Jul 31, 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
Christopher Marai - Oppenheimer Matthew Harrison - Morgan Stanley Michael Schmidt - Leerink Partners Boris Peaker - Cowen & Company Mara Goldstein - Cantor Fitzgerald Simos Simeonidis - RBC Capital Markets Andrew Peters - UBS
Operator
Welcome, everyone, to this ImmunoGen Fourth Quarter Fiscal Year 2015 Financial Results Conference Call. [Operator Instructions].
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. Good morning.
At 6:30 this morning we issued a press release that summarizes our financial results for our fourth quarter and fiscal year ended June 30. I hope you've all had a chance to review it; if not, it is 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 detail; 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, everyone. We said at the start of 2015 that we expected this to be a notable year for ImmunoGen and I think it has become apparent as the year evolves that this goes beyond notable to being transformational for the company.
There are a number of developments that would support that statement, the advancement of our proprietary pipeline being the most prominent. The findings reported at ASCO in June with our lead program, mirvetuximab soravtansine or IMGN853, were beyond expectations and, frankly, even our own expectations.
Over half of the women with platinum resistant ovarian cancer who received this ADC had marked tumor shrinkage for an objective response rate of 53%. Putting this in context, single agent therapy typically achieves response rates in the 15% to 20% range in this patient population.
These data support our aggressive advancement of mirvetuximab soravtansine for ovarian cancer, a disease where there is an acute need for new therapies. The data also make an important statement about the power of our ADC technology.
Mirvetuximab is now the fourth ADC with ImmunoGen technology to demonstrate marked activity in disease specific testing and, notably, the second in the solid tumor indication. In response to these findings we're investing to rapidly advance mirvetuximab to patients with pretreated ovarian cancer and also to expand its potential uses, as Charlie will discuss shortly.
You'll also hear from Charlie about our other wholly-owned compounds, IMGN529 and coltuximab ravtansine for B-cell malignancies and IMGN779 for acute myeloid leukemia. As he will cover these products let me turn to progress by our partners.
Sales of Kadcyla continue to increase on a global basis driven by strong growth in Europe, Japan and other international markets. As we monetized our Kadcyla royalty stream earlier this year, the expanding use of this important drug does not impact our current cash inflow, but we could benefit in the later years on the royalty stream.
Beyond the financial dimension though, we find it very rewarding to see Kadcyla finally helping so many women in its approved indication. Roche is continuing to invest behind Kadcyla and, if the data are positive, expects to apply for approval for second line treatment of advanced HER2 positive gastric cancer in 2016 using the Gatsby trial data.
They also have three registration trials underway in early breast cancer as well as a Phase 2 study in non-small cell lung cancer. Beyond Kadcyla there are nine compounds in the clinic through our partnerships, of which is many of three are expected to advance into later stage clinical testing either Phase 3 or pivotal Phase 2 studies in 2016.
Another two to four partnered compounds are expected to enter the clinic by mid-2016 in addition to our own IMGN779. So we're making very good progress with our wholly-owned pipeline.
We're seeing several of our partners preparing to advance compounds into late stage testing as well as bringing new ones into the clinic and we're in a solid cash position. So we're entering our fiscal 2016 with quite a bit of momentum.
With that let me turn it over to Charlie to take you through ImmunoGen's product programs in more detail. Charlie?
Charlie Morris
Thanks, Dan, good morning, everyone. I will start with mirvetuximab soravtansine, previously known as IMGN853.
We have noted that this is the first known ADC that targets folate receptor alpha that has entered clinical testing. I think it is distinctiveness became apparent as ASCO when study investors reported a response rate from the first 17 evaluable patients treated with mirvetuximab soravtansine, 53%, this is markedly above the 15% to 20% response rates normally seen with approved single agent therapies such as doxil or topotecan in platinum resistant ovarian cancer.
We have previously stated that a 30% to 40% response rate of the single agent will be sufficiently encouraging to pull the trigger on advancing mirvetuximab soravtansine into late stage testing as a single agent for this disease. Given the strength of these initial response data we're preparing to start a Phase 2 trial by year end that, if the data warrants, could potentially support an accelerated registration approach.
We're in the process of finalizing the design of this study and will disclose details later this year. The 53% response rate was seen in a group of patients selected for having folate receptor expression at a 2 plus level in at least 25% of the cells using an IHC-based diagnostic we're developing with Ventana.
In the data reported at ASCO, 80% of the patients screened exceeded this cutoff level. We're continuing to evaluate the relationship between target expression and patients' responses and will consider refining of the cutoff if we determine we can even more precisely target the patients who will benefit.
We plan to report our initial findings on the relationship between folate receptor alpha expression levels and response to mirvetuximab and are targeting the AACR-NCI-EORTC conference in November for this abstract. We're continuing to enroll patients into the Phase 1 cohort evaluating mirvetuximab as monotherapy for platinum resistant ovarian cancer and are confident we will complete enrollment of all 40 patients within the next few months.
Once these data are mature we plan to discuss the findings with regulatory authorities in conjunction with exploring opportunities for accelerated development. As a reminder, mirvetuximab soravtansine already has orphan drug designation in the U.S.
and Europe. We remain on track to initiate assessments of mirvetuximab soravtansine as part of combination regimens later this year.
We're pursuing this to further expand the potential of this promising agent to help women with ovarian cancer, including those with less heavily pretreated disease. In considering agents in combination with mirvetuximab soravtansine, we have looked at current usage data in various settings, taken input from opinion leaders on the spectrum of needs in the area and being guided by our preclinical findings with different combination regimens, data that we also plan to present in the near future.
Folate receptor alpha is reported to be highly expressed on a number of cancers besides ovarian cancer, including certain lung, breast and endometrial cancers. We're assessing mirvetuximab soravtansine for endometrial cancer in a Phase 1 expansion cohort and evaluating other indications preclinically.
We recently established a collaboration with the National Comprehensive Cancer Network's oncology research program to facilitate the assessment of mirvetuximab in a variety of preclinical and clinical settings including indications beyond ovarian cancer. With all of these studies underway and planned I would also note that we will not be further assessing the modified weekly dosing schedule for this ADC at this time.
While the weekly schedule has shown activity and tolerability consistent with what we saw with the three weekly schedule in dose escalation, we have not seen clear evidence of differentiation from the more convenient once every three week schedule we have been using. So we're focusing our efforts on the initiation of the two key mirvetuximab soravtansine studies, the single agent Phase 2 trial and the combination trial for scheduled to start by the end of this year.
I will turn out to our ADC for B-cell malignancies, CD37 targeting IMGN529 and CD19 targeting coltuximab ravtansine. We're excited to have these two highly promising agents as there remains a strong need for new therapies to treat B-cell malignancies, particularly relapsed refractory diffuse large B cell lymphoma where both of these agents have shown activity.
The LBCL is typically treated with a combination of therapies and we plan to initially advance both IMGN529 and coltuximab ravtansine in appropriate combination regimens and then determine next steps. For IMGN529 the path is clear, preclinically it has shown impressive synergy in combination with rituximab.
These data were recently presented at the 13th international conference on malignant lymphoma in Lugano. As you know, rituximab is widely used in the treatment of DLBCL and we've therefore planned to move IMGN529 forward in combination with rituximab; in fact, we're preparing to start a Phase 2 combination trial with these agents later this year.
For coltuximab ravtansine more preclinical work needs to be done prior to deciding which agent or agents to combine with. We're currently evaluating several options preclinically and expect to start preclinical testing of coltuximab ravtansine in combination next year.
We plan to submit preclinical findings with both IMGN529 and coltuximab ravtansine in combination regimens for the ASH conference in December. I will wrap up my comments by noting that we're on track for submitting the IND for our CD33 targeting ADC, IMGN779, in the next few months.
This is a new potential treatment for acute myeloid leukemia and myeloid dysplastic syndrome and uses our new DNA acting payload platform. So a lot is happening.
And with that I will turn the call over to Dave to discuss the financials.
Dave Johnston
Thanks, Charlie. As Carol noted earlier, we issued a press release this morning with our fourth quarter and fiscal full-year 2015 financial results.
I am going to review the highlights and then provide our financial guidance for fiscal year 2016. For our fiscal year ended June 30, 2015, we reported a net loss of $60.7 million or $0.71 per share compared with a net loss of $71.4 million or $0.83 per share for fiscal 2014.
Our net loss for the fourth quarter of 2014 was $30.5 million or $0.35 per share compared to a net loss of $26.5 million or $0.31 per share for the same quarter of last year. Revenues for the year were $85.5 million compared to $59.9 million in fiscal 2014.
And of that revenues from license and milestone fees were $57.8 million in fiscal 2015 compared to $39.5 million in fiscal 2014, with the increase primarily due to more licenses being taken by our partners, specifically Novartis and Lilly and the associated amortization of their upfront fees previously received. We also saw increased cash revenue from partner milestone payments.
We reported $19.4 million in Kadcyla royalty revenue. $13.9 million is cash royalty and $5.5 million is non-cash royalty revenue as compared to $10.3 million in cash royalty revenue we received in fiscal year 2014.
The $5.5 million non-cash royalty revenue in FY15 is on sales of Kadcyla occurring after January 1, 2015 which fall under the royalty purchase agreement we announced in March. As a reminder, this royalty purchase transaction closed early in the fourth quarter and provided us with net proceeds of approximately $194 million.
Going forward we will be reporting non-cash Kadcyla royalty revenue despite the royalty being passed to the purchaser of the royalty stream. Our statement of operations will also include non-cash interest expense associated with the royalty transaction which is treated as a liability from an accounting perspective.
This interest expense will only partially offset the impact of the non-cash royalty revenue resulting in non-cash net income. Our fiscal 2015 revenue also includes $5.5 million of clinical materials revenue and $2.8 million of research and development support fees compared with $2.9 million and $7.2 million respectively in the prior year.
Operating expenses in fiscal 2015 were $140 million compared to $131.4 million of last year. These consisted of $111.8 million in R&D expense in fiscal 2015 compared to $107 million in fiscal 2014 and $28.2 million in G&A expenses in fiscal 2015 compared to $24.5 million in fiscal 2014.
Driving the change from prior year are greater third-party costs related to the advancement of our product candidates and higher expenses related principally to recent hiring. Cash used in operations was $55.3 million in fiscal 2015, in line with our guidance.
Our capital expenditures totaled $7.4 million in fiscal 2015 and we ended the year with approximately $278.1 million in cash and cash equivalents which is slightly higher than our guidance. We provide a guidance for fiscal 2016 in our press release this morning.
This guidance is based on advancing our lead product, mirvetuximab, across multiple fronts, clinical, companion diagnostics as well as CMC. Additionally, it reflects substantially higher clinical enrollment across four development programs and the personnel growth needed to support these expanded programs.
So, turning now to the guidance. For our fiscal year ending June 30, 2016, we project revenues between $70 million and $80 million, operating expenses to be between $175 million and $180 million and net losses between $120 million and $125 million.
Cash used in operations to be between $100 million and $105 million. Capital expenditures to total between $13 million and $15 million.
And finally, we expect to end fiscal year 2016 with between $165 million and $170 million in cash. In summary, we're well-positioned to execute on advancing our product pipeline, including the initiation of later stage trials of mirvetuximab.
So with that let me turn the call back over to Dan.
Dan Junius
Thanks, Dave. As you heard from Charlie, there is a lot going on and we look forward to a steady news flow over the next 12 months.
Let me take you through that. So starting with our own programs, we intend to submit an abstract related to Biomarkers and clinical response to mirvetuximab soravtansine to the AACR-NCI-EORTC conference taking place in November.
On the clinical front we're prepared to start two trials with mirvetuximab soravtansine by year end that potentially could be transformational for many patients with folate receptor alpha positive ovarian cancer. This will be a Phase 2 trial that assesses mirvetuximab as a single agent in patients with pretreated disease and a separate trial that assesses it used in combination regimens.
If successful the single agent study could potentially provide an accelerated registration pathway in this disease. We will provide study details when finalized later this year.
Also we expect to complete enrollment in the 40 patient Phase 1 cohort assessing mirvetuximab as a single agent for platinum resistant ovarian cancer soon and plan to report these data in the second quarter of 2016. We're preparing to start a Phase 2 trial assessing IMGN529 in combination with Rituxan for diffused large B-cell lymphoma in the next few months.
Also for 529 we're submitting an abstract to ASH with interesting preclinical findings in combination with Rituxan, including potential mechanisms for synergy, as was reported for this combination at the Lugano conference in June. We expect to initiate Phase 2 testing with coltuximab ravtansine in a combination regimen in 2016 and to submit initial preclinical combination data to ASH this year.
We're on track to cement our IND for IMGN779 later this year. This will be the first ADC into the clinic using one of our new IGN DNA acting payloads.
We expect patient dosing to begin in early 2016. And finally a few highlights related to partner products.
We expect new clinical and preclinical data to be presented for several partner ADCs in the next 12 months and as many as three more partnered compounds to advance into late stage clinical testing in 2016. If the results are positive we expect Roche to apply in 2016 for approval of Kadcyla for second line treatment of advanced HER2 positive gastric cancer off of the Gatsby trial data.
And finally, we expect additional partnered compounds to advance into the clinic in the next 12 months. So we're making exciting progress in the clinic on a number of fronts.
We're also seeing interesting data on programs in the research organizations which we'll speak to in greater depth at our Analyst Day on September 18. But all of this amounts to significant momentum for our technology, for our product programs and for those of our partners.
So with that let me turn it back to Carol and we will move into the Q&A portion of the call. Carol?
Carol Hausner
Thanks, Dan. We're about to open the call to questions.
We ask that each asker limit their questions to one to two per person until everyone has had a chance to ask questions. You can get back in the queue then.
Operator, we're now ready to open the lines for questions.
Operator
[Operator Instructions]. We will go first to Christopher Marai of Oppenheimer.
Christopher Marai
You highlighted you were looking at two trials for 853, a fully targeted molecule. One being a single agent trial.
Is that expected to be a placebo-controlled trial? And then number two, you're looking at potential combination therapy Phase 1/2 trial.
Would that be something that would be an open label trial? And what type of combinations are you looking at?
Is that sort of platinums or are you looking in combination with Avastin? Thank you.
Charlie Morris
We have yet to disclose the details of the design of either of the studies, as you know. We will get into detail on that at the event that we're having in September.
And I think we will be ready at that point to disclose in detail. So I'm going to avoid answering the question to a certain extent, though I would not anticipate placebo control as being a feature of the single agent study.
From a combination, obviously the key thing in the first instance there is to look at the tolerability. We will look at more than one combination agent.
Again, we will disclose details a little bit later in the year. And that will include both the tolerability part as part of dose escalation and some dose expansion with one or more of those combinations.
As I said in my remarks, we have looked at that use data in the market, we have looked at where we believe things are going and we have looked at our own data in combinations. We think we're making very rational decisions in terms of those combinations and look forward to giving a bit more detail later in the year.
Christopher Marai
I'm just kind of curious. It doesn't sound like you are planning a Phase 2 placebo-controlled trial, but you think it might be registrationally worthy if the data is sufficient.
Have you talked with regulators either in the EU or the FDA about this? Is there any precedent that you are pointing to here that could get us comfortable with a strategy like that?
It seems a little higher--
Charlie Morris
Sorry, the question was whether it would be a placebo-controlled trial and the question -- I was saying it is unlikely to be a placebo-controlled trial. We have not got into detail of whether it will be a randomized study or not at this point.
We do plan to speak to agencies during next year. We want some more data to come forward from this ongoing study before we go and meet with them.
We're comfortable though that the designs that we're looking at would be able to support the strategies that we're working on. And obviously we continue to look at precedents; including obviously things like recent approval most notably I think from [indiscernible] where an approval on the basis of response rate was able to -- with durability was able to get them that approval.
As I said, I will get into detail a little bit later in the year. But we're not planning anything off the wall or outrageous here.
We're just planning reasonable studies primarily aimed of course at more fully defining the efficacy and safety profile, that is what Phase 2 is about. But if the data is strong we believe that the design will be able to carry us to an accelerated approval as well.
Christopher Marai
Okay and one last quick one here. And that sort of control arm, that would be sort of a maybe dealer's choice sort of chemo?
Thanks.
Charlie Morris
Details to follow.
Operator
We will go next to [indiscernible] of William Blair.
Unidentified Analyst
This is Andy Shae [ph] for John Sonnier, thanks for taking the question. Great data coming out of ASCO was mirvetuximab soravtansine.
We have gotten a couple of calls from investors about that the response rates were not confirmed by independent review. Do you guys have an estimate of what the discordance rates between the investigator or independent assessment might be in this setting?
Thanks.
Charlie Morris
I do not have anything that I could meaningfully offer you in terms of discordance rates there. As we know, if we do independent reviews there is sometimes some discordance.
I think we're seeing less and less of that. Obviously with this being a Phase 1 study that was not originally built in, though we're considering looking at getting some of these so that we can get comfortable ourselves.
But I don't think in Phase 1 it would be unusual to have response rates not confirmed by independent assessment. And of course it is notable that Avastin's approval was actually based off investigator assessments of response and progression as well.
But we're certainly looking at all considerations going forward including getting these scans reviewed and incorporating at least a potential for independent review into the Phase 2 program.
Operator
We will go next to Matthew Harrison of Morgan Stanley.
Matthew Harrison
I just wanted to ask about patient populations. Can you talk a little bit about the kinds of patients that you have been enrolling in the Phase 1 program?
Were those patients Avastin refractory, were they just chemo refractory or were they not refractory or double refractory? Can you just sort of go through the kinds of patients you have been enrolling and how you think that might be the same or different as you progress into a Phase 2 study?
Thanks.
Charlie Morris
I mean first of all, let's think about the eligibility criteria. We allowed up to five prior lines of therapy, so most patients would have had -- well, in fact all patients have previously been exposed to both platinums and to taxanes and in the majority of cases have been exposed to those on more than one occasion as is standard of care.
And then they would move to a mix of therapies based around the gains standards of care including weekly Taxol, including doxil and occasionally topotecan. Patients who had had -- progressed after prior Avastin therapy were included.
We have had patients who have had prior path inhibitors. We've even had patients who have received other ADCs in other clinical trials.
Now I am not going to break out such small individual numbers and attempt to characterize response rates in each of those subgroups. But I think it is a very representative group of patients with a reasonably heavily pretreated disease that we have been enrolling onto the study.
I don't think there is anything particularly unusual about them. Obviously our key selection criteria have been around their folate receptor expression.
The data there are some data that suggest that folate receptor expression has a negative prognostic impact, so this could be maybe a group of patients who would be expected to do less well. Though there isn't really strong data on that at the moment.
But I would say that this is very typical and representative of a group of patients coming through other clinical trials and that would be generalizable to a reasonably heavily pretreated population of patients. And again and just sort of extending that, as we move into Phase 2 these will be a similar group of patients.
We would anticipate that the patients we have treated again would have had prior platinum therapies of course in all cases. I would anticipate that that population would be those who had already -- are likely to have already seen Avastin if they are nations who are eligible for Avastin, though we won't actually specify that one way or the other in the inclusion criteria.
Operator
We will go next to Michael Schmidt of Leerink & Partners.
Michael Schmidt
Can you update us where you are with the endometrial cancer cohort and when we might expect an update from that portion of the trial? And the second question was on 529, will you have a clinical update at the upcoming ASH conference on that program?
And if so, what data should we expect there for 529? Thanks.
Charlie Morris
For endometrial we have not provided any data update at the moment, primarily because that has proved to be a more difficult population to recruit than perhaps we had anticipated and certainly relative to the ovarian. I mentioned in my words that we're seeing about 80% of ovarian patients who are screened are eligible at least on the basis of their folate receptor expression.
And it turns out in the real world that for endometrial cancer that expression level is not only lower quantitatively but it is also the number of patients expressing the target is lower than we had anticipated. So the reason we haven't seen any data yet is that there simply isn't enough to put it out there.
And as those data come through and I am sure they will, I would think we would be looking maybe at the middle of next year but before we were really able to give you something meaningful on patients with endometrial cancer. It is still a population that we plan to target and to explore further, though, with the expression rates being the way they are, we think ovarian is clearly going to be easier.
And obviously when you have data like the data we presented at ASCO, that also encourages people to want to be a part of those studies as well. From the 529 perspective I think you should probably be expecting more clinical update next year.
As I have said, we feel a little less urgency at the moment to get anymore -- around single agent data because I think we have made a pretty clear guide that our next step will be to move into combinations. The data that we presented at Lugano was really quite compelling.
Admittedly preclinical, but those are the data that we have and there was clear synergy there. And we think if we're going to have a differentiated profile in a competitive environment we need to be really moving forward in the combination arena.
Michael Schmidt
Yes. If I can ask one more.
So I think the experience in the past has been pretty limited in terms of combining an ADC with chemotherapy. And I was just wondering big picture what your thoughts are on concerns related to overlapping toxicities of some of those.
And I guess has there been any experience in the past on combinations with ADC?
Charlie Morris
I mean if we look in our own hands we have certainly -- the major experience we had of course was with IMGN901. We were able to successfully combine 901 with REVLIMID and dexamethasone in the treatment of multiple myeloma without excess toxicity there.
Though conversely we discontinued that because of some toxicities in combination with carboplatin and etoposide. But we're not dealing with that linked payload combination anymore.
We believe from nonclinical data that would expect efficacy advantages and we will look very carefully at the toxicity profiles both of our own products and combination targets and make those decisions very, very carefully. I think if you looked at where we're saying we would certainly want to go forward in combination with rituximab, don't anticipate much in the way for 529.
We would certainly not expect much in the way of overlapping toxicities there. For rituximab we're looking at a number of agents.
We're looking at those, as I mentioned, in what I said before that we have got preclinical data, we're looking at where we're with the toxicities and for overlapping toxicities. But that will be very carefully navigated to ensure that we can move on in a safe and effective manner, but we believe that will be possible.
Operator
We will go next to Boris Peaker of Cowen.
Boris Peaker
Just on the ASCO data, there has been a lot of questions -- I believe there were four unconfirmed PRs in that data set. Do we know for those patients that have gone on for their second scan if those PRs have now been confirmed?
Charlie Morris
We're not going to disclose any new information at this point. As we bring data forward in the future we will give you more information on those.
But as you rightly identified, the reason that these are unconfirmed is that simply not enough time had passed. Most of the patients who had been -- had a response and had been confirmed at the time we need more time to elapse and as that happens we will provide those data and those data updates.
Boris Peaker
And were there any special protocols implemented in this ongoing 40 patient study for managing side effects? And if so, how do you plan to change them or implement them in the plan studies?
Charlie Morris
I think the most important thing that we have seen from side effects has been blurred vision. If you remember the data from ASCO and I am sure we all do, we have seen some diarrhea, mostly grade 1/2.
That seems to be responsive to loperamide which is something that we'd recommend as a treatment, not [indiscernible] prophylaxis in the protocol. And from what we're hearing from our investigators and patients, that has not been especially troubling.
We have a number of things that we have implemented around trying to understand the blurred vision and the keratopathy that we see with this. Some with other ADCs.
And we continue to implement those, have been using lubricating eyedrops. We're looking at doing some further work understanding what the role for corticosteroid eyedrops may or may not be.
But I think that is the most important one. I think the thing which most encouraged us about the data from was ASCO was the reversibility and manageability of all of the side effects essentially, but particularly of the blurred vision which had been something which had been of some concern.
But I think we now understand it much better. It does reverse and patients are able to continue therapy.
They are able to both achieve and maintain response of that with lower doses. So I think the more that we can do to help understand that and keep patients on therapy the better it will be for them and the better it will be for us and we continue to explore our understanding there.
But it is nothing that is going to prevent us going forward, including work with this dosing schedule at this point given we feel that the preliminary benefit/risk, if you like, appears to be very positive.
Operator
We will go next to Mara Goldstein of Cantor Fitzgerald.
Mara Goldstein
I was just hoping we could go back for a moment to the dosing schedule in the Phase 2 and the discussion around weekly versus every three weeks and what you did or didn't see. You kind of glossed through that and I was hoping you could just revisit that for me.
Charlie Morris
Yes, certainly. So at ASCO we did present some data from dose escalation on the weekly schedule.
I think a lot of the focus obviously has been on the ovarian cancer poster but there was another poster looking at the dose escalation of both dosing schedules. You remember that the original intent here or thought was that it may be that we would be able to see a reduction in the rate of ocular adverse events as well as an increase in exposure and therefore putatively the potential for improved even higher efficacy with that modified weekly schedule.
I think as we looked at the dose escalation data from the weekly schedule what we saw was we saw some responses, we saw some CA-125 responses and we saw responses approximately -- which appeared to approximate to what we have seen on the three weekly schedule. Now it is far from a randomized comparison.
I cannot say with any certainty that it is better, worse or the same as three weekly. But it certainly wasn't strikingly different, strikingly differentiated from an efficacy point of view.
We then looked as well of course at the tolerability. We felt that for the relative inconvenience of a modified weekly schedule we would need clear differentiation in terms of the tolerability for that to be something to take forward.
But we saw the same -- we saw diarrhea, we saw some ocular adverse events as we had seen in the three-week schedule. So we felt that at this point where we're seeing this 53% response rate with the three weekly schedule, where we have not yet treated that particular population with the modified weekly schedule.
There was not enough there to say that it was worth slowing down what we're doing on the three weekly to further explore the weekly at this point because there was nothing there which was saying this is clearly going to be better. Now we will continue that work with the three weekly.
I am certainly not ruling out further work in the future with the modified weekly schedule. And we can all point to the differences between three weekly Taxol and weekly Taxol as a reason to think about coming to that in the future.
But I didn't see anything, nor did our investigator, see anything at this point that would say let's slow this train down because we need to understand this modified weekly. And they are saying this is very exciting data, let's push on with this three weekly schedule which we're starting to understand, where these patients are tolerating the drug, where they are having very high response rates, let's keep that going because we can always come back to modified weekly later.
Mara Goldstein
Okay. And if I could just ask a follow-on in terms of the modifications were made to try and reduce ocular toxicity.
Are you implementing those into any of the additional early studies for the other compounds?
Charlie Morris
Yes. I mean we will continue to explore that, we will make decisions over what we think are the right things to do and we will continue to do that and to continue for our own awareness and for our own education and learning.
I don't think any of us in the ADC field at this point can say that we know exactly the right thing to do. The good news is we do now have an increasing amount of information.
I think one of the benefits to us in the return of coltuximab ravtansine is that we have access to approximately 250 patients worth of experience with that particular product and very good work that Sanofi did trying to understand the ocular events there. Obviously we have got the experience that we have now with mirvetuximab soravtansine.
And this is generally well tolerated. We're doing well, we're on track, there's clearly some relationships to dosing and schedule and pharmacokinetics.
But there is other things that we want to do with lubricating eyedrops, understanding the role, if any of corticosteroid eyedrops and understanding how we can help patients have the best experience with the drug without the need for dose interruptions because of any of these adverse events.
Dan Junius
Just to be clear, you referenced other compounds. The phenomenon of blurred vision seems to be with compounds that utilize DM4.
So when we talk about for example, IMGN529, as we look at the profile of that particular compound blurred vision doesn't appear to be an issue with that. So there is nothing we need to think about in that particular area as we go forward.
It is the DM4 compounds where blurred vision has proven to be the dose limiting element and anything we can do to alleviate that would be constructive. But dose limiting but not to the point of not giving us constructive paths forward with the two that we still are advancing on our own which is 3419 or coltuximab and mirvetuximab.
Operator
We will go next to Simos Simeonidis of RBC Capital Markets.
Simos Simeonidis
The first one is for Charlie. For 529 plus Rituxan in DLBCL, as you mentioned, this is a fairly competitive phase.
Can you give us an idea of the type of response you are hoping to see in order to decide whether to pursue further testing? I know you guys have said that you are going to test both 529 and coltuximab and take one of the two and I know 529 is further ahead because have more data.
But in DLBCL specifically, what range of responses or efficacy would make you say that this is worth taking forward?
Charlie Morris
As we look across this particular field where, as you know, Simos, there's really almost nothing in terms of approved agents and the number of agents which have come through and have not made it. I think we have really got to be pretty far north of 50% of a response rate and almost certainly north of 60% with a good durability.
And by durability I would be thinking about progression free survival in excess of six months which would probably take a durability of responses probably in the eight to nine month range, to really think that you have got a competitive profile that could be taken forward in patients with relapsed and refractory disease. The agents which have -- going forward in development at the moment and as you know there are a number of them, seem to generally be landing in that sort of -- in combination seem to be landing in that mid-50% range.
Single agents, as we have seen with coltuximab, it seems to be in the 40%-ish range. But I haven't seen many agents where it is really starting to get clearly more effective than that.
So I think you have really got to be in the 60% and higher range to have a serious opportunity to have a differentiated profile which would make you feel confident that you could be successful in a Phase 3 setting. Those are the kinds of things that we will look for as we think of the design of our studies.
And we need to look at the data and the context of things which are available and going forward at that time. But it certainly hasn't been an easy area for drug development and therefore I think we've got to see something really striking to say, yes, this is something to invest in.
Dan Junius
And that said, Simos, it is Dan. What has us encouraged here is the activity we have seen in single agent.
And if you have got a chance to look at the Lugano data, very compelling data preclinically looking at 529 in combination with Rituxan. In this business when you have preclinical data that point you in that direction you have to conduct the experiment.
Because while there are a number of interesting agents, patients with diffuse large B-cell are not being cured. The agents are extending patients' lives, but at some point they relapse and some patient populations struggle with the available therapies today.
So we're going to conduct the experiment and, as Charlie said, we're setting the bar pretty high and we will see how it goes.
Simos Simeonidis
Last question for Dave because nobody is asking him anything, I don't what him to be left out. The guidance for $70 million to $80 million in revenue for fiscal 2016, can you break it down or how much of that would be in cash?
And secondly, does that include any existing -- does it account any existing -- sorry any new partnership or is it just the existing?
Dave Johnston
Yes, Simos. So we don't break it out specifically, but I think that there is a way within the guidance that we provide to do the math is that we have a net -- if we have a net loss of $125 million and capital expenditures and the cash used in operations between $100 million and $105 million, the implication is that there is roughly $20 million of cash revenue that is involved there in the guidance.
But just as a reminder, any of the Kadcyla royalty revenue and that will be growing obviously next year over this year, that was in the $20 million to $25 million range, I can't remember exactly, this year. But that will be non-cash.
Dan Junius
And partially offsetting that, as Dave said earlier, Simos, there is the interest expense component that ends up below the cash -- that is in the cash from operations line. But that tends to offset the revenue.
So we have to apologize if the accounting has made this more confusing than it probably needs to be, but that is where we end up with it.
Operator
We will go next to Jessica Fye of JPMorgan.
Unidentified Analyst
This is Ryan on for Jess, appreciate you taking the question. I guess just a question on the ovarian Phase 2 study.
Regarding the folate receptor output expression label, I am sorry if I missed it, but is the Phase 2 using the same expression level as the Phase 1? And I guess how comfortable are you that is the optimal cut off for the expression?
Thanks.
Charlie Morris
That is one of the things that we're still looking to get clear and get right as we look at the data. As we mentioned earlier, we're looking very extensively at relationships between folate receptor alpha and the response rate.
We do plan to submit an abstract to the triple meeting, the NCI-AACR-EORTC meeting in Boston for November that will explore that relationship in some detail. And if we believe that it is the right thing to raise that cut-off to give us the highest chance of success, we will not to be afraid to do it.
Because we believe we have got a highly active agent here and we don't want to dilute our responses and we want the patients the best counsel, the best response. So we haven't said exactly what we're going to do with the Phase 2 at this point.
But I think you can anticipate that it is something we will look at very, very carefully. And that we're not just going to say, well, let's put everybody in.
But we're going to do everything that we can to ensure the success of the program.
Operator
We will go next to Andrew Peters of UBS.
Andrew Peters
So it seems like the next real update we're going to get from 853 will be at ASCO next year. Yet you are continuing to enroll the remaining 20 patients to the study.
I guess should we infer that as you are going forward with the Phase 2 studies you are continuing to see additional responses as patients are enrolled? And at some point if the response rate observed starts to become meaningfully different, how would that change your thinking regarding kind of studies going forward?
Charlie Morris
There is a lot of speculation in the question I think Andrew. I think, obviously we continue to look at our data.
I think there will be some meaningful updates by the end of the year, but how much there will be of a clinical update versus sort of an exploration of biomarkers in the data at the triple meeting remains to be seen. We will continue to explore this.
We will continue to try to best understand who the patients are who are responding and we will design the Phase 2 accordingly. Obviously if this was some fluke and I don't see any reason to believe it would be, then we would have to address that as we designed the study.
I think it is very clear we have got a very active product. Obviously the thing that we know least about at the moment is the durability of the responses purely because not enough time has elapsed.
And obviously we're able to look at that and understand that as best we can on an ongoing basis and we will make adjustments accordingly as we go. So, yes if we need to make changes we will make changes and if they are substantial or material changes we will inform you as appropriate.
But I think at the moment we're feeling very, very positive, very optimistic. Our investigators are feeling very positive and optimistic and thankfully a lot of the patients we're treating are feeling better.
So I think on that basis we have got reason to really be looking at a design of these programs being very positive about these programs and believing that we have the ability to bring forward a new differentiated product for an underserved population. And we will continue to do that as long as the data continue to be strong.
Dan Junius
Andrew, it is Dan. Just to add to Charlie's comments, you referenced ASCO as being the next update.
There is a balance that we always have to be sensitive to. We will update with whatever information we can at appropriate times respecting the [indiscernible] investigators and the importance that they associate with preserving the data to disclose at appropriate medical conferences.
So we think there will be important -- first off maybe not from a data standpoint but in terms of direction and providing some depth of understanding to the investment community, we think we will have a robust discussion at our Analyst Day in September that I think will lay out in greater detail what our thinking is around how the single agent in combination studies coming up are going to be designed. And so I think that will provide some insight.
I think there will be additional insight at the triple meeting that Charlie has mentioned about certainly how we're looking at the profile of patients for biomarkers and the like, but potentially additional patient data as we enroll. I think that you can take the extension -- depending on how you interpret it, you can take comfort in the fact that we're enrolling the expansion cohort very well, we expect that to be completed soon.
I think that is a reflection of the investigator enthusiasm for what they are seeing as the potential for this particular compound. And the fact that we're investing as aggressively as we're -- I don't think that our history as a company or this management team have invested down pathways that weren't supported by data or once the data no longer supported it we adjusted appropriately.
So we're very enthused about where this is headed and our investment behind it I think is consistent with that enthusiasm.
Operator
Thank you. And with no further questions I would like to turn the conference back over to Carol Hausner for any additional or closing remarks.
Carol Hausner
Thank you. I would like to thank everyone for their interest in ImmunoGen and of course issue one more reminder that we will be having an analyst event on September 18.
Look forward to seeing a number of you there. If you have any additional questions today don't hesitate to call.
Have a great day.
Operator
Thank you for your participation. That does conclude today's conference.