Karyopharm Therapeutics Inc (KPTI) 2017 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Karyopharm Therapeutics Second Quarter 2017 Earnings Call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

I'd now like to introduce your host for today's conference, Mr. Chris Primiano, Senior Vice President, Operations, Business Development, General Counsel, and Secretary of Karyopharm Therapeutics. Sir, please go ahead.

Thank you. And thank you all for joining us on today's conference call to discuss Karyopharm's Second Quarter 2017 Financial Results. This is Chris Primiano, and I'm joined today by Dr. Michael Kauffman, Chief Executive Officer; Dr. Sharon Shacham, our Founder, President and Chief Scientific Officer; and Michael Todisco, our Vice President of Finance.

On the call today, Michael Kauffman will make some introductory comments and provide a short update on the clinical development programs and plans, then Mike Todisco will provide an overview of the second quarter 2017 financial results. Dr. Kauffman will then discuss our key upcoming milestones and provide some summary remarks. Then we'll open the call up for your questions, for which Sharon and I will also be available.

Earlier this morning, we issued a press release detailing Karyopharm's results for the second quarter 2017. The release is available on our website at karyopharm.com.

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended March 31, 2017, which was filed with the SEC on May 4, 2017, and any other filings we may make with the SEC, including our quarterly report on Form 10-Q for the second quarter of 2017, which we expect to file later today.

Any forward-looking statements represent our views as of today only and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. In addition, please note that any references we make to clinical trial data during today's discussion or refer to interim (inaudible) site data unless otherwise specified.

I'll now turn the call over to Dr. Michael Kauffman, Chief Executive Officer of Karyopharm.

Thank you, Chris, and good morning, everyone. Thank you for joining us on our call today. Today, I'd like to start by highlighting a number of events that have happened during the second quarter, which mark significant progress across several of our development programs, especially with selinexor.

First and foremost are the exciting data coming out of diffuse large B-cell lymphoma or DLBCL program, our second lead indication after multiple myeloma. In an oral presentation at EHA 2017, we were extremely pleased to present updated data from the Phase IIb SADAL study in patients with relapse or refractory DLBCL where the overall response rate has increased to 33% for the overall trial population and a median duration of response is over 7 months.

In patients with double or triple hit DLBCL, we saw similar response rates indicating clear activity in this population, which usually has a particular poor prognosis. Selinexor also showed robust single agent activity against both GCB and non-GCB sub-types of DLBCL and in relapsed DLBCL as well as refractory disease.

In the GCB subtype, we saw an ORR of 28% and in patients with a non-GCB, also called ABC subtype, the ORR was about 39%. The adverse events in the 60-milligram treatment [RNR], the dose level will be taken forward for predictable and manageable with dose modifications and/or standard supportive care. Side effects were consistent with those previously supported with selinexor and no new safety signals were identified, including in patients with DLBCL remaining on therapy over 1 year.

As many of you are aware, about 60% of patients with DLBCL are currently cured, 50% with initial therapy, typically R-CHOP, and another 10% with chemotherapy followed autologous stem cell transplantation in second line. There is no standard of care therapy for the remaining 40% of patients or about 10,000 patients per year in the United States and novel agents are required. Chimeric Antigen Receptors Modified T-Cells, commonly called CAR-T therapy, are being explored but are only suitable for the minority of patients who are medically stable enough to undergo this therapy.

Selinexor, which is taken as an outpatient, represents a completely novel option. The data reported to date from the SADAL study indicate that selinexor has a well-tolerated and effective safety profile and efficacy profile, and are exciting because they support our belief that as a single agent oral therapy, they can be taken at home. Selinexor has significant potential and could be a tremendous value to the patients and physicians in need of new treatments.

Along with the impressive SADAL data reported earlier this year, we also recently communicated our plan development path forward for selinexor in this indication. We have shared the SADAL clinical data with the U.S. FDA and given the robust response rate and duration, along with better tolerability and durability of the 60-milligram twice weekly dose cohort versus the 100-mg cohort, we obtained the FDA's agreement to continue the lower dose arm and remove the 100-mg arm. We plan to enroll up to 90 additional patients at the 60-milligram dose for a total of 130 patients in this arm, and are expected to report top line results from the SADAL study in the second half of 2018.

Assuming we continue to see the response rate and durability observed to date, we plan to use these data from the SADAL study to support submission of a new drug application with request for accelerated approval in the U.S. for single agent selinexor as a new treatment option for relapsed or refractory DLBCL.

We continue to make strong progress in multiple myeloma, our lead indication for selinexor. In June, we dosed the first patient in our pivotal, randomized, Phase III BOSTON study in evaluating oral selinexor in combination with the proteasome inhibitor, Velcade, also known as bortezomib, and low dose dexamethasone, a regimen we call SVD, compared to Velcade and low-dose dexamethasone or VD, in patients with myeloma who have at least 1 to 3 prior lines of therapy.

The dosing regimen on SVD is 100 milligrams of selinexor once weekly, 1.3 milligrams per meter squared of Velcade subcutaneously, also once weekly, given 4 out of every 5 weeks, and 40 milligrams of dexamethasone weekly, which is the standard low dose dexamethasone commonly used in the treatment of myeloma.

The BOSTON study incorporates 2 novel innovations into Velcade based myeloma regimens. First, to the best of our knowledge, this is the first study to evaluate once weekly subcutaneous Velcade in the experimental arm. Once weekly Velcade is a regimen preferred over the standard twice weekly regimen by many physicians because it carries significantly reduced risk of peripheral neuropathy and typically requires only once weekly office visits.

Second, the trial design permits patients on the VD control arm who receive standard twice weekly Velcade to cross over to the SVD arm once progression has been confirmed by the independent review committee. We believe that these innovative designs make the trial attractive for both caregivers and patients.

In BOSTON, the 2 primary endpoints are the differences in progression free survival along with overall response rate between the 2 arms. We expect this study to enroll approximately 360 patients at over 100 clinical sites internationally with accrual projected to complete in 2018 and top line data expected in 2019. Assuming a positive outcome from the BOSTON study, we expect to be well-positioned to support a request for full approval for selinexor for patients with at least one prior therapy for their myeloma.

Moreover, we believe that this simplified once weekly Velcade based therapy could become an important and convenient regiment for patients relapsing after front line treatment.

Turning to our other trials in myeloma, the ongoing Phase IIb STORM study continues to accrue well. STORM is evaluating oral selinexor in patients with penta-refractory myeloma, which we believe represents a significant unmet medical need. Perhaps our most important near term milestone, we remain on track to report top line response data from STORM no later than April 2018.

If we continue to see the robust responses in durability in this study that we previously reported at the interim at ASH 2016, we intend to submit the full STORM data to the FDA in the second half of 2018 with a request for accelerated approval for selinexor as a new treatment for patients with penta-refractory myeloma. In addition, the Phase 1B-II STOMP study continues as planned, evaluating a backbone of selinexor plus low-dose dexamethasone with a variety of other anti-myeloma agents. The data reported to date from this study indicates that the combination of a proteasome inhibitor and selinexor is highly synergistic in the clinic with the combinations of selinexor with either Velcade or Kyprolis are active, even against proteasome inhibitor resistant myeloma.

Enrollment in the selinexor or Velcade-dex arm of the ongoing STOMP study has reached 42 patients and is now complete. In addition, dose escalation is complete and expansion is ongoing in the arms evaluating the all-oral selinexor IMiD combinations, including selinexor plus dex with either Revlimid, so-called SRD, and separately with Pomalyst or SPD.

We expect to report updated data on these convenient oral regiments by year-end 2017. Finally, we have now dosed our first patients in the new STOMP arm, evaluating selinexor in combination with Darzalex and low-dose dex in patients with heavily pre-treated myeloma. The SDD arm is expected to enroll up to 16 patients with top line data from this cohort expected in the first half of 2018.

An important takeaway I'd like to mention here is about the emerging safety profile for selinexor particularly as we are no longer treating patients with doses higher than 80 milligrams twice weekly. With the dosing regimens that are being utilized in our key trials, including BOSTON, STORM, SADAL, STOMP, and SEAL, selinexor continues to be well tolerated particularly when used once weekly in the combination regimens of study. Adverse events tend to be highly predictable and manageable with standard supportive care and/or dose modifications. And as you know, we have had patients on selinexor for more than 1 to 2 years.

Turning now to our selinexor programs in solid tumors, enrollment is now complete in the Phase II portion of the blinded randomized Phase II/III SEAL study evaluating selinexor in patients with advanced liposarcoma after at least one prior therapy. We view this program as our third leap program after myeloma and DLBCL and we look forward to reporting the hazard ratio for the primary endpoint of PFS or progression free survival, from the Phase II portion of the SEAL study along with an update regarding the plan development path and the syndication in September or October 2017.

As a reminder, both the trial design and study endpoints have been accepted by both the FDA and the European Medicines Agency. Before I discuss a few highlights relating to our pipeline assets, I'd like to mention that in the Evaluate Pharmas reported entitled World Preview 2017 Outlook to 2022 that was recently published, in that report, oral selinexor was projected to be one of the top 5 selling oncology R&D products worldwide by 2022 with the potential to generate estimated revenues of just less than $1 billion in worldwide annual sales, and to capture an estimated 0.5% of the worldwide oncology market share in the same time frame. Evaluate Pharma is an industry leader in consensus forecast analyses for the biotech and pharma sectors. We are extremely pleased to receive this recognition and further validation of selinexor's future potential.

Turning now to the pipeline assets beyond selinexor, including KPT-9274 and KPT-8602. KPT-9274 is an oral dual inhibitor of PAK4/NAMPT. During the second quarter, we presented preclinical data highlighting KPT-9274's anti-cancer activity in K9 companion animals with spontaneous lymphomas. These data, which were presented by Cheryl London of Tufts University, as a late breaking abstract at the AACR 2017 annual meeting, demonstrated the activity and synergy of KPT-9274 with doxorubicin to treat spontaneous K9 lymphomas.

9274 is currently being evaluated in a Phase I study for safety and tolerability of patients with advanced solid tumor malignancies, including sarcoma, colon, and lung cancers whose disease has relapsed after standard therapy. We look forward to reporting top line data from this study later this year.

KPT-8602 is our second-generation SINE inhibitor compound with reduced blood-brain barrier penetration compared with selinexor. We expect to report additional data later this year from our ongoing Phase I/II study of 8602 [plus] dexamethasone in patients with multiple myeloma.

And finally, verdinexor, previously called KPT-335, is another oral SINE compound that is closely related to selinexor. We recently executed an out licensing agreement with privately held Anivive Lifesciences, transferring to them exclusive worldwide rights to research, develop, and commercialize verdinexor for the treatment of cancer in companion animals. Under the terms of the agreement, Karyopharm received a onetime upfront payment of $1 million and is eligible to receive up to an additional $43 million based on technology transfer and achievement of specific regulatory, clinical, and commercial milestones.

Karyopharm is also eligible to receive a low double-digit royalty based on future net sales of verdinexor. Important, this Anivive transaction enables us to monetize our non-core assets as we continue to focus on advancing the development of selinexor in our lead human indications of myeloma, DLBCL, and liposarcoma.

With that, I'd now like to turn the call over to Mike. Mike?

Thank you, Michael. Since we issued a press release earlier today outlining our second quarter 2017 financial results, I'll just review the highlights and then speak to our cash balance and financial guidance.

Cash, cash equivalents and investments as of June 30, 2017, including restricted cash totaled $181.2 million compared to $175.5 million as of December 31, 2016. During the second quarter, we closed an underwritten public offering of approximately 3.9 million shares of our common stock at a price to the public of $10.25 per share, resulting in net proceeds of approximately $37.9 million after deducting the underwriting discounts and commissions and offering expenses payable by us.

We also sold approximately 1.3 million shares under our ATM facility for net proceeds of approximately $14.4 million. The total net proceeds raised in equity financings in April was $52.3 million. For the second quarter of 2017, research and development expense was $23.1 million compared to $24.6 million for the same prior year period. For the second quarter of 2017, general and administrative expense was $6.6 million compared to $6 million for the same prior year period.

Karyopharm reported a net loss of $29.4 million or $0.64 per share for the second quarter of 2017 compared to a net loss of $30.2 million or $0.84 per share for the same prior year period. Net loss includes stock-based compensation expense of $5.1 million and $6.4 million for the second quarters of 2017 and 2016 respectively.

As for financial guidance, we expect our 2017 operating cash burn, including research and development and general and administrative expenses, to be in the range of $90 million to $95 million. Based on current operating plans, we expect that our existing cash and cash equivalents will be sufficient to fund our research and development programs and operations into 2019, including the continued clinical development of selinexor in our lead indications with a focus on filing for accelerated approvals for myeloma and DLBCL, and preparing to establish a commercial infrastructure for the potential launch of selinexor in North America and Western Europe.

I'll now turn the call back over to Michael Kauffman for concluding remarks. Michael?

Thank you, Mike. Before we open the call for questions, I would just like to recap the upcoming milestones expected for 2017, 2018, and beyond. First, in hematologic malignancies, we are diligently executing on both the STORM and SADAL studies in relapsed or refractory myeloma and DLBCL respectively. For STORM, we expect top line data from patients with penta-refractory myeloma to be reported by April 2018, followed by an NDA submission in the second half of 2018 requesting accelerated approval.

For SADAL, we expect top line data in the second half of 2018 followed by an NDA submission and request for accelerated approval likely in early 2019. Next, we expect to have multiple data readouts from the STOMP study, for DSVD, SRD, and SPD arms, we plan to report updated data towards the end of 2017 and for the SDD ARM, we plan to report top line data in the first half of 2018. And for the pivotal Phase III BOSTON study, we expect to complete enrollment in 2018 with top line data anticipated in 2019.

For solid tumor malignancies, we expect to report the hazard ratio for PFS from the Phase II portion of the blind and randomized Phase II/III SEAL study in patients with relapsed or refractory liposarcoma, our most advanced solid tumor indication, in September or October of this year. For our other pipeline assets, we expect to report top line Phase I safety and tolerability data for KPT-8602 in late 2017 and similarly, we expect to report top line Phase I safety and tolerability data for KPT-9274 later this year.

We've had a strong first half of 2017 and we believe we are well-positioned to execute on our clinical and corporate strategies and maintain the momentum we've created. With 2 potential accelerated approval submissions planned, we believe we have several exciting catalysts on the near-term horizon. We believe selinexor has tremendous potential to help patients suffering with certain hematologic and solid tumor cancers and we remain focused on achieving our milestones and enhancing future value for all of our stakeholders.

Thank you for listening today and we will now open the call for your questions. Operator?

(Operator Instructions) Our first question comes from the line of Mike King with JMP Securities.

I had a couple of questions. First on SADAL, are you guys done providing updates on both response rates and duration for the time being or -- in other words, next time we'll see SADAL updated data will be when you report out in 2018?

Yes, the interim analysis we presented at AACR lymphoma meeting and at EHA was preplanned. It was in the protocol and it was post the discussion of the FDA modified the trial. The next data update will be the final data from SADAL, which will be in the second half of 2018.

If I might ask, do you believe -- I assume the fact that you're continuing the study as planned is because you feel that the data today in terms of both response rates and duration are acceptable both from a regulatory as well as clinical standpoint, correct?

Yes, I think we believe that the kind of numbers we're seeing with the 33% response rate and the median duration that's seven months or better would be sufficient for an accelerated approval and we're continuing the study, and FDA has approved us continuing the study. And we hope to present the final data and then submit it for accelerated approval.

And then finally on DLBCL, is there any value in your eyes with respect to studying patients who have failed CAR-T therapies?

The protocol certainly allows for patients who failed CAR-T. We definitely have patients who have gone through, unfortunately failed after stem cell transplantation, a standard stem cell transplant. So as CAR-T gains some momentum, we certainly expect to see some patients that meet criteria, enter our study, and we could treat after CAR-T.

Given the difference in mechanism, there's no reason to believe we couldn't have activity there but we'll just have to see.

Okay, and if I might just a quick question on SEAL. On liposarcoma, Michael, could you enlighten us to whether the PFS hazard ratio is a go/no go decision point? In other words, if PFS does not hit the statistical -- desired statistical hurdle, will the study be stopped or will you continue on and look at overall survival?

The study is double-blinded. There was a PFS analysis that will be reviewed by the [VSMB] and there will be a recommendation for us to proceed or to stop, or to resize the study.

Okay, so it will be data driven then in other words.

Data driven, yes.

Our next question comes from Mara Goldstein, Cantor Fitzgerald.

I had 2 questions. For the SEAL study, will enrollment numbers in the Phase III adjust depending on the result of the Phase II hazard ratio?

Correct, that's exactly what's going to happen.

And then for the STOMP trial, in the DARA arm, I just wanted to confirm the selinexor dosing there is 100 milligrams or 16 milligrams depending on the cohort. And is there room for dose adjustment if you need to within those cohorts?

The Phase 1 includes 2 different escalation modes, once on a once weekly, which is starting at 100 mgs and the other one on a twice weekly, which is starting at 60 mgs twice weekly. And in both cohorts, you can adjust the dosing (inaudible) moving forward right now.

Our next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

This is Jenny on for Ying Huang. We just had one as CAR-T is changing in specifically multiple myeloma. I know we've spoken before that your patients are very different but as far as you know, is there any difference in your agreement with the FDA for what's acceptable for accelerated approval in these penta-refractory patients? Thanks.

The FDA always says that the review of any data would be subject to clinical, particularly efficacy and safety and not totality of the data. So there's no specific agreement. One certainly would agree that the patients that we're getting do not have any viable options according to FDA labels and according to the KOLs and the investigators who are putting patients on the trial in this Phase 2 study in penta-refractory disease. The patients did have other options with known clinical benefit, the patients would be offered those and presumably go on those.

So as far as our concern is CAR-T is very interesting and the conclusion criteria they have are very different from ours, and our patients really have minimal including criteria to come onto our study, especially in the myeloma study. So we continue to believe this is a very big population with unmet need and the good accrual that we're seeing to date would suggest that that's true.

Our next question comes from the line of Maury Raycroft with Jefferies.

I was wondering for ESMO, I'm seeing the Phase I ovarian and endometrial combo trial listed and I assume that you cannot give too many details on it but I was wondering if you could remind what the trial is, and the purpose. And then at ESMO 2016 based on the data reported there, you mentioned planning for Phase IIIs in ovarian and endometrial, and I'm wondering what the current status of the Phase III plans are.

So the Phase I study is a combination study of selinexor with carboplatin and paclitaxel. So in patients with ovarian or endometrial cancers, it is looking at taxel either once weekly or once every 3 weeks, and the results will be reported describe the study.

Did you ask for a reminder on the last ESMO data? That was the first question. Can you repeat the second question?

Sure, I think at the ESMO 2016 you mentioned you were planning for Phase IIIs in ovarian and endometrial and I was just wondering what the status of the Phase III plans are.

We are still planning on opening a Phase III study in endometrial cancer and this study is planned to start this year or early next year, towards the end of the year.

And then just a quick question. So I was wondering for the PAK4 PANAMA Study, if you can remind me why niacin is included in there and what the purpose of that is?

So typically, 9274 is 2 mechanism of (inaudible). One is PAK4 enervation and the other one is non-PT enervation, which is basically one of the pathways, which the cell is making, and in one of the most important metabolized in the cell. Another pathway that it can make is through -- the nicotinic acid, sorry, I was blanking -- it's for nicotinic acid is another metabolized. So there are 3 pathways to make NAD, one into tryptophan, one into nicotinic acid, and one to the non-PT pathways.

Most cancers are using the non-PT pathway but normal cells can use nicotinic acid and one way to overcome potential toxicity from non-PT inhibition is by providing nicotinic -- niacin, which is a nicotinic acid -- which making of that through the nicotinic acid pathway.

(Operator Instructions) Our next question comes from the line of Michael Schmidt with Leerink Partners.

I had one regarding the SEAL trial and apologies if you've already addressed this earlier. I joined the call a bit late but my impression was that initially you were planning to present Phase II data in the middle of this year, and you were talking about September, October now. Can you just remind me what changed or what's behind those changes in terms of data disclosure for the Phase II portion of the SEAL arm study? Thanks.

So this is a double blind study of a very rare disease, which is performing in various specific stem cells in the United States with (inaudible) centers for patients with liposarcoma. And the endpoint is also -- so (inaudible) really depends on finding a very rare patients with disease concept. In addition, if it's a PFS endpoint so the results depend on an endpoint of progression free survival and how long patients stay on either placebo or selinexor. With all of this together, we expect to provide guidance for this study in the September/October time frame.

So the PFS is longer than anticipated in the Phase II portion; is that correct?

It's the number of patients we have with the PFS. We don't know the PFS is the study that was blinded.

And remind me the Phase II portion, is that 60 patients, 30 in each arm; is that correct?

The Phase II will be 57 patients, almost 60.

We have a follow-up question from the line of Mike King with JMP Securities.

Just on STOMP, Michael, I was just wondering if you could give any update or guidance on your thoughts on the timing to enroll the ARM with Kyprolis and whether the recent updated of the label to include a benefit in overall survival has influenced your thinking at all about how aggressively you would like to combine selinexor with Kyprolis.

So the combination of selinexor with Kyprolis is not part of the STOMP study. It was studied in a different -- in an IST that is together with (inaudible). We have completed the first portion of the study, which was looking at combination of selinexor with carfilzomib and twice weekly selinexor and that recommended Phase II dose was with Kyprolis 27 milligrams per meter squared. We are now amending to look at other combinations including selinexor once weekly and will evaluate (inaudible) doses of Kyprolis out of this study, including once weekly and twice weekly in doses of Kyprolis.

Can you say what does of Kyprolis you'll be investigating? Will it be above the standard label or can you go higher?

We will -- we are still discussing the study with the University of Chicago and deciding on the once weekly and twice weekly regimens. So I can't provide more detail than that but it will be whatever our development doses of the Kyprolis that are being used in the (inaudible) study.

Okay. Can you say what you might want to see? Is it based on safety, Sharon, that would convince you to flip to a Karyopharm sponsored IND from an IST?

Efficacy is less of a concern. We do believe that selinexor once weekly is better tolerated and provide us the efficacy that we need in combination with proteasome inhibitors. So there's a lot of synergy between the two, but I would like to see that we are going with the once weekly will allow us to explore doses of Kyprolis that are higher than 27 (inaudible). We'll also get improvement on both efficacy and safety.

Our next question comes from the line of Arlinda Lee with Canaccord.

I was curious about the STOMP expansion oral data that you're presenting by year-end. Can you provide any information on the scope of the expansion cohort and what that might mean in terms of next steps? Thanks.

So we are expanding on once recommended Phase II doses achieved no oral (inaudible) arms that we will -- obviously, we have reached that and (inaudible) all of the arms. We will expand to get a better handle of efficacy and safety. These extension usually include, for example, in both selinexor, and Velcade, and the (inaudible) arm we get Velcade refractory and (inaudible) patients. And we might see those also in the other 2 arms.

So we will learn also in efficacy and IMiD refractory combination and proteasome inhibitor refractory population. And then from this, we are going to choose studies for next steps.

And then just to clarify on a couple of things. On the selinexor (inaudible) trial, originally I thought this was an investigator sponsored study of some sort. Is that true or is that (inaudible) registrational?

Yes, it is. It's going to be a Phase III randomized study and in the (inaudible) cancer that will be done as an investigator sponsored study.

And then the last question is at some point you talked about combination with immuno-oncology drugs. How is that going and when might we see data for that? Thanks.

The studies are part of an investigator sponsored study that is with MD Anderson, with the Phase 1 users MD Anderson, and it's still ongoing.

Our next question comes from David Nierengarten with Wedbush.

This is Dilip sitting in for David. Just wanted to clarify something mentioned in response to Michael's question on SEAL. Did you say 67 patients in the Phase II? And then also given that a few new therapies have been approved recently for soft tissue sarcomas, neither of which have been really widely adopted, do you ultimately except that an OS benefit would need to be demonstrated just for commercial benefits?

So the number of patients for the Phase II is 57, 5-7, so just below 60 and for your question, there is a crossover from placebo to selinexor at the point of progression in the study. So there is no need to show OS superiority between selinexor over a placebo but the FDA requests that we are to show that there is no detrimental effect of selinexor on OS as a secondary endpoint.

Okay, and just as a reminder, when did you start enrollment in that study and when did you complete it, at least in the Phase II portion?

Give us a minute. We'll probably have to get back to you on that. We completed enrollment recently and we're just waiting for the events to be completed in the central radiological review committee to review the data and then also it has to be sent over to the DSMD. In addition, the update will be following an FDA meeting to confirm the Phase III plan.

This is a Phase II/III study and it's ongoing and accrual is ongoing but one always have to have an end of Phase II meeting, even if the Phase III has sort of started. So that's the plan and we'll update after that.

But you never guided to when a Phase III would fully enroll or topline from that?

So it's just a good (inaudible) first patient was on January 2016 and the last patient was --

A couple months ago.

In April, yes. May, yes.

I'm showing no further questions in queue at this time. I'd like to turn the call back to Dr. Kauffman for any closing remarks.

Well, everybody, than you for joining us this morning. Thank you again for your interest in Karyopharm and for your time and attention, and have a great day. Cheers.

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program and you may now disconnect. Everyone have a great day.