Q4 2019 Earnings Call
He stepped by an operator will be with you. Shortly please be advised that your information presented in accordance with the Canadian personal information protection acts.
Okay.
And.
That France Center, how May help you.
Hi, I would like it like to connect to beyond Springs.
Certainly your name.
Rich I'll Smith.
Right I have your phone number list, but as 973 206 366 is that correct.
Could you put two one tool.
960.
Rich.
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Mm Hmm.
Well I've Oh.
Yes Walsh.
Fifth beta testing quick one called several Premia bunch in a couple places all over the watch.
Well, Yeah education. The current standard of care is <unk> <unk> as well not so deep.
Would you like that all I'll throw being the Mckenzie either.
I've been using your lifestyle.
About 90% of patients was high risk chemotherapy developed grade three or four neutropenia.
What's your cars the chemotherapy those to be would do.
The next cycle to be delayed.
And all that much.
To be downgrade that all the time it ought to get all these days affords me.
Oh this resolved.
Specifically, reducing survival rates for patients.
And have 11, when combined with you said that <unk>.
I didn't say would do the occurring all Israel for neutral P. young patients.
Which leads to stable with those that's the thing cycles and.
The same courses of chemotherapy, resulting in better survivor.
Yesterday, we announced that boring discussions with U.S. ft.
We have formally changed the probably I'm quite well the study a wankel sick So street superiority clinical trial.
Neil primary endpoint measure is right Oh prevention of waste for neutropenia in the first cycle chemotherapy.
Good believed that this meal primary endpoint.
Which is more kinda unquote irrelevant and more robust well set new standards shoot me about a secure ari to what's yet.
The primary endpoint what is that any indication has evolved over the last 30 years.
Got it always stuff that wouldn't be keeping l. age when you put your whats compared to note, though beat.
Formal by yes, San Diego true ups of into tripping out as a good sound a lot than the last summer and south them. A lot you said, that's nine CRD trials.
Sure effect, a meals to parallel so be it was habits and that's a meal and plunge what's needed to better evaluate concourse, yeah and chips or arty.
As such this is a timely advancement in clinical trials fine for our program.
We believe that the complementary mechanism of action will come out with him and he said that including you last fast to stand of care.
And it resolves all all of cone called trials to date, the just the high likelihood of success.
It's successful the Phenomenons she says that combination with its superior and a record Oh, that's protection from inspection will Mark the first depressant nice nice in preventing neutropenia in 30 years.
Our second phase G indication is in second and third line non small cell lung cancer with patients who are you just saw light type.
Which accounts for 85 cents of western patients.
Yeah. There are few approved therapies available.
Treatment option have a mother median overall survival rate of eight to 10 month.
Was there a diverse events such as future P. now and if the quality of life.
No problem in combination with dotted pack so with its unique mechanism of action can potentially improve patient survivor and at the same time reduced neutropenia caused by bus attack. So the standard of care.
Looking forward.
We continue to view phenomenon as a pipeline in the truck.
We believe that inappetence conforming potential in combination with PD, one PD L. One antibodies.
And maybe Asian, all chemotherapy to cheat multiple cancer types.
It's triple combo approach Optimizes, the dependency of immunotherapy activation all chemotherapy generates tumor antigen phenomenons PC maturation is that optimizes the present patients Oh, there's too much as a gen. Two cytotoxic T cells.
And checkpoint inhibitors nagel, the activated T cells to kill cancer cells.
Other wars and happening that's on the cats.
Okay, PV why they need to a break.
Were confident that a triple combination approach could prove to be a powerful cocktail.
Canceling the HIV cocktail therapy, which transformed HIV from a settlement disease to a chronic disease.
Good patients able to achieve normal life expectancy.
Second Oh.
Oh, Okay, let's say that is supported by strong scientific rationale.
In terms he matching phenomenons highly differentiated the mechanism.
It was published in peer review journals.
According to sell structure on those.
Further validating its potential as a potent pizza activator suji at each one activation and a DC maturation.
It'll also showing that the G and H, one hi, stepping into a tumor has long ago survivor and those with low signature.
In addition to have an exhibit early protection well neutrophils seems bone marrow.
Yeah and effects have been shown in multiple chemotherapy.
In my model.
This gives us the some type of foundation well, it's yeah indication.
There's publications out of is out.
Our effort to over five years by collaborating with leading scientists on over the ward.
Including from mass General Fred Hutch, and the Universal Basel.
Sorry.
The results Oh War efforts in 2019 has positioned B. I was growing well for the next 12 months, enabling us to leverage the regulatory milestones in multiple India falling in China, and the U.S. show off the largest pharmaceutical markets in the war.
Yeah.
This is first validated by our initiating the rolling NDA submission, but yeah and indication in China up in the first quarter of this year.
We expect to submit for the Guy indication in the U.S. into second half of 20 to 20.
Well also in frequent dialogue with regulatory agencies at a plan to submit and be a.
In the U.S. and you try not in the next six to 12 months.
Well no more than injured patients have thing she beds with panopolys globally with good possibility.
With me the safety database requirement for the U.S. at CA and try not npis.
Additionally, timetabling has so many for granted patents, including fixed jurisdictions, including six taking shoots U.S. patches, which protection through kind of 36.
Therefore, we believe that phenomena has a long runway to realize its commercial potential.
I'll now turn the call over to Dr. rebel my high level score to start Oh, This and clinical development in more detail ramble.
Thank you long.
Yes, I would like to recycle due to a registrational trials for NAV Lynn.
I will start with Saudi swung far from normalcy.
Which evaluates inappetence Fixie incrementing see I am.
We reach alignment with both the U.S.N.V. and China National Medical product administration and NPK.
On the fact that these so these would support abroad see I am label for.
For all kinds of Oh.
Oh people therapies combined Threed G CSF.
Freezes data from study Swanning farce phase two portion demonstrated that the NAV them given as a single dose cycle on the same day of chemotherapy.
It's not only its effectiveness velocity.
It also cost is much less will pay.
On improved quality of life and office superior immune profile compared with a lot. So.
It also has the benefit regarding thrombocytopenic.
As such for Navios long G CSF base unique mechanism of action.
Actually makes its complementary to the losses in preventing see I am.
Additionally, previous topline data from Saudi one of them six phase two portion of this trial.
Just a significant improvement in the secrecy.
When everything I see I am.
The significant decreases the perception so pieces were experiencing grade three or four see I am.
More than 90% reduction in patients experiencing bony pain and to reduce potentially immune suppressive scene of course.
When adding to navigate to the standard of care.
Islam mention on Wednesday, Vietnam Stuffy this whole speed the U.S.M.D.A.O. Whos primary endpoint change.
For the still do you want to six phase three superiority clinical trial.
The new primary endpoint this measure by the census patients, who did not experience grateful and use opinion.
We believe this new primary endpoint.
It's more clinically relevant and so you send it to evaluate superiority in CRM.
With the predominant velocity combination.
52 boys samples patients we are protected so grateful need to be huh.
To assist 40.9 person.
<unk> G CSF.
A 53% increase protection compared to last alone.
The improvement the great for me to Pena seed visit to navigate the loss of combination.
Even more important today's health care Harlan.
Due to the potential impact of closer to 90 on the immune suppressed patients.
Patients or monotherapy Dcs, that's typically experience great.
Three and four see again by the seven.
[laughter] infection and simultaneously compromise to do chemo regimens.
The phase three portion of so do you want to see.
We will compare to Mab then that's a four milligram fix those combined with six milligram of Neulasta.
This is six milligram of Manassas alone.
In a double blind study.
We enrolled the first spaces in October 2019.
A pre specified incident, they told me, though expects to incur losses to fall trendy.
And the final data will be though is expected in second half 2020.
We do not anticipate any impact on this time line due to cope with 19.
The data generated today suggest that can happen office novel approach to professing CRM and bumping in patients receiving chemotherapy.
Minimizing the to Kenya and growing pain.
A lot more pacing through the C.
Who goes off chemotherapy and complete the Friedman.
Blind. The addition of can imagine introduce yourself as a potential to significantly improve the good see again standard of care.
Which was so better efficacy outcomes facing quality of life.
Yes, I call for those implementations benefit into C.I.N. indication as this affects christening demonstrate in five independent clinical studies so far.
Number one.
In Saudi Warner Wong from them or reduce the incidence of graceful disappear.
33.8% isn't those fill alone arm.
To less than five.
In the permanent plus those.
Go stuck sell our.
He left an old 0.0, all three on day, eight Oh, sorry cool chemotherapy.
Cycle won't see it's the lowest point it needs to fill Carl after those sell those.
In the wrong harmless to be a patient savi born on three.
Perhaps reduce the incidence of great for me to be Ya.
From 27.47.
In the dose so alone arm to 3.1 person.
In the for them close those fill our.
Be lessen zero point.
General Zero zero Wong.
They eight of the sales cycle chemotherapy.
Number three.
In the phase two portion of Saudi model for.
Both from them and have also.
Have a 14% and then I'm grateful and due to Kenya.
It's a matter of demonstrated superior safety profile, that's smoking less on both sides senior.
Lets immune suppression.
Non before.
In the interim analysis of the phase three personal style do you want on pause.
And then a teas.
Oh, and two years duration or see I hate to PGR DSMB.
And more rapid onset of action compared with the loss though.
Non before.
The phase two portion of Saudi Renault suits, the put an avenue Lhasa combination <unk>.
Increased the rate offensive grateful to pena to 62.5 person.
From 40.9% in their lost some monotherapy.
Demonstrated superior safety profile flexible pain.
It enables patients to stay on the optimal goes off chemotherapy.
Second.
You don't see study will increase for non small cell lung cancer.
It's a five on the 54 patient phase three Registrational study.
Evaluating the anticancer effects can happen in combination with those accel compares to dose accel alone.
And second access line non small cell lung cancer.
We are the primary endpoint of median overall survival.
To date, we have enrolled over five homes patients in the U.S., Australia and China.
And the somebody has to pre specified interim analyses.
The first this won't fearful of patient that's the chiefs.
And the second.
Just to true of patient that teas.
In early 2019, we reached the first interim analysis.
And the data safety monitoring board or the SMB.
Recommended that the trials should continue without changes to the protocol pre specified number of patients.
The final so most of the trial that is definitely fan of form of 39 patients are expected to be available in the second half of 2020.
Additionally to that Vince Foster clinical results and mechanism data.
Had been percents in real clearing conferences.
Process ESCO ass.
Hi, Yes, L.C.S., most it see ESCO sissy and a CR.
With that I'll now turn the call over to rich.
I will discuss our commercial partnership Fran.
Great.
Thanks for Mike.
It's clear that there's a need to address the treatment grab surrounding see I am.
Today, I'd like to exercise a number of points that support our case as well as the impact that cobot 90 is having on cancer care and the potential role that Natalie could play.
First I want to applaud remote and his team for their leadership vision in the design and conduct at the tablet Skagen clinical program.
Beyond Springs approach to addressing see I'm has been to move beyond supported care.
Pivot toward proving cancer care.
Dennis data generated to date demonstrates that pineapple and has the potential to deliver on this promise.
As discussed previously C.I.N. remains the number one reason for modifications and chemotherapy care.
When white blood cells dropped to dangerous levels oncologists are forced to alter care.
As mentioned before we call this before D.
Hey ships are forced to decrease their dose for even delay downgrade or discontinue therapy.
The results can be devastating for patients.
It's really minor changes in care could result in significant changes in outcomes.
For instance, a 15% reduction relative dose intensity or already I can reduce overall survival by 50%.
Additionally, just 15 days of delay in delivering chemotherapy over six cycles in breast cancer patients.
Could result in a statistically significant reduction overall survival.
We believe that can add one has the potential to go beyond supportive care.
We believe that benevolent when used in combination with G CSF.
To prove compliance and persistency with chemotherapy and potentially improve cancer care outcomes.
Next I'd like to address the environmental changes that we've experienced in the recent weeks due to koby 19th.
Got it expanded to see I end market.
According to our two year patient visits Sean colleges are down 20% nationwide since the pin debit kids two to social distancing guidelines.
This is not unexpected sits cancer patients are among our most susceptible citizens.
Many that patients are experiencing pandemic related for the adjustments if therapy.
That is they're being forced to decide between GAAP downgrading to less effective treatments delaying treatment or discontinuing treatment to avoid exposure and infection.
The result is likely a poor cancer outcome.
Depend delek has exacerbated it already unmet clinical need.
In recognition of this the national cancer comprehensive cancer network or NCCN acted quickly.
Treatment guidelines promulgated by the NCC again for the profile access to see I had been dramatically expanded to begin to address the situation.
The NCCN guidelines historically recommended prophylactic treatment for patients at high risk of developing sat yen.
According to our research high risk segment represents about 32% of patients receiving chemotherapy.
As a result of these guidelines the C.I.N. market generated over $9 billion in sales annually.
Globally, we estimate that approximately 4 million cycles of gcs effort given annually.
Due to covert 19 pandemic NCCN recently updated its guidelines recommending that intermediate risk patients be considered for prophylactic see I am therapy as well.
Intermediate risk patients make up approximately 37% of all patients undergoing chemotherapy.
Yeah onscreen team is excited that that Adam has the potential to participate in improving the care for these patients as well.
As we've stated previously monotherapy G. CSF are not sufficient to ensure the cancer patients will get the chemotherapy regimens that are necessary to optimize their therapeutic outcome.
The data are clear.
See I and remains a significant obstacle to optimizing chemotherapy cancer care and potential outcomes.
Our data indicate that benevolent has the potential to improve on the standard of care positively affect the lives of cancer patients.
Particularly those who require prophylaxis of C. I am by transforming the four days into the four ounces.
And a four assets are stable doses.
The same cycles strongest regimens and staying the course of chemotherapy.
Finally, I'd like to provide a high level overview of our market research on can add one.
We reviewed our clinical results for can add one G. CSF combination with 100 and Ted U.S. based practicing oncologists.
Not only did the oncologists recognize the unmet need and therapy.
But they also had a very favorable response to combine internationally with G. CSF for the benefit of their patients.
The top three benefits for these appear to have one plus do you see ourselves for the encore oncologists, we just talked to we're number one.
Cree seem to mediate absolute neutrophil count or T. N C. This was very important.
Number two.
Reducing the bone paid associated with the monotherapy G CSF.
And number three let's see ability to control the relative dose intensity of chemotherapy.
Also more than 70% of oncologists stated that they strongly favorite the combination of Seattle and plus G. CSF over monotherapy G CSF.
And 65% said that they were likely to use accommodations for the benefit of their patients.
Our data generated to date demonstrates that pineapple and plus Dcsf combination represents a significantly better option to the current standard of care.
Complimentary mechanism of action of both benevolent N G CSF allowed for a speedy on says.
Longer lasting protection superior absolute neutrophil count and reduced don't pay for patients.
The key takeaway is that we have the potential to set a new standard of care for C. I am with this powerful combination approach.
Just to recap.
A combination approach provides a significant number of benefits for clinicians patients and payers, including.
Significant reduce neutropenia with a goal of driving to stable sustain cycles to enable oncologist to optimize chemotherapy for each patient.
And improve the own paying profile to ensure improved therapeutic experience at the potential for greater persistency.
Clinical data that suggest anti cancer activity.
And finally, hi, receptivity among oncology community to advance the standard of care to traveling plus G. CSF.
Given the global nature of our trial and our strong ongoing discussions with key opinion leaders in the industry.
All of this continues to build the case for example in as a potential game changing therapy and cancer care.
By developing today I'm going to work with and enhance G. CSF therapy goal is to allow H.C. piece to provide stable chemotherapy doses sustain chemotherapy cycles and the most affected chemotherapy regimens possible.
As we prepare for the upcoming data inflection points, we are well positioned to maximize the value of tablets, both in the U.S. and abroad.
Well go to market strategies.
As we will file for that went in China in the U.S. for our U.S. and global commercialization plans, we are aligned with our development regulatory timelines.
We're taking the steps to ensure that we can successfully launch I commercialized in Atlanta.
With that I'll turn the call over to Edward who will provide a financial uptick Edwards.
Thanks Rich.
Oh, no briefly discuss our fourth quarter 29, chief financial results.
Well grid or details related to these results and our full year 2019 financial results I refer you to our press release issued this morning, and two or 6K filing most of which can be accessed under the investor section of our website.
With that said Oh, no highlights some of the key numbers.
R&D expenses in the fourth quarter or 29 team were 12.6 million compared to 13.3 million in the same period of last year.
The decrease of 0.7 million was largely attributable to your point 5 million decrease in clinical trial expenses and 0.2 million decrease in noncash share based compensation.
She is a expenses were 2.7 million in the fourth quarter of 29 team compared to 2.3 million for the same corner.
HM.
The 0.4 million increase was mainly due to increased employee salaries and welfare.
Net loss attributable to be osprey in the fourth quarter or 29 team was 14.1 billion compared to 14.7 million for the same period of last year.
Our cash balance at the end of Q4 was 35.9 million.
We are confident that our current cash resources are sufficient to support our clinical trials and Andy a submissions in China and the U.S. Fulton Ablin for both C.I.N. and non small cell lung cancer indications I.
So as to advance our immuno oncology pipeline and it took a nation protein Degredation research powerful.
With that I'll now turn the call back over to launch to conclude.
Uh huh.
That add to watch.
I'm sure you agree we're extremely proud of all clinical development outlets as applaud payback that further validates some abalone favorable got scope out to improve cancer care.
And now that is the only novel agents in the amount of money that combine both the anti cancer and see I am prevention potential due to its very unique mode of action.
Okay I had.
We expect money imports in Bay, Bob and regulatory milestones in Twentytwenty.
Which well transform costs I'm, a cone costs stage company to a commercial stage company.
Together with our shareholders investors and partners were working hard to continue to create value and deliver innovative medicines to patients was severely unmet medical need all over the barge.
Especially doing cobot 19.
I look forward to keeping you updated a progress toward that goal in the coming months.
Not yet open to questions. Thank you.
Thank you.
We will now begin the question and answer session.
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Our first question comes from Murray Wright Croft of Jefferies. Please go ahead.
Hi, Good morning, everyone and thank you for taking my questions. Congrats on the endpoint change it seems to make sense in could be an important.
Oh important updates to the program I'm wondering if you can talk more about the background at par. The endpoint change came about I guess for example was it based on feedback from advisors Ftn advice or from the broader market research that you did.
Yeah, well make a maury I can start answering your question. So how did you say that yeah, just I thought that the only I spend a cap can take something like 40 years.
I would keep that that it's I mean, I'm quite happy evolving in the last year's starts, which Oh I get your opinion right right and if you put can compare to know Sir beat and later in 2000, when you're not has to be approved and I'm just that spend.
<unk> energy, Oh, so too to get a new problems and play which is the duration of Sibanda chips and yeah I stepped primary endpoint it because it's a very good cough and cold. So you can have fewer patients to the couldn't put together and they also have to spend time to probably late.
Yes, and what does that accelerate so currently as you see a the data Ken it's a very good primary I'm quite well the nine tragedy trials like I talked about seating effect was the T C plus yeah gosh that's.
It's concentrate that the I say is around 1.2 days. So there is a pretty high ceilings and it's very hard to it. It's good what can make it better down one point today.
Yeah, that's capital city swap so with all right discussion with our key opinion leaders and also probably also from I'm actually Mr. Trump best position. We had some discussion please which was an FDA because actually no keep does that still did not.
Meet the amendment to me, it's all about quit for you to Kenya and wait for any chipping Yeah sure literature research. It is directly correlated to infection as an organization.
You can also attached.
And that for you guys have current.
Yeah.
Okay.
83%.
My name is trips that so that give us up its ranch reduction yeah for our combination it's achievable. So if we can't cheap that then you have a very good hey, we see number like what does tradition touching a you know what she's going to maintain Uh huh.
Yes, let the immune system and that also kick in April that chemo does Oh optimum survivor benefit. So that was followed the you know history and also our thinking and that also we have a lightweight you know F.D.A.O. currently so probably actually.
Oh, so actually launch added fuel Oh warts today.
[laughter], yes, Thanks, you love.
So I would like to.
To state that we are fairly confident that we will also see it benefit.
With the S and did a combination over mono therapy alone.
Oh, that's actually probably more important it sets up the concept of DSN.
Not only has.
Has been poorly understood.
By.
The scientific and medical community.
It also but by the computer through community DSMB concept, it's very difficult to understand.
The concept of having no great for Q2 opinion at all avoidance total avoidance of great for the Kenya.
And that you have more patients with total avoidance of grateful due to P., Yeah, we had a combination of financing and pick servicing.
That is so much theater, Oh fault for physicians scientific community, but also from a computer show a status. It does not only clear that also more impactful. So so so those are the arguments that that we were able to convey successfully or two.
To the FDA and and.
The willingness to discuss to discuss it off this change in primary endpoints. Thank you.
Got it does very helpful.
And then the second question I had was I just wanted to clarify in the press release yesterday. It said a robust plan will be submitted to the FDA to perspectively validate this new primary endpoint.
I guess is that plan finalize a when will it be submitted and will it be validated before you eventually filed for approval just to clarify on that.
Oh, sorry, if I can just quickly I'm sure. There's still just has been submitted actually [laughter].
Yeah. So it's really it's to validate that place when you took t. Oh, no big money to pay a holiday delay to the kind of coke consequences of Uh huh.
Such as.
Sean a fan authorization and that's still at those kind of.
You know, how she says and I will be well be able to okay. That's from our perspective from a wild stake study and also what do the integrated that's it because she has done really two or something like this.
Got it so in the one of the six results, though that will basically validate the plan then.
Yes.
Okay, Okay and then the.
Last question I had was just so we're looking forward to the one or six update and in your Threeq. You 19, a press release you stated the study one or six read out would be a final read out in the first half the 20, but in the press release today. It says the 106 update this quarter will be an interim and so I'm just wondering if you.
Could explain the change and talk about what specifics we could see in the interim update this quarter.
Yeah, So probably I can't answer I guess, how quickly Seth. Thanks, so much what does great questions. So.
Currently I think our timeline is for the because of all of those are very important I'm trying to get to this interim analysis that she also state or is the primary endpoint.
Endpoint trench shoring up currently the timeline is well stick say street interim Oh like 120 patients will be done this quarter, which is quite a too and then the final well be done the second half of this yet.
Okay, and then the update this quarter, what should we expect what kind of specific.
Measures should we expect in that update we recorded.
So well I've used here was the Dutch boy, the new primary endpoint that stuff I blame Stearns and prevention always wonder tripping yeah.
The primary endpoint, which search and Peter.
Right. So it would probably say, it's all the detail data for us for scientific conference.
Got it okay. Thank you very much up taking my questions and congrats again.
Yeah. Thank you so much Mario Thank you for your support.
Our next question comes from Andy Hussain of William Blair. Please go ahead.
Excellent. Thanks for taking my question hope everybody has to be on spring as well and staying healthy.
And Ah Onez congratulations on a great here in 2018 so.
So I have a couple are probably more related to the non small cell lung cancer. So I think relocated talked about the first interim looking into final.
Analysis timing just wondering where are you are in the second second interim analysis.
I think last quarter, you mentioned that the number is then.
Actually trigger the second analysis of so any sort of information that you could provide would be much appreciated.
[laughter] yeah.
Probably I can start and Ramon can add to that so we have reached our second.
Interim analysis, what the non small cell lung cancer I'd actually event.
So well have oh, yeah can be needing a soon and I wish that stands at the SMB, Oh, where we can as a company. If we really cannot it's blinded to us that actually cookie data. So what's the meeting they were advised us to you don't go forward a notch they found a africa's Dan.
So the safety data so that's all we can't say.
Well you have anything to add.
Uh huh.
Thank you long I have nothing to add thank you.
[laughter].
Okay. So I also have a related question then and.
I don't know if this has been that it's got before but in the enrollment for Dublin, three easy as far as mutant patients are excluded and that's a little bit different from other second line studies that we've seen given the fact they could have.
Already received.
Yes.
Drugs that typically address the side you know driver mutations so just curious.
About the decision to exclude these patients.
As you probably I can start I'm does so as you know that currently Teekay eyes, you know that I gave rise to pick where I suppose you're very good just what the each outside mutant population right. So that you all 19th they're really not the that's a more severity unmet medical need wish that each I felt like.
Okay sense, if you look at the two most study touchy about actual was worse in the overall survivor, but it's just thought you pack. So in that you just saw why type patients and Meanwhile, you know each of my why patients what type patients can you know, it's not considering about 85% after watching population. So you know our oh.
You know a judgment, we just think that lung cancer I wish each I felt like type I bought severity on that competes population those other patient wouldn't you to.
Good bad about eight to two helped so that's one of the rationale why we only for of course funny jump out why tech that's definitely Oh. So you know just although trial.
There's a difference in the percentage of teach out five intense why type you know king Duff different actually Mississippi. So for the why some patients each outside light type is around 85%, but in the Asian population, it's a it's around 70% and the pension, which she shopped Fabio to that you're.
That much longer than that each outside why type patients. So it's why do we have global trolleys would do not you know gets we do not include well. If we do include the each outside mutant patient data.
Yes, so that's a day that would be very [laughter] very hard to another.
Also you know you just luck you attend yeah, there's a much longer so the study is going to me like long too.
[music] concept. So that's our recent make quite well only hockey team to each outside light type patients.
I don't like if I answer your question Pete.
Yeah, I know that that's it that's actually a perfect answer thank for that so last question I had a you know how it has to do with the endpoint change. So a lot I think you kinda talk about the goal of kinda positioning snapple and as you know.
All cancers.
It's basically a broad label and.
So so help us understand the endpoint teens for one of those fixes that going to impact.
105, as well as you're waiting for the final analysis.
I'm just curious because you know ultimately you have to.
Put all the data package together.
You know as one so that just curious if if you're planning on continuing.
The duration for.
Duration and point for.
For one of five and then.
Under the new endpoint for one of six or you're going to combine them together into one.
Yeah. So that's a quick question. So as you see that so wildfire, how many employees not gonna changed because wildfire is up now he's already trial right. So yes that is not good I'm quite well non inferiority child, Oh, so it's not going to change only it's going to be can.
In the Wild states because that is the shipyard Richard Count was a new regime, which has.
Potential to improve care I can we need the more clinically relevant and more robust endpoint to measure that superiority. So it's only going to could change in the while six.
I see okay that makes sense all together yeah it to five yeah.
Okay, great. Thanks for taking all my questions and congratulations again.
Gosh I saw your great question Sandy.
Our next question comes from Christopher Marai opinion, Laura. Please go ahead.
Hey, good morning, Thank you for taking my questions. So congratulations on your update its great progress.
Number one just to clarify either the change in the in the primary endpoint on study you want to six which was that based on an F.D.A. request or did you initiate this request.
Oh I can say, yeah, we will initiate the.
There's just discussion with FDA.
This is all about you know yeah, yeah, it's Josh.
But we did discuss it with some extensively.
Great in terms of also you know obviously you know study one of the side.
There's been an interim analysis and you have additional data.
Have you been able to look at that with respect to the new one point I know to different studies on in combination, but in terms of prevention upgrade work.
Neutropenia, how have you have you.
Any data from that one of five phase three studies that might be relevant here.
Oh, yeah. So it's like we're doing okay, well [laughter], so that the wild five phase three well pad Oh place right on the Tropeano raging debate first week, which is the.
Well on the show at the early onset of action to would do see up kind of set there as well.
Yeah, we have less Cleveland neutropenia opt to San touching the first week.
Even though <unk> five study persisting imagine that buys shops. So you see a rapid onset that's right. So that's like a better this out.
That's what the primary endpoint, but not changing its guilt yes.
Got it.
Okay and then.
Do you anticipate to two also in your U.S.
Da filing include data from the interim data from one it was six.
As long as obviously the Wanna five you I think previously planned to to submit for approval.
Yeah. So as a quick question. So it's always hard towards the U.S. SK.
Approval for a broad label, we always have climbed to submit <unk> five and a long six data together 'cause. It takes two studies to to validate Chile, they'll both be combined to submit.
Okay, and then and then just with respect to that then.
On the one it was six interim will you report the DSMB endpoint as well as your your new primary.
Well I don't know if we can at this moment because those are they the interim I think the that.
That's great well.
I cannot [laughter] never to to just say because it's going to be being discussion with the independent statistician, but were confident that you know the top pretty funny Chipping away does actually is a more robust.
Right if it meets yes, I should meet as well.
Okay got it Okay, and then any any progress I'm with you regulators on the path. It you know how does is this endpoint, perhaps work with that process.
Yeah. So you I think all were strategy is to first filed for U.S. and China out for that to you is Oh, we have plenty to have meeting was yesterday and then talking to them about college studies that of course now is coogan emptying. It's it's it's Uh huh.
That does [laughter] hard to meet with anyone so that it is Oh, you know it seemed a planning to discuss what set yet me.
Okay.
Excellent and then.
I guess me he recently presented some new data.
That highlights put out feelings ability to prevent tissue iron overload. So is there any plan to initiate a clinical study around that around that observation I'm trying to see helpful in central.
These isn't.
Oh, probably also relatively low hanging fruit like see I N.
Maybe walk us through how you'd like to.
To explore that data set more clinically.
Oh, yeah, so probably I came back remote to comment on this but we'll have to US right. There's a indication yeah no.
Thank you yes. Thank you.
Yes, we certainly have plans should indicate.
This is low hanging fruit follow.
This is an additional benefit the team they have an office.
Into chemotherapy setting so with people from P.S., we know a common side effect is at least opinions.
And that's for the the to Nambla indication in Cheyenne comes in.
Oh, the equally important seasonal a club unscientific people therapy is myelosuppression <unk>.
That often leads to anemia.
So not only due to pena, but also anemia.
The anemia, then typically in chemotherapy patients is addressed by block transfusions, and most cancer patients they have to dangerous and chronic blood transfusions over time.
I mean look transfusions patients get iron overload, because then the block.
In the patient degrades into Iran becomes freely available.
I haven't that sits in tissue, Dan creates iron overload and tissue damage.
So from that one has a fairly broad.
Oh.
Benefit.
Patients receiving chemotherapy, we we emphasize the emphasis couldn't TCIL use opinion for Finch.
With Dan we have all these additional benefits so be it kind of chemotherapy into India, India I have all flows.
Nabbed and then also will have said.
Major benefit this is fairly around listen this is a fairly rather from finding with tenacity because we see increasingly the trends is is that a cancer patients live longer.
I'll now cancer patients also oh, well in cancer, if they see the also combined chemotherapy with immuno therapy.
Therefore pace is increasingly live longer the trend no be comps for cancer patients to can live longer.
If then the patient had.
[laughter] software has been exposed.
Iron overload you two blocks transfusions.
That's the impact is quality of life over time.
So with viscosities increasingly living longer.
Our attention real real Swift to how then.
Can they live longer it's a high quality of life with the lowest morbidity overtime.
I haven't overload reduces morbidity overtime and we see here the benefit that plan also was especially <unk> and the for office, it's a fairly big advantage.
Looking forward.
Excellent. Thank you for the comprehensive though.
Apply I appreciate that and congratulations on all the progress.
Hi, Thank you saw nice Chris Thank you for your support and Youre further questions.
This concludes the question and answer session I would like to turn the conference back over to Dr. Wang for any closing remarks.
Thank you so much the audio president and in fact what question.
And also thank you for our that makes a nice to our call.
And I hope everyone has a nice day and domestic starwood. Thank you.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
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