Q2 2019 Earnings Call

Skylar: Good morning, my name is Skylar, and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics second quarter 2019 financial results conference call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Ian Karp, Karyopharm's Vice President, Investor, and Public Relations.

At this time I would like to welcome everyone to the Karyopharm Therapeutics second quarter 2019 financial results Conference call.

There will be a question and answer session to follow please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to Mr. and car.

Karyopharm, Vice President Investor and public relations.

Ian Karp: Thank you, Skyler. And thank you all for joining us on today's conference call to discuss Karyopharm's second quarter 2019 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kauffman, our Chief Executive Officer, Mr. Perry Monaco, Senior Vice President of Sales, Mr. Mike Mason, Chief Financial Officer, and Mr. Christopher Permiano, Chief Business Officer and General Counsel. On the call today, we'll provide an overview of key recent corporate developments, including an update on the initial commercial launch of Expovio, as well as an overview of the second quarter of Dr. Kaufman will then discuss our upcoming milestones and provide some summary remarks before we move into the Q&A portion. This morning, we issued a press release detailing Karyopharm's results for the second quarter. This release is available on our website at karyopharm.com.

This is the in car and I'm joined today by Dr., Mark Kaufmann, Our Chief Executive Officer, Mr., Terry Monaco, <unk> Senior Vice President of sales Mr., Mike Mason, Chief Financial Officer, and Mr., Christopher for me, our Chief business Officer, and General Counsel.

On the call today will provide an overview of key recent corporate developments, including an update on the initial commercial launch of exposure.

As well as an overview of the second quarter 2019 financial results.

Tom will then discuss our upcoming milestones and provide some summary remarks before moving to the Q1 a portion of the call.

Before we begin our comments I'll remind you that various remarks, we will make today constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 1995. These include statements about our future expectations clinical development 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 factor section of our most recent annual report on Form 10-K , which is on file with the SEC and another five that we may make with the FCC in the future.

Ian Karp: Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the State Partner Provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical development, 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 most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only.

Any forward looking statements represent our views as of today only 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 references we make to clinical trial data during todays discussion referred to interim.

Ian Karp: 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 references we make to clinical trial data during today's discussion refer to interim, unaudited site data unless otherwise specified. I'll now turn the call over to Dr. Michael Kaufman.

Unaudited, so I stayed up unless otherwise specified I'll now turn the call over to Dr., Michael Kauffman, Chief Executive Officer.

Michael P. Mason: Thank you, Ian, and good morning.

Thank you Anne and good morning, everyone.

Michael P. Mason: It has been a remarkable year so far for Karyopharm, which, of course, was accentuated by the recent accelerated approval of oral expovio, also known as Selenexert, by the U.S. Food and Drug Administration. Atrobovio is a first-in-class nuclear export inhibitor that was approved in combination with dexamethasone for the treatment of adult patients with relapse to refractory myeloma whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Expovio is the first and only prescription medicine approved in the U.S. for this indication, and it is the first approved cancer drug that targets nuclear export dysregulation, which is increasingly recognized as a fundamental mechanism in the generation of malignant cells. Importantly, because multiple myeloma is an incurable disease, an increasing number of patients will need new therapeutic options once their disease has become refractory to the currently available standards of care.

It's been a remarkable year, so far for Karyopharm, which of course was accentuated by the recent accelerated approval of oral exposure.

Also not to Selinexor find us food and drug administration.

Thanks, Bobby I was a first in class.

Your next one inhibitor it was approved in combination with estimates.

Adult patients with relapsed or refractory myeloma diseases refractory to at least two protease inhibitors at least two I mean, a modulatory agents and an anti cdtwenty monoclonal antibody.

Well, we always the first and only prescription medicine approved U.S. This indication and it is the first approved cancer drug that targets nuclear export just regulation, which is increasingly recognized fundamental mechanism and the generation of malignant cells.

Importantly, because multiple myeloma isn't terrible disease, an increasing number of patients when the new therapeutic options once their disease that become refractory to the currently available standards of care.

Michael P. Mason: Expovio represents an entirely new mechanism of action and a novel approach to the treatment of multiple myeloma. Our commercial colleagues have been doing a tremendous job educating the myeloma community about this new treatment option, and I'll now ask Perry Monaco, our Senior Vice President of Sales, to provide a brief update on how the commercial launch is progressing so far in just the first month or so post-approval.

More or less bogo represents an entirely new mechanism of action and a novel approach to the treatment.

Our commercial colleagues have been doing a tremendous job educating them island community about this new treatment option and I'll now ask Perry, our senior Vice President of sales, but it requires a commercial launch is progressing so far you just the first month or so post approval.

Perry Monaco: Barry?

Alright.

Absolutely Michael and I'm excited to provide some early commentary thanks to the hard work and dedication of the Karyopharm team.

Perry Monaco: Absolutely, Michael. And I'm excited to provide some early commentary. Thanks to the hard work and dedication of the Karyopharm team, Expovio became commercially available in the US on July 9, 2019, less than one week after its official FDA approval. We have deployed more than 70 sales representatives and nurse liaisons who are focusing on the 1,300 accounts who treat roughly 80% of all multiple myeloma patients. And not surprisingly, we are placing additional emphasis on those 400 higher volume accounts caring for roughly one half of all patients. These commercial efforts are also being supported by our comprehensive, fully integrated, carry-forward support program for patients, their caregivers, and healthcare providers. The Carry Forward program provides support services such as insurance benefits investigation, side effect management tools, and nursing support.

Well, we all became commercially available in the U.S. on July nine 2019 less than one week after its official FDA approved.

We have deployed more than 70 sales representatives and nursed liaisons, who are focusing on the 1300 accounts, who treat roughly 80% of all multiple myeloma patients and not surprisingly we are placing additional emphasis on those 400 higher volume accounts caring for roughly one half of all patients.

These commercial efforts are also being supported by our comprehensive fully integrated carryforwards support program for patients their caregivers and healthcare providers. The carry forward program provide support services such as insurance benefits investigation.

Side effects management tools and nursing support. Additionally, our focused network three highly experienced specialty pharmacy providers are providing additional support to patients being prescribed exposure.

Perry Monaco: Additionally, our focused network of three highly experienced specialty pharmacy providers is providing additional support to patients being prescribed Expovia. Finally, we are pleased that so many patient advocacy organizations throughout the U.S. are excited about the approval and are also educating the myeloma community about new treatment options. We thank them for all they do for patients and their families, and we remain committed to supporting patients and the myeloma community. While we are in the very early days post-FDA approval, the commercial launch thus far is off to a strong start. Early prescribing trends have been encouraging, with robust demand from both academic and community-based physicians throughout the U.S. Additionally, we are seeing early prescriptions being filled for patients with Medicare, as well as for those with commercial insurance coverage.

Finally, we are pleased that so many patient advocacy organizations throughout the U.S. are excited about the approval and are also educating the myeloma community about new treatment options. We thank them for all they do for patients and their families and we remain committed to supporting patients and the myeloma community.

While we are in the very early days post FDA approval. The commercial launch thus far is off to a strong start.

Early prescribing trends have been encouraging with robust demand from both academic and community based physicians throughout the U.S. Additionally, we are seeing early prescriptions being filled.

Patients, but Medicare as well as for those but commercial insurance coverage.

We are also already seeing encouraging progress within the payer environment as many payers clearly appreciate the urgency in which patients with heavily pretreated myeloma need new treatment options.

Perry Monaco: We are also already seeing encouraging progress within the payer environment, as many payers clearly appreciate the urgency with which patients with heavily pre-treated myeloma need new treatment options. Expovio is already being covered by some of the largest national payers and has been quickly added to some key formularies, including that of Express Scripts, one of the largest pharmacy benefit managers in the U.S. We look forward to providing more details regarding the ongoing launch at our third-quarter earnings call in November, when we will report on nearly a full quarter of Expovio sales. But so far, the early feedback from healthcare providers has been positive, and we remain optimistic in our ability to effectively bring this important new medicine to patients in need of novel treatment options. I'll now turn the call back over to Michael. Thank you.

Exposure is already being covered by some of the largest national payers and has been quickly added to some key formulary, including that of express scripts one of the largest pbms in the U.S.

We look forward to providing more details regarding the ongoing launch and our third quarter earnings call in November when we will report on nearly a full quarter of Ics phobias sales, but so far the early feedback from healthcare providers has been positive and we remain optimistic in our ability to effectively bring this important new medicine to patients in need of novel treatment options I'll now turn the call back over to Mike.

Thank you Barry.

Michael P. Mason: Thank you, Kary. Beyond this very important first accelerated approval, we continue to focus our efforts on gaining regulatory approval for Expovio beyond the U.S. market, as well as expanding the breadth and depth of approved indications for Selenaxer. To that end, we fully enrolled the Pivotal Phase III Boston study in January. Boston is evaluating Selenaxor in combination with Velcade indexomethazone compared to Velcade indexomethazone alone in patients with myeloma who have one to three prior lines of therapy. As we have highlighted previously, the Data Safety Monitoring Board for Boston convened earlier this year and determined that, first, on the safety side, no new safety signals were identified in the study, and that there was no imbalance in mortality in the two arms of the study. And second, on the efficacy side, based on the first interim analysis, the board recommended proceeding with the study as originally planned, with no changes in patient numbers.

Beyond this very important first accelerated approval, we continue to focus our efforts on getting regulatory approval price Fabio beyond the U.S. market as well as expanding the breadth and depth.

Good indications for Selinexor to that end, we fully enrolled the pivotal phase three Boston study in January .

Austin is evaluating Selinexor in combination helped get index.

Their development index in that zone alone in patients with myeloma, who have won three prior lines of therapy.

As we have highlighted previously the data safety monitoring board for Boston can be earlier this year and determined that first on the safety side no new safety signals have been identified on the study and that there were no. There was no imbalance in mortality. The two arms of the study and second on the efficacy side based on the first interim analysis. The board recommended proceeding with this study as originally planned no changes in patient numbers.

Michael P. Mason: Progression pre-survival is the Boston primary endpoint, and we've remained on track to have the top-line results from this study by the end of 2019 or early into 2020, depending on the occurrence of progression events. In parallel with these activities, we are also working with the European Medicines Agency on a Marketing Authorization Application, or MAA, requesting additional conditional approval for Selenaxer in combination with dextromethazone, based on the clinical data from the STORM study, which served as the basis for Expovio's U.S. accelerated approval. We expect to receive a decision on this application by the end of 2019 or early 2020 In addition to the Boston study, we are also investigating Felinexer in combination with other standard of care myeloma drugs as a potential new backbone therapy in patients with earlier Lyme myeloma.

Progression free survival is in Boston primary endpoint and we remain on track to have the topline results from this study by the end of 2019 or early in 2020, depending on the occurrence of progression events.

In parallel with the U.S. activity. We're also working with the European Medicines agency on a marketing authorization application or M&A requesting additional conditional approval for Selinexor in combination with equity method. So based on the clinical data from the storm study, which served as the basis for smoking as U.S. accelerated approval, we expect to receive decision on this application by the end of 2018 or early 2020.

In addition to the Boston study, we're also investigating selinexor in combination with other standard of care myeloma drugs as a potential new backbone therapy in patients with earlier line myeloma.

Michael P. Mason: Three abstracts highlighting new and updated clinical data from the Katrolis, Darzalex, and Pommelis arms of the Phase 1b2 Stump Study were presented in June at the European Hematology Association 2019 Annual Meeting. We continue to be encouraged by this combination data as we believe the full commercial and therapeutic potential for exfovio and multiple myeloma will be as part of combination regimens, subject, of course, to additional future Turning now to our other cell and XR development programs beyond my own, For diffuse large V-cell lymphoma, following the presentation of updated positive data from a Phase 2b FATAL study presented in June at the 2019 International Conference on Malignant Lymphoma,

Three abstracts, highlighting new and updated clinical data from the Kyprolis Arsenal and Pomalyst arms of the phase one B to Stomp study were presented in June at the European Hematology Association 2019 annual meeting.

We continue to be encouraged by this combination data as we believe the full commercial and therapeutic potential for exposure multi myeloma will be as part of combination regimens.

Of course, two additional future clinical trials regulatory buyouts and improves.

Turning now to our other Selinexor development programs beyond my own.

For diffuse large b cell lymphoma. Following the presentation of updated positive data from the phase Twob NADL study presented in June at the 2019 International Conference on malignant lymphoma, we're now working towards.

Michael P. Mason: are now working.

Michael P. Mason: NDA and MAA.

And da and M&A submission.

Submissions requiring celebrated a conditional approvals respectively.

Michael P. Mason: Submissions requiring accelerated and conditional approvals for patients with relapsed or refractory DLVCL who have received at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR T therapy. We expect to submit the NDA and MAA packages between the fourth quarter of 2019 and the first quarter of 2020. We anticipate some further clarity on timing and need feedback from a pre-NDA meeting we expect to schedule with the FDA in the fourth quarter of this year. Next, for the ongoing Phase 3 portion of the Phase 2-3 SEAL study, where Selenaxer is being investigated as a single agent versus placebo in liposarcoma, enrollment continues on track. Assuming a positive outcome on the primary endpoint of PFS, we intend to use the data from the SEAL study to support NDA and NAA submissions requesting

For patients with relapsed or refractory de LBC out who have received at least two prior multi agent therapies and who are ineligible for stem cell transplantation, including car T therapies.

We expect to submit the NDA and M- packages between the fourth quarter of 2019 in the first quarter of 2020.

We anticipate some fairly quiet clarity on timing any feedback from a pre NDA meeting, we expect to scheduled with the FDA in the fourth quarter of this year.

Next are the ongoing phase three portion of the phase two three seal study.

Where selinexor is being investigated as a single agent versus placebo and Michael sarcoma enrollment continues on track.

Assuming a positive outcome of the primary endpoint of PFS.

We intend to use the data from this study to support an NDA and any submissions requesting approval for selinexor for the treatment of advanced on respectable differentiate life cycle.

Michael P. Mason: for the treatment of advanced, unrespectable, de-differentiated leprosarcoma. Top-line data from the Phase III portion of this field study are anticipated in 2020. And finally, we were excited to present updated efficacy and safety data from the Phase 2 King Study, evaluating single-agent cell therapy and XR in patients with recurrent glioblastoma, which was recently highlighted at the American Society of Clinical Oncology (ASCO) 2019 annual meeting. Of the 30 patients treated in the 80 MIG dosing cohort, the overall response rate was 10%, with 19% of patients achieving a The most common treatment-related adverse events were cytopenias, along with gastrointestinal constitutional symptoms, and were primarily Grade I and II events.

Topline data from the phase three portion of this study are anticipated in 2020.

And finally, we are excited to present updated efficacy and safety data from the phase two King study evaluating single agent Selinexor in patients with recurrent Glioblastoma, which was recently highlighted at the American Society of clinical oncology ASCO 2019 annual meeting.

Of the 30 patients treated in the 80 make dosing cohort.

The overall response rate was 10% was 19% of patients achieving a six month PFS rate at 38% of patients achieving a second cycle, yes, that's right.

The most common treatment related adverse events for cytopenias, along with gastrointestinal ons.

Intuitional symptoms and were primarily great wanted to invest.

Based on these data we have recently entered into an exciting new collaboration with the Ivy brain tumor center at the Barrow Neurological Institute to conduct preclinical testing of several new drug combinations in Boston, Bobby Selinexor for the treatment of Glioblastoma.

The preclinical work proves successful viable selinexor combinations will advance the diabetes unique tissue based pay zero clinical trial format, which enables researchers to understand and experimental therapies impact individual patients brain tumor in as little as seven days saving critical time in this highly aggressive form of brain cancer.

Michael P. Mason: Based on these data, we have recently entered into an exciting new collaboration with the Ivy Brain Tumor Center at the Barrow Neurological Institute to conduct preclinical testing of several new drug combinations involving telonexer for the treatment of glioblastoma. The preclinical work proved successful, viable cell and extra combinations will advance into IB's unique tissue-based phase zero clinical trial format, which enables researchers to understand that an experimental therapy is impacting an individual patient's brain tumor in as little as seven days, saving critical time in this highly aggressive form of brain, Before I turn the call over to Mike to discuss the financials, I'd also like to take a moment to mention that our founder, president, and chief scientific officer, Dr. Sharon Shackham, recently received the esteemed New York Intellectual Property Law Association.

Before I turn the call over to Mike to discuss the financials I'd also like to take a moment to mention that our founder President and Chief Scientific Officer Dr. Sharon Shacham recently received these being New York intellectual property lawsuit.

2019 inventor of the year Award. This award recognizes Dr. Sharron firms are important research that led to a better understanding nuclear transport abnormalities in cancer and her cutting edge work designing and developing oral selinexor as well as several other of our pipeline assets past winners of this award included the adventures of car T therapy, Gleevec volume and Lasik laser vision correction amongst many others and of course your workers. The foundation for the accelerated approval of exposure all received last month.

Michael P. Mason: 2019 Inventor of the Year Award. This award recognizes Dr. Shackham for her important research that led to a better understanding of nuclear transport abnormalities in cancer and her cutting-edge work designing and developing oral spelonextra as well as several other pipeline assets. Past winners of this award have included the inventors of CAR-T therapy, Gleevec, Valium, and LASIK laser vision correction, amongst many others. And, of course, her work was the foundation for the accelerated approval that Expovio received last month. We offer our sincere congratulations to Dr. Shackham and the entire development team for winning this prestigious award. With that, I will now turn the call over to Mike.

We offer our sincere congratulations to dr. shot him and the entire development team are winning this prestigious award with that I will now turn the call over to Mike.

Thank you Michael since we just did a press release earlier today with the full financial results I will just focus.

As of June Thirtyth, 2019, cash cash equivalents and investments.

Including restricted cash totaled $217.9 million compared to 339.

As of December 30, Onest 2018.

As exposure was approved on July 3rd 2019, we will begin booking product revenues in the third quarter of 2000.

For the second quarter of 2019 license and other revenue was 9.5 billion compared to 19.9 million for the second quarter 2018.

Michael P. Mason: Thank you, Michael. Since we issued a press release earlier today with the full financial results, I will just focus on the highlights. As of June 30th, 2019, cash, cash equivalents, and investment, including restricted cash, totaled $217.9.

Primarily related to the company's license agreements with cancer gene and no respect.

For the second quarter 2019, R&D expense was 26.5 million compared to 44.7 million for the second quarter of 2015.

Michael P. Mason: compared to 330.9% on July 1, 2018. As Expovia was approved on July 3, 2019, we will begin booking product revenues in the third quarter of 2019. For the second quarter of 2019, we will begin booking revenues in the third quarter of 2019. License and other revenue is $9.5 million, compared to $19.9 million for the second quarter of 2018, primarily related to the company's

We expect R&D R&D expense on a quarterly basis to be relatively consistent.

The remainder of 2019 compared to the second quarter.

General and administrative expense for the second quarter of 2019 was $24.7 million compared to 9.5 million for the second quarter 2008, the increase in Jena expenses compared to the prior year period was due primarily to the hiring of the Karyopharm commercial team and related commercial launch preparation activities to support us commercial launch of exposure.

Michael P. Mason: primarily related to

Michael P. Mason: Antigen, and Ono, respectively. For the second quarter of 2019, R&D expense was $26.5 million, compared to $44.7 million for the second quarter of 2018. We expect R&D expense on a quarterly basis to be relatively consistent for the remainder of 2019 compared to the second quarter of 2018. General and administrative expense for the second quarter of 2019 was $24.7 million, compared to $9.5 million for the second quarter of 2018. The increase in GNA expenses compared to the prior year period was due primarily to the hiring of the Karyopharm commercial team and related commercial launch preparation activities to support the U.S. commercial launch of Exmovia. We expect G&A expenses for the remainder of the year.

We expect Gina expenses for the remainder of 2019 on a quarterly basis to be relatively consistent with Q2 2019.

For the second quarter of 2019, we reported a net loss of 43.4 million or 71 cents per share compared to a net loss of $33.7 million or 60 cents per share for the second quarter of 2015.

Net loss includes stock based compensation expense of 4.1 million.

At 4.4 million for the second quarters 2019.

Respect.

Based on our current operating plans, we continue to expect our full year 2019 operating expense to be between $200 million and 215 million excluding stock based compensation.

Additionally, we expect that our existing cash cash equivalents and investments will be sufficient to fund operations in the second half.

Michael P. Mason: 2019 For the second quarter of 2019, we reported a net loss of $43.4 million, or $0.71 per share, compared to a net loss of $33.7 million, or $62.5 million, for the second quarter of 2000. The net loss includes stock-based compensation expenses of $4.1 million and $4.4 million for the second quarters of 2019 and 2018, respectively. Based on our current operating plans, we continue to expect our full year 2019 operating expenses to be between $200,000,000 and $250,000,000. [inaudible] Additionally, we expect that our existing

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

Thank you, Mike before moving to the Q and eight I'd like to provide a quick overview of our key upcoming milestones first we will execute upon commercial launch initiatives as we've just begun to see the initial impact exposure, we have in the marketplace and more importantly on expanding the treatment options for patients battling multiple myeloma.

Next we continue to work closely with the EMA in support of our M&A requesting a conditional approval for Selinexor and we expect to receive a decision by the end of 2019 or early 2020.

Our next potential indication in relapsed or refractory deal Bcl, we plan to submit in India. The FDA requested accelerated approval based on the sale trial results sometime between the fourth quarter of 2019 in first quarter 2020.

Michael P. Mason: Podcast Equipment and Investments.

Michael P. Mason: will be sufficient to fund operations in the second half of 2020. I'll now turn the call back over to Michael for concluding remarks.

Michael P. Mason: Thank you, Mike. Before moving to the Q&A, I'd like to provide a quick overview of our key upcoming models. First, we will execute on our commercial...

We expect greater clarity on timelines following the pre NDA meeting with the FDA.

We also plan to submit an M&A in Europe .

Request for conditional approval in the same timeframe.

Michael P. Mason: and more importantly, expanding the treatment options for patients battling multiple myeloma. Next, we continue to work closely with the EMA in support of our MAA requesting conditional approval for Selenexer, and we expect to receive a decision by the end of 2019 or early 2020. For our next potential indication in relapsed or refractory DLV-CL, we plan to submit an NDA to the FDA with a request for accelerated approval based on the status of the STATA trial results sometime between the fourth quarter of 2019 and the first quarter of 2020. We expect greater clarity on timelines following a pre-NDA meeting with the FDA. We also plan to submit an MAA in Europe with requests for conditional approval at the same time. For the Pivotal Phase III Boston Study, enrollment was completed in January, and top-line data are expected by the end of 2019 or early 2020, depending on the occurrence of progression events in the trial.

For the pivotal phase three Boston study enrollment was completed in January and topline data are expected by the end of 2019 or early twenties.

I think on the occurrence progression events in the trial is positive these data could support regulatory submissions in 2020 in second line myeloma.

Next the various arms of the phase one b to Stomp study continue in myeloma, and we look forward to presenting updates on the various combination arms at future medical meeting.

And finally, we will continue to progress our solid tumor programs and lifeless or comment endometrial cancer.

In summary, 2018 is shaping up to be a truly.

Exciting and transformational year for Karyopharm and for patients battling both myeloma as we work to drive awareness and adoption of our first marketed product spoke.

We are also working in parallel to expand upon selinexors clinical and commercial potential the new territories in clinical settings, where there are patients with high unmet medical need.

We appreciate all of your support and we look forward to keeping you updated on progress in the coming months and quarters I'll now turn the call over to the operator for questions operator.

Michael P. Mason: in 2020 in the second line mile Next, the various arms of the Phase 1B2 STOMP study continue in myeloma, and we look forward to presenting updates from the various combination arms in future medical meetings. And finally, we will continue to progress our solid tumor programs in liposarcoma and endometrial cancer. In summary, 2019 is shaping up to be a truly exciting and transformational year for Karyopharm and for patients battling multiple myeloma as we work to drive awareness and adoption of our first marketed product, Spoga. We are also working in parallel to expand Selenix's clinical and commercial potential in new territories and clinical settings where there are patients with high medical needs. We appreciate all of your support, and we look forward to keeping you updated on progress in the coming months and quarters. I'll now turn the call over to the operator for questions. Operator?

Ladies and gentlemen, if you have a question at this time. Please press the Star then the number one key on your Touchtone telephone.

If your question of finance sector, you wish to remove yourself from the queue. Please press the pound cake.

Our first question comes from Maury Raycroft with Jefferies. Your line is now open.

Hi, This is Mitchell on for Morry. Thank you for taking your questions. My first question is can you remind us of what were the pre specified criteria for determining whether to upsize, the Boston study or not.

No I can't it's not to be cynical, but I cant remind you because we didnt announce that the trial is designed to show approximately 30% reduction in the risk of progression or death.

Against the control arm.

So you can imagine with a hazard ratio of about 0.7, if we were far off from that trial would have been stopped for futility and if we were close to that but not not in that zone.

Operator: Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from Maurice Raycroft, with Jefferies. Your line is now open. Hi, this is Mitchell Alonformori. Thank you for taking our questions. My first question is, can you remind us what the pre-specified criteria were for determining whether to upsize the Boston study or not?

We did upsize the trial, we did neither so you can assume that we were in the range.

Okay. Thanks, and then well what more can you say about the prescribing trends you're seeing are you seeing docs, combining suburbia with other myeloma drugs and can you talk about.

The types of patients that you're treating.

So.

I can't read still too early to really see trends in terms of how they're exactly using the drug what I can tell you is that we've seen.

Some.

Encouraging demand from all parts of the country and we're seeing demand come from both community and academic institutions, but again, we're still in the first month, so it's really hard to.

Michael P. Mason: You know, I can't, not to be cynical, but I can't remind you because we didn't announce this. The trial was designed to show approximately a 30% reduction in the risk of progression or death against the control arm. So you can imagine that with a hazard ratio of about 0.7, if we were far off from that, this trial would have been stopped for futility, and if we were close to that but not in that zone, we would have upsized the trial. We didn't either, so you can assume that we were in the range.

It's a really see what kind of trends it looks like in terms of each individual prescription that's coming through.

Okay, and then maybe my last one could you talk a little bit about the carry forward program and how involved the support program gets.

Yes. So the carry forward program is a it's a very comprehensive program that provides nursing services to patients.

Perry Monaco: Okay, thanks. And then, what more can you say about the prescribing trends you're seeing? Are you seeing doctors combining Expovio with other myeloma drugs? And can you talk about the types of patients that you're treating?

To help with.

Getting them through if theyre experiencing any side effects. They will also put patients.

Perry Monaco: So it's still too early to really see trends in terms of how they're exactly using the drug. But what I can tell you is that we've seen some encouraging demand from all parts of the country, and we're seeing demand come from both community and academia. But again, we're still in the first month, so it's really hard to really see what kind of trends it looks like in terms of each individual prescription that's coming through.

On our Quickstart program, we know that we understand that the dynamic of the patient that's receiving exposed me a lot of times is.

They are out of treatment options.

And a lot of times patients can't wait for insurance benefits Verifications. So they will put them on a quick start in order to get drug into a patient quickly and then they're transferred over are generally to our specialty pharmacies.

Perry Monaco: Okay, and then maybe my last one: could you talk a little bit about the Carry Forward program and how involved the support program gets?

They will also provide support to caregivers and.

Perry Monaco: Yeah, so the carry forward program is a very comprehensive program that provides nursing services to patients to help with getting them through if they're experiencing any side effects. They will also put patients on our quick start program. We know that we understand that the dynamic of the patient that's receiving Expobia a lot of times. They're out of treatment options, and a lot of times patients can't wait for insurance verifications, so they will put them on a quick start in order to get the drug into a patient quickly, and then they're transferred over generally to our specialty pharmacies. They will also provide support to caregivers and family members to help support the patient through their treatment.

Family members to help support the patient through their treatment.

Okay, Great and then assessed.

Thanks.

Our next question comes from Brian Abrahams with RBC capital markets. Your line is now open.

Hi, Thank you for taking my questions. Congrats an x. belvia launch and congratulations Sharon for the award.

I wanted to drill down a little bit more on the launch dynamics and I guess I'm curious.

How the openness.

Four and maybe capabilities for safety management.

Have how that's been overall, maybe how that's different between perhaps between academic versus community sites and the ways in which this management is being accomplished either through support of therapies dose reduction interruption et cetera, and then I had a follow up thanks.

Perry Monaco: Okay, great. Okay, next question. Thanks.

Yeah, I'll start and then I'll turn it over to Perry.

Operator: Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.

The label for exposure, we always fairly general and often include the words like.

Brian Corey Abrahams: Hi, thank you for taking my questions. Congratulations on the Expovio launch and congratulations to Sharon for the award. I want to drill down a little bit more on the launch dynamics, and I guess I'm curious how the openness, and maybe capabilities for safety management, how that's been overall, maybe how that's differed, perhaps between academic versus community sites and the ways in which this management is being accomplished, either through supportive therapies, dose reduction, interruptions, etc.

Use Institute of standards supported care, which gave us some leeway bombing. In addition for the typical side effects of exposure, which as you know our nausea anorexia and fatigue.

And low platelets, there very standard protocols out there with a number of drugs and often NCCN guidelines that can handle this so.

Sites have been very open to us relaying all of the knowledge that we gained during the clinical trials and I think doctors are very willing to use the best practices that so far have been determined.

For all of that so there has been really a great openness I think for standard supportive care in Alaska, as well or do you want to and I don't have a lot to add to that other than that are supportive care guidelines and our dose modification criteria are clearly laid out in our label and our reps are trained to do that.

Michael P. Mason: Yeah, I'll start, and then I'll turn it over to Perry. The label for Expovio is fairly general and often included words like, you know, used by the Institute of Standards-Supported Care, which gave us some leeway, and in addition to the typical side effects of exfobia, which are, as you know, nausea, anorexia, and fatigue, and low platelets, there are very standard protocols out there with a number of drugs and often NCCN guidelines that can handle this. So sites have been very open to us relaying all of the knowledge that we gained during the clinical trials, and I think doctors are very willing to use the best practices that have so far been determined for all of this. So there's been really a great openness, I think, to standard supportive care and prophylaxis as well.

On top of that.

A very critical pieces, our team of Karyopharm nursing liaisons.

They are they are working with practices to provide additional education on managing patients with exposure.

And then as mentioned earlier our carry forward program is a comprehensive support program for both the physicians and the patients. We also have our our network of highly specialized pharmacies.

And they provide some of those same services as well so what we're trying to do is we're trying to wrap that patient with the right amount of care in order for them to have a good experience with us.

Perry Monaco: Yeah, I don't have a lot to add to that, other than that our supportive care guidelines and our dose modification criteria are clearly laid out in our label, and our reps are trained to do that. On top of that, a very critical piece is our team of Karyopharm nurse liaisons. They are working with practices to provide additional education on managing patients with expovio. And then, as mentioned earlier, our Carry Forward program is a comprehensive support program for both physicians and patients. We also have our network of highly specialized pharmacies, and they provide some of those same services as well. So what we're trying to do is we're trying to wrap that patient in the right amount of care in order for them to have a good experience with expovio.

That's really helpful. Thank you and then you talked about the.

Interim and out in the first interim analysis for Boston.

I'm also wondering what sort of level of real time safety or mortality data.

Thank you and the FDA have coming out at the Boston study.

And whether this might give you any additional insights or confidence and insofar as the safety or efficacy of selinexor.

In the earlier line population thanks.

Yes.

On safety.

As the medical monitors for this as sponsoring medical monitors for the study and we have a very good view of ongoing.

Safety adverse events and any challenges that are on study it even.

Michael P. Mason: That's really helpful, thank you. And then you talked about the first interim analysis for Boston. I'm also wondering what sort of real-time safety or mortality data you and the FDA might have coming out of the Boston study and whether this might give you any additional insights or confidence as far as the safety or efficacy of Selenexer in the earlier line population. Thanks.

After patients leave the study.

Sitting here today, we feel as confident as we did six months ago.

Saying that there is no imbalance in depth on either arm of the study and we are Privy to these real time.

And.

For.

Adverse events again, we've not seen any new adverse events on the.

Efficacy side, we do not see compiled a rolled up information on efficacy. So we can't speak to that and of course phase three study. So we would.

Michael P. Mason: On safety, as sponsoring medical monitors for the study, we have a very good view of ongoing safety adverse events and any fatalities that are on the study and even after patients leave the study. Sitting here today, we feel as confident as we did six months ago, saying that there is no imbalance in deaths on either arm of the study, and we are privy to these in real time. Adverse events. Again, we've not seen any new adverse events. On the efficacy side, we do not see compiled or rolled up information on efficacy, so we can't speak to that. And, of course, it's a phase three study, so we wouldn't.

Thanks, again, and congrats again on all the progress.

Thank you very much.

Our next question comes from Eric Joseph with JP Morgan. Your line is now open.

Hey, good morning, everyone.

Turner on for Eric So just looking at the Boston, Dave I'd like to get a sense of your expectations for the proportion of patients having prior darzalex or.

See you.

And are there any treatment or that the stratification factor within the study design and.

Brian Corey Abrahams: Thanks again and congrats again on all the progress. Thank you very much.

It's better that potential for that level of granularity in that regard.

Yeah.

We don't have rolled up.

Operator: Our next question comes from Eric Joseph with JP Morgan. Your line is now open. Hey, good morning, everyone. This is Turner on behalf of Eric. So just looking ahead to the Boston data, I'd like to get a sense of your expectations for the proportion of patients having prior Darzalex or anti-CD8, or anti-CD8, Unknown Speaker, Unknown Attendee, Unknown Speaker, Unknown Speaker, Unknown Speaker,

Demographic data at this point and we'll have to wait for a medical meeting to to announce that I will say that there is no stratification for buyer cdthirty eight because it's not known to be a major.

And a major component of a response or not to sell deltak sorts of LTX itself. So that will have to wait and analysis I should also point out that the trial is.

Being conducted in U.S., Canada, Europe , and Europe , as well as Australia, and India and therefore, it's.

Michael P. Mason: Yeah, we don't have rolled up demographic data at this point. And we'll have to wait for a medical meeting to announce that I will say that there is no stratification for prior CD38 because it's not known to be a major and a major component of a response, or not to Selvaldex or to Valdex itself. So that'll have to await analysis.

The use of Darzalex is not quite as prevalent as in the U.S. So we don't expect it to be a major component of People's fire prior therapies in Boston.

Okay, and then on Selinexor and DLP Seattle is the current expectation that a confirmatory study would be required for full approval and if so how should we think about the design of that trial and any time line.

Michael P. Mason: I should also point out that the trial is being conducted in the U.S., Canada, and Europe, as well as Australia and India. And therefore, the use of Darzalex is not quite as prevalent as in the U.S. So we don't expect it to be a major component of people's prior therapies in Boston.

Yes.

As with all accelerated approvals there will be a commitment.

Michael P. Mason: Next question, is the current expectation that a confirmatory study would be required for full approval? And if so, how should we think about the design of that trial and any timelines?

Which we hope to be a post marketing commitments.

For a confirmatory randomized trial.

The.

Michael P. Mason: Yeah, as with all accelerated approvals, there will be a commitment, which we hope to be a post-marketing commitment for a confirmatory randomized trial. The design of that trial is being investigated now. We'll be proposing several designs, but in general, you should think of it as a chemotherapy-type backbone or a novel accepted therapy-type backbone, plus or minus selenectin. And that'll be a randomized study, most likely.

Design of that trial is being investigated now will be proposing several designs, but in general as you think of it as I chemotherapy type backbone or as a novel excepted therapy type backbone plus or minus selinexor.

And that will be a randomized study most likely in patients with at least one prior therapy.

Okay, Great. That's helpful and just one last quick one for me just in solid tumors in the ongoing phase three seal study and what the sitcom I'm. Just wondering if we could expect interim analyses to be performed thanks.

Operator: Okay, great. That's helpful. And just one last quick one for me, and I just installed tumors and the ongoing phase three seal study in my psychoma. I'm just wondering if we can expect any interim analyses to be performed.

Yes as soon as we have.

Any major endpoints from the seal study, we'll be happy to disclose them.

Michael P. Mason: Yeah, as soon as we have any major endpoints from the SEAL study, we'll be happy to disclose them. But I'm not, I'm not going to discuss anything, or give any more details.

But I'm not I'm not going to discuss anything any more detail at this point.

Great. Thank you.

Again, if you have a question. Please press star and then one.

Our next question comes from Arlinda Lee with Canaccord. Your line is now open.

Michael P. Mason: Great, thank you.

Operator: Again, if you have a question, please press star and then one. Our next question comes from Arlinda Lee with Canaccord. Your line is now open. Good.

Great. Thanks, very much for taking my questions.

I had a couple on.

If you could provide some color on discussion with payers and what we might hear about any update from the next call.

Arlinda Lee: Thanks very much for taking my questions. I had a couple on, so could you provide some color on the discussions with payers and what we might hear about in the update from the next call? And secondly, you've talked about education to help ameliorate the severity or duration of AEs. Can you talk about how Carry Forward might be helping with that? What is the dose modification scheme in Boston versus your current label, and what's allowed for bortezomib dose changes as well? Thank you.

And then secondly, youve talked about education to help ameliorate.

Severity or duration of AG can you talk about how carry forward.

Might be helping with that and then thirdly on Boston.

What is the post dose modification scheme.

In Boston versus your current label and what allowed for some of those changes as well. Thank you.

All right. So so I'll start.

Perry Monaco: All right, so I'll start. So with regard to payers, so far, the response from payers has generally been positive, and we're not encountering significant roadblocks. Of course, it's still early in the launch cycle, but our sense is that payers understand the urgency in which the indicated population for expovio needs new treatment options. We're already seeing prescriptions generated and subsequently approved from both large commercial payers and Medicare Part D plans. And as I mentioned earlier, Expovio has already been added to a number of payer formularies, including Express Scripts, one of the nation's largest PBMs. In terms of AE management and how the Carry Forward program works with that, what the Carry Forward team of nurses will typically do is they will set up a series of calls with patients based upon patient need and their desire for those services, and they will check in with them and find If the patient reports having some AEs, Karypharm will then report back to their health care provider so that they can make any adjustments to supportive care or anything like that that a patient might need. Michael, do you have anything that you want to add?

So with regards to Payors. So far the response from the payers has generally been positive and we're not encountering significant roadblocks.

Of course, it's still early in the launch cycle, but our sense is that the payers understand the urgency in which the indicated population for exposure need new treatment options.

We're already seeing prescriptions generated and subsequently approved from both large commercial payers and Medicare part D plans.

And as I mentioned earlier.

Exposure has already been added to a number of payer formulary, including express scripts being one of the nation's largest dbms in terms of AG management and how that carry forward program works with that what they what that carry forward a team of nurses will typically do is they will set up a series of calls.

With patients based upon patient need and and their desire for those services and they will check in with them find out how theyre doing if the patient reports, having some eightys.

Kerry for will then report back to their health health care provider. So that they can make any adjustments to supportive care or anything like that that a patient might need.

Michael you have anything that you want to add or no.

As far as Boston is concerned well the current dosing production scheme is actually very simple.

Michael P. Mason: As far as Boston is concerned, the current dosing reduction scheme is actually very simple for the indication for STORM patients, and that is starting at 80 milligrams twice a week with low-dose dexamethasone, and then the first dose reduction moves to 100 milligrams once a week, and then 80 milligrams once a week, and 60 milligrams once a week. The Boston dosing regimen starts at 100 milligrams once a week with felonexer, moves down to 80 and 60, and then the lowest dose on Boston is 40, which we do believe does confer some synergy with Velcade. Velcade dosing is standard for the control arm, and that's 1.3 mg per meter squared twice a week given subcutaneously two out of every three weeks for the first eight cycles, and then it moves into a maintenance regimen.

For the indication for the storm patients and Thats, starting at 80 milligrams twice a week with Lotus Texan method zone.

And then the first dose reduction moves to 100 milligrams once a week.

And then 80 milligrams once a week and 60 milligrams once a week the Boston dosing regiments starts at 100 milligrams once a week selinexor moves down to 80 and 60 and then the lowest dose on boss. This 40.

Which we do believe does compare some synergy with though.

Okay dosing is standard for the.

Control arm and that's 1.3 big per meter squared twice a week given subcutaneously two out of every three weeks for the first eight cycles and then it moves into the more maintenance regimen on the Selinexor arm.

Michael P. Mason: And this is a fundamental difference between Boston and most of the other phase three studies that have been done with Velcade. So the real-world use of Velcade is once weekly in most cases. And we're instituting that from the get-go with Cellinexor. So it's Vel-Vel-Vex once a week at 1.3 mg per meter squared of Velcade. And then dose reductions for Velcade are always 1.3 down to 1.0, then to 0.7, which is standard.

Importantly, velcade begins at once weekly.

And this is a fundamental differences between Boston and most of the other phase three studies that have been done with Velcade. So the real world use of Velcade is once weekly in most cases and we're instituting that from the get go with Selinexor. So its sell held ex once a week at 1.3 makes per meter squared and Velcade and then dose reductions for both eight are always 1.3 down to 1.07, which is standard.

Thank you.

Operator: Thank you. Our next question comes from Jonathan Chang with SVB Lyrinc. Your line is now open.

Our next question comes from Jonathan Chang with SVB Link Leerink. Your line is now open.

Jonathan Chang: Hi guys, thanks for taking my questions. First question, regarding the early launch, any color on physician feedback and any similarities and differences between academic and community-based physicians?

Hi, guys. Thanks for taking my questions first question regarding the early launch a any color on physician feedback and any similarities and differences between academic and community based physicians.

So it's still too early to say, whether there is any significant difference between academic and community based positions, but the general feedback is that things are going well and we're getting results that we would have expected.

Perry Monaco: So it's still too early to say whether there's any significant difference between academic and community-based positions, but the general feedback is that things are going well, and we're getting results that we would have expected.

Got it and can you talk about the implications of the Boston read out on the path forward and deal Bcm.

Michael P. Mason: Got it. And can you talk about the implications of the Boston readout on the path forward for DLBCL?

Michael P. Mason: Well, obviously, these are different diseases, but FDA is always looking for randomized data. We will be meeting with the FDA at a pre-NDA meeting to specify the exact timing of the DLBCL submission. The data are complete. We're cleaning them and preparing the NDA, so we don't see a major interaction between those two studies, but if the FDA would like to see data from Boston, as they did for the storm review, we, of course, would provide it.

Well, obviously these are different diseases, but FDA is always looking for randomized data.

We will be meeting with the FDA in a pre NDA meeting to specify the exact timing of the deal Bcl submission. The data are complete we're we're cleaning them and preparing the NDA. So we don't see a major.

The interaction between those two studies, but at the FDA, we'd like to see data.

From Boston as they did for the Storm review, we of course will provide.

Got it and then just last question any updated thoughts on how you're thinking about business development opportunities for Selinexor.

Jonathan Chang: Got it. And then just last question, any updated thoughts on how you're thinking about business development opportunities for SEL and XR?

[noise].

Chris Permiano: Sure. Yeah. Hi, this is Chris Permiano.

Sure Hi, this is Chris primiano.

Chris Permiano: Um, so, you know, uh, obviously we intend to maintain Commercial Rights in the U.S., and so then the question is, you know, how do you handle Europe? And, you know, there are a couple of different options that we have that we're continuing to assess. So one option could involve a partnership, and we, of course, would look for a partner that would have a mutually beneficial relationship with us and with the partner and maximize the potential of Selenexor in the European market. And it would be really important that we find a partner that aligns with our philosophy regarding long-term development and commercialization plans and has the expertise in marketing both heme and solid tumor drugs in the EU.

So you know obviously, we intend to maintain.

Commercial rights in the U.S. and so then the question is how do you handle Europe and.

There are a couple of different options that we have that we're continuing to assess the one option can involve partnership.

And we of course, we look for a partner that.

It would have a mutually beneficial relationship with us and with a partner and maximize the potential of Selinexor.

In the European market.

It will be really important that we find a partner that aligns with our philosophy regarding.

Long term development and commercialization plans and has the expertise and marketing.

In both team in solid tumor drugs in the EU and the second option would be to potentially launch. So next on our own in select European countries, where reimbursement negotiations in decisions typically occur more quickly and not acceptable levels and when you sort of have that step wise approach to expanding throughout Europe . So our view is that the value of selinexor were filled over time as we progress through our discussions with FDA M&A on the various different indications that we've been discussing.

Chris Permiano: And then a second option would be to potentially launch Selenexor on our own in select European countries where reimbursement negotiations and decisions typically occur more quickly and at acceptable levels, and then you sort of have that step-wise approach to expanding throughout Europe. So, you know, our view is that the value of Selenexor will build over time as we progress through our discussions with FDA, EMA, and the various different indications that we've been discussing, and we'll be focused on making sure that we are— Achieving the best value of Selenexor for the company.

And we will be focused on making sure that we are.

Achieving the best value of Selinexor.

For for the company.

Jonathan Chang: Got it. Thank you.

Got it thank you.

Our next question comes from Mike Olson with Baird. Your line is now open.

Operator: Our next question comes from Mike Ols with Baird. Your line is now open.

Michael P. Mason: Hey guys, thanks for taking the question and congratulations on the launch as well. Just a quick question on the European filing. I was wondering if you could comment on your interactions with the EMEA and if there's been any noticeable differences compared to that with the FDA.

Hey, guys. Thanks for taking the question and congrats on the launch as well.

Just a quick question on the European filing just just wondering if you could comment on your interactions with the EMEA and if there's been any noticeable differences compared to that with the FDA.

The interaction of the M&A, our intense we receive list of questions as expected.

Michael P. Mason: The interactions with the EMA are intense. We've received lists of questions, as expected, the 90-day questions and so on, and it's been a very, very scientific discussion back and forth. So a very comprehensive set of questions spanning the entire development program. And I would say it's similar to the FDA and, perhaps, in some areas, even more delving into details.

The 90 day questions and so on.

And it's been a very very scientific discussion back and forth. So.

So very comprehensive set of questions spanning the entire development program and.

I would say, it's similar to the FDA and perhaps in some areas.

Even more delving into the details.

Michael P. Mason: and more delving into details. Unknown Speaker Got it. And then in your prepared remarks, you mentioned, uh... Thinking about additional combinations with standard of care and beyond Velcade, which they are using in Boston. Maybe if you can just give us your current thinking there, maybe timing of starting some of those studies, if there's a particular combo you're thinking to go with next after Velcade. Thanks.

Got it.

And then in your prepared remarks.

You mentioned.

Thinking about additional combinations with standard of care and.

Beyond Velcade, which are using in Boston, maybe if you can just.

Give us your current thinking there may be timing of starting some of those studies if there's a particular combo unit you're thinking to go with next after Velcade. Thanks.

Sure we haven't firmed up.

Michael P. Mason: Sure. We haven't firmed up the next registrational studies in myeloma, and part of this is a larger, more comprehensive discussion about whether we should expand broadly in myeloma or expand into other different tumor types. As you know, one of the unique aspects of Expovio is that it's relevant to the generation of various types of malignancies, potentially any malignancy, and therefore can be used broadly. So we're exploring liposarcoma, uterine cancer, and brain cancer, as well as some of the immunologic malignancies. In terms of exact combinations in myeloma, the initial strategy is really to have the Boston data come in, hopefully positively, and that'll be, and then support that with NCCN guideline listings for the other various combinations that we're using.

The next Registrational studies in myeloma and part of this is a larger more comprehensive discussion about whether we expand broadly in myeloma.

And or expand into other different tumor types as you know one of the unique aspects of exposure. We always is that is relevant to the generation of various types of malignancies potentially any legacy.

And therefore can be used broadly so we're exploring LIFO sarcoma, uterine cancer and brain cancer as well as some of the immunologic malignancies.

In terms of the exact combinations in myeloma. The initial strategy is really to have the Boston data demand hopefully positively.

And that will be and then support that with NCCN guideline listings for the other various combinations that we're using we're quite excited about all the different combinations as highlighted recently.

Michael P. Mason: We're quite excited about all the different combinations, as highlighted recently at the EHA meeting, and we'll have additional highlights, I think, later this year. The combination with Darzalex is particularly exciting. This is a once-weekly regimen, as are all of our Selenix or dosing regimens. The combination with Patrolist, although early, looks extremely promising and is consistent with the Velcae data, and these are in more heavily pretreated patients than we would see with Boston. The all-oral combination with Pomalyst, where we see approximately a doubling of the expected response rate for Pomalyst itself and a much longer PFS than what you see with Pomalyst itself, makes that all-oral regimen particularly intriguing. And then, finally, we intend to update on a combination with Revlimid later this year. As new mechanisms come into play, we'll expect to be a simple oral once So this is really a broad-based backbone type of therapy where we've seen additivity or synergy with essentially all the combinations. Again, just to close, where we go in terms of approvals for the combinations, we have, but we will have guideline-based submissions.

At the meeting and we'll have additional highlights I think later this year.

The combination with Darzalex is particularly exciting.

This is a once weekly regimen as our all of our Selinexor dosing regimens the combination with Kyprolis, although early looks extremely promising and is consistent with the velcade data.

And these are being more heavily pretreated patients that we would see with Boston the all oral combination with pomalyst.

Where we see approximately a doubling of the expected response rate almost itself in a much longer PFS than what you see with finalist itself makes that all oral regimen, particularly intriguing and finally, we intend to update on combination with Revlimid later this year as well as as new new different new mechanisms come into play we'll expect to be in a simple oral once a week partner.

Essentially any new mechanism.

So this is really a broad based backbone type of therapy, where we've seen activity or synergy with essentially all this combination again just to close what we where we go in terms of approvals with the combinations, we have not decided yet.

But we will have guideline based.

Guideline based submissions.

Thank you.

Our next question comes from Ed White with HC Wainwright. Your line is now open.

Operator: Our next question comes from Ed White with HC Wainwright. Your line is now open. Hi, thanks for taking my question. So all of my Expovio questions have been asked and answered already, so I just wanted to ask about Eltanexor and when we'll see the next expected data. Thanks.

Hi, Thanks for taking my question. So all of my questions have been asked and answered already so.

Just wanted to ask about.

Well connects or yes.

You can just give us an update there and when we'll see the next expected data. Thanks.

Michael P. Mason: Sure. We presented data in prostate cancer in combination with second-generation androgen inhibitors earlier this year, and we expect to expand on those data later this year or early next. And then potentially, we'll be planning an approval study for eltinexer, most likely in prostate cancer, but we haven't decided exactly yet.

Sure we presented data in prostate cancer in combination with second generation androgen inhibitors earlier this year and we expect to expand on those data.

Later this year or early next and then potentially will be plenty potentially an approval study for LTX are most likely in prostate, but we haven't decided.

Exactly yes.

Okay. Thanks, Mike.

Operator: Okay, thanks, Mike. And at this time, I'm not showing any further questions. I'd like to turn the call back over to Michael Kaufman for any closing remarks.

And at this time Im showing no further questions I'd like to turn the call back over to Michael Kauffman for any closing remarks.

Michael P. Mason: Just to thank everybody for joining us, and we look forward to updating you on the launch and the rest of our progress over the next three months.

Just to thank everybody for joining us and we look forward to updating you on the launch.

And the rest of our progress in three months.

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

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