ImmunoGen Inc (IMGN) 2012 Q3 法說會逐字稿

Good day, and welcome, everyone, to this 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'd like to turn the call over to Executive Director Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Thank you. Good morning. At 6.30 AM this morning, we issued a press release that summarizes 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.

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 will then open the call to questions.

Dan?

Thanks, Carol, and good morning, everyone. It's certainly been an eventful and constructive past three 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 into Phase I, and taken IMGN853 to an active IND status.

So, by mid-2012, we'll have three 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 then] with a naked antibody therapeutic 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 two significant presentations for T-DM1, and one for SAR3419, and then additional meaningful data presentations in the second half of the year.

Let me turn to T-DM1 and EMILIA. 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 was referred to as patients in the second line setting. More accurately, it is for patients with metastatic disease who have previously received both Herceptin and a taxane; so, therefore, they could have received that therapy in adjuvant setting, 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 endpoint of significantly improving progression-free survival, or PFS. Here, we'll see the underlying data at ASCO. 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 that these data aren't mature. We do expect to see a tolerability comparison, and we would 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 anti-cancer products with better efficacy and better tolerability. That is the purpose -- that is 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 T-DM1 through EMILIA this year, and that would include both the US 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. Anthracyclines are backbones of adjuvant therapy for breast cancer. As Herceptin has been associated with adverse cardiac events in that patient population, it would make sense that they would want to look at T-DM1 to understand the safety profile in trastuzumab-naive 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 being 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 two indications -- acute lymphoblastic leukemia, as well as diffuse large B-cell lymphoma. In the former, they have a Phase II monotherapy study underway, and in DLBCL they have a monotherapy study, as well as a combination study underway with Rituxan. Now, here, the dose level and schedule were established in the Phase 1 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 is a Phase I-II study that evaluates IMGN901 in patients newly diagnosed with small-cell lung cancer. The design of this study is to enroll 120 patients, 80 with IMGN901 plus standard of care, and 40 with standard care alone. Standard care, in this instance, is defined as up to six cycles of Etoposide and Carboplatin.

Those patients in the 901 arm can continue to receive 901 if they're benefiting when Etoposide/Carboplatin ends. We have 30 to 35 clinical centers across four countries participating in the study. The countries are US, Canada, UK, and Spain. Many of these are already open for enrollment. We expect all of them to be open and available to enroll patients by June.

The primary endpoint of the study is progression-free survival, and there are secondary endpoints which include an objective response rate and overall survival at 12 months. In this study, we're going to look at an interim analysis after the first 59 patients are enrolled, and here we are looking for PFS at six 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 a 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 will be looking to have Phase II data in 2013.

Our IMGN529 compound has advanced into Phase I testing. This is the first ADC with an active antibody. The target of this compound is CD37, which is found now in a variety of B-cell malignancies such as non-Hodgkin's lymphoma and CLL. The Phase I trial underway is an NHL; it's open 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 and form our development pathway. We're working with several centers in the US, 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 the folate receptor 1. Here, a differentiating feature is that it uses one of the linkers we engineered to counter multi-drug resistance. We submitted the IND in the middle of March, and it became active 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 are 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 will be targeting ovarian patients specifically.

The design of this study should allow the dose-escalation Phase to proceed quite rapidly. The FDA was willing to approve a protocol here that allows for single patient cohorts at lower doses, so, we are 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 that are most advanced in our wholly-owned compounds.

Let me ask Greg to walk you through the financials.

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 for 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 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. 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 and clinical trial costs in the current period, in our support of our internal programs, but also had lower 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 from that 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, and we'll end our fiscal year on June 30, 2012 with cash and marketable securities of between $145 million and $150 million. Based on these figures, we expect that our current capital resources, including expected future collaborator payments, will be sufficient to meet our operational expenses and capital expenditures through our 2014 fiscal year.

As Dan noted, while there's a lot of focus on T-DM1 at this time, we are also seeing momentum building in our proprietary pipeline. We have 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?

Thanks, Greg. Let me summarize what we see as upcoming anticipated events, and I will take you through both 2012, and then at a higher level of 2013. So, coming through ASCO, T-DM1 -- we are 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. They've said [media or] ASCO would be the logical time to do that with the other information that's coming out.

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 in the back half of the year that we would see the marketing 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's the potential, sometime before the end of the year, for the first Phase II data on SAR3419, and potentially other clinical data from other compounds. The other one item I would note is, there's 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 are hopeful that we would then be seeing the start of T-DM1 commercialization. We also may get our first insight into the first-line 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 three of those compounds to give us sufficient information to develop our registration plans for those three compounds. We'd look for 3419 Phase II data, and plus, we have other partner compounds that will be coming more mature in their development that would lead to data for those as well.

And then, we would 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.

Great, thanks, Dan. We are about to open the call to questions. We ask that these be limited to one to two per person until each analyst has had a chance to ask questions. Operator, we're now ready to open the line for questions.

(Operator Instructions) The first question is from Thomas Wei with Jefferies.

Thanks. I would love to ask a couple questions on T-DM1. 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 remind me again when the overall survival data was expected to be mature? Thanks.

Thomas, the first question is just a very difficult one. We haven't seen any of the data coming out of the adjuvant study which I think would inform some of that. We haven't even seen the detailed data coming out of the EMILIA study. So, I think we would want to understand some of those dimensions better before we start to speculate on where it might be best used in duration of therapy and the like. So, I think that's -- 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 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'd be pure speculation on my part, in terms of when I thought -- when I would think that that might be available.

We'll take our next question from Bret Holley with Oppenheimer.

Yes, thanks for taking my question. I'm curious about the design of the 853 Phase I, and with a single-patient dose escalation, I'm just wondering what safeguards you have in place to really understand the dosing and the toxicity of the drug; I mean obviously very promising in ovarian; I guess I'm just a little bit concerned that you see one-off toxicity that is not necessarily related to the compound. How do you think about that with the kind of aggressive Phase I design you have?

This is Jim O'Leary. We are employing a well-used dose escalation trial design -- rapid-dose escalation single-patient cohort. And the difference between this design and the three plus three design, which is probably used more often, is that with the three plus three 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 design single patient cohort, you lower that threshold for toxicity. So, for instance, in a typical three plus three design, you may employ -- wait to have a DLT that's deemed grade three or grade four, whereas when you use single patient cohorts, you lower that to perhaps a grade two toxicity, in which case, if you do observe that grade two toxicity, you would expand that cohort to three patients. So, that really does safeguard against seeing, as you described, the one-off toxicity that you can't properly characterize with single patient cohorts.

And, I guess, on first principles, what might be the toxicity you are looking for there? Does that design assume that you have a certain subset of toxicities you might be looking out for?

You know, you can try to predict for toxicities based on the current literature for other folate inhibitors that are out there, and also based on pre-clinical data, but oftentimes, that doesn't bear out in the pre-clinical toxicity profile. So, it is 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 careful attention to any patient complaints during the execution of the trial.

Okay. Thank you very much.

Ling Wang, Summer Street Research.

Thank you for taking my questions; good morning. So, two questions, first, with regard to T-DM1, can you comment on the other indications that potentially has the potential in addition to breast cancer? And then secondly, for SAR3419, could you please clarify what data will be at ASCO and what Phase II data will be at second half of this year? Thank you.

Good morning, Ling. In terms of other indications off of T-DM1 -- the other, I guess I would break it into maybe an indication -- metastatic disease, adjuvant disease for breast cancer, and then gastric. And I think you were specifically asking for other than breast cancer. The one that we are waiting to hear more, and Roche has made at least one reference to looking at T-DM1 in gastric, and I believe that there have been some pre-clinical work done there, and we like to hear more about whether they're planning to pursue T-DM1 in that indication. There's no guarantees we will hear more. I think, with ASCO and the adjuvant data and with the EMILIA data, there's 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 had conducted several Phase I studies. They spent quite a bit of time around dosing to make sure that they optimized to be able to get maximum therapeutic benefit and address any toxicities that they were seeing, and that is the data that we expect to see at ASCO.

Phase II data, whether we see Phase II data on 3419 over the balance of 2012 is somewhat speculative at this point. It will depend on how rapidly they enroll patients and what they choose to do from a publication standpoint or whether they choose to share 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 of the year.

Great, thank you.

We'll take our next question from John Sonnier, with William Blair.

Thanks for taking the questions. Dan, I just want to make sure I understand the 901 design; it is 120 patients, it sounds like it is two to one randomization into active, but what I'm trying to understand is, the rationale and risk behind I guess cutting off enrollment at roughly half. And then looking at six months, is six months long enough with roughly -- would that be 40 patients on drug to make a determination to go forward based on the disease course?

Yes, this is Jim again. So, 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 for etoposide carboplatin alone.

Okay.

So, it's not a typical randomized design or power to statistical significance to do a randomized comparison between the two arms.

Okay, that's helpful. And, I guess just the normal disease course is six months, a long enough period of time where you would expect a difference in events between the two groups just to make the determination to go forward; that is the real question.

Yes, so, if you look through the literature, people are using typically PFS at four months as an early look, and PFS at six 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 five to six months.

Okay. No -- that's actually helpful. And then with -- I'm sorry?

John, one other -- you suggested in your question we were cutting off enrollment after the 59 patients; that isn't the case. What we're doing is isolating a cohort at 59 patients. We will continue to enroll the balance of the patients in the NORTH study, but just isolate those 59 patients to develop the data to make the assessment that we're talking about.

Oh, 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; are they platinum refractory? Is a single agent is in combination and how does the Doxil shortage play into the plan?

So, right now, it's Phase I exploration; it will all be single-agent exploration of the activities in [stacy] of 853 alone. So, Doxil will not factor into our plans in the immediate future. The study design with the Phase I dose escalation, which will be open to patients with any solid tumor -- solid tumors other than ovarian cancer, need to be classified or known to have full receptor expression before participating in the Phase I dose escalation, and then, that will allow patients who are platinum refractory and sensitive.

For the expansion cohort, we've designed it such that we have three distinct patient populations to better characterize safety and get a hint of activity or efficacy, and that includes various populations of ovarian cancer patients, as well as a subgroup of non-small cell lung cancer patients.

Okay. Thanks a lot.

Ryan Martins of Lazard Capital Markets.

Congratulations on being selected for a [primary] presentation for EMILIA. 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 enough for approval, or do you think they'll be either supportive or more than just supportive overall survival data required for approval?

I've got my view -- I will ask Jim to comment as well. I think the fact the study design is generating the PFS data that they've said is statistically significant, or they've shown as 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 two regimens because Tykerb and, Xeloda in particular, are notorious as being very difficult regimens to tolerate.

I think though, the other dimension that I think suggests that this will be acceptable to the regulators -- and first off, we're talking US, because PFS is an acceptable endpoint for the European regulars, but in the US, 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 would be looking for. So, obviously, you have to wait and see, but if the therapeutic benefit, both in terms of efficacy and tolerability, is compelling, I have to believe 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?

It's just difficult, as you mentioned, to speculate on -- 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.

Okay, thanks for providing that color. I 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 wanted to get your thoughts on the possibility that Roche could potentially even add on an arm to the affinity trial, they could add on an arm or they could have T-DM1 plus Pertuzumab; I just want to get your thoughts around that.

Yes, we don't know what their plans are there. We are very anxious to hear those and hopefully we will 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 is a fundamental dimension that Roche has focused on as they have talked about T-DM1 in a metastatic setting, that it is showing efficacy, but 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, Ryan.

Okay. Thanks a lot.

Jason Kantor with RBC Capital Markets.

Thanks, a lot of my questions have been asked, but could you give us some idea of what conference we might expect to see the Phase I IMGN901 data; I think you mentioned Q3. Any clues there for us?

I think it's early. We have identified a conference, we've submitted an abstract, I think that without the abstract having been accepted, it would be premature, Jason, but we would be happy to share that once it is clear. But it would be -- we are targeting Q3.

Okay. You've, obviously, highlighted the most advanced programs, but are there any other programs in your partnered pipeline you are particularly excited about or which may generate news flow that might get us excited about it over the next, say, 12 months?

I think the opportunity is there with some of them. Bayer's compound has been in the clinic now for some time; we may begin to see some data coming out there in the next nine months; possibility for end of year. So, some of the others, the ImmGen compounds just went into the clinic late last year; Biotest has seen some interesting pre-clinical data in solid tumors. They've talked about interest from third parties in that compound for solid tumors, so there's a potential of developments there.

I think the next one, though -- but across the board, those would be Phase I type data, and it's early -- we haven't seen much coming from our partners; it's just too early. I think the next one would be 3419, and seeing that Phase II data develop. That is a significant disease. CD19 I think has been validated as a target. Sanofi is very excited about it and putting a lot of resources behind developing 3419. So, if we would see some Phase II data later in the year, I think that could be exciting.

Okay. Can you comment at all on the pace of this development discussions?

With -- oh, business development --?

Just on your own technology or drug compounds that you might be considering?

There is certainly a fair amount of interest. We've had the two significant deals over the last year and a 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 it without compromising our efforts for our wholly-owned compounds. So, there is interest there.

How that --even with the prior two 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.

Thank you.

Yale Jen with ROTH Capital.

Good morning and thanks for taking the questions. Quickly, most of my questions have been answered, so I just have one. First of all, could you give a little color in terms of the non-cash expenses for the quarter in the P&L?

I think you're going to see more of that in terms of the Q when that comes out, but basically, our non-cash items in the quarter associated with amortization of deferred revenue and then depreciation and stock comp expense, those are usually the key drivers.

Okay, great. Secondly in terms of the 902, you mentioned that the control study really is looking for historical performance in chemo treatments. Just that, could you give us a little bit and sort of reference point in terms of six months -- of progression-free at six months, historically any range of that number?

Yes; so, typically, it's somewhere between I think 40% to 45% of patients are progression-free at six months, with first-line extensive stage small-cell lung cancer. And that's why I mentioned earlier a lot of companies choose to make decision points at PFS of four or five months in terms of overall survival -- so that translates to a PFS of about five to six months. And, in terms of overall survival, it ranges anywhere from about nine to 11 months for this patient population.

Just curious, given that you're doing the six months, would you be able to look at the data at the fourth months, sort of retrospectively, to see what that number might be, and actually, would that be meaningful?

I just want to make sure I understand your question -- when we see our six-month PFS data, could we look back retrospectively at four months?

Yes, recalculate at the four months and to see what that -- any meaningful?

Sure, we could probably do that, but, that probably would not be that meaningful if we had our six-month PFS data in hand.

Okay, great. Thanks a lot. I appreciate it.

Karen Jay, with JPMorgan.

Hi. This is Karen Jay in for Cory Kasimov. I just have one question on 901 meeting in the Phase II. Can you share any details on the dose that you are using, confirm that it's one, and maybe any color on the toxicities that were used to make the dose decision?

Yes, so, I don't believe we've revealed our Phase II recommended dose yet and that will be presented at the upcoming conference that Dan was mentioning earlier in the third quarter. And your -- the second part of that question?

Anything you can share on the toxicities.

I think it's the same answer, Karen.

Yes.

The medical conferences -- we really have to sequester that information ahead of a medical conference; otherwise, we run the risk of an abstract not being accepted because the data's already been disclosed.

Thomas Wei, with Jefferies.

Thanks for taking the follow-up. Just a quick one here on this non-randomized design, I guess I assume 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 PFS finding if the two groups are not randomized?

So, a lot of discussion with investigators who are small-cell lung cancer experts, and after reviewing multiple trial designs, we thought this was the best designed to go full forward with, but I just want to clarify a point. The two-to-one randomization is designed to help expedite recruitment. Having a control arm, probably does not have much bearing at all in terms of recruitment.

So the non-randomized aspect of the study -- I guess to me that --

It is non-comparative. It is a randomized study that is non-comparative.

Oh, I see. So there will be balance between the arms in terms of it tends to balance out baseline characteristics or risk factors of small-cell lung cancer?

Absolutely.

I see, so it's just not statistically powered for a comparison on a PFS end point?

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 of care for treatment for small-cell lung cancer. So, that historical data is pretty solid, which makes it easier to compare your treatment arm to a historical control that's pretty solid. In other tumor types, this type of design may not be as successful.

No, thank you. I must have misheard what you had said. That's very helpful clarification.

With no additional questions in the queue, I'd like to turn the conference back over to our speakers for any additional or closing remarks.

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.

This concludes today's conference. We appreciate your participation.