director of IR & Corporate Communications
Thanks, Dan. We're about to open the call to questions. We'd like to ask each person to limit their questions to one or two per person until everyone has had a chance to ask their questions. You can then get back into the queue. Operator, we are now ready to open the line for questions.
Operator
(Operator Instructions)
Adnan Butt, RBC Capital Markets.
Adnan Butt - Analyst
Two questions, first, for Dave, perhaps. Dave, reaching 2015 guidance requires a big step-up. Do you have more visibility into certain partnerships versus others could be generating revenue? Can you share that with us?
Then a second question on 529 specifically, is this data at ASH focused more on safety? Or is it for both activity and safety data? Maybe, could you repeat where it's being dosed at this time? If the population -- if the expansion cohorts aren't being selected at this time, until sometime in 2015, is it because you are seeing good tolerability? Thanks.
Dave Johnston - EVP & CFO
Sure. Hi, Adnan. I actually missed the first part of your question. I'm assuming that you're asking about the revenues part of our guidance. Is that correct?
Adnan Butt - Analyst
Correct. Thanks.
Dave Johnston - EVP & CFO
Yes. So, what we do when we're establishing guidance is we go through the expected activity of all of our partners. We do have some insight into what the expectations are. We obviously, handicap that some. But what we haven't done and I don't think we're going to do today is walk through partner by partner the activities that we expect to have. But it's a fairly well thought-out process. As of this point, we are confident that it reflects what we should expect in terms of 2015 revenues.
Dan Junius - President & CEO
Maybe just to provide a little bit more color, Adnan. Note that within the -- in Dave's comments, he pointed to, for example, Novartis. Where in the December quarter, we would recognize the revenue -- the deferred revenue associated with the licenses that they took in early October. So there are discrete events like that, that have revenue -- have characteristics where it's going to be somewhat lumpy. It's coming from multiple sources, in some cases deferred revenue.
Certainly, we expect -- as you noted, my comment about more partnered compounds coming into the clinic moving further into the clinic. All of those would be milestone-related events. Again, we have some degree of visibility into that. That's what underlies the revenue forecast.
Charlie Morris - EVP & Chief Development Officer
So in terms of 529, what we will present at ASH will be updates on the information that we currently have from dose escalation. We are still in that dose escalation phase. But based on available information and we know about the rest of our pipeline, we believe that we will likely be in a position to move into the sort of expansion efficacy testing during 2015. So I think what you should expect is an update on the safety, efficacy, pharmacokinetics, all available information from the dose escalation phase.
Adnan Butt - Analyst
Thanks.
Operator
Matthew Harrison, Morgan Stanley.
Matthew Harrison - Analyst
So first one on 529, just want to confirm in your remarks and the answer to the last question. Does that specifically mean you haven't reached the MTD yet with 529?
Then separately on 853, in terms of where you are with the dosing schedule -- so you've started on the weekly schedule. Exactly when do expect to have completed data that you'll be able to share with us when you choose which schedule and which dose you're going to go forward with? Thanks.
Charlie Morris - EVP & Chief Development Officer
For 529, I think it's safe to say that we have not yet established a maximum tolerated dose. Though, that's obviously in dose escalation as a moving target -- rapidly moving target on occasion.
But for 853, what we would anticipate is that -- we are pleased with the progress that we've made in escalating with the weekly schedule. We believe that we are doing the right thing here, which is continuing to add patients into the expansion efficacy cohorts on the three weekly.
We imagine that around about the middle of 2015, we would anticipate having information both from the dose cohorts at three weekly, as well as having enough information from the dose escalation of the weekly, that we would be in a position to at the very least get some further information on that weekly and hopefully able to make the decision between which of those will be going to the next stage.
But I think the basic message is that we're pleased with the progress on all fronts here. We're pleased with the three weekly, but we are seeing what we -- the weekly has been an interesting step as well. We're learning more from it. I think overall, we're putting ourselves in a good position to being able to make the best decisions during 2015.
Operator
Andrew Peters, UBS.
Andrew Peters - Analyst
Congrats on the progress. A couple, first on 779. As you kind of look ahead to filing the IND, I was just curious. When you look at the history of CD33-targeting agent in AML, what have you learned in terms of -- maybe a potential benefit in certain patient populations, as well as kind of your own experience with the previous Sanofi/Aventis, CD33 in terms of kind of targeting that area. So just a broad question there.
Secondly, on 529, as you start the disease-specific patient populations later next year, to what extent does the competitive landscape play a role in kind of defining which populations you plan to target? Or is that going to be purely data-driven?
Carol Hausner - Executive Director of IR & Corporate Communications
Charlie?
Charlie Morris - EVP & Chief Development Officer
So CD33 -- I think one of the interesting things as we go out and talk to the opinion leaders is that clearly Mylotarg had a complex history. But I think a lot of the investigators you find now feel that they finally understood how to use the product around about the time that it was taken away from them. There is actually quite an interest in this as a target.
Obviously, we try to learn. We try to understand what some of the pitfalls were, particularly around the toxicity issues. We believe that the design of the payload will have some advantages in terms of the potential for lower risk of some of the long-term effects.
I think we also -- what we know from the prior experience with a maytansinoid based targeting of this one. First of all, we have a good sense of the pharmacokinetics of the antibody, which gets off to a good start. Perhaps at one of the other learnings, of course, was that we did see some degree of activity in there. But the activity that we saw was in patients with particularly high levels of CD33 expression.
So I think now using a more potent payload, the level of expression is likely to be key. So with a more potent payload the extra -- we should be able to have benefit in patients with the lower target expression. I think we're using a different mechanism of action than we used in maytansinoid because we're now targeting DNA rather than targeting the microtubules. I think we all know that the expression of CD33 on normal tissue is relatively low.
So I think there's a real opportunity here. I think there's a good opportunity, first of all, to learn a lot about our IGN platform. But I think there's reasons to be positively optimistic that this is actually a good target with a well defined population in acute myeloid leukemia.
From 529, I think we have to be impacted by the competitive landscape. But we also have to be impacted by the data that we see as we emerge. We've -- we'll update on what activity we've seen at ASH. I think that may influence some of our thinking.
I'll remind you that of the interesting single agent data for example for SAR3419, Sanofi, in diffuse large B-cell lymphoma, which would suggest that our platform may have a role in DLBC, an aggressive lymphoma, which despite all of the new agents coming in remains an area, I would argue, of high unmet need. So I think we will be impacted by our data. But we're not going to just sort of -- we've got to be aware of idelalisib, ibrutinib and where others are working and trying to understand what the new opportunities are, which are created by those new agents coming in.
Andrew Peters - Analyst
Great. Thanks.
Operator
Jason Kantor, Credit Suisse.
Jason Kantor - Analyst
I'm just wondering a couple of things. Just looking at your forecasted year-end cash. It looks like you'll be needing to get more cash if you're going to move these things forward. So I'm just wondering with your stock where it is, if you've thoughts around partnering your proprietary drugs? Where your head is on that? Whether or not that's something we might also look forward to in the coming year?
Then if you could give us any kind of update on your thinking around ocular toxicity? Whether or not, that's something that you've gained a better understanding of in terms of managing it and the causes of it, et cetera. Thank you.
Carol Hausner - Executive Director of IR & Corporate Communications
Dave, do you want to take the cash one?
Dave Johnston - EVP & CFO
Sure. Hi, Jason. Yes. So we're in a pretty good cash position. We anticipate ending the year in a pretty strong position.
But you're right, the more success we have with our products -- with our own proprietary products clinically, the more demand that there's going to be to advance them. As you understand, that's an expensive business.
So you're also right. With our current stock price, we would not be eager to be issuing new equity at these prices.
But we do have several other options available including one that you mentioned, which is potentially doing a partnership probably on a geographic basis at some point in the future on some of our internal products. But there's other options as well that are open to us. So in terms of having cash available, what I always tell the guys here is you guys advance the products and we will find the cash.
Charlie Morris - EVP & Chief Development Officer
From, clearly, the agent where we're experiencing some of the ocular adverse effects that have been seen both with our own and other platforms with 853, I think we are -- well, I know we are pleased with the progress that we've made. Particularly, I think the dose adjustment works made a big difference here. We, as you know -- we changed the dosing calculation to based on adjusted ideal bodyweight. We've been doing the work on the weekly schedule.
We are pleased with the progress and obviously, as we get toward ASCO we'll be able to give a full update on that as we go through. But I think those have been the key activities. We continue to try to understand whether there are other interventions that may help, but I don't think we're in a position to make any sort of concrete statements about successful or otherwise there. But I think the dosing work has clearly made an important difference there. It's enabled us to be -- I think very optimistic about where we are with 853, right now.
Jason Kantor - Analyst
In terms of the dosing, you're looking at the weekly dose versus the every three week dose. Would you -- you're going to have the dose escalation around the same time you have the cohort -- expansion cohort data for the every three weeks. Would you have enough information to move directly to an advanced study with weekly, if that's the way you wanted to go? Or would you have to run an expansion cohort part for the weekly dosing?
Dan Junius - President & CEO
The slightly unhelpful answer I guess there is, it depends. I think if we saw encouraging data during dose escalation, we would -- we may be prepared to go straight to a more advanced study.
The other option would be to do -- to conduct expansion cohorts using that weekly schedule. But all of that obviously would be to try to confirm what we believe was the important findings in dose escalation.
So I don't think we're in a position today to make that call one way or the other. But I certainly wouldn't rule out being able to move to quite rapidly to more advanced studies if we like what we see in dose escalation.
Jason Kantor - Analyst
Thank you.
Operator
Brian Klein, Stifel.
Brian Klein - Analyst
First on 529, just wondering if now might be the right time to start thinking about combination studies with some of the approved agents and maybe other immuno-oncology agents that are being investigated?
Then my second question is on 853, if you could just comment beyond the ocular toxicity. If you're seeing any other major toxicities arising in the three-weekly dose versus the weekly dose. Thanks.
Charlie Morris - EVP & Chief Development Officer
So 529 combinations are, yes, it is the time to start thinking about that. We are doing an extensive panel of pre-clinical work to really try to get the best insights into what would be the right combinations there and I think that will be an important part of future development.
In terms of immuno-oncology, I think broadly speaking whether it's 529, 853, 289 or anything else, that's certainly something that we are keeping a very close eye on. I think as we get closer to understanding our own profile and our own safety profile or an efficacy profile, that will be another possibility if not probability for seeking opportunities for combination work. For 853 I'm completely blanking on what the question was.
Brian Klein - Analyst
The question, are we seeing any other toxicities.
Charlie Morris - EVP & Chief Development Officer
All right. Obviously, we'll discuss full information at -- when we next present data, but at this point, I wouldn't -- I don't have any new concern at this particular time.
Dan Junius - President & CEO
Yes. Brian, it's Dan. I would point to the data that we disclosed as we were talking about 853 on the every three-weeks. That the DLT was ocular which caused us to look back. So there wasn't any -- there were no other major issues that we were seeing from a toxicity standpoint. The reason we adjusted dosing was to deal with the DLT so I think I'd leave it at that for now.
Brian Klein - Analyst
Great. Thank you.
Operator
John Newman, Canaccord.
John Newman - Analyst
I had a couple. So the -- I think it was the $29 million you mentioned from Novartis in terms of amortization revenue. I just want to confirm that would all be recognized in the fourth quarter.
Then I wondered if you could give us a sense as to whether or not there's going to be a milestone payment associated with submission of the sBLA for Roche, assuming MARIANNE is successful.
Then finally, just wondered if you had any thoughts on Roche's comments on their recent quarterly call regarding their expectations for the MARIANNE study. Thanks.
Dave Johnston - EVP & CFO
Hi, John. This is Dave. I'll start with the Novartis question on terms of the amortization of the revenue. I think what we said is it'll trigger about $22.7 million of amortization. Yes. That would all hit in what would be our second fiscal quarter of 2015, which would be the calendar year fourth quarter. Yes. Then the other question was on -- is there a milestone associated --
Dan Junius - President & CEO
You should not. We've disclosed incremental milestones. The filing of an sBLA for first-line metastatic would not trigger a milestone.
Your question around the Roche comments for MARIANNE. I think the major caveat, I think, we ought to pay attention to is that Roche -- any comments they made were qualified by, well, it all depends on what the data says.
But I think that they continue to emphasize an important role for Kadcyla in their HER2 franchise, looking at it as an avenue to pursue for first-line metastatic as well as earlier HER2-positive breast cancer. But they covered a pretty wide range as they made those comments. But I think that what they tried to do -- what I heard them trying to do is to make sure investors waited until the data was available to be able to provide a more detailed discussion around where Kadcyla will fit in the treatment paradigm.
John Newman - Analyst
Right. Okay. Great. Thank you.
Operator
Chris Marai, Oppenheimer & Co.
Chris Marai - Analyst
First question really regarding 853. I'm wondering in the early data, if you've seen any differential activity in patients who are higher expressed to that receptor? Then secondarily, with respect to any Phase II trials, will you be stratifying by receptor expression? Thanks.
Charlie Morris - EVP & Chief Development Officer
Certainly obviously, in dose escalation, you've got relatively small numbers. So it's hard to be -- difficult to be absolute about this, but as we've presented previously, the activity that we've seen whether -- both in terms of objective responses, CA125 responses, and long-term stable diseases they certainly seem to be most of the patients having that had the higher expressions of the receptor. As we go forward, we certainly anticipate selecting patients according to their folate receptor expression.
I think it's an important part of patient selection. I think if you're going to call it a precision agent, you need to be precise about who you're going to treat. I think all of the science and the logic would say that we should be selecting for higher expression. That is the plan. Even in the expansion cohorts that we are now conducting, we are selecting patients according to their folate receptor expression both for ovarian and for endometrial carcinomas.
Chris Marai - Analyst
Okay. Great. Well, thanks. Congratulations on the quarter.
Charlie Morris - EVP & Chief Development Officer
Thanks, Chris.
Operator
Maury Raycroft, Guggenheim Securities.
Maury Raycroft - Analyst
Just to follow up on Brian's question earlier, for the combo studies with 529, can you provide any more clarity on that? So, what type of regimens --
Charlie Morris - EVP & Chief Development Officer
(laughter) Probably not.
Maury Raycroft - Analyst
Okay.
Charlie Morris - EVP & Chief Development Officer
(laughter) There's a whole bunch of new agents out there that we need to be thinking about and a whole bunch of older agents that we need to be thinking about testing with. We have a significant screen ongoing. I think we have -- clearly we have to be aware of a broad class of agents. BTK inhibitors, PIC kinase inhibitors, other B-cell receptor signaling mechanisms, as well as what now seems like the old school treatments of monoclonal antibodies against CD20.
So all of these things need to be under consideration. All of these things are in play. We will -- with so many choices we need to -- get pre-clinical data to -- which helps us prioritize which would be the right way to go. That's what we are -- that's what we're working on doing right now.
Maury Raycroft - Analyst
Okay. Thank you.
Operator
Thank you. With no further questions, I'd like to turn the conference back over for any additional or closing remarks.
Carol Hausner - Executive Director of IR & Corporate Communications
Thank you. I'd like to thank everyone for your interest in ImmunoGen and if you have any subsequent questions, please do not hesitate to call. Have a great day.
Operator
That does conclude today's conference. Thank you for your participation.