Operator
Good day, and welcome everyone to the ImmunoGen Third Quarter Fiscal Year 2012 Financial Results Conference Call. Today’s call is being recorded.
At this time for opening remarks and introductions, I would like to turn the call over to the Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.
Carol Hausner
Thank you, good morning. At 6:30 this morning we issued a press release that summaries our financial results for the quarter ended March 31, 2012, the third quarter of our 2012 fiscal year.
I hope you’ve all had a chance to review it, if not, it’s available on our website.
Carol Hausner
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.
Dan?
Daniel Junius
Thanks, Carol, and good morning, everyone. It’s certainly been an eventful and constructive past 3 months for ImmunoGen.
That would include positive top line results from the lead Phase III trial for T-DM1. As well as visible progress with our proprietary product portfolio, where we’ve advanced 901 into Phase II, IMGN529 in the Phase I and take IMGN853 to an active IND status.
Daniel Junius
So by mid-2012, we’ll have 3 wholly owned TAP compounds being dosed to patients in the clinic. And this will bring to 10, the number of TAP compounds in the clinic through our own programs and those of our partners Roche, Sanofi, Bayer, Biotest and Amgen.
This is along now with a naked antibody therapeutics being advanced by Sanofi, so that would mean a total of 11 compounds using our technology TAP and antibody technology in the clinic. This clinical progress is driving an increased flow of data.
At ASCO, we expect at least 2 significant presentations for T-DM1 and one for SAR3419, and an additional meaningful data presentations in the second half of the year.
Let me turn to T-DM1 and EMILIA. So EMILIA is the lead T-DM1 Phase III study.
It assesses T-DM1 in patients with HER2-positive metastatic breast cancer. At one point, this is referred to as patients in the second line setting.
More accurately, it is for patients with metastatic disease who previously received both Herceptin and a taxane.
So therefore, they could have received that therapy in adjuvant studying, they would be receiving EMILIA effectively as their first line treatment for metastatic disease. The design of the study is comparing T-DM1 used alone versus Tykerb plus Xeloda.
What we know so far in the findings from this study is that T-DM1 met the end point of significantly improving Progression Free Survival or PFS. Here we’ll see the underlying data at ASCO, which we understand that it will be reported in a plenary session on Sunday, June 3.
We don’t know if we’ll see anything on overall survival. Roche reported last month these data aren’t mature.
We do expect to see a tolerability comparison and we’d expect this to favor T-DM1 over Tykerb plus Xeloda, based on prior experience. As well as on Roche’s guidance that the tolerability findings with T-DM1 in this trial were consistent with prior studies.
If you step back and look at it, our goal with our TAP technology is to deliver any cancer products with better efficacy and better tolerability. We purpose that’s the initial concept of this technology and it’s very exciting to see this being realized with T-DM1.
Roche plans to apply for marketing approval with the T-DM1 through EMILIA this year, and that would include both the U.S. and Europe.
Now moving beyond EMILIA, Roche also submitted to ASCO data from a Phase II trial evaluating cardiac safety of T-DM1 in the adjuvant, neoadjuvant setting. This is for patients previously treated with anthracycline-based regimens.
Anthracycline is a backbone of agimen therapy for breast cancer. As Herceptin has been associated with adverse cardiac events in that patient population, it would make sense that they wanted to look at T-DM1 to understand the safety profile in trastuzumab naïve patients.
Finally, Roche has said that it expects to provide an update on its plans with T-DM1 in the adjuvant setting around the middle of this year. While ASCO would be a logical setting for this update they’ve not specified, they’ve been Roche haven’t specified when it will be provided.
Moving beyond T-DM1, but staying with ASCO SAR3419, which is the next most advanced partner compound, is underway in an aggressive Phase II program through Sanofi. They are looking at it in 2 indications, acute lymphoblastic leukemia, as well as diffused large B-cell lymphoma.
In the former they have a Phase II mono-therapy study underway and in DLBCL they have a mono-therapy study, as well as a combinations study underway with Rituxan. Now here is a dose level and schedule were established in the Phase I setting these data will be reported at ASCO in June.
So those are our most advanced partner programs. Let me spend a minute now and talk about what’s going on with our wholly owned compounds.
IMGN901 now is advanced into Phase II testing. We have our NORTH trial, which was a Phase I/II study that evaluates IMGN901 in patients newly diagnosed with small-cell lung cancer.
The design of the study is to enroll 120 patients, 80 with IMGN901 plus standard care and 40 with standard care alone. Standard care in this instance is defined as up to 6 cycles of etoposide and carboplatin.
Those patients in the 901 are continued to receive 901 if they are benefiting when etoposide/carboplatin ends.
We have 30 to 35 clinical centers across 4 countries participating in this study. The countries are U.S., Canada, U.K., and Spain.
Many of these are already hoping for enrollment. We expect all of them to be hoping and available to enroll patients by June.
The primary endpoint of the study is progression free survival and there are secondary endpoints, which include objective response rate and overall survival at 12 months.
In this study, we’re going to look an interim analysis after the first 59 patients are enrolled and here we’re looking for PFS at 6 months. This will give us the opportunity to understand the direction of the study at an earlier stage and move forward potentially decisions that we have around future plans for the study being prepared for a pivotal or Phase III study.
We plan to report the Phase I data from the north study at a medical conference in the third quarter of this year and we’ve been looking to have Phase II data in 2013.
Our IMGN529 compound has advanced its Phase I testing. This is the first ADC with an active antibody.
The target of this compound is CD37, which is found on a variety of B-cell malignancies such as non-Hodgkin's lymphoma and CLL. The Phase I trial underway is in NHL, it’s opened to an array of key subtypes such as follicular, diffuse large B-cell, marginal zone and mantle cell, and the data here will help us help inform our development pathway.
We’re working with several centers in the U.S. and one internationally.
Here we expect the first data next year, that would be either ASCO or ASH. And then in terms of our third compound in the clinic is IMGN853.
This is a TAP compound again, it targets folate receptor 1. Here a differentiating feature is that it uses one of the linkers we engineered to count our multidrug resistance.
We submitted the IND in the middle of March and it became active in mid-April. This enables us to start clinical testing around the middle of this year, around mid-2012.
And here we’ll be looking at various types of ovarian cancer as well as non-small cell lung cancer. This will include as we look at the centers we’re working with.
We’re looking at centers that will specifically recruit ovarian patients as they tend to come in through different channels of the various centers, and so we want to have some centers that we will be targeting ovarian patients, specifically.
The design of the study should allow the dose-escalation fees to proceed quite rapidly. The FDA was going to approve a protocol here that allows for single patients cohorts at lower doses.
So we’re excited that we will be able to move through the early dosing cohorts pretty rapidly. And we look to have our first data sometime in 2013.
So that’s what’s going on in the various compounds, those are the most advanced in our wholly-owned compounds. Let me ask Greg to walk you through the financials.
Gregory Perry
Thanks, Dan. Our net loss for the third quarter of fiscal year 2012 was $18.7 million or $0.24 per share compared with $15 million or $0.22 per share from the same quarter last year.
Our revenues for our third quarter this year were $3.3 million as compared to $5.2 million in the same quarter last year. Our third quarter of this year includes $1.3 million in research and development support and $0.9 million in clinical materials reimbursement compared with $2.2 million for each in the same quarter last year.
These revenue items vary by quarter, depending on the work we’re doing supporting our partners.
Gregory Perry
Our third quarter this year also includes $1 million in license and milestone fees compared with $0.9 million in the same quarter last year, as neither quarter includes a significant milestone payment from our partners. Our operating expenses for the third quarter of our 2012 fiscal year were $22 million as compared to $20.3 million in the same quarter last year.
We had increased personnel costs, including increased stock comp expense in clinical trial costs in the current period and are supported by internal programs. But also we had low expenses for clinical materials for partner programs compared with the same period last year.
We had approximately $175.3 million in cash and cash equivalents as of March 31, 2012, as compared with $191.2 million as of June 30, 2011.
Our guidance for our full 2012 fiscal year remains unchanged and as provided at our last quarterly call. We project our net loss will be between $78 million and $82 million.
Our net cash used in operations will be between $40 million and $45 million. We will end our fiscal year on June 30, 2012 with cash and marketable securities of between $145 million and then $150 million.
Based on these figures, we expect that our current capital resources, including our expected future collaborative payments, will be sufficient to meet our operational expenses and capital expenditures through our 2014 fiscal year. As Dan noted, while there is a lot of focus on T-DM1 at this time, we’re also seeing momentum building in our proprietary pipeline.
We’ve advanced IMGN901 into Phase II, IMGN529 into Phase I and IMGN853 to having an active IND. We expect this momentum to continue, reporting Phase II data with 901 in 2013 along with the first clinical data, with 529 and 853.
We also expect to advance our next wholly-owned compound into the clinic in the latter part of 2013. Dan?
Daniel Junius
Thanks, Greg. Let me summarize what we see as upcoming anticipated events and I’ll take you through both 2012 and at a higher level of 2013.
So coming to ASCO and T-DM1, we’re going to see the EMILIA Phase III data what’s available to-date, the only thing we may not see is survival information. And then the Phase II adjuvant data, we may also hear about Roche’s plans for T-DM1 in the adjuvant setting, it’s said midyear ASCO would be the logical time to do that with the other information that’s coming out.
Daniel Junius
The other ASCO highlight, from a partner standpoint, will be the Phase I findings and the Phase II dose coming out from Sanofi on SAR3419. Following that we’ll be looking to dose our first patient in IMGN853 sometime around the middle of the year and then it would follow on the back half of the year that we would see the market submissions for T-DM1.
Also in the back half of the year we’d look for the Phase I data out of the NORTH trial with IMGN901 dosed with etoposide and carboplatin. And then there is a potential, sometime before the end of the year, for the first Phase II data on SAR3419 and potentially other clinical data from other compounds.
And the other one item, I would notice, there is the potential that we would hear more about Roche’s plans with T-DM1 in gastric cancer over the course of 2012. As we move into 2013, we’re hopeful that we would then be seeing the start of T-DM1 commercialization.
We also make it our first insight into the Phase -- into the first line of Phase III study, the MARIANNE study with T-DM1 sometime before the end of 2013. I think we will see a very active year around data for IMGN901 as well as 529 and 853.
We hope to have sufficient data across all 3 of those compounds to give a sufficient information to develop our registration plans for those 3 compounds.
We look for 3419 Phase II data and plus we have other partners in compounds that will becoming more mature in there development they would lead to data with for those as well. And then we will look for further expansion of our own product pipeline including bringing our own next wholly-owned compound into the clinic, sometime during the course of 2013.
So an exciting quarter and it portends a very active back half of the year in 2013 for ImmunoGen.
So with that let me turn it back to Carol and we will start the Q&A
Carol Hausner
Great, thanks, Dan. We’re about to open the call to questions.
[Operator Instructions] Operator, we are now ready open the line for questions.
Operator
[Operator Instructions] We’ll take our first question from Thomas Wei with Jefferies.
Thomas Wei
I just have couple of question on T-DM1. Just one is just your updated thoughts on T-DM1 in adjuvant breast cancer.
If you were designing the adjuvant development program, how do you think T-DM1 best fits into adjuvant testing, what duration of dosing would you want to explore? And then also an update on EMILIA and when the next analysis of the data would be, can you just remind me again when the overall survival data was expected to be mature?
Daniel Junius
Thomas, the first question, just a very difficult one. We don’t -- we haven’t seen any of the data coming out of the adjuvant study, which I think would inform some of that.
And we haven’t even seen the detailed data coming out of the EMILIA study. So I think we’d want to understand some of those dimensions better before we’d start to speculate on where it might be best used in duration of therapy and the like.
So I think that it’s an interesting question, but maybe just a little bit premature. Survival data, we don’t know.
Again, they indicated when they announced the top line data that overall survival was not mature. Frankly, I’d be a little bit surprised if that were available for ASCO.
To some extent, frankly, the longer it’s not available I think the better, because that suggests that it’s being very effective in extending overall survival for patients. But I think it would be pure speculation on my part in terms of when I thought -- when I would think that that might be available.
Operator
We’ll take our next question from Bret Holley with Oppenheimer.
Bret Holley
I’m curious about the 853 Phase I and with a single patient dose escalation, I was wondering what safe guards you have in place to really understand the dosing toxicity of the drug. I mean, obviously very promising in ovarian.
I guess, I’m a little bit concerned that you see kind of one-off process not necessarily related to the compound. How do you think about that with the chemical aggressive Phase I that you have?
James O'Leary
This is Jim O'Leary. We’re implying a well-used trial – a dose escalation trial design rapid dose escalation single patient cohort.
And the difference between this design and a 3 plus 3 design, which is probably used more often, is that with a 3 plus 3 design, you allow for a higher level of toxicity in order to make a call whether or not you’re going to expand that cohort. As a safeguard with this rapid dose escalation is not single patient cohort, you lower that threshold for toxicity.
So for instance, in a typical 3 plus 3 design, you may employ ways to have a DLC that’s deemed Grade III or Grade IV, whereas when you use single patient cohort you lower that to perhaps at Grade II toxicity, in which case if you do observe that Grade II toxicity you would expand that cohort to 3 patients. So that really does safeguard against seeing, as you described, the one-off toxicities that you can properly characterize with single patient cohorts.
Bret Holley
Yes. And I guess on for the principles, what might be the toxicity you are looking for there I guess, does that design assume that you have a certain subset of toxicity that you might be looking out for?
James O'Leary
You can try to predict for toxicities based on the current literature for other fully inhibitors that are out there and also based on you preclinical data. But often times that doesn’t bear out in the clinic, your preclinical toxicity profile.
So it’s really kind of just being very attuned to anything that would appear to you to be unusual, and that’s achieved through very safe patient follow-up and capital attention to any patient complaints during the execution of the trial.
Operator
We’ll take our next question from Ling Wang, Summer Street Research.
Ling Wang
Two questions, first off with regard to T-DM1, can you comment on the other indications that are just, initially has the potential in addition to breast cancer. And then secondly, for SAR3419, could you please clarify what that will be at ASCO, and what Phase II data will be at second half of this year?
James O'Leary
In terms of other indications off of TDM-1, the other -- I guess I’d break it into may be indication, the metastatic disease, adjuvant disease for breast cancer and then gastric. And I think you were specifically asking for other than in breast.
The one that we’re waiting to hear more, and Roche has made at least one reference to looking at T-DM1 and gastric. And I believe that there have been some preclinical work done there.
And we’d like to hear more about whether they’re planning to pursue T-DM1 in that indication. There is no guarantees we’ll hear more, I think with ASCO and the adjuvant data, and with the EMILIA data.
There is an opportunity for them to provide further insight, but we don’t know whether that will be the case. The ASCO data for 3419, what that will be is the Phase I data that informed their dosing and the schedule of dosing in the Phase II studies.
Recall that they have conducted several Phase I studies. They spent quite a bit of time around dosing to make sure that they optimized to able to get maximum therapeutic benefit and address any toxicities if they were seeing, and that’s the data that we expect to see at ASCO.
Phase II data, whether we see Phase 11 data on 3419 over the balance of 2012, it is somewhat speculative at this point. It will depend on how rapidly they involve patients and what they choose to do from a publication standpoint or whether they choose to show that at medical conferences.
But given that these Phase IIs have been underway for certainly several months now, it affords the opportunity to potentially have data in the back half for the year.
Operator
We will take our next question from John Sonnier with William Blair
John Sonnier
Dan, I just want to make sure I understand the 901 design. It’s 120 patients, it sounds like it’s.
2 to 1 randomization and they’re active. What I am trying to understand is the rational and risk behind, I guess, cutting off enrollment at roughly half.
And then looking at 6 months, is 6 months long enough with roughly 30,40 patients on drug to make the termination to go forward based on the disease course?
James O'Leary
Yes, this is Jim again. So you know it’s always a tough balance trying to figure out what your Delta will be between your treatment arm and your control arm in terms of patient size and cost associated with the study.
120 patients, and it’s important to point out that this is a non-comparative randomized trial. So the control arm really serves to replicate the historical control data, or etoposide carboplatin alone.
So it’s not a typical randomized design or 2 statistical significance to do a randomized comparison between the 2 arms.
John Sonnier
Okay, that’s helpful. And I guess just a normal disease course, is 6 months a long enough period of time?
You’d expect a difference in advance between the 2 groups as to make a determination to go forward, that’s the real question.
Daniel Junius
Yes, so if you look through the literature people are using typically TSS at 4 months as an early look and TSS, at 6 months as a decision point as to whether or not to go forward, keeping in mind that meeting progression free survival in this patient population is pretty dismal on the order of about 5 to 6 months.
John Sonnier
Okay, no and that’s actually helpful. And then with -- I’m sorry.
Gregory Perry
John, one of the -- you suggested in your question that it was cutting off enrollment after the 59 patients, that isn’t the case. What we’re doing is isolating a cohort of 59 patients.
We will continue to enroll the balance of the patients and more study, but just isolate those 59 patients to develop the data to make the assessment you were talking about.
John Sonnier
Okay, that’s a helpful clarification. And then with 853, I apologize if I missed this, interesting developments with the ovarian cancer patients.
Did you say whether or not these are still platinum sensitive patients or platinum refractory is a single agent is in combination, and how does the dark still shortage play into the plan.
Gregory Perry
So right now in Phase I exploration it will all be single agent exploration of the activity and safety of 853 alone, so docetaxel will not factor into our plans in the immediate future. The patients that stay design with the Phase I dose escalation, which will be opened to patients with any solid tumor.
Solid tumor doesn’t, ovarian cancer, need to be classified or known to have willing to have expression before participating in the Phase I dose escalation. And then the several lab patients who are platinum refractory and sensitive for the expansion cohort, we’ve designed it such that we have 3 distinct patient populations to better characterize safety and get a activity or efficacy, and that includes various populations of ovarian cancer patients, as well as the subgroup or non-small cell lung cancer patients.
Operator
We’ll take our next question from Ryan Martins, Lazard Capital Markets.
Ryan Martins
Just Dan, I know you mentioned that the overall survival data may or may not be presented at ASCO. But on those lines from a regulatory perspective, do you believe just a very strong PFS benefit should be in the ASCO approval or do you think that would be either supportive of more than just supportive on all survival data required for approval?
Daniel Junius
I think -- I’ve got my view Jim or I’ll ask Jim to comment as well. I think the fact that the study design is generating the PFS data that they’ve said is statistically significant, or they’ve shown a statistical improvement over the standard of care is important obviously the level of separation will be important, as well as the tolerability profile between the 2 regimens because Tykerb and Xeloda in particular, notorious as being very difficult regimens to tolerate.
I think for the other dimensions that I think suggest that this will be acceptable to the regulators. And first off, we’re talking U.S., because PFS is an acceptable endpoint for the European regulators.
But in the U.S., you also are using the same patient population to develop the overall survival information. So I think that, and I have to believe that Roche has had extensive discussions with the regulators about the design, and what data they’d be looking for.
So obviously, you have to wait and see, but if there is -- if the therapeutic benefit both in terms of efficacy and tolerability is compelling, I have to believe that the regulators will be willing to consider it for approval, particularly in light of pending overall survival data from the same patient population. Jim, anything to add?
James O'Leary
It’s just difficult, as you mentioned, to speculate on as since we were not involved in the discussions between the FDA and Roche to understand what the FDA was looking for or how large that delta is at present to really make a comment.
Ryan Martins
Okay. Just also wanted to follow-up on your -- obviously Roche will make a decision as to what they want to do in the adjuvant setting, but do you believe, I just want to get your thoughts on the possibility that Roche could potentially even add on an arm to the Affinity trial, I mean they could add an arm, they could have T-DM1 plus pertuzumab, just want to get your thoughts on that?
James O'Leary
Yes. We don’t know what their plans are there.
We’re very anxious to hear those, and hopefully we’ll get informed at ASCO. I think the fact that, with T-DM1 you do have the opportunity to offer a therapy to patients that takes chemotherapy out of the picture is very important.
How that factors into their thinking and study design and the like just remains to be seen. But I do think that, that’s a fundamental dimension that Roche has focused on as they talked about T-DM1 in the metastatic setting that one of the –- it’s showing efficacy, but they are also, they also push very hard the dimension that you are taking chemo out of the picture.
And I think the opportunity to do that in adjuvant should represent something that they would be very interested in, but we have to hear more.
Operator
We’ll take our next question from Jason Kantor with RBC Capital Markets.
Jason Kantor
A lot of my questions have been asked, but could you give us some idea of what conference you might expect -- we might expect to see the Phase I IMGN901 data, I think you mentioned Q3. Any clues there for us?
Daniel Junius
I think it’s early. We have identified a conference.
We’ve submitted an abstract. I think that without the abstract having been accepted rather, it would be premature Jason.
But we’d be happy to share that once it’s clear, but it would be -- we are targeting Q3.
Jason Kantor
Okay. And you’ve obviously highlighted the most advanced programs, but are there any other programs in your partnered pipeline that you guys are particularly excited about or which may generate news for them that might get us excited about it over the next 12 months?
Daniel Junius
I think the opportunity is there with some of them. Buyers compound has been in the clinic now for some time and we may begin to see some data coming out there in the next 9 months, it’s possibility for end of year.
But some of the others, the Amgen compounds just went into the clinic late last year, BioCAST has been some –- seen sine interesting preclinical data. In solid tumors, they’ve talked about interesting third parties in that compound for solid tumor.
So there is a potential of developments there. I think the next one though, across the board that would be -- those would be Phase I type data and in its early -- we haven’t seen much coming from our partners, it is just too early.
I think the next one to be 3419 and seeing that Phase II data develop, that’s a significant diseases, CD19, I think it has been validated as a target. Sanofi is very excited about it, and putting a lot of resources behind developing 3419.
So if you would see some Phase II data late in the year, I think that could be exciting.
Jason Kantor
Okay, and what could you comment at all on the pace of this development discussions.
Daniel Junius
Our business development….
Jason Kantor
Yes, your own technology or drug compound that you might be considering?
Daniel Junius
Well, there is certainly a fair amount of interest. We have the 2 significant deals over the last year and half.
There is further interest. As I said on other calls, one of the challenges we have is balancing that interest out against our ability to service that without comprising our efforts for our wholly-owned compound.
So there’s interest there, how that -- even with the prior 2 deals, interest sometimes takes a while to develop into a transaction. So there is a lot there, we just have to see how that evolves.
I don’t want to give any timeline or any suggestion, but it’s fertile territory depending on how it all develops.
Operator
We will take our next question from Yale Jen with Roth Capital.
Yale Jen
Just quickly, most of the questions have been answered. So I just have, first of all, is the -- could you give a little bit color in terms of the non-cash expenses for the quarter in the P&L.
Daniel Junius
I think you’re going to see more of that in terms if a Q&A comes up, but basically non-cash items in the quarter associated with amortization of deferred revenue, and then depreciation and stock comp expense is usually the key drivers.
Yale Jen
Okay. Okay, great.
And definitely, in terms of the 902, you mentioned that the controlled study release looking for historical performance for chemo treatment, just that could you give us a little bit reference point in terms of 6 month progression free, 6 months, historically any range of that number?
James O'Leary
Yes, so typically it’s somewhere between, I think 40% to 45% of patients are progression free at 6 months with first line extensive stage small-cell lung cancer. And that’s why I mentioned earlier, a lot of the companies also choose to make decision points at PSS of 4 or 5 months.
In terms of overall survival, that translates to a PSS of about 5 to 6 months, and in terms of overall survival, it ranges anywhere from about 9 to 11 months for this patient population.
Yale Jen
Just curious that during the 6 months, would you be able to just look at the data at the fourth month sort of respectively to see what that number might be and actually will that be meaningful?
James O'Leary
I just want to make sure I understand the question. When we see the last 6 month PFS data, could we look back retrospectively at 4 months?
Yale Jen
Yes, we recalculate the 4 months and to see what it has any meaningful?
James O'Leary
Sure, we could probably do that, but that probably would not be that meaningful if we had our 6 month PFS data in hand.
Operator
We’ll take our next question from Karen Jay with JPMorgan.
Karen Jay
This is Karen Jay in for Cory Kasimov. I just have one question on 901 moving into Phase II.
Can you share anything on the dose that you are using, confirm that it’s one and maybe any color on the toxicities that were used to make those dose decisions?
Daniel Junius
Yes. So I don’t believe we revealed our Phase II recommended does yet, and that will be presented at the upcoming conference that Dan was mentioning earlier in the third quarter.
And the second part of that question.
Karen Jay
Anything from gen toxicities.
Daniel Junius
Yes I think that’s the same answer, Karen.
Gregory Perry
Yes.
Daniel Junius
The medical conferences we really have to sequester that information ahead of the medical conference, otherwise we run the want the risk of an abstract not being accepted because the data has been already been disclosed.
Operator
We will take our next question from Thomas Wei with Jefferies.
Thomas Wei
Thanks for taking the follow-up, just a quick one here on this non-randomized design. I guess, I have seen for 901 that was meant to accelerate enrollment, but could you help us understand the rationale for that and doesn’t that actually impair the ability to interpret the DSF finding, if the 2 groups are not randomized?
James O'Leary
And so a large discussion with the investigators who are small cell lung cancer experts, and after viewing multiple trial designs, we thought this was the best design to go forward with. But I just want to clarify a point, that 2 to 1 randomization is designed to help expedite recruitment.
Having a control on probably did not have much variant at all, in terms of recruitment.
Thomas Wei
And so the non-randomized aspect of the study, I guess you know to me that seems like…
Daniel Junius
No, it’s non-comparative. It’s a randomized study that’s non-comparative.
Thomas Wei
Oh, I see, so there will be balance between the arms in terms of, it tends to balance that baseline characteristics or risk factors of the lung cancer?
Daniel Junius
Absolutely.
Thomas Wei
I see, so it’s just not statistically powered for a comparison on the PFS endpoint?
Daniel Junius
Exactly, exactly and this is kind of more easy, I guess, I would say in a small cell lung cancer patient population, because we have 20 years plus experience of just a single standard care for treating for small cell lung cancer. So that historical data is pretty solid, which makes it easier to compare your treatment on to a historical control that’s pretty solid.
In other tumor types, this type of design may not be as successful.
Thomas Wei
Yes. I must have misheard what you had said, that’s very helpful clarification.
Operator
With no additional questions in the queue, I’d like to turn conference back over to our speakers for any additional or closing remarks.
Carol Hausner
Great. I’d like to thank you for your interest and if you have additional questions give us a call and have a good day.
Thank you.
Operator
This concludes today’s conference. We appreciate your participation.