Oct 27, 2015
Executives
Carol Hausner - Executive Director of IR & Corporate Communication Dan Junius - President & CEO Charlie Morris - EVP & Chief Development Officer Dave Johnston - EVP & CFO
Analysts
Jessica Fye - JP Morgan Securities Matthew Harrison - Morgan Stanley Andrew Peters - UBS Simos Simeonidis - RBC Capital Markets Mara Goldstein - Cantor Fitzgerald Christopher Marai - Oppenheimer John Newman - Canaccord Genuity Boris Peaker - Cowen & Company Michael Schmidt - Leerink Partners
Operator
Good day and welcome, everyone, to the ImmunoGen First Quarter Fiscal Year 2016 Financial Results Conference Call. Today’s call is being recorded, and 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
Thank you and good morning. At 6:30 this morning we issued a press release that summarizes our financial results for the quarter ended September 30, 2015, the first quarter of our 2016 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 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 compounds in greater depth; and our Chief Financial Officer, Dave Johnston, will discuss our financial results and guidance.
We will then open the call to questions. Dan?
Dan Junius
Thanks Carol and good morning everybody. In previous calls, I have referenced this being a transformational year for ImmunoGen.
I think that characterization continues to be accurate given the progress we are making with our lead product, our Mirvetuximab Soravtansine and our other wholly owned programs, as well as the activity we’re seeing from our partners. We are extremely excited about Mirvetuximab Soravtansine and has the potential to make an important difference for patients with cancers that express its target folate receptor alpha, and we are successfully executing on our strategy of progressively advancing Mirvetuximab as a single agent for pre-treated ovarian cancer, while also expanding its potential uses.
Data and support of Mirvetuximab Soravtansine continued to expand as evidenced by the AACR-NCI-EORTC of what I’ll be referring to as Triple meeting abstracts that became public last night. Of particular note is the association we are finding between level of folate receptor alpha expression on patients tumor cells and response to treatment with Mirvetuximab monotherapy.
As you recall, at ASCO, we reported an impressive 53% response rate with Mirvetuximab in patients with platinum-resistant ovarian cancer. When we look at responses stratified by the level of target expression on the patients’ cancer cell, the findings become even more interesting; notably with the data available at the time the abstract was submitted, there was a remarkable 80% response rate among the 10 patients with the highest level of folate receptor alpha on their tumor cells.
Charlie will take you through this in greater detail. Clearly this is an exciting finding and we’ll be providing updated data on these patients at the triple meeting.
I am pleased to note that we completed enrollment for the full 40 patient cohort in August, well ahead of plan and that patient enrollment is going faster than expected in our ovarian cancer cohort which require biopsies. We look at this progress as being a strong indicator of investigator support.
We are planning to meet with the FDA about an accelerated pathway for Mirvetuximab in ovarian cancer in the first half of 2016 and to report findings for the full 40 patient dataset at ASCO next year. And of course we’ll be preparing to start our Forward I and Forward II trials by the end of 2015.
As we’re successfully executing on Mirvetuximab Soravtansine, we are also advancing a promising earlier stage programs. We’re on track to begin assessment of our IMGN 529 and Coltuximab Ravtansine ADCs in combination regimen by year-end and in 2016 respectively.
These trials will focus on treating with patients with Diffuse Large B-cell Lymphoma. Also of significance, we’ve submitted the IND for IMGN 779 product candidate.
This is the fourth IND in four years ahead of our goal of submitting an IND for new product candidates every 18 months. This is ADC has a potential treatment for acute myeloid leukemia and myeloid dysplastic syndrome where new and better therapies are needed, and it uses the first of our new IGN payload agents.
We see great potential with our IGN program and look forward to begin treating patients with this first IGN. Before Charlie takes you through our programs in more detail, let me briefly touch on some of the progress being made by our partners.
Exciting Phase IB findings with Bayer’s ADC Anetumab Ravtansine in the treatment of mesothelioma were reported at the World Conference on Lung Cancer last month as discussed at our recent analyst event. Of particular note is the durability of some responses with five of the 16 pre-treated patients with this deadly cancer on treatment for over a year and three still on study after more than two years.
I’m also pleased to report that both Sanofi and Amgen have additional ADCs with our technology and patient dosing has started with the first ADC from our collaboration with Lilly. So we’re making very solid progress on our wholly-owned pipeline as are many of our partners.
With that Charlie will now discuss our programs in more detail.
Charlie Morris
Thanks Dan and good morning everyone. I will start with the lead program Mirvetuximab Soravtansine.
As Dan mentioned, the triple meeting abstract became public last night. If you’ve had a chance to read abstract C47 and C170, I am sure you will understand our continued excitement about this program.
The C47 (inaudible) abstract provides initial findings on the association between the level of folate-receptor alpha from patient tumor cells and response to Mirvetuximab. Using data from the 22 patients with platinum resistant ovarian cancer in the phase 1 expansion cohort reported at ASCO in May.
At the time the abstract was submitted to the [clinical] meeting, we have response rate data for 17 patients as we have the tabs go and so that is what is in the poster. The post will be presented on Sunday November 8, and will include updated data for all 22 patients including updated response and duration of treatment information for all the valuable patients.
As noted in the abstract, this analysis divided patients in to three groups based on level of target expression. High expresses have moderate to a high level of folate receptor alpha on at least 75% dead cancer cells, medium expresses on the 50% to 74% of cells and lower expresses on 25% to 49% of cells.
Notably, about half the treated patients were high expresses and more than three to four were medium or high expresses. In abstract and objective response from treatment with Mirvetuximab was reported in a remarkable [8x10] or 80% of the high expresses; one of the five medium expresses and neither of the two lower expresses.
This is consistent with our high (inaudible) higher expresses may have a higher response rate, and explains why forward one will be limited to the higher medium expressing patients; with stratification between the high and medium groups. This approach will give us considerable flexibility around our registration strategy, as we continue to build patient data.
Our findings to date indicate that nothing rolling low expresses exclusive in minority of patients will ensure you that we retain the opportunity to provide benefit to a majority of ovarian cancer patients. Our success in the enrollment of patients with ovarian cancer encourages to think that Forward I could be recruited in good time.
As Dan mentioned, we completed enrollment in 40 patient cohorts ahead of schedule, and enrollment in our other ovarian cancer cohort with 20 patient cohorts for patients requiring biopsies before and on treatment also is ahead of schedule. In fact we dosed 20th patient yesterday.
We are now gaining safety, efficacy and durability results for the [form] on 40 patient cohorts with platinum resistant ovarian cancer and plan to discuss these findings when they mature with the FDA. We also expect report in the ASCO next year.
The other Mirvetuximab abstract to the triple meeting, abstract C170 relates to our interest in rapidly moving this ADC in to assessment in combination regimens and the design of our Forward II trial. Our pre-clinical assessment indicate that the addition of Mirvetuximab to Avastin to Carboplatin to Avastin and Carboplatin together and to Doxil has a potential to meaningfully enhancement the efficacy.
For example, we found using Mirvetuximab with Avastin had a more than additive impact on activity in models of platinum resistant ovarian cancer. The four data will be disclosed on November 8, where you can see from the abstract that these preclinical models suggest that Mirvetuximab in combination with agents like Carboplatin and Avastin could potentially exceed the efficacy of current standard of care combinations.
Of course this requires that the drugs can be safely combined and this will be evaluated along with initial assessment of efficacy in the Forward II study, which like Forward I were on track to begin by the end of 2015. While we spend considerable time on Mirvetuximab, I should know that we are also making meaningful progress with our other pipeline programs.
We submitted the IND for IMGN779 and expect to begin Phase I testing in the first part of 2016. We are on track to begin clinical assessment via IMGN529 using combination with Rituxan this quarter and to start clinical testing of Coltuximab ravtansine and a combination regimen 2016.
In all we are making solid progress advancing our strong pipeline. On that note, I’ll turn the call over Dave to discuss the financials.
Dave?
Dave Johnston
Thanks Charlie and good morning everyone. So as Carol noted we issued a press release this morning with our first quarter fiscal year 2016 financial results, and I will review the highlights and then also review the guidance for our full fiscal year of 2016.
For the quarter, revenues in our first quarter of our fiscal year were 14.9 million as compared to 13.2 million for the same quarter last year. Above that revenue from license and milestone fees was approximately $6 million which includes milestones earned from Lilly and Amgen, with advancement by each with a new ADC to clinical testing.
Our revenue in the current period also includes $5.7 million of non-cash royalty revenue on sales of Kadcyla for the three months ended June 30, 2015. As a reminder, the royalty is passed to the purchaser of the royalty stream and we report non-cash Kadcyla royalty revenue that is partially offset by non-cash interest expense resulting in non-cash net income.
Finally, our revenue results include $3.1 million of clinical materials revenue and research and development support fees. Operating expenses for our first quarter and fiscal year 2016 were $43.5 million compared to 35.1 million in the first quarter of last year.
These consisted of $35.1 million of R&D expense for the first quarter of this fiscal year compared to 28 million in the same period last year, and 8.3 in G&A expenses this year compared to 7.1 in the same quarter of last year. Driving the change from previous fiscal year, our greater third party cost related to the advancement of our product candidates especially Mirvetuximab and higher personnel related expenses related principally to recent hiring.
For the first quarter of fiscal ’16, we reported a net loss of $33.7 million or $0.39 per share compared with a net loss 22.3 million or $0.26 per share for the same quarter of last year. Cash used in operation was 31.4 million for the first three months of fiscal ’16 compared with 18.9 million in the same period of last year.
Our capital expenses were 3.4 million in the first quarter compared with 1.7 in the same period of last year, and lastly we ended the quarter with 247.8 million in our cash and cash equivalents compared with 270.1 million as of June 30,2 015 and we continue to have no debt. So let’s go over our fiscal year on guidance, and it remains unchanged from what we issued on July 31 of 2015.
Specifically revenues are expected to be between 17 million and 18 million, operating expenses to be between $175 million and $180 million and net loss to be between a $120 million and $125 million. Cash used in operations between 100 million and 105 million; capital expenditures to total between $13 million and $15 million; and we expect to end fiscal year 2016 with between 165 million and 170 million in cash.
We firmly believe the development of our own portfolio compounds will result in the greatest creation of value for our shareholders and we are making significant investments to advance Mirvetuximab Soravtansine as aggressively and expeditiously as possible. So with that let me turn the call back over to Dan.
Dan Junius
Thank you Dave. As you heard from Charlie, we have a lot going on and look forward to continued strong progress in a steady new way.
Of particular importance our anticipated Mirvetuximab event starting with the presentation of patient response (inaudible) data followed by level of target expression on November 8 at the triple meeting. We intend to report the findings from the full 40 patient cohort of patients with platinum resistant ovarian cancer at the 2016 ASCO meeting.
We’d like to have an additional presentation on Mirvetuximab at ASCO such as the findings in the patients with endometrial cancer and/or from biomarker assessment of tumor biopsies. We’ll have to see how these data mature and where we are at the time of abstract submission.
And of course to expect to start Forward I and Forward II by the end of this year and a meeting the FDA about an accelerated approval pathway in the first half of 2016. We’ll also be reporting findings from preclinical assessment of Mirvetuximab in combination regimens for ovarian cancer of the triple meeting, and for IMGN529 in Coltuximab ravtansine in combination regimen for B-cell malignancies at HASH.
We expect to begin testing of IMGN529 in combination with Rituxan this year and assessment of Coltuximab and a combination regimen in 2016, both in pretreated diffused large B-cell lymphoma patients. Finally we plan to advance our IMGN779 ADC in to patient testing early next year.
We are looking for marked progress in the partner front as well including two of our partners starting registration enabling trials in 2016. So we are executing on our product plans, we look forward to providing you updates as these programs progress.
And with that I will turn it over to Carol so we can take your questions.
Carol Hausner
Thank you, Dan. We are about to open the call to questions.
We ask that these be limited to one to two questions per person until each analyst has had a chance to ask a question. Operator we are now ready to open the lines to questions.
Operator
[Operator Instructions] We’ll go first to Jessica Fye with JP Morgan.
Jessica Fye - JP Morgan Securities
Couple on Mirvetuximab; first, do you see the mix of high-end medium for your receptor alpha expressors you enrolled in that ovarian cohort you are talking about. Do you think that’s reflective of the overall patient population?
I know they are small numbers, but what gives you confidence that those won’t swing around too much. And then second question is, can you walk through the decision to enroll both mid and high expressors in Forward I and not just tie, and is there are target number of patients for each level of expression or do you take them how they come, just thinking about how the mix of those patients could affect the results of the first stage of the study.
Thanks.
Charlie Morris
Thanks Jessica. I think the first question is an important question.
What we have been doing is tracking not just the patients who go in to the study, but obviously we do get patients who come in to screening and for various reasons don’t make it in to the study. I would say that the mix of patients who have gone on to the study has been reflective of the overall screening pool, if that makes sense.
So I think in that larger cohort patients, yes, I think there is a consistency between what we are seeing and I think this kind of, if you like, the 60-20-20 mix between the high-medium lows is probably going to be of 50-25-25 roughly. It’s roughly how we expect things to come out.
In terms of making decisions, in each individual base at this point is relatively small numbers of patients right, and clearly there is high activity in the high expressors, you’ll see more about that in a couple of weeks’ time. I think there is clearly activity in the medium expressors and we just want to have more opportunity to understand that in greater detail.
We are not trying to limit specific numbers of patients by those categories, we’ll take what we get. But we will stratify to make sure there’s a balance.
On one of the slides of the two stage design of course is that at the end of stage one of Forward I, we’ve got an opportunity to take a look and say, do we want to keep those medium patients in or is there enough evidence the benefit will just tick with the high. So enables that decision to be.
As for the [kick] down the road, without necessarily impacting our ability to make comparisons to the physicians choice.
Jessica Fye - JP Morgan Securities
Can I just squeeze in one follow-up on that. The one patient that you had in that mid expressor group who was a responder; I know you had some unconfirmed partial response that were just over the threshold.
Was that mid-level patient kind of one of these border line responders or do they have a more significant response.
Charlie Morris
November 8th.
Operator
We’ll go to Matthew Harrison with Morgan Stanley.
Matthew Harrison - Morgan Stanley
One just a follow-up on Jessica’s question, can you tell us how many patients you’ve screened just so we have some idea of the sample size you guys are looking at. And then just can you help us think us about your meeting with the FDA.
I think you said you completed the 40 patient cohort enrollment in August, so when do you think you’ll internally have data and how is that that you are up for a timeline in terms of meeting with the FDA and do you need to have that - would you send that full dataset in to them before requesting a meeting or how should we think about those order of events.
Charlie Morris
So in terms of numbers clearly I apologize I don’t have the exact number, it’s around a 100 that have been screened in total at various points along the way. On the FDA front, the whole has been to allow that dataset to mature so that we have the patients who were coming in remembering that we recruited last patient in August would like at least to give those patients the opportunity to respond and get some durability to their individual responses before we take that data then to the agency.
So the plan would be to have all of that [third] stage that the next study begins that we would have their feedback, the input and their thoughts on the second stage long before that second stage begins.
Matthew Harrison - Morgan Stanley
So just to be clear there are certain level of duration that you are looking for in that first 40 patients before going to meet with the FDA.
Charlie Morris
I think it’s more a matter of knowing what it is. I think to start to see things as particularly interesting I think would like to at least think about the six months median duration of response.
We got some sense as you’ll see in that couple of weeks’ time on how durable the responses are. But it’s early to be thinking definitively about what that is.
So I think taking a more complete dataset and having a real sense of where that is will help us enormously in our conversation with the agency.
Operator
We’ll go to Andrew Peters with UBS.
Andrew Peters - UBS
Just a couple, I guess first to follow-up on Jessica and Matthew’s question on screening. So if I heard you right, you said you had screened a 100 patients.
Just wanted to understand, what’s the primary cause this screen failure that you’re encountering so far. And just on fully expression levels, just wanted to understand is there any reason that expression would change as patients by previous therapy.
Just want to understand if you’d expect before a receptor expression to be similar as you move in to earlier settings.
Charlie Morris
In terms of screen failures without necessarily bearing down in to all of the details. In the phase one population as you, you are often dealing with sick patients who have a variety of other things and you have your set entry criteria.
So you got a certain number of patients who come in and they walk out of their screening, but then you find here in the rest of the screening process that may be their chemistry doesn’t work or their baseline hematology doesn’t work. So it’s a variety of things.
Some patients decide they don’t want to go on to a clinical trial after all. Some even progress between within the screening period.
So there’s a variety of things that can happen and there’s no sort of fixed pattern to it other than sort of fairly typical for what you see in a phase one setting. The expression changes is a really important question, and that’s really what one of the key questions that we are asking in this biopsy cohort that we’ve talked about, because that will give us the expression to look back to the archival tissues on which we’ve been basing our entry decisions so far, and say well does that appear to correlate with what we see at the time of a fresh biopsy, two, three, four, however many years later it is.
Those data obviously is not mature at this point. I would hope that we would have enough information on that to also submit that to ASCO.
But I think intuitively you would think well the high expressor seem to be doing very well that makes kind of intuitive sense, so I am thinking we’re probably going to find that it’s a stable phenotype, but we’ll have data to confirm that.
Operator
We’ll go to Simos Simeonidis, RBC Capital Markets.
Simos Simeonidis - RBC Capital Markets
On slides that Carol sent us before the call, when you are describing the entry criteria for Forward, there’s a line there that says, raise the FRA [card-off]. Can you talk about what that change was, from what to what?
Is it that before you were using low expressors and now you’re just going to use mid and high.
Charlie Morris
Yes, so previously it was 25% of at least two plus, now we’re just raising that to be 50%. That will include the medium and high and then so those two groups we will also stratify the randomization so that we have an equal distribution between arms which I think is particularly important in stage one of course, because what you don’t want to do is find that your efficacy is influenced by that distribution and it gives another opportunity to take a look at the medium patients and say are we seeing enough.
So the lower expressors is the 25 to 50 of which you will notice there’s not many [invested] anyway, those we think we will leave those out even starting now.
Simos Simeonidis - RBC Capital Markets
One last for you Charlie, can you without getting too touch-and-go I guess, talk a little bit about the assay used, and how much of a variability do you think there would be in these assay, one scoring cells for low, high and medium expressions depending on how the biopsy is exercised. And what I mean by that is, when you look in that cells - the chemistry and you’re scoring tumor cells versus cells from the adjacent tissue is that a concern or do you think that the difference would be pretty much the same or similar across samples.
Charlie Morris
At this point we believe it would likely be the same. Again it’s another important question and indeed it’s one of the reasons I think to not just focus entirely on the highs at this point.
It is to say well, given there is indeed, will I exceed is, if you like, subjective element. People will look at it, they’ll look at the density of staining and make their interpretation of whether it’s two plus or is three plus.
So I think the patients that are maybe close to the line if you’d like around that 75% level I think it’s important that we understand that how they do before sort of excluding that medium group of patients. It should be reproducible, it’s part of the testing that happens and obviously as and hopefully when we get around having a commercial product, part of the process is to educate pathologists on the use of a diagnostic.
And we think it is important that the working with the very experienced diagnostic group of working with Ventana that’s a collaboration that is going well and we think that’s an important, it’s going to be clearly especially having made these decisions about the cut-offs is going to be an important part of the success as a product.
Operator
We’ll go to Mara Goldstein with Cantor Fitzgerald.
Mara Goldstein - Cantor Fitzgerald
I have a question and I’m guessing you’re going to tell me this is a November 08 kind of an answer, but with respect to the responses that you’re seeing and the expression levels and durability, are we going to be able to look at patients and duration of treatment according to this stratification.
Dan Junius
What you will see is, if you remember the swim lengths that we’ve used previously you will those swim length laid out by high, medium and low expression. So it won’t be that just sort of looking at a median, I think this is the individual numbers in each subset are very low to be talking about medians, but you’ll have an expression because you will see that data split out according to the level of expression on those swim lengths.
Mara Goldstein - Cantor Fitzgerald
And just to get back to Simo’s question for a quick second. So if you think about it for a second and when you’re looking at HER2, for those patients who appear on the margin between two plus and three plus, they often go on to [Fish] payment diagnostics just to confirm treatment.
Is there any opportunity to do the same with the folate receptor in terms of really being able to identify which of these patients on the (inaudible) might really be those that should be in the high group versus the moderate group.
Charlie Morris
Since at this point we are guessing, we are including both. At this point we have not looked to that.
I think it’s an interesting question to see whether would those be patients for example who might be candidates at that point, rather than to use the archivable tissue might ask for a fresh biopsy at that point to see how it looks today. I think that’s a story that will continue to evolve particularly if we continue to see what we would think were important differences between the medium and the high group.
But we haven’t looked at that at this point.
Operator
And we’ll go to Christopher Marai of Oppenheimer.
Christopher Marai - Oppenheimer
So in keeping with the theme on the call here, I will touch up on the folate expression. I was wondering if you could comment on any regulatory discussions you’ve had regarding the measurements of the folate receptor expression.
Obviously it seems like you’d be looking to enrich a patient population or a trial based on those levels. So is the FDA okay with your measurement techniques and how would you implement that in a real world setting post approval I’d say or even think about it with respect to the label.
Charlie Morris
Well at this point that will be another part of the discussion with FDA as we go forward. FDA might clearly refuse all of our protocols, how the opportunities come unto us as we go forward and there’s nothing that we are doing here that I think anybody would consider anything other than the relatively standard approach to how we are seeing oncology products being developed.
So I don’t think that there’d be any particular concern there. But that will be part of the discussion with FDA, and clearly thinking about as you move through the various stages to having something defined as companion diagnostic, clearly one of the things that will be happening is that we will be launching a diagnostic at the same time as we’d launch the product if we are successful enough to have the pleasure of being in a launch situation.
So I think the two will go together. But I think it will be an important part of success, and it enables you to define a population who if we continue to see anything like this level of activity that would define a population, that would be very important.
Dan Junius
Chris to re-emphasize Charlie’s point, the FDA does have exposure in the protocol submission to the full scope of what we’re doing and therefore they can see what this screening technique is that’s going to be used and have the opportunity to come and [honor] it at that point. So I do think they have that exposure and hopefully that addresses the concern that you raised.
Christopher Marai - Oppenheimer
Okay, and the with respect to the diagnostic in terms of development where are you at and may be when do we expect to hear an update from that.
Charlie Morris
Well in terms of where we are, I’d say we are working with Ventana, you go through the various stages where you have if you like an outcome, a design of what we hope will be a diagnostic. At this stage it’s officially diagnosis investigational use only diagnostic.
But that would be intended to not need any further tweaking if you like apart of being hopefully approved at some point to the companion diagnostic to go along. So we would anticipate this would be a part of what would be in the prescribing information, would be to say that it would patients define us to the appropriate level of expression as defined by this particular diagnostic.
Christopher Marai - Oppenheimer
Great, and you remind us that you are using this diagnostic in the Forward trial.
Charlie Morris
Yes, that’s correct.
Christopher Marai - Oppenheimer
Great, and then finally, just one last question and I’ll throw in here. Thinking about the competitive landscape obviously Opdivo is something that’s being investigation in the folate setting.
I am wondering how are you guys looking at potential combinations with I/O type therapies, thanks.
Dan Junius
It’s something we’re exploring. We are looking at the full range of existing therapies and potential emerging therapies.
So I think we want to make sure that we look at the full range of opportunities of how these things may benefit patients. So that’s certainly on the radar screen Chris.
Operator
We’ll go to John Newman with Canaccord.
John Newman - Canaccord Genuity
My question is with regard to the design of the studies going forward. I am just wondering if there has been any changes to any sort of a cut off that was in the expansion cohort whereas you set a time limit in terms of the fastest amount of time that a patient could have progressed, and if they progress faster than that they are excluded from the study.
So I am just curious if there’s been any changes there just so that you can screen out people that might have relapsed or progressed really, really quickly in this studies going forward.
Charlie Morris
The key criteria will be that we are targeting patients who have had three or four prior lines of therapy, and are otherwise eligible according to a variety of criteria, we are including epithelial ovarian; we are not including clear-cell we are not including some of the more low grade ovarian tumors. But I think in terms of rapidity of (inaudible) progression, there wasn’t actually anything specifically defined in the current expansion cohort.
So I think the population that you’re going to see is going to be largely similar. They won’t be as heavily pre-treated as they were obviously in those escalation in the prior studies.
But other than that, it would be a typical of what you would see in a resistant population. Now what we had said in prior studies was that the traditional definition of platinum refractory, those were excluded.
But those patients who basically don’t respond to platinum refractory, they are a thankfully a relatively uncommon if not rare population, and the sad thing that they don’t generally get before (inaudible) patients because they do very badly on subsequent therapy. So I don’t think that population is likely to be a candidate unless they are one of the fortunate minority who have the opportunity to respond to subsequent therapies.
Dan Junius
And to emphasize John there wasn’t anything on that criteria that looked at the rate of patient progression. If there is a suggestion that we were looking for a patient population that - you know the disease was not progressing as rapidly, we are getting a quote less sick patient population.
That isn’t anything that even would have come up. It was simply a matter of a number of criteria, a number prior therapies etcetera.
But the time it took for the patient to progress is not something that would be evaluated at all.
Operator
We’ll go to Boris Peaker with Cowen and Company.
Boris Peaker - Cowen & Company
I just want to know about the Forward II study. Will you specifically select high expressors there?
And in general how many patients do you plan to include in each combination arm for that study?
Charlie Morris
So Forward II we are actually not changing these as the (inaudible) for that, that will remain at 25%. The data that we have suggests the ability for activity across, so we will continue to look at low, medium and high and obviously we have the opportunity to change that according to what the data show.
When it gets to the expansion piece of that, it’s 24 patients in each of the Avastin groups that we were planning to treat. I’ll remind you that was one group who had not had prior Avastin exposure to one who had prior Avastin exposure.
And although we haven’t necessarily sort of discussed what other expansions may occur. I think that will be determined by what we see in those escalations, but I think it would be similar sized cohorts.
Boris Peaker - Cowen & Company
Got you. And will you have some data from that study as ASCO?
Charlie Morris
It’d just be too soon. We are not anticipating recruiting patients until towards the end of this year, the best within the world.
It’s always a slow start because you got to get your eye on the approvals (inaudible) else going. So I don’t think there’d be anything that should be particularly helpful to present at ASCO for that one.
Operator
We’ll go to Michael Schmidt with Leerink Partners.
Michael Schmidt - Leerink Partners
I just had one on Forward I, I noticed you’re also enrolling a once every four weeks dose cohort in this first part of the study. And my question is, can you just remind us of what you’ve learnt in terms of the PK relationship and associated toxicities and what side effects could be reduced with a less frequent dosing.
Is that mainly an attempt to lower the ocular side effect or are there other adverse events that might benefit in terms of lower rate from this less frequent dosing.
Charlie Morris
The thought here is to take the opportunity to say, how do we get the best possible experience for the patients. Patients having a good experience respond to it.
In fact the tolerability is good, we are not seeing any high rate of discontinuation with the eye effect while reversible and manageable. But if we can have less [unretanius] activity we’d like to do that.
So the concept behind the full weekly was more about the recovery time. Based on the half-life of the product which we’ve got around four to five days, you’d expect the fourth week would just give you a little bit more freedom if you like from the treatment.
So that would enable the cornea a longer time to recover in theory. And so the hypothesis there is just so that may reduce the number of ocular [case] and reduce the amount of blurred vision.
Clearly with the data that we’ve got and the safety tolerability efficacy we’ve got. We would be a moment prepared to go forward with the three week schedule, but we just wanted to have that look to see if the four weekly could provide is even better.
We’re not going to give up on efficacy here; it’s too important to us. So we’ll take a look at that at the end of the first stage and make our decision at that point.
Operator
We’ll go back to Simos Simeonidis with RBC Capital Markets.
Simos Simeonidis - RBC Capital Markets
A quick follow-up; on November 8th are we going to see data on the 17 patients or could we data on the 22, the five that were not evaluable could we have enough information to see data on those?
Charlie Morris
There will be data on all 22.
Simos Simeonidis - RBC Capital Markets
Okay, great. And finally since nobody is asking Dave anything, can you tell us what the milestones from Lilly and Sanofi were for entering the clinic.
Dave Johnston
Sanofi was actually received in October, so that would be actually reported in next quarter. So Lilly was $5 million for this quarter, for the first quarter, Amgen was $1 million, and we’re looking for Sanofi one to be recorded for next quarter, that was $2 million.
Operator
That does conclude today’s question-and-answer session, and at this time I would like to turn the call back over Carol Hausner for any additional or closing remarks.
Carol Hausner
Would like to thank you for your interest ImmunoGen, and if you have any additional questions please don’t hesitate to call. And have a great day.
Take care. Bye.
Operator
And this does conclude today’s conference. Thank you for your participation.