Good morning. My name is Carmen, and I will be your conference operator today. At this time, I would like to welcome everyone to the Keriopharm Therapeutics Third Quarter 2018 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. You may begin.
Thank you, Carmen, and thank you all for joining us on today's conference call. To discuss Karyopharm's third quarter 2018 financial results and business update. This is Ian Karp, and I'm joined today by Doctor. Michael Kaufman, our Chief Executive Officer Mr. Mike Falvey, Chief Financial Officer Doctor.
Sharon Schackam, our Founder, President and Chief Scientific Officer Mr. Chris Permiano, our Chief Business Officer and Mr. Anand Baradan, our Chief Commercial Officer. On the call today, Michael Kaufman will make some introductory comments. Then Mike Falley will provide an overview of the quarter 2018 financial results.
Doctor. Kapan will then discuss our key upcoming milestones and provide some summary remarks. We'll then open up the call for questions. For which Sharon, Mike, Chris, Anani and I will also be available. Earlier this morning, we issued a press release detailing Karyopharm's results for the third quarter 2018.
The release is available on our website at karyopharm.com. 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 Safe Harbor's provision under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of 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 quarterly report on Form 10 Q 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?
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 the 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 Kaufman, our Chief Executive Officer. Thank you, Ian, and good morning, everyone. Thank you for joining us on today's call. Over the past few months, we've continued to make great progress towards bringing oral selinexor, our lead product candidate to patients with refractory forms of cancer.
In fact, just yesterday, We announced that the FDA has granted fast track designation to selinexor for the treatment of patients with diffuse large B cell lymphoma who have received at least 2 prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR T therapy. Of course, this fast track designation marks Selinexure's 2nd such distinction following the fast track designation granted earlier year for patients with tetr refractory multiple myeloma. Regarding myeloma, we are particularly encouraged that the FDA has now assigned a priority review for our new drug application seeking accelerated approval for selinexor as a new treatment for patients with tenter refractory myeloma and has set an action date of April 6, 2019, under PDUFA, the prescription drug user feedback. The filing of Karyopharm's first NDA is a significant milestone for both selinexor and our entire company. If approved, we believe that selinexor's novel mechanism of action oral administration and compelling clinical profile will make it a meaningful treatment option for patients with highly refractory myeloma We are also actively working towards the submission of a marketing authorization application to the European Medicines Agency with their press for conditional approval for selinexor in this same pentorefactory indication in the first quarter of 2019.
These NDA and MAA packages are supported by positive results from Part 2 of the Phase 2b STORM study evaluating twice weekly oral selinexor plus low dose dexamethasone or cell Dex in patients with pender refractory myeloma. To put the current level of unmet medical need in perspective for these patients with highly refractory myeloma. We know from the existing published literature that heavily pretreated patients who are also refractory to DARZALEX have a efficacy of 4 months or less. So this is a particularly vulnerable patient population. In September, we presented updated data from the STORM study of Society of Hematologic Oncology 2018 annual meeting.
For the STORM study's primary endpoint, with myeloma refractory to Imides, proteasome inhibitors and DARZALEX, oral cell Dex achieved a 26.2% overall response rate which included 2 stringent complete responses, 6 very good partial responses and 24 partial responses. The 2 stringent CRs were also negative for minimal residual disease. In addition, both of the patients in the STORM study disease had relapsed following CAR T therapy achieved partial responses on oral cell Dex. The clinical benefit rate which includes Median overall survival across the study was 8.6 months and median overall survival in the nearly 40% of patients who achieved at least a minimal response on Seldex was 15.6 months. This compared to a median overall survival of only 1.7 months in patient whose disease progressed or whose responses were not evaluable.
The data are encouraging and compare favorably to the survival data reported in the literature which indicate expected survival of 4 months or less as mentioned previously in this heavily pretreated triple class refractory patient population Side effects of oral selinex were generally predictable and manageable with dose adjustments and our supportive care with safety results that were consistent with those previously reported from part 1 of the STORM study and from other selinexor studies. Additionally, we are very pleased that updated data from the STORM trial have been selected for oral presentation at this year's annual ASH meeting on Monday, December 3. In addition to the storm data to be presented at ASH this year, A total of 10 abstracts have been selected for presentation, including our top line Phase 2b SADAL data evaluating oral selinex as a single The SADAL study has enrolled 125 patients in a single arm trial, evaluating selinexor alone dosed at 6 milligrams twice weekly in patients who had previously received 2 to 5 lines of therapy. Unfortunately, of relapsedrefractory DLBCL patients and the available literature suggests that these patients typically only have a median life expectancy of less than 6 months If the results from the SADAL study are positive, we plan to submit a second NDA to the FDA in the first half of twenty nineteen.
With a request for accelerated approval for selinexor in this relapsed or refractory DLBCL patient population. And as I mentioned previously, the FDA has now granted selinex a fast track designation for this treatment setting, which further underscores the high level of unmet medical need that exists in this patient the nation arms of the phase 1btwo Stomp study. And just to remind you, on the Stomp study, the Stomp study is evaluating the Sel Dex regimen in common with a variety of other standard approved anti myeloma agents. In data reported previously from these stop arms, selinexor demonstrated evidence of synergistic anti myeloma activity when combined with these standard approved therapies. Data from the STOMP study will continue to be critically important to our overall clinical development strategy as we believe the greatest potential benefit selinexor can have in improving the standard of care in multiple myeloma.
Will be when used in combination regimens in earlier lines of treatment subject to future positive clinical data and regulatory approvals. Let me also provide a in combination with once weekly Velcade compared of therapy. Enrollment in the Boston study has been progressing well, and we are on track to complete a recruitment by the end of 2018. With top line data expected support a full approval for the Celldex plus Velcade nomination has a highly active, well tolerated and convenient second line treatment for myeloma. Finally, on the commercial front, inhibitor of nuclear export selinexor in the United States next year.
The entire team has been working with great passion and urgency to the important groundwork for our future commercial success with this drug. We have recently hired our regional sales directors and anticipate hiring our full U. S. Sales 1st before the end of January. With that, I'll now turn the call over to Mike to review the financials.
Mike?
Thank you, Michael. Since we issued a press release earlier today outlining our full financial results, I'll just review our third quarter 2018 financial highlights. As of September 30, 2018, cash, cash equivalents and investments, including restricted cash, totaled $212,300,000, compared to $176,400,000 as of December 31, 2017. On October 26, 2018, We completed a private offering of $172,500,000 aggregate principal amount of 3% convertible senior notes due in 2025. This offering included the full exercise of the initial purchaser's option to purchase additional notes.
After deducting the initial purchaser's discounts and commissions, other estimated operating expenses, the net proceeds are $166,900,000. For the third quarter 2018, research and development expense was $36,400,000 compared to $25,200,000 for the same period in 2017. General and administrative expense for the 13 was $13,000,000 compared to $5,800,000 for the same period in 2017. Comparing deemed to the prior quarter, the second quarter of 2018, R and D decreased by $8,300,000, This quarter's clinical trial spend was below trend, while the 2nd quarter spending was above trend. General and administrative expense increased $3,500,000,000 the prior quarter, primarily because of increased spending on our commercial efforts.
For the third quarter of 2018, we reported a net loss of 40 $100,000 or $0.79 per share compared to a net loss of $30,600,000 or $0.65 per share for the third quarter of 2017. Net loss includes stock based compensation expense of $4,800,000 $4,900,000 for the third quarters of 2018 2017, respectively. Cardiobium expects its operating cash burn, including research and development and general and administrative expenses. And for the year ended December 31, 2018, to be in the range of $175,000,000 to $185,000,000. Following our private placement of convertible senior notes during October 2018, and based on our current operating plans, we expect that our existing cash, cash equivalents and investments will be sufficient to fund operations into the second quarter of 2020.
If selinexor receives FDA approval, cash generated from product sales could extend this runway even further. Our current operating and plans include the continued clinical development of selinexor in our lead indications and on preparing the commercial infrastructure and hiring a sales force for the potential launch of cell in the United States. I'll now turn the call back over to Michael Kaufman for concluding remarks. Michael?
Thanks, Mike. Before I review our upcoming milestones and move to Doctor. Carsten Theal. Doctor. Theal currently serves as Chief Executive Officer of Aviano Therapeutics and brings extensive experience and leadership positions with leading innovative and commercially successful life science companies, including Alexion, Amgen and Roche.
We believe his strategic insight and operational expertise, commercializing medicines in international markets will be invaluable as we prepare to bring oral selinexor to patients across the globe and maximize its full commercial potential. Moving on now to our upcoming milestones. For our first selinexor NDA, we look forward to an FDA decision by April 6, 2019. And if approved, we expect to be well positioned to commercially launch selinexor as a new tree for pentor refractory myeloma very shortly after approval. Additional data from the Phase 2b storm study supporting this NDA will be presented at this year's ASH meeting in December.
For our SADAL study in DLBCL, we also expect to report top line data at ASH in December, which positive could support a regulatory submission in the first half of twenty nineteen. For the pivotal Phase III BOSTON study, we expect complete enrollment by the end of this year with top line data expected by the end of 2019. And if positive, could support a regulatory submission in 2020 second line multiple myeloma. In Q1 twenty nineteen, we plan to submit an MAA to the EMA for conditional approval for selinexor in patients with pentorefractory myeloma. For the Stomp study in multiple myeloma, we look forward to presenting updates for the combination arms with DARZALEXON homolist at ASH and expect to provide additional updates from the other arms of the study at future medical meetings.
Finally, Regarding development in solid tumors, our ongoing phase 3 seal study in liposarcoma and SIENDO study in endometrial cancer. Continue to actively enroll patients and top line data are expected by the end of 20192020, respectively. In closing, I would just like to take a moment to express my thanks to the entire Karyopharm team for all their hard work getting the 1st selinexor NDA filed. This was one of our most important milestones and brings us one giant step closer important new medicine to patients battling myeloma. We are committed to working the FDA grants our request for accelerated approval, oral selinexor could be available to patients in the first half of twenty nineteen.
I'll now
And our first question comes from Jonathan Chang with Leerink Partners. Please go ahead. Good morning. Thanks for taking my questions. First question, looking ahead
to ASH, what do you see as the efficacy benchmark for the SADAL study and how do you see the of selinexor versus CAR T in the 3rd line DLBCL setting?
Yes. First of all, let's be clear that we're not positioning against CAR T at all. These These are extraordinarily different therapies. There are 2 CAR T products that are approved in the 3rd line setting. And for patients that are eligible for CAR T and want to consider that, that's a great option.
Our study specifically excluded patients who are eligible for high dose chemotherapy and any sort of transplantation, which would include CAR T and our fast track designation specifically set for patients who are not eligible for any kind of transplant, including CAR T. So these are very different therapies. There are currently no small molecule drugs approved at all in the treatment of diffuse large B cell therapy. And the only drug that's approved in that is rituximab, which is Gullian first line as an add on therapy to our CHOP chemotherapy combination and similar combinations. So we believe the benchmark in this huge unmet medical need is pretty similar to that, which we described for myeloma, which was a response rate above 20% so that 1 in 5 patients or better, would show a partial or complete response.
And a duration of response that's 5 months or longer would be sufficient And I'll just close by reminding everyone that the interim data that were presented at ESMO, sorry, at EHA, at the European atology association meeting showed in 30 patients a response rate of approximately 30% with the duration of response longer than 7 months we believe that if we're in that kind of a range, this drug could get over the goal line for DLBCL.
Great. Thank you. 2nd question, how do you view the commercial opportunity for selinexor in the pentorfactory multiple myeloma setting? How are you thinking about expectations as it pertains to what a launch trajectory could look like?
I'm going to send that question over to Anan Verde and our Chief Commercial Officer, Anan.
Great. Yeah.
And thank you for the question. So in the
the market research that we've been doing recently, what we've found is very much aligned with what, how Michael created in his prepared remarks. There is a significant unmet need in these patients who don't have any other options after they failed these prior therapies. And in that setting, the reaction to the, especially the efficacy that selinexor demonstrated in the SCORM study, is very encouraging to these clinicians, especially for those patients who are able to achieve a response. So in that sense, I came away from research having sort of validated that there is a is it commercial opportunity that's driven by the unmet need in that marketplace? And the uptake trajectory is something that we're going to spend some time really trying to understand more fully, but I think the fact that there is that level of demand and that level of unmet need gives us encouragement in terms of the overall opportunity there and also the obviously the potential benefit for the patients.
Great. Thanks very much and congrats on the progress.
Thank you.
Thank you. And our next question comes from Brian Abrahams with RBC Capital Markets. Please go ahead.
Hi, thanks for taking my questions. Congrats on all the progress and congrats too on your 5 year anniversary as a public company. I guess my first question is on the recent announcement of fast track status. Can you give us any sense of, I guess, what type of data of the and I guess what type of elements the FDA was looking at to guide their decision to grant fast track status?
Yes. It's a pretty standard review. FDA needs to be apprised of all available data that are present at the time of the submission. So FDA has been updated on the progress of the study and the results to date that we've presented. I don't want to say a lot more than that, but I can assure that FDA is up to date on all of our available data.
Okay. Got it. Understood. And then, as you approach and MAA submission. Can you give us any updates on how European regulators might view the bar in myeloma, any similarities or differences versus FDA?
And where you stand with respect to your views on commercialization outside of the U. S?
Yes. So I'll start and then I'll again turn it over to Chris and then Anand on the commercialization front. We've certainly met with a variety of different countries to bring potentially bring selinexor through to approval in Europe. And frankly, they see the unmet medical need very similar to the way the FDA viewed it. Which is that patients whose disease is refractory to the 3 major classes of anti myeloma medicines, namely, immense proteasome inhibitors and DARZALEX, really are in dire straits with a very short expected survival and novel therapies, particularly those with completely new mechanism of action are very much welcomed.
So they were very excited about the data and we expect to work closely with the Europeans to move that through the process. That says, let me move it over to Chris, and then potentially are not.
Sure. Yes, this is Chris Permiano, Chief Business Officer. So, we're continuing to explore, potential partnerships to maximize the potential of selinexor in the European market we'll certainly provide more information on that when appropriate. We haven't set a specific timeline or structure. As I think I've said before, ultimately, we'll only move forward a partner who shares our vision and sense of urgency.
And of course, we'd only pursue a collaboration that maximizes the full commercial and financial potential of of a novel 1st in class compound like selinexor. Right now, as Michael described, our focus is on the regulatory approval of selinexor in Europe based on the MAA that we plan to submit to the EMA in the first quarter of next year. And I'd also add that as our enthusiasm regarding the commercial potential for selinexor increases, we're also evaluating the potential slides still on our own in select European Country.
Our next question comes from Maury Raycroft with Jefferies. Your line is open.
Hi, good morning and congrats on the progress. First question is just on a DLBCL. So There are several investigator led trials in lymphoma that are ongoing assessing selinexor in combos. And I think you've mentioned before that those could inform infirmatory trial in DLBCL. Can you go over how the story will come together and what plans and timelines are for a confirmatory study?
Sure. So we're exploring a variety of different options for combination of selinexor with various generally with chemotherapy because currently, as I mentioned, those are pretty much the standard of care, in the treatment of DLBCL. We are considering, combinations with ice therapy in the second line setting. We'll be looking at things like bendamustine as well as a selinexor plus Benda usually plus rituximab versus chemo rituximab or similar kinds of designs. We're conducting studies also in combination with ibrutinib, which is ongoing and including DLBCL and with venetoclax.
As well. So there are a variety of different options here. And if I had to be bedding man today and this is completely preliminary, I would bet it would be selinexor or placebo with a back against the backbone of, chemo plus rituxan. And then likely at the second time.
Got it. And will some of the investigator led data will that be added?
To a discussion that we will have with the FDA that we at the end.
Okay. And then also for the Saddle study. So think you've
got to go into a
fifty-fifty split between the GCB and the non GCB populations And I don't think you broke out the durability for the 2 populations in the EHA 2017 data. Is that something that we should be focused on for the ASH update? Or I don't know how important is that something that we should be focused on for the ASH update? Or I don't know how important it is for the durability differences between those two populations?
Yes. So as you intimated, we do include at least 50% of patients with GCB. And this is really part of the unmet medical need discussion to ensure that we're getting an adequate representation in patients with that subtype of DLBCL. As some of you are aware, the response to chemotherapy for the GTV patients is period to that for ABC. So there tend to be fewer of them.
But it means that the subsequent responses to either chemo or novel agents tend to be a lot worse for the GCP subset, in some ways, making it a higher unmet medical need. We do intend to provide full data that are available to us at the time of the presentation at ASH. So I would definitely look for that. But in the past, as you're aware, both the response rate has certainly been similar in the 2 populations, which is consistent with selinexor's broad mechanism of And, we would anticipate that there shouldn't be extraordinary differences in the duration, but hope to provide similar supportive data at ASH.
Thank you. Our next question comes from Eric Joseph with JP Morgan. Please go ahead.
Hi, good morning and thanks for taking the questions. For selinexor and storm, I'm wondering if you have any greater ability on the likelihood of an ODAC panel and how the team is preparing an anticipation, what specific issues the agency might be interested in relative some of the other late line approvals that we've seen to date. And with the SADAL study in DLBCL, I'm wondering how you're viewing selinexor relatively positioned to some of the developing, monoclonal antibody approach we're seeing, specifically more 208 and palliuzumab and sort of whether their clinical potential is impacting how you're thinking about the 3rd line relapsed refractory DLBCL commercial opportunity? Thanks.
Yes. So simple answer on the first part. We don't have any more insights beyond what was what we disclosed publicly that MGA has said that there may be an ODAC panel, which is a standard positioning for FDA on any new molecule for storms. So I can't give you any more update on that at all. On the second part, I can say that we really need to remember that selinexor is not only a novel therapy, but the mechanism of action, which to which is to activate tumor suppressor proteins by forcing them to stay in the cell nucleus to do their job and also to reduce the levels of Onco protein such as CMIC and Vcl-two, which are both relevant, especially in DLBCL.
That this is really an opportunity to bring a new oral therapy to combine with many of the available therapies. You've already seen our combinations in myeloma and across the board with image proteasome inhibitors and DARZALEX, the preliminary data suggests that there is strong additive or synergistic activity And particularly with DARZALEX, will there be an update with ASH, which is a monoclonal, as you know. So we see, actually, the advent of new monoclonals in myeloma and in DLBCL, and frankly in other diseases where we'll be studying selinexor as a real boon to to our mechanism where we can come in and activate tumor suppressors, the monoclonal do their job killing cells, which usually involves a P53 or similar type of tumor suppressor step. And we expect to see, where we might see additive or synergistic activity in a lot of these combinations. Taking an oral pill while you're getting your antibody infusion is really simple.
So it doesn't add a lot of burden, to the daily life of the patient.
Got it. Thanks for taking the questions.
Thank you. Our next question comes from Mike Old with Baird. Please go ahead.
Hi guys and thanks for taking the questions. I guess just at the upcoming ASH meeting, you mentioned your presenting some additional data from Stomp in combo with DARZALEX and POMALISSE. So I'm just curious if
you can talk about your combination strategy in multiple myeloma going forward, sort of beyond Velcade and next steps there and timelines and maybe how you're thinking about prioritizing potential other combinations? Thanks.
Yes. Thanks very much for the question. Mike. Yeah, this is a part of a very much, much larger discussion about whether we push deeply into myeloma. Where we already have an ongoing Phase III and second line myeloma in combination with Velcade, we will be coming up with phase 1two data in first line myeloma in combination with Revlimid, the all oral selinexor Revlimid Dex regimen, and in later lines, in combination with DARZALEX, where we've seen very nice response rates in patients whose disease at double refractory.
We're also working in myeloma with the major cooperative groups in the U. S. And outside of the U. S. Because doing some of these trials in myeloma has become very complicated.
And we're working actively working inside to determine how much carryover farm will directly run. Cooperative groups will run and also how broadly we want to move. As you know, we're moving into DLBCL. We have trials in solid tumors ongoing, including our seal study in liposarcoma, our SIENDO study in uterine cancer, our study in glioblastoma multiforme and the King study, an additional investigator sponsored trials and other types of cancer, and particularly solid tumors. In addition, we're studying our 2nd generation compound out to nexor and prostate and colon cancers as well as in myelodysplastic syndrome.
So we have a great deal going on. And then the mechanism of action of both selinexor and the 2nd generation sign, eltonxor, really lend themselves broadly across multiple types of cancers And as an ongoing process here and this will change in time and new data come out, we'll be determining how deeply we move to registration trials in myeloma. Or do we go more broadly into different types of cancer. Got it. Thanks guys.
Thank you. Our next question comes from Konstantinos Abrolakis with JMP Securities. Please go ahead.
Hi, guys. This is Simon on for Constantino's. Thanks for taking the question. I'm just curious on the safety front in DLBCL versus Penter refractory, multiple myeloma, obviously, both, indications with relatively frail patients. Just curious if you've seen the same kind of trend or heard about it from your study physicians, where there's kind of a learning curve, a lot of the side effects are kind of constitutional symptoms.
I think you've said in the past that your study physician had kind of learned to mitigate or address these symptoms before they even occur. I'm just curious if you've seen the same kind of trends in the DLBCL patients as you have in that enter refractory multiple myeloma?
So very good. Keep in mind that patients in the, STORM study had an average of 7 prior regimens and 6 years or and a half years of disease. So these are extremely heavily pretreated patients. And they've received some of the best drugs available in all of hematology oncologic drugs. So it's a very, very frail population.
Unfortunately, because of the slower drug development in DLBCL, we're getting patients with 3, a median of 3 prior regimens in our interim. We're not giving them decks because we don't need to in this. And also because Dex is not a standard of care, for treatments in lymphoma, the way it is for myeloma. And we're also using a lower dose of selinex in the patients with DLBCL. So the patients enrolled in the SABL are less frail and have less issues and less prior therapies than patients in the myeloma study they're receiving a dose that's 25 percent lower.
And while the physicians do have somewhat of a learning curve with selinexor, as they do frankly for all new drugs, We definitely see a dose response on side effects, and there do appear to be fewer side effects in the SADAL population than in the storm population.
Okay. Thanks a lot.
And qualitatively, I'd just add that qualitatively, the side effects are similar.
Thank you.
And our next question comes from Ed White with H. C. Wainwright. Please go ahead.
Hi guys. Thanks for taking my questions. So first just quickly on the commercialization in the U. S. How should we be thinking about the hiring of the sales force, the size.
And if you said January, is January going to be the full bolus of salespeople or will you be ramping up throughout the year? And then I have a follow-up question.
Great. So I'll turn it over to Anan
Sure. Thanks. What we're targeting is a group of around 70 in the field. And the timing for that, the recruiting for that is ongoing and the timing to have them on board would be in January. As what we're doing.
So we already have our full group of sales managers. We've had excellent response from the, from the sales community for opportunities with Karyopharm, we're going through that process now and we will have those folks onboard and beginning training in that timeframe.
Okay, great. Thank you. And then just on the endometrial cancer side, so what is the the company's plans there. I know that's an investigated sponsored trial in phase 3. So, will the company follow-up with a their own phase with your own phase 3 or how should we be thinking about moving forward in endometrial?
Yes. It's too early to say exactly what our plans are with endometrial. It's a good study. It's ongoing. It's a big unmet medical need in the May in setting, there are currently no maintenance agents approved in uterine cancer and people unfortunately generally do relapse after chemotherapy So we're assessing that.
And our it's part of the earlier question that was asked, as part of the more global question about how deep we go in myeloma and lymphoma and other diseases versus how broad.
Okay. Thanks, Michael. And then just I was wondering if you can give us an update on eltonixor and colorectal and the other indications as well. When should we plan to see more data?
So we are very close to finish the phase 1 of FELZANEXO. Present some of the early results in ESMO this year, then we'll continue to present data on the other indications that are included in this study in including the process in the upcoming conferences in 2019. And in 2019, we also decide on the next steps without anecdotal and which indication we are going to develop it.
Thank you. And our last question comes from Jing Huang with Bank of America Merrill Lynch. Please go ahead.
Hey, guys. This is Alec on for Ying. Thanks for taking our questions. Couple on the SADAL trial. Are there any major differences between responders and nonresponders that you can point to as explaining the differential response?
And at ASH, should we expect more than 32 patients for efficacy in the 60 mgs arms since the abstract was submitted?
So for your first question, this is a very good question and we are all with by ourselves and with many, many collaborators to identify biomedical for response. We don't have MDS and the risks we are doing, we are planning to, share some of these results and meetings in 2019. For your second question, as we mentioned in the stock, we will provide as up to date data as we can at ASH.
Austin trial, so it's almost fully enrolled at this point. I was wondering if you've gotten a sense as to physician comfort with selinexor in Panther refractory versus using it in earlier lines of therapy? And what do they sort of see as the biggest value add in the earlier lines of ERP? Thanks.
Yes, this gets back a little bit to the question with addition of selinexor to other agents. The thing about the Salveldex regimen is, that it's a once a week regimen and to our knowledge, it's the only Phase III or the 1st Phase III study that uses an experimental arm involving once weekly Velcade. Keeping in mind that cutaneous Velcade does require a physician's office visit. So reducing the number of office visits is a substantial reduction on patients. Many of whom are elderly.
Secondly, again, people are coming in to get an injection. They generally have to check the standard vital signs and all. And taking a pill while you're getting your Velcade injection doesn't add a lot of time or effort for the patient. So it's a very nice, simple regimen to use. The Selveldex phase 1two paper has been published, and that's in blood.
We recently. So that's available online. And I'll just close by saying that if we can deliver the kinds of efficacy that we saw in the phase 1two in this phase 3, where we also had a much lower rate of neuropathy, with cell Vildex, as compared to standard VELD this could be a real improvement. Selinexor itself is only given once a week in these combinations. And the dose of 100 once a week, which is used is about 60% lower than the weekly dose used in the STORM study in much thicker patients.
So the combination a reduced dose once weekly dosing and a much, much healthier population of patients, mean that selinexor as part of SVD and other regimens is considered well tolerated by most physicians, and we haven't seen significant pushback on that even in our global Phase 3 study. Thank
you. And ladies and gentlemen, this concludes our Q and session for today. I would like to turn the call back to Michael Kaufman, Chief Executive Officer for his final remarks.
Yes. Thank you, everybody, for joining this call. And I want to just also thank, again, all of the patients, their caregivers and their families who participating in our studies as well as our clinical investigators for helping move this exciting new potential oral medicine forward towards approval next year. Thanks all, and we look forward to seeing many of you at ASH, and have a good day. Bye bye.
Participating in today's conference. This concludes the program and you may all disconnect. Have a wonderful day.