Q3 2022 Karyopharm Therapeutics Inc Earnings Call
Yeah.
Good afternoon.
My name is Jason and I'll be your conference operator today at this time I would like to welcome everyone to carry a farm therapeutics third quarter 2022 financial results conference call.
There will be a question and answer session to follow please be advised that this code is being recorded at the company's request. If you. If you require operator assistance. Please press Star then zero on your telephone keypad.
I'd like to turn the call over to Alan Weber Senior Vice President of Investor Relations.
Thank you operator, and thank you all for joining us on today's conference call to discuss the cattle farms third quarter 2022 financial results and recent company program.
Today I'm joined by Richard Carlson, President does seal, so higher Chang Chief commercial officer, Dr duration, Myron Rolla, Chief Medical Officer, and Mike Mason, Chief Financial Officer.
Today, we issued a press release detailing carrefour on financial results for the third quarter 'twenty to 'twenty two.
This release, along with a slide presentation that we will reference during today's call are available on our website for todays call as seen on slide to Richard who will start with some opening remarks Sarnia will provide the commercial update Dan raised my will provide an update on our clinical development programs.
Mike will then present an overview of.
Financial highlights from the courtyard and Richard will end with some closing remarks before opening the call up for questions.
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 provisions under the private Securities Litigation Reform Act of 1995 as outlined on slide three.
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 have.
May make with the FCC 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 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 subsequent to today.
In addition, we will also be providing on this call I'll look for non-GAAP , R&D and SG&A expenses for 2022.
We are not providing recourse tiliaceous off these forward looking non-GAAP measures because projections all stock compensation expense, which is required for such reconciliations are not available without unreasonable effort.
I will now turn the call over to Richard Please turn to slide four.
Thank you Alan and good afternoon to everyone joining us on the call and webcast today I'm excited to provide an update on our plan as we continue to execute on our growth strategy through our focused pipeline targeting life threatening cancers.
Turning to slide five.
Carrier farm was founded in 2008, as an innovation and patient focused company.
Eloping first in class oral selective inhibitors of nuclear export which target <unk> one.
Mediates multiple processes integral to cancer cell growth.
Fast forward to carry a farm today, where we are successfully leveraging that fundamental mechanism of action to build upon our existing auto myeloma franchise anchored around our commercial drug exposure.
<unk> footprint now reaches 40 countries and combined with increasing use in earlier lines of therapy in multiple myeloma. We are currently expecting total revenue of between $155 million to $165 million in 2022.
We are working to expand indications through advancing our focused clinical pipeline.
This pipeline is comprised of mid and late stage clinical development programs.
It is being purpose built and strategically focused to help patients who suffer from cancers with high unmet need.
To demonstrate efficacy at lower doses with improved tolerability.
And where we believe we will have the highest probability of success.
To lead us in delivering our targeted mid and late stage clinical pipeline.
With a strength and leadership team in place. We believe we can achieve both scientific and commercial excellence, while executing on our key corporate objectives.
But now turn to the third quarter of 2002.
Which was marked by several meaningful achievements as outlined on slide six.
And Q3, we saw <unk> net product revenues of $32 million what's.
Which translated to a 20% year over year growth compared to Q3 of 21, despite an increasingly competitive multiple myeloma market.
We continue to see increasing use of exposure in earlier lines with strong growth in the community setting.
Honea will provide more detail in a moment.
Internationally next Poggio received full marketing authorization in July 22 from the European Commission for the treatment of patients with multiple myeloma after at least one prior therapy.
This has opened the door for recent commercial launches in Germany, and Austria by our partner men or any important steps forward for patients in Europe , where nearly 51000, new cases of multiple myeloma are diagnosed each year.
With patient access for Selinexor, starting to expand across the world, We expect revenues and X U S territories to have an increasing contribution to total selinexor revenues in the future.
On the clinical side, we are delivering on our focus pipeline give.
Giving the meaningful improvement in PFS observed with Selinexor, an exploratory TP 53, wild type subgroup on our <unk> study.
We are excited about the initiation of our pivotal phase III study.
This study will utilize foundation medicines tissue base next generation sequencing test to identify this important group of patients.
As highlighted in the Ash abstracts released today, the combination of Selinexor and Ruxolitinib evaluated in the phase one export MF all three four study continue.
Continues to demonstrate compelling activity and.
<unk> will provide more detail on this momentarily.
In addition, we were granted Y-you orphan medicinal product designation for Selinexor.
For the treatment of myelofibrosis in Europe .
And my oldest plastic syndromes after completing enrollment in Q2 for the interim analysis and our relapse refractory Mds phase two study.
We are waiting for overall survival data to mature and expect to present data late this year or early next year.
Finally, as Mike will provide more detail later in the call and the third quarter, we continued to execute on our cost reduction initiatives in line with the evolution of our focused and prioritized pipeline.
As we now turn to slide seven.
I'd like to turn the call over to so honea for her review of the commercial performance for the quarter. So Anya. Thank you Richard and good afternoon, everyone.
I am pleased to talk about the growth story of <unk>, the first and only drug in the novel class assigned therapy and a key combination partner in the second to fourth line multiple myeloma, setting and and evolving marketplace.
Turning now to slide eight and a commercial highlights for the third quarter of 2022 net product revenue grew by 20% versus the same period last year, and we continue to make progress across key indicators.
Team executed with strength to access and educate our physician community, resulting in the growth of both new patient starts and prescription refills.
We continue to make progress with our primary growth driver and what we believe is most important to patients which is the continued shift <unk> into early aligned with over half of our patients in the second to fourth line.
In fact during the first half of 2022, we were the fastest growing brand in third line multiple myeloma.
As patients move into earlier lines, and physicians gain experience and confidence using <unk> at the new once weekly lower dose we.
We see that patients have continuing to stay on therapy longer.
As we have seen increasing competition in the late lines setting at academic centers with new approvals and ongoing trials. Our focus remains on expanding the use of <unk> in the community setting, which contributed over 65% of our business in Q3.
With our continued focus on growing both breadth and depth prescribing accounts.
In Q3, we reached the highest number of total prescribing accounts since the launch of <unk>. Two thirds of these accounts were in the community setting.
Our focus is to continue to expand breath of use while leveraging this broad base of accounts and building upon their positive experience to drive that.
We continue to see a positive shift in the perception of <unk> and the second to fourth line per I intend to prescribed data due to the growing confidence among physicians in using the lower dose once weekly Expo via bass triplet regimen with approximately 93% of patients now starting on 100.
Billy Graham weekly dose or less.
This evolution since I first approval from higher to lower dose and from late to earlier line youth is one that we have seen with many other myeloma therapies.
The growing marketplace experience, we see with exposure you at lower doses is enabling better patient experiences and adherence to therapy.
Ray smell will expand upon our ongoing development and dose optimization plans for Selinexor.
As we look to the future growth potential of exposure within an evolving multiple myeloma landscape.
It is clear that continues to be a high unmet need both in the near made an longterm.
First as the anti C. D 38 class moves to the front line, there's a significant need for a class switch to a novel therapy for patients who progress on an anti C. D 38 therapy.
Unlike many other myeloma agents, we have generated data from our Boston study in the post anti C. D 38, setting and we continue to generate more data across multiple settings and the second to fourth line.
Second while new therapies continue to emerge many of them are expected to enter in the late lines setting with patient Tolerability and accessibility in the community, becoming an increasing challenge.
Our focus remains on growth in the community setting and positioning Expo <unk> and second to fourth line as a novel class of therapy that is effective.
Easily combinable and a convenient oral regimen with a manageable safety profile.
With that please advanced to slide nine and I will turn the call over to <unk> to review our clinical pipeline progress.
Thank you so <unk> before I go into more detail unplugged programs I would like to highlight Hello, how we have been working to optimize the dose of Selinexor and how it relates to our ongoing clinical development programs on slide 10.
So how you mentioned due to the growing confidence amongst physicians and using the lower once weekly dose of <unk> <unk> bass triplet Regiment.
Patient and physician experience as well as adherence is improving.
Since <unk> was launched in 2019, we have utilized real world experience, coupled with observations from a clinical trials to demonstrate that lower doses of selinexor can.
Can optimize the patient benefit by improving as Tolerability, which will ultimately allow patients to remain on therapy longer improving their overall benefit.
As a result, all of our ongoing clinical trials incorporate selinexor doses X 40 to 60 milligrams weekly, which is a quarter to less than half of the originally approved dose of 80 milligrams twice quickly such dose optimization will further enable our opportunity to accelerate new approvals in the next two to four years.
I'm quite 11, and I would like to highlight the advancements we have made in our development pipeline, which include initiation of the phase three E. C. O four two trial and women with endometrial cancer and completion of enrollment in the phase one portion of the M. S O three four trial.
And our <unk> program, we have stopped enrollment on the phase one combination trial and treatment naive N D. S. So that we can reevaluate the combination regimen can.
And we have completed enrollment in the interim analysis and a relapse refractory program and are awaiting for overall survival data to mature.
Now as we turn to slide 12, I would like to discuss the unmet need an endometrial cancer and why we find this opportunity so exciting for women and do Metrial cancer is the most common form of gynecologic cancer in the U S with approximately 50% of advanced a recurring tumors classified as T. P 53 wild type.
Second the current treatment landscape for advanced or recurrent endometrial.
Cancer consists of the first line chemotherapy.
Upon completion of chemotherapy the N C C N guidelines recommend a watch and wait approach until disease progression.
This approach clearly needs improvement given that the five year survival rate in this patient population is only 17%.
<unk> is administered orally and maintenance therapy as well established in other cancer types. We believe selinexor has the potential to offer a maintenance option.
Could sustain the response from chemotherapy and improve the overall clinical benefit for these patients.
Please turn to slide 13 presented I'd ask of 2022 with a subgroup analyses in molecular classification data from <unk> study evaluating sullen excellent endometrial cancer as a maintenance therapy.
Previously disclosed this analysis indicated that patients whose tumors were T. P 53, wild type and treated with Selinexor demonstrated a median progression free survival of 13.7 months compared to 3.7 months for patients treated with a placebo in contrast patients whose tumors are either T. P 53 mutant or a.
<unk> and treated with Selinexor demonstrated a median P. F. S. A 3.7 months compared to 5.6 months for patients treated with placebo. These data suggests that T. P. 53, wild type has the potential to be a robust biomarker and selinexor may provide a meaningful benefit to patients with T. P 53, wild type and <unk>.
<unk> Sir.
We are very encouraged by the hypothesis generating data gain from RCN to study and are eager to study selinexor further in the T. P 53 wild type population.
Cause you can see on slide 14, we are excited to announce that we have initiated the phase three maintenance study designed to evaluate the efficacy and safety of Selinexor and T. P 53, wild type patient stage for a recurrent endometrial cancer and expect to just the first patient in the <unk> in the fourth quarter.
This study will utilize foundation medicines tissue based next generation sequence test to identify patients and enroll.
Approximately 220, women, whose tumors or T. P 53, wild type pace.
Patients will be randomized in one to one man or to receive either once weekly selinexor at a dose of 60 milligrams or placebo studies primary end point is progression free survival with the keys secondary endpoint of overall survival. The study is a collaboration between carry a farm and in God The European Network <unk>.
Clinical logical oncological trial Grits M. G O G. The gynecology oncology group data from this study are expected in 2024 and could represent a paradigm shift for women with endometrial cancer.
If you would now turn to slide 15, I would like to highlight are rapidly advancing myelofibrosis program and the current treatment landscape <unk>.
<unk> is the current standard of care for newly diagnosed might've fibrosis. However, only approximately 40 per cent of patients respond to frontline treatment once patient stop responding the expected median survival is approximately 14 months and the five year survival rate is only 18%.
There was a clear unmet need for a novel new mechanisms both in the frontline and relapse refractory setting as no other drug classes other than Jack inhibitors have been approved in the last 10 years.
Selinexor has the potential to be a convenient and safe and effective oral treatment for frontline and relapse refractory patients.
On slide 16 is a novel agent targeting X P. O. One Oh next door has the potential to mediate relevant factors beyond the jacks that pathway, which can enhance or complement the efficacy of Jack inhibitors and can also serve as a single agent and Jack resistance cells.
On slide 17, the phase two essentials study evaluated single agent Selinexor in patients who received prior Jack one or two therapies 40 per cent of patients achieved a screen volume reduction of 35% or greater following at least 24 weeks of treatment. The two year probability of survival was 92%.
To put these data into context currently available therapies in a similar patient population lead to a screen volume reduction of 35 per cent or greater and only approximately 15% of patients. Furthermore.
Furthermore, in the essential trial, we observe positive impacts on hemoglobin levels, including 50 per cent of patients achieving either stable or improved hemoglobin levels or transfusion independence as well as hemoglobin increases by at least two grams per deciliter and 65 per cent of patients.
Contrast, this with other approved agents in which anemia, often worsens on therapy. In this study selinexor was generally well tolerated with a medium treatment duration of 11 months.
Although the Essentials study is small and the data are still a preliminary the results until them compelling nonclinical in preclinical data by demonstrating monotherapy activity and highlights the potential of this novel classical therapy to improve outcomes, including durable screen volume reduction and maintaining or even improving hemoglobin levels.
Turning now to slide 18, we continue to enroll her most advanced myelofibrosis study the ongoing space to M. F. O. Three five study and we look forward to reporting our top line results in the second half of 2023.
Study is a randomized open label study evaluating single agent stolen excellent versus physician's choice therapy, and patience with myelofibrosis, who have had at least six months prior treatment with the Jacqueline two inhibitor. The primary objective of this study is to assess SPR 35, Q secondary endpoints include TSS.
50 O R. R O S anemia response and safety.
Turning now to slide 19, here's our frontline Myelofibrosis study if they as one study evaluating the combination of Selinexor N ruxolitinib impatience with the treatment naive myelofibrosis.
In this study we completed enrollment at the phase one portion and does 24 patients our objectives for this study are <unk> explore the combination of Selinexor Ruxolitinib building on the single agent activity of both of these compounds given.
Given the potential synergism between these two drugs, we believe that the combination of Selinexor plus ruxolitinib has the potential to improve upon key efficacy parameters, including rapid spleen reduction symptom improvement hemoglobin stabilization and overall survival. We are looking forward to advancing combination into the <unk>.
Registrational portion.
Turning to slow 20, I am delighted to share updated results published in the Ash obstruct earlier today based upon the July data cut 79 per cent of Evaluable patients achieved a 35% or greater screen volume reduction at week 12 in 86 per cent of the valuable patients achieved to 35% or greater spleen volley.
Production at week 24. In addition, 69% of the valuable patients achieved a 50% or greater reduction of their total symptoms score at week 12.
And finally, a 65 per cent of transfusion independent patients, but at least eight weeks of treatment maintained stabled hemoglobin or improved hemoglobin levels last follow up.
These results are notable given that the grade three four anemia rates observed with the combination we're only 21% compared to the 45 per cent observed with Ruxolitinib alone.
The combination of Selinexor and Ruxolitinib was generally well tolerated and had a manageable safety profile with the most common reported great three four adverse events being thrombocytopenia anemia and neutropenia.
The hematologic adverse events were reversible with just interruptions and reductions that occurred with both Ruxolitinib and Selinexor <unk>.
Current observations suggests that the rates and grades of adverse events are dose dependent.
In light of the meaningful impact we're seeing in patients across all relevant advocacy parameters combined with a manageable safety profile. All investigators are Gary encouraged and enthusiastic about the potential of this novel combination for treatment naive mild fibrosis patients. We look forward to presenting further updated resulted ash with a longer follow.
Oh up an additional patients and the 40 milligram dose arm, we will be hosting a webcast at ash to discuss these data with investors.
With that I'll know advance to slide 21, and turn the call over to Mike to review the third quarter financial highlights Mike.
Thank you <unk> since we issued a press release today with the full financial results I will just focus on the highlights which begin on slide 22.
Total revenue for the third quarter of 2022 was $36.1 million compared to $37.7 million for the third quarter of 2021, which included a 9.8 million dollar milestone from antigen.
With increasing approvals and commercial launches for stolen extra globally, we expect milestone the royalty payments by our partners.
To deliver a larger contribution to our total revenues in 2023 and beyond.
That product revenue from U S commercial sales of exposure, though for the third quarter of 2022 was 32 million compared to 26.7 million for the third quarter of 2021.
Representing a 20% increase year over year.
The girls can of discount <unk> from the third quarter was 18 per cent. We continue to expect gross can a discount to be in the 15 to 20 per cent range for the full year 2022.
We recognized 4.1 million of license and other revenue from the third quarter of 2022, which includes 2.4 million earned in royalties from our partners and $1.4 million earned and reimbursement of development expenses.
R&D expenses for the third quarter of 2022 or $31.4 million.
Compared to 45.8 million for the third quarter of 2021.
The decrease was primarily driven by the recognition of 7.4 million of cops in connection with the acquisition of certain Netflix from new medicines in the third quarter of 2021.
Additionally, clinical trial and related costs decreased primarily due to the prioritization of our core programs in a clinical pipeline.
We continue to expect or 2022, non-GAAP R&D expenses to decreased by approximately 10% compared to 2021.
SG&A expenses for the third quarter of 2022 $34.6 million compared to $35.1 million the third quarter of 2020.
Cash cash equivalents restricted cash and investments as of September 30th 2022 totaled $150.1 million compared to 235.6 million as of December 31st 2021.
Based on our current operating plans, we are reaffirming guidance for the full year 2022.
<unk> <unk>.
Total revenue in the range of 155 265 million.
<unk> on that product revenue of 120 $230 million.
And non-GAAP , R&D, and SG&A expenses, which excludes stock based compensation expense to be in the range of 250 to 265 months.
We initiated cost reduction initiatives in the second quarter that accelerated in the second half of 2022.
Including stopping certain signal seeking programs, such as our lungs and call a rectal cancer studies.
In addition, we have optimized our R&D NGA infrastructure.
And any rules as we continue to align the organization with are prioritize programs.
We continue to expect an overall reduction of R&D expensive approximately 10 per cent in 2022 compared to 2021.
We projected our existing cash cash equivalents in investments as well as the revenue we expect to generate from exposure your product sales and license revenues, including a 20 million dollar cash payment from anther gene that we expect to receive near the end of the year for lipitor milestones that we previously recognized will be sufficient to fund our planned operations.
And two early 2024.
Let's move to slide twenty-three and turn the call back to Richard for some final thoughts.
Thank you, Mike and in closing I would like to thank all of our teams at Carroll farm in our investigators as we work everyday to positively impact the lives of patients with cancer, helping us deliver on our commitment as you can see onside 24.
With that I would now like to ask the operator to open the call up to the question and answer portion of today's call operator.
Thank you I will now begin the question and answer session to ask a question you made for a store then one on your telephone keypad.
Using a speaker phone please pick up your handset before pressing the keys.
At any time your question has been address and you'd like to withdraw. Your question. Please press store then too at this time.
We'll pause momentarily to assembler roster.
Our first question comes from Mardi right Cross from Jeffries. Please go ahead.
Hi, This is Kevin.
Thank you for taking our questions and Congrats me update just a quick question on the myelofibrosis data.
You should 19 patients Semi-abstract and you mentioned that you had the 24 patients.
Could you just say how many of those patients we might say dash and and how many of those patients would be on the 40 milligram.
Dose and and based on what you're saying so far how the dose is influencing safety and efficacy. Thanks.
Okay. Thanks, Kevin I'll turn to a race you meant to go through those those questions Yeah and thank you for the question. So you're correct in the Ash abstract and this is from a July data caught we included 19 patients who received at least one dose the S. C. R data and the TSS 50 day.
Data are from those patients who are efficacy of valuable for both the S. P. R as well as the T. S. S N points. When we look forward to ash, we are going to provide additional updates both in terms of patient numbers as well as follow up and <unk> and.
And expect to provide uhm TSS in S. P. R data on approximately 21 patients from the entire 24 patient cohort in terms of the breakdown between the 40 milligram and 60 milligram doses. So we enrolled 10 patients as part of the 40 milligram dose level.
<unk> and 14 patients as part of the 60 milligram dose level and will be providing safety and efficacy data at ash across those two dose levels and then lastly in terms of a E rates dose dependency you're correct. So this is a phenomenon that we are seeing with.
Selinexor across all of our indications, including endometrial cancer multiple myeloma as well as myelofibrosis and that there is a dose dependency between a E rates grades and you know with the doses and this is again an observation that we're seeing also with the M. F program in which we're <unk>.
Dining with Ruxolitinib.
Great. Thank you and then just to follow up for for the T. S was 50 that you're seeing at <unk>. We saw that there were three out of seven responders I believe in in the abstract say, we're seeing nine and a 13 can you talk about if these are new responders or if this is essentially a D.
Response, and you know and why is the the symptoms for getting better is there any are there any learnings that you can carry forward into future studies.
Yeah. So again, the TSS 50 that we're presenting in ash abstract similar to the ASKO or from the efficacy evaluable patients and we are seeing a very nice improvement in that T. S. S score at week 12 from 43 per cent now, 69% and that includes <unk> symptoms <unk>.
It or deepening in the patient centered initially responded in the <unk> data set as well as the new patients who are responding as well so really very encouraged by these symptoms scores that are occurring as early as T as as weak 12th.
Hi, Kevin.
Thank you.
The next question comes from Colleen.
From our W. Bird. Please go ahead.
[noise] Hi, this is Abby gray on for calling thanks for taking our questions.
First off congratulations on the my <unk> My <unk> update and then I was wondering.
On the T. S. S 50, do you have any update on B T. S. S 50 scores on those patients that have followed up out to 24 weeks and it's not to have any commentary on how the symptoms are changing over time.
Yeah, Great question, So we weren't able to provide the TSS 50 data and <unk> 24, and the Ash abstract you know this is again a July data cut in and Unfortunately, we just had some missing data at that time, but look forward to presenting week 24 data in the ash presentation come December.
And then I have a follow up it looks like the rates of nausea, and vomiting increased from the last update IOSCO. So is there any additional color on the G. I toxicities your theme and is it mostly presenting at the beginning of the study or does that present later and how persistent is it throughout the.
Study follow up Uhm and have you implemented any anti <unk> protocol is to help with that.
<unk>, sorry, any diabetic yeah, I'll help with that.
Yeah I appreciate the question. So you know as you know Selinexor causes nausea. This is an E. E that has been observed in multiple myeloma as well as our other cancer types, including myelofibrosis as well as <unk> as well as endometrial cancer. It's important to note that while we see the nausea this isn't dose limiting for the.
Patients. So we aren't seeing patients who are discontinuing therapy due to the nausea, nor does it limit their ability to stay on therapy. We also see nice improvements as you know in the PSS goopy scores in wallet nausea is not included in that TSS 50 domain, specifically it really is a testament to their overall.
Overall global symptom improvement so it again it does not clinically relevant to this patient population lastly, I'll note, we do incorporate anti <unk> with Selinexor and this is again just a standard mitigation strategy that we use across all of our <unk>.
Programs.
Great. Thank you so much.
Thanksgiving.
The next question comes from Brian Abrams from RBC capital markets. Please go ahead.
Hi, there thanks for taking my questions and congrats on all the progress of continuing on the theme of of the myelofibrosis data as.
As you mentioned that the T. S. S scores looks like the improved versus the last cut and I'm curious what sorts of TSS 50 scores would you be looking for it to be confident that you're getting additive activity over ruxolitinib, just giving me over to the challenges of an open label study.
Yeah, I Gotta say, Brian Oh, we're very encouraged by these data right now as well as the evolution and the TSS 50 over time <unk> as you know, we presented 43% of the patients achieving that TSS 50, and now we're seeing a nice evolution to 69%. So again, we're very encouraged especially.
<unk> when we coupled that with a very meaningful S. P R and hemoglobin stabilization as well as improvement score as well really does suggest that this combination one is added it if not synergistic in combination with Ruxolitinib, we're having meaningful and improvement on all efficacy and points in the context of.
Of a manageable safety profile. So you know again very encouraged by the data so far.
Great and you mentioned that as expected you saw some dose dependents to the the the teller ability profile did you also see a dose dependence related to screen response or T. S. S response.
So those data are maturing and we look forward to presenting that data at ash, you'll ultimately we will identify the recommended phase two dose either 40 or 60 milligrams based upon the totality of data, including safety efficacy and of course pharmacokinetics data.
Great and it made me one last one on on also on M. F. Wondering uhm I think in the past you should've alluded to consistency of response across different patient profiles and risk profiles, just wondering if you're continuing to see that or or if there are any predictors of of who might have the deepest.
Most durable responses here.
Yeah, we are seeing uhm improvement really across all the patient demographics. It's also notable to know that approximately 70 70 per cent of our patients are classified as into our high risks of these really are you know a.
A high risk patient population despite that again, we're really seeing meaningful improvement across all efficacy domains. In this patient population in terms of you know are we seeing anything predictive still interrogating the data, but right now the data again really are very encouraging and we're seeing it across all patient.
Summagraphics.
That's great. Thanks, so much and look forward to the next day today.
Thanks, Brian .
Again, if you have a question please press stores in one.
And our next question comes from Air Joseph from J P. Morgan. Please go ahead.
Good evening, Thanks for taking my questions I guess with the.
And getting more efficient on the R&D spend I'm, just curious to get a sense of.
Whether you see the need to sort of prioritize between.
So what extra development in combination with rugs, <unk> setting versus and the rugs experience population.
I guess ultimately you see both regiment advancing to a later stage development and I guess in.
As it relates to the <unk>.
Is it still a pretty conservative sample size and just wondering if that is is sufficient to make a call on the prospects of potentially advancing the rugs combo, Florida as part of a pivotal study. Thanks.
Yeah, Yeah, Thanks, Eric maybe I'll I'll turn duration ready to talk to that really in terms of the the totality of building. The most of my <unk> I'm, sorry, I didn't have the mild fibrosis franchise, and then I'll come back to talk to the spend.
Yeah, and thanks for the question I mean, I think one of the key differentiating factors for Selinexor is the fact that it has robust monotherapy activity, especially in that relapse refractory patient population. This builds upon preclinical nonclinical data that demonstrates selinexor is.
Active and Jack resistant cells, we see that again in that phase two essential trial.
But that allows us again to be able to develop selinexor in the widest patient pocket population of myelofibrosis really why we are focused on both the treatment naive opportunity in combination with Ruxolitinib, but also as a monotherapy in those patients that have been treated with at least six months prior Jack inhibition.
And we will get our plans Eric in terms of our pipeline. The work we've done I think over the last year and your natural you prioritize the pipeline both the the Rio upsetting in the front lines heading our in our plans moving forward and.
As we're really very encouraged other data is evolving we're excited to keep moving forward with them.
Operator.
There are a number of questions in the queue. This concludes our question and answer session I would like to turn the conference back over to Richard Paulson for any closing remarks.
Thank you everyone again for joining the call today, and we wish everyone a great evening Goodnight.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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