Karyopharm Therapeutics Inc (KPTI) 2014 Q3 法說會逐字稿

Good morning. My name is LaToya. I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics' third-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, Executive Vice President and Chief Financial Officer; and Chris Primiano, our Vice President of Corporate Development and General Counsel. Welcome to the third 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 third-quarter 2014 results, which is available on our website at Karyopharm.com. Various remarks we make will 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 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 overview of our financial results through the third quarter of 2014 and then provide a corporate update including our clinical development programs and regulatory strategy. We are happy to take a few questions following the prepared comments.

I will turn the call over to Justin now to review the financials.

Thank you, Michael.

Since we issued a press release earlier this morning, outlining our third-quarter 2014 financial results, I will just review the highlights and then speak to our cash balance and financial guidance. The Company reported a net loss of $19.7 million or $0.61 per share, for the quarter ended September 30, 2014. That compares with a net loss of $9.3 million or $3.66 per share for the same period in 2013. These losses include stock-based compensation expense of $2.9 million and $1.3 million for the quarters ended September 30, 2014 and 2013, respectively.

For the nine months ended September 30, 2014, Karyopharm reported a net loss of $49.9 million or $1.63 per share, compared to a net loss of $21.8 million or $9.11 per share, for the same period in the previous year. These amounts include stock-based compensation expense of $9.7 million and $1.8 million for the nine months ended September 30, 2014 and 2013, respectively. Research and development expense was $16 million in the third quarter of 2014, compared to $7.7 million for the same period in the previous year.

General and administration expense was $3.8 million compared to $1.6 million in the same period in the prior year. For the nine months ended September 30, 2014, research and development expense was $40.1 million, compared to $18.8 million for the same period in the prior year. General administration expense was $10 million, compared to $3.4 million for the same period in the prior 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 administration expenses resulted primarily from the costs of operating as a public Company throughout 2014 and an increase in stock-based compensation expense. Cash and cash equivalents as of September 30, 2014, totaled $227.1 million, compared to $156 million at the end of the year.

Based on our current operating plans, we expect our existing cash will fund our R&D programs and operations into the second half of 2017, including moving our two registration studies in AML and Richter's to their next data inflection points. We expect to end 2014 with a cash balance of approximately $210 million.

With that, I will turn the call back over to Dr. Kauffman.

Thank you, Justin. We made considerable progress this quarter, including advancing our lead product candidate, Selinexor, a first-in-class oral Selective Inhibitor of Nuclear Export, or SINE compound. As you are aware, Selinexor is a covalent inhibitor of exportin-1, also called XP01. Inhibition of XP01 leads to the accumulation and activation of many tumor suppressor proteins such as p53, BRCA1, FOXO and IkappaB, as well as to the reduction of oncoproteins such as c-Myc, NF-kappaB, Flt 3 and BCL-2. At the present time, Selinexor is the only XP01 inhibitor in clinical development.

Following our large Phase 1/2 trials of Selinexor in a diverse set of cancers, we have now initiated two registration-directed clinical studies, including one in Acute Myeloid Leukemia and as announced earlier today, another in Richter's transformation. Additional registration-directed studies are planned and will be discussed during the call. Thus we have made significant strides toward accelerating Selinexor's development in hematologic cancers with high unmet medical need. In addition, we also expanded our leadership team in global presence to pursue our aggressive development in commercialization strategy.

We are continuing to develop Selinexor for the treatment of solid tumors as evidenced by encouraging clinical data presented from an ongoing Phase 1 clinical study of Selinexor in patients with advanced heavily pre-treated solid tumors. Consistent with its broad mechanism of action, Selinexor demonstrated signs of clinical activity in hormone and chemotherapy refractory prostate cancer, head and neck squamous cell carcinomas and gynecologic cancers. Previously, we showed durable disease stabilization and tumor shrinkage in patients with chemotherapy relapsed sarcomas.

Importantly, Selinexor has shown to have manageable and predictable side effects, primarily nausea, fatigue and anorexia, which improve over time on treatment. On the regulatory front, we received US FDA and European PMA orphan drug status for Selinexor in both AML and DLBCL. We also received US patent allowance covering composition of matter of 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 clinical development plans.

Thank you, Michael.

Now, I will provide an update of our clinical development plans for Selinexor. To date, over 450 patients across various hematological and solid tumor indications have been treated with oral Selinexor, with several remaining on study for over 12 months and the longest for over 2 years. We have observed broad and durable anti-tumor activity of Selinexor in both hematological and solid tumor cancers, consistent with the known mechanisms of Selinexor action. This breadth of activity and other mechanism of action provide us with multiple paths to potential commercialization of Selinexor.

In addition to our own clinical activities, there are numerous Investigative Sponsored Trials or IST, either ongoing or planning, planned evaluating Selinexor alone or in combination with other therapies for hematological or solid tumor malignancies. Starting with hemetological malignancies, we initiated and are actively enrolling patients in two registration-directed Phase 2 studies of Selinexor in hemetological malignancies. The first called SOPRA or Selinexor in Older Patients with Relapsed or Refractory AML is enrolling patients who are ineligible for intensive chemotherapy and/or transplantations.

The second is called SIRRT, Selinexor in a Relapsed Refractory Richter's Transformation. We expect both of these studies to take approximately two years to complete. The first study is a single arm Phase 2 trial designed to evaluate the safety and efficacy of Selinexor, given all indications with Richter's transformation, where the disease of relapsed, after all is a refactor to chemimmunotherapy with overall response rate as the primary study end point. It is an open label, multi-central study and will involve approximately 50 patients in approximately 35 sites worldwide.

Richter's transformation is a rare condition in which chronic lymphocytic leukemia changes into a fast-growing or aggressive type of non-Hodgkins lymphoma. Approximately 1,500 patients are diagnosed with Richter's transformation is each year in the USA, with similar numbers in the European Union.

Current treatment options for these patients are limited and prognosis is poor, with median survival of less than 10 months from diagnosis. We initiated this study based on early signals of activity shown in patients with Richter's transformation and/or aggressive lymphomas as part of the Phase 1 study of Selinexor in advanced hematologic malignancies.

This study comes on the heels of our first registration directed clinical study in older patients with AML and clearly demonstrates progress towards our goal of expeditious development in severe hematological indications with high unmet medical need. All of this in the clinical development of Selinexor will be reported in the upcoming American Society of Hematology, ASH meeting being held in San Francisco December 6 to 9.

Abstracts for this meeting were released last week, summarizing clinical and preclinical data for Selinexor in patients with heavily pre-treated relapse and refactory non-Hodgkins lymphoma, as well as pre-clinical and clinical data demonstrating synergistic activity of Selinexor when combined with dexamethasone in multiple myeloma. As reported in the abstract of non-Hodgkins lymphoma, Selinexor showed a dose response relationship with the 60-milligram per meter squared cohort, showing a 40% overall response rate in 10 patients with aggressive non-Hodgkins lymphoma, mainly DLBCL. This dose is similar to a flat dose of 100-milligrams, which represents the high dose in our planned randomized Phase 2 studies of Selinexor and relapse/refactory DLBCL.

We will also be studying a flat dose of 60-milligram in that randomized trial, corresponding to a dose of 35-milligrams per meter squared. This 35-milligrams per meter squared dose was associated with a 33% overall response rate in 27 patients in the ongoing Phase 1 study. Based on this data, to be updated at the ASH meeting, we will initiate the so-called SADAL study, or Selinexor and dexamethasone in aggressive lymphoma before the end of the year.

SADAL will be our third registration-directed study. We'll evaluate the 100-milligram and 60-milligram doses in patients with DLBCL that has relapsed after at least 2 and no more than 4 bio lines of therapy. At least 50% of the patients of each arm will have the Germinal-Center B Cell or GCB subtype of DLBCL. The study for which the FDA has indicated could support an accelerated approval will involve 200 patients, randomized one to one, to 60- and 100-milligrams Selinexor twice weekly, given with 8- to 12-milligram of dexomethozone.

With over 12,000 deaths each year in the USA due to DLBCL, there remains a major unmet medical need for this indication and we are developing Selinexor expeditiously to help address this. We will also be providing an update on Selinexor and dexamethasone in heavily pre-treated multiple myeloma. Based on the expected synergy between XPO1 inhibition and glucocorticoid signaling, we included a separate dose escalation arm for the combination of Selinexor and so-called low dose dexamethasone of 40-milligram per week in patients with heavily (inaudible) myeloma in our Phase 1 study.

We evaluated two doses of Selinexor in this study, 45-milligram per meter squared and 60-milligram per meter squared. Each group included up to 10 patients. As noted in our ASH abstract, the combination of 45-milligrams per meter squared of Selinexor and 20-milligrams dexamethasone twice weekly was well tolerated.

With this combination we observed a 60% overall response rate in the 10 patients treated in this 45-milligrams per meter squared cohort. Several of our patients in this cohort have remained on study for later than 6 months and durability and response data will be updated at ASH. This 45-milligram per meter squared dose of Selinexor is our recommended Phase 2 dose and corresponds to an 80-milligram flat dose.

As the higher dosage of Selinexor is not well-tolerated in this population, we will be taking this 80-milligram flat dose forward in our development in myeloma. Despite the approval of multiple novel therapies and a doubling of median survivors, multiple myeloma remains an incurable cancer with over 15,000 deaths every year in the USA, with similar or higher numbers in the European Union. Based on the high and durable response rates, we have observed with Selinexor in combination with dexamethasone we are planning our development path in patients with myeloma, including a fourth registration-directed study in patients with heavily pretreated myeloma, whose disease is refractory to a cortizone inhibitor and immunomodulatory agent.

We anticipate updating you on more specific plans in early 2015. In addition to our clinical updates in non-Hodgkins lymphoma and myeloma, post those detailing pre-clinical data of Selinexor, in acute myeloid leukemia, leukemic stem cells, multiple myeloma and aggressive lymphomas will be presented at ASH. This poster will report new data on mechanism of action of Selinexor as a single agent and in combination with other anti-tumor agents. In addition, preclinical data from the Karyopharm's Pak4 inhibitor program will be presented.

Finally, on hematological malignancies, a number of investigator sponsored clinical studies evaluating the potential of Selinexor in combination with other therapy oncology ongoing or planned, including: high risk MDS, after hypomethylating agent; combination with carfilzomib in myeloma; combination with liposomal doxorubicin odoxil in myeloma; combination with ibrutinib in CLL and mantle-cell lymphoma; combination with low dose azacitidine in older patients with AML; combination with Idarubcin and Ara-C in AML; combination with FLAG or Fludarabine Ara-C and G-CSF in pediatric AML. Additional Company and investigator sponsored trials are planned including a combination study with pomalidomide or pertuzumab in patients with myeloma.

On the solid tumor front, Karyopharm is actively enrolling patients in four Phase 2 solid tumor studies, evaluating Selinexor in patients with heavily pretreated gynecological malignancies, or the SINE study; glioblastoma in multi-forma or the KINK study, with the studied prostate cancer; SHIP study; and squamous head and neck, lung and esophageal cancers, the STARRS study with the goal of reporting infant data from this study at an oncology meeting in mid 2015.

Additional investigator sponsored trials are activity enrolling or planned, including combination with irinotecan in gastric cancer; combination with carboplatin and paclitaxel in patients with ovarian or endometrial cancers; combination with gemcitabine and Abraxane in patients with pancreatic cancer; combination with chemoradiation as neoadjuvant in rectal cancer. We are also considering approval strategies in solid actual tumors.

In summary, we believe that in inhibition of XP01, leading to the activation of tumors suppressor protein and the reduction in oncoprotein are relevant to many tumor types as demonstrated by the single agent activity of all Selinexor across a large number of diverse and heavily pretreated cancers. We continue to be enthusiastic about the broad potential of Selinexor as novel oral anti-cancer agent as immunotherapy and in combination with other agents.

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

Thank you, Sharon.

Switching gears now, I will take a moment to recap the progress we have made on the corporate side during this quarter. Recently, we appointed Justin Renz as our Chief Financial Officer and Executive Vice President of Finance. Justin brings over 15 years of financial experience including EMD Serono, Coley Pharmaceuticals, CombinatoRx and Zalicus, and is leading our Investor Relations efforts, as well as our internal financial functions.

On the clinical front, as you know, we are developing Selinexor in multiple countries. We anticipate a substantial number of our clinical trial patients, as well as our commercial markets, to be focused in Europe. Therefore, we have expanded Karyopharm's global presence at the opening of our wholly-owned European subsidiary to provide the corporate structure necessary to support Karyopharm's expanded clinical and regulatory activities in Europe.

We appointed Ran Frenkel as Executive Vice President, Worldwide Clinical Development, to run this subsidiary. Ran has significant experience managing global clinical operations and regulatory affairs activities within the bio-pharmaceutical industry. Also this quarter, the Board elected J. Scott Garland, Senior Vice President and Chief Commercial Officer at Relypsa to Karyopharm's Board of Directors.

Scott brings nearly 25 years of oncology commercial leadership to Karyopharm including experience in Genentech, Amgen, Merck and Exelixis. His skills and experience in leading oncology, focus sales and marketing organizations within the bio-pharmaceutical industry will be valuable to Karyopharm as we continue to advance the Selinexor development program towards commercialization.

In summary, we believe that inhibition of XP01 by oral Selinexor represents a widely applicable approach to treating neoplastic diseases. The activation of multiple tumor suppressors coupled with the reduction in oncoproteins are novel modes of successfully killing cancer cells with minimal effects on normal cells.

Preclinical data have shown that XP01 is a non-redundant pivotal survival pathway for cancer cells. The development of the XP01 is therefore difficult, allowing for prolonged disease control over extended periods. Karyopharm is continuing to execute on our clinical and regulatory development strategy as demonstrated with the significant progress made to date in advancing the development of Selinexor, our novel oral XP01 inhibitor product candidate.

With that operator, we are ready to take questions.

(Operator Instructions)

Yigal Nochomovitz, Oppenheimer.

I just wanted to get a better understanding of why you're opting for the switch to the flat dosing versus the milligrams per meter squared for DLBCL in myeloma, as well as possibly other settings. Thanks.

Obviously, flat dosing is much easier to handle, both for the clinicians, the sites, and for the patients. We have done an exhaustive analysis of all of our pharmacokinetic data. We can see that the exposure of Selinexor is not dependent on the body surface area; therefore, we are able to switch from body-surface-area based dosing to flat dosing.

Okay. Great.

You briefly mentioned it on the call, Sharon, regarding the solid tumor plans. Can you discuss in more detail what you're thinking there in terms of where you might focus on for an approval trial?

We do have a number of options in front of us. With the Board discussion ongoing about our plans to move ahead aggressively in both hema and solid, we are not ready to talk about future solid tumor plans. We will update on the Phase 2 data, which we are excited about next year. We are looking at the combinations as well. But we will pursue a solid tumor plan. We just haven't honed in on one or two yet since we seem to have a growing number.

Okay. Great. If I could just squeeze in one more.

You mentioned the European subsidiary, which you've started. Is there any sort of signal that you may be interested in commercializing Selinexor independently in the EU? Or is that just a basis for further partnering discussions potentially down the road, across the pond?

Yes. I think, as we've said, our plan is to move aggressively, from a regulatory point of view, in the major Western, including Western European, venues. We have great interactions with FDA, EMA, Health Canada, and the like to date. And per the Board's recommendation, we want to keep all of our options open regarding commercialization. If it makes sense for us to do it on our own, we will do it, or direct it on our own, we will do it in Europe as well. We feel we can move expeditiously without large company processes here. So we are definitely keeping our options open.

Okay. Thank you.

Steve Byrne, Bank of America.

Just regarding the dose, do I understand correctly that in both the Richter's and the DLBCL studies that you're planning, that you are going for the 60-milligrams per meter squared dose? Maybe it is 60 milligram flat dose; I'm not sure I heard that right. But can you just talk a little bit about why you thought that dose was intolerable in the multiple myeloma patients? And do you have a concern about that dose moving forward?

Just to clarify, in both the DLBCL and in the Richter's study, we are looking at the dose of 60 milligrams per meter squared. That is equivalent to a dose of 100 milligrams flat dose. In the DLBCL, we will also evaluate a lower dose of 60 milligram, that is equivalent roughly to 35-milligrams per meter squared.

In the myeloma, we will follow-up with a dose of 45 milligrams per meter squared, which is more or less about 80 milligrams flat dose. And at ASH, we will report the results of both the 45 milligrams per meter squared as well as the 60 milligrams per meter squared. Based on this, as we mentioned, we made our decision to move forward with 45 milligrams per meter squared. Patients stayed on that dose for a long period of time. The side effects profile at this dose of 45 milligrams per meter squared is very manageable.

Sharon, how do you think about the dose of dexamethasone that you mentioned in the DLBCL study, that I think you said 8 milligrams to 12 milligrams twice weekly? Do you view that as a therapeutic dose or more of a prophylactic dose?

The dose of dexamethasone in the DLBCL study is a prophylactic or supportive care dose, mostly to help mitigating potential nausea, anorexia and fatigue. We found it to be very helpful in the ongoing Phase 1 study.

What do you think about the merits of raising that dose and including dexamethasone in the Richter's study?

In the Richter's study, we will also have a similar dose of dexamethasone as supportive care, the 8 mg to 12 mg dose. In future studies, we might look at increasing the dose of dexamethasone in combination with other chemotherapies and Selinexor, and to look at the potential synergy and [informa].

Just lastly, what do you view as a response rate in the Richter's study that you would view as a hurdle for approval?

We are looking for a response rate that is over 20%.

Okay. Thank you.

Mike King, JMP Securities.

Congrats on the progress throughout the year.

I had a couple of quick follow-ups on all three trials. Just wondering, with regard to SIRRT -- I'm sorry if I'm getting my nomenclature mixed up -- but SIRRT versus SADAL? SADAL is the DLBCL study? Or is that AML?

DLBCL.

Okay, so in SIRRT and SADAL, how does one keep the two patient populations separate from one another? Is the presentation of Richter's so clear that one can determine that this is, in fact, Richter's and not a new case of aggressive lymphoma? I mean I know it is a transformed form of CLL. But is it clear in the clinic that it is actually Richter's versus aggressive lymphoma?

In the SIRRT study, the patient has to come up with aggressive lymphoma that is rising after CLL and has to be confirmed by histopathology. In the SADAL study, the DLBCL study, we are looking at patients with de novo DLBCL. Again, the decision will be confirmed by histology, as well as well as the sub-type of DLBCL.

Right, okay.

So these are varied populations.

Are there going to be overlapping sites in both of those studies?

Right.

I'm sorry?

Yes, several.

Yes. Okay.

Then with regard to AML, can you talk about how you will account for possible confounding by transplant? I can't imagine that this population is one that is heavily going to go to transplant. But just in the case that you do get clear marrow, are patients going to go to transplant? If so, how do you account for that in the statistics?

The patients that are going to into the SOPRA study, the AML study, could have not been candidates for transplantation in the past. Even if they were treated with high-dose induction chemotherapy, they were not able to go to transplantation, even if they achieved a complete response in that setting. So the likelihood of these patients to go to transplantation after treatment with Selinexor is very small.

We will have an interim data analysis after 50% of the events. At that point, if we need to adjust our statistics to account for people who will seek transplantation, then we will do that at this point.

Sharon, can you say what your expectation is there? Is it single-digit percent that might go to transplant?

Yes, single-digit. Mostly, because they were not eligible for transplantation coming here.

Okay. All right.

Then finally, I just wanted to ask you if you have considered applying for breakthrough therapy designation? You seem like you've got a robust data set, 450 patients plus, et cetera. Is BTD contemplated for Selinexor in any of these indications?

Well, of course we are contemplating that and several other regulatory strategies that will take place, some of it in 2016.

Do you feel you have an adequate data set now to do that -- to apply for BTD?

The guidance we have discussed is actually with FDA. Given the orphan drug designations we have already received, as Sharon mentioned, there are other things like fast track designation that are actually more relevant. But, yes, we do think we have sufficient data. We've just got to prioritize -- the fast track seems to be the most pressing one next.

Okay. Great. Thanks. I appreciate it.

Michael Schmidt, Leerink.

I wanted to follow up on the multiple myeloma study results so far. Can you help us to benchmark the ration of response, have you seen so far, to that of other drugs in late-stage multiple myeloma?

Yes, a lot of this data will be presented at ASH next month. But based on that, we already published several of these patients have stayed on the current dose of 45 milligrams per meter squared with dexamethasone for over four and six months with durable responses.

Okay. How did that compare to pomalidomide or carfilzomib, for instance?

Pomalidomide plus dex, or carfilzomib, both had a PFS of four months. And that is the benchmark that we are comparing our data to.

Okay.

Now, many of our patients in this study, as we already reported it here and other meetings, are coming after carfilzomib or after pomalidomide plus dex or after both.

Yes. Okay. Then I saw a poster at ASH from you on the thrombocytopenia side effect of the drug. I was wondering what your thoughts are on how that side effect might affect the combinability of Selinexor with other drugs that might have potential overlapping toxicities.

The effect of Selinexor on thrombocytopenia is unique. Basically Selinexor, as we reported in the aspects in an excerpt, caused arrest of the stem cells and delayed maturation of megakaryocytes and therefore unshedding of platelets, which is different from the mechanism of thrombocytopenia, for example, that is induced by proteasome inhibitors.

We are paying much attention to the potential overlapping toxicity of thrombocytopenia with other drugs. And we will address this by tweaking the schedule of Selinexor when combined with other drugs. In addition, the use of TPO agonists is very helpful in treating Selinexor-induced thrombocytopenia. And we will continue to use TPO agonists in the combination studies.

Great. When do you think we will see the first Selinexor combination study data? Will you have something at ASH already? Or will that be a sort of 2015 data point?

As you may have seen, there is an abstract on the combination of Selinexor and carfilzomib from the University of Chicago. The PI on this study is Andrzej Jakubowiak. He mentioned in his poster that he will share some very early clinical data.

Great. Thank you.

David Nierengarten, Wedbush Securities.

Just a couple quick ones.

Have you spoken with the FDA on what would be an acceptable overall response rate for the Richter's study -- potentially for registration?

FDA approved the protocol and allowed us to initiate the study. But we have not discussed with FDA directly the response rate that is needed for approval of Selinexor in Richter's transformation based on this study. There is an interim data analysis in this study; and at that point, we will discuss it with the FDA.

Thanks for that. Then quickly, on the esophageal, head and neck, and the gynecological cancers. Will you be looking at patients according to HPV status or other viral infections in conjunction with your overall response rate endpoints? Are they pre-stratified, or is that something you might be looking at otherwise?

Certainly, we will look at the HPV studies. As you may know, patients with HPV usually have p53 wild type, with Selinexor caused [neutral] localization and reactivation of p53 in these patients. So this is a population that is of large interest to us. And all patients with head and neck and esophageal cancer will have a biopsy to determine HPV status in a central lab.

Great. Thank you.

Arlinda Lee, MLV.

I have two. One, on the timing for this SADAL trial, you said that it was going to take about two years for both SIRRT and SOPRA. Is that going to be the same for SADAL? Or might that take a little longer?

It is about two years.

It is about two years as well?

For the study as well, yes.

Okay. Thank you.

Then mechanistically, it seems that there is rationale for Selinexor in squamous lung cancer. Might we see data for that at ASCO next year? I mean I know you don't want to talk about necessarily your plans for the solid tumors. But might we get an update in lung cancer? And then about your regulatory strategy forward around that?

Well, we want you to continue to come to our earnings calls. So you'll have to (laughter) -- hopefully.

Okay. Great. Thanks.

(Operator Instructions)

Mike King, JMP Securities.

Just a quick follow-up. Can you say, roughly speaking, what the average time on therapy will be shown at ASH for both myeloma and DLBCL?

It is probably whatever is mentioned in the abstract, and then the data will be presented at ASH. We can discuss it at that point.

Okay. Fair enough. Thanks.

(Operator Instructions)

There are no further questions at this time. I'd like to turn the call back over to Dr. Kauffman for closing remarks.

That concludes our third quarter 2014 conference call. Thank you all for participating.

We look forward to providing additional clinical updates for Selinexor in both hematologic and solid tumors at the upcoming medical meetings, including a clinical update to coincide with the ASH meeting in early December.

Have a good day, everybody.

Thank you, ladies and gentleman. This concludes today's program. You may now disconnect. Good day.