Good morning. My name is Skyler and now will be your conference operator today. At this time, I would like to welcome everyone to the Keriopharm 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.
Ann Karp, Karyopharm's Vice President, Investor And Public Relations.
Thank you, Skyler, and thank you all for joining us on today's conference call to discuss Cariopharm's second quarter 2019 financial results and business update. This is Ian Karp, and I'm joined today by Doctor. Michael Kaufman, our Chief Executive Officer Mr. Perry Monaco, Senior Vice President of Sales Mr. Mike Mason, Chief Financial Officer 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 Xpobio, as well as an overview of the second quarter 2019 financial results. Doctor. Kaufman will then discuss our upcoming milestones and provide some summary remarks before we move into the Q And A portion of the call. Earlier 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. Before we begin our formal comments, I'll remind you that various remarks we'll make today constitute forward looking statements for purposes of the Safe Harbor provisions under the privacy Litigation Reform Act of 1995. These include statements about our future expectations, clinical development and regulatory matters and timelines, 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 another filing that we may make with the SEC in the future. 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 today's discussion, refer to interim unaudited site data unless otherwise specified. I'll now turn the call over to Doctor. Michael Kauffman, Chief Executive Officer.
Thank you, Ian, and good morning, everyone. It's been a remarkable year so far for Karyopharm, which of course was accentuated by the recent accelerated approval of oral exposure. Also known as selinexor by the U. S. Food And Drug Administration.
Xplovio is a 1st in class nuclear export inhibitor that was approved in combination with dexamethasone treatment of developed patients with relapsed or refractory myeloma, whose diseases refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents and an anti CD38 monoclonal antibody. Xpobio is the 1st and only prescription medicine approved in the U. S. With 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 and an increasing number of patients will need new therapeutic options once their disease has become refractory to the currently available standards of care.
Oral exposure represents an entirely new mechanism of action and a novel approach in 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 1st month or so post approval. Barry?
Absolutely, Michael, and I'm excited to provide some early commentary. Thanks to the hard work and dedication of the Keriopharm team, EXFOio became commercially available in the U. S. On July 9, 2019, less than 1 week after its official on the 1300 accounts, who treat roughly 80% of all multiple myeloma patients and not surprisingly, we are placing additional emphasis on These commercial efforts are also being supported by our comprehensive fully integrated carry forward support program for patients, their caregivers and health care providers. The carryforward program provides support services such as insurance benefits investigation, side effects management tools and nursing support.
Additionally, our focused network of 3 highly experienced specialty pharmacy providers are providing additional support to patients being prescribed Expobia. 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 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. We are also already seeing encouraging progress within the retreated myeloma need new treatment options. Xpovio 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 PBMs in the U S. We look forward to providing more details regarding the ongoing and we will report on nearly a full quarter of Xpovio sales.
But so far, the early feedback from health care 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, Perry.
Beyond this very important first accelerated approval, We continue to focus our efforts on gaining regulatory approval for Expevio beyond the U. S. Market as well as expanding the breadth and depth of approved indications for selinexor. To that end, we fully enrolled the pivotal Phase III BOSTON study in January. Boston is evaluating selinexor in combination with Velcade and dexamethasone compared to Velcade and dexamethasone alone.
In patients with myeloma, who have one 3 prior lines of therapy. As we have highlighted previously, the data safety monitoring board for Boston can mean earlier this year and determine that first, on the safety side, no new safety signals had been identified on 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 is originally planned with no changes in patient numbers. Progression free survival is a Boston primary endpoint, and we remain 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 the U. S. Activities, we are also working with the European Medicines Agency on a marketing authorization application. Or MAA requesting additional approval for selinexor in combination with dexamethasone based on the clinical data from the STORM study which served as a basis for Expobio'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 BOSTA study, we are also investigating selinexor in combination with other standard of care myeloma drugs as potential new backbone therapy in patients with earlier line myeloma. 3 abstracts highlighting new and updated clinical data from the Petrolis, DARZALEX and POMALIST arms in the Phase 1btwo 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 Xphobia in multiple myeloma will be as part of combination regimens, subject reports to additional future clinical trials, regulatory filings and approvals.
Turning now to our other selinexor development programs beyond myeloma. For diffuse large B cell lymphoma, of updated positive data from Phase 2b SADAL study presented in June at the 2019 International Conference on malignant lymphoma. We are now working towards NDA and MAA submission, recoup submissions requiring accelerated and conditional approvals, respectively. For patients with relapsed or refractory DLBCL who have received at least 2 prior multi agent therapies and who are ineligible for stem cell transplantation, including CAR T therapies. We expect to submit the NDA and MAA packages during the fourth quarter of 2019 first quarter of 2020.
We anticipate some further clarity on timing and any feedback from our 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 twothree seal study, where selinexor is being investigated as a single agent first placebo and liposarcoma enrollment continues on track, assuming a positive outcome on the primary endpoint of PFS, We intend to use the data from the CLEAL study to support NDA and MAA submissions requesting approval for selinexor the treatment of advanced, unresectable, de differentiated liposarcom. Top line data from the Phase 3 portion of the CIO study are anticipated in 2020. Finally, we are excited to present updated efficacy and safety data from the Phase II King study evaluating single agent selinexor in patients with recurrent glioblastoma which was recently highlighted in 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% with 19% of patients achieving a 6 monthly of S rate and 38% of patients achieving a 6 high healthy accessory.
The most common treatment related adverse events for cytopenias, along with gastrointestinal constitutional symptoms and were primarily Grade 1 and 2 events. Based on these data, we have recently entered into an exciting new collaboration with the IV brain tumor Center at the Baro Neurological Institute to conduct preclinical testing of several new drug combinations involving selinexor for the treatment of Glioblastoma. If the preclinical work proves successful, viable selinexor combinations will advance into IV's unique tissue based Phase 0 clinical trial format, which enables research to understand that an experimental therapy is impacting an individual patient's brain tumor and as little as 7 days saving critical time in this highly aggressive cancer.
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 Thoughts Doctor. Sharon Shackham recently received the esteemed New York Intellectual Property Law Associates, 2019 inventor of the Year Award. This award recognizes Doctor. Shaq confirmed her important research that led to a better understanding of 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 have included the inventors of CAR T therapy, Vivek, Valium and LASIK laser vision correction, amongst many other and of course, her work was the foundation for the accelerated approval of Xpovia received last month. We offer our sincere congratulations to dot Shackham and the entire development team for winning this prestigious award. With that, I will now turn the call over to Mike.
Thank you, Michael. Since we issued a
press release earlier today with the full financial results, I will just focus 2019 cash, cash equivalents and investments, including restricted cash, totaled $217,900,000 compared to 330.9 as of December 31, 2018. As Xplovia was approved on July 3, 2019, we will begin booking product revenue in the third quarter of 2019. For the second quarter of 2019, license and other revenue was $9,500,000 compared to 19 $900,000 for the second quarter of 2018, primarily related to the company's license agreements with antigen and ono, respectively. For the second quarter of 2019, R and D expense was $26,500,000 compared to $44,700,000 for the second quarter of 2018. Expect R and D expense on a quarterly basis to be relatively consistent for the remainder of 2019 compared to the second quarter of 2019.
General and administrative expense for the second quarter of 2019 was $24,700,000 compared to 9,500,000 for the second quarter of 2018. The increase in G and A expenses compared to the prior year period was due primarily to the hiring of the carrier farm commercial team related commercial launch preparation activities to support the U. S. Commercial launch of Xplovio. We expect G and A 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 $43,400,000 $7,000,000 or $0.60 per share for the second quarter of 2018. Net loss includes stock based compensation expense of 4,100,000 and $4,400,000 for the 2nd quarters of 2019 and 'eighteen, respectively. Based on our current operating plans, we continue to expect our full year 2019 operating expense to be between 200,000,000 $215,000,000, excluding stock based compensation. Additionally, we expect that our existing cash, cash equivalents and investments be sufficient to fund operations in the second half of twenty twenty. I'll now turn the call back over to Michael for concluding remarks, Michael.
Thank you, Mike. Before moving to the Q And A, I'd like to provide a quick overview of our key upcoming milestones. First, we will execute upon our commercial launch initiatives we've just begun to see the initial impact, exposure, and 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 MAA requesting conditional approval for selinexor and we expect to receive a decision by the end of 2019. Early 2020.
For our next potential indication in relapsed or refractory DLBCL, we plan to submit an NDA to the FDA with a request for accelerated approval based on the SADAL trial results sometime between fourth quarter of 2019 1st quarter of 2020. We expect greater clarity on timelines following a pre NDA meeting with the FDA yet. We also plan to submit an MAA in Europe with requests for conditional approval on the same time frame. 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. If positive, these data could support regulatory submissions in 2020 in 2nd line myeloma.
Next, the various arms of the Phase 1btwo sump study continue in myeloma, and we look forward to presenting updates from the various combination arms and future medical meetings. And finally, will continue to progress our solid tumor programs in liposarcomline 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 with Spogu. We are also working in parallel to expand upon selinexor's clinical and commercial potential in new territories and 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.
Our first question comes from Maury Raycroft with Jefferies.
Hi, this is Mitchell on for Maury. Thank you for taking our questions. My first question is, can you remind us what were the pre specified criteria for determining whether to upsize the Boston study or not?
No, I can't not to be cynical, but I can't remind you because we didn't announce this. The trial is designed to show approximately a 30% reduction in the risk of progression or death against the control arm. So can imagine with the 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 did neither.
So you can assume that we were in the range.
Okay. Thanks. And then what more can you say about the prescribing trends you're seeing? Are you seeing docs combined Expovio with other myeloma drugs and can you talk about the types of patients that you're treating?
So, I can't it's 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 institution. But again, we're still in the 1st month. So it's really hard to really see what kind of trends it looks like in terms of each individual prescription that's through it.
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 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 Xpobia a lot of times is they're out of treatment options And a lot of times, patients can't wait for, insurance verification. So they will put them on a quick start in order to get drug into a patient quickly and then they're transferred over, generally to our specialty pharmacies. They will also provide support to caregivers and, and family members to help support the patient through their treatment.
Okay, great.
Thanks. 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 on the XBovio launch and congratulations to Sharon for the award. Wanna drill down a little bit more on the launch dynamics. And I guess I'm curious how the openness for and maybe capabilities for safety management, have how that's been overall, maybe how that's differed between perhaps between academic versus community sites and the ways in which this management is being accomplished either through supportive therapies, dose reduction interruptions, etcetera? And then I had a follow-up.
Thanks.
Yes, I'll start and then I'll turn it over to Perry. The label for Expobio is fairly general and often included words like use Institute of Standards Supportive Care, which gave us some leeway. And in addition for the typical side effects of Expedited, which, as you know, are nauseanarexian 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 so far have been determined for all of this. So there's been really a great openness, I think, for standard support of care. And prophylaxis as well. Barry, do you want to add? Yes.
I don't have a lot to add to that other than that, our supportive care guidelines and our dose patient 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 Keriopharm nurse liaisons. They are working with practices to provide additional education on managing patient with EXBOVIO. 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 exposure.
That's really helpful. Thank you. And then you've talked about the interim analysis for Boston. I'm also wondering what sort of what level of real time safety or mortality data might you and the FDA 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 selinexor in the earlier line population? Thanks.
Yes. So on safety, as the medical monitors for the sponsoring medical monitors for the study, We have a very good view of ongoing safety adverse events and any fatalities that are on study and even after patients leave this study. Sitting here today, we feel as confident as we did 6 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. And for 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 Epic So we can't speak to that. And of course, it's a Phase III 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. This is Turner on for 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 CD38 treatment? Was it a stratification factor within the study design? And is better for that level of granularity and the readout?
Yes, 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 strat application for prior CD38 because it's not known to be a major, a major component of a response or not to cell Beldex or to Beldex itself. So that'll have to await an analysis. I should also point out that the trial is being conducted in U.
S, Canada, 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.
Okay. And then on selinexor and DLBCL, 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 timeline?
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 posing several designs. But in general, as you think of it as a chemotherapy type backbone or a novel accepted therapy type backbone, plus or minus selinexor. And that'll be a randomized study, most likely in patients with at least one prior therapy.
Okay, great. That's helpful. And then just one last quick one for me. And, I just installed tumors in the ongoing Phase 3 seal study in length of sarcoma, I'm wondering if we can expect any interim analyses to be performed.
Yes. As soon as we have, any major endpoints from the CEL study, we'll be happy to disclose them. But I'm not going to discuss anything any more details at this point.
Great. Thank
Our next question comes from Arlinda Lee with Canaccord.
I had a couple on, if you could provide some color on discussion with payers and what we might hear about in the update from the next call? And then secondly, you've talked about, education to help ameliorate severity or duration of AEs. You talk about how carry forward, might be helping with that? And then thirdly on Boston, what is the dose modification scheme in Boston versus your current label and what's allowed for bortezimib dose changes as well? Thank you.
All right.
So, so I'll start. So with regards to payers, so far the response from the payers generally been positive and we're not encountering significant roadblocks. Of course, it's still early in the launch cycle, but sense is that the payers understand the urgency in which the indicated population for Expovio 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, Expevio has already been added to a number of payer formularies, including Express Scripts, being one of the nation's largest PBMs.
In terms of A. E. Management and how the carry forward program works with that, what they 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, find out how they're doing. If the patient reports having some AEs, Carrie 4 will then report back to their health care providers 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? Or
As far as Boston's concerned, the current dosing reduction scheme is actually very simple, for the indication for the storm patients. And that's 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 selinexor moves down to 8060 and then the lowest dose on BOSTON is 40.
Which we do believe does compare some synergy with Velcade. Velcade dosing is standard for the control arm, and that's 1.3 mgs per meter squared twice a week, given subcutaneously, 2 out of every 3 weeks for the 1st 8 cycles. And then it moves into the more maintenance regimen. On the selinexor arm, importantly, Velcade begins at once weekly. And this is a fundamental difference between Boston and most of the other Phase III 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 it's selveldex once a week at 1.3 mgs per meter square to Velcade. And then dose reductions for Velcade are always 1.3 down to 1.0.
Than 0.7, which is standard.
Our next question comes from Jonathan Chang with SVB Leerink. Your line is now open.
First question, regarding the early launch, 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's any significant difference between like in 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 redo on the path forward in DLBCL?
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 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. As they did for the storm review, we of course would provide it.
Got it. And then just last question. Any updated thoughts on how you're thinking about business development opportunities for selinexor?
Sure. Yeah. Hi. This is Chris fromiano. So, 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. So one option can involve a partner ship. And we, of course, would look for a partner that, would have a mutually beneficial relationship with us and with a partner and maximize the potential of selinex are, 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. It has the expertise in marketing, in both keen and solid tumor drugs in the U. S. In the EU. And then the second option, would be to potentially launch selinexor 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 to stepwise approach to expanding throughout Europe.
So our view is that the value of selinexor will build over time as we progress through our discussions with FDA, EMA, various different indications that we've been discussing. And, and we'll be focused on, you know, making sure that we are achieving the best value of selinexor, for the company.
Our next question comes from Mike Ulz with Baird. Your line is now open.
Hey guys, thanks for taking the question and congrats on the launch as well. Just a quick question on the the European filing. Just wondering if you can comment on your interactions with the EMEA and if there's been any noticeable differences compared to that with the FDA?
The interactions with the EMA are intense. We 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 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 details.
Got it. And then in your prepared remarks, You mentioned, thinking about additional combinations with standard of care and beyond Velcade, which you're 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.
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 expand broadly in myeloma and or expand into other different tumor types. As you know, one of the unique aspects of Xpobio is, 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 immunological malignancies. In terms of the exact combinations in myeloma, the initial strategy is really to 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. We're quite excited about all the different combinations. As highlighted it 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 selinexor dosing regimens. The combination of Peprolis, although early, looks extremely promising and is consistent with the Velcade 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 Palmas itself in a much longer PFS than what you see with thrombosis itself makes that oral regimen particularly intriguing.
And finally, we intend to update on a combination with Revlimid later this year, as well as new mechanisms come into play, we'll expect to be in a simple oral once a week partner. Or essentially any new mechanism. So this is really a broad based backbone type of therapy where we've seen adaptivity or synergy with essentially all the combinations. 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 H. C. Wainwright. Your line is now open.
Hi, thanks for taking my question. So all of my ex Folio questions have been asked and answered already. So Just wanted to ask about eltonixor, if you can just give us an update there and when we'll see the next expected data. Thanks.
Sure. We presented data in prostate cancer in combination with 2nd 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 potentially, an approval study for eltonx are most likely in prostate, but we haven't decided, right, exactly yet.
And at this time I'm showing no further questions. I'd like to turn the call back over to Michael Kaufman for any closing remarks.
Just to thank everybody for joining us and we look forward to updating you on the launch. And the rest of our progress in 3 months.
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude program. You may now disconnect. Everyone have a great day.