Good morning. My name is Debbie, and I will be your conference operator today. At this time, I would like to welcome everyone to Karyopharm Therapeutics Second Quarter 2020 Financial Results Conference Call. 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, Senior Vice President, Investor And Public Relations. Please go ahead.
Thank you, Debbie, and thank you all for joining us on today's conference call. To discuss Karyopharm's second quarter 2020 financial results and business update. This is Ian Karp, and I'm joined today by Doctor. Michael Kauffman, Chief Executive Officer Doctor. Sharon Schackam, President and Chief Scientific Officer Mr.
Mike Mason, Chief Financial Officer Mr. John Demray, Chief Commercial Officer Mr. Christopher Primiano, Chief Business Officer And General Counsel. On the call today, Michael and John will provide an overview of key recent corporate developments an update on our commercial progress. And then Mike Mason will highlight the second quarter 2020 financial results.
We will conclude with the Q and A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the second quarter of 2020. This release, along with a slide presentation that we plan to reference, are 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 Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments, regulatory matters and timelines, the potential success of our products and product candidates, including our expectations relating to the commercialization of Expevio, 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 another filings that we may make with the SEC in the future. Any forward looking statements represent our views of today only. What 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 any 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, Chief Executive Officer.
Thank you, Ian, and good morning, everyone. Before I specifically review Karyopharm's performance in the second quarter, I'd like to put into some context where Karyopharm is on its journey to becoming a leading global oncology focused pharmaceutical company. For those following along in the presentation, please turn to Slide 4. When Doctor. Sharon Shaqman and I founded the company over 12 years ago, We had a vision that one day, we would create medicines that improve the lives of patients suffering from cancer and other serious diseases.
We spent the 1st 5 or so years building the organization growing the body of scientific and clinical evidence around XB-one inhibition, leading to the approval of 1st in class oral compound Xpovio. And in July of last year, we officially transitioned to a commercial company with the initial FDA approval and launch of Xpovio and relapsed or multiple myeloma. This year, we achieved an additional important milestone on our journey as Exposvio received its 2nd FDA approval at the end of June became the 1st branded therapy to be approved in both myeloma and DLBCL. And as we look out towards next year beyond, we expect to expand our commercial reach and advance a robust clinical development pipeline, including into solid tumor indications, all in support of the pace and families in need of new treatment options for devastating cancers. Please now turn to Slide 5.
In the second quarter, we achieved record quarterly Xpovio sales of $18,600,000, the strongest quarter since our July 2019 launch. Total revenue for the quarter reached $33,500,000, which included most of the payment from one of our international partners, Entergy, in the quarter for our expanded territory agreement, which we announced earlier this year. The 16% increase in Expobio net sales compared to the first quarter of 2020 was driven by increased demand from both academic and community based physicians. Importantly, we saw more than 170 new physician accounts prescribe Expevio for the first time in the quarter even as in person activities were limited due to regional restrictions related to the ongoing COVID pandemic. This represents more new accounts added in Q2 than in Q1, despite the ongoing pandemic.
The second quarter was also marked by the FDA granting accelerated approval of Xpovio for the treatment of patients with diffuse large B cell lymphoma or DLBCL, including DLBCL arising from follicular lymphoma after at least two lines of systemic therapy. This represents the 2nd approved indication for Expobia. We were able to launch immediately by leveraging our existing commercial infrastructure given the overlap between oncologists treating myeloma and DLBCL, particularly in the community setting. At the annual ASCO meeting in May, We presented the detailed results from the highly successful Phase III BOSTON study in patients with previously treated myeloma. Boston is our randomized trial of once weekly selinexor with once weekly Velcade along with dexamethasone compared to standard twice weekly Velcade and dexamethasone.
The trial met its pre specified primary endpoint And based on these results, we quickly submitted a supplemental new drug application or sNDA to the FDA for Xpovio for the treatment of myeloma after at least one prior line of therapy. FDA has filed the application and assigned an action date of March 19, 2021 under the prescription drug user fee act or PDUFA. I'm also pleased to announce that we have now completed enrollment in our Phase III study of selinexor in patients with heavily pretreated de differentiated liposarcoma and expect top line data in the second half of this year. If these data are positive, we believe this will be a very important step towards our goal of bringing exposure to patients battling solid tumor. In addition to those with hematologic malignancies.
We also made important progress in our clinical pipeline outside of cancer And today, we are providing an update on our placebo controlled phase 2 trial of low dose selinexor for patients with severe COVID-nineteen. That is patients who are hospitalized, hypoxic, and require supplemental oxygen. This program was prioritized at Karyopharm and rapidly advanced into the clinic in a matter of weeks due to the encouraging antiviral and anti inflammatory activity Recall that in addition to its roles in cancer, Xpl1 may also be an important target in viral infections by facilitating the transport of several key viral proteins from the nucleus At the planned interim analysis of the randomized Phase 2 study with approximately 120 patients, the results indicated that selinexor is unlikely to demonstrate typically significant efficacy benefit across the entire population of patients hospitalized with severe COVID 19, who were studied. However, selinexor does appear to confer clinical benefit in a subpopulation of patients that represents about 3 quarters of the whole severe COVID-nineteen population. Based on these results, we have discontinued the current study and expect that future clinical development of low dose selinexor for patients with COVID-nineteen will focus on the subpopulation where we saw the significant effects.
I'll provide some additional details on these specific results later in today's presentation. On the corporate development front, we were excited to announce our entry into a cooperative research and development agreement or Krata, with the National Cancer Institute's Cancer Therapy Evaluation Program for the Research of Xpobio in various oncology indications. Which we hope yields additional opportunities for us and patients in the future. Finally, on the financial front, we ended the quarter with a strong cash position of approximately $348,000,000 that we expect will be sufficient to fund our planned operations into the middle of 2022. Please now turn to Slide 6, where I'll ask John Demery, our Chief Commercial Officer, to provide some additional details on Expobio sales performance during the second quarter.
John?
Thank you, Michael, and good morning, everyone. As Michael noted earlier, we were pleased with the commercial momentum seen during the quarter. Despite being impacted by some of the challenges associated from the COVID 19 pandemic, including limited in person sales visits to our customers, I commend the carrier for our commercial organization for driving our educational initiatives forward virtually during these challenging times in support of our community of patients, families and caregivers. Our virtual initiatives for both multiple myeloma and DLBCL include digital tools to facilitate continued sales force, nurse liaison, and payer team engagement with customers, search engine marketing and media placement and virtual peer to peer programs. Additionally, we believe Xpovio's product profile offers some distinct advantages for our patients during frequently is commonly used for enteral therapies.
As of June 30, approximately 3200 Bovial prescriptions have been filled in the U. S. Since launch and approximately 950 prescriptions were filled in the 2nd quarter. Prescription demand increased by 12% compared to the first quarter. And as Michael highlighted earlier, net sales in by 16% in the quarter.
The 2nd quarter was the strongest quarter to date for both net sales and patient demand. This growth was particularly exciting as the overall demand in the U S for a number of other multiple myeloma drugs declined in the second quarter as a result of the ongoing pandemic, further underscoring the strong performance for Expobio. There was also some incremental added some incremental inventory added at our distribution partners in Q2, driven by initial stocking at the end of June of 3 new Expedited package sizes to support the commercial launch in patients with DLBCL. Turning to Slide 7, I will provide some additional color on patient metrics that we follow closely and believe further reinforce the positive experience many physicians and patients are having with exposure treatment. The graph on the left side of this slide highlights average treatment cycles or prescriptions per patient based on data from our participating specialty pharmacies.
What you will notice is that this number has increased steadily each quarter since launch as we believe physicians are getting more comfortable treating patients with Xpovio and effectively managing its potential side effects. As of the end of June, the average number of prescriptions per patient On the right side of the slide, the graph shows the prescription refill rate over time for both the first and second prescription refills for those patients eligible. These numbers have also continued to improve significantly each quarter since launch. As an example, in September of 2019, which marked the end of the first quarter, the Xpovio became commercially available roughly 42% of patients were going on to get a second prescription. At the end of June 2020, that number stood at 61% an impressive improvement.
These increasing refill rates coupled with the increasing average number of treatment cycles further reinforce the positive feedback we have received from patients and physicians regarding their experience and usage of Xplovio. Moving forward, we plan to continue to engage with the medical community and reinforce the potential benefits of Xpobio through virtual and in person engagements where possible. We will continue to fully leverage the newly approved indication in DLBCL to access our key stakeholders, educate on this new indication and also generate increasing excitement in multiple myeloma to help more patients impacted by these diseases. Now I'd like to turn the call back over to Michael to discuss our key clinical development activities and priorities which began on Slide 8. Michael?
Thank you, John. A critical milestone for us in the second quarter included the formal presentation of the positive BOSTON study results, As a reminder, this was the first large Phase III study in previously treated myeloma to directly compare a once weekly triplet regimen with standard twice weekly Velcade. We were thrilled that the study met its primary endpoint of a statistically and clinically significant improvement in PFS with a 47% increase in the median progression free survival on the SVD arm as compared to the VD arm, representing a 4.47 month improvement. The median progression free survival in the SVD arm was 13.93 months compared to 9.46 months in the VD arm, with a hazard ratio of 0.70. SVD was superior to BD across other key efficacy endpoints, such as overall response rate, the rate of very good partial response or better and the duration of responses.
The results were consistent across most of the subpopulations, including patients over the age of 65, patients who are frail, those with prior lenalidomide treatment and those with high risk cytogenetics. Media and overs all survival on the SVD arm has not yet been reached, but it was 25 months on the VD arm. Moreover, There were numerically fewer deaths on the SVD arm than on the VDR. We were also pleased to report the rate of peripheral neuropathy on the SVD arm was significantly lower than the rate in the BD control arm. Remember that peripheral neuropathy is among the most common causes of treatment limitation and discontinuation of BD and combination BD regimens and a significant differentiator for the Boston regimen and the future regulatory approval.
The data also showed no new safety signals in the SVD arm relative to previously reported adverse events from other selinexor myeloma trials. In summary, we are able to conclude from the Boston study that in patients with multiple myeloma, who have received 1 to 3 prior therapies, including prior linalidomide or proteasome inhibitor once weekly SVD offers patients an effective convenient triplet regimen requiring approximately 40% fewer clinic visits and a reduced rate of peripheral neuropathy pending future regulatory approval, of course. On Slide 9, I'll provide a brief update on our key upcoming regulatory activities. Our Boston sNDA was accepted for filing in July with decision expected by March 19, 2021. In Europe, we plan to submit the final additional monitoring data requested by EMA from the STORM study in patients with advanced refractory myeloma in September.
We then expect to submit the BOSTON data to the EMA in the fourth quarter of this year. Exact timing of potential regulatory decisions based on both the storm and Boston data will be determined following feedback from EMA. As we turn to Slide 10, I will highlight our recent accelerated approval for Xphobia for the treatment of adult patients with relapsed or refractory DLBCL. The SADAL study, which served as the basis for approval, Xpovio demonstrated an overall response rate of 29%, including a complete response rate of 13%. Responses were seen in all subgroups, regardless of age, gender, prior therapy, GCV or ABC subtype, or prior stem cell transplant therapy.
Importantly, responses were associated with longer survival, underscoring the potential of oral Xp01 inhibition as a simple non caribbean therapeutic option for patients with recurrent DLBCL. While we have just kicked off our commercial launch in this indication, we believe Expevio's product profile address several key treatment considerations for this difficult to treat disease as displayed on Slide 11. Physicians commonly examined patient history and disease subtype previous therapies used in treatment efficacy and durability when deciding on an appropriate treatment pathway. The simple administration, single agent and novel mechanism of action of Xpobio provides additional advantages for use with a manageable safety profile. Next, please turn to Slide 12, who will review the updates from our COVID 19 study.
Based on anti SARS coronaviral activity in vitro, and anti inflammatory activity in vitro and in vivo. Keriopharm began enrollment in a placebo controlled randomized Phase II study to evaluate low dose oral selinexor in hospitalized patients with severe COVID-nineteen in April of this year. These patients require supplemental oxygen and are at high risk for clinical worsening. Many of them had already received remdesivir, steroids, convos and plasma and other agents used to treat COVID-nineteen. As mentioned previously, The data safety monitoring board for the study concluded that the trial is unlikely to demonstrate a statistically significant efficacy benefit across the entire population of severe patients who were enrolled.
However, they also concluded that the trial was likely to show a benefit in the subpopulation of patients are less than seventy five years old and have a COVID GRAM non high risk score, which represented approximately 75% of the entire population enrolled in the study. Preliminary results from the unaudited site data indicate that in this specific subpopulation, on the primary endpoint for the entire study, which was a 2 point improvement in ordinal score at day 14. Statistically significant results were obtained. Significant significance with P is less than a reglow.05. And very importantly, the rate of hospital discharge by day 14 was significantly higher with selinexor stopped requiring supplemental oxygen more rapidly than those on placebo and could leave the hospital sooner.
Finally, while all patients entering the study were required to have positive SARS CoV-two PCR results, conversion to SARS CoV-two PCR negative status was significantly higher on the selinexor arm as compared with the placebo arm across the entire population. Fatalities were similar in the subpopulation mentioned above. While the rate of fatalities in the study were imbalanced in the patient 75 years or older, or with a COVID GRAM high risk score, the DSMB considered that all deaths on the study were due to severe COVID-nineteen disease and or underlying comorbidities without a clear contribution continue the current trial and plan to analyze the data to further characterize the specific subpopulation that will likely benefit from selinexor. We plan to work with the FDA and other regulatory bodies to identify a path forward for future clinical development, even these initial positive findings. Furthermore, we plan to engage with potential partners and seek external funding to advance future clinical development in COVID-nineteen.
Before turning the call over to Mike Mason, I do want to take a moment to sincerely thank all of the patients and investigators who participated in this study support of our collective efforts to make a positive difference in the ongoing pandemic. With that, I'll now turn the call over to Mike for a review of the financial Mike?
Thank you, Michael. Since we
issued a press release earlier
today with the full financial results, I will just focus on the highlights, which began on Slide 14. Net product revenue for the second quarter of 2020 was $18,600,000 and total revenue was 33,500,000 As previously mentioned, 2nd quarter sales were driven by patient demand from academic and community based positions with minimal channel inventory build in the 2nd quarter. Related to our DLBCL launch in late June. The estimated gross to net discount for Expovio in the second quarter was approximately 16% We continue to expect the gross to net discount to fall between 15% 20% throughout the remainder of this year. Research and development expense for the second quarter quarter of 2019.
The increase in R and
D expenses compared to the second quarter of 2019 was mainly due to the rapid initiation and enrollment in our COVID-nineteen study, which as discussed, will now be discontinued, and we expect R and D costs to be relatively consistent for the remainder of 2020 on a quarterly basis. For the second quarter of 2020, SG and A expense was $30,800,000, compared to $24,700,000 for was primarily due to activities to support the U. S. Commercialization of Xpovio and preparations for the launch of Xpovio as a treatment for patients with relapsed or refractory DLBCL. Cash, cash equivalents, restricted cash and investments as of June 30, 2020, toll $348,200,000 compared to $265,800,000 as of December 31, 2019.
Based on our current operating plans, we expect our non GAAP R and D and SG and A expenses, which exclude stock based compensation expense for the full year of 2020, to be in the previously projected range of $240,000,000 to $206,000,000. In addition, as shown on Slide 15, we currently expect that our existing cash, cash equivalents and investments and the revenue we expect to generate from Expavio product sales, will be sufficient to fund our planned operations into the middle of 2022, which puts us in a terrific position to further advance our strategic aspirations. I'll now turn the call back over to Michael for some concluding remarks. Michael?
Thank you, Mike. Before moving to the Q and Let me highlight some of the key clinical and regulatory milestones that we expect for the remainder of 2020 shown on Slide 16. As you can see, We have done a terrific job so far in 2020, achieving many of the goals we set forth at the start of the year, but we have some important goals still to accomplish. First, we plan to submit additional storm data and the full Boston data to EMA in the coming months. We hope to have greater clarity on the timing of future EMA regulatory decisions following feedback from the agents.
Next, we expect to share top line Phase III data from the Seal study, evaluating selinexor and liposarcoma. Assuming positive results on the primary endpoint of PFS, we plan to file subsequent regulatory submissions. And finally, we anticipate initiating a confirmatory Phase III study of Xpovio and DLBCL in support of our recent accelerated approval. And of course, we will work diligently through the remainder of the year to support our sNDA based on the Boston study, as well as explore potential next step for selinexor development in patients with severe COVID-nineteen. As we look forward to the next several years, These include uterine cancer with the ongoing Phase 3 SIENDO study, glioblastoma multiformity, both alone and in combination, colon cancer and lung cancer.
We appreciate your ongoing support and look forward to keeping you updated on our 2020 progress. I'll now turn
questions. The first question comes from Maury Raycroft with Jefferies. Please go ahead.
Hi, good morning, everyone, and thanks for taking my questions and congrats on the progress. I had a question about the COVID-nineteen study So for the, the less than seventy five year old patients that are gram, non high risk, patients, where you saw this benefit. Can you go into more details on what you know so far about, how other medications or treatments could have impacted results And then it seems like this is the larger population of COVID-nineteen patients. Do you expect, additional funding and support come from an external pharma partner or would it be from governments?
Yes, the second part is we're ongoing and expect additional discussions, for all options in terms of next steps. Given all of the things on our own plate in oncology, We believe these strong proof of concept results will lead to some kind of a partnership to make sure this moves along, but we don't we will not be able to fund that. In terms of the risk factors for response or if you will, or better prognosis with selinexor, So far, we've not found that prior therapy, really impacts the outcomes in this population where there was a significant benefit. In fact, what was, I think more surprising was many of the patients we received, including in that, that particular group had already gone through and were worsening on the available therapy. So we kind of got a relapsed or refractory population.
But so far, there's no specific prior therapies that mattered. And that's somewhat consistent with the novel mechanism of selinexor in this disease.
Got it. And maybe one quick question on the commercial update. So you mentioned the new package sizes Can you just go into any more specifics on how the DLBCL package size could impact multiple myeloma? And then for inventory, if you can provide any more specifics on what you saw in inventory this quarter.
Sure.
Can we
take that, Michael? Yes. We introduced 3 new package sizes at the end of this quarter to match the label dosing requirements for patients with DLBCL. So we introduced a 60 milligram twice a week, a 40 milligram twice a week,
kind of
40 milligram, once per week to address the patient dosing within the context of the package insert. Of course, these package sizes could also be used if a doctor chose to use them in the context of multiple myeloma also. That those 3 package sizes were specifically introduced to address the need in DLBCL. And I'll turn it over to Mike to address the inventory.
Sure. So, we reported $18,600,000 in sales for the quarter. About 5% of that was inventory build related to the DLBCL launch. To the approved so late in June 95% was driven by patient demand.
Great. Thanks everyone.
The next question comes from Mike Ulz with Baird. Please go ahead.
Hey guys, thanks for taking the question and congrats on the progress as well. Just a question on Expovio, I guess, just post presentation, the Boston data at ASCO, maybe you can provide some color on the types of feedback you've gotten from there? And then separately, have you noticed any increase in off label use post ASCO presentation?
Yes. Thanks, Mike. Look, the feedback has really been uniformly very positive. I would say there's sort of several camps out there. There were the people that always believed and were early adopters that were, very gratified to see the results and so they were not surprised.
Were the people that were somewhat on the fence and using the drug more cautiously. We're quite excited and actually impressed with the, with the drug. And then the group of people that were really skeptical and perhaps not using the drug yet, all sort of nodded and said, it's time to learn how to use this drug. And you can easily see some tweets, for some folks that have sort of converted and they are using the drug. It's very difficult to tell, how the drug is being adopted immediately.
We suspect that there there may be increased use in combination. But in general, the use is in the patients who've already gone through the available therapies. And are in need of something new. The good news is that the once weekly combination therapy does seem to be well tolerated. And, we do believe there's some increase you to that.
But again, it's in the advanced refractory population. We have submitted to NCCN guidelines, and we're awaiting, responses from the MCCN and hopefully we'll be able to see adoption of Boston regimen and earlier lines of therapy. And of course, the PDUFA date early year.
Question comes from Peter Lawson with Barclays. Please go ahead.
Just maybe around, kind of the impact of COVID and any of the dynamics you could talk through around new script growth, patient growth, and level of discounting would be much appreciated around the quarter.
John, you want to take that?
Sure. Two parts of that. First, I'll address the new patient growth. We continue to add new patients each quarter. One of the key drivers of our sales, especially when you consider that some patients will also come off exposure therapy each quarter.
We're encouraged by recent trends and new patient starts we don't break out our sales figures by the new patient starts compared to existing patients. What we did see in Q2 was increasing total demand, as mentioned earlier, up 12 percent even in the context of the full, even in the context of the pandemic. The increase was driven primarily by multiple myeloma as the new DLBCL indication was approved at the end of the quarter. In terms of the impact, the COVID 19 pandemic on our commercial efforts. We believe the COVID-nineteen impact is having multiple effects.
As reported by many other companies as well on secondary data sources, patient visits to their doctors continue to be lower than pre pandemic levels, in the context of this environment, we were pleased to be able to grow demand for Xpovio in the quarter. We've also seen as an impact in person visits by our sales force, nurse liaisons and payer teams to be extremely limited. Based on secondary data in our own experience, we estimate only about 18% of HDPs can be seen in in person visits. We've also seen, of course, ASCO was virtual this year, which limited the ability to have a number of engaged with academic and community based oncologists. We are doing a number of things specifically to offset the impact of being virtual continuing to grow Expovio back to the DLBCL launch we planned on and executed a virtual launch.
We've increased our level of non personal promotion and digital content, including implementing virtual meeting technology for field force engagements, launching email and mail campaigns, direct to professional and through the field force, increasing search engine marketing spend for both HCP and patient audiences, increasing media placements, launching new websites and executing Xpovio education at the point of diagnosis in EMR system. So just some examples of things we're doing to offset the ongoing impact from the COVID-nineteen pandemic.
Got you. Thanks. And then Did you get any sense of where study has been used in DLBCL and multiple alignment? What lines?
Sean? So as Michael
just mentioned before, we see the most use of Xpobio in the context of the indicated lines. So in the context of multiple myeloma, most of the use is in that petro refractory setting where indicated, And while we just have limited data given the early launch in DLBCL, we see it being used there in after 2 or more lines of therapy where it's indicated as well.
Great. Thank you so much. Thanks for taking the questions.
Thanks for your questions, Peter.
The next question comes from Eric Joseph with JP Morgan. Please go ahead.
Hi, good morning guys. Thanks for taking the questions and really appreciate all the, added commercial color on Xpovio today. I'm just wondering if you could comment on the latest trends in terms of, discontinuation in the myeloma indication, how that's split between progression of disease, versus tolerability and whether you see much more headroom to expansion of time on therapy, from the current duration here at 2.7 months.
Hi, John. I'll take that.
Yes, thanks for the question, Aaron. The discontinuation rate due to adverse events remains 13% same number we reported last quarter since our launch. We attribute this in part due to the emphasis our commercial organization has had in discussing with physicians and their teams, the proactive measures that can be taken to prevent and mitigate some of Xpovio's potential side effects, particularly the recommended supportive care guidelines and dose occasions included in the product label. We've also enhanced we also offer enhanced nurse service offerings through our specialty pharmacy partners to ensure patients have a positive experience with Xpovio. And additionally, we're finding that physicians as physicians gain more personal experience with Xpovio they're becoming much more familiar with how to best support, keep their patients on therapy.
In terms of the duration of therapy, We would expect that as a proactive group of patients to continue to improve over time as we would expect longer duration of therapy in the DLBCL patients. And then with the future indication pending FDA approval, longer duration of therapy in earlier stages of myeloma.
Of course, got it. Okay. And just a housekeeping question here regarding the provided cash guidance. Can you talk a little bit about what that anticipates in terms of exposure sales in 2021? Thanks.
We're not going to give a specific number for 2021 sales, but obviously includes you know, the currently approved indications, and then obviously at some point, if
all goes well, Boston
approval. Which we predict the dates March 2021.
Yes. Okay. Got it. Thanks for taking the questions guys.
The next question comes from Jonathan Chang with SVB Leenick. Please go ahead.
Good morning and thanks for taking my questions. First question, can you provide any color on what the outstanding questions and re monitoring data are from the European regulators?
Yeah. I mean, they were just requested that all efficacy data, be re monitored for all the responders. And, and it's not an unreasonable request. The problem we ran into was in something that would have normally taken 4 to 8 weeks, was impossible during during the COVID problem because a lot of the sites were completely shut down with zero access at all. So we're just providing all efficacy data and any updated data that are available for those patients who responded to the drug and that will all be completed and submitted in September.
Got it. Thank you. And second question for the Xpovio launch Do you have a sense of whether things were trending up in July versus June? Are there any metrics you can share with us today?
Yes, I mean, I think what we would say is, again, we tend not to, project monthly data, but certainly, with the law. Certainly, there's a lot of positive momentum, and we're without doubt seeing prescriptions generated from the DLBCL indication. So certainly, we are seeing more patients coming into the system in July the June, certainly by the fact that we now have DLBCL patients being prescribed in Expobo. But I would say in general terms, we continue to be pleased with the momentum, that we're seeing based on the approval in DLBCL, the BOSTON data being presented, and EXPLOYEO being added to NCCN guidelines. Etcetera, etcetera.
And we think that that momentum will continue to build as we get out into the second half of this year and into early next year, with the progression of publications, medical meetings, as well as hopefully an approval by the first quarter of next year.
The next question comes from Brian Abrahams with RBC Capital Markets. Please go ahead.
I was wondering if you could talk a little bit more about maybe how the FDA's views on Xpobio's benefit risk profile, maybe evolving at all, following the Boston presentation and submission, now that randomized, detailed safety and efficacy data are available, Do you expect we could see label expansion even sooner than the standard review PDUFA in March? And then we're also curious about the potential timeline and impact you might expect from getting on the NCCN guidelines? Thanks.
Sure. I mean, look, we recognize we all recognize the FDA is inundated and they're under the same difficult working conditions that the rest of us are in. So they have a lot on their plate, myeloma with 1 to 3 prior therapies has always been a standard review time. But we're hopeful that our rapid responsiveness to their information requests and their strong knowledge about Xpobio in both myeloma and DLBCL will help facilitate the review. And of course, we're hopeful they can get it done sooner.
But right now, we have to stick with the PDUFA date. Remember that for the original approval for storm, they did look the early data from Boston and those data, which we were not aware of, have clearly borne out. And, so I guess they're probably gratified that they followed the phase 3 trends back then. And, we think that they will, they have now felt comfortable with their decision to get this drug out 1, but 2, accelerated approvals. In terms of the, the code, the NCCN, situation.
We've submitted to the NCCN, and we're hopeful that we'll see action from the NCCN sooner. Interestingly, we submitted our DLBCL data at approximately the same time and that immediately moved onto the NCCN guidelines. It really is myeloma just dependent upon the myeloma group at NCCN getting together and rendering a decision.
Really helpful. Thanks a lot.
The next question comes from David Leibowitz with Morgan Stanley. Please go ahead.
Would you be able to
give us any thoughts on cadence of Exposvio sales going into the second half of the year?
John, Mike? Yes, I
mean, I think what you saw in Q2 with the, the $18,600,000 of revenue, about 95% of that as we mentioned was demand versus 5% was channel. And we expect, the launch to continue strong, and the sales in the second half of the year, but we're not going to give specific, color, as far as numerically on the call.
And with respect to the upcoming liposarcoma data, could you tell us, I guess, run us through what your expectation for that study is given, what occurred in the phase 2 part of the trial. And what your thoughts are on what that data might mean for the broader topic of solid tumors?
Yes, I think this, the, importantly, this is a strategic, not a shift, I would say, but it's definitely a focus area that we'll be focusing considerably more of our resources and solid tumors. And liposarcoma represents an extreme unmet medical need, relatively small population def differentiated liposarcoma, but unfortunately, pretty much uniformly fatal. And only chemo enteral chemotherapies are available. There's no oral treatments there. So demonstrating activity in these very large tumors that are chemo refractory, we think is an excellent precedent and an excellent first first potential approval for Xpovio into solid tumors.
The phase 2 study, as you may recall, showed a hazard ratio of just shy of 0.7 which is what the phase 3 was powered to do. And we hope to see a similar kind of result. And if we do, then we will be filing that to both the U S and other regulatory bodies. And we think that this will be an important drug for liposarcoma and our and also in general, showing that expovial has activity, not only in hematologic malignancies, but also in solid tumors, particularly chemo refractory tumors. Following that, we have our SIENDO study, that should read out the end of next year.
In uterine cancer in the adjuvant setting. So that's after 1st line, completion of chemotherapy. And then, to try to delay progression after chemotherapy in patients with advanced uterine cancer. And we have additional trials ongoing in glioblastoma with multiforme, both now in the frontline in combination with radiation plus or minus temozolomide and in the second line in combination with alkylator therapy. We have additional, studies that are also ongoing now, both investigator and company sponsored in colorectal cancer.
And in lung cancer, and we hope to be sharing some additional data in other solid tumors towards the end of this year. So long story that the company will be focusing to a large extent on solid tumors while continuing to move expeditiously in both myeloma DLBC UCL.
The next question comes from Ed White with H. C. Wainwright.
So maybe just staying on solid tumors Michael, if you can just give us,
a little update on
the glioblastoma trial. You had the 1st patient enrolled in June. Can you give us any further enrollment update or timing to the phase 1 data? And then also on the colorect cancer and lung cancer studies, in Israel, just, are they progressing? Has there been any impact on any of these studies for with the COVID pandemic?
Thank you.
Yes, I'll turn that to Shahram.
So the study is progressing nicely on all three arms that Michael just mentioned in the in the newly diagnosed first line as well as in patients that have a current GBM. And we hope to be able to present the results on this study scientifically next year.
Okay. Thank you.
The next question comes from Arlinda Lee with Canaccord. Please go ahead.
Hey, good morning. It's Ben shim calling in for Heartland. Thanks for taking my questions. Congrats on the strength of ex Covia sales, and we really appreciate all the details that you guys provide on sales metrics. Just two questions.
Have you rethought or are you thinking about your EU commercialization strategy in oncology to keep partner? And I'll ask my follow-up after that.
Chris Permian, I'll take that. Sir, hey, Ben,
you know, it can be hard to keep satisfying incremental updates when it comes to these types of things. But as you know, we continue to assess numerous options for potential commercialization in Europe. Now that we've regained the development in commercial rates in Japan, we think those potential options for us have increased One option and probably the most likely one that can involve a partnership. In this scenario, we'd look for a partner and a partnership that is mutually beneficial for both parties maximizing the potential of selinexor in the European market. We've said often that we're looking for a partner who aligns with our philosophy regarding our long term development and commercialization plan for selinexor, and has the expertise in marketing hematologic malignancy drugs in the EU.
And then obviously, building towards a solid tumor presence as well. The second option could be to potentially launch Selinexure on Selinexor on our own in select European countries where, reimbursement negotiations and decisions typically occur more quickly and at accessible levels. But in either scenario, our belief is that the value of selling or will build over time, particularly as we progress through the regulatory process in myeloma. And just as an aside in myeloma, Obviously, the most significant opportunity in Europe will come following a potential approval, based on the data from the BOSTON study. And I just also know that there are opportunities to leverage approvals in the U S for paid new patient programs in certain territories where we wouldn't anticipate any impact to reference pricing.
So we may also, avail ourselves of these opportunities as well, subject, of course, to the always evolving, global pricing and reimbursement landscape.
Great. That's very helpful. I'm switching gears to COVID-nineteen and I guess some of this may touch upon potential partnering in oncology. Will you be pursuing emergency youth authorization here in kind of wonder what the implications will be for pricing, both in a pandemic and a post pandemic world?
Yes, I think both of those questions and parts are a little premature. I mean, our intention is to demonstrate prospectively that we have this what appears to be a significant benefit. Now in this specific subpopulation, it's important large subpopulation. And once we get there, we'll work with, all of the different constituents to do the right thing. And this is not a time to start playing around.
People are suffering greatly, and we'll do the right thing. But we've got to demonstrate prospectively that this is correct. And replicate the results, and then we'll move ahead. And I we don't believe this is a low dose of selinexor. It's 20 milligrams, given three times a week.
We don't believe this will have implications for the, for the oncology franchise.
Okay. Thanks very much for the color and good luck to you guys.
Thank you.
This concludes our question and answer session. I would like to turn the conference back over to CEO, Michael Kaufman, for any closing remarks.
Thanks very much, and thank you all for joining today's call. We look forward to updating you on our progress in the future.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.