Q3 2023 Karyopharm Therapeutics Inc Earnings Call
Good morning, My name is drew and I will be your conference operator today.
At this time I would like to welcome everyone to the carrier farm Therapeutics third quarter 2023 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.
If you require operator assistance press Star then zero.
I would now like to turn the call over to del Webb Senior Vice President Investor Relations.
Okay.
Thank you and thank you all for joining us on today's conference call to discuss carrier farms third quarter 2023 financial results and recent company progress.
We issued a press release this morning detailing our financial results for the third quarter 2023.
This release, along with a slide presentation that will be the restaurants during our call today are available on our website.
For today's call as seen on slide two I'm joined by Richard duration Master Han Yun, Mike who will provide an update on our results for the third quarter, our recent clinical developments.
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 as outlined on slide three.
Actual results may differ materially from those indicated by these entellus as a result of various important factors, including those discussed in the risk factors section of our most recent Form 10-Q, which is on file with the SEC and in other filings that we may make with the FCC and the <unk>.
P J and yeah, Phil as representing our views as of today.
While we may elect to update these SLS at some point in the future, we specifically disclaim any obligation to do so even if our view change. Therefore, you should not rely on these SLS as representing our views as of any later date I will now turn the slide over to.
Please turn to slide four.
Thank you Alan Good morning, everyone and thank you for joining carrier farms Q3, 2023 earnings call.
Turning to slide five we are strongly positioned for our next stage of growth driven by our focused and rapidly advancing mid and late stage pipeline of innovative first in class oral selective inhibitors of nuclear export their target X P O one.
As well as a strong commercial organization that continues to positively impact the lives of multiple myeloma patients every day.
Our U S and global commercial presence is on track to deliver $145 million to $160 million of annual total revenues in 2023.
And provides us with the capabilities needed to launch in new indications if approved following the outcome of our three pivotal phase III clinical trials.
We have the opportunity to significantly improve standard of care for patients across these indications and we continued to generate compelling data, including impressive durability data observed with Selinexor 60 milligrams in combination with rux and whatnot.
In patients with myelofibrosis.
Why was the substantial progression free survival observed in patients with T. P 53, wild type endometrial cancer.
<unk> will expand upon shortly.
We are committed to deliver on the opportunities ahead of us and believe selinexor could generate approximately $2 billion.
Peak annual revenues in the U S alone.
With a cash runway through late 2025, we have the financial strength to deliver on key data readouts from our three phase III studies.
We will continue to be disciplined about our expense management, focusing our resources on our prioritized late stage pipeline.
As we move to slide six presented here is an overview of the timing of the upcoming key data Readouts, which we expect in 2024 and 2025.
Each of our ongoing phase III clinical trials, if successful represents an incredibly meaningful growth opportunity for our organization with the potential to deliver roughly $2 billion in annual peak revenues.
Our proven and established commercialization in late stage development capabilities are focused on executing with our current label and a rapidly progressing these pivotal phase III programs.
And approval in just one of these three indications as a transformational opportunity for carryover arm.
And the clinical data that ratio I'll review today continues to strengthen our confidence in each of these programs.
With the potential for a pivotal catalyst over the next two years and with the cash runway to deliver on each of these topline readouts, we are well positioned for our next stage of growth.
Moving to slide seven I would now like to turn the call over duration to expand further on our clinical pipeline progress ratio.
Thank you Richard turning to slide eight we have a very promising late stage pipeline with pivotal data readouts over the next two years I will focus on our three phase III trials, where our confidence only grows given a positively evolving preclinical and clinical data that support each indication each.
These trials could position selinexor to substantially change the treatment paradigms in each of these populations if approved.
Turning our attention first to myelofibrosis on slide 10.
[laughter] JAK naive myelofibrosis patients remains an area of high unmet need with more than 20000 myelofibrosis patients in the U S alone.
Russell at Nib remains the standard of care for the majority of JAK naive patients. However, there is an opportunity to improve benefit given that the efficacy with rux I'll, let Ned is limited with less than 50% of patients achieving an SCR a 35 N T. S. S. 50, we are evaluating the potential for Selinexor in <unk>.
Combination with rux, a little <unk> to provide benefit across all of the hallmarks of the disease, including spleen reduction symptom improvement disease modification and stabilization if not improvement outside opinions.
On Slide 11, you see that X P. L. One inhibition is a fundamental mechanism in myelofibrosis given that it targets, both Jack and non JAK pathways, underscoring selinexor is additive or potentially synergistic activity when dosed in combination.
Non JAK mechanisms include inhibition of Nf Kappa beta induction of cell cycle arrest and P. 53, driven cell death, together X P. L. One inhibition increases malignant cell death decreases malignant cell proliferation and reduces inflammation.
We presented updated phase one data at the acetone Ehealth conferences in June 2023, and which can be seen on slide 12. These data show meaningful SVR thirty-five in T. S. That's 50 improvement with 60 milligrams selinexor, including a 79% SVR 35, and a 58%.
T S. That's 50 at week 24 in the intent to treat populations.
Partly amongst the evaluable patients, 100% achieved an SVR 35 at any time.
Today at the N P and Congress data are being presented including SCR response and T. S. F 15 durability amongst the 11 out of 14 patients who achieved a 35% or greater spleen volume reduction at week 24, and the southern out of 12 patients who achieved the P. S. That's 50 at the same time point.
We are very encouraged by these data given the impressive durability as seen on slide 13 for both of these endpoints as of August two 2023, none of the week 24, SVR 35 responders dosed at solid excellent 60 milligrams had observed radiographic progression.
That the longest patients has been followed for 78 weeks and the median duration of follow up as of the data cut off its 32 weeks. Similarly, none of the week 24 T. S. That's 50 responders had observed symptom progression with the longest follow up at 64 weeks and a median duration of 51 weeks wildly.
I acknowledge the apparent limitations and cross trial comparisons contrast, these data to Russell lynde to balloon and which only approximately 70% of responses were ongoing at 78 weeks data for Rux I'll, let Nick P. S. That's 50 durability data beyond week 24 have not been provided these data add to this.
Stansell benefit observed with week 24 F. B R. A N T. S. That's 50 and highlight the substantial benefit that may be observed with this novel combination compared to Russell at Nib alone.
Together these data illustrate the rapid deep and now durable spleen and symptom improvement achieved with Selinexor in combination with Brookville Internet and further demonstrate the potential for this combination to change treatment paradigms for JAK naive myelofibrosis patients.
This profile in conjunction with the subgroup analysis shown on slide 14, which depicts SVR 35 N. T. S. That's 50 responses despite treatment with suboptimal doses of Brookfield, Internet, which is suggestive of a potential monotherapy activity underscores our confidence in the ongoing phase III study.
As seen on slide 15, our phase III study is evaluating the combination of solid extra 60 milligrams with Rockville at nib versus Russell letting up alone and 360 JAK naive myelofibrosis patients. This important trial. In addition to the phase two selinexor monotherapy trial that we are planning and treatment.
I use myelofibrosis patients with moderate thrombocytopenia has the potential to entrench selinexor as a foundational therapy and approximately 90% of all treatment naive myelofibrosis patients.
As we turn to slide 17, endometrial cancer is a key focus in our pipeline given the high unmet need and the substantial benefit observed in patients whose tumors are P 53 wild type.
Advanced and recurrent endometrial cancer, the most common form of gynecologic cancer in the United States with the current treatment landscape being driven by the molecular classifications.
As a result, and MMR deficient patients who represent approximately 20% of all advanced recurrent endometrial cancer patients the new F. D. A approved standard is just starting to map in combination with chemotherapy followed by just starlet map maintenance.
For MMR proficient patients, which represent the remaining 80% of advanced recurrent endometrial cancer checkpoint inhibitors are not approved as such the primary treatment option is chemotherapy, followed by watch and wait.
Importantly, wild type piece of the three is found and a majority of all exams recurrent endometrial cancer as seen on slide 18 taken together patients whose tumors are both MMR proficient and P 53, wild type represent 40% to 55% of all advanced or recurrent endometrial.
Metrial cancer patients in the substantial population the benefit observed with Selinexor is considerable as seen on slide 19, given that is 68% decrease in the risk of disease progression or death corresponding to a hazard ratio of 0.32, and the median progression free survival.
It has not been reached was observed in this exploratory subgroup of patients from the <unk> trial as of March 30th 2023 data cut off the.
The progression free survival results observed in those patients who are P 53, wild type and MMR deficient are also noteworthy with a median PFS for selinexor with 13.1 months and hazard ratio of 0.45.
Further strengthening our rationale in P 53, wild type endometrial cancer are the preclinical data that were recently presented at the ACR NCI E. R. T C International conference on molecular targets and cancer Therapeutics in October.
These data for endometrial cancer models to further confirm the biology by demonstrating significantly better potency and P. 53, wild type models as compared to P. 53 mutant models further validating the design of the ongoing phase III study is shown on slide 20.
D E. C 042 pivotal phase III study is evaluating selinexor as a maintenance therapy in patients with the P. P 53, wild type advanced or recurrent endometrial cancer.
This study will enroll approximately 220 women, whose tumors are P. P 53 wild type ultimately this trial will enable the development of a companion diagnostic and we anticipate the approval of the companion diagnostic put a car at the same time Selinexor if approved the.
The study is a collaboration between carry a farm in and got the European network for Gynecological Oncological trial groups N. G O G. The gynecology oncology group and got in G. O. G include the top opinion leaders in gynecology oncology their participation in the ongoing phase III study.
Further underscore the strength of the data observed in the P 53, wild type subgroups and the potential Selinexor may have in providing a new standard of care to P 53, wild type of endometrial cancer patients.
Together, we are making strong progress and have been intensely focused on activating sites and enrolling patients. We are now expecting topline results in the first half of 2025 with the slight timing shift related to country specific regulatory delays in a few European countries.
As seen on slide 22, we are expanding our multiple myeloma franchise with the ongoing phase III trial that is evaluating selinexor at the low dose of 40 milligrams in combination with the well established backbone therapy of Pummelled with <unk> and dexamethasone.
S. P D. An all oral combination and evaluated after an anti CD 38 antibody has the potential to benefit a significant number of patients across the multiple myeloma and journey.
On slide 23, the phase three trial is enrolling patients with relapsed refractory multiple myeloma, who have received an anti CD 38 antibody is their most recent therapy.
T sell resistance and builds upon the multiple selinexor combinations that have already demonstrated clinical benefit and multiple myeloma.
In summary, we have near term late stage opportunity is supported by compelling data and are rapidly advancing pipeline that will potentially benefit multiple cancer patient populations of high end meant need building an hour approved indications with that please turn to slide 25, and I will now hand, it over to some <unk>.
Tanya for a review of our commercial performance for this quarter.
Thank you <unk> and good morning, everyone on slide 26, I'm pleased to present the progress we have made an author a quarter performance as we delivered sequential growth in net product revenues over three consecutive quarters in 2023 in an increasingly competitive landscape and <unk>.
He shouldn't have free drug throughout patient assistance program.
<unk> delivered 30.2 million in net sales in Q3, and when compared to Q3 of last year net sales was adversely impacted by higher utilization of our patient assistance program due to the impact from Myeloma Foundation closures as we have previously discussed in.
In the third quarter two of the four main multiple myeloma Foundation's we're open and continue to remain open as a result, new patients entering pop have largely normalized although we saw the refill impact of patience already in pop earlier in the year.
Total pop utilization contributor to nine per cent of total demand in Q3, 2023 verses or per cent in Q3 2022.
As we mentioned before in 2024 due to the I R. A related changes in the design of Medicare part B, which will eliminate the patient burden up to five per cent beneficiaries co insurance requirement, we expect significantly less need for Medicare part D patients to Utilise pop for Co-pay assistance edition.
<unk> net revenue was impacted by two points higher year over year gross Jeanette in the third quarter, driven by increased Medicaid rebates and 340 be discounts.
Total demand year over year decline to 3% when compared to Q3 of last year, which was our strongest quarter. Thus far total demand growth year over year for Q3 was negatively impacted by increased competition in the late lines in the academic setting in.
In the early a line we continue to make strong progress in Q3, 2023 exposure new patient chair mixed with greater than 60% in the second or fourth line, which represents approximately 20 per cent growth year over year.
This shift a mix of patients continues to drive higher refill use as earlier line patients tend to stay on therapy longer.
Furthermore, opportunity in the earlier lines is enhanced by the elevation of <unk> C. C. N guidelines to a category, one and now prefered regimen and the Lenalidomide refractory patient population in relapsed or refractory multiple myeloma.
This is meaningful in guiding treatment choices for physicians, particularly in the community and for patients progressing from regiments like the Darzalex Revlimid dexamethasone combination.
In addition, new subgroup data was presented at the European Hematological Association for my Faith, three Boston study, which showed that patients that are P. I naive or not previously exposed to a proteasome inhibitor and that are treated with X V. D showed in approximately tripling of P.
F S up 29.5 months versus the control arm V. D of 9.7 months with a hazard ratio a 0.29.
Patients are increasingly treated with P. I for Ya regiments like the Darzalex Revlimid dexamethasone combination in the front line, which constitutes up to about 10% upfront lying patience with the segment growing over time.
Multiple myeloma patients are living longer with the emergence of new classes of therapy expose your represents an opportunity for these patients to be treated with an effective a novel class if therapy earlier in their treatment journey and allow for potential sequencing in the future with other classes of therapies.
Our commercialization team is laser focused on sharing our new data sideline updates and leveraging the experience of a broad base of physician that have used <unk> to drive further use in an earlier lines all amidst an intensifying competitive landscape in the late.
Lines.
We reaffirm our U S. <unk> net revenue guidance of 110 to 125 million in 2023.
Let's now turn to slide 27 to review, how we are distinctly positioning expo viewing the community in academic settings in an evolving landscape.
In the community setting, while we do see competitive pressures in the late line with some larger accounts. The majority of physicians in the community tend to treat early a line patience and I'll looking for agents that are effective manageable inconvenient, we believe <unk> as a novel cloth that is an effective.
Manageable easily combinable and a convenient oral therapy fits the needs of the community well.
Furthermore, the M. C. C. N has recently updated their guidelines to recommend switching classes of therapy that patients have not been exposed to previously versus recycling. It can be anti C. D 38 class, which occurs frequently in the community.
<unk> combined with the elevation of <unk> of the a C. C. N guidelines highlights the importance of changing the mechanism of action with a novel class like <unk>.
A highly compelling new P. I naive subgroup data further strengthens our positioning in the community and the second to fourth life.
In the academic setting, where we're seeing the impact of competition from new approvals, including T cell therapies. We continue to build the body of evidence to demonstrate how exposure may be used as an optimal therapy with a novel mechanism of action pre or post T cell therapies.
Also the opportunity to launch S. P D. When approved up the lower dose of 40 milligrams could lead to the only all oral and potentially T fell sparing regimen.
In queue for we remain focused on <unk> in the community, which represents about 60% of our business and driving earlier line growth. While we expect further intensification of the competitive landscape in the late of lines.
In the mid to long term, we believe that the potential approval of S. P. D and further data generation around the T cell fitness space with novel combinations could unlock further benefit from myeloma patients with <unk>.
Furthermore, carrier farm has a tremendous opportunity for growth across multiple indications in the future and we look forward to leveraging our strong commercialization team and capabilities and a deep relationships in the community and centres of excellence for these launches.
These advanced now to slide 28, and I'll turn the call over to Mike.
Thank you. So on you during 2023, we have further reduced our cost structure to focus resources on our pivotal phase three trials and in August we reduced our workforce by approximately 20% including contractors.
[noise] steps further strengthen our financial position turned up for free ongoing phase three studies top line data readouts expected within our cash right away.
Now on 429.
Focus on the quarter's financial Harlots total revenue for third quarter of 2023 for 36 million compared to 36.1 million for the third quarter of 2022.
That product revenue from U S commercial sales or <unk> or third quarter of 2023 30.
<unk> $30.2 million compared to 32 million for the third quarter of 2022.
S. On your disgust net product revenue continue to be adversely affected by more patients using our patients Ah system program as well as higher growth cannot discuss.
Broken at discounts for 20 per cent.
Third quarter of 2023 as compared to 18% in the third quarter of 2022.
Turning to cough with our continued focus on cost management, we are pleased to be delivering a come on 12% year over year reduction.
<unk> expenses for the nine months ended September 30th 2023.
R&D expenses for the third quarter of 2023 35.6 million compared to 31.4 million for the third quarter of 2022.
Do you expect for quarter of 2023, R&D expenses to be relatively consistent for the third quarter, because we continue to invest in our three ongoing phase three studies with each representing a large addressable market <unk> patient with me.
We have reduced SG&A expenses in the third quarter of 2023 by 12% at 30.8 million compared to 34.6 million for the third quarter of 2022.
Cash or cash equivalents restricted cash investments as of September 30th 2023.
Total 209.2 <unk> <unk>.
Compared to 279.7 million.
December 31st 2022.
Based on our current operating plans, we are reaffirming revenue guns for full year of 2023 at fault.
Total revenues expected to be in the range of 145 260 million <unk>.
<unk> U S product revenue is expected to be in the range of 110 $225 million.
We're also reaffirming our expense guidance for the full year of 2023 as follows.
<unk> R&D, Kenneth <unk> expenses, which exclude stock based compensation expense is expected to be in the range of 240 to 255 million.
And importantly, coming to our cash guidance are existing cash cash equivalent some investments as well as the revenue we expect to generate from exposure your product sales and other license revenues will be sufficient to fund our plan of operations through late 2025, excluding maturity of our convertible bonds in October 2025.
I'll now turn to slide 30, some final thoughts from Richard.
Thank you Mike turning beside 31.
As we have discussed today, we are rapidly advancing or pipeline concentrating or investments in three phase three programs that are expected to read out through 24, and 25 as we work to create near and long term value for all our stakeholders.
We are well prepared for the next stage of growth as we continue to expand on our foundation and multiple myeloma with our proven commercialization and a late stage development capabilities.
I would like to thank our teams who continued to execute in a disciplined manner.
Drive each day for patients with high unmet needs.
Thank you again for joining us today, and I would now like to ask the operator to open the call up to the two and a portion of today's call.
Robert or <unk>.
We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
If you're using a speaker phone please pick up your handset before pressing the keys if at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then too.
At this time, we will pause momentarily to assemble our roster.
The first question comes from Peter Lawson with Barclays. Please go ahead.
Hi, My name is Shay on for Peter Thanks for taking my question.
Congratulations on the new M F data today.
Oh contextualize for us everything about getting that top line data from phase three of 2025, maybe with a more appropriate bar has to be looking at rather than just check inhibitor mono therapy.
And then secondly, you're just a quick question for all to next door and M. D S potentially.
Potentially going to get an update on development plans here is that still on track for something we could learn about more app in this quarter or is that something we should be thinking of Steve prioritized, Sir can I confirm at this point.
Thanks for your for your question I will turn to Rush me for that professional yeah. Thank you Sir <unk>.
A lot of excitement around you know the new M. F data that we are presenting today at the N P. In Congress and in New York, You know would only builds upon the impressive efficacy that we see with the combination of Selinexor and Ruxolitinib and this Jack naive patient population you know as you mentioned you know we've already presented day.
At week 24 for both S V R as well as P. S is 50, 79% a P R rate as well as the 58 per cent T. S. That's 50 right you know what patients and physicians really want to know is that how long are those S. V. R. N T S.
Data or or you know response is gonna last and that's the durability data that we're presenting today and what you see is a very impressive durability for both of these end points in fact as of the date of cut off of August 1st none of the patients experienced a radio graphic progression for either S. B R. R. T S.
50, so it again just builds upon the body of evidence that really suggest that this combination could be a game changer for patients who are Jack naive myelofibrosis and will continue to evaluate this is part of our phase three study right now the focus is very much on S. B R. T. S is 50 at week 20.
Before but as he mentioned will continue to look at her ability as well as multiple other advocacy and points that are relevant to this patient population.
In regards to your question about the appropriate compared her it still remains Ruxolitinib Ruxolitinib is the standard of care for patients who are Jack naive myelofibrosis, who have platelet counts above 100, so the.
Study design is appropriate and evaluates again the efficacy with this combination relative to the current standard of care.
In terms of your question about I'll connect four great question very enthusiastic about those data as well specifically observed from the phase one phase two study we have been evaluating connect four and a very hard to treat patient populations, specifically relapse refractory a higher risk M. B S.
Patients overall survival is very poor and that's patient population around four to six months and as we've Ah disclosed previously the survival that we've seen as part of both the phase one and phase two are very encouraging right nine to 10 months median overall survival we are in the process.
Set of optimizing our next steps in this program and look forward to updating everybody probably around the queue for a call.
Was there a follow up.
Ma'am.
That's it thanks so much.
Thank you <unk>.
The next question comes from Maury Raycroft with Jeffries. Please go ahead.
Hi, good morning, Congrats on the purpose and thanks for taking my questions. My husband is one on endometrial so for someone X R. As maintenance an enemy drill when do you think you could show the initial overall survival data from the <unk> Phase three study and then also separately how is the export <unk>.
His three and the the T. P 53, wild type patience enrolling and do you have a sense of how many patients are getting anti P. D. One therapy with chemo upfront. If you can provide any perspective on that.
Okay, Great question more it. So you know it's it's it's you know so we continue to follow overall survival. We are very excited we are going to be presenting overall survival data for the first time from the <unk> trials, specifically from the P 53 Wild type subgroup later this year so more to <unk>.
[noise] in the next couple of months.
Obviously, a key and point in addition to the progression free survival some more to come over there in terms of the question around the P. D. One inhibitors in combination with chemotherapy. So there is a new standard as I mentioned on the call. It has to start on the map in combination with chemotherapy followed by the Starlet Mad Nathan.
Keep in mind that the approval is only for patients who are in the morgue thief.
The fish it so they represent the minority of patients at only 20%.
The remaining patients.
R. P M M R. A proficient in their M. M R as well as T. P 53, do not have a new standard of care continues to remain chemotherapy followed by watching wait.
Got it that's that's helpful and.
Any other prospective into enrollment and how that's going and then also wanted to ask a separate question on multiple myeloma commercial you said there were approximately 20 per cent. There was 20 per cent year over year growth in second mind for my New start can you give us some color on how repo rates.
<unk> specifically in these early lying patients versus when you were just in the later lying setting.
Yeah, maybe I'll I'll turn duration might just to follow up on the trial question and so on your on the on the progress of multiple myeloma.
Thank you so enrollment is going well, there's a lot in largely that could you just from the enthusiasm around these data and I think that was highlighted most recently it as no you know a couple of weeks ago and spend a lot of enthusiasm largely because the benefit that we are.
I'm in straightening his again in the tie it in it need patient population that doesn't have a new standard of care that is translating to activation sites and enrollment onto our clinical trials. We in fact have you know 70 plus sites that are already active and enrolling patients onto the study. So the study is.
It's going it's proceeding quite nicely.
Tonya and I can yeah address my question around the 20% year over year growth. So when you look at our our mix of <unk> new starts over 60% of that is in the second or fourth line, which represents in Q3 year over year, a 20 per cent growth now the ship.
Into earlier lines as you pointed out is it huge growth driver for us.
Primarily because of the benefit of duration that we see that as we think about duration of therapy data as we've discussed previously the data can be choppy takes time to mature, but as we triangulate multiple data sources, we are seeing a nice upward trend.
In our duration of therapy and refills and this is largely driven by this increasing patience on the earlier lines Uhm and also better management of patients on the lower dose and supportive care.
Got it that's helpful. Thanks for taking my questions.
Okay.
Again, if you have a question. Please press Star then one.
The next question comes from call in to see with Bird. Please go ahead.
Great. Thanks, Good morning, and thanks for taking our questions first one on on multiple myeloma with the elevation of the N. C. C. N guideline recommendation for X B D to category. One can you help us to understand how much of a tailwind if that could be through the end of the year and then I have a column.
Yeah, Thanks for calling so.
Yeah. So as we think about the evolving competitive landscape and multiple myeloma expose your has become established as a foundational mechanism now this elevation from <unk> from category, one which used to be other recommended regimens to know category, one and preferred <unk>.
Regimens is meaningful, particularly in the community setting where it's a large driver of treatment decisions uhm, so notably the M. C. C. N guidelines need to update that were favorable for I spoke to you as I mentioned, one was recommending class switching again support.
A novel classes therapy, like <unk> as well as the the elevation of Expo V O L. K decks into the category, one and preferred status in terms of you know impact.
We we <unk>, we are not gonna see an impact overnight. However, with multiple myeloma. It is an area that is highly promotionally sensitive and we see steady growth over time. So we are excited that our field T. M is now able to actively promote this update today and moving forward.
And and we believe this strengthens our position in the community in the earlier lines.
That's helpful. Thank you and then for endometrial given the evolution of the treatment landscape with those Tylenol P. M. D. M M R and you're really encouraging results in P. M. M. R have used pre specified any sort of analysis and that's P. M. M. R. P 53, wild type P. G population for the ongoing phase three studies.
Yeah.
Great question call in so similar to see window in which you know we had and points looking specifically at the D. M. M. R vs. P. M Tomorrow will continue to do that in our ongoing phase three as well.
It's not a stratification factor, we assume that the vast majority of patients are going to be M. M. R. Proficient you know given the fact that they represent 80%.
[noise] insure balance likely but again, we will be looking specifically at the advocacy across these two M. M. R subgroups.
Great. Thanks for taking our questions.
The next question comes from Bear with Joseph J P. Morgan. Please go ahead.
Hi, there. Thanks to your question is necessarily on for Eric.
Uhm quick once in a while.
I was just going to be a combination.
In a stroke the.
<unk> I'm just move it goes on one of the rationales errors in terms of the combination with <unk>.
Yeah, absolutely Great question were really really excited about this novel combination.
You know just to give you a little bit of insight right. This combination was pushed for some of our key K O L. It's coming out of data Farber Cancer Institute, specifically, Paul Richardson. He just thought that this builds upon the number of combinations that selinexor has already shown remarkable advocacy in patients with multiple myeloma.
The other aspect that is intriguing to him, but also be M S and of course.
Fact that both of these drugs X P O one inhibition with solar neck for as well as this novel, so mud and Victimised as individually and potentially in combination shown that it can reverse T cell resistance and this concept peaceful resistance is of course, becoming more and more important for more.
People myeloma traders given the fact that they are now introducing T cell therapies into the multiple myeloma Arsenal cause. This novel combination potentially gives a really important tool to help with the sequencing of these therapies for their multiple myeloma patients.
That's helpful. Thank you and then just one if you don't mind quickly on the patient's system program kind of see the impact of the foundation Crouches I'm going forwards and then.
Of.
Oh, a medical <unk>.
The design.
Might be effectiveness and tried to Michael.
Yep. Thank you for the question I can I can take that so in terms of <unk> as we know we saw an increase utilization of tap a free drug this year due to foundation closure is now your to date through Q3 the impact of <unk>.
Has been roughly $5 million to $6 million, which includes about a one to 2 million dollar Pap impact in Q3 Uhm.
Uhm now in Q3, there were two of the foundations that were open and we as a results on new patient starts in <unk> normalize, but the refill impact remained now in queue for these two of the four foundations remain open to date.
And we anticipate the Pap impact being very similar in queue for as it was in Q3, assuming the foundation dynamic does not change <unk>.
As we move forward into 2024.
Where we are encouraged by the the I already related change to the design of the Medicare part D, which eliminates the patient to burden of the five per cent beneficiary co insurance requirement and we expect therefore significantly less need for these patients to utilize.
Patient assistance program for Co-pay assistance.
Alright, so I'm thinking of questions.
Again, if you have a question. Please press Star then one.
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 operator, and I drove one for joining us today as I mentioned, we were well prepared for the next stage of growth as we are continuing to expand on our foundation of multiple myeloma.
Proven commercialization late stage development capabilities.
As we continue to rapidly advance our pipeline concentrating investments in our three phase three programs that are expected to read out through 24 and 25.
[noise] worked to create near and long term value for all stakeholders. Thank you for joining and have a wonderful day.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
[music].
[noise] Goodbye.
[noise] [music] [noise].