Karyopharm Therapeutics Inc (KPTI) 2014 Q4 法說會逐字稿

Good morning, my name is Amanda and I will be your conference operator today. At this time I would like to welcome everyone to the Karyopharm Therapeutics fourth-quarter 2014 financial results conference call. Dr. Michael Kauffman, Chief Executive Officer of Karyopharm Therapeutics, please begin your conference.

Thank you and good morning. This is Michael Kauffman, the Chief Executive Officer of Karyopharm. I am here with Dr. Sharon Shacham, our Founder, President and Chief Scientific officer; Justin Renz, the Executive Vice President and Chief Financial Officer; and Chris Primiano, our Vice President of Corporate Development and General Counsel.

Welcome to the fourth-quarter 2014 earnings call where we will provide a brief review of our finances followed by a clinical and regulatory update. We will then have time for questions.

Earlier today we issued a press release detailing Karyopharm's results for the fourth quarter and year ended December 31, 2014. The release is available on our website at www.karyopharm.com.

Various remarks we make constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory 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 statements as a result of various important factors including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC. Any forward-looking statements represent our views as of today only.

We may update these statements in the future but we disclaim any obligation to do so. Therefore, you should not rely on the these forward-looking statements as representing our views as of any date subsequent to today.

Over the next 30 minutes we will provide a brief review of our financial results through the fourth quarter of 2014 and then provide a corporate update including our clinical development programs and business strategy. We are happy to take a few questions following the prepared comments. I'll turn the call over to Justin to review the financials.

Thank you, Michael. Since we issued a press release earlier outlining our fourth quarter and year ended December 31, 2014, financial results I will just review the highlights and then speak to our cash balance and our financial guidance.

The Company reported a net loss of $25.9 million, or $0.79 per share for the quarter ended December 31, 2014. That compares with a net loss of $12.1 million, or $0.72 per share for the same period in 2013 including stock-based compensation expense of $4.6 million and $2 million for the quarters ended December 31, 2014, and 2013 respectively.

For the 12 months ended December 31, 2014, Karyopharm reported a net loss of $75.8 million, or $2.43 per share compared to a net loss of $33.9 million, or $5.59 per share for the same period in the previous year including stock-based compensation expense of $14.2 million and $3.8 million for the 12 months ended December 31, 2014, and 2013 respectively.

Research and development expense was $20 million for the fourth quarter of 2014 compared to $9.7 million for the same period in the prior year. And general and administration expense was $5.9 million compared to $2.5 million for the same period in the prior year.

For the 12 months ended December 31, 2014, research and development expense was $60.1 million compared to $28.5 million for the same period in the previous year and general and administrative expense was $15.9 million compared to $5.9 million for the same period in the previous year. This increase in expenses for both periods is primarily related to the significantly expanded clinical development activities for our lead drug candidate selinexor, KPT-330, and the increase in general and administrative expense resulted primarily from an increase in personnel costs including headcount and stock-based compensation expense and the cost of operating as a public company.

Cash, cash equivalents and investments as of December 31, 2014, totaled $214.8 million compared to $156 million at December 31, 2013. Further, Karyopharm raised $90.9 million in a common stock follow-on offering which closed in January 2015.

Based on our current operating plans we expect our existing cash will fund our R&D programs and operations into 2018 including moving our registration-directed clinical studies to their next data inflection points. We expect to end 2015 with a cash balance greater than $200 million.

With that I'll turn the call back over to Dr. Kauffman.

Thank you, Justin. We made considerable progress advancing our lead product candidate, selinexor, a first-in-class oral selective inhibitor of nuclear export or SINE compound across a number of hematologic and solid tumor indications this past quarter. We initiated two additional registration-directed clinical studies in hematologic malignancies bringing our current total to three including one in acute myeloid leukemia, or AML; one in Richter's transformation; and a third in diffuse large B-cell lymphoma, or DLBCL. Additional registration-directed studies are planned and will be discussed during this call.

The basis for accelerating selinexor's development in hematologic malignancies with high unmet need is supported by positive clinical data including data presented at the American Society of Hematology, or ASH meeting, this past December demonstrating selinexor's anti-tumor activity, durable cancer control and tolerability across all non-Hodgkin's lymphoma type study and high rates of durable responses in patients with heavily pretreated multiple myeloma with selinexor in combination with dexamethasone, or with selinexor in combination with carfilzomib and dexamethasone. Induction of responses in prolonged stable disease in patients with heavily pretreated AML were reported at ASCO and EHA last year supporting our ongoing registration-directed study in patients over 60 years of age with AML.

We are also construing to develop selinexor for the treatment of solid tumors based on encouraging data from an ongoing Phase 1 clinical study of selinexor in patients with advanced solid tumors. In these patients with heavily pretreated solid tumors selinexor continues to demonstrate signs of clinical activity across a variety of different malignancies. Dr. Shacham will talk more about our plans in this area.

On the regulatory front we have now been awarded orphan drug designation for selinexor by both the US and European regulatory authorities in multiple myeloma, acute myeloid leukemia, diffuse large B-cell lymphoma, chronic lymphocytic leukemia and small lymphocytic leukemia. Richter's transformation is covered under DLBCL in the United States and under CLL in Europe.

We also received US patent allowance covering composition of matter for selinexor. Once issued this patent will provide Karyopharm with patent protection for selinexor and pharmaceutical compositions comprising selinexor through the middle of 2032.

I will now turn the call over to Dr. Sharon Shacham to provide an update on selinexor's clinical development plans.

Thank you, Michael. Now I'll provide an update of our clinical development plans for selinexor.

To date over 600 patients across various hematological and solid tumor indications have been treated with oral selinexor with several patients remaining on study for over 12 months and the longest for over two years. We continue to observe broad and durable anti-tumor activity of selinexor in both hematologic and solid tumor cancer consistent with its known mechanism of action. Selinexor's breadth of activity and novel mechanism of action provide multiple paths to potential commercialization.

In addition to our own clinical studies there are numerous investigator-sponsored trials, or ISDs, either ongoing or planned evaluating selinexor alone or in combination with other therapies for hematologic or solid tumor malignancies. Between company- and investigator-sponsored trials there are 35 clinical studies listed on clinicaltrials.gov related to selinexor. We plan to present highlights from some of these studies at medical conferences during the remainder of this year.

I will begin by discussing selinexor in hematologic malignancy. We initiated and are actively enrolling patients in three registration-directed clinical studies of selinexor in hematologic malignancies. The first called SOPRA, or selinexor in older patients with relapsed or refractory AML, is enrolling patients older than 60 years olds of age who have received one prior line of therapy and who are ineligible for intensive chemotherapy and transplantation.

The second study is called SIRRT for selinexor in relapsed refractory Richter's transformation. And the third is called SADAL for selinexor against diffuse aggressive lymphoma, is enrolling patients with relapsed refractory DLBCL.

Parliamentary top-line data from all three studies are anticipated in the second half of 2016. Our enthusiasm for initiating these registration-directed studies with selinexor in hematologic malignancies is supported by the data presented at several medical meetings in 2014.

For example, in an ongoing Phase 1 clinical trial of selinexor in patients with heavily pretreated progressive non-Hodgkin's lymphoma, or NHL, including aggressive B-cell NHL such as DLBCL, Richter's transformation and T-cell NHL as well as other forms of lymphoma demonstrated a 37% overall response rate defined as complete or partial responses and 73% of disease control rate defined as stable disease or better, including five complete responses. In patients with heavily pretreated DLBCL, selinexor demonstrated a medium duration of response of approximately seven months.

Clear activity was observed across all DLBCL subtypes evaluated including a 36% overall response rate in patients with GCB and 40% in ABC subtypes. Moreover, amongst four patients with double-hit DLBCL, a particularly difficult to treat form of lymphoma, a response rate of 50% and a 75% disease control rate was observed.

In addition, based on responses in patients with peripheral and cutaneous T-cell lymphoma leukemia observed in the Phase 1 study, we've initiated a Phase 2 study in this patient population. In multiple myeloma an ongoing Phase 1 clinical trial of selinexor in combination with low dose dexamethasone demonstrated a 67% overall response rate and an 89% clinical benefit rate defined as minimal response or better in nine evaluable patients with heavily pretreated and refractory multiple myeloma. Among these patients the overall medium duration of response was approximately seven months.

Also in multiple myeloma in a separate ongoing Phase 1/2 study selinexor in combination with the protosome inhibitor carfilzomib, or kyprolis, and the low dose dexamethasone induced responses in all three of the patients enrolled to date. All of these patients had received carfilzomib in their most recent regimen and their disease was refractory to it.

With over 10,000 deaths per year in the USA in a similar or higher number than the European Union, significant unmet medical need remains for the treatment of multiple myeloma despite the approval of novel therapies and increased median survival. Based on the durable response rates we have observed with selinexor in combination with dexamethasone, we believe to have the potential to offer improved treatment options for these heavily pretreated relapsed and refractory multiple myeloma patients.

Based on our encouraging data in heavily pretreated multiple myeloma along with discussions with key opinion leaders, Karyopharm plans to initiate a single ARM trial in multiple myeloma called STORM for selinexor treatment of refractory myeloma in the first half of 2015. The study will initially enroll 80 patients with myeloma is refractory to bortezomib, carfilzomib, lenalidomide and pomalidomide.

In addition, 25% of the patients will have myeloma refractory to an anti-CD38 monoclonal antibody such as daratumumab. If the data from those 80 patients is promising we may expand the size of the study for potential registration.

On the solid tumor front, Karyopharm is actively enrolling patients in four Phase 2 solid tumor studies evaluating selinexor. The first trial, our SIGN study, is in gynecologic malignancies; the second trial, the KING study, is in glioblastoma multiforme; and the third trial, the SHIP study, is in metastatic prostate cancer; and the fourth trial, our STARRS study, is in squamous head and neck, lung and esophageal cancers. We hope to present interim data from SIGN and KING for presentation at the oncology meeting in mid-2015.

In addition we hope to present an update of our ongoing studies in patients with locally invasive or metastatic sarcoma including patients with liposarcoma at an upcoming oncology meeting. Based on the data we have seen in that study in patients with relapsed progressive liposarcoma we are planning to initiate a Phase 2b randomized study of single-agent selinexor versus placebo to treat liposarcoma in the second half of 2015.

Furthermore, we are considering a approval strategy in other solid tumors. In addition to the single-agent activity of selinexor a number of investigator-sponsored as well as company-sponsored trials evaluating the potential of selinexor in combination with either chemotherapy or targeted agents are currently ongoing or planned. For example, in hematologic malignancy some of the combination therapies for selinexor that are ongoing or planned include carfilzomib and dexamethasone in multiple myeloma as described earlier, bortezomib and dexamethasone in multiple myeloma, pomalidomide and dexamethasone in multiple myeloma, rituximab and various chemotherapy agents in non-Hodgkin's lymphoma including DLBCL, ibrutinib in CLL and NHL and decitabine in AML.

And in solid tumors some of the combination therapies for selinexor that are ongoing or planned include irinotecan in gastric or esophageal cancers, carboplatin and paclitaxel in patients with ovarian or endometrial cancers, gemcitabine and abraxane in patients with pancreatic cancer and chemo-radiation as a new adjuvant in rectal cancer. Although our lead program is focused broadly in oncology exportin 1 the target of our SINE compound including selinexor is relevant in several other disease settings. Along these lines we recently published data in the Journal of Nature Neuroscience reporting that Karyopharm's SINE compounds reduced the progression of multiple sclerosis in preclinical models.

In the paper scientist from Dr. Patrizia Casaccia laboratory at the Icahn School of Medicine at Mount Sinai along with Karyopharm's scientists described the ability of our SINE exportin 1 inhibitors to reduce neurodegenerative symptoms and disease progression in multiple sclerosis models both by reducing neuronal inflammation and more importantly in providing bona fide neuroprotective effects. This is just another exciting example of the breadth of opportunity for SINE compounds to help patients with limited treatment options and demonstrates why top-tier institutions such as Mount Sinai are actively exploring the potential of SINE compounds across multiple diseases.

I will turn the call back to Michael now to provide a brief summary before we take questions.

Thank you, Sharon. In summary, our aggressive selinexor development program continues in 2015 with plans to initiate additional potential registration-directed studies for selinexor in multiple myeloma and liposarcoma. We look forward to the presentation of selinexor clinical data updates in both solid and hematologic tumors at upcoming medical conferences later this year.

In addition to our own internal efforts, oral selinexor is being studied broadly alone and in combination with other therapies in a variety of investigator-sponsored trials across both hematologic and solid tumor indications. And we look forward to reporting these results when available.

With that, operator, we are ready to take questions.

Thank you. (Operator Instructions) Steve Byrne, Bank of America.

That original cohort of 10 patients that you initiated the multiple myeloma study in combo with dex, you had at some point started another cohort and I believe you added on to this 45 migs per meter squared dose. Can you update us on how many additional patients you have in that study?

We reported the results on the additional cohort at ASH last December, so we opened another cohort at the higher dose, 60 migs per meter squared plus low-dose dexamethasone. This was part of the dose escalation of this combination of selinexor plus low-dose dexamethasone.

60 migs per meter squared with low-dose dex was not tolerated and the vast majority of the patients didn't complete cycle one and based on that we are not able to evaluate the response rate in this cohort. So basically the results are still the results that we reported at ASH for the 10 patients that were involved at 45 migs per meters squared plus low-dose dexamethasone out of those nine were available for response.

And there weren't a few more added to that cohort at the lower dose?

There are one or two more patients that are being added now and we will report this results in the future.

Okay. And then on STORM, the Phase 3 program in multiple myeloma, would you anticipate that that will ultimately be based on patients that are also refractory to the CD38 antibodies?

We require in the protocol that 25% of these patients will be refractory to CD38 antibodies. So we expect that we will be able to evaluate at least have an initial result evaluating the effect of selinexor plus those low-dose dexamethasone in this patient population.

Okay, but if you expand that study it would likely be to include more of the CD38 refractory patients?

It depends on the regulatory situation at that point of the CD38 antibodies and the responses that we will see in this first set of 80 patients. But based on the ongoing situation I expect that we will have many more patients that will be refractory to CD38 antibodies.

Okay. And then just lastly on the liposarcoma Phase 3 program, can you just refresh our memory on the Phase 1 results in that indication that give you the confidence to move ahead in that indication?

As we mentioned on the call we will present the results of the study, this Phase 1 study in patients with sarcoma in the next upcoming meetings. And based on the results we presented at last ASCO in general in patients with liposarcoma, in sarcoma including several with liposarcoma, we see a PFS of about 45 months with some real reduction in the tumor load.

Okay. Thank you.

Michael Schmidt, Leerink.

On the multiple myeloma studies, I was really intrigued by the selinexor/kyprolis combination data presented at ASH last year in these three patients. I was wondering when or whether -- when the investigator would present additional data from this combination study? And secondly, how do you see selinexor positioned in multiple myeloma following, in that context, following the recently presented ENDEAVOR trial results?

So as we presented at last ASH, the study is conducted by the -- the PI is Dr. Andrzej Jakubowiak from the University of Chicago and we have no control on the conduction of this study. However, we believe that they will present more data on this study later this year. Michael, do you mind just repeating your second question?

Just wondering how you see the treatment landscape changing following the recent reported ENDEAVOR data for kyprolis and if or whether that affects your plans or the opportunity for selinexor?

Yes, I think the ENDEAVOR data were quite striking. Clearly high-dose carfilzomib provides a benefit certainly against Velcade in that population.

This trial is a combination study with carfilzomib that we are doing and we can escalate the doses of carfilzomib. Clearly the ENDEAVOR results allow us to go up even further than we had originally planned if we need to.

All that said, everyone agrees that the goal will be to use combination therapies effectively to even further improve PFS, so we are excited. Carfilzomib is a great partner.

The only thing that we consider is that it's an IV therapy twice a week, which is why we are also embarking on the Velcade combination, which will be subcutaneous for the most part and with the pomalidomide combination, which will be oral.

Got it, thanks. And then you mentioned two updates from to solid tumor studies later this year. Can you remind me which indications and potentially how many patients worth of data you would plan to report in each of those two data sets? Thank you.

So the first one is in gynecological indication including ovarian, cervical and endometrial cancer. And the second study we will present will be in glioblastoma, and the third that we are planning to present around midyear will be our results in sarcoma. And each one of those will have between 20 to 60 patients overall.

And so I guess that would be a cut on a part of those 20 to 60 patients, I assume?

These are cut off of the study as we didn't finish enrolling it any of the studies. But it will be all the patients that are part of these studies.

Okay, great. Thank you.

Mike King, JMP Securities.

We've sort of touched on all the topics I wanted to discuss. Maybe just drill down a little bit more on STORM. Just curious, so the 80 patient initial phase, if you will, I know Sharon you had said that it was -- you were looking at what develops on the regulatory front but I'm just wondering, I think it's a fair assumption that CD38 antibodies will be approved at some point.

So I'm just wondering why do this in a two-stage fashion rather than just assume that the CD38s will be approved and structure the protocol that way and just go right into a registration trial rather than a Phase A/phase B, if you will?

Wages need to keep in mind that patients that are already quite refractory to carfilzomib/bortezomib, lenalidomide and pomalidomide are very heavily pretreated and in many cases are not in condition to join clinical trials. On top of that patients with -- there are not yet many patients that are refractory to CD38 based on the feasibility studies that we did in sites in the US.

I believe as you mentioned that in the next year there will be more patients that are coming that will be post-CD38 and at that point we can definitely change the design of STORM. And just to also mention that in these studies with CD38 they did not require that the patient will be quite refractory but other that they are refractory to each class. So patients that are coming on CD38 not necessarily received all four agents before that.

Okay, great. And then so I get that. So then once one can look at QUAD refractory plus CD38 refractory you can get a sense of what an expected PFS would be and then power a registration study accordingly?

Exactly.

Okay, great. That's helpful. Thanks.

And then I think Michael Schmidt asked a question about the carfilzomib study, so I just want to ask about liposarcoma. A couple of questions there, one, surprised you can roll against placebo. I would have thought something like ifosfamide or some other relative standard of care would have been required.

Second, just talk about do you have to do an OS trial in lipo given the small population and the unmet need? Or could something like response rate or would durability be a plausible registration end point?

So first we just need to keep in mind that there are no drugs approved currently for patients with liposarcoma and that chemotherapy is not very effective for patients with well differentiated liposarcoma. It is very minimal activity and even for patients with de-differentiated liposarcoma, chemotherapy is not that active.

So that is some of the basis for this design. Also keep in mind that bortezomib had a study and the drug was approved in patients with soft tissue sarcoma that was often up against control with no crossover.

And you can look at the design of this study with a PFS endpoint. Our intention is to do a study in liposarcoma, including all the different types of liposarcoma with selinexor versus control, with a PFS endpoint, 2 to 1 randomization and crossover, at this point.

Okay, great. That's helpful, too. And then just finally, there wasn't a comment made about PAK4. I'm just wondering if you are still expecting to have an IND candidate by end of 2015 for PAK4?

We are still planning on having a candidate by the end of the year for PAK4. (multiple speakers)

Thanks, guys. Appreciate it.

Yigal Nochomovitz, Oppenheimer.

Could you just clarify, Sharon, did you say you will or will not have a crossover component in the randomized study for lipo? Thanks.

We are still working on the design of the study, but we were are likely to have a crossover.

Okay. And then I think you mentioned the PFS of 45 months in lipo? What did you see for PFS in some of the other subtypes like leiomyo, synovial and chrondro? I know the SD rate was 100% for lipo, which looked better than all the other subtypes but do you have anything more to say on the PFS compared to those other ones? Thanks.

So just to clarify, I was referring to our poster at last ASCO in which we presented data not only on liposarcoma but on all types of sarcoma. And at that study we presented data showing a PFS of around four months for all the difference sarcomas that were tested. If you want I can send you a copy of that poster.

Okay, so do you have a breakout of PFS in the lipo patients specifically?

Not in that study, but as I mentioned, we are planning to present more data later this year.

Okay. And then on the STORM study in myeloma, can you go into a little more detail on what you mean by promising data that would trigger the expansion? Is there some sort of a specific hurdle rate that you want to hit before you would move forward with an expansion?

Yes, I think the numbers are pretty much out there. I believe daratumumab in their study with dexamethasone prophylaxis had about a 29% response rate.

We know that pom/dex was approved on a 29%-ish response rate and carfilzomib on about a 23% response rate. So somewhere in that 30% range is what is considered meaningful.

The key for us as you've already heard is that we're in a population of true unmet medical need. And I think clearly Sharon and the team have defined a very obvious unmet medical need as there is still no cures in myeloma, at least not in the relapsed refractory setting.

And then just one last question, given the interesting paper that you guys published on MS in Nature Neurosciences, are you thinking of starting a study there, or is that just more for the academics to pursue?

Yes, the plan and consistent with our pipeline chart is that we will have a drug candidate for non-oncology indications that is a SINE candidate for non-oncology. It will be orally available. It will have shown activity in some or all of the different autoimmune indications including MS and lupus and things like that. And the goal is to have that by I believe the end of the year is what we have said.

Okay, great. Thanks, Mike.

Arlinda Lee, MLV.

Sorry to keep asking about STORM but could you provide some additional information about the 25%? You said that would include people who have been exposed to anti-CD38.

Is that going to be included in all the 80 patients or in the eventual expansion? And can you explain maybe how the mechanics might work there in terms of rolling into a registrational trial and whether this is also something you have talked to the EMA about? Thank you.

Yes, so a couple of things. The regulatory path in myeloma right now is clearly muddy and mainly muddied by the progress of primarily daratumumab and then followed up by other anti-CD38 antibodies.

Daratumumab and the others represent an entirely new approach to myeloma with promising initial data both as a single agent and in combination. In order to try to navigate that muddy -- those muddy waters -- our goal has been to try to do something that we can begin now and then after we see 80 patients worth of patients worth of data can modify the trial, if needed, based on the progress of daratumumab et al.

So the first 80 patients, of them, 25% of them will have had to have been refractory to daratumumab or another anti-CD38. And as Sharon mentioned, that is based on feasibility studies. We believe that we could enroll a reasonable number of patients there given our site survey data.

Once those 80 patients worth of data are available we will have both an overall response rate and durability but also we will know what the response rate is in the CD38 refractory population as well. We'll also have much better clarity on where the progress of the daratumumabs et al are from a regulatory perspective and then decide whether the next set of patients will have to be refractory to a CD38 or again fall under the kinds of inclusion criteria that we described for the first set. So it really gives us a chance to modify the trial, if needed, based on ongoing data that will become publicly available with the CD38 class of compounds.

Great. So it basically allows you to have the flexibility depending on how things shake out with the rest of the myeloma dynamic?

Exactly.

On the solid tumors, are you going to be presenting additional information midyear on maybe some prostate data or maybe the squamous lung patient population? Is that Phase 1 still ongoing and are you going to be presenting data on those? Thanks.

These two studies are ongoing but they are in earlier state of enrollment compared with the other studies that we mentioned. So based on that I don't expect that we will present data on the prostate and squamous indications this year.

Okay, thank you.

(Operator Instructions) David Nierengarten, Wedbush.

I had a more science-oriented question. If there any particular reasons or rationale why liposarcoma is one of the more promising solid tumor indications that you are looking at? Thanks.

The hypothesis -- so liposarcoma, the number of mutation is generally reduced compared with other type of solid tumor cancers and even other type of sarcoma. There are several translocations in overexpression like MDM2 overexpression which results in reduction in p53 levels and similar with the CDK4.

These two -- p53 is a target for selinexor. And what we see is that following treatment with selinexor there is an increase in p53 levels in liposarcoma cells, which might lead to apoptosis and similar selinexor causes inhibition of CDK4 activity. We have not done correlated studies to see whether the patients that have these overexpression are the ones that are more sensitive to selinexor but that will be part of what we will probably do as part of the liposarcoma studies.

Thanks.

Mike King, JMP Securities.

The whole discussion about using selinexor in conjunction with a multidrug regimen that includes a CD38 antibody brings up an intriguing notion about perhaps instead of a PFS end point looking at something like minimal residual disease. And I know that is way into the future but I don't know if that is something that you guys had contemplated as a potential eventuality for the development of selinexor in a combination including in anti-CD 38? Thanks.

Yes, looking at MOD as well as looking at combinations with CD38 antibodies are all part of our plan for selinexor and part of studies that we are either working on or planning to start working on in the future.

Yigal Nochomovitz, Oppenheimer.

I just had one quick follow-up on the competitive landscape. It seems we saw an in licensing from Stemline for a competing reversible XPO1 inhibitor, I am just wondering have you had any initial thoughts as to how that one compares in terms of potency and selectivity and just have you actually tested the CanBas inhibitor pre-clinically in your laboratories? Thanks.

The reported potency of the Stemline compound is similar in terms of the IC50 individual to ours. And based on the activity, the preclinical activity that they reported, selinexor is as potent or potentially has better potency and better tolerability than the Stemline compound.

As part of our understanding of the selinexor, the exportin 1 space we are obviously evaluated many analogues that the structure are publicly available and compare them with the activity of selinexor. And in all of those we are not concerned about the development of selinexor.

Thanks, Sharon.

Thank you. I am showing no further questions. I would now like to turn the call back to Dr. Michael Kauffman for closing remarks.

Thank you very much. That concludes our fourth-quarter and year-end 2014 conference call.

Thanks very much for participating and look forward to speaking with you in the future. Have a good day, everyone.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program.

You may all disconnect. Everyone have a great day.