ImmunoGen Inc (IMGN) 2011 Q2 法說會逐字稿

Good day, and welcome, everyone, to this ImmunoGen second quarter fiscal year 2011 financial results conference call. Today's call is being recorded.

At this time for opening remarks and introductions, I would like turn the call over to the Executive Director Investor Relations and Corporation Communications, Carol Hausner. Please go ahead.

Thank you. At 4 o'clock this afternoon we issued a press release that summarizes our financial results for the quarter ended December 31, 2010, which is the second quarter of our 2011 fiscal year. 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 the projections made. 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, and our Chief Financial Officer, Greg Perry, will discuss our financial results and guidance. We will then open the call to questions. Dan?

Thanks, Carol, and good afternoon, everybody, thank you for joining us. We came out of 2010 having made, I think, considerable progress, which we would expect to continue across multiple programs in the current calendar year, 2011. That would include continued advancement of T-DM1, and we would look to see data coming out across multiple presentations over the course of the year, as well as further progress in the two Phase III trials that are underway.

We'd also look for other TAP compounds to attract attention, which would include the most advanced clinical compounds, SAR3419 and IMGN901, as well as our lead pre-clinical compounds, which we designated IMGN529 and IMGN853. Beyond the clinical and pre-clinical compounds, we would look for three additional partner compounds to have their INDs filed over the course of 2011.

While there are other clinical-stage compounds, both ours and partner's that are promising, I want to focus today on the three most advanced clinical programs, along with the two lead pre-clinical programs that I just noted. Let me start with T-DM1 and review what's come out since our last quarterly call in October.

First, Roche has reiterated an expected filing in the US and in Europe in 2012 off of their EMILIA Phase III trial, which is evaluating T-DM1 versus the combination of TYKERB plus Xeloda in patients previously treated with Herceptin plus a taxane for HER2 positive metastatic breast cancer.

They've indicated they intend to file with progression-free survival data, and that would qualify for accelerated approval in the US, and then for full approval in Europe, as Europe will accept PFS as an end point for approval. They've further indicated that they'll have overall survival data a year-and-a-half later, and at that time in the US they would look to convert an accelerated approval to a full approval.

We also look for data, or at least for continuation of the study of the MARIANNE Phase III trial. This is looking at T-DM1 in first line HER2 positive metastatic breast cancer. Here, data is expected in 2014, with a filing in 2015 in the US and in Europe. Beyond those two registration studies, they have an Adjuvant Phase II trial that's underway, and we expect a presentation of new data across a number of studies on an ongoing basis.

Since the last call, there have been a number of presentations, many of them coming out at San Antonio Breast Cancer Symposium in December. These included pre-clinical data across a number of studies, as well as PK for several combination regimens. Of particular note, there was data for T-DM1 plus Pertuzumab in first-line HER2 positive metastatic breast cancer. This being a Phase II study, where they noted a 57% objective response rate. This was a relatively small study, but impressive response rate data.

There also was data that came out last fall on a Phase II assessment of T-DM1 used alone in a randomized study against Herceptin plus a taxane for first-line treatment of HER2 positive metastatic breast cancer. This was reported at ESMO, it's interim data, in a relatively small study with early data, so it has some -- we need to look for later data to get a better fix.

But across this study, with the preliminary data there was very impressive efficacy as well as very good tolerability. The indication from Roche is that we would expect to see updated data here in the third quarter of 2011. This would include progression-free survival that was not available with the early data reported at ESMO.

The next partnered compound that we think we'll see increased attention over the course of the year is SAR3419. Sanofi-Aventis has indicated that there will be a number of steps taking place with this compound that should give us increased visibility over 2011, and that would include data coming out in June at ASCO. And it would be data off of a -- their second Phase I study that looks at this compound in weekly dosing.

They also will have data at the Lugano Lymphoma Symposium in July. They have indicated that they expect to begin Phase II testing of 3419 in the second half of this year, with trials in combination expected to start earlier in the year.

Recall this is a compound created by ImmunoGen scientists. We selected the CD19 target. We developed the antibody. This compound uses our linker and our payload. It went to Sanofi in the broader research collaboration that was established back in 2003, and it targets non-Hodgkin's lymphoma, a market dominated today by Rituxan.

The final clinical compound I'll talk about is our own IMGN901. This is our most advanced proprietary compound, which we expect to see becoming more prominent over the course of the year. It's currently being evaluated in four types of CD56 positive cancer. That would be small-cell lung cancer, Merkel cell carcinoma, multiple myeloma, and ovarian cancer, and we'll see progress over the course of the year in each.

Let me start with small-cell lung cancer, where we initiated a Phase I/II trial in November for first-line therapy. This is being studied in combination with etoposide and carboplatin, which is the standard first-line therapy for small cell. The rationale here is that based on the tolerability and the activity that we saw with IMG901 in monotherapy would make it conducive to a combination therapy, plus, that's supplemented by very impressive pre-clinical data looking at this particular combination.

The design of the study that's underway is that we have a Phase I that will establish the dose. We are currently enrolling patients with any solid tumor that would treat with etoposide and carboplatin in first-line. It's not limited to small-cell patients or for that matter to first-line patients. We want to get to the safe dose and therefore, we have broader inclusion criteria during this Phase I leg. Once we establish the Phase II dose, we will then randomize, and we will limit patients to small cell only, and in small-cell patients who have had no prior therapy.

We don't need to pre-screen for CD56, since small-cell patients all express the target, but the randomization will include a two-for-one with 60 patients going to the etoposide-carbo IMGN901 arm, and then 30 patients going to the control arm of etoposide plus carboplatin. These patients will receive up to eight cycles of therapy, and then patients getting the IMGN901 in that particular arm, if they show benefit, they will have the option to continue on IMGN901 alone as maintenance therapy.

The primary endpoint here is progression-free survival. The PFS for the control arm, etoposide-carbo, the median there is about five months, so that's sort of the target that we're looking at. The expectation is that we will be able to start the Phase II leg sometime in the second half of 2011, and we plan to report clinical findings sometime in the back half of this year.

The second indication for 901 I want to talk about is Merkel cell carcinoma, because that has a relationship to what we're doing in small cell. We have seen encouraging findings here with monotherapy. We reported at ESMO, across 13 patients, that we had two complete responses that are ongoing, and three patients with clinically relevant stable disease, which gives us a clinical benefit rate of almost 40%. We're looking at a pivotal trial here.

It's a pivotal trial because of the size of the indication that would be relative. We want it to be small in scale. We wanted something that could be conducted in a reasonable period of time. At the same time, we wanted to do everything we can to ensure that we get unequivocal results.

We believe that's best achieved by assessing IMGN901 in metastatic Merkel-cell as first-line therapy, and in combination with etoposide plus carboplatin. The rationale for this particular combination is, while there's no approved therapy for metastatic Merkel cell, it's treated today with etoposide plus carboplatin since it shares many biologic characteristics with small-cell lung cancer.

The plan here is to establish the MTD of IMGN901 in this triple combination using our small cell combination study. Once we have the MTD, it will give us the capability to finalize the protocol for a pivotal study in metastatic Merkel cell. And that will be done in conjunction with discussions with regulators both here and in Europe. And all of this then would allow us to potentially start a study sometime around the middle of 2012.

Now, for multiple myeloma, we have trials underway both in monotherapy and in combination. The monotherapy studies were most recently reported at ASH, and they included additional objective responses. We've seen six total objective responses in the monotherapy study. Of the 37 patients we've dosed in this study, 15 had durable clinical benefit, 9 of them were treated for at least 20 weeks, with 2 receiving IMGN901 for more than a year. We think we have the data we need now in terms of monotherapy activity in multiple myeloma, and so this trial is now wrapping up.

What is also in place at the same time, however, is a combination study looking at IMGN901 in combination with Revlimid and dexamethasone. We reported initial data on this study at ASH from the first of two cohorts. They were dosed with this triple combination and the IMGN901 element being a 75 mg/m2 as well as a 90 mg/m2.

Out of those first 7 patients, 6 of them showed evidence of activity, and this included 5 objective responses. All 5 of the objective responses had received prior thalidomide or lenalidomide. We have not yet defined the MTD in this particular study, although we do intend to submit an abstract with updated findings for potential presentation at ASCO this year.

We have recently received orphan drug destination in the US for multiple myeloma. We also have a favorable opinion from EMA in Europe, which is a step on the path to orphan drug designation. Recall, we already have orphan drug designation for small-cell as well as for Merkel cell carcinoma.

And finally, ovarian cancer. We're starting to gain experience here in the OO2 monotherapy study with ovarian patients. This will help inform us as to what the next steps should be for this particular indication. We are planning to submit an abstract on ovarian for ASCO for this year.

Beyond the clinical compounds, we also have been working to expand our pipeline working in the pre-clinical area of repopulating that pipeline, post the Sanofi-Aventis research collaboration. Our plan was to target an IND every 18 months. The pace of productivity should allow us to exceed that. As we're looking at compounds, we have benefit of the knowledge that we've gained over the last several years from both our own compounds, the work that we've done in collaboration with partners, as well as the clinical data that's been coming out around our technology.

At the same time, we have the benefit of the new tools that we've developed from investment in our technology platform; most particularly some of the additional linkers that we've developed that bring different attributes to a compound. What that has led to is IMGN529 and IMGN853, which are our lead pre-clinical compounds. The former, IMGN529, a TAP compound, targets hematologic malignancies. The expectation here is that we'll have an IND in place around the middle of this year.

With IMGN853, this also is a TAP compound that targets Folate Receptor 1, whose principal indication is ovarian cancer. This is following pretty closely with 529. The expectation is that we'll have an IND filing in place in early 2012. For both of these compounds, we expect to have data at AACR, which will disclose more detail around the compounds.

With that, let me pass it to Greg to take you through the financials for our second quarter.

Thanks, Dan. Our financials reflect the strength of our business model, which, as Dan noted, is to aggressively develop our own compounds to value-inflection points, and use business development to generate non-dilutive cash to help fund our proprietary pipeline.

Our net loss for the second quarter of our 2011 fiscal year was $14.2 million, or $0.21 per share. Revenues were $4.2 million compared to $3.1 million in the same quarter last year, with the difference due principally to increased revenue from research and development support, and from clinical materials reimbursement. Expenses were $19.7 million, which compare with $16.1 million in the same period last year. And this increase in expenses is principally due to our increased investment in our proprietary programs.

Included in our second quarter 2011 fiscal year as other income is $1.2 million in federal grant funding that we were awarded under the Patient Protection and Affordable Care Act of 2010. This grant funding was available for innovative product programs assessed to be able to significantly improve patient treatment, and potentially reduce healthcare costs. Five of our product programs were selected for these awards.

Our guidance for our full 2011 fiscal year is unchanged from our last quarterly call. We project that our net loss will be between $60 million and $64 million. And while we're increasing the financial commitment to our own compounds, we project our cash use in operations in our 2011 fiscal year will be less than $4 million, primarily because of the $45 million we received from Novartis in October. That up-front payment essentially added another year to our cash runway.

We expect to end our fiscal year on June 30, 2011, with between $106 million and $110 million in cash and marketable securities, which we believe is sufficient cash to fund our operations into 2013, based on our expense projections and anticipated cash inflow from existing partnerships. We expect that business development will continue to extend our runway, as we bridge to the potential sustained cash inflow from royalties on T-DM1 product sales.

We're seeing heightened interest in the ADC space, and we intend to continue to establish partnerships on a selective basis. Our agreement with Novartis established a new benchmark for ADC technology licenses. For the first time, we're having discussions with potential partners about certain pre-clinical product candidates. Our proven technology, product partnerships, and financial strength, position us well as we aggressively advance our own compounds. Dan?

Thanks Greg. I'd like to reiterate, we do come out of this quarter in a very strong financial position, probably the strongest that we've seen in several years. And it is in very large fashion due to the interest that we're seeing in the space that's led to some business development opportunities; one in particular with Novartis, that as Greg referenced, that has certainly bolstered our financial position.

But beyond that, we are very proud of the position that we're in given our strong and advancing pipeline. We potentially will have 14 clinical compounds by mid-2012, actually by --- yes, by mid-2012; four of them ours and 10 of them through partners. And at the same time, we expect to see several compounds entering Phase II over the course of 2011. All of this leads to a large number of events. Let me just highlight a few of them for you that we see taking place over the course of 2011.

For IMGN901, we think there will be clinical data coming out in both the second and fourth quarters of this year. Our other clinical compound, IMGN388, we would look to have clinical data in the fourth quarter. This would be around a more frequent dosing schedule that we are now pursuing for that particular compound.

IMGN529, we look to have pre-clinical data in the second quarter of this year, with an IND filing around the middle of 2011. For IMGN853, we will have pre-clinical data in the second quarter of this year. Both of those compounds, we should see pre-clinical data at AACR.

For T-DM1, we'd look to see clinical data both in the third and fourth quarters of this year. And then for SAR3419, clinical data in the second quarter, and the start of a Phase II study in the second half of this year. And then across the second, third and fourth quarters, as it just happens to turn out, we would expect to see new partner compounds having INDs filed. Just with the highlights, a very active year for ImmunoGen and the various compounds where we have an interest.

So with that, let me turn it back over to Carol for the Q&A.

Thanks, Dan. We're about to open the call to questions. We do ask that you limit your questions to one to two per person, so that -- until everybody has had a chance to ask their questions, and then you can come back in.

Operator, we are now ready to open the call to questions.

(Operator Instructions). David Miller of Biotech Stock Research.

Hello, good afternoon, thanks for taking my call. The first question I have is, you mentioned you were going to have data on 901 in small-cell lung cancer in the back half of 2011. Is this Phase I data, or Phase I data plus some early read on the Phase II data?

Little hard to say until we get there, David, but we are enrolling the Phase I portion pretty well. That's moving along at a good clip. It will depend on how that enrollment continues, when we determine MTD, what the weighting is between the Phase I data and whether there's anything meaningful in Phase II data. But we'll accumulate whatever data we have at an appropriate cut off. I'd like to think maybe we'll have early Phase II data, but it's probably too soon to have much that's going to be meaningful.

Okay. The second question is, do you see 901 as ready to partner at this point? Or are there some key data points that you really want to get a read on before you are able to get the value you're looking for?

I think we're at a stage where, particularly with the combination study in multiple myeloma, and more so the combination study in small cell, that there's going to be an opportunity to generate some important data that would be very meaningful to what the value would be for this particular compound.

Now obviously, there's a risk element associated with developing that data, but I think that our preference at this point would be to let this data develop, and let it demonstrate what its full potential is, or at least an indication of its full potential is. And that would be the point in time when we'd have the option of deciding whether we want to pursue partnership discussions.

Okay, great. Thank you very much.

Ling Wang of Brean Murray Investment Bank.

Thank you for taking my questions. My first question is with regard to the Merkel cell carcinoma strategy. It looks like you changed it into the front-line. Can you maybe talk about the potential trial design in the front-line patients, and what kind of end point do you think you might need to, in this setting?

And then secondly, just a clarification on the timelines for potential data for T-DM1 in the front-line breast cancer patients? Is that now the PFS data is expected third quarter? I just wanted to make sure that I heard it correctly. Thank you.

Yes, Ling, to the second question, yes, that is an update. That changed from an expectation of the data being available in second quarter to now it will be third quarter; so that is new information.

With respect to Merkel cell, it's a little premature to talk about what the study may look like. I think the parameters that I would put out is, as I noted given the limited patient population, it's important to have a study design that will be able to have the study completed in a reasonable period of time. I define reasonable as being two years.

But I don't want to get ahead of what the regulators may be looking for. I think we need to have the data so that we know what the dose would be; have some broad thoughts around protocol; and then discuss those with the regulators and get their input to be able to refine the study design to one that will give the right data to allow a decision around approval.

I think there's probably greater flexibility on endpoints in Europe than there may be in the US, as Europe will accept a PFS, but I do think we just have to let those discussions take place.

All right. Thank you.

Brett Holley of Oppenheimer.

Hi, this is Eric Chang in for Brett. I just wanted to talk more about the increasing demand for partnerships. Do you feel that you're at a point where you can be more selective in deal terms, or do you feel a need to maintain a scarcity of the technology?

Eric, this is Greg. No, I do think that we're at a point where TAP technology has advanced in terms of proof-of-concept in the clinic with the data we're seeing from T-DM1, the advancement of SAR3419 by Sanofi towards a Phase II, and of course, the promise of our own 901. I do think that the technology has evolved and our Company has evolved to a point where we can be more selective in thinking through the nature of, say, a TAP technology license or a multi-target that we might want to do.

And as I mentioned in my comments, for the first time we're also looking at certain pre-clinical candidates that we have developed through our research team, that we think may be of more interest to a partner to develop than, for instance, ImmunoGen to bring forward on our own. And that could be quite interesting to a partner who might want to jump-start their ADC efforts. To some extent, this could save them as much as 18 to 24 months off their effort.

Great. And just one last housekeeping question. Can you explain the fluctuation in license and milestone fees this quarter? Was there a recategorization of the accounting from milestones to clinical materials reimbursement?

No, not that I'm aware of. The only -- and I'm not sure if you're meaning fluctuation from last year, but clinical material reimbursement, of course, is going to be somewhat lumpy pending the timing of batches and when they're released to partners. And license and milestone fees can sometimes be lumpy just simply based on the timing of, and relative timing of achieving certain milestones, but I'd say that the quarter unfolded pretty much as expected.

Okay. Thank you.

Shiv Kapoor of Morgan Joseph Investment Bank.

Thank you for taking my questions. And thanks for providing an overall update on all the clinical programs. That's very useful. I have two questions. First on SAR3419, it seems that the trial that they started with more frequent dosing, that Sanofi started was around the middle of last year, maybe a little bit before that, around ASCO time, I think, we were trying to discuss what that was. Why do you think it has taken -- why it has taken so long to report, I guess you will have reports of that data reported in the fourth quarter?

And a related question; it seems like last year when they did have the data from the less frequent dosing, they were not ready to take the plunge into beginning a Phase II, but since now they have made that decision to begin a Phase II, should it be our understanding that that has been based on the results that they've seen from this more frequent dosing study, that you guys have access to, or only they have access to?

Shiv, we have to be careful in that, as you know, we don't like to get ahead of our partners. The one comment just for clarification, the data, I think you referenced fourth quarter. The data from that more frequent dosing schedule will be available second quarter, so that would be an ASCO event.

But what they've done across the study they've conducted -- I think I've made reference to the fact that in doing the weekly dosing, that they spent quite a bit of time around dosing to make sure that they got that right. But for them to give a conclusion about what, quote, right is, and how that's going to impact how they take the compound forward, I think we'll leave that to them at the point in time that they take care of their reporting and give further guidance on what a Phase II study might look like.

But they've used the more frequent dosing data to determine the viability of the next, of a Phase II study?

Well, certainly they have that information available to them now. They have information across a few different dosing regimens. So they will incorporate all of that in determining how they want to set the protocol for the Phase II, but I just don't want to provide -- that's about as much as I can say about what dosing is going to look like. They certainly have benefit of all of that data to think about when they look at a Phase II.

Okay. One more question before I jump back.

Yes.

It seems there was a little uptick in your R&D spend this quarter, gradual. Is that a normalized level that we should look at, or should we look at the uptick and assume it will then uptick in the next few quarters?

I'd say a portion of that uptick is probably the trend in terms of the investment in our proprietary pipeline in terms of what's in the clinic, but also as we advance two other compounds towards an IND. And there's another portion of that, which is also somewhat timing related, associated with some antibody purchase. And so I'd say, probably about half of that is trend and half of that is more temporal based on timing of the antibody.

Okay. Fair enough. I'll jump back.

Jason Kantor of RBC Capital Markets.

Hi, thanks for taking my questions. I'm wondering on the Sanofi programs, when do you start triggering some milestones. Do you get a milestone for starting Phase II for SAR3419, or are there other near-term milestones that we can expect out of that program?

Yes, so the next milestone would be triggered with, I believe it's the Phase II start.

And is that factored into your guidance?

Yes, but -- well the Phase II start is the second half of 2011.

Yes, that would be a fiscal 2012 event.

I see. And then in terms of your next drug in the clinic, was it 529? This is, you say it's for a hematology indication. Is this a target that's already existing out there in terms of other clinical candidates, or is this something that's totally novel?

We haven't disclosed the target at this point, Jason, so yes, that will be coming out, I think they -- that will be disclosed at AACR.

Right. I'm not asking you to disclose the target. I'm just asking whether or not the target is already out there in terms of other clinical candidates and whether it's a totally novel target.

Yes, I think we'll wait until we get to AACR on that.

Okay. Thank you.

Thanks, Jason

Cory Kasimov of JPMorgan

Hi, good afternoon, guys, thanks for taking the questions. The first one is on your small-cell study with 901. You indicated that the median PFS you'd expect is about five months for the control arm. What's the incremental benefit that you're looking for 901 to add there?

Well, we would hope to see at least -- well, you'd like to see more, but I think the minimum threshold would be if you are looking for a two- to three-month improvement in PFS, but clearly we'd like to see more.

Okay. And then on T-DM1 and Roche's Adjuvant strategy, I know they're in Phase II now, they started that work. But do you know what the pivotal clinical program would look like for this indication, and do you have any best guesses on timelines there?

They really have been silent on that, Cory, so we can't provide any insight. I think that we were encouraged to see them initiate clinical studies in Adjuvant that says they'd moved past the thinking about it to want to look at what they were going to see in human studies, but they haven't gone beyond that to talk about what a strategy might look like or make, for that matter at this point, make a commitment to T-DM1 in Adjuvant.

Okay, do you recall what the scope of the Herceptin Adjuvant program was in breast cancer? I just don't remember off the top of my head.

The scope in terms of number of patients?

In terms of the trial? Just in terms of the trial in general and, yes, how big and how long it was?

Yes, we can get that. I don't know offhand.

Okay. Thank you.

Sure. Thanks.

Mark Monane of Needham & Company.

Hi, good afternoon. Thanks for that comprehensive review. I have two questions on the pivotal trials. First question is, do you expect Roche to describe any more information on the combination of TYKERB plus Xeloda, and from the previous trials that were used in preparation for the current pivotal trial?

And the second is, at the San Antonio conference, there was very good data, in my opinion, on Herceptin plus Pertuzumab. I was wondering if you thought those data portend good data as well for T-DM1, or what lessons we could learn from those data, the T-DM1 plus Pertuzumab.

With respect to any more disclosure around TYKERB plus Xeloda, I don't know. It's unclear if there's going to be anything more that they're going to say, and whether they're going to provide any interim look at the data that's coming out of the EMILIA study, Mark, so that's just up in the air.

The T-DM1 plus Pertuzumab data, I don't know if we're going to be seeing more on that or not. We know we're going to be hearing more about the T-DM1 versus Herceptin plus a taxane, but whether we'll hear more about that, or the Herceptin plus Pertuzumab data, I just don't know.

No, I'm sorry, maybe I didn't ask it right. Excuse me. I wanted to know what you thought of the Herceptin plus Pertuzamab data that were (multiple speakers)?

Well, a small study, and a 57% response rate was certainly encouraging, but I do think you have to look at that in the context of the size of the study.

Right.

That's fair. That's helpful. And so it sounds like AACR, last question. Is sounds like AACR is going to be a big meeting for you. Did you say that you expect any of these -- I think you said you expected to submit INDs for 529 and 853; is that right, by the end of the year?

Yes, for 529. 853, I would expect to be early next year.

Early next year.

2012.

Thanks for the added information.

Sure.

David Miller of Biotech Stock Research.

Hi, just a couple of quick follow-ups. How many front-line MCC patients have you dosed to date, if any?

Front-line Merkel cell?

Yes.

I don't think we've dosed any, David. I think we're getting all as later-stage patients.

Okay. And you mentioned that the combination trial that you're enrolling, the Phase I portion is all-comers. Do you think you're going to be able to get any dosing in front-line Merkel cell patients with the combination strategy out of that trial, or anytime before you actually launch the pivotal trial?

Don't know. I mean, we allow patients coming into that study to have received prior therapy, so they can have up to three prior therapies before they come into the dose escalation phase. So to think that we would get a first-line, in some ways anything is probably not likely. In Merkel cell, in particular, given the size of the patient population. So I don't know that we're going to get the opportunity to get any insight out of that into a first-line Merkel cell patient.

Okay. So then the first-line Merkel cell trial that you describe, that you'd likely go in combination, you're likely going to launch that without actually having previously dosed front-line Merkel cell patients with that combination.

That's correct. But we think that given the fact that we've seen the level of activity noted in later-stage patients, it provides a pretty good basis for us, so that we would expect to see, certainly at a minimum that, but probably better based on the combination and getting patients earlier in the treatment regimen.

Okay. And you would expect to get some MCC patients in the combination, second-line anyway in the trial you have going on right now, the combination, the Phase I portion?

No, I don't know that. As I say, since we're taking anyone, any patients who would be receiving an etoposide carboplatin regimen for their particular therapy, I don't know that we have any expectation that we would see Merkel cell patients. Right now we're seeing quite a mix of patients. We're seeing some small-cell patients, but again, not necessarily first line.

All right.

David, maybe I didn't express this. I mean, Merkel cell does share biologic characteristics with small-cell.

Right.

So that is some of the rationale, so that's why we think we can take the dosing from small-cell and have it apply to the Merkel cell study. But we haven't designed it, nor are we working to attract Merkel cell patients into the Phase I portion of that combination study.

Okay. Good. Thanks for the clarification, I appreciate it.

Sure.

And that does conclude today's Q&A session; I'll hand the call back to Carol Hausner for any closing remarks.

Great. Thank you very much for your interest, and many good questions. Again, if you have any additional questions, give me a call at 781-895-0600. And I hope you have a good evening, and a snow-free evening. Take care.

And this does conclude today's conference call. We thank you for your participation, and have a wonderful day.