Karyopharm Therapeutics Inc. (KPTI) Q2 2017 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Karyopharm Therapeutics Second Quarter 2017 Earnings Call. At this time all participants are in a listen only mode. [Operator Instructions] Later we will conduct a question-and-answer session and instructions will follow at that time. I would 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, 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 and we will 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 will 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 04, 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 refer to interim unaudited inside data unless otherwise specified. I will 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 on the exciting data coming out of the 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 2B SADAL study in patients with relapsed or refractory DLBCL where the overall response rate has increased to 33.3% for the overall trial population and a median duration of response is over seven months. In patients with double or triple-hit DLBCL, we saw similar response rates indicating a clear activity in this population which usually has a particularly poor prognosis. Selinexor also showed robust single-agent activity against both GCB and non-GCB subtypes 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 non-GCB also called ABC subtype the ORR was about 39%. The adverse events in the 60 mg treatment arm the dose level will be taken forward are predictable and manageable with dose modifications and/or standard supportive care. Side effects were consistent with those previously reported with selinexor and known and safety signals were identified including in patients with DLBCL remaining on therapy over one year. As many of you are aware, about 60% of patients with DLBCL are currently cured, 50% with initial [indiscernible] typically are chopped and another 10% with chemotherapy followed by autologous stem cells transplantation in second line. There is no standard of care therapy for the remaining 40% of patients or about 10,000 per year in the United States and novel agents are required. Chimeric is in receptor 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 indicates 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 that 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 planned development path forward for selinexor in this indication. We have shared the SADAL clinical data with the U.S. FDA and given their robust response rate and duration, along with better tolerability and durability of the 60 mg twice weekly dose cohort versus the 100 mg cohort, we have 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 mg 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 3 BOSTON study evaluating oral selinexor in combination with a proteasome inhibitor Velcade also known as bortezomib and low dose dexamethasone, the regimen we call SVd. Compared to Velcade and low dose dexamethasone or Vd in patients with myeloma who have at least one to three prior lines of therapy. The dosing regimen on SVd is 100 mg of selinexor once weekly, 1.3 mg per meter square of Velcade subcutaneously, also once weekly given four out of every five weeks and 40 mg of dexamethasone weekly which is a standard low dose dexamethasone commonly used in the treatment of myeloma. The BOSTON study incorporates two 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 to received 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 two primary endpoints or the differences in progression free survival along with overall response rate between the two arms. We expect the 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 regimen for patients relapsing after frontline treatment. Turning to our other trials in myeloma, the ongoing Phase 2B STORM study continues to approval arm. 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 and durability in this study, that we have 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 1B2 STORM study continues as planned evaluating the 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 combination of selinexor with either Velcade or Kyprolis are active even against proteasome inhibitors as to myeloma. Enrollment in the selinexor-Velcade-dex arm or the ongoing STORM study has reached 42 patients and is now complete. In addition, dose escalation is complete and expansion is ongoing in the arms evaluated in the all oral selinexor IMID combinations including selinexor plus dex with either Revlimidm so called SRd and separately with Pomalyst or SPd. We expect to report updated data on these convenient oral regimens 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 pretreated 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 that our emerging safety profile of selinexor particularly is we are no longer treating patients with doses higher than 80 mg twice weekly. With the dosing regimens that are being utilized in our T trials including BOSTON, STORM, SADAL and SEAL selinexor continues to be well tolerated particularly when used once weekly in the combination regimens under study. Adverse events tend to 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 one to two years. Turning now to our selinexor start up programs in solid tumors. Enrollment is now complete in the Phase 2 portion of the blinded randomized Phase 2/3 SEAL study evaluating single-agent selinexor in patients with advanced liposarcoma after at least one prior therapy. We view this trial as our third lead program after myeloma and DLBCL and we look forward to reporting hazard ratio for the primary endpoint or PFS or progression free survival from the Phase 2 portion of the SEAL study along with an update regarding the planned development path in this indication in September or October 2017. As a reminder, both the trial design and study endpoints have been accepted by both the FDA and European Medicines Agency. Before I discuss a few highlights relating to our pipeline assets, I'd like to mention that in EvaluatePharma's report titled 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 timeframe. EvaluatePharma 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 dose inhibitor PAK4/NAMPT. During the second quarter we presented preclinical data highlighting KPT-9274 in anticancer activities in canine companion analysis on canine lymphomas. These data which are represented by Cheryl London of Tufts University has late breaking abstract at the AACR 2017 Annual Meeting demonstrating the activity and synergy of KPT-9274 with doxorubicin to treat spontaneous canine lymphomas. 9274 is currently being evaluated in a Phase 1 study for safety and tolerability in 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 1/2 study of 8602 plus dexamethasone in patients with multiple myeloma. And finally, verdinexor previously called KPG 335 is another oral SINE compound that is closely related to selinexor. We recently executed and out licensing agreement with privately held Anivive Lifesciences, transferring to them exclusive worldwide rights to develop, to research, develop and commercialize verdinexor for the treatment of cancer and compare analysis. Under the terms of the agreement, Karyopharm received a one-time 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 and advance on advancing the developing of selinexor in our lead human indications of myeloma, DLBCL and myelosarcoma. 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 operating 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 were $52.3 million. For the second quarter of 2017 research and development expenses $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 $6million 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 periods. Net loss includes stock-based compensation expense of $5.1 million and a $6.4million for the second quarter 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 $95million. 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 will 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 STORM study, for the SVd, SRd and SPd arms we plan to report updated data towards the end of 2017 and for the SDd arm plan to report top-line data in the first half of 2018. And for the pivotal Phase 3 BOSTON study we expect to complete enrollment in 2018 with the top-line data anticipated in 2019. For solid tumor malignancies we expect to report added ratio for PFS from the Phase 2 portion of the blind and randomized Phase2, Phase3 SEAL study in patients with relapsed or refractory liposacroma our most advanced solid tumor indication in September or October this year. For our other pipeline assets we expect to report top-line Phase 1 safety intolerability there for KPT-8602 in late 2017 and similarly we expect to report top-line Phase 1 safety intolerability data for KPT-9274 later this year. We have had a strong first half of 2017 and we believe we are well positioned to execute on our clinical corporate strategies and maintain the momentum we have created. There are two potential accelerated approval submission 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 creating future value for all of our stakeholders. Thank you, for listening today. 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.

Hi guys, good morning. Thanks for taking the questions, congrats on the progress. I just have 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 like last time, next time we’ll see SADAL updated data will be when you report out in 2018?

Yes, this is – the interim analysis we presented at ACR and the meeting at EHA was pre-planned, it was in the protocol and it was proof of discussion of the FDA to modify the trial. The next data update will be the final data from SADAL which will be in the second half of 2018.

Right, okay. If I might ask, do you believe, I assume that you have started to continue the study as planned is because you feel that the data to date 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 kinds of numbers we’re seeing with the 33% response rate and the duration, medium duration is seven months or better will be sufficient for an accelerated approval and we are continuing this study and FDA has approved us continuing the study and we hope to present the final data and then submit it for accelerated approval.

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

The protocol certainly allows for patients who failed CAR-T. We definitely have patients who’ve gone through unfortunately failed after stem cell transplantation, standard stem cell transplant. So, as CAR-T gained some momentum we certainly expect to see some patients that meet criteria into our study and we could treat after CAR-T. Given the difference in mechanism, there is no reason to believe we couldn’t have activity there, but we will just have to see.

Okay. And if I might, just a quick question on SEAL, first on lipoma Michael, could you enlightened us to whether there is the PFS hazard ratio is a go, no go decision point? Another one if PFS does not hit the desired statistical hurdle, will the study be stopped, or will you continue on and look at overall survival?

This study is double blinded. There was a PFS analysis that will be reviewed by the [indiscernible] there will be a recommendation for us to proceed, all the stuff, also restarted the study.

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

Data driven, yes.

Okay. All right, thank you, I will get back in queue.

Our next question comes from Mara Goldstein with Cantor Fitzgerald.

Oh, thanks very much. I had two questions for the field study; will enrollment numbers in the Phase 3 are just depending on the results of the Phase 2 hazard ratio?

Correct, the exact number was [indiscernible].

Okay, that’s great. And then for the STORM trial, in the data arm, I just wanted to confirm this, so an extra dosing there is 100 mg or 60 mg depending on the cohort and is there room for dose adjustment if you need to within those cohorts?

Yes, so we are, the Phase 1 includes two different escalation modes, one once weekly which is starting at 100 mg and the other one on twice weekly which is starting at 60 mg twice weekly, and in both cohorts you can adjust the dosing which of cause are moving forward right now.

Okay, thank you.

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

Hi, guys, this is Jenny I am filling in for Ying. Thank you so much for taking our questions. We just had one kind of 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 is acceptable for accelerated approval in these Penta-refractory patients? Thanks.

Yes, the FDA always says that the review of any data would be subject to, you know, clinical particularly efficacy and safety and totality of the data. So there is no specific agreement when one certainly would agree that the patients that we are 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 no 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 inclusion criteria to come on to 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 are seeing today would suggest that is true.

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

Hi, thanks for taking my questions. I was wondering, I am seeing the Phase 1 ovarian and endometrial combo trial [indiscernible] and I assume that you cannot give too many details on it, but I was wondering if you can remind what the trial is and the purpose, and then at ESMO 2016 based on the data reported there you mentioned planning for Phase 3 is in ovarian and endometrial, then wondering what that current status of the Phase 2 plans are?

The phase 1 study is a combination study of selinexor with carboplatin and Paclitaxel and patient is ovarian or endometrial consult. It is looking at Taxol either once weekly or once every three weeks and the results they told us were described the study. Did you also reminded on the last annual data, so that was your third question, can you repeat the second question.

Sure. Just for the, I think at the ESMO 2016 you mentioned you are planning for Phase 3 in ovarian endometrial, now you are just wondering what the status of the Phase 3 plans are?

We are still planning on opening a Phase 3 study in endometrial cancer and we will – this study is planned to start this year or early next year, towards the end of the year.

Okay, great. 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, the KPT-9274 has two mechanisms of action, one is PAK4 inhibition and the other one is NAMPT inhibition which is basically one of the pathways which the cell is making NAD, one of most important of metabolizing the cells and another pathway that it can make is through nicotinic acid, sorry I was blanking, is full nicotinic acid is another metabolite. So there are three pathways to make NAD, one is through tryptophan, one is through nicotinic acid and one is through the NAMPT pathway. Most cancers are using the NAMPT pathway, but normal cell can use nicotinic acid and one way to overcome the potential to [indiscernible] from NAMPT inhibition is by providing niacin which is a nicotinic acid, so it is more making of non-nicotinic acid pathway.

Got it, okay. Thank you.

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

Hey, guys, good morning, thanks for taking my question. I had one regarding the SEAL trial and a part that you already addressed is earlier, I joined the call a little bit late, but my impression was that initially you were planning to present Phase 2 data in the middle of this year and you are talking about September-October now, can you just remind me what changed, so what’s behind those changes in terms of data disclosure for the Phase 2 portion of the SEAL arm study? Thanks.

So, this one is double-blind study, also very rare disease which is performing in very specific centers in the United States, these are all centers for patients with liposarcoma. The endpoint is also, so at a moment it really depends on finding this very rare patients with this cancer. In addition it is a endpoint, so the results depends on an endpoint of provision [ph] how long patients stay on either placebo or selinexor. With all this together we expect to provide guidelines for this study in the September-October timeframe.

So the p vessel is longer than anticipated in a Phase 2 part is that correct?

That’s not; it’s the number of patients we have with the PFS.

I see.

We don’t know the PFS is the study double-blinded.

Okay and to remind you that Phase 2 portion is that 60 patients 30 in each arm is that correct?

The Phase 2 will be 57 patients.

Okay, well thanks for the clarification.

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

Thanks for taking the follow up guys. 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 you know the recent update of the label to include 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. That study is in a different and in IST that is done together with Dr. Jakubowiak of University of Chicago and the animal act. We have completed the first portion of the study which was looking at combination of selinexor with bortezomib and twice weekly selinexor and that recommended space of dose that was based Kyprolis 27 mg/m2. We are now amending to look at other combination including selinexor once weekly and we will evaluate different doses of Kyprolis as part of this study including once weekly and twice weekly doses of Kyprolis.

Can you say what doses of Kyprolis you will be investigating at the above the standard label or can you go higher?

We are still discussing the study with the University of Chicago and deciding on the once weekly and twice weekly regimen. So, I can’t provide more details on that, but it will be - whatever are the relevant doses of Kyprolis that are being used in the different studies.

Okay, can you say what you might want to see, is it based on safety trial that would convince you to flip to Karyopharm sponsored IND from an IST?

The safety is less of a concern. We do believe that selinexor once weekly is better tolerated and provide the efficacy that we need in combination with bortezomib doses. There is a lot between synergy between these two. But we 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 mg/m2.

Right.

So we will hopefully get improvement on both efficacy and safety.

Right. Okay, thanks again.

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

Hi, guys, thanks for taking my questions. I was curious about the STOMP expansion oral data that you are 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 one recommended Phase 2 dose as achieved on all before arms we will - obviously we have reached that in several of the arms. We will expand to get a better handle of efficacy and safety. This expansion usually includes for example in both selinexor and in Velcade and the arm we get Velcade with plateau and plateau in patients. There might be those also in the other two arms. So, we will learn also on efficacy and immaterial [ph] factors population and proteasome inhibitor refractory population and based on this we're going to choose studies for our next step.

Okay, great and then, just to clarify couple of things, on the selinexor in the [indiscernible] trial originally I thought this was an investigator sponsored study of some sort, is that true or is that [indiscernible]?

Yes, yes.

Okay.

It’s going to be a Phase 3 randomized study and in the middle of consult that will be done as an investigator sponsored study.

Okay. And then, I guess 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 study is part of an investigator sponsored study the design is MD Anderson's with the paying on the MD Anderson and the, it’s still ongoing.

Okay, thanks.

Our next question comes from David Nierengarten with Wedbush.

Hi this is Dilip sitting in for David. Just want to clarify something mentioned in response to Michael's question on SEAL. Did you say 67 patients in the Phase 2 and 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 expect that I know it has been said would need to be demonstrated just for commercial benefits?

So the number of patients for the Phase 2 is 57 so just below 60. And for your question there is a cross over from placebo to selinexor at the point of progression in the study, so there is no need to show OS [ph] superiority between selinexor overall placebo. So the FDA request we have to show that there is no decremented Phase 2 selinexor in OS [ph] that's it and the secondary endpoint.

Okay and just a reminder when did you start enrollment in the study and when did you complete it at least in the Phase 2 portion?

Give us a minute. We’ll probably have to get back to you on that, we completed enrollment recently.

Yes.

And we are 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 DSMB. In addition, the update will be following an FDA meeting to confirm the Phase 3 plan. This is a Phase 2/3 study and it's ongoing and it grows ongoing, but one always have to have an inter Phase 2 meeting, you have the Phase 3 has sort of started, so that’s the plan and we will update after that.

All right, so you never guided to when the Phase 3 would fully enroll or top-line from that?

So there is just the good, bad day, first patient was on January 2016 and the last patient was – Yes, it was May.

Okay. All right, thank you very much.

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 thank you for joining us this morning and I'll 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.