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Sunesis Pharmaceuticals (NASDAQ:SNSS)

Q2 2012 Earnings Call

August 09, 2012 10:30 am ET

Executives

Eric H. Bjerkholt - Chief Financial Officer, Principal Accounting Officer, Executive Vice President of Corporate Development & Finance and Corporate Secretary

Daniel N. Swisher - Chief Executive Officer, President and Director

Adam R. Craig - Chief Medical Officer and Executive Vice President of Development

Analysts

Eric Schmidt - Cowen and Company, LLC, Research Division

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

George B. Zavoico - MLV & Co

Operator

Good day, ladies and gentlemen, and welcome to the Second Quarter 2012 Sunesis Pharmaceuticals, Incorporated Earnings Conference Call. My name is Regina, and I'll be your conference operator for today. [Operator Instructions] Today's event is being recorded for replay purposes.

I would now like to turn the conference over to your host for today, Mr. Eric Bjerkholt, Executive Vice President of Corporate Development and Finance and Chief Financial Officer. Please go ahead, sir.

Eric H. Bjerkholt

Thank you, Regina, and thank you for joining us today. With me from Sunesis are Dan Swisher, President and Chief Executive Officer; and Dr. Adam Craig, Executive Vice President of Development and Chief Medical Officer.

During today's call, Dan will review recent corporate and clinical events, Adam will provide an overview of the ongoing Phase III VALOR study and other clinical programs, and I will discuss second quarter 2012 financial results. Dan will then recap the company's upcoming milestones before opening the call for questions.

Before we begin, let me remind you that during today's conference call, we will be making forward-looking statements that represent the company's intentions, expectations or belief concerning future events. These forward-looking statements are qualified by important factors set forth in today's press release and the company's filings with the SEC, which could cause actual results to differ materially from those in such forward-looking statements. Furthermore, information discussed on today's call is accurate as of today, and we do not intend to update.

With that, let me turn the call over to Dan Swisher. Dan?

Daniel N. Swisher

Yes. Thanks, Eric. And good morning, and thanks for joining us today on our second quarter 2012 financial results and corporate highlights conference call. In the first half of 2012, Sunesis made significant progress in the clinic with our pipeline and with our regulatory, financial and intellectual property strategies. Thanks to these accomplishments, today we're on the cusp of validating our lead drug candidate, vosaroxin's clinical potential in AML, as we await the outcome of next month's interim analysis, the single pre-specified review of unblinded efficacy and safety data by the Data and Safety Monitoring Board from our ongoing Phase III VALOR trial.

Our progress touched on a number of important areas in the second quarter. First is vosaroxin, thanks to the continued strong execution and investigator support of the trial. Our Phase III randomized double-blind, placebo-controlled pivotal study in first relapsed or primary refractory AML, we do remain very much on track to complete our planned full enrollment of 450 evaluable patients later this year, with over 110 leading sites recruiting in the U.S., Canada, Europe, Australia and New Zealand. As of yesterday, 391 patients had been enrolled to the study.

Second, in September, our DSMB for the study will examine pre-specified unblinded efficacy and safety data and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients. This interim analysis is the first and only interim analysis, and it will look at VALOR's unblinded efficacy results and will provide important insight into the likely timing of the unblinding of the trial's key data, including its primary endpoint, which is overall survival.

So one, the study can unblind immediately if the trial is halted early for efficacy or futility. Two, it can unblind in the second half of 2013 if the trial continues to its planned 450 patient sample size. Or three, we can unblind in the first half of 2014 if the trial expands to 675 patients. Adam, later on this call, is going to walk through the implications of these different scenarios and discuss VALOR's key statistical considerations.

In terms of other recent VALOR progress, this June we announced that the trial's DSMB completed one of several planned, periodic, safety reviews of the trial and recommended that we continue as planned without change to study conduct.

On the regulatory front, in April, the European Commission granted orphan drug designation to vosaroxin for the treatment of AML, a designation we already enjoy in the U.S. Orphan drug designation in Europe provides for 10 years of marketing exclusivity, following product approval. With regard to our kinase inhibitor pipeline in cancer with Millennium Takeda Pharmaceuticals and in immunology with Biogen Idec, those programs continue to progress.

MLN2480 is the pan-Raf inhibitor and the first Millennium collaboration compound that has gone to the clinic. It continues to be studied in patients with relapsed or refractory solid tumors in the Phase I trial, which began last September.

In our Biogen immunology-focused collaboration, in June, we received and announced a $1.5 million payment for the advancement of pre-clinical work under our 2011 amended collaboration agreement. This milestone signals that we are one step closer to an IND of the lead product candidate, something we look forward to discussing in further detail, as it progresses into the clinic, hopefully, next year.

These collaborations are free options for us, and they allow us to leverage the resources of 2 leading biopharmaceutical companies to advance a broader product pipeline, giving us an attractive future stream of milestone and product royalty payments, along with future co-development and co-promotion options on 2 high potential programs, while we focus our own resources on advancing vosaroxin forward.

As we continue to make important progress on the clinical and regulatory fronts, the company remains well positioned from a capital standpoint to reach its goals, especially the continued successful prosecution of VALOR to its unblinding of key results.

We ended the second quarter with $29.3 million in cash and investments. Behind this, we have additional committed sources of capital, which Eric will speak to in greater detail later in the call.

But for now, I'd like to turn the call over to Adam to discuss our clinical programs in more detail.

Adam R. Craig

Thank you, Dan. I'd like to start by reiterating what it is that we believe makes vosaroxin a promising therapy in development for acute myeloid leukemia and touch on why VALOR is the right study to elucidate this potential.

AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. Treatment standards for this disease have not changed appreciably in the last 40 years, and the prognosis for adult patients diagnosed with AML remains quite poor, with a 20's% 5-year survival rate that drops to just 5% among patients aged 65 years and older.

Treatment of AML can often be challenging, as it's important to find the appropriate balance of response to therapy, durability and safety. As a first-in-class treatment, vosaroxin has a promising clinical profile. Data collected from our prior AML studies point to a profile characterized by good remission rates, single-digit early mortality rates and encouraging survival outcomes.

In addition, vosaroxin therapy has provided a bridge to stem cell transplantation for many responders, a key treatment goal for AML patients. The 450-patient VALOR study is the largest company-sponsored trial ever undertaken in relapsed or refractory AML. It is 90% powered to detect 40% difference between the overall survival curves of vosaroxin, combined with cytarabine versus cytarabine plus placebo. The difference will be very clinically meaningful and establish vosaroxin in combination with cytarabine as a new treatment standard in this setting.

As Dan mentioned, VALOR has enrolled 391 patients as of yesterday, which reflects strong investigator enthusiasm to this program and the serious unmet medical need this trial represents. Next month, the DSMB will review unblinded efficacy and safety data in its single, pre-planned interim analysis. Following this review, it will make one of the following recommendations: stop the trial for efficacy or futility, continue the trial to its planned data readout expected then in the second half of 2013; or undertake a pre-planned sample size adjustment of 225 patients for a total of 675 patients.

As a reminder, sample-size expansion occurs when the DSMB believes the power of the study will benefit from the increase in the sample size to maintain adequate statistical power across a broader range of survival outcomes. We believe that VALOR offers an efficient design that capitalizes on vosaroxin's promising clinical profile, while overcoming the challenges that have limited the success of other AML development candidates, including under-powering or the use of non-randomized pivotal trial designs.

Vosaroxin was recently highlighted in a peer-reviewed paper published in this month's issue of Expert Opinion on Investigational Drugs. The paper, authored by 2 opinion leaders, Dr. Jonathan Abbas and Dr. Rob Stuart of MUSC, provides an in-depth review of the development history of vosaroxin, its mechanism of action, pharmacology and metabolism, as well as pre-clinical and clinical data to date. It is available online at our corporate website.

Beyond relapsed refractory AML, the vosaroxin pivotal program has expanded into newly diagnosed elderly AML and the high-risk MDS in a Phase II, Phase III trial known as Less Intense 1 or LI-1. LI-1 is being conducted by the United Kingdom's National Cancer Research Institute under the direction of Professor Alan Burnett, Head of Hematology at Cardiff University. It Employs a "Pick a Winner" design to evaluate a number of promising investigation agents versus low-dose cytarabine in patients who are considered too high-risk or frail to be candidates for intensive standard induction chemotherapy.

Selection of vosaroxin for 2 of the experimental treatment arms in this investigational-related international crafted study speaks to its growing regard within the hematology community. It also builds upon the promising results from our Phase II revealed [ph] study of single-agent vosaroxin in newly diagnosed elderly AML patients with poor prognostic factors. The other one study enrolled its first patient in March. It continues to enroll nicely, and we look forward to updating you on the progress of this trial at a later date.

In addition to vosaroxin, we have an emerging pipeline of kinase inhibitor programs, which are continuing to progress in and towards the clinic. The first is the oncology-directed collaboration with Millennium Pharmaceuticals. This includes our -- an oral pan-Raf inhibitor, MLN2480.

In September 2011, Millenium initiated a Phase I multi-centered, open-label, dose-escalation trial of MLN2480 in patients with relapsed or refractory solid tumors. This study is designed to evaluate the safety, tolerability and maximum tolerated dose of MLN2480 and will be conducted in 2 stages: dose escalation and dose expansion. The focus of the dose expansion phase will be on patients with metastatic melanoma. Secondary endpoints will assess primary tumor activity, as well as pharmacokinetic and pharmacodynamic properties of MLN2480. We look forward to updating you on the progress of this trial at a future date.

In April, we were pleased to see Millennium present new pre-clinical data on the Raf program at the AACR's New Drugs on the Horizon session. The data presented showed impressive single-agent and combination pre-clinical activity in relevant in vitro tumor models.

Our second kinase inhibitor collaboration is with Biogen Idec for immunology-directed targets. As Dan pointed out, in June, we received the milestone payment from Biogen Idec for the advancements of pre-clinical work under our collaboration. This program remains an important R&D priority for Biogen Idec, and we are hopeful that it will reach the IND stage and progress into the clinic next year, at which point, we look forward to revealing the target and the high potential market it addresses.

Let me now turn the call over to Eric.

Eric H. Bjerkholt

Thanks, Adam. I will recap the financials announced this morning, beginning with our cash position. We ended the second quarter with $29.3 million in cash, cash equivalents and marketable securities. For the income statement, revenue for the 3 and 6 months ended June 30, 2012, was $1.5 million as compared to 0 and $4 million for the same periods the year before. Revenue in the 2012 period was due to the receipt of the payment of $1.5 million in June for the advancement of pre-clinical work into the company's 2011 amended and restated multi-kinase inhibitor collaboration agreement with Biogen Idec.

Revenue in the 2011 6 months period was due to an upfront payment of $4 million that we received in connection with the signing of the March 2011 kinase inhibitor agreements with Biogen Idec and Millennium.

R&D expenses increased to $8.1 million and $14.4 million for the 3 and 6 months ended this June as compared to $6 million and $10 million for the same period last year. The increases were due primarily to increases in clinical and other expenses related to the VALOR trial.

G&A expenses for the 3 and 6 months ended June 30 this year were $2.2 million and $4.4 million, respectively, as compared to $2 million and $4 million for the same period last year. The increase was primarily due to higher non-cash, stock-based compensation expenses.

We reported a net loss of $8.6 million and $22.5 million for the 3 and 6 months ended June 30, 2012, which included a non-cash expense of $4.1 million in the 6 months period related to a non-cash revaluation of certain warrants as compared to net losses of $8.2 million and $6.4 million for the same periods last year.

As Dan mentioned earlier at the upcoming interim analysis, we have access to several committed financial resources. For example, we will, at our discretion, have access to the $15 million second tranche of our 2011 loan facility, provided that the DSMB recommends either to end the trial early for efficacy or to continue the study with or without a sample size adjustment. The interim analysis may also, under 2 scenarios, trigger an immediate $25 million payment from Royalty Pharma in exchange for royalty payments on future product sales of vosaroxin.

Our current cash balance, combined with these committed capital sources, enables us to fund the VALOR trial through data unblinding, regardless of the outcome of the upcoming interim analysis.

Let me now turn the call back over to Dan.

Daniel N. Swisher

Thanks, Eric, and thanks, Adam. So before we open the call for questions, I'd like to reiterate the importance of the upcoming interim analysis of VALOR. So in September, just next month, the DSMB will be conducting a single, pre-specified interim analysis. It will be risk mitigating for us to safely pass the futility analysis and be provided with the important clarity on the likely timing of the unblinding of our pivotal trial results. Our strategy, with successful results from the VALOR trial, is to rapidly move to regulatory submissions and commercialization of vosaroxin in all of the major markets, alone in the United States and likely, in partnership with leading established companies elsewhere.

On October 4, I hope many of you will be able to join our management team at our second annual analyst and institutional investor meeting in New York City. This will include presentations and a panel discussion by principal investigators from the VALOR and the LI-1 trials.

So with that, Regina, I'll ask you to open the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] And gentlemen, your first question today is from the line of Eric Schmidt with Cowen and Company.

Eric Schmidt - Cowen and Company, LLC, Research Division

In terms of the DSMB review that you passed in June, do you recall what number review that was?

Daniel N. Swisher

Adam, do you want to answer that?

Adam R. Craig

I'm sorry, number of review?

Eric Schmidt - Cowen and Company, LLC, Research Division

Yes. I know that you had a series of safety reviews. So I just -- I guess I could go and pull up the press releases over the last year or so. But I don't know if you...

Adam R. Craig

There is a review every 6 months, Eric. So it would be the fourth time they've met.

Eric Schmidt - Cowen and Company, LLC, Research Division

And I guess, where the question is going is, on this potential for the trial to be halted for futility, I don't want to put words in your mouth, but it would seem less likely to me that if the trial is being reviewed every 6 months, Adam, for safety and that you're passing those reviews, that there would be much of a likelihood of the trial being stopped for futility. So I guess what I'm asking is, at these intermittent safety reviews, I assume things like death rates are reviewed.

Adam R. Craig

Certainly, there's not been any concern expressed by the DSMB about the safety of the drug and -- to this date. And so far, as we've spoken about before, the profile of the drug appears to be good. However, the DSMB will look at all data at the interim, and it will be the first time they look at efficacy data. So they will look at the risk-benefit profile of the drug as a whole before they make their decision. But you're correct. So far to date, the -- there have been no concerns from the DSMB about the safety profile of the drug, and they have, on repeated occasions, told us to continue the drug -- the study as planned.

Eric Schmidt - Cowen and Company, LLC, Research Division

So I mean at these planned interim safety reviews, would they not look at things like the overall mortality rates in either arms?

Adam R. Craig

They have some data. I don't want to go into detail exactly what they look at, but they do look at some data. But they don't look at the complete efficacy data set. That will be -- that review is reserved for September.

Daniel N. Swisher

Eric, just to reiterate. I mean, they are looking at the unblinded safety data between the 2 arms, but it's the efficacy piece that's missing, as Adam is mentioning.

Eric Schmidt - Cowen and Company, LLC, Research Division

But isn't mortality both a safety and efficacy consideration in this context?

Adam R. Craig

Yes, you are correct. Yes.

Eric Schmidt - Cowen and Company, LLC, Research Division

Okay, that's helpful. I guess that's all you kind of want to say on that, so I'll move on. Just a couple of nips for Eric. On R&D, it looks like things tweaked up a little bit quarter-on-quarter, even the trend over last year has increased. I assume that's maybe enrollment related. I don't know if there are other factors. And is this a new baseline run rate that we should move off of?

Eric H. Bjerkholt

No. I mean nothing's really changed. I mean the R&D expenses will be a little bit lumpy depending on actual enrollment trends and also depending on CMC activities. There's quite a lot of work going on in the background to prepare registration vouchers to stay on our NDA time line. So that tends to result in some lumpiness. The main methods remain the same, but we are funded path and blinding in all scenarios.

Eric Schmidt - Cowen and Company, LLC, Research Division

Okay. And then the last question, you reported, I think, maybe for the first time a basic and diluted net loss that's different from one another. Just trying to understand that.

Eric H. Bjerkholt

That just has to do with how dilutive or anti-dilutive warrants are calculated for purposes of those 2 numbers.

Eric Schmidt - Cowen and Company, LLC, Research Division

So the stock price increase over the last few months triggered that change. Is that...

Eric H. Bjerkholt

Correct.

Operator

Your next question is from the line of Adnan Butt with RBC Capital Markets.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

The first one is the pace of enrollment seems to be picking up. Is that a valid statement? And then, if the trial were to continue enrollment, would you need to add centers? Or at this pace, with the same centers, you'd be able to complete enrollment by the end of the year.

Daniel N. Swisher

Adam, do you want to address that?

Adam R. Craig

Yes. The pace of the enrollments has been very good. As you can see from the numbers that we publish, the updates we give, I'm very pleased. And not only do we have good enrollment both in Europe and in the U.S., we do anticipate enrollment to continue at rates that will allow us to continue to complete our goal of 450 patients by the end of the year. Our projections show that we should hit that. With respect to more sites, once we get to the interim analysis and we understand the position we're in and how many patients are -- we will look at enrollment again. It is pretty brisk at the moment, and I don't think we would need to add a large number of sites. If we have to, we may add 1 or 2, if there is some interest. But we -- currently with the number of sites we've got and the enrollment we have. We can -- I'm happy that we will be able to achieve our enrollment goals.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

And a follow-up on the LI-1 study, can you give us an update? What's the enrollment status like and data might be expected from that study?

Adam R. Craig

We haven't given an update on that yet. That's something we will do at a future date. The study has opened. It's enrolled while -- at this stage, we haven't given any more information on that. Dan, would you like to comment on that?

Daniel N. Swisher

Yes. I mean, I think what we can reiterate what we've given in terms of guidance is that we expect to get to a Phase II/III decision some-time next year. So we expect they would complete at least one of the arms with 50 patients' worth of data and be able to make that evaluation in 2013. And we can say that both arms are now enrolling patients, both the vosaroxin and the vosaroxin in combination with low-dose cytarabine.

Operator

Your next question is from the line of Mara Goldstein with Cantor Fitzgerald.

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Two questions for you. At this interim checkpoint that's coming up in September, will you get information other than keep going or sample size adjust? Is there any other data that will be revealed to you at that point? And then secondarily, with the Biogen Idec collaboration, what is the next milestone point for the company for you?

Daniel N. Swisher

Yes. So for the interim, I'll have Adam address that.

Adam R. Craig

Yes. We get very little information. We will get told which of the 4 options -- which of the 4 outcomes the DSMB has decided upon. And we will continue accordingly. They do not reveal a large -- well, they do not reveal information to us at that time. It usually is a one-line response according to the 4 options.

Daniel N. Swisher

Obviously, if the study is being stopped, we would be unblinded at that point in time and have access to the data set. But in the other scenarios, you're right. We're not going to get any further information. We do plan just to reiterate -- I mean, we do plan to press release when the interim occurs and probably have a short teleconference to make sure everyone understands what the recommendation is and what the implications are for the trial going forward.

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Okay. And then just on the Biogen Idec partnership?

Daniel N. Swisher

So on the Biogen Idec, it's a -- it's -- at this stage, it's pre-clinical. And so our expectation is if the next set of pre-clinical work goes well, the program could be in the clinic in 2013. And with that, we're hoping working with Biogen, we can reveal the target and the disease areas that they're going to be addressing with this program.

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Okay. And do you get a milestone payment once that proceeds into clinic?

Eric H. Bjerkholt

Yes.

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Are on the same order of magnitude as the one you just received?

Eric H. Bjerkholt

Yes.

Mara Goldstein - Cantor Fitzgerald & Co., Research Division

Okay. And if you don't mind, let me just -- I'm thinking on one more question for Eric. I don't know if you have this, but can you just give us a sense of non-cash charges, Eric, in the quarter or non-cash expenses in the quarter?

Eric H. Bjerkholt

They're largely related to the valuation of the warrants and the deferred stock compensation charges. And as I stated, they were about the -- the revaluation of the warrant is really the other expense line. And as far as that total non-cash charges, we haven't disclosed that.

Daniel N. Swisher

I think -- I mean, one thing just to note is maybe the change in cash balance between the quarters. And I think in Q1, it was $34.9 million and it's $29.3 million, which includes, Eric, the milestone payment.

Eric H. Bjerkholt

Correct.

Daniel N. Swisher

Of the $1.5 million.

Operator

Your next question is from the line of Joe Pantginis with Roth Capital Partners.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

A couple of nuance questions. I guess the first one has to do with, if you were to upsize the trial, I guess the projected relative ease by which you can increase that enrollment and I guess around the -- a pool of patients that would be available at clinical sites to be able to upsize with, would any clinical sites have to adjust their protocol. I don't know if any sites are restricted as to the maximum number of patients. I guess the general question again is just the ease of which you can upsize, and then I have a follow-up.

Daniel N. Swisher

Yes. I'll just say a word and then turn over to Adam. So we've been very pleased, as Adam said, for the pace of enrollment that's been consistently at the 25- to 30-patient-per-month level since end of last year, as we got all the sites opened. And there's no reason to think that, that pace should not continue. And we're going to be doing quite a bit of outreach efforts, working with the clinical sites for them to also understand the recommendations of the interim and to maintain the progress. We are really still for this specific setting, the only industry-sponsored trial. And so there's been a lot of interest, I think, both in the trial itself, the trial design and the clinical profile of vosaroxin. Adam, do you want to mention? Are there any kind of nuances or other things here?

Adam R. Craig

Yes. We -- It's basically what you've already said, Dan. We spent the spring and early part of the summer communicating and preparing our sites for the interim. They're very much aware, but obviously, because they've been helping us collect the data, but also aware of the consequences of it and that they need to go forward. I think the point Dan makes about there not being much competition for a trial like this is for us the most important thing, because it means that the majority of patients who present at the out [ph] sites are considered for the study. And I think that's one reason why enrollment has moved forward very briskly, together with the fact this is an unmet medical need and patients need to be treated ideally on clinical trials. So I'm not concerned that, post interim, that enrollment will be an issue at this stage. I think it will continue as planned. We have very well-motivated and high-performing sites. To answer your question about number of patients at sites, we don't at the moment have any plans to cut any individual sites. It's not necessary at this time point.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

That's very helpful. And then just a quick follow-up and again, this is even more nuanced. On the BD [ph] front looking for potential extra color here. I guess one could make the assumption that you've already had, obviously, discussions. You guys have talked about that. Obviously, this is very data driven with regard to consummating a deal. Maybe I guess, can you provide sort of any anecdotes without giving specifics about potential partners, commentary and excitement around the safety profile of the drug and the very low rates of treatment-induced mortality?

Daniel N. Swisher

I think you're going to join our team, Joe. I like the way you frame the business opportunity. Eric?

Eric H. Bjerkholt

Well, I mean the way we think about partnering in general is that vosaroxin is a unique, late-stage, high-value oncology program. And we do have worldwide rights to the program with IP out to 2030. And as Dan said in his comments, our base strategy is to market vosaroxin ourselves in North America and partner the rest of the world. And at this time, we have the team, the expertise and the financial resources to prosecute the VALOR trial on our own. And that gives us the tremendous leverage and flexibility to do the best deal at the time of our choosing.

Operator

[Operator Instructions] Your next question comes from the line of George Zavoico with MLV & Company.

George B. Zavoico - MLV & Co

Everyone is looking forward, obviously, to the DSMB meeting on and review on -- in September. Assuming -- Adam you said the pace of enrollment should complete -- you should get complete enrollment by December, I think you said. Given that, what would be the next point at which you would unblind the data. I mean your overall survival is your endpoint, but the trial is sort of open-ended in the sense that the primary endpoint -- the OSR [ph] is up to 5 years or the duration of the study.

Daniel N. Swisher

So Adam, you want to take that?

Adam R. Craig

Sorry Dan. So the trigger is -- will be 375 events. That would be the trigger for the end of the study. When we have the 375th event, we will then move forward to make sure the data is clean, and all the data is in the house. And then from that -- from there on, we will then be able to unblind into the -- and the projected time line, Dan has already spoken about. So the answer to your question is it's the 375th event that will be the trigger for the final data analysis -- final data preparation and the unblinding.

George B. Zavoico - MLV & Co

Okay, thanks for the reminder. And with the amount of capital potentially coming in with a good DSMB review and you mentioned it's enough to take you through the completion of VALOR. Then -- and I guess it means that's enough to take you through the 375th event, obviously. But that could signal -- I mean you've also got evidence that the drug works well in solid tumors. And is there a plan B, at which point, you would move forward on other indications? Or would that require having a partnership on board already?

Daniel N. Swisher

Yes. Let me take a crack at that and then have Adam join in. Yes. We're very pleased this year to get the LI-1 study up and running. So it's a major cooperative group study, which takes vosaroxin into the additional line of therapy in AML that we know we've got a very compelling profile and an unmet medical need, which is this front-line elderly. And so I'd say near term, our strategy is to ensure that vosaroxin, with successful trial results, becomes the new standard of care in multiple lines of AML therapy. I think the next most promising area, which is very related to AML, same type of treating physicians and we'll get some clinical experience even from the LI-1 study, is to move into high-risk MDS patients. So that's probably going to be where you're going to see, near term, the company-directed efforts is into the hematology space. But as you point out, and George, you've been following this program for a number of years, you remember we've got nice single-agent solid tumor experience, albeit it was in some very relapsed/refractory patients. And given how well the drug combines with cytarabine, which is a fairly potent cytotoxic, we have a lot of promising pre-clinical data that showed synergistic combinations with other standards in those solid tumor settings. And so at that appropriate time where we've got a little more bandwidth, I would say, I think the investigator -- the investor -- investigator interest is out there. But as we have a little more bandwidth, with or without a partner, we will start to explore those other settings. But near term, the focus is clearly on VALOR, LI-1 and to get a few more studies up and running in the hematology space. Adam, do you want to...

Adam R. Craig

I agree with you, Dan. I have nothing to add to that.

Operator

Ladies and gentlemen, this does conclude the question-and-answer portion of today's event. I'd like to turn the call back over to Dan for some closing remarks.

Daniel N. Swisher

Yes, thanks. Thanks to everyone for joining us. I think we've reiterated enough times that just one month away, we've got the interim analysis. And it's taken a lot of effort on the part of our development team to get to that point. There's a lot of [indiscernible] data cleanup. And in trial prosecution, we also really appreciate the support from the investigator sites to get that data into a clean data set, so we can have that analysis. I think I would just want to reiterate, vosaroxin has emerged in AML as the leading development program. It's very high potential with worldwide peak sales of $1 billion. We've got full, unencumbered rights to this program at this point in time. Long exclusivity, as Eric mentioned, out to 2030 in the United States and out very far in the major markets. And then we have these additional programs, they're going to start to come to light with data milestones, both with Biogen and Millennium. So we really appreciate everybody's following the company and following the progress of this. We look forward to seeing many of you in the coming months. And as always, we're open for further follow-up or discussion. Thanks for joining this morning.

Operator

Ladies and gentlemen, thank you so much for your participation today. This does conclude our presentation, and you may disconnect. Have a great day.

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