ImmunoGen Inc (IMGN) 2013 Q3 法說會逐字稿

Good day and welcome to the Immunogen third quarter fiscal year 2013 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 Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Thank you. Good morning.

At 6.30 this morning we issued a press release that summarizes our financial results for our third quarter ended March 31. 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, and our Chief Financial Officer, Greg Perry, will discuss our financial results and guidance. We'll then open the call to questions. Our Chief Development Officer, Dr. Charlie Morris, is here for the Q&A section of the call.

Dan?

Thank you, Carol, and good morning to everyone. Think you for joining us.

This past quarter was a very significant one for Immunogen. We had the approval and launch of Kadcyla, the first product with our TAP technology. We also saw meaningful progress with our own pipeline. We are seeing good enrollment in the trials that we have underway with our three proprietary compounds, and we reported pre-clinical findings on our fourth compound, which is on track enter the clinic later this year. We are also seeing continued progress by our partners with the first clinical data reported by Bayer, and the license taken by our partner, Novartis.

All of this was done in a context of us continuing to maintain a strong financial position, as you will hear later from Greg. Let me first mention -- talk about Kadcyla. Kadcyla received FDA approval on the 22nd of February and launched immediately thereafter. All the indications are that it is off to a very good start. There are reports of physicians conducting Genentech for product once it was first approved. There is also reports of reordering taking place within the first month.

Roche indicated that Kadcyla was incorporated into NCCN guidelines 19 days post-approval, which is an extremely fast pace. They also indicated that Kadcyla sales for the month period, or barely a month after it was approved, were CHF18 million, roughly $19 million. It's too little data to extrapolate, but certainly it's indicative of a strong start for the compound. This is the first ADC that received full FDA approval. We had certainly had clinical validation earlier, but we can now add to that regulatory validation. And it's also the first ADC approved for a solid tumor indication.

Roche continues to make progress with additional markets and indications. They have an application under review in Europe for the same indication as the US approval off of the EMILIA data. We would be looking for approval later this year, later 2013. Is it -- have also submitted in Japan, again for the same indication. That application went in in late January. Based on the MARIANNE data, which would be for first-line treatment of HER2-positive metastatic breast cancer, they would expect to apply in 2014 for approval in both the US and Europe.

Beyond this, they have a trial underway, a trial's name GATSBY, in advanced HER2-positive gastric cancer. They would expect to apply for this use in 2015. And finally, they started the first phase three trial in early breast cancer. This study is named KATHERINE. This is one of three early breast cancer studies planned to start in the first half of this year. Let me now turn to our wholly-owned compounds. And we discussed these programs extensively at our analyst event two weeks ago, so my remarks today will be limited to highlights and updates.

First, let me start with IMGN901. Recall this is in phase two testing for first-line treatment of small cell lung cancer. It is dosed in combination with etoposide and carboplatin in a randomized study. Our starting dose is now 30 mg per meter squared as discussed at our analyst event. This modified dose has been well received by study investigators. One clear indication of that is that the pace of patient enrollment remains very strong. Based on the current pace, we would expect to complete patient enrollment by the end of 2013.

This would include an additional 15 patients that we are adding to the study, associated with the change in the starting dose. Our first look at efficacy will come in mid-2014 from the full now 135 patient study. IMGN853 is a folate receptor alpha-targeting TAP compound for ovarian, lung and other solid tumors that over-express this target. This trial is also enrolling well.

We will report our first clinical data at ASCO, and this will be from the dose escalation phase of the trial. Once maximum tolerated dose is defined, we will be evaluating IMGN853 in patients with ovarian cancer or adenocarcinoma non-small cell lung cancer in the expansion cohorts. IMGN529 is in phase one testing for non-Hodgkin's lymphoma. Recall this is a TAP compound with an active antibody. We are in the dose escalation phase, which is open to most prevalent subgroups with NHL, and we expect to report our first data at a medical conference in late 2013.

Finally, IMGN289, here we have reported pre-clinical data at AACR just a couple weeks ago. We had multiple posters, which attracted considerable attention. What we have here is an EGF-targeting ADC. We have -- and EGFR is a validated, well-known target. Like IMGN529 and Kadcyla, it has two separate mechanisms of action -- EGFR inhibition by the antibody plus direct killing by the DM1 payload.

In pre-clinical models, it showed efficacy superior to Erbitux on EGFR-overexpressing cancers. This is any cancers that are dependent on EGFR, those that are not dependent on EGFR, as well as in one's resistant to tyrosine kinase inhibitors. Here we're on track to submit an IND in midyear, and we're looking to begin clinical testing shortly after we receive acceptance of the IND. This will be our fourth wholly-owned clinical stage compound. Beyond our own proprietary compounds and Kadcyla, there are other progress with our partners, as our seven other compounds in the clinic through our collaborations with companies such as Amgen, Bayer, Biotest and Sanofi.

The first clinical data was reported at AACR with BAY94-9343, which is a compound being advanced by Bayer Healthcare. This TAP compound targets mesothelin and it uses our linker and payload. The data reported in the study indicated it was a dose escalation phase of previously-treated meso -- patients previously treated with mesothelioma. In the study, they indicated that they had one confirmed PR, one unconfirmed PR, and three patients with durable stable disease. This compound is now being evaluated in two expansion cohorts, one in mesothelioma, the other in ovarian cancer.

Recall the economics of this license has milestone payments totaling $170 million with royalties that go into the upper single digits. We expect data from most if not all of the rest of the partner clinical compounds over the rest of this year, with the potential for one partner compound to enter pivotal testing in 2013. The other partner item of note is that Novartis took a license in the quarter just ended. With that, let me turn it over to Greg to review our financials.

Thanks, Dan. Our net loss for the third quarter of fiscal year 2013 was $1.4 million or $0.02 per share, compared to a net loss of $18.7 million or $0.24 per share for the same quarter last year. Revenues for our third quarter were $25 million, as compared to $3.3 million in the same quarter last year. And revenues in the third quarter of fiscal year 2013 included the $10.5 million milestone payment we earned with the approval of Kadcyla in the US. It also contained $11.1 million in amortization of up-front license fees from Novartis. This $11.1 million in revenue includes a portion of the original $45 million up-front fee and of the recent $3.5 million license amendment and other fees.

These revenues were recognized in our third quarter because Novartis took a license under our agreement in this quarter. Our third quarter revenues also included $2.3 million from research and development support, compared to $1.3 million for the same quarter last year, and $700,000 of clinical material reimbursement compared to $900,000 for the same quarter last year. These revenue items vary by quarter, depending on the work we're doing to support our partner programs.

Our operating expenses for the third quarter of our fiscal year 2013 were $26.3 million, compared to $22 million for the same quarter last year. Current quarter operating expenses included $21.3 million of research and development expenses, compared to $16.9 million in the same quarter last year. This difference is primarily due to the increased investment we're making to advance and build our pipeline of wholly owned product candidates, including increased costs for third-party production of antibody for use in clinical materials and increased personnel expenses.

We currently have three high potential, wholly owned compounds in the clinic and are preparing to advance our fourth into the clinic later this year. Operating expenses in the third quarter of our current fiscal year also included general and administrative expenses totaling $5 million, which is comparable to the same quarter last year. Our cash used in operations in the first three quarters of our fiscal year 2013 was $48.7 million. As we stated in today's release, we are updating our guidance for our fiscal year 2013 and expect to use less cash for operations than previously projected due to reductions in our anticipated expenses and working capital needs.

We now project our net cash used in operations for fiscal 2013 will be between $65 million and $69 million compared to our previous projection of between $78 million and $82 million. Consequently, we will also anticipate ending this fiscal year with more cash than previously projected. We now expect to end our fiscal year with between $186 million and $190 million in cash and cash equivalents, up from our previous projection of between $172 million and $176 million.

We're projecting a net loss of between $76 million and $80 million compared to our previous projection of a net loss between $70 million and $74 million. This change reflects that some license-associated non-cash revenue that we had expected to recognize in this fiscal year, we now expect will shift into our next fiscal year. We believe our current cash position, along with the revenues we expect to receive from Kadcyla and our partnerships, will be sufficient to advance our lead wholly owned compounds to proof of concept, an important value inflection point.

Dan?

Thanks, Greg.

I got a note that I may not have been clear on the starting dose in the NORTH study. The starting dose now in the NORTH study is 90 milligrams per meter squared. And as I noted, that has been well-received by the investigators and we continue to see very good enrollment there. Let me just go through some anticipated events and then we can take your questions.

And I will start with Kadcyla. We do expect to begin recording our first royalty revenues in the current quarter, that being the fourth quarter of the current fiscal year. And over the course of the quarter, with Roche's announcement coming around midyear, we will get clearer insight into the rate of adoption in the US. We look for approval in Europe later this year, and with the first launches to begin shortly thereafter.

The data from the MARIANNE study, which will be using Kadcyla in first-line metastatic disease, will come in early 2014, followed by submission for this use, and then approval for Japan sometime over the course of 2014. We look for submission for treatment of HER2-positive gastric cancer in 2015, and then a series of submissions for early breast cancer to follow thereafter.

With IMGN853, we will see the first clinical data at ASCO. This will be for dose escalation. For IMGN289, the IND will be submitted in mid-2013 and, once active, we would look to begin clinical testing in the second half of this year. For IMGN901, we will complete patient enrollment, we would expect, sometime in the fourth quarter of this year. And we will look to provide an update around dosing once we have enough patient data to have a clear view of that. So once we have the information, we will be -- we will want to pass that along. And then have the first results from the full study in mid-2014.

And finally, for IMGN529, with enrollment, we should see the first clinical data coming in late 2013. This would be from the dose escalation phase.

Carol, let me turn it back over to you for questions.

Thanks, Dan. We are about to open the call to questions. We ask you to please be limited to one to two questions per person until each person has had a chance to ask questions. Operator, we're now ready to open the line to questions.

(Operator instructions)

Adnan Butt, RBC Capital Markets.

Good morning, everyone, and thanks for taking my question. I'll start with 853. Previously, the Company had mentioned on potential TAPs that could accelerate the development of 853. Can you take us through what you are thinking along those lines, please?

Yes, it's Charlie here. Obviously, the first thing that we need to do is to begin to gather data from the ongoing study. With the expression of folate receptor being seen in a high proportion of patients with ovarian carcinomas, also in adenocarcinoma of the lung. We are of course looking at the opportunities, if we see high activity in otherwise treatment-resistant patients, we would certainly be interested in trying to accelerate that program quite quickly. We think one of the better opportunities there may be ovarian carcinoma, based both on the pre-clinical data as well as the lack of new therapies, which have been seen in that area for too long, quite honestly.

So, I think it's got to be data-dependent. We are in the -- we are pleased with the progress of the phase one. We are recruiting well. We hope to -- we will be presenting some of the initial data from that at ASCO, and then as we move into those dose expansion phases, if we see a clear signal, we would certainly be looking to advance that. Based on the strength of the pre-clinical data, we remain very optimistic that there may be a path forward.

Just one quick follow-up, can you say, at ASCO, how many patients -- ovarian cancer patients you have, and then I will get back in queue, please.

In the study so far, as I see, it's -- as I say, we are in a dose escalation phase, as you know. That started off with single patient cohorts and are escalating through to a standard three plus three. It is approximately half the patients in that study to date have been ovarian cancer patients. So, obviously, we are not looking at high numbers of total patients in the study yet.

Marshall Urist, Morgan Stanley.

This is Yigal Nochomovitz standing in for Marshall. Thanks for taking the question. Just one on 853. I was just curious, with the data released at ASCO, is it going to be available for the additional analyses of the IHC status related to the folate receptor, or will that come later down the road?

I think -- the most important thing, I think, for ASCO is to really -- I would be talking about and showing the data from the dose escalation. And the -- what we know to date about potential to dose limiting toxicities and potentially maximum tolerated dose. We -- as we move into the expansion phase, as we will certainly be beginning to restrict those patients more in terms of their expression of folate receptor. And so I think we will have a greater understanding of the relationship between folate receptor and efficacy as we move further into the study.

Okay, thanks. And just one quick follow-up on 901. You mentioned at the analyst day that of the nine patients at 90 milligrams per meter squared in the phase one escalation, you didn't see any grade three peripheral neuropathy. I was just curious if you had a number or percentage of patients that had great one/two peripheral neuropathy in those nine patients?

I apologize. I don't have those numbers in front of me, but that's something that we could follow up with after the call.

Okay. Thank you.

Joel Sendek, Stifel.

Hi, thanks. My question has to do with the financial guidance, Greg. Wondering, with regard to the delay in the new licenses, is there anything we should read into that, or is it just a matter of one week versus the other and how it fits into the calendar?

No, I think it's, as we have described in the past, our revenues can be lumpy, and that's even when we are talking about reimbursement for clinical material or even some of the research work that we do. But certainly, when it gets to licenses, because of the accounting dynamic that the up-fronts are basically hung up on the balance sheet. And then when we take a license -- when a partner takes a license, and there is a big chunk of that that gets basically amortized into the P&L. So in this quarter here, we saw the license taken by Novartis actually right at the end of the quarter, which was a bit earlier than we expected. And we are seeing some licenses and milestones push out, but there is -- I think this is part of the normal ebb and flow in the unpredictability of some of the partner activities.

Now, when you said you see some milestones pushed out, is that due -- I guess you're -- it's how quickly the partners move their products along, and then you're -- you'll get the milestones as they make progress. But I guess the press release only mentioned new licenses. Is it -- maybe some of the revenue recognition has to do with milestone payments under the in-place agreements? Is that also part of the change?

Yes, that's a smaller element of it, but there is some of that as well. Yes. Exactly.

Okay. All right.

Simos Simeonidis, Cowen and Company.

This is [Yetin] calling in for Simos. Could you provide first an update on the Sanofi compound, SAR3419? I think it was in three phase three trials. And when can we expect data from that compound, and what is the expectation there?

This is Dan. 3419 -- it is actually in three phase two trials, not phase three trials, and they continue to advance it. Some of those are monotherapy. They have some studies in combination with Rituxan. And I would expect that we will hear data on, I believe, all three of those studies over the course of the year. I think Sanofi feels that they are generating good data. They are pleased with the progress, but we will have to see what the data is. But they are advancing it. It is showing -- the data that has been disclosed thus far suggests activity in later stage non-Hodgkin's lymphoma patients. The studies that they are conducting right now are both in follicular and DLBCL. So -- but again, over the course of the year, I think that they will be disclosing that data.

Mara Goldstein, Cantor Fitzgerald.

Thank you very much. Just two questions. One is, could you remind us of any remaining milestone payments for Kadcyla that you would expect to receive in the next year? And the second is -- it's a compound we don't talk much about, and it's the Biotest compound. I believe you have opt-in rights for development on that, and maybe if you can remind us when you might think about doing that?

Mara, this is Dan. On the Kadcyla milestones, we have indicated that we have a $5 million milestone due on approval in Europe, and another $5 million would be due on approval in Japan. So depending on the timing of that, those would be the next milestones we would expect. With the other compound, you asked about BT-062?

Yes.

Yes, we do have opt-in rights on BT-062. We are monitoring development of that compound. There are certain points in time when we would need to exercise those rights. That window still exists, and it would provide us the opportunity to develop that compound in the US. So we will just have to -- we will continue to monitor that and see how that is developing.

Okay, but is that a -- obviously, a post-phase one, but is it an opt-in for phase two or phase three, and are there different hurdles?

Yes, there are different ones. There is a post-phase one and a post-phase two.

Okay.

And so we are waiting, and we will look and see how the phase two there, and a phase two-A monotherapy study. I think it's a phase one combination study. And so we'll just see how that evolves. There is some time before we would have to make a decision there. There would be some dollars involved for us to exercise. Not an exorbitant amount, but a meaningful amount of money. But we are some ways away from having to make that decision.

Okay. Thanks so much.

Thomas Wei, Jefferies.

Just a couple of questions on 901. I know at the analyst meeting, you didn't have handy the number of patients in the first cohort who have actually discontinued treatment. Do you happen to have that number today?

We are looking at each other, so I think the answer to that is no, Thomas. Sorry.

And I know that you had talked about taking a look at the data at the end of the year on maybe the first cohort. But from the comments that you made today, have you actually decided that no -- there will be no efficacy data until the whole trial has matured to the six months of follow-up in mid-2014? So, even if you will look at the safety data from the first cohort, you've decided not to look at efficacy?

No, we haven't made that decision. I think we're -- how we look at it at this point is that we want to -- we don't want to have, necessarily, a fixed time at which we're going to commit to have efficacy data, because it is dependent on enrollment and maturation of the data. Once we have some clear view on the efficacy data, we will find a way to convey that, given that it's received the attention that it has to date. But I just don't want to be as locked into a fixed point in time when we will have that data. So we'll just see how that evolves.

Yale Jen, Roth Capital.

Thanks for taking the question. Just a little follow-up, a little bit on Thomas' question, that -- so, in terms of the safety data, it may or may not be in the end of the fifth year to be released, or is that the case?

Yes, we'll find a way to communicate it once it's available and has matured to the point that we -- that it is clear to us, Yale. So that -- it may be this year, it may be next year. I just -- it's too early to get locked in on when that might be available.

Okay, great. And just a quick follow-up in here is that, in terms of the data potentially to be presented at ASCO, given that this approaching the meeting time and abstract time. So do you get some sense of other partner program, though, other products, also could be -- have data presented at ASCO besides your own?

The only ones that we will see clearly at ASCO at the moment would be some additional Kadcyla data for various studies that are underway. I don't have information on other partner products that may have data at ASCO.

Okay, great.

Jason Kantor, Credit Suisse.

Great. Thanks for taking my question. Does -- I think previously you said that your guidance didn't include royalties from Kadcyla. I'm wondering if your new guidance includes the expected Q4 royalty? And then also, can you just walk us through in a little bit more detail how the revenue for the quarter breaks out in terms of what's cash and non-cash and what was triggered by this Novartis decision? And how you get to more -- bigger net loss, but less cash used, if you could just walk us through some of that calculation, that would be helpful.

Sure, Jason. It's Greg. In terms of our guidance, again, technically it would include the royalty revenue expected in this that we record in the fourth quarter. And as Dan mentioned, at roughly CHF18 million, $19 million, we can do the math. So it's not going to be a huge driver of the financials in the fourth quarter. But nonetheless, it's very exciting for the Company, and we're very anxious to get that in the books in this fourth quarter. I think, too, the simplest way to look at the drivers and the change in the guidance on the net loss side, there's an interesting dynamic, because on the revenue side, you have got non-cash revenue that is triggered. So, for instance, in the current quarter, where we saw significant revenue from the $10.5 million milestone, that's going to be basically turned into cash and sitting in receivables at the end of the quarter. But of the $11.1 million of Novartis license, the majority of that is a non-cash number, effectively.

So, when you look at the changing guidance with the net losses increasing, it's primarily because we're going to be pushing into next fiscal year, recognition of a license, which is primarily non-cash recognition deferred income. And those are -- each license is anywhere from -- could be between $7 million and $8 million. So, that's really to reconcile the dynamic between the P&L guidance and the cash guidance on the cash side. We saw lower prepaid working capital and actually a bit lower expense run rate, which is a cash item. So, that's improving the cash balance forecast. Then, on the P&L side, we see a push out of a license, which is basically going to be a non-cash item, and some other items that offset the low run rate. Is that helpful, Jason?

It does, but can you explain how -- why you are booking non-cash revenue for Novartis in the quarter if they paid you a milestone?

Yes. No, the -- so when we booked the multi-target agreement, and there's a significant upfront, and say we booked $45 million up front on the license, basically that goes into -- on the balance sheet as deferred revenue. And then from the accounting perspective, there is a quite complicated mechanism you go through to then determine when you are going to be able to actually recognize the revenue from that up front, in what accounting period. And one of the big triggers is when the partner takes a license. And in this case here, when Novartis took a license right at the end of the quarter, that triggered the recognition of between $7 million to $8 million of deferred revenue. So, that's a non-cash item. And then we have the additional license amendment, which was another $3.5 million or so.

All right. Thanks.

Cory Kasimov, JPMorgan.

It's actually Matt Lowe in for Cory today. Just a quick question on 853, the abstract for ASCO for that compound. Will this have meaningful data in it when it is released, or will it just be more of a placeholder? Thanks.

The abstract itself will -- has not -- will not have an immense amount of detail, because obviously with it being a dose escalation study, but we have made quite a lot of progress in the intervening time between then and now. So I think you will see some tidbits of information, but obviously, the most complete data will be on the poster itself.

Okay. Thank you.

Morris Peaker, Oppenheimer.

This is Boris Peaker. Quick question, maybe for Greg. You mentioned a decrease in operating expenses for the rest of the year. Could you just give us some more details of which departments, what areas those reduced operating expenses are coming from?

This is really -- first it's, Boris, versus previous forecasts, and again we're seeing that across a number of different areas, but also in the pre-clinical, clinical area, also associated with some of the manufacturing supplies, et cetera. So, we're seeing it in those two areas.

I see. And my second question is, regarding Kadcyla, and with the drug gaining traction, and a 10-year limited royalty window, I just wonder if you considered monetizing Kadcyla royalties, either fully or at least partially at some point?

Yes, Boris, as I think I mentioned at the analyst meeting, we certainly are aware that it is a very valuable asset to the Company. It's the type of asset that we -- it's a very valuable asset for the Company and it's something that we think of in the context of financing the Company. So, we know that there are a variety of ways to monetize that asset, should we feel as though that's the appropriate lever to pull in terms of it capitalizing the Company. At the moment, we feel very good about the capital position that the Company has, with a cash balance of $206 million. But it's certainly something that we are -- there are a number of parties that are interested in helping us to do that, if we ever felt as though that was the right thing or the right time to do it.

Great. Thank you for answering my question.

Boris, this is Dan. You mentioned 10 years. We view that to be a 12-year royalty. We think that, while it's IP dependent, we think that the IP portfolio will cover us in the major markets to receive royalties over a 12-year opportunity that exists within the license.

Thank you for that clarification.

Bret Holley, Guggenheim Securities.

Yes. Thanks for taking the question. I'm wondering, in looking at the pre-clinical results for 289, it is a little bit surprising that the efficacy in the pre-clinical models is comparable with a compound versus Erbitux. Obviously you would expect, with that compound, to be more potent. How do you think about what the bar, the clinical bar, for success is in early development of that compound?

I think there's a broad range of information in the pre-clinical data. Certainly if we look at the naked antibody has similar potency to Erbitux, but generally speaking, in the models where we tested it in EGFR-driven or dependent cell lines, we saw higher levels of activity than we saw with Erbitux. I think the critical thing here is, I think it gives us a broader opportunity than we had -- than has managed to be realized with both tyrosine kinase inhibitors and with the monoclonal antibodies. And in terms of the fact that we are dependent upon expression of the target rather than necessarily the active pathway. And I think in that sense, therefore would be, we are excited that we are seeing data.

For example, in TKI-resistant populations, we are excited that we've seen monotherapy activity in the squamous cell patients with non-small cell lung cancers, while it extends out -- I'm sorry, I meant to say models -- as well as in head and neck models. So I think there is multiple opportunities wherever the target is expressed, which I think takes us broader than has managed to be realized with the TKIs and with the monoclonal antibodies. So I think all of those, particularly on the head and neck side and the non-small cell lung cancer side, where we see the highest levels of expression, and therefore with the opportunity to deliver maximum amounts of payload, gives us a great clinical opportunity in each of those two diseases as our first areas for investigation.

Great. Thanks.

John Sonnier, William Blair.

Thanks for taking the questions. With 901, a lot of the dose reduction commentary and questions have centered around safety. I guess that's understandable. I want to ask just a little bit about efficacy. Can you talk about, maybe, some of the earlier clinical experience? And then just remind us, in terms of where you saw clinical activity at the lowest dose? In other words --.

We've seen clinical activity at doses down as low as 40 milligram per meter squared in the monotherapy studies. And we have seen, in the patients we have treated, in combination with carboplatanin/etoposide in the phase one portion of the ongoing study, we saw more than one response in the patients there where the combination dose was 90 milligram per meter squared. I think the other thing to remember is, in addition, is that we are comfortably within the sort of PK exposure limits that -- at 90 -- that we would have expected to require based on the pre-clinical information. And in addition, although it's a different disease, we were very encouraged by the data that we saw in the combination study with myeloma.

Overall in myeloma, although that was 75 milligram per meter squared dose. So, a lower grams per dose, if you like, but that was on the three out of four week schedule. So, the dose intensity is very similar to at 90 milligram per meter squared on the schedule that we're using in small cell lung cancer. We were very encouraged by the activity there. I think, broadly speaking, we started out at 112 as a classic, that was the maximum tolerated dose. We now had to revise our view about what the optimal dose for phase two investigation is. We have gone with 90, feeling comfortable that we have both pre-clinical and clinical support for that data, as well as -- and bring it back to the safety -- comfort, from the initial data at least, that we should be able to find that to be a manageable dose for the patients as well.

That's actually real helpful. And then with the etopocide/carbo adjustment, is that modification pre-specified in the NORTH protocol? Is it a range? Is it a set modification? What's happening there?

There are -- it depends on what the need is for those modifications. Obviously, there's certain adoptions that we may make according to myelosuppression. When it comes to the neuropathy, what we have suggested is that the first step should be an adjustment of 901. If there is a requirement for a second dose change because of persistent or worsening neuropathy despite that dose reduction, we then have recommended a dose reduction of -- a further dose reduction of both 901 and a dose reduction of carboplatinin at that point.

Got it. Thanks so much.

At this time we have no further questions. I would like to turn the call back over to Carol Hausner for closing comment.

Great. Thank you very much. I would like to thank you all for your interest in Immunogen, and of course if you have additional questions, don't hesitate to call. Have a nice day.

That does conclude today's conference. We thank you for your participation.